Page Range | 73087-73629 | |
FR Document |
Page and Subject | |
---|---|
80 FR 73232 - Sunshine Act Meeting Notice | |
80 FR 73201 - Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2016 | |
80 FR 73265 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: B4UFLY Smartphone App | |
80 FR 73268 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Pilot Schools-FAR 141 | |
80 FR 73267 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Operating Requirements: Commuter and On-Demand Operation | |
80 FR 73187 - Notice of the 2016 Presidential Transition Directory | |
80 FR 73265 - Culturally Significant Objects Imported for Exhibition Determinations: “Titanosaur” Exhibition | |
80 FR 73266 - Approval of Noise Compatibility Program, Ted Stevens Anchorage International Airport and Lake Hood Seaplane Base, Anchorage, AK | |
80 FR 73266 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Dealer's Aircraft Registration Certificate Application | |
80 FR 73208 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Yankton Sioux Tribe and the State of South Dakota) | |
80 FR 73200 - Agency Information Collection Activities: Employment Eligibility Verification, Form I-9; Revision of a Currently Approved Collection | |
80 FR 73161 - Wireline Competition Bureau Extends Comment and Reply Comment Deadlines in Business Data Services (Also Referred to as Special Access Services) Rulemaking Proceeding | |
80 FR 73229 - Federal Advisory Council on Occupational Safety and Health (FACOSH) | |
80 FR 73193 - Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry; Availability | |
80 FR 73194 - Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability | |
80 FR 73104 - New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct | |
80 FR 73264 - Culturally Significant Objects Imported for Exhibition Determinations: “Keir Collection of Art of the Islamic World” Exhibitions | |
80 FR 73264 - Additional Culturally Significant Objects Imported for Exhibition Determinations: “Power and Pathos: Bronze Sculpture of the Hellenistic World” Exhibition | |
80 FR 73264 - Culturally Significant Object Imported for Exhibition Determinations: “Jan Van Eyck's Crucifixion and Last Judgment: New Discoveries” Exhibition | |
80 FR 73187 - Information Collection; Simplifying Federal Award Reporting | |
80 FR 73212 - United States et al. v. Springleaf Holdings, Inc., et al.; Proposed Final Judgment and Competitive Impact Statement | |
80 FR 73268 - Proposed Agency Information Collection Activities; Comment Request | |
80 FR 73168 - Pacific Fishery Management Council; Public Meeting | |
80 FR 73168 - Grant of Interim Extension of the Term of U.S. Patent No. 5,808,146; fluciclovine (18 | |
80 FR 73182 - Application To Export Electric Energy; MAG Energy Solutions, Inc. | |
80 FR 73191 - Request for Nominations of Candidates To Serve as Members of the Community Preventive Services Task Force (CPSTF); Reopening of Nomination Period | |
80 FR 73230 - ZionSolutions, LLC, Zion Nuclear Power Station, Units 1 and 2; Partial Site Release | |
80 FR 73229 - Advisory Committee on Reactor Safeguards; Notice of Meeting | |
80 FR 73269 - Proposed Information Collections; Comment Request (No. 56) | |
80 FR 73162 - Shasta-Trinity National Forest; California; Trinity Post Fire Hazard Reduction and Salvage | |
80 FR 73162 - Francis Marion-Sumter Resource Advisory Committee | |
80 FR 73171 - Revised Non-Foreign Overseas Per Diem Rates | |
80 FR 73246 - Notice of Public Meeting of Presidio Institute Advisory Council | |
80 FR 73208 - Agency Information Collection Activities Under OMB Review; Renewal of a Currently Approved Information Collection | |
80 FR 73187 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
80 FR 73262 - ETF Series Solutions and U.S. Global Investors, Inc.; Notice of Application November 18, 2015 | |
80 FR 73188 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
80 FR 73190 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
80 FR 73207 - Endangered Species; Receipt of Applications for Permit | |
80 FR 73118 - Cost of Living Adjustment to Satellite Carrier Compulsory License Royalty Rates | |
80 FR 73117 - Cost of Living Adjustment for Performance of Musical Compositions by Colleges and Universities | |
80 FR 73090 - Stress Testing of Regulated Entities | |
80 FR 73263 - California Disaster #CA-00241 | |
80 FR 73164 - Call for Applications for the International Buyer Program Calendar Year 2017 | |
80 FR 73166 - Call for Applications for the International Buyer Program Select Service for Calendar Year 2017 | |
80 FR 73211 - Certain Marine Sonar Imaging Systems, Products Containing the Same, and Components Thereof; Commission's Final Determination Finding a Violation of Section 337; Issuance of Limited Exclusion Order and Cease and Desist Orders; Termination of the Investigation | |
80 FR 73186 - Igor Ovchinnikov, Irina Rzaeva, and Denis Nekipelov v. Michael Hitrinov a/k/a Michael Khitrinov, Empire United Lines Co., Inc., and Carcont, Ltd.; Notice of Filing of Complaint and Assignment | |
80 FR 73198 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
80 FR 73198 - Center for Scientific Review; Notice of Closed Meeting | |
80 FR 73185 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
80 FR 73184 - FCC To Hold Open Commission Meeting Thursday, November 19, 2015 | |
80 FR 73105 - Ballast Water Management Reporting and Recordkeeping | |
80 FR 73182 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Natural Experiments and Model Career-Focused Schools: An Environmental Scan | |
80 FR 73209 - Certain Laser Abraded Denim Garments; Commission Decision Terminating the Remaining Respondents From the Investigation; Setting the Date for the Commission To Determine Whether To Grant the Petition for Review of Order Nos. 43 and 83 | |
80 FR 73258 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting Proceedings to Determine Whether To Approve or Disapprove Proposed Rule Change Relating To Implementation of a Fee on Securities Lending and Repurchase Transactions With Respect to Shares of the CurrencyShares® Euro Trust and the CurrencyShares® Japanese Yen Trust | |
80 FR 73256 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Administration of Livevol X License Agreements | |
80 FR 73247 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing of a Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Adopt Rule 8.17 To Provide a Process for an Expedited Suspension Proceeding and Rule 12.15 To Prohibit Disruptive Quoting and Trading Activity | |
80 FR 73252 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Granting Approval of Proposed Rule Change Relating to Margin Requirements | |
80 FR 73254 - Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Withdrawal of a Proposed Rule Change Relating to a Corporate Transaction Involving Its Indirect Parent | |
80 FR 73252 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Withdrawal of a Proposed Rule Change Relating to a Corporate Transaction Involving Its Indirect Parent | |
80 FR 73254 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Delivery of the Regulatory Element of C2's Continuing Education Program | |
80 FR 73199 - Merchant Mariner Medical Advisory Committee's Response to Task Statement 1, Navigation and Vessel Inspection Circular 04-08 Revision | |
80 FR 73198 - Merchant Mariner Medical Advisory Committee; Vacancies | |
80 FR 73115 - Safety Zone, Delaware River; New Castle, DE | |
80 FR 73245 - Market Dominant Price Adjustment | |
80 FR 73153 - BASF Corp.; Filing of Food Additive Petition (Animal Use) | |
80 FR 73119 - Air Plan Approval; ME; Repeal of the Maine's General Conformity Provision | |
80 FR 73160 - Air Plan Approval; ME; Repeal of the Maine's General Conformity Provision | |
80 FR 73087 - Treatment of Financial Assets Transferred in Connection With a Securitization or Participation | |
80 FR 73169 - Agency Information Collection Activities: Comment Request | |
80 FR 73170 - Agency Information Collection Activities: Comment Request | |
80 FR 73210 - Certain Footwear Products; Notice of Request for Statements on the Public Interest | |
80 FR 73156 - Disapproval of California Air Plan Revisions, South Coast Air Quality Management District | |
80 FR 73183 - Draft Integrated Science Assessment for Sulfur Oxides-Health Criteria | |
80 FR 73153 - Infectious Disease Management: Voluntary and Involuntary Testing | |
80 FR 73150 - Proposed Establishment of Class E Airspace, South Naknek, AK | |
80 FR 73152 - Proposed Establishment of Class E Airspace, South Bend, WA | |
80 FR 73147 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
80 FR 73148 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
80 FR 73156 - Regulated Navigation Area; Reporting Requirements for Barges Loaded With Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District; Stay (Suspension) Expiring | |
80 FR 73103 - Establishment of Class E Airspace; Newberry, MI | |
80 FR 73099 - Airworthiness Directives; Airbus Airplanes | |
80 FR 73232 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
80 FR 73096 - Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes | |
80 FR 73122 - Best Practices for Designing Vision Field Tests for Locomotive Engineers or Conductors | |
80 FR 73128 - Atlantic Highly Migratory Species; Smoothhound Shark and Atlantic Shark Management Measures | |
80 FR 73273 - Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services | |
80 FR 73555 - Takes of Marine Mammals Incidental to Specified Activities; U.S. Navy Training and Testing Activities in the Northwest Training and Testing Study Area | |
80 FR 73092 - Airworthiness Directives; Airbus Airplanes |
Forest Service
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Indian Affairs Bureau
Reclamation Bureau
Antitrust Division
Prisons Bureau
Occupational Safety and Health Administration
Copyright Royalty Board
Federal Aviation Administration
Federal Railroad Administration
Alcohol and Tobacco Tax and Trade Bureau
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Federal Deposit Insurance Corporation.
Final rule.
The Federal Deposit Insurance Corporation (the “FDIC”) is issuing a final rule (the “Final Rule”) that revises certain provisions of its securitization safe harbor rule, which relates to the treatment of financial assets transferred in connection with a securitization or participation, in order to clarify the requirements of the securitization safe harbor as to the retention of an economic interest in the credit risk of securitized financial assets in connection with the effectiveness of the credit risk retention regulations adopted under Section 15G of the Securities Exchange Act.
Effective January 25, 2016.
Phillip E. Sloan, Counsel, Legal Division (703) 562-6137; or George H. Williamson, Manager, Division of Resolutions and Receiverships (571) 858-8199.
The Federal Deposit Insurance Corporation (FDIC), in regulations codified at 12 CFR 360.6 (the Securitization Safe Harbor Rule), set forth criteria under which in its capacity as receiver or conservator of an insured depository institution the FDIC will not, in the exercise of its authority to repudiate contracts, recover or reclaim financial assets transferred in connection with securitization transactions. Asset transfers that, under the Securitization Safe Harbor Rule, are not subject to recovery or reclamation through the exercise of the FDIC's repudiation authority include those that pertain to certain grandfathered transactions, such as, for example, asset transfers made prior to December 31, 2010 that satisfied the conditions (except for the legal isolation condition addressed by the Securitization Safe Harbor Rule) for sale accounting treatment under generally accepted accounting principles (GAAP) in effect for reporting periods prior to November 15, 2009 and that pertain to a securitization transaction that satisfied certain other requirements. In addition, the Securitization Safe Harbor Rule provides that asset transfers that are not grandfathered, but that satisfy the conditions (except for the legal isolation condition addressed by the Securitization Safe Harbor Rule) for sale accounting treatment under GAAP in effect for reporting periods after November 15, 2009 and that pertain to a securitization transaction that satisfies all other conditions of the Securitization Safe Harbor Rule (such asset transfers, together with grandfathered asset transfers, are referred to collectively as Safe Harbor Transfers) will not be subject to FDIC recovery or reclamation actions through the exercise of the FDIC's repudiation authority. For any securitization transaction in respect of which transfers of financial assets do not qualify as Safe Harbor Transfers but which transaction satisfies all of its other requirements, the Securitization Safe Harbor Rule provides that, in the event the FDIC as receiver or conservator remains in monetary default for a specified period under a securitization due to its failure to pay or apply collections or repudiates the securitization asset transfer agreement and does not pay damages within a specified period, certain remedies can be exercised on an expedited basis.
Paragraph (b)(5)(i) of the Securitization Safe Harbor Rule sets forth the conditions relating to credit risk retention that apply to transfers of financial assets in connection with securitizations that are not grandfathered by the Securitization Safe Harbor Rule. Under paragraph (b)(5)(i)(A) of the Securitization Safe Harbor Rule as currently in effect, prior to the effective date of regulations required under Section 15G of the Securities Exchange Act, 15 U.S.C. 78a
Section 15G provides that regulations issued thereunder become effective with respect to residential mortgage securitizations one year after the date on which the regulations are published in the
In connection with the notice of proposed rulemaking relating to the Section 15G Regulations, FDIC staff received a comment that suggested that
On January 30, 2015, the FDIC published a notice of proposed rulemaking relating to the Securitization Safe Harbor Rule (the “NPR”). The NPR was designed, in part, to eliminate any confusion that might be created by the use of “effective date” in the Section 15G Regulations
The second is a clarification that paragraph (b)(5)(i)(B) of the Securitization Safe Harbor Rule does not require that any action be taken with respect to issuances of asset-backed securities that close prior to the applicable compliance date of the Section 15G Regulations.
These two clarifications, which were included in the Proposed Rule, together with an additional change suggested by a comment letter relating to the Proposed Rule, are included in the Final Rule.
The FDIC received one comment letter, from an industry trade association, in response to the Proposed Rule. This letter supported the changes included in the Proposed Rule and requested that the Final Rule include one additional change relating to the credit risk retention condition of the Securitization Safe Harbor Rule. The commenter referred to the applicable compliance dates for the Section 15G Regulations and proposed that the Final Rule provide securitization sponsors the option, with respect to a securitization transaction, to comply with the credit risk retention condition of the Securitization Safe Harbor Rule by adopting the Section 15G risk retention requirements during the period preceding the applicable compliance date for such transaction, even though the Section 15G Regulations do not require such compliance before such applicable compliance date. The commenter stated that providing such optionality “would effectuate the principle underlying the credit risk retention condition of the Securitization Safe Harbor Rule.”
The policy objective underlying the Final Rule is to create certainty and eliminate unnecessary burdens in connection with the transition to the Section 15G Regulations requirements as to credit risk retention.
The Final Rule clarifies that the Securitization Safe Harbor Rule condition relating to credit risk retention requires that the documents governing a securitization transaction that closes on or after the applicable compliance date under the Section 15G Regulations must require that an economic interest in the credit risk of the financial assets is retained in accordance with the Section 15G Regulations. The Final Rule provision effecting this clarification also makes clear that the migration of the Securitization Safe Harbor Rule to the Section 15G Regulations governing credit risk retention will not require changes to documents governing securitizations that closed prior to the applicable compliance date. The provision also makes clear that the transition to the Section 15G standard is a documentation requirement and, thus, does not put investors at risk if a securitization sponsor, in violation of transaction documents, does not retain credit risk in accordance with the Section 15G Regulations.
Because securitization investors have relied on the Securitization Safe Harbor Rule to obtain an understanding of how the FDIC might exercise its powers if it is appointed receiver or conservator for an insured depository institution which transferred assets in connection with a securitization transaction, the FDIC believes that it is important to make clear to securitization market participants the date upon and after which the Securitization Safe Harbor will require reference to the Section 15G Regulations. In addition, the FDIC wants to eliminate possible confusion among market participants as to whether an asset-backed security issuance that complies with all requirements of the Securitization Safe Harbor Rule could forfeit the benefits afforded by the Securitization Safe Harbor Rule based on the action or inaction of a securitization sponsor or other party with respect to retention of credit risk following the date of such issuance. This is different from the Section 15G Regulations, under which non-compliance with the credit risk retention requirements will constitute a violation of the Regulations.
Consistent with the clarifications to the process for migration to the Section 15G Regulations included in the Proposed Rule, the Final Rule follows the commenter's suggestion and permits securitization sponsors to comply with the credit risk retention requirements of the Securitization Safe Harbor Rule by opting in the securitization's governing documents to require compliance with the Section 15G Regulations earlier than required by the Section 15G Regulations. It is the FDIC's view that since the Securitization Safe Harbor Rule has always required the transition to the Section 15G risk retention requirements, there is no compelling reason to require that securitization sponsors await the applicable compliance date in order to use one of the risk retention methods available under the Section 15G Regulations. In following the commenter's proposal, the FDIC wished to avoid imposing unnecessary burdens on sponsors that otherwise might need to establish a securitization structure for the issuance of multiple series before the applicable compliance date and then need to amend the structure after the applicable compliance date. The FDIC sees no reason to require such extra expense. The FDIC recognizes that permitting securitization sponsors to cause a securitization transaction to comply with the Securitization Safe Harbor Rule by exercising an option to require compliance with the Section 15G Regulations before the applicable compliance date also has the effect of allowing greater flexibility with respect to risk retention for purposes of complying with the Securitization Safe
The Final Rule adds a new definition, “applicable compliance date” to paragraph (a) of the Securitization Safe Harbor Rule. This definition reflects that the Section 15G Regulations impose two dates for compliance: December 24, 2015 for securitization of residential mortgages, and December 24, 2016 for all other securitizations.
The Final Rule revises paragraph (b)(5)(i) of the Securitization Safe Harbor Rule to make the following three points clear:
(i) In order to qualify for the benefits of the Securitization Safe Harbor Rule, the documents governing the issuance of asset-backed securities in a securitization transaction must require retention of an economic interest in the credit risk of the financial assets relating to the securitization transaction in compliance with the Section 15G Regulations if such issuance occurs upon or following the date on which compliance with Section 15G is required for such type of securitization transaction;
(ii) The Securitization Safe Harbor Rule does not require inquiry as to whether the sponsor or other applicable party in fact complies with the risk retention requirements of the documentation; and
(iii) The Securitization Safe Harbor Rule requirements as to the Section 15G Regulations do not require changes to securitization documents governing asset-backed security issuances that are closed prior to the applicable compliance date under the Section 15G Regulations.
In addition, the Final Rule revises paragraph (b)(5)(i) of the Securitization Safe Harbor Rule to permit a securitization transaction, that closes between the date of the publication of the Final Rule in the
This rule would entail an information collection for sponsors that exercise the option to become subject to the Section 15G Regulations earlier than otherwise required. Because the information to be collected is the same, however, as that encompassed by the collection of information that was approved under OMB No. 3064-0183, no new submission is being made to OMB with respect to the Paperwork Reduction Act (44 U.S.C. 3501,
The Regulatory Flexibility Act 5 U.S.C. 601,
The Office of Management and Budget has determined that the Final Rule is Not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), (5 U.S.C. 801
Section 722 of the Gramm-Leach-Bliley Act (Pub. L. 106-102, 113 Stat.1338, 1471), requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. The FDIC has sought to present the Final Rule in a simple and straightforward manner.
Banks, Banking, Bank deposit insurance, Holding companies, National banks, Participations, Reporting and recordkeeping requirements, Savings associations, Securitizations.
For the reasons stated above, the Board of Directors of the Federal Deposit Insurance Corporation amends 12 CFR part 360 as follows:
12 U.S.C. 1817(b), 1818(a)(2), 1818(t), 1819(a) Seventh, Ninth and Tenth, 1820(b)(3), (4), 1821(d)(1), 1821(d)(10)(c), 1821(d)(11), 1821(d)(15)(D), 1821(e)(1), 1821(e)(8)(D)(i), 1823(c)(4), 1823(e)(2); Sec. 401(h), Pub. L. 101-73, 103 Stat. 357.
The addition and revision read as follows:
(a) * * *
(1)
(b) * * *
(5) * * *
(i)
(B) For any securitization that closes upon or following the applicable compliance date for regulations required under Section 15G of the Securities Exchange Act, 15 U.S.C. 78a
(C) Notwithstanding paragraph (b)(5)(i)(A) of this section, for any securitization that closes following ________ November 24, 2015 and prior to the applicable compliance date for regulations required under Section 15G of the Securities Exchange Act, 15 U.S.C. 78a
By order of the Board of Directors.
Federal Housing Finance Agency.
Final rule.
The Federal Housing Finance Agency (FHFA) is adopting a final rule amending its stress testing rule adopted in 2013 to implement section 165(i) of the Dodd-Frank Wall Street Reform and Consumer Protection Act. FHFA received no comments to its proposed amendments, published for comment in an August 21, 2015 Notice of Proposed Rule. These amendments adopt the proposed amendments without change to modify: The start date of the stress test cycles from October 1 of a calendar year to January 1 of the following calendar year; the dates for FHFA to issue scenarios for the upcoming cycle; the dates for the regulated entities to report the results of their stress tests to FHFA; and the dates for the regulated entities to publicly disclose a summary of their stress test results for the severely adverse scenario. These amendments align FHFA's rule with rules adopted by other financial institution regulators that implement the Dodd-Frank stress testing requirements.
Effective January 1, 2016.
Naa Awaa Tagoe, Senior Associate Director, Office of Financial Analysis, Modeling and Simulations, (202) 649-3140,
FHFA is an independent agency of the federal government established to regulate and oversee the Federal National Mortgage Association (Fannie Mae), the Federal Home Loan Mortgage Corporation (Freddie Mac) (collectively, the Enterprises), and the Federal Home Loan Banks (Bank(s)) (collectively, the regulated entities).
On September 26, 2013, FHFA published a final rule implementing section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),
FHFA's regulation also requires that the Agency issue to the regulated entities stress test scenarios that are generally consistent with and comparable to those developed by the FRB not later than 15 days after the FRB publishes its scenarios.
On October 27, 2014, the FRB published a final rule amending several dates relevant to its rule and from which FHFA measured to determine appropriate dates for stress testing cycles, scenario issuance, test reporting, and summary test disclosures.
The final rule realigns FHFA's stress testing rule with those of the FRB, Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency (OCC) by modifying: (1) The start date of the stress test cycles from October 1 of a calendar year to January 1 of the following calendar year; (2) the dates regulated entities are required to report stress test results to FHFA and the FRB; (3) the dates by which the regulated entities are required to publicly disclose summaries of the results for the severely adverse scenario; and (4) the date by which FHFA is required to issue stress testing scenarios to its regulated entities.
As a result of FHFA's experience through two stress test cycles, these amendments also lengthen the time between FRB's issuance of its scenarios and FHFA's issuance. The original rule's 15 day period after FRB's issuance has proven to be too short to allow appropriate analysis, stakeholder input, and adjustment of the scenarios to account for the differences in business models between the Enterprises and Banks as compared with other regulated institutions conducting Dodd-Frank stress tests under their regulators' rules. Consequently, FHFA is extending the time by which it is required to issue its scenarios to 30 calendar days following FRB's issuance of its final element of the supervisory scenarios.
On August 21, 2015, FHFA published in the
Section 1238.3 of the rule changes the “as of” date for the data used for stress testing from September 30 of that calendar year to December 31 of the previous calendar year. As a result of the shift, the stress test cycles would begin on January 1, based on data as of December 31 of the preceding calendar year. This cycle matches the cycle recently adopted by the other Dodd-Frank stress testing regulators.
Section 1238.3(b) lengthens the amount of time by which FHFA commits to providing a description of the baseline, adverse, and severely adverse scenarios to all regulated entities from within 15 calendar days to within 30 calendar days after the FRB publishes its scenarios. This will provide additional time for FHFA to analyze and adjust the scenarios it issues to the Enterprises and Banks.
Section 1238.5 changes the date by which stress test results are required to be reported to the FRB and FHFA. Instead of February 5 of each year, reports are required on or before May 20 for the Enterprises. Instead of April 30 of each year, reports are required on or before August 31 for the Banks. These changes reflect the shift in the stress test cycle and corresponding reporting dates adopted by the FRB and other regulators.
Section 1238.7 specifies a two week period within which the mandatory publication of a summary of the stress test results for the severely adverse scenario must occur. Instead of requiring publication between April 15 and April 30, the Enterprises must publish between August 1 and August 15 of each year. Instead of requiring publication between July 15 and July 30, the Banks must publish between November 15 and November 30 of each year. These changes reflect the shift in the stress test cycle and corresponding publication dates adopted by the FRB and other regulators.
In accordance with section 165(i)(2)(C) of the Dodd-Frank Act, (12 U.S.C. 5365(i)(2)(C)), FHFA has coordinated with both the FRB and the Federal Insurance Office (FIO). On October 27, 2014, the FRB published a final rule covering “bank holding compan[ies] with total consolidated assets of greater than $10 billion but less than $50 billion and savings and loan holding companies and state member banks with total consolidated assets of greater than $10 billion,”
Section 1313(f) of the Safety and Soundness Act requires the Director to consider the differences between the Banks and the Enterprises whenever promulgating regulations that affect the Banks. In developing the amendments to this rule, FHFA considered the differences between the Banks and the Enterprises, but also adhered to the statutory mandate that the regulation be “consistent and comparable” with the regulations of the other agencies. In implementing the regulation, FHFA will define scenarios for the regulated entities, bearing in mind the key risk exposures at each regulated entity.
In the final rule, FHFA requires different timeframes for reporting stress test results for the Enterprises versus the Banks. For the Enterprises, FHFA sets the dates for reporting stress test results to the regulator, the FRB, and the public in proximity to similar dates in the other agencies' rules for institutions with over $50 billion in assets. Reporting dates for all the Banks, regardless of size, are set in proximity to similar dates for institutions with less than $50 billion in assets. As a result, the Banks have over three additional months to report results to FHFA, the FRB, and the public.
The final rule does not contain any collections of information pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
The final rule applies only to the regulated entities, which do not come within the meaning of small entities as defined in the Regulatory Flexibility Act (see 5 U.S.C. 601(6)). Therefore, in accordance with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the General Counsel of FHFA certifies that this final rule will not have a significant economic impact on a substantial number of small entities.
Administrative practice and procedure, Capital, Federal Home Loan Banks, Government-sponsored enterprises, Regulated entities, Reporting and recordkeeping requirements, Stress test.
For the reasons stated in the preamble, and under the authority of 12 U.S.C. 4513, 4526, and 5365(i), FHFA amends part 1238 of title 12 of the Code of Federal Regulations as follows:
12 U.S.C. 5365(i); 12 U.S.C. 4513, 4526, 4612; and 12 U.S.C. 1426.
(a) * * *
(1) Shall complete an annual stress test of itself based on its data as of December 31 of the preceding calendar year;
(b)
(a)
(a)
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2008-22-20 for certain Airbus Model A330-200, A330-300, and A340-300 series airplanes. AD 2008-22-20 required repetitive high frequency eddy current (HFEC) inspections for cracking, repair if necessary, and modification of the upper shell structure of the fuselage. This new AD shortens certain compliance times. This AD was prompted by a determination from a fatigue and damage tolerance evaluation that the compliance times must be reduced. We are issuing this AD to prevent fatigue cracking of the upper shell structure of the fuselage, which could result in reduced structural integrity of the airplane.
This AD becomes effective December 29, 2015.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 29, 2015.
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of December 17, 2008
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2008-22-20, Amendment 39-15717 (73 FR 66747, November 12, 2008). AD 2008-22-20 applied to certain Airbus Model A330-200, A330-300, and A340-300 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0012R1, dated January 24, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200, A330-300, and A340-300 series airplanes. The MCAI states:
During fatigue tests (EF3) on the A340-600, damage was found in the longitudinal doubler at the Vertical Tail Plane (VTP) attachment cut out between Frame (FR) 80 and FR86. This damage occurred between 58,341 and 72,891 simulated flight cycles (FC).
Due to the higher Design Service Goal and different design of the affected structural area (
This condition, if not detected and corrected, could affect the structural integrity of the upper shell structure between FR80 and FR86.
Prompted by these findings, EASA issued AD 2007-0284 [(
Since that [EASA] AD was issued, in the frame of a new fatigue and damage tolerance evaluation, taking into account the airplane utilisation, the inspection threshold and intervals have been reassessed and the conclusion was that the thresholds and intervals for inspection, as well as the threshold for modifying the airplane, must be reduced.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2007-0284, which is superseded and introduces redefined thresholds and intervals.
This [EASA] AD is revised to clarify that, under some conditions, accomplishment of a repair constitutes terminating action for the repetitive inspections. One of the outcome of this clarification is the deletion of paragraph (5) of this [EASA] AD.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 13799, March 17, 2015) and the FAA's response to each comment.
An anonymous commenter agreed with the safety benefit provided by the NPRM (80 FR 13799, March 17, 2015).
Delta requested that we revise the NPRM (80 FR 13799, March 17, 2015) to relay the heavy impact of accomplishing Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012. Delta explained that the modification specified in Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012, requires removal of the vertical stabilizer and the aft galley, which can heavily impact the operation. Delta reasoned that it has consulted with its maintenance organization and it is estimated to take 400 work-hours instead of 208 work-hours.
We disagree with the request to revise this AD. We made the cost estimate based on the information provided in Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012. The required work-hours defined in Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012, are based on the direct labor cost to do the work. The need to remove and reinstall the aft galley depends on the airplane interior configuration and may differ from operator to operator. We are unable to determine all possible interior configurations and thus determine the maximum work-hours which may be required for any specific configuration. This estimate assumes that the work will be done by experienced personnel, and may need to be revised upwards to suit an operator's circumstances. The estimate does not include the time to prepare, plan, or inspect the work. We have made no changes to this AD in this regard.
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 13799, March 17, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 13799, March 17, 2015).
Airbus has issued the following service information.
• Airbus Service Bulletin A330-53-3159, Revision 02, dated March 29, 2010, describes procedures for a modification of the fuselage, which includes inspections (
• Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012, describes procedures for applicable actions, including an eddy current rotating probe test for cracking of the fastener holes and an HFEC inspection for cracks in the upper shell
• Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011, describes procedures for a HFEC inspection for cracking of the upper shell structure of the fuselage between FR80 and FR86.
• Airbus Service Bulletin A340-53-4165, Revision 02, dated March 29, 2010, describes procedures for a modification of the fuselage, which includes inspections (
• Airbus Service Bulletin A340-53-4172, Revision 01, dated July 8, 2009, describes procedures for inspections (
• Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011, describes procedures for a HFEC inspection for cracking of the upper shell structure of the fuselage between FR80 and FR86.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 26 airplanes of U.S. registry. We also estimate that it will take about 208 work-hours per product to comply with the basic requirements (inspection and modification) of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $28,360 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,197,040, or $46,040 per product.
We have received no definitive data that will enable us to provide cost estimates for the on-condition actions specified in this AD.
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective December 29, 2015.
This AD replaces AD 2008-22-20, Amendment 39-15717 (73 FR 66747, November 12, 2008).
This AD applies to Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-311, -312, and -313 airplanes; certificated in any category; all manufacturer serial numbers on which Airbus Modification 44205 has been embodied in production, except those on which Airbus Modification 52974 or 53223 has been embodied in production.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by the results of a fatigue and damage tolerance evaluation that concluded existing compliance times must be reduced. We are issuing this AD to prevent fatigue cracking of the upper shell structure of the fuselage, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For Model A330-300 and A340-300 airplanes, except Model A340-300 WV 027 airplanes: At the applicable time specified in paragraph (g)(1) or (g)(2) of this AD, do a high frequency eddy current (HFEC) inspection for cracking of the upper shell structure between frame (FR) 80 and FR86, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011; or Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011; as applicable. Repeat the inspection thereafter at the applicable time specified in paragraph 1.E., “COMPLIANCE,” of Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011; or Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011; as applicable.
(1) For airplanes that, as of the effective date of this AD, have not been inspected in accordance with Airbus Service Bulletin A330-53-3168; or Airbus Service Bulletin A340-53-4174; as applicable: Inspect at the later of the times specified in paragraphs (g)(1)(i) and (g)(1)(ii) of this AD.
(i) Before reaching the applicable threshold specified in paragraph 1.E., “COMPLIANCE,” of Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011; or Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011; as applicable for airplane model, configuration, and utilization, since the airplane's first flight.
(ii) Within the threshold defined in paragraph 1.E, “COMPLIANCE,” of Airbus Service Bulletin A330-53-3168, Revision 01, dated February 15, 2008; or Airbus Service Bulletin A340-53-4174, Revision 01, dated February 15, 2008; as applicable for airplane model, configuration, and utilization since the airplane's first flight; or within 12 months after the effective date of this AD; whichever occurs first.
(2) For airplanes that, as of the effective date of this AD, have been inspected in accordance with Airbus Service Bulletin A330-53-3168; or Airbus Service Bulletin A340-53-4174; as applicable: Inspect at the later of the times specified in paragraphs (g)(2)(i) and (g)(2)(ii) of this AD.
(i) Within the applicable interval specified in paragraph 1.E., “COMPLIANCE,” of Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011; or Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011; as applicable; to be counted from the last inspection.
(ii) Within 12 months after the effective date of this AD without exceeding the intervals defined in paragraph 1.E, “COMPLIANCE,” of Airbus Service Bulletin A330-53-3168, Revision 01, dated February 15, 2008; or Airbus Service Bulletin A340-53-4174, Revision 01, dated February 15, 2008; as applicable for airplane model, configuration, and utilization to be counted from the last inspection.
If any crack is detected during any HFEC inspection required by the introductory text to paragraph (g) of this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). Accomplishment of a repair for a specific area, as required by this paragraph, is terminating action for the repetitive HFEC inspections required by the introductory text to paragraph (g) of this AD, as applicable, for that specific repaired area only. The need and definition of subsequent repetitive inspections (if any) for that specific repaired area will be defined in the applicable repair method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA) or Airbus's EASA Design Organization Approval (DOA).
For Airbus Model A330-300 and A340-300 airplanes, except Model A340-300 WV 027 airplanes: Modification, which includes inspections and applicable corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3159, Revision 02, dated March 29, 2010; or Airbus Service Bulletin A340-53-4165, Revision 02, dated March 29, 2010; as applicable; terminates the repetitive HFEC inspections required by the introductory text to paragraph (g) of this AD, except where Airbus Service Bulletin A330-53-3159, Revision 02, dated March 29, 2010; or Airbus Service Bulletin A340-53-4165, Revision 02, dated March 29, 2010; as applicable; specifies to contact the manufacturer, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
Within the compliance times specified in paragraph (j)(1) or (j)(2) of this AD, whichever occurs later: Do all applicable actions, including an eddy current rotating probe test and an HFEC inspection for cracks, and modify the airplane upper shell structure between FR80 and FR86; in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012.
(1) Within the compliance times identified in paragraph 1.E., “COMPLIANCE,” of Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012, as applicable for airplane configuration and utilization since the airplane's first flight.
(2) Within 12 months after the effective date of this AD without exceeding the threshold defined in paragraph 1.E, “COMPLIANCE,” of Airbus Service Bulletin A330-53-3160, Revision 02, dated March 29, 2010, since the airplane's first flight.
For Model A340-300 airplanes, WV 027 only: Before the accumulation of 14,200 total flight cycles from the airplane's first flight, do all applicable inspections and modify the airplane upper shell structure between FR80 and FR86; in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-53-4172, Revision 01, dated July 8, 2009.
If any crack is detected during the inspection required by the introductory text to paragraph (j) of this AD, or paragraph (k) of this AD, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA; concurrently with modification required by paragraph the introductory text to paragraph (j) of this AD, or paragraph (k) of this AD.
(1) For the purposes of this AD, the term “Threshold,” as used in paragraph 1.E., “COMPLIANCE,” of the service information specified in paragraphs (m)(2)(i) through (m)(2)(vi) of this AD means the total flight cycles or flight hours accumulated since the airplane's first flight.
(2) For the purposes of this AD, the term “Interval” as used in paragraph 1.E., “COMPLIANCE,” of the service information specified in paragraphs (m)(2)(i) through (m)(2)(vi) of this AD means the total flight cycles or flight hours accumulated since the last inspection, as applicable.
(i) Airbus Service Bulletin A330-53-3168, dated September 19, 2007.
(ii) Airbus Service Bulletin A330-53-3168, Revision 01, dated February 15, 2008.
(iii) Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011.
(iv) Airbus Service Bulletin A340-53-4174, dated September 19, 2007.
(v) Airbus Service Bulletin A340-53-4174, Revision 01, dated February 15, 2008.
(vi) Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011.
(1) For Model A330-300 and A340-300 airplanes, except Model A340-300 WV 027 airplanes: This paragraph provides credit for the modification specified in paragraph (i) of this AD, if those actions were performed before the effective date of this AD using the service information identified in paragraph (n)(1)(i), (n)(1)(ii), (n)(1)(iii), or (n)(1)(iv) of this AD, as applicable. This service information is not incorporated by reference in this AD.
(i) Airbus Service Bulletin A330-53-3159, dated September 19, 2007.
(ii) Airbus Service Bulletin A330-53-3159, Revision 01, dated June 15, 2009.
(iii) Airbus Service Bulletin A340-53-4165, dated September 19, 2007.
(iv) Airbus Service Bulletin A340-53-4165, Revision 01, dated June 17, 2009.
(2) For Model A330-200 airplanes: This paragraph provides credit for the inspection
(i) Airbus Service Bulletin A330-53-3160, dated July 9, 2007, which was incorporated by reference in AD 2008-22-20, Amendment 39-15717 (73 FR 66747, November 12, 2008).
(ii) Airbus Service Bulletin A330-53-3160, Revision 01, dated April 28, 2009, which is not incorporated by reference in this AD.
(iii) Airbus Service Bulletin A330-53-3160, Revision 02, dated March 29, 2010, which is not incorporated by reference in this AD.
(3) For Model A340-300 airplanes, WV 027 only: This paragraph provides credit for the inspection and modification required by paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A340-53-4172, dated July 10, 2007, which is was incorporated by reference in AD 2008-22-20, Amendment 39-15717 (73 FR 66747, November 12, 2008).
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0012R1, dated January 24, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (q)(3) and (q)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on December 29, 2015.
(i) Airbus Service Bulletin A330-53-3159, Revision 02, dated March 29, 2010.
(ii) Airbus Service Bulletin A330-53-3160, Revision 03, dated January 6, 2012.
(iii) Airbus Service Bulletin A330-53-3168, Revision 02, dated December 21, 2011.
(iv) Airbus Service Bulletin A340-53-4165, Revision 02, dated March 29, 2010.
(v) Airbus Service Bulletin A340-53-4172, Revision 01, dated July 8, 2009.
(vi) Airbus Service Bulletin A340-53-4174, Revision 02, dated December 21, 2011.
(4) The following service information was approved for IBR on December 17, 2008 (73 FR 66747, November 12, 2008).
(i) Airbus Service Bulletin A330-53-3168, Revision 01, dated February 15, 2008.
(ii) Airbus Service Bulletin A340-53-4174, Revision 01, dated February 15, 2008.
(5) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for all ATR—GIE Avions de Transport Régional Model ATR42 and ATR72 airplanes. This AD was prompted by new occurrences of certain cracked main landing gear (MLG) rear hinge pins. This AD requires identifying the serial number and part number of the MLG rear hinge pins, and replacing pins or the MLG if necessary. We are issuing this AD to detect and correct cracked rear hinge pins, which could lead to MLG structural failure, possibly resulting in collapse of the MLG and consequent injury to the occupants of the airplane.
This AD becomes effective December 29, 2015. The Director of the
You may examine the AD docket on the Internet at
For service information identified in this AD, contact ATR—GIE Avions de Transport Régional, 1, Allée Pierre Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18; email
Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all ATR—GIE Avions de Transport Régional Model ATR42 and ATR72 airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0074, dated March 21, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all ATR—GIE Avions de Transport Régional Model ATR42 and ATR72 airplanes. The MCAI states:
Prompted by cases of rupture of Main Landing Gear (MLG) rear hinge pin part number (P/N) D61000 encountered in service in 1994 and 1996, DGAC France issued [an] AD * * * for ATR 42 aeroplanes and [another]AD * * * for ATR 72 aeroplanes to require inspection and, depending on findings, corrective action.
Since those [French] ADs were issued, new occurrences of cracked rear hinge pin P/N D61000 were reported on ATR72 MLG.
The result of subsequent investigation revealed that the affected pins were subjected to a non-detected thermal abuse done in production during grinding process. Analysis also showed that other MLG pin P/N's could be affected by the same nonconformity.
This condition, if not detected and corrected, could lead to MLG structural failure, possibly resulting in collapse of the MLG and consequently injury to the occupants of the aeroplane.
For the reasons described above, this [EASA] AD requires inspection and, depending on findings, replacement of affected pins.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 19246, April 10, 2015) or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 19246, April 10, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 19246, April 10, 2015).
Messier-Bugatti-Dowty has issued the following service information, which describes procedures for inspecting the MLG hinge pin.
• Service Bulletin 631-32-213, dated December 16, 2013.
• Service Bulletin 631-32-214, dated January 13, 2014.
• Service Bulletin 631-32-215, dated January 13, 2014.
• Service Bulletin 631-32-216, Revision 1, dated December 17, 2013.
• Service Bulletin 631-32-219, dated March 3, 2014.
• Service Bulletin 631-32-220, dated March 3, 2014.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 81 airplanes of U.S. registry.
We also estimate that it will take about 8 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $16,000 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,351,080, or $16,680 per product.
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator.
“Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective December 29, 2015.
None.
This AD applies to ATR—GIE Avions de Transport Régional Model ATR42-200, -300, -320, and -500 airplanes; and Model ATR72-101, -201, -102, -202, -211, -212, and -212A airplanes; certificated in any category; all certified models; all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 32, Landing Gear.
This AD was prompted by new occurrences of certain cracked main landing gear (MLG) rear hinge pins. We are issuing this AD to detect and correct cracked rear hinge pins, which could lead to MLG structural failure, possibly resulting in collapse of the MLG and consequent injury to the occupants of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For Model ATR72 airplanes: Within 12 months after the effective date of this AD, inspect for the serial number of the left-hand (LH) and right-hand (RH) MLG rear hinge pins having part number (P/N) D61000. A review of airplane maintenance records is acceptable in lieu of this identification if the part number and serial number of the LH and RH MLG rear hinge pins can be conclusively determined from that review. If a rear hinge pin having P/N D61000 has a serial number listed in Messier-Bugatti-Dowty Service Bulletin 631-32-213, dated December 16, 2013; or Messier-Bugatti-Dowty Service Bulletin 631-32-216, Revision 1, dated December 17, 2013; as applicable: Within 12 months after the effective date of this AD, replace the pin with a serviceable part as identified in paragraph (h) of this AD, in accordance with the Accomplishment Instructions of Messier-Bugatti-Dowty Service Bulletin 631-32-213, dated December 16, 2013; or Messier-Bugatti-Dowty Service Bulletin 631-32-216, Revision 1, dated December 17, 2013; as applicable.
For Model ATR72 airplanes: For purposes of paragraph (g) of this AD, a serviceable MLG rear hinge pin is a pin that is specified in paragraph (h)(1) or (h)(2) of this AD.
(1) A hinge pin that is not identified in Messier-Bugatti-Dowty Service Bulletin 631-32-213, dated December 16, 2013; or Messier-Bugatti-Dowty Service Bulletin 631-32-216, Revision 1, dated December 17, 2013; as applicable.
(2) A hinge pin that has been inspected and reconditioned, in accordance with the Accomplishment Instructions of Messier-Bugatti-Dowty Service Bulletin 631-32-213, dated December 16, 2013; or Messier-Bugatti-Dowty Service Bulletin 631-32-216, Revision 1, dated December 17, 2013; as applicable.
For Model ATR72 airplanes: At the earlier of the times specified in paragraphs (i)(1) and (i)(2) of this AD, inspect all LH and RH MLG pins for a part number and serial number listed in Messier-Bugatti-Dowty Service Bulletin 631-32-214, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-219, dated March 3, 2014; as applicable. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and serial number of the LH and RH MLG pin can be conclusively determined from that review. If any affected MLG pin is found: At the earlier of the compliance times specified in paragraphs (i)(1) and (i)(2) of this AD, replace the MLG with a serviceable MLG as identified in paragraph (j) of this AD, using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or ATR—GIE Avions de Transport Régional's EASA Design Organization Approval (DOA).
(1) No later than the next MLG overhaul scheduled after the effective date of this AD.
(2) Within 20,000 flight cycles or 9 years, whichever occurs first, accumulated since installation of the MLG on an airplane since new or since last overhaul, as applicable.
For Model ATR72 airplanes: For purposes of paragraph (i) of this AD, a serviceable MLG is one that incorporates pins specified in paragraph (j)(1) or (j)(2) of this AD.
(1) Pins that are not identified in Messier-Bugatti-Dowty Service Bulletin 631-32-214, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-219, dated March 3, 2014; as applicable.
(2) Pins that have been inspected and reconditioned in accordance with the Accomplishment Instructions of Messier-Bugatti-Dowty Service Bulletin 631-32-214, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-219, dated March 3, 2014; as applicable.
(1) For Model ATR42 airplanes: Within the compliance time identified in paragraph (k)(1)(i) or (k)(1)(ii) of this AD, whichever occurs first, inspect for any LH and RH MLG pins having a part number and serial number listed in Messier-Bugatti-Dowty Service Bulletin 631-32-215, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-220, dated March 3, 2014; as applicable. A review of airplane maintenance records is acceptable in lieu of this identification if the part number and serial number of the LH and RH MLG pin can be conclusively determined from that review.
(i) No later than the next MLG overhaul scheduled after the effective date of this AD.
(ii) Within 20,000 flight cycles or 9 years, whichever occurs first, accumulated since installation of the MLG on an airplane since new or since last overhaul, as applicable.
(2) If the MLG pin having a part number and serial number listed in Messier-Bugatti-Dowty Service Bulletin 631-32-215, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-220, dated March 3, 2014; as applicable; is found to be installed during the identification required by paragraph (k)(1) of this AD, within the compliance time identified in paragraph (k)(1) of this AD, replace the MLG with a serviceable MLG, using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or ATR—GIE Avions de Transport Régional's EASA DOA. A serviceable MLG is a part that has pins as identified in paragraph (k)(2)(i) or (k)(2)(ii) of this AD.
(i) Pins that are not listed in Messier-Bugatti-Dowty Service Bulletin 631-32-215, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-220, dated March 3, 2014; as applicable.
(ii) Pins that have been inspected and reconditioned, in accordance with the Accomplishment Instructions of Messier-Bugatti-Dowty Service Bulletin 631-32-215, dated January 13, 2014; or Messier-Bugatti-Dowty Service Bulletin 631-32-220, dated March 3, 2014; as applicable.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Messier-Bugatti-Dowty Service Bulletin 631-32-216, dated October 30, 2013, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0074, dated March 21, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(3) and (o)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Messier-Bugatti-Dowty Service Bulletin 631-32-213, dated December 16, 2013.
(ii) Messier-Bugatti-Dowty Service Bulletin 631-32-214, dated January 13, 2014.
(iii) Messier-Bugatti-Dowty Service Bulletin 631-32-215, dated January 13, 2014.
(iv) Messier-Bugatti-Dowty Service Bulletin 631-32-216, Revision 1, dated December 17, 2013. Pages 4, 5, and 8 of this service bulletin are the original issue and are dated October 30, 2013.
(v) Messier-Bugatti-Dowty Service Bulletin 631-32-219, dated March 3, 2014.
(vi) Messier-Bugatti-Dowty Service Bulletin 631-32-220, dated March 3, 2014.
(3) For service information identified in this AD, contact ATR—GIE Avions de Transport Régional, 1, Allée Pierre Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for all Airbus Model A318, A319, A320, and A321 series airplanes. This AD was prompted by a determination that, in specific flight conditions, the allowable load limits on the vertical tail plane could be reached and possibly exceeded. Exceeding allowable load could result in detachment of the vertical tail plane. This AD requires modification of the pin programming flight warning computer (FWC) to activate the stop rudder input warning (SRIW) logic; and an inspection to determine the part numbers of the FWC and the flight augmentation computer (FAC), and replacement of the FWC and FAC if necessary. We are issuing this AD to prevent detachment of the vertical tail plane and consequent loss of control of the airplane.
This AD becomes effective December 29, 2015.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 29, 2015.
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A318, A319, A320, and A321 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0217R1, dated February 26, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition. The MCAI states:
During design reviews that were conducted following safety recommendations related to in-service incidents and one accident on another aircraft type, it has been determined that, in specific flight conditions, the allowable load limits on the vertical tail plane could be reached and possibly exceeded.
This condition, if not corrected, could lead, in the worst case, to detachment of the
To prevent such a possibility, Airbus has developed modifications within the flight augmentation computer (FAC) to reduce the vertical tail plane stress and to activate a conditional aural warning within the flight warning computer (FWC) to further protect against pilot induced rudder doublets.
Consequently, EASA issued AD 2014-0217 (ad.easa.europa.eu/blob/easa_ad_2014_0217.pdf/AD_2014-0217_1) to require installation and activation of the stop rudder input warning (SRIW) logic. In addition, that [EASA] AD required, prior to or concurrent with modification of an aeroplane with the activation of the SRIW, upgrades of the FAC and FWC, to introduce the SRIW logic and SRIW aural capability, respectively. After modification, the [EASA] AD prohibited installation of certain Part Number (P/N) FWC and FAC.
Since that [EASA] AD was issued, an additional previously-published Airbus Service Bulletin (SB) was identified, and a new SB was published, for the concurrent requirement to replace the FAC with a unit having a P/N as listed in Table 3 of Appendix 1 of the AD.
For the reasons described above, this [EASA] AD is revised to amend paragraph (2), adding references to additional Airbus SBs.
In addition, this AD requires, prior to or concurrent with modification of an airplane with the activation of the SRIW, upgrades of the FAC and FWC to introduce the SRIW logic and SRIW aural capability, respectively. After modification, this AD prohibits installation of FWCs and FACs having certain part numbers. You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 11960, March 5, 2015) and the FAA's response to each comment.
Airbus requested that we refer to revised service information.
We agree with the Airbus request to refer to revised service information. No additional work is required by the revised service information. We have revised paragraph (g) of this AD to refer to Airbus Service Bulletin A320-22-1480, Revision 02, dated March 30, 2015. We have added new paragraph (m)(1) of this AD to provide credit for the actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-22-1480, dated July 9, 2014; or Airbus Service Bulletin A320-22-1480, Revision 01, dated February 6, 2015.
We have revised paragraph (i) of this AD to refer in part to the following service information.
• Airbus Service Bulletin A320-22-1427, Revision 05, including Appendix 01, dated November 24, 2014 (FAC 622 hard B).
• Airbus Service Bulletin A320-22-1447, Revision 03, dated April 21, 2015 (FAC CAA02 hard C).
• Airbus Service Bulletin A320-22-1454, dated February 12, 2014 (FAC CAA02).
• Airbus Service Bulletin A320-22-1461, Revision 07, including Appendix 01, dated March 23, 2015 (FAC B623 hard B).
• Airbus Service Bulletin A320-22-1502, dated November 14, 2014 (FAC CAA02).
We have redesignated paragraph (m) of the proposed AD (80 FR 11960, March 5, 2015) as new paragraph (m)(2) of this AD to provide credit for the actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using the following additional service information.
• Airbus Service Bulletin A320-22-1427, Revision 04, dated February 11, 2014.
• Airbus Service Bulletin A320-22-1447, Revision 01, dated September 18, 2014.
• Airbus Service Bulletin A320-22-1447, Revision 02, dated December 2, 2014.
• Airbus Service Bulletin A320-22-1461, Revision 04, dated September 15, 2014.
• Airbus Service Bulletin A320-22-1461, Revision 05, dated November 13, 2014.
• Airbus Service Bulletin A320-22-1461, Revision 06, dated January 21, 2015.
United Airlines (UAL) requested that we split paragraph (h)(3)(iv) of the proposed AD (80 FR 11960, March 5, 2015) into two paragraphs to clarify the approved parts. UAL stated that paragraphs (h)(3)(i), (h)(3)(ii), and (h)(3)(iii) of the proposed AD clearly denote three of the four possible standards of FAC, but paragraph (h)(3)(iv) of the proposed AD leads one to believe that a FAC CAA02 hard C is required regardless of the airplane configuration.
We agree with UAL's request to clarify the FWCs and FACs having the part numbers that are compatible with SRIW activation required by paragraph (g) of this AD. We have revised paragraph (h)(3)(iv) of the AD to state that for all airplanes configured with an FAC standard CAA01, an FAC having soft P/N G2856AAA02 installed on hard P/N C13206AA00 (CAA02 hard C) are compatible with SRIW activation required by paragraph (g) of this AD. We have added new paragraph (h)(3)(v) of this AD to state that for all airplane configurations, an FWC having P/N 350E053021212 (H2-F7) are compatible with SRIW activation required by paragraph (g) of this AD.
The National Transportation Safety Board (NTSB) stated that there are differences between the Airbus Model A300/A310 series airplane SRIW system and the Airbus Model A320 series airplane SRIW system. The NTSB explained that the Model A300/A310 series airplane SRIW contains a red warning light on the glareshield, which lights when the SRIW is activated; however, the NPRM (80 FR 11960, March 5, 2015) did not mention the warning light as part of the Model A320 series airplane SRIW. The NTSB also stated that details associated with the modifications of the FAC and FWC are not stated in the NPRM (80 FR 11960, March 5, 2015). The NTSB stated that without details regarding the changes associated with the Model A320 series airplane SRIW it cannot fully assess the FAA response for the Model A320 series airplanes to NTSB safety recommendations A-04-56 (
We agree with the NTSB that there are differences between the Airbus Model A300/A310 series airplane and Model A318/A319/A320/A321 series airplane SRIW systems, such as, the latter does not include a light on the glareshield in front of each pilot; instead it includes a red master caution warning in addition to the aural synthetic voice warning to prevent pilots from making any further reversals. In addition, the Model Airbus A318/A319/A320/A321 series airplane SRIW modification includes a rudder travel limiter unit (RTLU) modification in the FAC that minimizes the available deflections for all the possible combinations of altitude and speed. This will ensure that after one full rudder pedal reversal, the vertical tail
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 11960, March 5, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 11960, March 5, 2015).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued Service Bulletin A320-22-1480, Revision 02, dated March 30, 2015. This service information describes procedures for modifying the pin programming to activate the SRIW logic.
Airbus has also issued the following service information. The service information describes procedures for replacing FWCs and FACs.
• Airbus Service Bulletin A320-22-1375, dated January 15, 2014.
• Airbus Service Bulletin A320-22-1427, Revision 05, dated November 24, 2014.
• Airbus Service Bulletin A320-22-1447, Revision 03, dated April 21, 2015.
• Airbus Service Bulletin A320-22-1454, dated February 12, 2014.
• Airbus Service Bulletin A320-22-1461, Revision 07, dated March 23, 2015.
• Airbus Service Bulletin A320-22-1502, dated November 14, 2014.
• Airbus Service Bulletin A320-31-1414, Revision 03, dated September 15, 2014.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 953 airplanes of U.S. registry.
We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $243,015, or $255 per product.
In addition, we estimate that any necessary follow-on actions will take about 6 work-hours (3 work-hours for an FWC and 3 work-hours for an FAC), for a cost of up to $510 per product. We have received no definitive data that will enable us to provide part cost estimates for the on-condition actions specified in this AD. We have no way of determining the number of aircraft that might need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective December 29, 2015.
None.
This AD applies to the airplanes identified in paragraphs (c)(1) through (c)(4) of this AD, certificated in any category, all manufacturer serial numbers.
(1) Airbus Model A318-111, -112, -121, and -122 airplanes.
(2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(3) Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes.
(4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
Air Transport Association (ATA) of America Code 22, Auto Flight; 31, Instruments.
This AD was prompted by a determination that, in specific flight conditions, the allowable load limits on the vertical tail plane could be reached and possibly exceeded. Exceeding allowable load could result in detachment of the vertical tail plane. We are issuing this AD to prevent detachment of the vertical tail plane and consequent loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 48 months after the effective date of this AD, modify the pin programming to activate the stop rudder input warning (SRIW) logic, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-22-1480, Revision 02, dated March 30, 2015.
Prior to or concurrently with the actions required by paragraph (g) of this AD: Inspect the part numbers of the FWC and the FAC installed on the airplane. If any FWC or FAC having a part number identified in paragraph (h)(1) or (h)(2) of this AD, as applicable, is installed on an airplane, prior to or concurrently with the actions required by paragraph (g) of this AD, replace all affected FWCs and FACs with a unit having a part number identified in paragraph (h)(3) of this AD, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraph (i) of this AD.
(1) Paragraphs (h)(1)(i) through (h)(1)(xvii) of this AD identify FWCs having part numbers that are non-compatible with the SRIW activation required by paragraph (g) of this AD.
(i) 350E017238484 (H1D1).
(ii) 350E053020303 (H2E3).
(iii) 350E016187171 (C5).
(iv) 350E053020404 (H2E4).
(v) 350E017248685 (H1D2).
(vi) 350E053020606 (H2F2).
(vii) 350E017251414 (H1E1).
(viii) 350E053020707 (H2F3).
(ix) 350E017271616 (H1E2).
(x) 350E053021010 (H2F3P).
(xi) 350E018291818 (H1E3CJ).
(xii) 350E053020808 (H2F4).
(xiii) 350E018301919 (H1E3P).
(xiv) 350E053020909 (H2-F5).
(xv) 350E018312020 (H1E3Q).
(xvi) 350E053021111 (H2-F6).
(xvii) 350E053020202 (H2E2).
(2) Paragraphs (h)(2)(i) through (h)(2)(xxxiv) of this AD identify FACs having part numbers that are non-compatible with the SRIW activation required by paragraph (g) of this AD.
(i) B397AAM0202.
(ii) B397BAM0101.
(iii) B397BAM0512.
(iv) B397AAM0301.
(v) B397BAM0202.
(vi) B397BAM0513.
(vii) B397AAM0302.
(viii) B397BAM0203.
(ix) B397BAM0514.
(x) B397AAM0303.
(xi) B397BAM0305.
(xii) B397BAM0515.
(xiii) B397AAM0404.
(xiv) B397BAM0406.
(xv) B397BAM0616.
(xvi) B397AAM0405.
(xvii) B397BAM0407.
(xviii) B397BAM0617.
(xix) B397AAM0506.
(xx) B397BAM0507.
(xxi) B397BAM0618.
(xxii) B397AAM0507.
(xxiii) B397BAM0508.
(xxiv) B397BAM0619.
(xxv) B397AAM0508.
(xxvi) B397BAM0509.
(xxvii) B397BAM0620.
(xxviii) B397AAM0509.
(xxix) B397BAM0510.
(xxx) B397CAM0101.
(xxxi) B397AAM0510.
(xxxii) B397BAM0511.
(xxxiii) B397CAM0102.
(xxxiv) Soft P/N G2856AAA01 installed on hard P/N C13206AA00.
(3) Paragraphs (h)(3)(i) through (h)(3)(v) of this AD identify the FWCs and FACs having the part numbers that are compatible with SRIW activation required by paragraph (g) of this AD.
(i) For airplane configurations with no sharklet, an FAC having P/N B397BAM0621 (621 hard B).
(ii) For airplanes configured with sharklet A320 and A319, an FAC having P/N B397BAM0622 (622 hard B).
(iii) For airplanes configured with sharklet A321, an FAC having P/N B397BAM0623 (623 hard B).
(iv) For all airplanes configured with an FAC standard CAA01, an FAC having soft P/N G2856AAA02 installed on hard P/N C13206AA00 (CAA02 hard C).
(v) For all airplane configurations, an FWC having P/N 350E053021212 (H2-F7).
Do the actions required by paragraph (h) of this AD in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (i)(1) through (i)(7) of this AD.
(1) Airbus Service Bulletin A320-22-1375, dated January 15, 2014 (FAC 621 hard B).
(2) Airbus Service Bulletin A320-22-1427, Revision 05, including Appendix 01, dated November 24, 2014 (FAC 622 hard B).
(3) Airbus Service Bulletin A320-22-1447, Revision 03, dated April 21, 2015 (FAC CAA02 hard C).
(4) Airbus Service Bulletin A320-22-1454, dated February 12, 2014 (FAC CAA02).
(5) Airbus Service Bulletin A320-22-1461, Revision 07, including Appendix 01, dated March 23, 2015 (FAC 623 hard B).
(6) Airbus Service Bulletin A320-22-1502, dated November 14, 2014 (FAC CAA02).
(7) Airbus Service Bulletin A320-31-1414, Revision 03, dated September 15, 2014 (FWC H-F7).
An airplane on which Airbus Modification 154473 has been embodied in production is excluded from the requirements of paragraphs (g) and (h) of this AD, provided that within 30 days after the effective date of this AD, an inspection of the part numbers of the FWC and the FAC installed on the airplane is done to determine that no FWC having a part number listed in paragraph (h)(1) of this AD, and no FAC having a part number listed in paragraph (h)(2) of this AD, has been installed on that airplane since date of manufacture. A review of airplane maintenance records is acceptable in lieu of this inspection if the part numbers of the FWC and FAC can be conclusively determined from that review. If any FWC or FAC having a part number identified in paragraph (h)(1) or (h)(2) of this AD, as applicable, is installed on a post-Airbus Modification 154473 airplane: Within 30 days after the effective date of this AD, do the replacement required by paragraph (h) of this AD.
After modification of an airplane as required by paragraphs (g), (h), and (j) of this AD: Do not install on that airplane any FWC having a part number listed in paragraph (h)(1) of this AD or any FAC having a part number listed in paragraph (h)(2) of this AD.
Installation of a version (part number) of the FWC or FAC approved after the effective date of this AD is an approved method of compliance with the requirements of paragraph (h) or (j) of this AD, provided the requirements specified in paragraphs (l)(1) and (l)(2) of this AD are met.
(1) The version (part number) must be approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
(2) The installation must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
(1) This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-22-1480, dated July 9, 2014; or Airbus Service Bulletin A320-22-1480, Revision 01, dated February 6, 2015. This service information is not incorporated by reference in this AD.
(2) This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using the applicable Airbus service information identified in paragraphs (m)(2)(i) through (m)(2)(xviii) of
(i) Airbus Service Bulletin A320-22-1427, dated January 25, 2013.
(ii) Airbus Service Bulletin A320-22-1427, Revision 01, dated July 30, 2013.
(iii) Airbus Service Bulletin A320-22-1427, Revision 02, dated October 14, 2013.
(iv) Airbus Service Bulletin A320-22-1427, Revision 03, dated November 8, 2013.
(v) Airbus Service Bulletin A320-22-1427, Revision 04, dated February 11, 2014.
(vi) Airbus Service Bulletin A320-22-1447, dated October 18, 2013.
(vii) Airbus Service Bulletin A320-22-1447, Revision 01, dated September 18, 2014.
(viii) Airbus Service Bulletin A320-22-1447, Revision 02, dated December 2, 2014.
(ix) Airbus Service Bulletin A320-22-1461, dated October 31, 2013.
(x) Airbus Service Bulletin A320-22-1461, Revision 01, dated February 25, 2014.
(xi) Airbus Service Bulletin A320-22-1461, Revision 02, dated April 30, 2014.
(xii) Airbus Service Bulletin A320-22-1461, Revision 03, dated July 17, 2014.
(xiii) Airbus Service Bulletin A320-22-1461, Revision 04, dated September 15, 2014.
(xiv) Airbus Service Bulletin A320-22-1461, Revision 05, dated November 13, 2014.
(xv) Airbus Service Bulletin A320-22-1461, Revision 06, dated January 21, 2015.
(xvi) Airbus Service Bulletin A320-31-1414, dated December 19, 2012.
(xvii) Airbus Service Bulletin A320-31-1414, Revision 01, dated March 21, 2013.
(xviii) Airbus Service Bulletin A320-31-1414, Revision 02, dated July 30, 2013.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0217R1, dated February 26, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (p)(3) and (p(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A320-22-1375, dated January 15, 2014.
(ii) Airbus Service Bulletin A320-22-1427, Revision 05, including Appendix 01, dated November 24, 2014.
(iii) Airbus Service Bulletin A320-22-1447, Revision 03, dated April 21, 2015.
(iv) Airbus Service Bulletin A320-22-1454, dated February 12, 2014.
(v) Airbus Service Bulletin A320-22-1461, Revision 07, including Appendix 01, dated March 23, 2015.
(vi) Airbus Service Bulletin A320-22-1480, Revision 02, dated March 30, 2015.
(vii) Airbus Service Bulletin A320-22-1502, dated November 14, 2014.
(viii) Airbus Service Bulletin A320-31-1414, Revision 03, dated September 15, 2014.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects an error in the legal description of a final rule published in the
Effective date: 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under 1 Code of Federal Regulations, Part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Raul Garza, Jr., Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 10101 Hillwood Parkway., Fort Worth, TX 76177; telephone 817-222-5874.
On September 24, 2015, a final rule was published in the
Accordingly, pursuant to the authority delegated to me, in the
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.
This rule is effective November 24, 2015.
Larisa Rudenko, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, email:
AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754 filed NADA 141-454 for an
In addition, AquaBounty Technologies, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this firm.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application (FOI Summary) may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The Agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact (FONSI) and the evidence supporting that finding, contained in an environmental assessment (EA), may be seen in the Division of Dockets Management (address in the previous paragraph) between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain the FOI Summary, EA, and FONSI at the Center for Veterinary Medicine FOIA Electronic Reading Room:
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 528 are amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
(c) * * *
(1) * * *
(2) * * *
21 U.S.C. 360b.
(a)
(b)
(c)
(d)
Coast Guard, DHS.
Final rule.
This final rule amends the Coast Guard's ballast water management reporting and recordkeeping requirements. Upon the effective date of this rule, the Coast Guard will require vessels with ballast tanks operating exclusively on voyages between ports or places within a single Captain of the Port Zone to submit an annual report of their ballast water management practices. This rule also simplifies and streamlines the ballast water report form. Finally, this rule will allow most vessels to submit ballast water reports after arrival at a port or place of destination, instead of requiring submission of such reports prior to arrival. This rule will reduce the administrative burden on the regulated population, while still providing the Coast Guard with the information necessary to analyze and understand ballast water management practices.
This final rule is effective February 22, 2016, except for the amendments to 33 CFR 151.2060(b) through (f) and 151.2070, which contain collection of information requirements that have not yet been approved by the Office of Management and Budget (OMB). The Coast Guard will publish a document in the
Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2012-0924 and are available on the Internet by going to
If you have questions on this rule, call or email Ms. Regina Bergner, Environmental Standards Division (CG-OES-3), Coast Guard; telephone 202-372-1431, email
A vessel brings water into its ballast tanks to control or maintain trim, draft, stability or stress of the vessel when it is fully or partially empty of cargo. Generally, the vessel will discharge ballast water when it loads cargo, often at another port of call. Vessels discharge more than 80 million tons of ballast water annually into U.S. waters.
Many invasive species have been introduced into U.S. waters through ballast water discharge because ballast water often contains organisms indigenous to the area where it was loaded. These organisms can become invasive species when they are discharged in a new location, often with damaging results.
The Great Lakes provide many examples of the damage invasive species can inflict on an environment. According to the U.S. Environmental Protection Agency (EPA),
The Non-Indigenous Aquatic Nuisance Prevention and Control Act of 1990 (NANPCA, Pub. L. 101-646), as amended by the National Invasive Species Act of 1996 (NISA), (Pub. L. 104-332), requires the Secretary of Homeland Security (Secretary) to ensure, to the maximum extent practicable, that aquatic nuisance species are not discharged into U.S. waters from vessels (16 U.S.C. 4701
The Secretary has delegated the regulatory functions and authorities in 16 U.S.C. 4711 to the Commandant of the Coast Guard (Department of Homeland Security Delegation No. 0170.1 (II.) 57). Coast Guard regulations regarding BWM are located in 33 CFR part 151, subparts C and D. With limited exceptions, these regulations apply to all vessels, U.S. and foreign, equipped with ballast tanks, that operate in U.S. waters. (
This final rule revises the regulatory provisions that deal with BWM reporting and recordkeeping requirements. A full discussion of the statutory and regulatory history of the Coast Guard's broader actions to implement both NANPCA and NISA may be found in the preamble to the final rule entitled “Standards for Living Organisms in Ships' Ballast Water Discharged in U.S. Waters,” published on March 23, 2012 (77 FR 17254).
This regulatory action implements provisions of NANPCA and NISA by requiring the collection of records on vessel BWM practices. The Coast Guard will now require vessels with ballast tanks operating exclusively on voyages between ports or places within a single Captain of the Port (COTP) Zone to submit an annual report of their BWM practices. This rule also allows most vessels to submit ballast water reports after arrival at a port or place of destination, instead of requiring submission of such reports prior to arrival. Additionally, this rule simplifies and streamlines the ballast water report form. This rule will reduce reporting redundancies affecting the regulated population, while still providing the Coast Guard with the information necessary to analyze and understand BWM practices. By doing so, this rule is intended to improve the Coast Guard's knowledge about such practices, which will enable us to reduce the discharge of aquatic nuisance species into U.S. waters from vessels and to reduce future damage caused by such discharges.
Efficient and effective BWM data collection is essential to the Coast Guard's ability to evaluate the availability of BWM technologies for the range of vessels operating in waters of the U.S. These important data directly inform the Coast Guard's decision making efforts to ensure, to the maximum extent practicable, that aquatic nuisance species are not discharged into waters of the U.S.
On June 5, 2013, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled “Ballast Water Management Reporting and Recordkeeping” in the
The Coast Guard proposed a three-year requirement applicable to vessels equipped with ballast tanks and operating exclusively on voyages between ports and places within a single COTP Zone to submit an annual summary report of their BWM practices. Historically, the Coast Guard has not collected extensive information about the BWM practices of this segment of the vessel population because it seemed unlikely that vessels operating within a single COTP Zone would introduce invasive species from place to place within the COTP Zone. Public comments received in response to the most recent Coast Guard rulemaking on ballast water
The Coast Guard also proposed to simplify ballast water reporting for all vessels by revising the report form and encouraging electronic report submission. We proposed to streamline the reporting process and to revise the report to include only data that are essential to understanding and analyzing BWM practices.
Finally, the Coast Guard proposed to allow vessels bound for a port or destination outside of the Great Lakes or the Hudson River north of the George Washington Bridge to submit ballast water reports either no later than six hours after arrival, or prior to departure, whichever is earlier. Prior to this rulemaking, the regulations required certain vessels to submit ballast water reports before arriving at the port or destination. As a practical matter, vessels often discovered information after arrival that necessitated amending the reports. Accordingly, the Coast Guard proposed the change in submission requirements to reduce the need for amended reports.
In response to the NPRM, the Coast Guard received 6 public comment letters containing a total of 13 separate comments. The comments are available for viewing in the public docket for this rulemaking, where indicated above under
This section contains a description of each comment, followed by the Coast Guard's response. Since several of the letters raised similar issues, this section is organized by comment topic. Except for the changes identified in this section, the Coast Guard adopts the regulations as proposed in the NPRM without change.
One commenter supported the proposal to require vessels operating within a single COTP zone to submit annual reports for three years. The commenter stated that annual reporting would provide data that is useful to the Coast Guard for making regulatory decisions affecting these vessels. The Coast Guard agrees.
One commenter opposed the proposal to require vessels operating within a single COTP zone to submit annual reports, arguing that the burden of the reporting requirement is not justified due to the low risk of introduction of aquatic invasive species within a single COTP zone. The Coast Guard disagrees. An annual report, limited to three years, presents a minimal burden, but will provide the essential data for the Coast Guard to determine whether vessels that operate solely in a single COTP zone should be subject to the same or similar BWM regulations as those applicable to vessels operating in multiple COTP zones.
The commenter also suggested the Coast Guard could obtain all necessary ballast water operation information from advisory committees and trade associations instead of introducing new reporting requirements. The Coast Guard disagrees. Data from such sources would be limited because not all vessel owners and operators are members of trade associations or represented in advisory committee studies.
Two commenters supported the Coast Guard's proposal to streamline and simplify the ballast water reporting form. In this final rule, the Coast Guard is taking an additional step to simplify the regulations in §§ 151.2060 (Reporting requirements) and 151.2070 (Recordkeeping requirements). The Coast Guard intends to align the information required for reporting and recordkeeping purposes as much as possible because the information required to satisfy both requirements is almost identical. The NPRM, however, listed the information required for reporting purposes under § 151.2060, and separately listed similar information required for recordkeeping purposes in § 151.2070. Upon further review of the NPRM, the Coast Guard wishes to avoid any confusion or misunderstanding regarding the lists of information required for reporting and recordkeeping. Specifically, the Coast Guard wishes to avoid a misunderstanding that there is one set of information required under § 151.2060 for reporting purposes, and a separate set of information required under § 151.2070 for recordkeeping purposes. Accordingly, for regulatory clarity, this final rule now lists the information required for reporting purposes in § 151.2060. Instead of repeating that list of information for recordkeeping, § 151.2070(a) simply states that there is a requirement to maintain records of all the information required to be reported under § 151.2060. Also in § 151.2070, there is an additional recordkeeping requirement regarding sediment discharge. Sediment discharge is the one data point which is subject to the recordkeeping requirement, but is not subject to the reporting requirement.
Another commenter requested an additional change to the form that would enable a reporting officer to sign the form electronically. The Coast Guard is granting this request. Ballast water reporting forms are submitted to the National Ballast Information Clearinghouse (NBIC) using any of the methods on the NBIC Web site.
One commenter requested an additional change to the form that would enable reporters to highlight an entire column and fill it out with one entry that stays constant (or near-constant) throughout the body of the report. The Coast Guard wishes to clarify that while we manage the content of the form, NBIC manages the functionality of the form. The Coast Guard communicated the commenter's request to NBIC for its consideration. NBIC advised against the commenter's request, noting that it implemented this option into an earlier test version of the form and found that it resulted in too many errors. Specifically, the ease of use of auto-fill columns was outweighed by the tendency of reporters to not enter data in these columns accurately. As form technology evolves, NBIC will consider adding an auto-fill function pending availability of a system that is better at identifying and eliminating errors.
One commenter requested that the Coast Guard continue to allow all vessel operators the choice of reporting ballast water capacities and discharge volumes in gallons or metric tons. The Coast Guard communicated the commenter's request to NBIC for its consideration. NBIC has agreed to change the form to include a drop-down menu that enables reporters to choose gallons or cubic meters as their preferred unit of measurement. Because the form will now allow reporters to choose which volumetric unit to use, we have removed the specific reference to cubic meters from the regulatory text in 33 CFR 151.2060.
One commenter noted that the form requires reporters to provide the vessel's International Maritime Organization (IMO) number, though many U.S.-flagged vessels are not issued IMO numbers. The commenter recommended an amendment to the form to specify another acceptable identification number for such vessels. In response, the Ballast Water Reporting form will be updated to offer an option for inputting either the IMO number or other documentation number.
Three commenters supported the Coast Guard's proposal to allow vessels to submit ballast water reports after arrival at a port or place of destination. The Coast Guard adopts the proposal without change. For purposes of clarity, we note that Coast Guard regulations in 33 CFR 151.2005 define the phrase “[p]ort or place of destination” to mean “. . . any port or place to which a vessel is bound to anchor or moor.” The Coast Guard provides further guidance on the practical application of the phrase “port or place of destination” for ballast water reporting purposes in Navigation and Vessel Inspection Circular NVIC 07-04, Change 1 (Oct. 29, 2004).
One commenter requested a change to the regulations to emphasize that vessels operating on the Great Lakes are covered under the new provision permitting report submission within six hours after arrival at a port or place of destination. While the Coast Guard agrees that the vessels in question are covered under this provision, we are not granting the commenter's request to change the regulatory text because the language in 33 CFR 151.2060 is sufficiently clear on this point, and it is unnecessary to add specific language solely for Great Lakes vessels.
One commenter suggested 2 alternatives for when the 6-hour post-arrival submission window should start in order to further reduce the need for amended reports. The commenter suggested that the 6-hour window should start when the vessel's cargo operations commence, even if this is some time after the vessel arrives at berth. Alternatively, the commenter suggested that the 6-hour window should start when the vessel arrives at berth. The Coast Guard rejects the commenter's preferred approach because it would mean different timing for different vessels, causing inconsistency in applying and enforcing the 6-hour submission window. Regarding the commenter's alternative approach, the Coast Guard expects that the 6-hour submission window starting upon arrival at the “port or place of destination” as discussed above will give the vessel crew ample time to submit an accurate ballast water report, without the need for an amended report
One commenter requested that the Coast Guard provide a definition of the term “trip” for reporting purposes on operations exclusively within a single COTP Zone. We agree that the term “trip” is ambiguous. To clarify, the Coast Guard is not seeking reported information on each and every vessel movement. Instead, we are seeking reported information on the number of ballast water discharges, if any. The Coast Guard has modified the regulatory text by removing the term “trip” to more clearly reflect the Coast Guard's intention.
Two commenters questioned the utility of BWM data to the Coast Guard, and requested that we consider eliminating BWM reporting and recordkeeping requirements altogether. For the reasons discussed below, the Coast Guard cannot grant this request.
The Coast Guard requires vessels to report and to maintain records of BWM practices and activities pursuant to a statutory mandate (16 U.S.C. 4711(f)). More specifically, this information enables us to assess the rate of effective compliance with established BWM requirements and guidelines. The information provides important data on volumes of ballast water discharged by different types of vessels, patterns of ballast water transport (
Additionally, the Coast Guard uses the reported information to track patterns of BWM and delivery in the U.S. over time. These data provide information on the relative amounts of ballast water that different types of vessels must manage, as well as the circumstances (
One commenter questioned whether this rulemaking applies to vessels that operate outside of U.S. waters (
Two commenters requested exemptions from the ballast water reporting requirements for certain vessels, including those that do not discharge ballast water from their tanks and those that use potable water for ballast. The Coast Guard is not granting these requests for blanket exemptions. The controlling statutory provisions in 46 U.S.C. 4711(c) and (f) require the Coast Guard to apply these regulations to “. . . all vessels equipped with ballast water tanks that operate in the waters of the United States.” It is the presence of a ballast water tank that triggers the applicable reporting requirement, not the discharge of ballast water. When a vessel is equipped with a ballast water tank, the non-discharge of ballast water or the use of potable water for ballast is a BWM practice, and the reporting requirement provides useful information regarding the effectiveness of these measures in preventing the introduction or spread of invasive species. The purpose of the reported information is to assist the Coast Guard in evaluating BWM practices in general, regardless of whether a vessel discharges ballast water. However, we remind owners and operators that 33 CFR 151.2065 provides relief under certain circumstances (
We are revising the text in 33 CFR 151.2015 in several places to refer to a “single” COTP zone instead of “one” COTP zone for clarity and consistency with the rest of that section. Additionally, we are revising the text in 33 CFR 151.2060(b)(1)(ii) to reflect the accurate name of the “St. Lawrence Seaway Ballast Water Reporting Form.” These are non-substantive technical changes.
We developed this final rule after considering numerous statutes and executive orders related to rulemaking. Below, we summarize our analyses based on these statutes or executive orders.
Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
This final rule has not been designated a “significant regulatory action” under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” as supplemented by Executive Order 13563, “Improving Regulation and Regulatory Review,” and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. Accordingly, the final rule has not been reviewed by the Office of Management and Budget (OMB).
We received no public comments that affect the Regulatory Assessment (RA); nor have we identified any new information or data that would require us to reassess the RA in the NPRM. We, therefore, adopt the NPRM's Regulatory Assessment as the final assessment to this final rule. A final Regulatory Assessment is provided as follows:
Table 1 presents a summary of the economic impact of this final rule. A detailed description of the estimates is presented in the next sections.
This final rule would modify and amend the following recordkeeping requirements and procedures:
In this final rule, the Coast Guard requires owners or operators of vessels with ballast tanks operating exclusively on voyages between ports or places within a single COTP Zone to submit an annual summary report of their BWM practices for a period of 3 years.
Based on data from the Coast Guard Marine Information for Safety and Law Enforcement (MISLE) and the Ship Arrival Notification System (SANS), we estimate that the final rule will have an annual affect on 1,280 U.S.-flagged vessels that operate exclusively between ports or places within a single COTP Zone. Table 2 presents the vessel types affected by this requirement. These vessels are currently exempt from the ballast water reporting requirements under 33 CFR 151.2070. Owners or operators of these vessels will be required to submit an annual summary report of their BWM practices to the Coast Guard for a period of 3 years.
For the purposes of the cost analysis, we assume that all vessels discharge ballast water. We estimate the total annual burden hours required to complete the report will be approximately 40 minutes per vessel per year. We anticipate vessel owners or operators will need 15 minutes to complete and submit their annual ballasting report. Most of the information required is well known by the vessel owner or operator and does not require additional document consultation. The information that does not require additional document consultation includes: Vessel name, identification number, type, operator, tonnage, call sign, COTP Zone of operation, number of ballast water tanks, total ballast water capacity, and primary port of ballast water loading and discharge.
The remaining 25 minutes accounts for the total time allocated (over the entire year) for vessel operators to assemble and review information to determine the number of times ballast water is discharged and the volume of
We assume that the vessel owner or operator, with an estimated wage rate of $69/hr
This final rule will collect information on ballast water operations from vessels operating exclusively between ports or places within a single COTP Zone, a segment of the industry for which the Coast Guard has limited information. Therefore, the Coast Guard seeks to improve the breadth and quality of its BWM data so it can make the most informed programmatic and regulatory decisions.
The Coast Guard considered several alternatives for collecting the needed information on the ballast practices for vessels operating exclusively between ports or places within a single COTP Zone. One alternative would require these vessels to complete a full ballast water reporting form (33 CFR 151.2060) upon each entry into port, similar to existing requirements for other vessels operating outside a single COTP Zone. The Coast Guard instead chose the alternative that requires only an annual summary report of ballast activities with a limited number of required data elements. The Coast Guard will also collect this data for only 3 years. The Coast Guard believes that the annual summary report for 3 years provides enough information to characterize BWM practices for vessels operating exclusively between ports or places within a single COTP Zone, while minimizing the reporting burden to these entities.
The Coast Guard is updating the ballast water reporting form to make it more concise and include only essential data on BWM practices. Current recordkeeping requirements in 33 CFR 151.2070 are amended to include only data fields essential for understanding and analyzing BWM practices of vessels operating in waters of the U.S.
Vessel owners or operators who currently submit ballast water reports to comply with 33 CFR 151.2060 requirements will not incur additional burden due to the reporting updates. Updates to the report form will make questions more clear and concise. The most time consuming section of the report (section 5, “Ballast Water History”) will be restructured, but the content will be maintained. We do not expect that changes to the reporting form will affect the amount of burden time necessary to fill-out the form. Currently, vessels equipped with ballast water tanks bound for ports or places within the U.S. or those entering U.S. waters are required to submit a ballast water report. According to the Coast Guard's estimate in OMB collection of information Control Number 1625-0069, it takes approximately 40 minutes to complete and submit the report. The CFR at 33 CFR 151.2060 and 151.2070 presents detailed information on reporting and recordkeeping requirements.
In addition, updating the current reporting form will improve the utility of the data provided by the vessel population to the Coast Guard.
Prior to this final rule, 33 CFR 151.2060 required vessels to predict their ballasting operations and submit reports on BWM 24 hours before arrival at port. Often, vessel owners and operators would revise their reports with the actual ballasting information and resubmit them to NBIC. NBIC estimates that approximately 40 percent of the amended reports it receives are due to the timing of the report submission. Allowing those vessels travelling from outside of the EEZ that are not bound for the Great Lakes or the Hudson River north of the George Washington Bridge to submit ballast water reports after arrival to the port or place of destination greatly reduces the need for amended reports. We estimate that an average of 10,717 reports
The Coast Guard expects reporting efficiency and data handling will improve by changing the format of the electronic report that can be found in Information Collection Request (ICR), OMB Control number 1625-0069. The Coast Guard will standardize the data formats and add pull down menus. Since the pull down menu will make the reporting form simpler and will reduce response variability, we do not anticipate any significant change in the reporting burden. These efficiencies will not result in cost savings. Therefore, we do not expect additional costs or cost savings to the industry. According to NBIC data from the past 6 years, approximately 99 percent of reports have been submitted electronically. Within the last 2 years, 100 percent of the reports have been submitted electronically. Standardized data entry will improve data quality and, as a result, data analyses will be easier and less time consuming.
This final rule will impact the industry for a limited time only (3 years). During this time, we estimate a total annual non-discounted cost savings of $125,694 and a total 10-year non-discounted cost savings of $1,671,160. We also estimate an annualized cost savings of $162,758, with a discounted ten-year saving of $1,443,145 both respectively discounted at 7 percent for a 10-year period of analysis. These estimates are developed and shown in Table 5.
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), we have considered whether this final rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are
As described in the “Regulatory Analyses” section, we expect costs per vessel (an annual cost of $46.23 for a 3-year period) to owners or operators of vessels operating exclusively between ports or places within a single COTP Zone. Based on available data, we estimate that about 74 percent of entities affected by this final rule are small under the RFA and the Small Business Administration's size standards. The economic impact of the 3-year reporting requirement is less than 1 percent of revenue for 100 percent of the small entities. We determine that each entity, on average, manages a total of 3 vessels with an estimated annual cost of $139 (3 * $46.23) (non-discounted). We have estimated that for this rule to have a revenue impact of greater than 1 percent, total annual revenue for small entities must be less than $13,900. Therefore, we anticipate that this final rule will not have a significant economic impact on small entities. Through this final rule, the Coast Guard will obtain information on ballast water operations from a segment of the industry for which there is limited information, and improve the utility of the data provided to Coast Guard.
Owners and operators of applicable vessels already reporting BWM practices under 33 CFR 151.2060 would incur a cost savings as a result of the elimination of post-arrival amendments due to time of the reporting.
Therefore, the Coast Guard certifies that under 5 U.S.C. 605(b), this final rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this final rule so that they can better evaluate its effects on them and participate in the rulemaking. If the final rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Ms. Regina Bergner, Environmental Standards Division, U.S. Coast Guard (CG-OES-3); telephone 202-372-1431, email,
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).
This final rule modifies an existing collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other, similar actions. The title and description of the information collection, a description of those who must collect the information, and an estimate of the total annual burden follow. The burden-hour estimates cover the time for reviewing instructions, searching existing sources of data, gathering and maintaining the data needed, and completing and reviewing the collection.
(a) Owners and operators of vessels with ballast water tanks operating exclusively on voyages between ports or places within a single COTP Zone.
(b) Owners and operators of vessels currently reporting BWM activities under 33 CFR 151.2060.
(a)
(b)
This final rule will result in a total annual burden increase of 858 hours due to the new requirement for vessels
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we will submit a copy of this final rule to the Office of Management and Budget (OMB) for its review of the collection of information.
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Our analysis is explained below.
This rule revises the Coast Guard's BWM reporting and recordkeeping requirements promulgated under the authority of NANPCA, as amended by NISA. NANPCA, as amended by NISA, contains a “savings provision” that saves to States their authority to “adopt or enforce control measures for aquatic nuisance species, [and nothing in the Act would] diminish or affect the jurisdiction of any State over species of fish and wildlife” (16 U.S.C. 4725). This type of BWM reporting and recordkeeping is a “control measure” saved to States under the savings provision and would not be preempted unless State law makes compliance with this rule's requirements impossible or frustrates the purpose of Congress. No such State law has been identified. Additionally, the Coast Guard has long interpreted this savings provision to be a congressional mandate for a Federal-State cooperative regime in which federal preemption under NANPCA, as amended by NISA, would be unlikely.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights.”
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks.” This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A final environmental analysis checklist supporting this determination is available in the docket where indicated under the “Addresses” section of this preamble. This rule involves regulations that are editorial and procedural, and falls under section 2.B.2, figure 2-1, paragraph (34)(a) of the Instruction.
Administrative practice and procedure, Ballast water management, Oil pollution, Penalties, Reporting and recordkeeping requirements, Water pollution control.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 151 as follows:
16 U.S.C. 4711; Department of Homeland Security Delegation No. 0170.1.
(a) The master of each vessel equipped with ballast tanks must provide the following information, in written form, to the Captain of the Port (COTP):
16 U.S.C. 4711; Department of Homeland Security Delegation No. 0170.1.
The revisions and addition read as follows:
(b) Crude oil tankers engaged in coastwise trade are exempt from the requirements of §§ 151.2025 (ballast water management (BWM) requirements), 151.2060 (reporting), and 151.2070 (recordkeeping) of this subpart.
(c) Vessels that operate exclusively on voyages between ports or places within a single COTP Zone are exempt from the requirements of §§ 151.2025 (ballast water management (BWM) requirements), and 151.2070 (recordkeeping) of this subpart.
(d) * * *
(1) Seagoing vessels that operate in more than a single COTP Zone, do not operate outside of the EEZ, and are less than or equal to 1,600 gross register tons or less than or equal to 3,000 gross tons (International Convention on Tonnage Measurement of Ships, 1969).
(3) Vessels that operate in more than a single COTP Zone and take on and discharge ballast water exclusively in a single COTP Zone.
(b) Unless operating exclusively on voyages between ports or places within a single COTP Zone, the master, owner, operator, agent, or person in charge of a vessel subject to this subpart and this section must submit a ballast water report to the National Ballast Information Clearinghouse (NBIC) by electronic ballast water report format using methods specified at NBIC's Web site at
(1)
(ii) Non-U.S. and non-Canadian flag vessels may complete the St. Lawrence Seaway Ballast Water Reporting Form and submit it in accordance with the applicable Seaway notice as an alternative to this requirement.
(2)
(3)
(c) The ballast water report required by paragraph (b) of this section must include the following information:
(1)
(2)
(3)
(4)
(i) The numerical designation, type and capacity of the ballast tank.
(ii) The source of the ballast water. This includes date(s), location(s), and volume(s). If a tank has undergone ballast water exchange, provide the
(iii) The date(s), starting location(s), ending location(s), volume(s), and method(s) of ballast water management.
(iv) The date(s), location(s), and volume(s) of any ballast water discharged into the waters of the United States or to a reception facility.
(5)
(d) If the information submitted in accordance with paragraph (c) of this section changes, the master, owner, operator, agent, or person in charge of the vessel must submit an amended report before the vessel departs the waters of the United States or not later than 24 hours after departure from the port or place, whichever is earlier.
(e) The master, owner, operator, agent, or person in charge of a vessel operating on voyages exclusively between ports or places within a single COTP Zone, and subject to this subpart and this section, must submit the information required by paragraph (f) of this section to NBIC by electronic Annual Ballast Water Summary Report format using methods specified at NBIC's Web site at
(1) Report on the vessel's ballasting practices for calendar year 2016 due no later than March 31, 2017.
(2) Report on the vessel's ballasting practices for calendar year 2017 due no later than March 31, 2018.
(3) Report on the vessel's ballasting practices for calendar year 2018 due no later than March 31, 2019.
(f) The Annual Ballast Water Summary Report will include the following information:
(1)
(2)
(3)
(a) The master, owner, operator, agent, or person in charge of a vessel bound for a port or place in the United States, unless specifically exempted by § 151.2015 of this subpart, must ensure the maintenance of written or digital records that include the information required to be reported by § 151.2060 of this subpart and the sediment information in paragraph (a)(1) of this section.
(1)
(2)
(b) The master, owner, operator, agent, or person in charge of a vessel subject to this section must retain a signed copy of this information onboard the vessel for 2 years.
(c) The recordkeeping requirements in this section may be met by maintaining a copy of the reporting form completed pursuant to § 151.2060 of this subpart, in addition to maintaining a record of the sediment information in paragraph (a)(1) of this section. These records may be stored on digital media but must be readily viewable by the Coast Guard during an inspection.
(d) The master, owner, operator, agent, or person in charge of a vessel subject to this section must retain the monitoring records required in 46 CFR 162.060-20(b) for 2 years. These records may be stored on digital media but must be readily viewable by the Coast Guard during an inspection.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the waters encompassing Pea Patch Island Anchorage No. 5 and the upper portion of Reedy Point South Anchorage No. 3 to facilitate dredging in New Castle Range in the Delaware River. This regulation is necessary to provide for the safety of life on the navigable waters of the Delaware River in the vicinity of Pea Patch Island Anchorage No. 5 and Reedy Point South Anchorage No. 3. These closures are intended to restrict vessel anchoring to protect mariners from the hazards associated with ongoing pipe-laying and dredging operations.
This rule is effective without actual notice from November 24, 2015 through December 31, 2015. For purposes of enforcement, actual notice will be used from November 20, 2015 through November 24, 2015.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Brennan Dougherty, U.S. Coast Guard, Sector Delaware Bay, Chief Waterways Management Division, Coast Guard; telephone (215) 271-4851, email
The Coast Guard is issuing this temporary rule without prior notice and
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231; 33 CFR 1.05-1 and 160.5; and Department of Homeland Security Delegation No. 0170.1. The Captain of the Port, Delaware Bay, has determined that potential hazards associated with dredging and pipe laying operations starting November 20, 2015, will be a safety concern for anyone attempting to transit in the Delaware River, along New Castle Range, in the vicinity of Pea Patch Island Anchorage No. 5, the upper portion of Reedy Point South Anchorage No. 3, and near the entrance to the C & D Canal. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while dredging is being conducted.
The Coast Guard Captain of the Port is temporarily establishing a safety zone on the waters of Pea Patch Island Anchorage No. 5 and the upper portion of Reedy Point South Anchorage No. 3 from November 20, 2015 to December 31, 2015, unless cancelled earlier by the Captain of the Port. The safety zone will include all waters within the boundaries of Pea Patch Island Anchorage No. 5 and all waters within a portion of Reedy Point South Anchorage No. 3 north of a line drawn between positions 39°33′7.5″ N., 75°33′2.0″ W. and 39°33′8.8″ N., 75°32′31.8″ W., as charted on NOAA chart 12311. The waters of the anchorages are described in 33 CFR 110.157. Entry into, transiting, or anchoring within the safety zone is prohibited unless vessels obtain permission from the Captain of the Port (COTP) or make satisfactory passing arrangements with the dredge ESSEX per this rule and the Rules of the Road (33 CFR chapter I, subchapter E).
The Captain of the Port will terminate the safety zone once all submerged pipeline has been recovered and dredging operations are complete. Notice of the implementation and the termination of the safety zone will be made per 33 CFR 165.7.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, and duration of the safety zone. Although this regulation will restrict access to the regulated area, the effect of this rule will not be significant because Pea Patch Island Anchorage No. 5 and Reedy Point Anchorage No. 3 are not frequently used anchorages for vessels in the Delaware River, especially during the period of the closure, and there are a number of alternate anchorages available for vessels to anchor. Furthermore, vessels may be permitted to transit through the safety zone with the permission of the Captain of the Port or upon making satisfactory passing arrangements with the dredge. Extensive notification of the safety zone to the maritime public will be made via maritime advisories allowing mariners to alter their plans accordingly.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States,
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone in force from November 20, 2015 to December 31, 2015, that prohibits entry of vessels in Pea Patch Island Anchorage No. 5 and the upper portion of Reed Point Anchorage No. 3. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(2)
(c)
(1) Entry into, transiting, or anchoring within the safety zone is prohibited unless vessels obtain permission from the Captain of the Port (COTP) or make satisfactory passing arrangements, via VHF-FM channel 16, with the dredge ESSEX per this rule and the Rules of the Road (33 CFR chapter I, subchapter E).
(2) To seek permission to transit the safety zone, the Captain of the Port's representative can be contact via VHF-FM channel 16.
(3) Vessels granted permission to transit the safety zone must do so in accordance with the directions provided by the Captain of the Port or his designated representative.
(4) No person or vessel may enter or remain in a safety zone without permission from the Captain of the Port;
(5) Each person and vessel in a safety zone shall obey any direction or order of the Captain of the Port or his designated representative.
(6) At least one side of the main navigational channel will be clear for safe passage of vessels in the vicinity of the safety zone. At no time will the main navigational channel be closed for vessel traffic. Vessels are advised to ensure safety passage by contacting the dredge ESSEX on VHF-FM channel 16 one hour prior to arrival.
(7) This section applies to all vessels wishing to transit through the safety zone except vessels that are engaged in the following operations: enforcing laws; servicing aids to navigation, and emergency response vessels.
(d)
(e)
Copyright Royalty Board, Library of Congress.
Final rule.
The Copyright Royalty Judges announce a cost of living adjustment (COLA) of 2% in the royalty rates that colleges, universities, and other educational institutions not affiliated with National Public Radio pay for the use of published nondramatic musical compositions in the SESAC repertory for the statutory license under the Copyright Act for noncommercial broadcasting.
LaKeshia Keys, CRB Program Specialist, by telephone at (202) 707-7658 or by email at
Section 118 of the Copyright Act, title 17 of the United States Code, creates a statutory license for the use of published nondramatic musical works and published pictorial, graphic, and sculptural works in connection with noncommercial broadcasting.
On November 29, 2012, the Copyright Royalty Judges (Judges) adopted final regulations governing the rates and terms of copyright royalty payments under section 118 of the Copyright Act for the license period 2013-2017.
The change in the cost of living as determined by the CPI-U during the period from the most recent index published before December 1, 2014, to the most recent index published before December 1, 2015, is .2%.
Copyright, Music, Radio, Television, Rates.
In consideration of the foregoing, the Judges amend part 381 of title 37 of the Code of Federal Regulations as follows:
17 U.S.C. 118, 801(b)(1), and 803.
(c) * * *
(3) * * *
(iv) 2016: $149 per station.
Copyright Royalty Board, Library of Congress.
Final rule.
The Copyright Royalty Judges announce a cost of living adjustment (COLA) of 0% in the royalty rates satellite carriers pay for a compulsory license under the Copyright Act. The COLA is based on the change in the Consumer Price Index from October 2014 to October 2015.
LaKeshia Keys, CRB Program Specialist, by telephone at (202) 707-7658 or by email at
The satellite carrier compulsory license establishes a statutory copyright licensing scheme for the retransmission of distant television programming by satellite carriers. 17 U.S.C. 119. Congress created the license in 1988 and has reauthorized the license for additional five-year periods, most recently with the passage of the STELA Reauthorization Act of 2014, Public Law 113-200.
On August 31, 2010, the Copyright Royalty Judges (Judges) adopted rates for the section 119 compulsory license for the 2010-2014 term.
The change in the cost of living as determined by the CPI-U during the period from the most recent index published before December 1, 2014, to the most recent index published before December 1, 2015, is .2%.
Copyright, Satellite, Television.
In consideration of the foregoing, the Judges amend part 386 of title 37 of the Code of Federal Regulations as follows:
17 U.S.C. 119(c), 801(b)(1).
(b) * * *
(1) * * *
(vii) 2016: 27 cents per subscriber per month (for each month of 2016).
(2) * * *
(vii) 2016: 56 cents per subscriber per month (for each month of 2016).
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Maine. This revision removes State Regulation Chapter 141—Conformity of General Federal Actions from the SIP. The intended effect of this action is to remove the repealed State Regulation and leave the Federal General Conformity provisions in place to demonstrate conformity with the applicable SIP as required by section 176(c) of the Clean Air Act. This action is being taken in accordance with the Clean Air Act.
This direct final rule will be effective January 25, 2016, unless EPA receives adverse comments by December 24, 2015. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID Number EPA-R01-OAR-2015-0593 by one of the following methods:
1.
2.
3.
4.
5.
In addition, copies of the state submittal and EPA's technical support document are also available for public inspection during normal business hours, by appointment at the State Air Agency; the Bureau of Air Quality Control, Department of Environmental Protection, First Floor of the Tyson Building, Augusta Mental Health Institute Complex, Augusta, ME 04333-0017.
Ariel Garcia, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, telephone number (617) 918-1660, fax number (617) 918-0660, email
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Organization of this document. The following outline is provided to aid in locating information in this preamble.
Section 176(c) of the Clean Air Act, as amended (the Act), prohibits Federal entities from taking actions in nonattainment or maintenance areas which do not conform to the State Implementation Plan (SIP) for the attainment and maintenance of the national ambient air quality standards (NAAQS). Therefore, the purpose of conformity is to: (1) Ensure Federal activities do not interfere with the emission budgets in the SIPs; (2) ensure actions do not cause or contribute to new violations; and (3) ensure attainment and maintenance of the NAAQS. Section 176(c) of the Act also requires EPA to promulgate criteria and procedures for demonstrating and ensuring conformity of Federal actions to an applicable implementation plan developed pursuant to Section 110 and Part D of the Act. EPA promulgated a final rulemaking on November 30, 1993 consisting of 40 CFR part 93, subpart B “Determining Conformity of General Federal Actions to State or Federal Implementation Plans,” which applied to Federal agencies immediately (hereafter referred to as the General Conformity rule); and 40 CFR part 51, subpart W “Determining conformity of general Federal Actions to State or Federal Implementation Plans” which established requirements for States in submitting SIPs. The general conformity rules, except for the 40 CFR 51.851(a) language requiring State submission of a SIP revision, were repeated at 40 CFR part 93, subpart B. The General Conformity rule establishes the criteria and procedures governing the determination of conformity for all Federal actions, except Federal highway and transit actions.
The General Conformity rule also establishes the criteria for EPA approval of SIPs. See 40 CFR 51.851 and 93.151. These criteria provide that the state provisions must be at least as stringent as the requirements specified in EPA's General Conformity rule, and that they can be more stringent only if they apply equally to Federal and non-Federal entities (§§ 51.851(b)). Following EPA approval of the State conformity provisions in a SIP revision, the approved State criteria and procedures would govern conformity determinations and the Federal conformity regulations contained in 40 CFR part 51 and part 93 would apply only for the portion, if any, of the State's conformity provisions that is not approved by EPA. Finally, all SIP-approved requirements relating to general conformity remain enforceable until the State revises its SIP to specifically remove them from the SIP and that revision is approved by EPA.
On October 11, 1996, the State of Maine submitted a formal revision to its SIP. The SIP revision consisted of incorporating-by-reference 40 CFR 51.850 through 51.860 (with the exception of § 51.851) thereby establishing general conformity criteria and procedures in the Maine SIP no more stringent than the Federal rule and not imposing any additional controls on non-Federal entities. EPA approved Maine's General Conformity SIP through a direct final rule published in the
On June 29, 2007, the State of Maine submitted a second revision to its General Conformity SIP. This SIP revision consists of incorporating by reference 40 CFR 51.852 (Definitions), and 51.853 (Applicability), of 40 CFR part 51, subpart W, “Determining Conformity of General Federal Actions to State or Federal Implementation Plans,” as amended on July 17, 2006 in the
On April 5, 2010, EPA revisited the Federal General Conformity Requirements Rule to clarify the conformity process, authorize innovative and flexible compliance approaches, remove outdated or unnecessary requirements, reduce the paperwork burden, provide transition tools for implementing new standards, address issues raised by Federal agencies affected by the rules, and provide a better explanation of conformity regulations and policies. EPA's April 2010 revised rule simplified state SIP requirements for general conformity, eliminating duplicative general conformity provisions codified at 40 CFR part 93, subpart B and 40 CFR part 51, subpart W by removing section 51.850, and sections 51.852 through 51.860. Finally, the April 2010 revision updated the Federal General Conformity Requirements Rule to reflect changes to governing laws passed by Congress since EPA's 1993 rule.
The “Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users,” (SAFETEA-LU) passed by Congress in 1995 contains a provision eliminating the Clean Air Act requirement for states to adopt general conformity SIPs. As a result of SAFETEA-LU, EPA's April 2010 General Conformity rule eliminated the Federal regulatory requirement for states to adopt and submit general conformity SIPs, instead making submission of a general conformity SIP a state option.
The 2010 General Conformity amendments (Sections 51.851(c) as well as section 93.151) restated the requirement that in the absence of an EPA approved General Conformity SIP, Federal agencies shall use the provisions of 40 CFR part 93, subpart B to demonstrate conformity with the applicable implementation plan as required by section 176(c) of the Clean Air Act (42 U.S.C. 7506).
On August 18, 2015, the Maine Department of Environmental Protection submitted a formal SIP revision to remove Chapter 141-Conformity of General Federal Actions. Maine's Chapter 141 regulation incorporated-by-reference 40 CFR part 51, subpart W “Determining Conformity of General Federal Actions to State or Federal Implementation Plans” as published in the November 30, 1993,
As the State of Maine did not revise its SIP-approved Chapter 141—
Maine Department of Environmental Protection repealed Chapter 141 in July 2015 after public notice and opportunity for public hearing. The removal of Chapter 141—Conformity of General Federal Actions from the SIP will leave the Federal General Conformity Regulations at 40 CFR 93.150 through 93.165 as well as 40 CFR 51.851, in place for administrative and enforcement purposes. Once EPA approves the removal of Chapter 141 from Maine's SIP, Federal actions can take advantage of the flexibility provided by the Federal General Conformity Rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
EPA is approving Maine's August 18, 2015, SIP revision to remove Chapter 141—Conformity of General Federal Actions from the SIP. EPA has evaluated this SIP revision and has determined that the State has complied with its administrative procedures to repeal Chapter 141. The appropriate public participation and comprehensive interagency consultations have been undertaken during development and adoption of this SIP revision. Finally, EPA has determined that removing Chapter 141 from the Maine SIP will result in Federal agencies using the provisions of 40 CFR part 93, subpart B to demonstrate conformity with the applicable implementation plan as required by section 176(c) of the Clean Air Act (42 U.S.C. 7506). Federal actions can take advantage of the flexibility provided by the Federal General Conformity Rule which includes EPA's April 2010 General Conformity Amendments.
EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this
If EPA receives such comments, then EPA will publish a notice withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on the proposed rule. All parties interested in commenting on the proposed rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on January 25, 2016 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 25, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Interim interpretation with request for comments.
FRA is issuing this interim interpretation to clarify provisions in its locomotive engineer and conductor qualification and certification regulations with respect to vision standards and testing. In particular, this document addresses further evaluation of persons who do not meet the vision threshold criteria provided for in those regulations, and provides best practices guidance for designing valid, reliable, and comparable vision field tests for assessing whether persons who do not meet those thresholds can perform safely as locomotive engineers and conductors.
Written comments on the interpretation must be received on or before January 25, 2016. Comments received after that date will be considered to the extent possible without incurring additional expense or delay.
Comments related to Docket No. FRA-2015-0123 may be submitted by any of the following methods:
•
•
•
•
Dr. B.J. Arseneau, Medical Director, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 493-6232; Alan Nagler, Senior Trial Attorney, FRA, Office of Chief Counsel, Mail Stop 10, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 493-6049; or Joseph D. Riley, Railroad Safety Specialist, FRA, Mail Stop 25, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 493-6318.
FRA is issuing this interim interpretation to clarify provisions in its locomotive engineer and conductor qualification and certification regulations related to further evaluation of persons who do not meet the vision threshold criteria in Title 49 Code of Federal Regulations (CFR) 240.121(c) and 242.117(h), and to provide best-practices guidance for designing valid, reliable, and comparable vision field tests, in response to: (1) The fatal railroad accident that occurred near Goodwell, OK, on June 24, 2012; (2) inquiries FRA has received requesting clarification of the applicable regulatory provisions; and (3) numerous requests for FRA review, under the locomotive engineer and conductor certification regulations, when individuals have been denied recertification by a railroad based on a color vision or monocular vision deficiency.
The fatal accident that occurred near Goodwell, in which two Union Pacific Railroad (UP) trains collided head-on, exemplifies how important it is to railroad safety that each railroad establish valid, reliable, and comparable procedures to evaluate persons who do not meet the vision thresholds in 49 CFR 240.121(c) or 242.117(h), and to strictly adhere to those procedures. The
During its investigation of the Goodwell accident, the NTSB found that: (1) The eastbound engineer last underwent vision testing required for recertification in 2009; (2) during that testing, the eastbound engineer failed an initial color vision test (
As indicated in the NTSB's report on the Goodwell accident, there are numerous eye conditions, including color vision deficiency and monocular vision, which can affect a person's ability to safely perform as a locomotive engineer or conductor. The American Optometric Association defines “color vision deficiency” as the inability to distinguish certain shades of color, or in more severe cases, see colors at all. The term “color blindness” is also used to describe this visual condition, but very few people are completely color-blind. People who have complete color-blindness, a condition called achromatopsia, can only see things as black and white or in shades of gray. The severity of color vision deficiency can range from mild to severe. “Red-green” is the most common deficiency. Another form of color deficiency is “blue-yellow.” The latter is a rare and more severe form of color vision deficiency since persons with blue-yellow deficiency frequently have red-green deficiency too. Color vision deficiency can be inherited. About 8 percent of Caucasian males are born with some degree of color deficiency. Women are typically asymptomatic if they are carriers of the color deficient gene (
There are many other eye conditions and visual disturbances other than color-vision deficiency. Examples of these problems and disturbances include halos, blurred vision (
FRA's locomotive engineer and conductor qualification and certification rules do not require railroads to categorically disqualify or decertify individuals who do not meet the vision thresholds in 49 CFR 240.121(c) or 242.117(h) because they may have a color-vision, sub-threshold distance visual acuity, or field of vision (
The Railway Association of Canada (RAC) has published medical guidelines that are applicable to qualification and certification of locomotive engineers in Canada.
Depending on their assigned responsibilities, a person generally must have sufficient distant visual acuity and
FRA recognizes that railroads may assign some employees the responsibility to recognize and distinguish color light railroad signals, but not other employees. For example, some passenger conductors may not have responsibility to recognize and distinguish between colors of railroad signals. FRA also recognizes that some locomotive engineers and conductors only perform service in unsignalled (
There are many types of eye conditions and visual disturbances ranging in severity from very mild to severe and many types and designs of railroad signals and railroad operating rules. Accordingly, FRA's locomotive engineer and conductor qualification and certification rules grant railroad medical examiners discretion in determining the methods and procedures the medical examiner will use to further evaluate persons who do not meet the vision thresholds in 49 CFR 240.121(c) and 242.117(h). In the 1991 final locomotive engineer certification rule, FRA stated that “[m]edical discretion will allow railroads to respond appropriately when they encounter individuals who fail to meet FRA-prescribed acuity levels, but demonstrate that they can compensate to a sufficient degree for their diminished acuity level.” 56 FR 28228, 28235; June 19, 1991. FRA granted railroad medical examiners similar discretion in further evaluating persons for the purposes of conductor qualification and certification. FRA states in its locomotive engineer and conductor certification rules that, should a person not meet specific vision thresholds, appropriate further evaluation may include optometric or ophthalmologic referral, or (secondary) testing with a field or other practical or scientific screening test. Although FRA's rules grant discretion to railroads in selecting a test protocol, FRA's longstanding interpretation of this provision is that the test offered by a railroad must be a valid, reliable, and comparable test for assessing whether a person who fails an initial vision test can safely perform as a locomotive engineer or conductor.
A “practical test,” more commonly known as a “field test” within the railroad community, is a test performed outdoors under test conditions that reasonably match actual operating or working conditions. A railroad is permitted to conduct field testing on a moving train, positioned in a stationary locomotive, or standing on the ground at distances from a signal or other object that the person must see and recognize to perform safely as a locomotive engineer or conductor.
Before issuing this interpretation, FRA contacted several organizations to collect information that would help in the development of recommended best practices for field tests, and FRA has captured that feedback in memoranda and documents it has placed in the docket. First, FRA wants to thank the American Academy of Ophthalmology and the American Optometric Association for providing expert medical information regarding testing and evaluating color perception during six conference calls held with FRA personnel. Second, FRA wants to thank the Brotherhood of Locomotive Engineers and Trainmen (BLET) and United Transportation Union-SMART Transportation Division for providing information and concerns regarding the strengths and weaknesses of current field testing practices, and asking that FRA find a way to encourage each railroad to conduct such field testing, during a conference call with FRA personnel. Third, FRA wants to thank the Association of American Railroads (AAR) for providing a written overview of the different practices currently used by various Class I railroads. AAR stated, in a July 14, 2015, Discussion on Color Vision Field Testing that field “testing is, at the moment, the preferred way of determining whether an individual's unique set of deficits actually impacts performance.” FRA provides best practices for designing valid, reliable, and comparable vision field tests in Section III, “Best Industry Practices for Conducting Color Vision Field Testing” of this interpretation.
A scientific vision test is a test instrument that, based on the results of a rigorous scientific study published in a peer-reviewed scientific or medical journal or other publication, is a valid, reliable, and comparable test for assessing whether a person has sufficient distance visual acuity, field of vision, or color vision, which, for purposes or railroad operations, allows the person to safely perform as a locomotive engineer or conductor. Examples of such scientific screening tests include, but are not limited to, a simulator, the Ishihara test and other color plate tests, a perimetry test (
In addition to field and scientific tests, FRA's locomotive engineer qualification and certification regulations also permit optometric or ophthalmologic referral which can provide important information about the nature and severity of a person's eye condition or visual disturbance. The referral can also provide information about whether the vision condition is stable or should be monitored more frequently than triennially by the railroad's medical examiner because it is likely to worsen to a level that would make it unsafe to perform service prior to a certified employee's next triennial recertification evaluation.
Sections 240.121(e) and 242.117(e) permit railroads to conditionally certify a person as a locomotive engineer or conductor if the railroad's medical examiner determines in writing that a special condition of certification is necessary on the basis of findings elicited on further evaluation of the person's vision. Examples of special conditions of certification include: (1) More frequent evaluation of an eye condition or visual disturbance by a railroad's medical examiner that will likely deteriorate prior to the person's next required triennial recertification examination to a level that the person may not be able to safely perform; (2) required use of corrective lenses (
FRA's locomotive engineer and conductor certification rules do not permit examinees to use chromatic lenses when taking an initial test the railroad selects from the list of accepted color vision test protocols in the appendices to parts 240 and 242. Although examinees may not use chromatic lenses during an initial color vision test, FRA grants each railroad the discretion to determine whether it will permit examinees to use chromatic lenses during a secondary field or other practical or scientific test offered by a railroad to further evaluate his or her ability to perform safely. However, since the time FRA last amended part 240, the Food and Drug Administration (FDA), issued the following cautionary information about the use of ChromaGen chromatic lenses:
Based on FDA's findings, and the fact that railroads generally operate to a degree under similar environmental lighting and weather conditions as operating an automobile, FRA recommends that railroads take a conservative approach.
Railroads should not permit locomotive engineers and conductors that have responsibility to recognize and distinguish between colors of railroad signals to safely perform as locomotive engineers and conductors until data from a valid, reliable, and comparable research study clearly establishes operating conditions when it is safe to use chromatic lenses for that purpose, and then restrict use to those operating conditions. Please note that both the FDA and FRA make a distinction between chromatic lenses and contact lenses manufactured to correct distant, intermediate, and near visual acuity that have a very light blue tint to aid the user
The railroad medical examiners are required by FRA certification regulations to document the basis for his or her decision that a person can or cannot safely perform as a locomotive engineer or conductor. This includes reports of testing, and should the examiner use optometric or ophthalmologic referral, the report of testing and evaluation from the optometrist or ophthalmologist.
FRA's locomotive engineer and conductor regulations require each railroad subject to those regulations to have a written visual testing program on file with FRA. Among other things, the certification program must include a railroad's procedure for evaluating the visual acuity of its locomotive engineers and conductors when those train crew members fail to meet the vision threshold criteria provided for in parts 240 and 242.
FRA considers this type of program modification to be a “material modification” requiring railroads to submit their revised programs to FRA for review and approval.
The following best practices are intended to guide each railroad in designing, implementing, and scoring color vision field testing for locomotive engineer and conductor certification. They are broadly drafted to allow each railroad to develop field testing procedures that will work for its own operational environment and to consider the unique medical circumstances of each examinee tested. Furthermore, these best practices will guide railroads to establish best field testing practices. Of course, FRA recognizes and appreciates that some railroads already follow many of these best practices, and will readily adopt additional best practices that are viewed as making the field test more valid, reliable, and comparable. FRA encourages each railroad to consider adopting all best practices.
(1)
(2)
(3)
(4)
a. The date and location of the test;
b. The participants' names and contact information;
c. The number of signals viewed;
d. Which signals were incorrectly identified; and
e. The aspects of each signal encountered.
(5)
(6)
(7)
(8)
a.
b.
c.
(9)
(10)
(11)
a.
b.
i.
ii.
iii.
iv.
c.
i.
ii.
iii.
iv.
d.
i.
ii.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; fishery notification.
This final rule implements Amendment 9 to the 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP) (Amendment 9) to bring smoothhound sharks under Federal management and establishes an effective date for previously-adopted shark management measures finalized in Amendment 3 to the 2006 Consolidated Atlantic HMS FMP (Amendment 3) and the 2011 Final Rule to Modify the Retention of Incidentally-Caught Highly Migratory Species in Atlantic Trawl Fisheries (August 10, 2011) (2011 HMS Trawl Rule). Specifically, this final rule establishes Atlantic and Gulf of Mexico regional smoothhound shark annual commercial quotas based on recent stock assessments; implements the shark gillnet requirements of the 2012 Shark and Smoothhound Biological Opinion (BiOp); and modifies current regulations related to the use of vessel monitoring systems (VMS) by Atlantic shark fishermen using gillnet gear. The term “smoothhound sharks” collectively refers to smooth dogfish (
Additionally, NMFS will hold an operator-assisted, public conference call and webinar on December 15, 2015, to discuss the methodology used to calculate the Atlantic and Gulf of Mexico smoothhound shark quotas (see
Effective March 15, 2016. An operator-assisted, public conference call and webinar will be held on December 15, 2015, from 2:00 p.m. to 4:00 p.m., EST.
The conference call-in phone number is 1-800-857-9816; participant pass code is 9776014. Participants are strongly encouraged to log/dial in 15 minutes prior to the meeting. NMFS will show a brief presentation via webinar followed by public questions. To join the webinar go to:
Copies of Amendment 9, including the Final Environmental Assessment (EA) and other relevant documents, are available from the HMS Management Division Web site at
Steve Durkee by phone: 202-670-6637 or Karyl Brewster-Geisz by phone: 301-427-8503 or by fax: 301-713-1917.
Atlantic sharks are managed under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and the authority to promulgate regulations under the Magnuson-Stevens Act has been delegated from the Secretary to the Assistant Administrator (AA) for Fisheries, NOAA. On October 2, 2006, NMFS published in the
A brief summary of the background of this final action is provided below. A more detailed history of the development of these regulations and the alternatives considered are described in the Final Environmental Assessment (EA) for Amendment 9, which can be found online on the HMS Web site (see
NMFS published a proposed rule on August 7, 2014 (79 FR 46217), outlining the alternatives analyzed in the Draft EA, identifying preferred alternatives, and soliciting public comments on the measures, which would impact the smoothhound shark and Atlantic shark fisheries. Specifically, the proposed rule included the following measures: For smooth dogfish only, modifying prohibitions on at-sea fin removal to be consistent with the SCA; implementing Term and Condition 4 of the 2012 Shark BiOp; based on updated catch data, adjusting the smoothhound shark quota finalized in Amendment 3; and modifying the VMS requirements for shark gillnet vessels. The full description of the management and conservation measures considered is included in both the Final EA for Amendment 9 and the proposed rule and is not repeated here.
The comment period for the Draft EA and proposed rule for Amendment 9 ended on November 14, 2014. The comments received, and responses to those comments, are summarized below under the heading labeled Response to Comments.
Management measures in Amendment 9 will impact both the smoothhound shark and Atlantic shark fisheries. This rule finalizes most of the management measures, but modifies others, that were contained in the Draft EA and proposed rule for Amendment 9. This section provides a summary of the final management measures being implemented by Amendment 9 and notes changes from the proposed rule to this final rule. Measures that are different from the proposed rule, or measures that were proposed but not implemented, are described in detail under the heading titled Changes from the Proposed Rule.
This final rule implements the smooth dogfish-specific measures in the SCA to establish an allowance for the removal of smooth dogfish fins while at sea. To implement the measures, the proposed rule considered three categories of requirements—catch composition, state permitting, and geographic applicability of the exceptions—and a range of alternatives within each category (“sub-alternatives”). Only fishermen that meet the requirements under all three of these categories and that are, as specified in the Act, fishing within 50 nautical miles of shore and possess fins in an amount that does not exceed 12 percent of the carcass weight, would be authorized to remove smooth dogfish fins at sea.
For catch composition, NMFS preferred in the proposed rule a sub-alternative that would have required that smooth dogfish make up at least 75 percent of the retained catch on board and that no other sharks could be retained. For state permitting, the proposed rule included a sub-alternative that would have required an individual to hold a state commercial fishing permit that allows smooth dogfish retention, in addition to a Federal smoothhound permit. With regard to geographic applicability, the proposed rule included a sub-alternative that would have applied the SCA exception for smooth dogfish along the entire Atlantic coast but not to Florida's coast in the Gulf of Mexico. During the public comment period, NMFS received support for the two proposed sub-alternatives related to state fishing permits and geographic applicability of the SCA provisions. However, NMFS received many comments opposing the catch composition requirement of 75 percent and the “no other sharks on board” provision. Commenters expressed concern that these requirements do not meet the intent of the statutory exception because they do not reflect the mixed nature of catch in the smooth dogfish fishery and would render the exception largely meaningless. They also stated that the catch composition requirement would lead to excessive dead discards and would be burdensome.
As detailed under the Changes from the Proposed Rule heading, NMFS is implementing the two sub-alternatives related to state fishing permits and geographic applicability of the exception as originally proposed. NMFS is changing the catch composition requirement and will require smooth dogfish to make up at least 25 percent of the total retained catch in order to remove the fins of smooth dogfish while at sea. Additionally, fishermen may retain other sharks on board provided that the fins of other shark species remain naturally attached to the carcass through offloading. Only fishermen adhering to the measures in the three sub-alternatives, as well as fishing within 50 nautical miles of shore and possessing fins in an amount that does not exceed 12 percent of the carcass weight, will be authorized to remove smooth dogfish fins at sea.
This final rule also establishes separate Atlantic and Gulf of Mexico regional smoothhound shark total allowable catches (TACs) and commercial quotas based on the results of the 2015 Southeast Data Assessment and Review (SEDAR) 39 stock assessments for smoothhound sharks. The assessments were finalized and peer reviewed in March 2015. On June 29, 2015, NMFS issued a stock status determination notice (80 FR 36974) that stated that “[d]ata from tagging and genetic research in SEDAR 39 support the existence of two distinct Atlantic and Gulf of Mexico stocks of smooth dogfish separated by peninsular Florida. Therefore, smooth dogfish was treated as two separate stocks, one in the Atlantic region and one in the Gulf of Mexico region.” 80 FR 36974 (June 29, 2015). Each stock had a status of not overfished with no overfishing occurring. Based on public comments requesting that commercial quotas be based on stock assessments and not
Term and Condition (TC) 4 of the 2012 Shark BiOp addressed soak time and net check requirements for gillnet gear. In order to comply with TC 4, this final rule modifies the soak time and net check requirements based on the type of gillnet gear used in the Atlantic shark and smoothhound shark fisheries. NMFS has determined that current regulations meet the specifications for other TCs in the 2012 BiOp. This final rule will establish a soak time limit of 24 hours for sink gillnet gear and a 0.5 to 2 hour net check requirement for drift gillnet gear in the Atlantic shark and smoothhound shark fisheries. This requirement would not significantly change smoothhound shark fishing practices, since most smoothhound shark gillnet fishermen primarily use sink gillnet gear and those fishermen already use a soak time of 24 hours or less.
This final rule also modifies current regulations related to the use of VMS by federal directed shark permit holders using gillnet gear. Before this rule, federal directed shark permit holders with gillnet gear on board were required to use VMS regardless of vessel location in order to simplify compliance and outreach for fishermen operating across multiple regions. This requirement was implemented as part of the 2003 Amendment 1 to the 1999 FMP for Atlantic Tunas, Swordfish, and Sharks to ensure shark gillnet vessels were complying with the Atlantic Large Whale Take Reduction Plan (ALWTRP) time/area closures and observer requirements (50 CFR 229.32). However, since implementation, it has become apparent that while some fishermen do fish in multiple regions, many do not fish in or even near the Southeast U.S. Monitoring Area. As such, this final rule will require federal directed shark permit holders with gillnet gear on board to use VMS only in the vicinity of the Southeast U.S. Monitoring Area, pursuant to ALWTRP requirements. Requirements to minimize large whale interactions would not change; rather, only the geographic area of the VMS requirement would change, consistent with the ALWTRP.
This final rule also establishes an effective date for previously-adopted smoothhound shark management measures in Amendment 3 and the 2011 HMS Trawl Rule. The final rule implementing conservation and management measures in Amendment 3 published on June 1, 2010 (75 FR 30484) but delayed the effective date of the smoothhound shark management measures until approximately 2012 pending approval for the data collection measures under the Paperwork Reduction Act (PRA) by the Office of Management and Budget (OMB), to provide time for implementation of a permit requirement, to provide time for NMFS to complete a Biological Opinion under Section 7 of the Endangered Species Act (ESA), and to provide time for affected fishermen to change business practices, particularly as it related to keeping shark fins attached to the carcass through offloading. OMB approved the PRA data collection in May of 2011 and NMFS met informally with smoothhound shark fishermen along the east coast in the fall of 2010. In November 2011, NMFS published a rule (76 FR 70064, November 10, 2011) that indefinitely delayed the effective date for all smoothhound shark management measures in both Amendment 3 and in another rule, the 2011 Final Rule to Modify the Retention of Incidentally-Caught Highly Migratory Species in Atlantic Trawl Fisheries (76 FR 49368, August 10, 2011 (2011 HMS Trawl Rule)), to provide time for NMFS to consider the smooth dogfish-specific provisions in the SCA and for NMFS to finalize a Biological Opinion on the federal actions in Amendment 3, among other things. Previously-adopted management measures from Amendment 3 that will become effective on January 1, 2016, include: A research set-aside quota; an accountability measure (AM), which closes the fishery when smoothhound shark landings reach, or are expected to reach, 80 percent of the quota; a requirement for a dealer permit to purchase smoothhound sharks; a requirement for dealers to report smoothhound shark purchases; a smoothhound permit requirement for commercial and recreational fishing and retention; a requirement for vessels fishing for smoothhound sharks to carry an observer, if selected; a requirement for vessels fishing for smoothhound sharks to comply with applicable Take Reduction Plans pursuant to the Marine Mammal Protection Act (MMPA); and a requirement for commercial vessels to sell catch only to Federally-permitted shark dealers. Management measures affecting smoothhound sharks in the HMS Trawl Rule will allow retention of smoothhound sharks caught incidentally with trawl gear, provided that the total smoothhound shark catch on board or offloaded does not exceed 25 percent of the total catch by weight.
Finally, this rule makes administrative changes to the observer regulations. Currently, the Atlantic shark fishery observer program is administered by the Southeast Fisheries Science Center (SEFSC). However, a portion of the commercial smoothhound shark fishery occurs in the Northeast region in an area typically covered by observer programs administered out of the Northeast Fisheries Science Center (NEFSC). Since the fishery spans the geographic area of both the NEFSC and SEFSC, smoothhound shark observer regulations need to accommodate the administrative processes of both programs. The two regional science center observer program processes are slightly different. The SEFSC process is currently outlined in the 50 CFR part 635 regulations but the NEFSC process is not. Thus, this final rule implements changes to the observer regulations in 50 CFR part 635 to incorporate the relevant portions of the NEFSC observer regulations found at 50 CFR part 648.
During the proposed rule stage, NMFS received approximately 500 written comments from fishermen, States, environmental groups, academia and scientists, and other interested parties. NMFS also received feedback from the HMS Advisory Panel; constituents who attended the two public hearings in October 2014 in Toms River, New Jersey, and Manteo, North Carolina; and constituents who attended the conference calls/webinars held on September 24 and November 4, 2014. Additionally, NMFS consulted with the New England, Mid-Atlantic, South Atlantic, Gulf of Mexico, and Caribbean Regional Fishery Management Councils, along with the Atlantic States and Gulf
Based on public comments, however, it has become apparent that the 75 percent level used in other fisheries is not appropriate in the smooth dogfish fishery and does not accurately reflect fishing practices in that fishery. To verify the feedback from commenters, NMFS reviewed data on the mixed nature of the smoothhound shark fishery and how well catch composition reflects the fishery and discovered that, as asserted by the commenters, the smooth dogfish fishery is far more mixed than NMFS assumed in the proposed rule. As a result, implementing a 75 percent catch composition requirement would make the exception largely meaningless. Thus, while NMFS' objective for the implementation of the smooth dogfish-specific provision of the SCA remains the same as described in the Draft EA, and NMFS still needs to give meaning to the phrase “fishing for smooth dogfish” as opposed to simply “fishing,” NMFS agrees with the majority of the commenters that a catch composition requirement of 25 percent is more appropriate. This is consistent with the smooth dogfish-specific provision in the SCA that limits the exception to those fishermen that are
• Sink gillnet gear, the predominant gear used in the directed smooth dogfish fishery, often catches other species along with the targeted species. If a fisherman retains other legal species in an amount greater than 25 percent of the total retained catch, it does not necessarily mean that effort was not being directed on smooth dogfish, it could simply mean that other species were encountered in a greater amount than anticipated.
• Although a 75 percent catch composition is an appropriate indicator of target species in other HMS fisheries, such as the squid trawl fishery, it is not appropriate at this time in the smooth dogfish fishery. In the squid trawl fishery, swordfish caught in squid trawls can only be retained if at least 75 percent of the retained catch is squid, indicating that squid is the targeted fishery. In that fishery, the catch is predominantly squid but swordfish that are feeding on the squid are sometimes inadvertently caught. The smooth dogfish fishery is a more mixed fishery and the target species is often co-located with other species, resulting in less certainty of target species catch levels
• When fishermen decide to remove fins from smooth dogfish while at sea, the fins are not removed at the end of the trip. Rather, the fins are removed shortly after the smooth dogfish is brought on board in order to maintain the highest quality product. This processing method negates the benefits of a high catch composition requirement. For example: If a fishermen is directing effort on smooth dogfish and removing the fins as the smooth dogfish are brought on board, that fishermen does not know what the final catch composition will be. The first part of the trip could be 100 percent smooth dogfish, but if the catch transitions to predominantly other species, the fishermen may have found that he no longer meets the high catch composition requirement. In that case, the fisherman has two options: To either discard all the smooth dogfish carcasses and fins that have been processed or discard the non-smooth dogfish catch in an amount that will meet the catch composition requirement. Either way, a high catch composition could lead to unnecessary regulatory discards. Although this last example could also pertain to the preferred 25 percent catch composition, the lower threshold provides a greater amount of flexibility and reduces the instances of regulatory discards, consistent with National Standard 9.
• Smooth dogfish, and the fishery that targets them, closely follow specific water temperature gradients. Fisherman intending to land primarily smooth dogfish may find their gear in sub-optimal water temperatures leading to lower smooth dogfish catch despite the intention to directly target the species and resulting in a lower catch composition than expected.
Allowing other sharks onboard is consistent with the objective of Amendment 9 to narrowly focus the at-sea fin removal allowance for the smooth dogfish fishery and would not undermine the enforcement of the limited smooth dogfish exception or impact the conservation of non-smooth dogfish sharks because smooth dogfish carcasses can be readily differentiated from other non-smoothhound shark carcasses by the presence of a pre-dorsal ridge. As a practical matter, smooth dogfish and other smoothhound species
Section 9 and regulations implementing section 4(d) of the ESA prohibit the “take” or incidental take of listed species without an exemption. Under the terms of Section 7(b)(4) and Section 7(o)(2), otherwise prohibited take that is incidental to and not intended as part of the agency action may be permitted if it complies with reasonable and prudent measures (RPMs) and terms and conditions of an incidental take statement (ITS). Two RPMs were included in the 2012 Shark BiOp to minimize the effects of the action on sea turtles, smalltooth sawfish, and Atlantic sturgeon by the smoothhound and Atlantic shark fisheries and to monitor the level of incidental take: (1) Minimize the Potential Effects to Sea Turtles, Smalltooth Sawfish, Atlantic Sturgeon and Marine Mammals, and (2) Monitor the Frequency and Magnitude of Incidental Take. One remaining term and condition will be implemented in this final rule and will require gillnet fishermen to conduct net checks and limit gillnet soak times mitigating or reducing interactions with protected species.
Since finalizing the 2012 BiOp, NMFS issued a final determination to list four separate DPSs of the scalloped hammerhead shark (
On October 30, 2014, based on the new listings, NMFS requested re-initiation of ESA section 7 consultation on the continued operation and use of HMS gear types (bandit gear, bottom longline, buoy gear, handline, and rod and reel) and associated fisheries management actions in the 2006 Consolidated Atlantic HMS FMP and its amendments. NMFS has preliminarily determined that the ongoing operation of the fisheries is consistent with existing biological opinions and is not likely to jeopardize the continued existence of the Central and Southwest DPS of scalloped hammerhead sharks or the threatened coral species or result in an irreversible or irretrievable commitment of resources which would foreclose formulation or implementation of any reasonable and prudent alternative measures for these species.
Regarding marine mammals, the final 2014 MMPA List of Fisheries classified the southeastern Atlantic shark gillnet fishery as Category II (occasional serious injuries and mortalities). The southeastern Mid-Atlantic and Gulf of Mexico shark BLL shark fishery is classified as Category III (remote likelihood or no known serious injuries or mortalities). Commercial passenger fishing vessel (charter/headboat) fisheries are subject to Section 118 and are listed as a Category III fishery. This action would not significantly increase fishing effort rates, levels, or locations or fishing mortality. The preferred alternatives would not increase effort because the smoothhound quotas are based on the most recent smoothhound shark stock assessments (SEDAR 39). In addition, final management measures are not expected to alter interactions with protected species.
Through Addendum II to the Coastal Sharks Interstate FMP, the ASMFC instituted state shares of the Federal smoothhound shark quota. Although this system was finalized in May 2013 before the Federal smoothhound shark quota was effective, Addendum II proactively divided the quota among several of the Atlantic states in an amount that would total 100 percent of the Federal quota. This agreement among the Atlantic states to limit each state's harvest does not impact nor influence the Federal quota. Although NMFS recognizes that closing the fishery when landings reach, or are expected to reach, 80 percent of the quota could prevent some states from harvesting their full state share of the quota per the ASMFC plan, the measure is an important and effective way to ensure that the sustainability of the smoothhound shark fishery is not jeopardized by overharvests.
NMFS made several changes from the proposed rule, as described below.
1.
NMFS received numerous public comments that the 75 percent catch composition requirement did not adequately reflect the mixed nature of the smooth dogfish fishery and would lead to excessive dead discards. Based on this public comment, NMFS reconsidered the 75 percent smooth dogfish requirement, and determined that it does not properly reflect fishing “for” smooth dogfish. According to public comment, fishermen that fish for smooth dogfish often encounter and retain other species of fish. NMFS verified this by evaluating data from vessel trip reports (VTR). On trips that landed smooth dogfish caught in sink gillnet gear between 2003 and 2014, smooth dogfish only made up 36 percent of the total retained catch while other species such as croaker, bluefish, monkfish, and spiny dogfish made up the remainder.
Related to the catch composition change and concern about discards, this final rule also makes a change from the proposed rule by allowing retention of other shark species provided that their fins remain naturally attached to the carcass through offloading. This measure is included based on public comment and additional analyses and recognizing that a prohibition on having other sharks on board would likely increase regulatory discards. Specifically, additional analyses indicate that the smooth dogfish fishery is more mixed than previously thought, and that other sharks, particularly spiny dogfish and common thresher sharks, make up a portion of the catch and revenue for fishermen also fishing for smooth dogfish. Given that fishermen process smooth dogfish as they are brought on board, including removing the fins where allowable, the proposed rule approach would have forced fishermen to choose whether to land smooth dogfish with the fins removed (and discard the other species) or land the other species of shark with the fins attached and discard the smooth dogfish with their fins removed at sea. As proposed, a fisherman who wanted to remove smooth dogfish fins at sea would not have been able to retain non-smooth dogfish sharks even if those sharks were dead and otherwise legally retainable based on species, size, and permits. In either situation, as proposed, dead discards would likely have increased given the mixed catches in the smooth dogfish fishery. Thus, other sharks will be allowed on board when smooth dogfish fins have been removed at sea as long as the fins of the non-smooth dogfish sharks remain naturally attached through offloading, as is currently required.
Allowing other sharks on board should not raise enforcement concerns or impact the conservation of non-smooth dogfish sharks because smooth dogfish carcasses can be readily differentiated from other shark carcasses by the presence of a pre-dorsal ridge. While other “ridgeback sharks” have an interdorsal ridge, smooth dogfish are the only shark species in the Atlantic that have a pre-dorsal ridge. We will work with the Office of Law Enforcement to ensure that they are aware of this identifying feature and will update outreach information for shark identification including relevant workshops as appropriate to make permitted shark fishermen and dealers aware of the distinction. NMFS will also continue to monitor all shark catches and discards and take additional action, if necessary to address non-compliance.
The changes in this final rule are consistent with the conservation and management objectives of the Magnuson-Stevens Act and Amendment 9 and the SCA. These changes will not impact the conservation of smooth dogfish or other sharks because landings of these species, regardless of catch
2.
During the public comment period on the proposed rule and draft EA, commenters expressed concern about implementing a smoothhound shark commercial quota based on historical landings, and requested that NMFS wait for SEDAR 39 to be completed. Based on these comments, in this final rule, NMFS is implementing region-specific commercial quotas based on SEDAR 39. Specifically, this final rule establishes an overall TAC of 1,940.2 mt implemented as follows: An Atlantic regional smoothhound shark TAC of 1,430.6 mt dw with a commercial quota of 1,201.7 mt dw, and a Gulf of Mexico regional smoothhound shark TAC of 509.6 mt dw with a commercial quota of 336.4 mt dw. Although the TAC identified in the final rule is inclusive of sources of mortality other than a commercial quota (which is thus necessarily less than the TAC), the overall TAC in the final rule is only 201 mt more than the 1,739.9 mt dw commercial quota from the proposed rule. Thus, establishing a TAC of this level does not raise concerns about requiring additional environmental analyses or additional regulatory action, which may have been the case if the stock assessment had identified a significantly greater allowable TAC (and resultant commercial quota) than those anticipated and analyzed in the proposed rule. The proposed rule presented and analyzed an alternative that anticipated the stock assessment would determine that “the commercial smoothhound shark quota should be set at approximately equal to or greater than 1,739.9 mt dw.” As acknowledged in the EA, even with a higher quota, effort is likely to remain the same relative to current effort. Thus the ecological, economic and social impacts of quota establishing a quota greater than 1,739.9 mt would be within the range analyzed in the Draft EA. In the final rule, the combined regional commercial quotas (1,538.1 mt) are twelve percent less than the original proposed overall quota (1,739.9 mt) but higher than recent annual commercial landings. Both the commercial quotas and the overall TAC in this final rule are within the range of actions considered in the proposed rule and analyzed in the draft EA.
With regard to the regional quota approach, in the Draft EA, NMFS acknowledged that the stock could be split between two regions based on the SEDAR 39 stock assessments and that the analyses performed for one over-arching quota could apply to multiple regions. Based on information supplied during the Data Workshop for SEDAR 39, including tagging data, the stock assessment scientists decided to split smoothhound sharks into two regional stocks, with smooth dogfish in the Atlantic and smooth dogfish, Florida smoothhound, and Gulf smoothhound in the Gulf of Mexico. This regional split, however, does not affect the impact analyses detailed in the Draft EA under Alternative B4, scenario 4. As noted in Section 3.4 of the Draft EA and as confirmed in the SEDAR 39 stock assessments, the smoothhound shark fishery primarily occurs in the Mid-Atlantic region and is composed entirely of smooth dogfish catch. In the Gulf of Mexico region, only a very small, negligible, number of commercial landings occur and there is no commercial fishery. Thus, the Draft EA Alternative B4 quota analyses were informed entirely by data from the Atlantic region including catch location, price data, landings data, and fishery operations. If NMFS applied the single over-arching quota analyses to regional smoothhound shark quotas at the Draft stage, there would have been no information available for the Gulf of Mexico and, with no commercial fishery in that region, a finding of neutral impact. In the Atlantic region where the fishery is located, all impacts detailed in the Draft EA would apply because all data, including catch location, price data, landings data, and fishery operations, came from the Atlantic. Furthermore, the Atlantic smoothhound shark stock assessment would not have resulted in any new impacts because the assessment found current harvest levels and effort are sustainable with no changes required. In summary, the impact analyses detailed in the Draft EA under Alternative B4, scenario 4 are equally applicable to two regional quotas as to one over-arching quota. The changes in this final rule are consistent with the conservation and management objectives of the Magnuson-Stevens Act and Amendment 9 and based on the best scientific information available. Implementing TACs based on the stock assessment results would ensure continued sustainable harvest of smoothhound sharks in the Atlantic and Gulf of Mexico regions and increase the likelihood of maintaining healthy smoothhound shark stocks in both regions.
3.
4.
Pursuant to the measures being implemented in this final rule, the 2016 base quotas for smoothhound sharks in the Atlantic and Gulf of Mexico regions would be 1,201.7 mt dw and 336.4 mt dw, respectively. The fishing season for the smoothhound shark fishery will open on January 1, 2016.
The AA has determined that this final rule is consistent with the 2006 Consolidated Atlantic HMS FMP and its amendments, the Magnuson-Stevens Act, and other applicable law.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
A Final Regulatory Flexibility Analysis (FRFA) was prepared for this rule. The FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA), and a summary of the analyses completed to support the action. The full FRFA and analysis of economic and ecological impacts are available from NMFS (see
Section 604(a)(1) of the Regulatory Flexibility Act (RFA) requires a succinct statement of the need for and objectives of the rule. Chapter 1 of the Final EA and the final rule fully describe the need for and objectives of this final rule. The purpose of this final rulemaking, consistent with the Magnuson-Stevens Act, the ESA, and the MMPA, and the 2006 Consolidated HMS FMP and its amendments, is to provide for the sustainable management of smoothhound sharks and Atlantic shark species. The management objectives are to achieve the following: Implement the smooth dogfish-specific provisions of the SCA; implement smoothhound shark quotas based on the results of SEDAR 39; implement Term and Condition 4 of the 2012 Shark BiOp related to gillnet impacts on ESA-listed species; and revise Atlantic shark gillnet VMS regulations in compliance with the ALWTRP, per the MMPA.
Section 604(a)(2) of the RFA requires a summary of the significant issues raised by the public comments in response to the IRFA and a summary of the assessment of the Agency of such issues, and a statement of any changes made in the rule as a result of such comments. NMFS received many comments on the proposed rule and the Draft EA during the public comment period. A summary of these comments and the Agency's responses, including changes as a result of public comment, are included above. NMFS did not receive comments specifically on the IRFA.
Section 604(a)(4) of the RFA requires agencies to provide an estimate of the number of small entities to which the rule would apply. The small business size standard for Finfish Fishing is $ 20.5 million, for Shellfish Fishing is $5.5 million, and for Other Marine Fishing is $7.5 million.
NMFS does not have exact numbers on affected commercial fishermen. The smoothhound shark commercial permit has not yet been established, so NMFS does not know how many smoothhound shark fishermen will be impacted. An annual average of 169 vessels reported retaining smooth dogfish through VTR from 2003-2014. This is NMFS' best estimate of affected smoothhound shark fishermen.
Additionally, while the retention of sharks in Federal waters requires one of two limited access commercial shark permits, these permits do not specific gear type, including gillnets. For this reason, NMFS does not know the exact number of affected shark gillnet fishermen. As of May 21, 2015, there are 208 directed shark and 253 incidental shark permit holders. Logbook records indicate that there are usually about 18 Atlantic shark directed permit holders that use gillnet gear in any year. However, the universe of directed permit holders using gillnet gear can change from year to year and could include anyone who holds an Atlantic shark directed permit.
As of May 21, 2015, there are 97 Atlantic shark dealers. These dealers could be affected by these measures to varying degrees. Not all of these dealers purchase smoothhound sharks and those that do are concentrated in the Mid-Atlantic region. NMFS will know more about the number of affected dealers when smoothhound reporting requirements become effective. Similarly, not all of these dealers purchase Atlantic sharks caught with gillnet gear. The number is likely low and is concentrated in Florida and the Gulf of Mexico.
Section 604(a)(5) of the RFA requires Agencies to describe any new reporting, record-keeping and other compliance requirements. The Federal commercial smoothhound shark permit requirement analyzed in Amendment 3 will become effective upon the effective date of this rule. NMFS submitted a PRA change request to The Office of Management and Budget (OMB) to add this permit to the existing HMS permit PRA package (OMB control number 0648-0327). OMB subsequently approved the change request to add the Federal commercial smoothhound shark permit to the HMS permit PRA package in May 2011. In November 2015, NMFS submitted a revision to transfer the previously approved commercial smoothhound shark permit from the HMS permit PRA package (OMB Control Number 0648-0327) to the Southeast Regional Office (SERO) permit PRA package (OMB Control Number 0648-0205). That request is still pending approval. Once OMB approves the request, NMFS will issue a notice in the
The RFA requires a description of the steps the Agency has taken to minimize any significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and the reason that each one of the other significant alternatives to the rule considered by the Agency that affect small entities was rejected. These impacts are discussed below and in the FRFA for Amendment 9. Additionally, the RFA (5 U.S.C. 603 (c)(1)-(4)) lists four general categories of “significant” alternatives that could assist an agency in the development of significant alternatives. These categories of alternatives are: Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; use of performance rather than design standards; and, exemptions from coverage of the rule for small entities.
In order to meet the objectives of this rule, consistent with Magnuson-Stevens Act and ESA, we cannot exempt small entities or change the reporting requirements only for small entities because all the entities affected are
The alternatives considered and analyzed are described below. The FRFA assumes that each vessel will have similar catch and gross revenues to show the relative impact of the final action on vessels.
With regard to the implementation of the SCA, NMFS considered two alternatives. Alternative A1, which would not implement the smooth dogfish-specific provisions of the SCA and would instead implement the fins-attached requirement finalized in Amendment 3, and Alternative A2, which would implement the smooth dogfish-specific provisions of the SCA and has sub-alternatives that address the specific elements of the of the smooth dogfish-specific provisions.
Alternative A1 would not implement the smooth dogfish-specific provisions of the SCA and would require all smooth dogfish to be landed with fins naturally attached. This alternative would change current fishing practices since smooth dogfish caught in the directed and incidental fisheries are fully processed while at sea. As a result, this Alternative A1 would likely lead to reduced landings and a lower ex-vessel price because the product would not be fully processed. This could lead to adverse socioeconomic impacts.
Under Alternative A2, the preferred alternative, an allowance for the removal of smooth dogfish fins at sea would increase efficiency in the smooth dogfish fishery and provide a more highly processed product for fishermen to sell to dealers. Quantifying the financial benefits is difficult because baseline effort and increases in efficiency cannot be calculated, but the benefit would fall somewhere between the two extremes of $0 and $699,364, the ex-vessel value of the entire fishery (Section 3.6.2). Assuming that amount is spread evenly across all 169 vessels per year that retain smooth dogfish (Section 6.1), the benefit to individual vessels would be $4,138. However, vessels and trips retain smooth dogfish in widely varying amounts, thus, this per vessel estimate may not provide an accurate picture of individual revenues.
Supporting entities, such as bait and tackle suppliers, ice suppliers, dealers, and other similar businesses, could experience increased revenue if the efficiency of fin removal at sea results in a higher quality product. However, while supporting businesses would benefit from the increased profitability of the fishery, they do not solely rely on the smooth dogfish fishery. In the long-term, it is likely that changes in the smooth dogfish fishery would not have large impacts on these businesses.
Under Sub-Alternative A2-1a, smooth dogfish could make up any portion of the retained catch on board provided that no other sharks are retained. This sub-alternative would authorize smooth dogfish fishermen to retain any non-shark species of fish while still availing themselves of the at-sea fin removal allowance. Smooth dogfish are often caught incidentally during other fishing operations, thus, this sub-alternative would allow fishermen to maximize the profitability of each trip and allow individual operators the flexibility to make decisions, before the trip and while on the water, as to the retained catch composition that would maximize ex-vessel revenues. Under this alternative, fishermen could remove smooth dogfish fins at sea during any type of trip including those trips that are directing effort on other non-shark species. This alternative would maintain the current practice in the fishery and vessels could continue to have ex-vessel revenues of $699,364 per year across the entire fishery (Section 3.6.2).
Under Sub-Alternative A2-1b, fishermen could avail themselves of the at-sea fin removal allowance only if smooth dogfish comprise 25 percent of the retained catch on board. This sub-alternative would authorize smooth dogfish fishermen to retain some non-shark species of fish while still availing themselves of the at-sea fin removal allowance. This sub-alternative would allow some fishermen to maintain the profitability of each trip and allow individual operators some flexibility to make decisions, before the trip and while on the water, as to the retained catch composition that would increase ex-vessel revenues. This increase in flexibility would be to a lesser extent than Sub-Alternative A2-1a which would not have a catch composition requirement, but greater than the other sub-alternatives that limit the fins-attached exception to higher catch composition percentages. This sub-alternative would decrease total ex-vessel revenues relative to the current level of $699,364 per year (Section 3.6.2).
Under Sub-Alternative A2-1c fishermen could avail themselves of the at-sea fin removal allowance only if smooth dogfish comprise 75 percent of the retained catch on board. This sub-alternative would allow fishermen limited flexibility to maintain the profitability of each trip and would allow fishermen to make decisions, before the trip and while on the water, as to the retained catch composition that would increase ex-vessel revenues. While limited, the flexibility in this alternative would be greater than in sub-alternative A2-1d, which would require smooth dogfish catch composition of 100 percent. Because some fishermen catch smooth dogfish along with other species, this sub-alternative could decrease the number of mixed species trips where fishermen could take advantage of the at-sea fin removal allowance. This sub-alternative would likely decrease total ex-vessel revenues relative to the current level of $699,364 per year.
Sub-Alternative A2-1d would require smooth dogfish to comprise 100 percent of the retained catch on board the vessel in order for fishermen to avail themselves of the at-sea fin removal allowance for smooth dogfish. This sub-alternative would eliminate the ability of mixed trips to take advantage of the at-sea fin removal, and would reduce flexibility in deciding which species to retain on each fishing trip. However, approximately 31 vessels (annual average 2003-2014) on directed smooth dogfish trips often only retain smooth dogfish due to the processing practices in place. Thus, these fishermen would not be impacted by a 100 percent smooth dogfish requirement and would benefit from the ability to remove the smooth dogfish fins at sea. This sub-alternative would likely decrease total ex-vessel revenues relative to the current level of $699,364 per year.
Sub-Alternative A2-1e, the preferred sub-alternative, would, similar to Sub-Alternative A2-1b, allow fishermen to avail themselves of the at-sea fin removal allowance only if smooth dogfish comprise 25 percent of the retained catch on board. However, under Sub-Alternative A2-1e, other sharks could be retained as well, provided they are maintained with the fins naturally attached to the carcass. This sub-alternative would allow some
Sub-Alternative A2-2a would require federal smoothhound permitted fishermen to obtain a smooth dogfish-specific state commercial fishing license in order to be able to remove smooth dogfish fins at sea. The requirement to obtain a smooth dogfish-specific state commercial fishing license may be more difficult for fishermen who are in states that do not have smooth dogfish-specific permits in place. This sub-alternative would result in the increased burden on fishermen to obtain another permit, and depending upon the state, could result in an additional permit charge. Since most permits are valid for one year, fishermen would likely need to renew the permit each year for as long as they wish to retain smooth dogfish and remove the fins while at sea. Because not all states have smooth dogfish-specific permits, NMFS does not prefer this alternative.
Sub-Alternative A2-2b, the preferred alternative, would require fishermen to hold any state commercial fishing permit that allows retention of smooth dogfish. It is likely, however, that most smooth dogfish fishermen already hold this type of state permit and would be unaffected by this requirement. This sub-alternative would likely be the most straightforward for regulatory compliance because the permit requirement would be the simpler than sub-alternative A2-2a. Thus, NMFS prefers this sub-alternative.
NMFS considered two alternatives for Geographic Application of the SCA exception. Under Sub-Alternative A2-3a, the exception would apply along the Atlantic Coast and the Florida west coast in the Gulf of Mexico. As explained earlier, as a practical matter, smooth dogfish and other smoothhound species are indistinguishable, although smoothhound are distinguishable from other ridgeback sharks by the presence of a pre-dorsal ridge. The best available scientific information indicates that smooth dogfish are likely the only smoothhound shark species along the Atlantic coast. In the Gulf of Mexico, however, there are at least three different smoothhound species, with no practical way to distinguish among them. This sub-alternative would apply the smooth dogfish exception 50 nautical miles from the baseline of all the States that fall under the SCA definition of “State.” This sub-alternative could result in other smoothhound sharks indirectly falling under the exception, because they cannot be distinguished from smooth dogfish. NMFS does not expect any impacts because there is no commercial fishery for smooth dogfish in the Gulf of Mexico at this time. However, NMFS does not prefer this sub-alternative because, if a fishery does develop, species misidentification could result in enforcement action.
Under Sub-Alternative 3b, the preferred sub-alternative, the exception would only apply along the Atlantic coast and not the Florida west coast in the Gulf of Mexico. By not extending the exception into the Gulf of Mexico, this sub-alternative would ensure that the SCA's exception to the fins-attached requirements for smooth dogfish would only apply along the Atlantic Coast where the population is almost entirely smooth dogfish, reducing identification problems and inadvertent finning violations. NMFS does not expect any impacts because, at this time, there is no commercial fishery for smooth dogfish in the Gulf of Mexico. NMFS prefers this sub-alternative because it simplifies enforcement and compliance without adverse impacts. This sub-alternative would not affect total ex-vessel revenues relative to the current level of $699,364 per year.
With regard to the smoothhound quota alternatives, NMFS considered four alternatives. Alternative B1, which would implement the smoothhound shark quota finalized in Amendment 3; Alternative B2, which would establish a rolling quota based on the most recent five years of landings data; Alternative B3, which would calculate the smoothhound quota using the same method as in Amendment 3 but would use updated smoothhound landings information; and Alternative B4, which would establish smoothhound shark quotas that reflects the results of the SEDAR 39 smoothhound shark stock assessments.
Alternative B1 would implement the quota finalized in Amendment 3 (715.5 mt dw), which was based on highest annual landings from (1998 to 2007) and adding two standard deviations. Current reported smoothhound shark landings are higher than the quota level in Alternative B1. As such, implementing this quota would prevent fishermen from fishing at current levels, resulting in lost revenues. In 2010 when landings peaked, total smoothhound shark landings totaled 2,688,249 lb dw (ACCSP data) resulting in ex-vessel revenues across the entire smoothhound sink gillnet fishery of $2,458,135 (2,688,249 lb of meat, 322,590 lb of fins). Implementation of the Amendment 3 quota (715.5 mt dw) would result in ex-vessel revenues of only $1,442,367 (1,577,391 lb of meat, 189,287 lb of fins), which is $1,015,768 less than current ex-vessel revenues. Both of these estimates assume $1.62/lb for fins, $0.72/lb for meat, and a 12 percent fin-to-carcass ratio (prices based on 2014 dealer data and fin-to-carcass ratio based on the SCA). Seventy-five percent of all landings in the smoothhound shark fishery come from sink gillnets and there are approximately 77 vessels that use sink gillnet gear to fish for smoothhound sharks in any given year. Assuming an average of 77 sink gillnet vessels fishing for smoothhound sharks, the quota in this alternative would result in annual ex-vessel revenues of $18,732 per vessel which is less than 2010 ex-vessel revenues of $31,923 per vessel. This is an average across all directed and incidental sink gillnet vessels and this individual annual vessel ex-vessel revenue may fluctuate based on the degree to which fishermen direct on smoothhound sharks.
The quota in Alternative B1 does not accurately characterize current reported landings of smoothhound sharks. Vessels that fish for smoothhound sharks likely fished opportunistically on multiple species of coastal migratory fish and elasmobranches, and it is unlikely that any sector within the fishing industry in the Northeast (fisherman, dealer, or processor) relies wholly upon smoothhound sharks. Longer-term impacts are expected to be neutral given the small size of the fishery and the generalist nature of the sink gillnet fishery.
Alternative B2 would establish a rolling smoothhound shark quota set above the maximum annual landings for the preceding five years; this quota would be recalculated annually to account for the most recent landing
Setting the quota above current landings levels should allow the fishery to continue, rather than be closed, allowing for NMFS to collect more information that can be used in future stock assessments. Alternative B2 is consistent with the intent of Amendment 3, which was to minimize changes to the fishery while information on catch and participants was collected. Because landings in the smoothhound shark fishery are likely underreported, it is unclear at this time whether the increase in reported landings is due to existing smoothhound fishermen reporting in anticipation of future management or increased effort (
Alternative B3 would create a smoothhound quota equal to the maximum annual landings from 2005-2014 plus two standard deviations and would equal 1,733.9 mt dw. This alternative would establish a smoothhound quota two standard deviations above the maximum annual landings reported over the last ten years which is the method used to calculate the smoothhound shark quota that was finalized in Amendment 3. This quota would result in potential annual revenues in the entire fishery of $3,495,345 (3,822,556 lb of meat, 458,707 lb of fins) assuming an ex-vessel price of $1.62 lb for fins and $0.72 for meat. Seventy-five percent of all landings in the smoothhound shark fishery come from sink gillnets and there are approximately 77 vessels that use sink gillnet gear to fish for smoothhound sharks. Assuming an average of 77 sink gillnet vessels fishing for smoothhound sharks, the quota proposed in this alternative would result in individual vessel annual revenues of $45,394. This is an average across all sink gillnet vessels, regardless of catch levels, and this individual annual vessel revenue may fluctuate based on the degree to which fishermen direct on smoothhound sharks.
At the time of publication for the Draft EA, the SEDAR 39 smoothhound stock assessments were underway, but not yet complete. In anticipation that the final stock assessments could be finalized before this final rule, NMFS considered a range of scenarios under Alternative B4 to implement potential results and scenarios, recognizing that results beyond the scope of those analyzed could require additional analysis or regulatory action. The SEDAR 39 stock assessment is now final; thus, the scenarios considered in the Draft EA are no longer appropriate to consider. Rather, NMFS has analyzed the actual results of the stock assessments, which would establish an Atlantic smoothhound commercial quota of 1,201.7 mt dw and a Gulf of Mexico smoothhound shark quota of 336.4 mt dw. These quotas would result in annual revenues of $2,422,251.54 (2,649,006 lb of meat, 317,881 lb fins), assuming an ex-vessel price of $1.62 lb for fins and $0.72 lb for meat. Seventy-five percent of all landings in the smoothhound shark fishery come from sink gillnets and there are approximately 77 vessels that use sink gillnet gear to fish for smoothhound sharks. Assuming an average of 77 sink gillnet vessels fishing for smoothhound sharks, the quota in this alternative would result in individual vessel annual revenues of $31,458. This is an average across all sink gillnet vessels, regardless of catch levels, and this individual annual vessel revenue may fluctuate based on the degree to which fishermen direct on smoothhound sharks. The quotas under Alternative B4 are both consistent with the intent of Amendment 3, which was to minimize changes to the fishery while information on catch and participants was collected, while also implementing science-based quotas to ensure continued sustainable harvest of smoothhound sharks in the Atlantic and Gulf of Mexico regions. NMFS anticipates short-term, direct minor beneficial socioeconomic impacts under this alternative given the combined commercial quotas for the Atlantic and Gulf of Mexico regions under this alternative would result in increased revenues compared to the commercial quota under Alternative B1, though lower than those anticipated under Alternatives B2 or B3. These commercial quotas would allow the fishery to continue at the rate and level observed in recent years into the future without having to be shut down prematurely. Given that the fishery would expect to operate as it currently does, NMFS anticipates in the short term, indirect, minor, positive socioeconomic impacts for shark dealers and processor. Since this alternative establishes scientifically-based quotas and would result in beneficial socioeconomic impacts, NMFS prefers this alternative.
In order to implement TC 4 of the 2012 Shark BiOp in the smoothhound shark fishery, NMFS considered 4 alternatives. The No Action alternative, which would not implement TC 4 of the 2012 Shark BiOp; alternative C2, which would require smoothhound shark fishermen to conduct net checks at least every 2 hours; alternative C3, which would require smoothhound shark fishermen to limit their gillnet soak time to 24 hours and those smoothhound shark fishermen that also have a Atlantic shark limited access permit to check their nets at least every 2 hours; and finally, Alternative C4, which would require smoothhound and Atlantic shark fishermen using sink gillnet to soak their nets no longer than 24 hours and those fishermen using drift gillnets to check their nets at least every 2 hours.
Alternative C1 would not implement the BiOp term and condition that would require all smoothhound shark permit holders to either check their gillnet gear at least every 2.0 hours or limit their soak time to no more than 24 hours. This alternative would likely result in short and long-term neutral direct socioeconomic impacts. Under Alternative C1, smoothhound shark fishermen would continue to fish as they do now and so this alternative would not have economic impacts that differ from the status quo. Similarly, this alternative would likely result in neutral short and long-term indirect
Alternative C2 would require smoothhound shark fishermen using gillnet gear to conduct net checks at least every 2.0 hours to check for and remove any protected species, and would likely result in short and long-term direct moderate adverse socioeconomic impacts. Some smoothhound shark gillnet fishermen fish multiple nets at one time or deploy their net(s), leave the vicinity, and return later. Alternative C2 would require these fishermen to check each gillnet at least once every 2 hours, making fishing with multiple nets or leaving nets unattended difficult. This would likely lead to a reduction in effort and landing levels, resulting in lower ex-vessel revenues. Quantifying the loss of income is difficult without information characterizing the fishery including the number of nets fished. However, limiting the amount of fishing effort in this manner is likely to reduce total landings of smoothhound sharks or, in order to keep landing levels high, extend the length of trips. Landings of incidentally caught fish species could be reduced as well, although under preferred Sub-Alternative A2-1c, smoothhound shark fishermen that wish to remove smooth dogfish fins at sea could not retain other species. This alternative would not have a large impact on supporting businesses such as dealers or bait, tackle, and ice suppliers since these businesses do not solely rely on the smoothhound shark fishery. The smoothhound shark fishery is small relative to other fisheries. Thus, Alternative C2 would likely result in short and long-term indirect neutral socioeconomic impacts. Alternative C2 would impact the approximately 77 vessels that annually catch smoothhound sharks with gillnet gear (annual average from 2003-2014, Table 3.1).
Alternative C3 would establish a gillnet soak time limit of 24 hours for smoothhound shark permit holders. Under this alternative, fishermen holding both an Atlantic shark limited access permit and a smoothhound shark permit must abide by the 24 hour soak time restriction and conduct net checks at least every 2 hours. This alternative would likely result in short- and long-term direct minor adverse socioeconomic impacts to those smoothhound permitted fishermen that also have an Atlantic shark limited access permit and therefore would be required to check their nets at least every 2 hours. Currently, smoothhound shark gillnet fishermen sometimes fish multiple nets or leave nets unattended for short periods of time. Rarely are these nets soaked for more than 24 hours, thus, this alternative would not impact smoothhound shark gillnet fishermen that do not have an Atlantic shark limited access permit. Adverse socioeconomic impacts resulting from this alternative would likely occur to the subset of smoothhound shark fishermen that also hold an Atlantic shark limited access permit. These smoothhound shark fishermen would be at a disadvantage to other smoothhound shark fishermen that do not have an Atlantic shark limited access permit because they would be required to check their gillnets at least every 2 hours which is a large change in the way the smoothhound shark fishery currently operates. Dropping the Atlantic shark permit to avoid the net check requirement is unlikely to be feasible because Atlantic shark permits allow limited access (NMFS is no longer issuing new permits) and cannot be easily obtained. Additionally, pelagic longline fishermen are required to have an incidental or directed shark permit when targeting swordfish or tunas, even if they are not fishing for sharks, due to the likelihood of incidental shark catch. In practical terms, this could result in smoothhound shark gillnet fishermen abiding by the 2 hour net check requirement even if they do not fish for Atlantic sharks and only hold a Atlantic shark limited access permit to fish for swordfish or tunas (note that gillnets cannot be used to target swordfish or tunas, but some vessels may switch gears between trips). For this subset of fishermen, basing gillnet requirements on permit types could introduce fishing inefficiencies when compared to other smoothhound fishermen, likely resulting in adverse socioeconomic impacts to these fishermen. It is unlikely that this alternative would have a large impact on supporting businesses such as dealers or bait, tackle, and ice suppliers since these businesses do not solely rely on the smoothhound shark fishery. The smoothhound shark fishery is small relative to other fisheries. It is difficult to determine the number of fishermen that would be adversely affected because NMFS does not yet know which vessels will obtain a smoothhound shark fishing permit. However, it is likely that this number will be approximately equal to 169 which is the average annual number of vessel that retain smoothhound sharks (Section 3.4).
Alternative C4, the preferred alternative, would establish a soak time limit of 24 hours for fishermen using sink gillnet gear and a 2 hour net check requirement for fishermen using drift gillnet gear in the Atlantic shark and smoothhound shark fisheries. Drift gillnets would be defined as those that are unattached to the ocean bottom with a float line at the surface and sink gillnet gear would be defined as those with a weight line that sinks to the ocean bottom, has a submerged float line, and is designed to be fished on or near the bottom. Alternative C4 would likely result in neutral short and long-term direct socioeconomic impacts. Smoothhound shark fishermen, who typically use sink gillnets, would be required to limit soak times to 24 hours and as discussed above, this requirement is unlikely to significantly alter smoothhound shark fishing practices. Drift gillnet fishermen, who are more likely to target Atlantic sharks rather than smoothhound sharks, would be required to check their nets at least every 2 hours, as is currently required. Thus, this alternative is unlikely to have any socioeconomic impacts to Atlantic shark and smoothhound shark fishermen because it would not change current fishing practices. Similarly, this alternative would likely result in neutral short and long-term indirect socioeconomic impacts because supporting businesses including dealers and bait, tackle, and ice suppliers should not be impacted. Alternative C4 would impact the approximately 77 vessels that annually catch smoothhound sharks with gillnet gear (annual average from 2003-2014, Table 3.1). Because Alternative C4 would have minimal economic impact but is still consistent with the 2012 Shark BiOp, NMFS prefers this alternative.
NMFS also considered two alternatives to streamline the current VMS requirements for Atlantic shark fishermen with gillnet gear on board. The No Action alternative would maintain the current requirement to have VMS on board when fishing for Atlantic sharks with gillnet regardless of where the vessel is fishing and alternative D2 would require VMS on board only for Atlantic shark fishermen using gillnet gear in an area specified by the ALWTRP requirements at 50 CFR 229.32.
Alternative D1 would maintain the current requirement of requiring Atlantic shark permit holders fishing with gillnet gear to have VMS on board, regardless of where the vessel is fishing.
Alternative D2, the preferred alternative, would change the gillnet VMS requirements and would require federal directed shark permit holders with gillnet gear on board to use VMS only in the vicinity of the Southeast U.S. Monitoring Area, pursuant to ALWTRP requirements, and would have short and long-term direct minor beneficial socioeconomic impacts. Atlantic shark gillnet fishermen fishing in the vicinity of the Southeast U.S. Monitoring Area would still incur the installation costs of the VMS, but data transmission would be limited to those times when the vessel is in this area. Furthermore, shark gillnet fishermen outside of this area that do not fish in the vicinity of the Southeast U.S. Monitoring Area would not need to install a VMS unit or, if they already have one, maintain the VMS unit or replace a malfunctioning one. Thus, the socioeconomic impacts from this alternative, while still adverse, are of a lesser degree than those under Alternative D1, the No Action alternative. This alternative would likely result in neutral short and long-term indirect socioeconomic impacts because supporting businesses, including dealers and bait, tackle, and ice suppliers, would not be impacted. While the retention of sharks in federal waters requires one of two limited access commercial shark permits, these permits do not specify gear type, including gillnets. For this reason, NMFS does not know the exact number of shark gillnet fishermen that would be affected by this alternative. As of October 11, 2014, there are 206 directed shark and 258 incidental shark permit holders. Logbook records indicate that there are usually about 18 Atlantic shark directed permit holders that use gillnet gear in any year. However, the universe of directed permit holders using gillnet gear can change from year to year and could include anyone who holds an Atlantic shark directed permit. Because this alternative is more in line with the requirements of the ALWTRP, and because it would reduce socioeconomic impacts while still maintaining beneficial ecological impacts for protected whale species, NMFS prefers this alternative.
This final rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by OMB under control number 0648-0372. Public reporting burden will be reduced under the modified VMS requirements under this final rule. The burden estimate burden will be reduced by this rule, but the changes will be requested as part of the 2016 extension, at which time the estimate of the burden change will be more accurate.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide (the guide) was prepared. Copies of this final rule are available from the HMS Management Division (see
Fisheries, Fishing, Fishing vessels, Foreign relations, Imports, Penalties, Reporting and recordkeeping requirements, Treaties.
For reasons set out in the preamble, 50 CFR part 635 is amended as follows:
16 U.S.C. 971
(e) * * *
(4) Owners of vessels that fish for, take, retain, or possess the Atlantic oceanic sharks listed in section E of Table 1 of Appendix A to this part with an intention to sell them must obtain a Federal commercial smoothhound permit. In addition to other permits issued pursuant to this section or other authorities, a Federal commercial smoothhound permit may be issued to a vessel alone or to a vessel that also holds either a Federal Atlantic commercial shark directed or incidental limited access permit.
(m) * * *
(2)
(a)
(b)
(c)
(d)
(e)
(1) Provide accommodations and food that are equivalent to those provided to the crew.
(2) Allow the observer access to and use of the vessel's communications equipment and personnel upon request for the transmission and receipt of messages related to the observer's duties.
(3) Allow the observer access to and use of the vessel's navigation equipment and personnel upon request to determine the vessel's position.
(4) Allow the observer free and unobstructed access to the vessel's bridge, working decks, holding bins, weight scales, holds, and any other space used to hold, process, weigh, or store fish.
(5) Allow the observer to inspect and copy the vessel's log, communications logs, and any records associated with the catch and distribution of fish for that trip.
(6) Notify the observer in a timely fashion of when fishing operations are to begin and end.
(f) Vessel responsibilities. An owner or operator of a vessel required to carry one or more observer(s) must provide reasonable assistance to enable observer(s) to carry out their duties, including, but not limited to:
(1) Measuring decks, codends, and holding bins.
(2) Providing the observer(s) with a safe work area.
(3) Collecting bycatch when requested by the observer(s).
(4) Collecting and carrying baskets of fish when requested by the observer(s).
(5) Allowing the observer(s) to collect biological data and samples.
(6) Providing adequate space for storage of biological samples.
(d)
(e) * * *
(5) There is no size limit for smoothhound sharks taken under the recreational retention limits specified at § 635.22(c)(6).
(g) * * *
(2) While fishing with a drift gillnet, a vessel issued or required to be issued a Federal Atlantic commercial shark limited access permit and/or a Federal commercial smoothhound permit must conduct net checks at least every 2 hours to look for and remove any sea turtles, marine mammals, Atlantic sturgeon, or smalltooth sawfish, and the drift gillnet must remain attached to at least one vessel at one end, except during net checks. Smalltooth sawfish must not be removed from the water while being removed from the net.
(3) While fishing with a sink gillnet, vessels issued or required to be issued a Federal Atlantic commercial shark limited access permit and/or a Federal commercial smoothhound permit must limit the soak time of the sink gillnet gear to no more than 24 hours, measured from the time the sink gillnet first enters the water to the time it is completely removed from the water. Smalltooth sawfish must not be removed from the water while being removed from the net.
(c) * * *
(6) The smoothhound sharks listed in Section E of Table 1 of Appendix A to this part may be retained and are subject only to the size limits described in § 635.20(e)(5).
(a) * * *
(7) A person who owns or operates a vessel that has been issued a Federal commercial smoothhound permit may retain, possess, and land smoothhound sharks if the smoothhound fishery is open in accordance with §§ 635.27 and 635.28. Persons aboard a vessel in a trawl fishery that has been issued a Federal commercial smoothhound permit and are in compliance with all other applicable regulations, may retain, possess, land, or sell incidentally-caught smoothhound sharks, but only up to an amount that does not exceed 25 percent, by weight, of the total catch on board and/or offloaded from the vessel. A vessel is in a trawl fishery when it has no commercial fishing gear other than trawls on board and when smoothhound sharks constitute no more than 25 percent by weight of the total catch on board or offloaded from the vessel.
(b) * * *
(1) * * *
(i) * * *
(E)
(ii) * * *
(F)
(4) * * *
(iv) The base annual quota for persons who collect smoothhound sharks under a display permit or EFP is 6 mt ww (4.3 mt dw).
(c)
(2) A person who owns or operates a vessel that has a valid Federal Atlantic commercial shark permit may remove the head and viscera of the shark while on board the vessel. At any time when on the vessel, sharks must not have the backbone removed and must not be halved, quartered, filleted, or otherwise reduced. All fins, including the tail, must remain naturally attached to the shark through offloading, except under the conditions specified in paragraph (c)(5) of this section. While on the vessel, fins may be sliced so that the fin can be folded along the carcass for storage purposes as long as the fin remains naturally attached to the carcass via at least a small portion of uncut skin. The fins and tail may only be removed from the carcass once the shark has been landed and offloaded, except under the conditions specified in paragraph (c)(5) of this section.
(3) A person who owns or operates a vessel that has been issued a Federal Atlantic commercial shark permit and who lands sharks in an Atlantic coastal port, including ports in the Gulf of Mexico and Caribbean Sea, must have all fins and carcasses weighed and recorded on the weighout slips specified in § 635.5(a)(2) and in accordance with part 600, subpart N, of this chapter. Persons may not possess any shark fins not naturally attached to a shark carcass on board a fishing vessel at any time, except under the conditions specified in paragraph (c)(5) of this section. Once landed and offloaded, sharks that have been halved, quartered, filleted, cut up, or reduced in any manner may not be brought back on board a vessel that has been or should have been issued a Federal Atlantic commercial shark permit.
(5) A person who owns or operates a vessel that has been issued a Federal commercial smoothhound permit may remove the fins and tail of a smooth dogfish shark prior to offloading if the conditions in paragraphs (c)(5)(i) through (iv) of this section have been met. If the conditions in paragraphs (c)(5)(i) through (iv) of this section have
(i) The smooth dogfish was caught within waters of the United States located shoreward of a line drawn in such a manner that each point on it is 50 nautical miles from the baseline of an Atlantic State from which the territorial sea is measured, from Maine south through Florida to the Atlantic and Gulf of Mexico shark regional boundary defined in § 635.27(b)(1).
(ii) The vessel has been issued both a Federal commercial smoothhound permit and a valid State commercial fishing permit that allows for fishing for smooth dogfish.
(iii) Smooth dogfish make up at least 25 percent of the catch on board at the time of landing.
(iv) Total weight of the smooth dogfish fins landed or found on board a vessel cannot exceed 12 percent of the total dressed weight of smooth dogfish carcasses on board or landed from the fishing vessel.
(a) * * *
(3) Pursuant to Atlantic large whale take reduction plan requirements at 50 CFR 229.32(h), whenever a vessel issued a directed shark LAP has a gillnet(s) on board.
(d) * * *
(6) Fail to maintain a shark in its proper form, as specified in § 635.30(c). Fail to maintain naturally attached shark fins through offloading as specified in § 635.30(c), except for under the conditions specified in § 635.30(c)(5).
(7) Sell or purchase smooth dogfish fins that are disproportionate to the weight of smooth dogfish carcasses, as specified in § 635.30(c)(5).
(18) Retain or possess on board a vessel in the trawl fishery smoothhound sharks in an amount that exceeds 25 percent, by weight, of the total fish on board or offloaded from the vessel, as specified at § 635.24(a)(7).
Table 1 of Appendix A to Part 635—Oceanic Sharks
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Turbomeca S.A. Arriel 1E2 turboshaft engines. This proposed AD was prompted by reports of uncommanded in-flight shutdowns (IFSDs). This proposed AD would require removing the tachometer box on affected engines. We are proposing this AD to prevent failure of the tachometer box, which could lead to failure of the engine, IFSD, and loss of control of the helicopter.
We must receive comments on this proposed AD by January 25, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
You may examine the AD docket on the Internet at
Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2015-0175, dated August 24, 2015 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
There have been reports of Arriel 1E2 engines having experienced an uncommanded in-flight shut-down (IFSD) due to an untimely activation of the tachometer box shut-off system which was activated by the power turbine monitoring function of the tachometer box.
This condition, if not corrected, could potentially lead to further cases of IFSD, possibly resulting in a forced landing.
You may obtain further information by examining the MCAI in the AD docket on the Internet at
Turbomeca S.A. has issued Mandatory Service Bulletin No. 292 77 0844, Version B, dated July 6, 2015. The service information describes procedures for removing pre-TU 369 tachometer boxes. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of France, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This NPRM would require removing the pre-TU 369 tachometer box from the engine.
We estimate that this proposed AD affects 200 engines installed on helicopters of U.S. registry. We also estimate that it would take about 3 hours per engine to comply with this proposed AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $51,000.
Title 49 of the United States Code specifies the FAA's authority to issue
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 25, 2016.
None.
(1) This AD applies to Turbomeca S.A. Arriel 1E2 turboshaft engines with tachometer boxes with the following part number (P/N) and serial number (S/N) combinations:
(i) P/N 9580116170—all S/Ns
(ii) P/N 9580116260—all S/Ns
(iii) P/N 9580116900—all S/Ns
(iv) P/N 9580117110—all S/Ns
(v) P/N 9580117550—all S/Ns 1499 and below with or without suffix letters and all S/Ns 1500 and above that do not contain the suffix letters EL.
(2) This AD applies only to Turbomeca S.A. Arriel 1E2 turboshaft engines with tachometer boxes identified in paragraph (c)(1) of this AD that also have installed electrical connectors labeled as P10106, P10098, and P10108 or P11F, P13F, and P15F.
This AD was prompted by reports of uncommanded in-flight shutdowns (IFSDs). We are issuing this AD to prevent failure of the tachometer box, which could lead to failure of the engine, IFSD, and loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 1,600 flight hours after the effective date of this AD, remove the affected tachometer box from the engine.
(2) Reserved.
You may take credit for the action required by paragraph (e) of this AD if you performed the action before the effective date of this AD in accordance with Turbomeca S.A. MSB 292 77 0844, Version A, dated March 4, 2015 or earlier version.
The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0175, dated August 24, 2015, which includes Mandatory Service Bulletin No. 292 77 0844, Version B, dated July 6, 2015, for related information. You may examine the MCAI in the AD docket on the Internet at
(3) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Turbomeca S.A. Arriel 2B, 2B1, 2C, 2C1, 2C2, 2D, 2E, 2S1, and 2S2 turboshaft engines. This proposed AD was prompted by a report of an uncommanded in-flight shutdown of an Arriel 2 engine caused by rupture of the 41-tooth gear, which forms part of the bevel gear in the engine accessory gearbox (AGB). This proposed AD would require inspection, and, depending on the results, removal of the engine AGB. We are proposing this AD to prevent failure of the engine AGB, which could lead to in-flight shutdown, damage to the engine, and damage to the aircraft.
We must receive comments on this proposed AD by January 25, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 0 5 59 74 40 00; fax: 33 0 5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
You may examine the AD docket on the Internet at
Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2015-0162, dated August 6, 2015 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
An uncommanded in-flight shut-down (IFSD) of an ARRIEL 2 engine was reported, caused by rupture of the 41-tooth gear, which forms part of the bevel gear of the accessory gearbox (module M01). The subsequent investigation revealed that wear on the housing of the front bearing of this gear was a major contributor to this rupture. In addition, the investigation showed that this wear mechanism had resulted in positive Spectrometric Oil Analysis (SOA) indications before the event.
This condition, if not detected and corrected, could potentially lead to further cases of IFSD, possibly resulting in an emergency landing.
You may obtain further information by examining the MCAI in the AD docket on the Internet at
Turbomeca S.A. has issued Mandatory Service Bulletin No. 292 72 2861, Version A, dated April 24, 2015. The service information describes procedures for inspecting the engine AGB. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of France, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This proposed AD would require inspection, and, depending on the results, removal of the engine AGB.
We estimate that this proposed AD affects 250 engines installed on aircraft of U.S. registry. We also estimate that it would take about 0.5 hours per engine to comply with the initial inspection requirement in this proposed AD and about 2 hours per engine to remove the engine AGB. The spectrometric oil analysis kit costs about $79. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $72,875.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 25, 2016.
None.
This AD applies to Turbomeca S.A. Arriel 2B, 2B1, 2C, 2C1, 2C2, 2D, 2E, 2S1, and 2S2 turboshaft engines with an engine accessory gearbox (AGB), part number 0292120650, with a machined front casing.
This AD was prompted by a report of an uncommanded in-flight shutdown of an Arriel 2 engine caused by rupture of the 41-tooth gear, which forms part of the bevel gear in the engine AGB. We are issuing this AD to prevent failure of the engine AGB, which could lead to in-flight shutdown, damage to the engine, and damage to the aircraft.
Comply with this AD within the compliance times specified, unless already done.
(i) Perform an initial SOA within the compliance times given in paragraph (e)(1)(i)(A) or (e)(1)(i)(B) of this AD:
(A) If the engine AGB has less than 800 engine hours (EHs) since new or since last overhaul, do an initial SOA before exceeding 850 EHs since new or since last overhaul.
(B) If the engine AGB has 800 EHs or more since new or since last overhaul, or if the EHs are unknown, do an initial SOA within 50 EHs after the effective date of this AD.
(C) Use paragraphs 2.4.2.1 and 2.4.2.2 of Turbomeca S.A. Mandatory Service Bulletin (MSB) No. 292 72 2861, Version A, dated April 24, 2015, to perform the SOA required by paragraph (e) of this AD.
(ii) Reserved.
(i) If the aluminum concentration determined from the most recent SOA is less than 0.8 parts per million (PPM), repeat the SOA required by paragraph (e) of this AD within 100 EHs time since last analysis (TSLA).
(ii) If the aluminum concentration determined from the most recent SOA is between 0.8 PPM and 1.4 PPM, inclusive, repeat the SOA required by paragraph (e) of this AD within 50 EHs TSLA. Do not perform draining before doing the next SOA.
(iii) If the aluminum concentration determined from the most recent SOA is greater than 1.4 PPM, remove the engine AGB from service within 50 EHs TSLA.
The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0162, dated August 6, 2015, for more information. You may examine the MCAI in the AD docket on the Internet at
(3) Turbomeca S.A. MSB No. 292 72 2861, Version A, dated April 24, 2015, can be obtained from Turbomeca S.A., using the contact information in paragraph (g)(4) of this proposed AD.
(4) For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 0 5 59 74 40 00; fax: 33 0 5 59 74 45 15.
(5) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace extending upward from 700 feet above the surface at South Naknek NR 2 Airport, South Naknek, AK, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures developed for the airport. The FAA is proposing this action to enhance the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Comments must be received on or before January 8, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-3108; Airspace Docket No. 12-AAL-15, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Richard Roberts, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4517.
The FAA's authority to issue rules regarding aviation safety is found in
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-3108/Airspace Docket No. 12-AAL-15.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This document would amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the South Naknek NR 2 Airport, South Naknek, AK. Development of new RNAV (GPS) standard instrument approach procedures have made this action necessary for continued safety and management of IFR operations at the airport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of South Naknek NR 2 Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Willapa Harbor Heliport, South Bend, WA, to accommodate new standard instrument approach and departure procedures developed at the heliport. Controlled airspace is necessary for the safety and management of Instrument Flight Rules (IFR) operations at the heliport.
Comments must be received on or before January 8, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-3771; Airspace Docket No. 15-ANM-28, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Willapa Harbor Heliport, South Bend, WA.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-3771; Airspace Docket No. 15-ANM-28.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This document would amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Willapa Harbor Heliport, South Bend, WA. Establishment of a GPS approach and departure procedure has made this action necessary for the safety and management of IFR operations at the heliport. Class E airspace would be established within a 1.8-mile radius of the Willapa Harbor Heliport, with a segment extending from the 1.8-mile radius to 5.5 miles northwest of the heliport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 1.8-mile radius of Willapa Harbor Heliport, and that airspace bounded by a line beginning at a point where the Willapa Harbor 278° bearing intersects the Willapa Harbor 1.8-mile radius, thence northwest to lat. 46°42′26″ N., long. 123°55′39″ W.; to lat. 46°45′28″ N., long. 123°52′46″ W.; to lat. 46°43′55″ N., long. 123°48′46″ W.; to lat. 46°41′18″ N., long. 123°46′14″ W.; to a point where the Willapa Harbor 98° bearing intersects the Willapa Harbor 1.8-mile radius, thence clockwise along the 1.8-mile radius to the point of beginning.
Food and Drug Administration, HHS.
Notice of petition.
The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of sodium formate as a feed acidifier in poultry feed.
The food additive petition was filed on October 15, 2015.
Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729,
Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2293) has been filed by BASF Corp., 100 Park Ave., Florham Park, NJ 07932. The petition proposes to amend the food additive regulations in 21 CFR part 573
The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r) because it is of a type that does not individually or cumulatively have a significant effect on the human environment. In addition, the petitioner has stated that to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.
Bureau of Prisons, Justice.
Proposed rule.
In this document, the Bureau of Prisons proposes two minor revisions to its regulations on the management of infectious diseases. One change would remove the requirement for HIV pre-test counseling for inmates, because the counseling requirement has become an obstacle to necessary testing. Inmates testing positive for HIV will continue to receive HIV post-test counseling. The second change would alter language regarding tuberculosis (TB) testing to clarify that it is testing for the TB infection, but not “skin testing.” This would account for advances in medical technology that allow for newer testing methods.
Written comments must be submitted on or before January 25, 2016.
Rules Unit, Office of General Counsel, Bureau of Prisons, 320 First Street NW., Washington, DC 20534.
Rules Unit, Office of General Counsel, Bureau of Prisons, phone (202) 353-8214.
Please note that all comments received are considered part of the public record and made available for public inspection online at
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also locate all the personal identifying information you do not want posted online in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment contains so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on
Personal identifying information identified and located as set forth above will be placed in the agency's public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the “For Further Information Contact” paragraph.
The Bureau proposes two minor revisions to its regulations on the infectious disease management program (28 CFR, part 549, subpart A). One change would remove the requirement for HIV pre-test counseling for inmates, because the counseling requirement has become an obstacle to necessary testing. Inmates testing positive for HIV will continue to receive HIV post-test counseling. The second change would alter language regarding tuberculosis (TB) testing to clarify that it is testing for the TB infection, but not “skin testing.” This would account for advances in medical technology that allow for newer testing methods.
The CDC set forth guidelines in 1994 for counseling and testing persons with high-risk behaviors which specified prevention (pre-test) counseling to develop specific prevention goals and strategies for each person (client-centered counseling). However, in 2003, CDC introduced an initiative entitled “Advancing HIV Prevention: New Strategies for a Changing Epidemic”. One key point of this initiative was to make HIV testing a routine part of medical care on the same voluntary basis as other diagnostic and screening tests. In its technical guidance, CDC acknowledged that although prevention (pre-test) counseling is desirable for all persons at risk for HIV, such counseling might not be appropriate or feasible in all settings. Because time constraints caused some providers to perceive requirements for prevention counseling and written informed consent as a barrier to uniform testing, the initiative advocated streamlined approaches. The CDC found that although targeted testing programs, like the Bureau's infection disease management program, were implemented in acute-care settings and nearly two thirds of patients in these settings accept testing; risk assessment and prevention (pre-test) counseling are time-consuming, so only a limited proportion of eligible patients can be tested.
There are significant benefits of HIV testing for inmates because treatment for HIV can be initiated promptly preventing serious complications and death. The CDC has found that requirements for pre-test prevention counseling pose a barrier to testing and therefore CDC recommends that an “opt-out” testing protocol be utilized, in which persons are informed that they will be tested unless they choose not to be tested. Specifically CDC recommends that:
• HIV screening is recommended for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
• Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
• Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings.
In addition to the above, the Bureau also notes that eliminating the pre-test counseling requirement would save Bureau staff approximately 20 minutes per counseling session. Since the Bureau strives to test all inmates, the time savings this would permit are substantial. We therefore propose to delete the requirement for pre-test counseling in order to conform with CDC guidelines and to remove this barrier to testing as many inmates as possible.
We also propose to remove the requirement for post-HIV-test counseling for inmates who have tested negative for HIV. Those testing positive will continue to receive post-test
The Bureau currently primarily uses the tuberculin skin test for testing for latent TB infection. However, a new type of test for TB infection has become available, a blood test called the Interferon Gamma Release Assay (IGRA). In the next 5 to 10 years it is anticipated that blood tests for TB infection will replace the tuberculin skin test. These tests appear to be at least as accurate as the skin test and have the benefit of requiring only one interaction with an inmate to draw blood (rather than place the skin test and reading it 2 to 3 days later). Using this type of test would eliminate the need for a second health care visit to conduct the test, as no “reading” would be required, which would result in great time savings to Bureau staff.
Once more, we make this change to bring the Bureau into conformance with CDC guidelines. In 2010, the CDC issued “Updated Guidelines for Using Interferon Gamma Release Assays to Detect
However, several risks are associated with the use of TSTs: Difficulty with the very specific administration needed, unreliable patient return to the health-care provider for the test reading, and inaccuracies and biases existing in reading the TSTs, such as false-positives. IGRAs, however, assess the presence of specific tuberculosis proteins, and therefore offer improved test specificity compared with TSTs.
For this reason, the CDC has recommended increasing use of IGRAs. Although skin testing may still be used, it will not be used exclusively, so we propose to update our regulatory language to allow for the possibility of other kinds of testing for TB infection.
We also propose to make minor changes to § 549.12(a)(2), Exposure incidents, to clarify that the current language stating that the Bureau will test “when there is a well-founded reason to believe that the inmate may have transmitted the HIV infection” means the following: The Bureau tests an inmate, regardless of the length of sentence or pretrial status, when there is a well-founded reason to believe that the inmate
This proposed regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review”, section 1(b), Principles of Regulation. The Director, Bureau of Prisons has determined that this proposed regulation is a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this proposed regulation has been reviewed by the Office of Management and Budget.
This proposed regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, under Executive Order 13132, we determine that this proposed regulation does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
The Director of the Bureau of Prisons, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), reviewed this proposed regulation and certifies that it will not have a significant economic impact upon a substantial number of small entities for the following reasons: This proposed regulation pertains to the correctional management of inmates committed to the custody of the Attorney General or the Director of the Bureau of Prisons. Its economic impact is limited to the Bureau's appropriated funds.
This proposed regulation will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This proposed rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. This proposed regulation will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Prisoners.
Under rulemaking authority vested in the Attorney General in 5 U.S.C. 301; 28 U.S.C. 509, 510 and delegated to the Director, Bureau of Prisons in 28 CFR 0.96, we proposed to amend 28 CFR part 549 as follows.
5 U.S.C. 301; 10 U.S.C. 876b; 18 U.S.C. 3621, 3622, 3524, 4001, 4005, 4042, 4045, 4081, 4082 (Repealed in part as to offenses committed on or after November 1, 1987), Chapter 313, 5006-5024 (Repealed October 12, 1984 as to offenses committed after that date), 5039; 28 U.S.C. 509, 510.
(a)
(2)
(3)
(4)
(5)
(b) * * *
(4) An inmate who refuses TB screening may be subject to an incident report for refusing to obey an order. If an inmate refuses testing for TB infection, and there is no contraindication to testing, then, institution medical staff will test the inmate involuntarily.
Coast Guard, DHS.
Notice of intent.
The stay of reporting requirements under the Regulated Navigation Area (RNA) applicable to barges loaded with certain dangerous cargoes on the inland rivers in the Eighth District area of responsibility (AOR) is scheduled to expire on December 31, 2015. The Coast Guard intends to allow the stay to expire in part. Once the stay partially expires, RNA reporting requirements in a limited form will resume under the existing regulation. The Coast Guard is developing an amendment to the existing regulation.
November 24, 2015.
For information about this document call or email Shelley Miller, Coast Guard; telephone 504-671-2330, email
The reporting requirements under 33 CFR 165.830, “Regulated Navigation Area; Reporting Requirements for Barges Loaded with Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District,” were initially suspended in January 2011 due to the expiration of the contract for the reporting system at the Inland River Vessel Movement Center (IRVMC). This suspension was published in the
Additionally, the Coast Guard published a final rule in January 2015 (80 FR 5282), titled Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System. This rule contains an exemption, at 33 CFR 160.204(a)(3), for any vessel required to report its movements, its cargo, or the cargo in barges it is towing under 33 CFR 165.830 after December 31, 2015.
The Coast Guard intends to allow the suspension of certain reporting requirements under 33 CFR 165.830 to expire as scheduled. The Coast Guard does not intend to reinstate reporting, 24 hours per day, 365 days per year, at 90 plus reporting points under the RNA as currently published. Rather, we anticipate reporting will be required in response to specific concerns, under a limited form of the RNA currently in the CFR.
Specifically, the Coast Guard is considering whether existing § 165.830(d)(1)(ix), (d)(2)(iv), (f)(9), (g)(4), and (h) of the existing RNA may take effect on January 1, 2016, with revisions to the references to IRVMC. Although we have not yet developed revisions to the existing regulation, we are publishing this document to inform members of the public who are aware of, and may have questions about, the upcoming expiration of the suspension.
This document is issued under authority of 5 U.S.C. 552(a).
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to disapprove revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP) concerning Vehicle Scrapping, Employee Trip Reduction, and procedures for the hearing board concerning variances and subpoenas.
Any comments must arrive by December 24, 2015.
Submit comments, identified by docket number EPA-R09-OAR-2015-0545, by one of the following methods:
1.
2.
3.
Idalia Pérez, EPA Region IX, (415) 972-3248,
Throughout this document, “we,” “us,” and “our” refer to the EPA.
Table 1 lists the rules proposed for disapproval with the date that they were adopted or amended and submitted by the California Air Resources Board (CARB).
On December 3, 1997, the submittal for SCAQMD Rule 1610 was deemed by operation of law to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review. On December 3, 1999, the submittal for SCAQMD Rule 2202 was deemed by operation of law to meet the completeness criteria. On May 5, 1989, the EPA determined that the submittal for SCAQMD Rules 503.1 and 511.1 met the completeness criteria. On July 10, 1991, the EPA determined that the submittal for SCAQMD Rule 504 met the completeness.
There are no previous versions of Rule 1610 in the SIP, although the SCAQMD adopted earlier versions of this rule on 02/11/94, 10/13/95, 02/08/96 and 04/11/97, and CARB submitted them to us on 07/13/94, 10/18/96, 10/18/96 and 06/03/97 respectively. There are no previous versions of Rule 2202 in the SIP, although the SCAQMD adopted earlier versions of this rule on 12/08/95, 03/08/96 and 11/08/96, and CARB submitted them to us on 11/26/96, 11/26/96 and 12/19/97 respectively. There are no previous versions of Rules 503.1 and 511.1. There are no previous versions of Rule 504 in the SIP, although the SCAQMD adopted an earlier version of this rule on 02/05/88. While we can only act on the most recently submitted version, we have reviewed materials provided with previous submittals.
Nitrogen oxides (NO
Rules 503.1 describes procedures for how sources can apply for ex parte variances. Rule 504 specifies rules for which the SCAQMD hearing board will not grant variances. Rule 511.1
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193). In addition, pursuant to CAA section 110(i), neither EPA nor a state may revise a SIP by issuing an “order, suspension, plan revision, or other action modifying any requirement of an applicable implementation plan” without a plan promulgation or revision.
Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs and NO
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).
3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).
4. “Review of State Implementation Plans and Revisions for Enforceability and Legal Sufficiency,” EPA from J. Craig Potter, Thomas L. Adams Jr., Francis S. Blake, September 23, 1987.
5. “Guidance an Enforceability Requirements for Limiting Potential to Emit through SIP and § 112 Rules and General Permits” EPA from Kathie A. Stein, January 25, 1995.
EPA supports SCAQMD efforts to implement nontraditional and innovative strategies for reducing air pollutant emissions, including commuter programs to reduce the frequency that employees drive alone to work, and programs to incentivize early adoption and turnover to cleaner, less-polluting mobile sources.
EPA and California have long recognized that a state-issued variance, though binding as a matter of state law, does not prevent EPA from enforcing the underlying SIP provisions unless and until EPA approves that variance as a SIP revision. The variance provisions in Rules 503.1 and 504 are deficient for various reasons, including their failure to address the fact that a state- or district-issued variance has no effect on enforcing the underlying federal requirement unless the variance is submitted to and approved by EPA as a SIP revision. Therefore, the inclusion of these rules in the SIP is inconsistent with the Act and may be confusing to regulated industry and the general public.
States and Districts can adopt various provisions describing local agency investigative or enforcement authority, including the authority to issue subpoenas such as in Rule 511.1, to demonstrate adequate enforcement authority under section 110(a)(2) of the Act. These rules should not be approved into the applicable SIP, however, to avoid potential conflict with EPA's independent authorities provided in CAA section 113, section 114 and elsewhere.
The deficiencies listed below are some of the provisions that of the submitted rules that do not satisfy the requirements of section 110 and part D of Title I of the Act and prevent full approval of the SIP submittals.
We propose to disapprove the SIP revision for Rule 1610 based at least in part on the following deficiencies:
1. The Section (e)(2) requirement that engines of scrapped vehicles be destroyed is insufficiently federally enforceable for various reasons.
2. The Section (f)(2)(A) requirement that the vehicle be registered for two years within SCAQMD is not fully enforceable by allowing the Executive Officer to approve different documentation.
3. The Section (g) requirement of a visual and functional inspection of the vehicle has no recordkeeping requirements.
4. There is no recordkeeping requirement to demonstrate compliance with the Section (g)(1) requirement that vehicles be driven under their own power to the scrapping site.
5. There is no requirement to maintain records for the life of the MSERCs.
We propose to disapprove the SIP revision for Rule 2202 based at least in part on the following deficiencies:
1. Per Section (f)(1), the rule relies on Regulation XVI, which is not currently in the SIP.
2. Per Section (f)(3), the rule relies on AQIP (Rule 2501), which is not currently in the SIP.
3. Per Section (f)(4), the rule relies on emission reduction strategies approved on a case-by-case basis by the Executive Officer.
4. Per Section (g)(4), the rule relies on vehicle miles travelled reduction programs approved on a case-by-case basis by the Executive Officer.
We propose to disapprove the SIP revision for Rules 503.1 and 504 because they conflict with CAA sections 110(a) and (i) and fail to address that a state- or district-issued variance has no effect on enforcing the underlying federal requirement unless the variance is submitted to and approved by EPA as a SIP revision.
We propose to disapprove the SIP revision for Rule 511.1 to avoid potential conflict with EPA's independent authorities provided in CAA section 113, section 114 and elsewhere.
As authorized in section 110(k)(3) of the Act, we are proposing full disapproval of the submitted SCAQMD Rules 1610, 2202, 503.1, 504, and 511.1. There are no sanctions or Federal Implementation Plan (FIP) implications should EPA finalize this disapproval. Sanctions would not be imposed under CAA section 179(b) because the submittal of Rules 1610 and 2202 is discretionary (
We will accept comments from the public on the proposed disapproval for the next 30 days.
This action is not a “significant regulatory action” under the terms of Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the E.O.
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant impact on a substantial number of small entities. This proposed rule does not impose any requirements or create impacts on small entities. This proposed SIP disapproval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new requirements but simply disapproves certain State requirements for inclusion into the SIP. Accordingly, it affords no opportunity for EPA to fashion for small entities less burdensome compliance or reporting requirements or timetables or exemptions from all or part of the rule. Therefore, this action will not have a significant economic impact on a substantial number of small entities.
We continue to be interested in the potential impacts of this proposed rule on small entities and welcome comments on issues related to such impacts.
This action contains no federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, for State, local, or tribal governments or the private sector. EPA has determined that the proposed disapproval action does not include a federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This action proposes to disapprove pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely disapproves certain State requirements for inclusion into the SIP and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, Executive Order 13132 does not apply to this action.
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP rules EPA is proposing to disapprove would not apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
EPA interprets E.O. 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the E.O. has the potential to influence the regulation. This action is not subject to E.O. 13045 because it is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997). This proposed SIP disapproval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new regulations but simply disapproves certain State requirements for inclusion into the SIP.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
The EPA believes that this action is not subject to requirements of Section 12(d) of NTTAA because application of those requirements would be inconsistent with the Clean Air Act.
Executive Order (E.O.) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA lacks the discretionary authority to address environmental justice in this rulemaking.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Maine. This revision removes State Regulation Chapter 141 Conformity of General Federal Actions from the SIP.
Written comments must be received on or before December 24, 2015.
Submit your comments, identified by Docket ID No. EPA-R01-OAR-2015-0593 by one of the following methods:
1.
2.
3.
4.
5.
Please see the direct final rule which is located in the Rules Section of this
Ariel Garcia, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, telephone number (617) 918-1660, fax number (617) 918-0660, email
In the Final Rules Section of this
For additional information, see the direct final rule which is located in the Rules Section of this
Federal Communications Commission.
Proposed rule; extension of comment and reply deadlines.
In this document, the Wireline Competition Bureau grants in part a request seeking an extension to the comment and reply comment deadlines in the business data services (also referred to as special access services) rulemaking proceeding,
Comments may be filed on or before January 6, 2016, and reply comment comments may be filed by February 5, 2016.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Joseph Price, Pricing Policy Division, Wireline Competition Bureau, 202-418-1540 or
This is a summary of the Commission's document, WC Docket 05-25, RM-10593, DA 15-1239, released November 2, 2015. This document does not contain information collection(s) subject to the Paperwork Act of 1995 (PRA), Public Law 104-93. In addition, therefore, it does not contain any new or modified “information collection burdens[s] for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002. The full text of this document may be downloaded at the following Internet address:
In Section IV.B of the FNPRM accompanying the Data Collection Order, adopted on December 11, 2012, the Commission sought comment on possible changes to its rules for the business data services provided by incumbent local exchange carriers in price cap areas. The Commission set the comment deadlines on this portion of the
Forest Service, USDA.
Notice of meeting.
The Francis Marion-Sumter Resource Advisory Committee (RAC) will meet in Columbia, South Carolina. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held December 10, 2015, at 10:00 a.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Harbision State Forest, Environmental Education Center, 5600 Broad River Road, Columbia, South Carolina.
Written comments may be submitted as described under
Mary Morrison, RAC Coordinator, by phone at 803-561-4000 or via email
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is:
1. Review project proposals; and
2. Recommend Title II projects.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by November 5, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Mary Morrison, RAC Coordinator, 4931 Broad River Road, Columbia, South Carolina 29212; by email to
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The proposed action would treat approximately 8,100 acres to reduce hazardous conditions within a buffer along open roads that burned in the 2015 wildfires. Standing dead and downed trees would be utilized to the extent practicable.
Comments concerning the scope of the analysis must be received by December 24, 2015. The draft environmental impact statement is expected April 2016 and the final environmental impact statement is expected August 2016.
Send written comments to Trinity Post Fire Hazard Reduction and Salvage Project, Attn: Brenda Olson, Shasta-Trinity National Forest, 3644 Avtech Parkway, Redding, CA 96002. Comments may also be sent via email to
Brenda Olson by phone at 530-226-2422, or by email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
The Shasta-Trinity National Forest and Six Rivers National Forest have experienced wildfire on approximately 220,000 acres as a result of lighting in 2015. The majority of acres affected are the result of a July 30, 2015 lightning event. Much of the fire areas burned through National Forest System lands, but a number of private landowners were also affected. Approximately 161,000 acres of the Shasta-Trinity National Forest were burned. Wildfires affected most land allocations including designated Wilderness, Adaptive Management Areas, and Late-Successional Reserve, as well as Inventoried Roadless Areas. Fires burned in a mosaic of intensities; acres burned have been categorized into high, moderate and low severity based on Rapid Assessment of Vegetation Condition After Wildfire (RAVG) data. Five fire complexes and one separate
• The Fork Complex near the communities of Hayfork, Post Mountain, and Wildwood (34,500 acres; 8,900 acres of high and moderate severity);
• The South Complex north and east of the community of Hyampom (29,400 acres; 5,900 acres high and moderate severity);
• The Mad River Complex near the communities of Mad River, Ruth, and Forest Glen (39,200 acres; 6,600 acres high and moderate severity);
• The Route Complex near the communities of Mad River and Hyampom (35,700 acres; 6,300 acres high and moderate severity);
• The River Complex near the Hoopa Reservation, the communities of Burnt Ranch and Denny, and within the Trinity Alps Wilderness Area (78,600 acres; 17,100 acres high and moderate severity); and
• The Saddle Fire northwest of the town of Hyampom (1,500 acres; 600 acres high and moderate severity).
A portion of the areas that burned at moderate and high severity had conifer forest cover prior to the fires (other acres were brush, grasslands or oak woodlands). The acres of conifer and mixed conifer forest that burned at high severity generally have no remaining live trees, and the areas that burned at moderate severity also have a high likelihood of deforestation or large pockets of mortality due to fire-injury. Many trees showing signs of live branches or tops immediately following the fire will be lost due to cambium death or secondary mortality from insects compounded by years of drought.
The areas affected by the 2015 wildfires on the Shasta-Trinity National Forest include vegetation along 387 miles of road (353 miles of National Forest System roads, 32 miles administered by state and county). Of these 387 miles, 248 miles are open to the public, including 233 miles through National Forest System lands. The vegetation along these roads experienced wildfire at varying degrees of intensity. Forested lands experiencing moderate and high intensity fire has resulted in a substantial number of dead and dying trees. Structural integrity of fire-killed trees has been compromised and it is expected many of them will fall during a wind or storm event.
Current conditions within the burned area differ from the desired condition as identified in the Shasta-Trinity National Forest Land and Resource Management Plan (Forest Plan; 1995). Trees that were killed by the fire become less stable and increase the risk to all forest users. Once this material is on the ground and combined with the dead brush, fire behavior is likely to be more intense and more difficult to control. Because of the expected future fire behavior and the elevated risk of fire killed trees falling on firefighters, wildfire suppression strategies would be limited. Desired future conditions would be safe firefighter and public access; conditions that lead to a slower rate of wildfire spread and reduced intensity, with associated increased effectiveness of initial attack by firefighters; and roadside conditions that could be used as a line of defense for control of wildfires.
Within areas experiencing large scale disturbance on the Shasta-Trinity National Forest in 2015 due to wildfire, the purpose of this project is to move towards the desired conditions in the following ways:
1. Reduce hazards (
2. Sustain and establish forest cover; and,
3. Within the treated areas, capture the economic value of felled trees and support the economies of local communities by providing forest products.
Based on the Forest Plan and post fire assessment, we have identified a need to:
• Provide for public safety and protection of structures by managing fuel loading, distribution and arrangement within Wildland Urban Interface for low flame lengths and rate of spread (Forest Plan 4-18);
• Remove danger/hazard trees (Forest Plan 4-26);
• Reduce surplus activity fuels that remain after meeting wildlife, riparian, soil and other environmental needs (Forest Plan, pg. 4-17);
• Create conditions that will support the restoration of fire to its natural role in the ecosystem (Forest Plan 4-4).
• Establish forest stands at densities appropriate to contribute to forest harvest in the future and to maintain wildlife habitat (Forest Plan, pg. 4-154).
• Quickly recover the monetary value of wood through salvage and sale, where feasible and appropriate, to provide economic stimulus to local communities (Forest Plan 4-5).
Dead vegetation will be treated on National Forest System lands along 233 miles of roads open to the public (
• 153 miles of NFS Maintenance Level 2 (accessible with high clearance vehicles) roads;
• 34 miles of NFS Maintenance Level 3 (accessible with passenger cars) roads;
• 19 miles of NFS Maintenance Level 4 (paved) roads; and
• 27 miles of state and county roads.
Treatments along these roads could include:
• Remove or treat dead vegetation (using one of the “treatment types” listed below) within a 300 foot total width buffer. Width of the buffer on either side of the road would change but would always total 300 feet;
○ Hand felling of dead trees and brush. Dead vegetation will be identified at the time of treatment.
○ Mastication, which pulverizes or chops standing trees and logs into small particles. This treatment can include mowing, mulching, or chipping.
○ Lopping woody debris (slash) and scattering around the treated area, which redistributes woody material.
○ Hand piling slash, which reduces surface fuels.
○ Machine piling slash, which reduces surface fuels.
○ Pile burning, which reduces surface fuels.
○ Jackpot burning, which is a burning method used to reduce heavy intermittent fuel concentrations, where fuels are not continuous enough to carry a broadcast fire.
○ Broadcast burning, which is a burning method used where heavy continuous fuel concentrations exist.
○ Chipping, which pulverizes or chops trees, brush, and logs into small particles.
• Maintain treated areas through understory burning, where feasible.
• Utilize wood products whenever possible. This can include salvage logs, commercial or personal firewood, biomass removal, etc.
○ Large timber sales are expected to be feasible on up to 128 miles of the roads proposed for treatment.
• Provide for future forest cover through planting, utilizing a species
• Create a control line on the outside edge of treatment areas where necessary to maintain fuel reductions with prescribed fire.
• Where appropriate, stumps of freshly cut conifers will be treated with an EPA-registered borate compound to prevent spread of Heterobasidion root disease.
• Trees or snags that are imminent hazards to the road and/or operations would felled; trees that are felled outside the treatment buffer would be left onsite.
• No treatments are proposed within Wilderness.
• Additional Resource Protection Measures will be developed to address resource concerns for wildlife, watersheds, soils and other issues that are identified.
Fuels reduction treatment goals are to:
• Reduce downed logs to 10-20 tons per acre. Downed logs includes woody material >3-inches in diameter including fuels created by salvage and suppression actions.
• Reduce dead brush by 50-100%.
David R. Myers, Forest Supervisor, Shasta-Trinity National Forest.
The Forest Supervisor will decide whether to implement the proposed action, take an alternative action that meets the purpose and need or take no action.
This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. This project is within Wildland Urban Interface and as such is consistent with the Healthy Forest Restoration Act of 2003 (HFRA), which contains provisions to expedite hazardous fuels reduction and forest restoration projects on federal lands. Project authorized under HFRA are defined under Section 102(a) of the act and are designed to actively involve the public (Section 104(e) and (f) of the act). In an effort to provide for collaborative design of this project or alternatives, you are invited to participate in open public meetings at the following locations and times: Hyampom Community Center on November 30, 2015 at 5:00 p.m.; Weaverville Board of Supervisor's Chambers on December 1, 2015 at 5:00 p.m.; Trinity County Fairgrounds dining hall in Hayfork on December 2, 2015 at 5:00 p.m.; Ruth Lake Community Services District Hall in Mad River on December 3, 2015; and, Burnt Ranch School on December 4, 2015 at 5:00 p.m. Additional project information is available on the project Web site:
It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and alternative means of meeting the purpose and need.
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered; however, anonymous comments will not provide the respondent with standing to participate in subsequent administrative review or judicial review. An Emergency Situation Determination will be requested for this project consistent with regulations at 36 CFR 218.21. An Emergency Situation Determination would eliminate the 30-day Objection period prior to a decision.
International Trade Administration, Department of Commerce.
Notice and Call for Applications.
In this notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) announces that it will begin accepting applications for the International Buyer Program (IBP) for calendar year 2017 (January 1, 2017, through December 31, 2017). The announcement also sets out the objectives, procedures and application review criteria for the IBP. The purpose of the IBP is to bring international buyers together with U.S. firms in industries with high export potential at leading U.S. trade shows. Specifically, through the IBP, the ITA selects domestic trade shows which will receive ITA assistance in the form of global promotion in foreign markets, provision of export counseling to exhibitors, and provision of matchmaking services at the trade show. This notice covers selection for IBP participation during calendar year 2017.
Applications for the IBP must be received by Friday, January 8, 2016.
The application form can be found at
Vidya Desai, Acting Director, International Buyer Program, Trade Promotion Programs, International Trade Administration, U.S. Department of Commerce, 1300 Pennsylvania Ave. NW., Ronald Reagan Building, Suite 800M—Mezzanine Level—Atrium North, Washington, DC 20004; Telephone (202) 482-2311; Facsimile: (202) 482-7800; Email:
The IBP was established in the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. 100-418, codified at 15 U.S.C. 4724) to bring international buyers together with U.S. firms by promoting leading U.S. trade shows in industries with high export potential. The IBP emphasizes cooperation between the DOC and trade show organizers to benefit U.S. firms exhibiting at selected events and provides practical, hands-on assistance such as export counseling and market analysis to U.S. companies interested in exporting. Shows selected for the IBP will provide a venue for U.S. companies
Through the IBP, ITA selects U.S. trade shows with participation by U.S. firms interested in exporting that ITA determines to be leading international trade shows, for promotion in overseas markets by U.S. Embassies and Consulates. The DOC is authorized to provide successful applicants with assistance in the form of overseas promotion of the show; outreach to show participants about exporting; recruitment of potential buyers to attend the events; and staff assistance in setting up international trade centers at the events. Worldwide promotion is executed through ITA officers at U.S. Embassies and Consulates in more than 70 countries representing the United States' major trading partners, and also in Embassies in countries where ITA does not maintain offices.
The International Trade Administration (ITA) is accepting applications from trade show organizers for the IBP for trade events taking place between January 1, 2017, and December 31, 2017. Selection of a trade show is valid for one event,
For the IBP in calendar year 2017, the ITA expects to select approximately 20 events from among the applicants. The ITA will select those events that are determined to most clearly meet the statutory mandate in 15 U.S.C. 4721 to promote U.S. exports, especially those of small- and medium-sized enterprises, and the selection criteria articulated below.
There is no fee required to submit an application. If accepted into the program for calendar year 2017, a participation fee of $9,800 is required for shows of five days or fewer. For trade shows more than five days in duration, or requiring more than one International Trade Center, a participation fee of $15,000 is required. For trade shows ten days or more in duration, and/or requiring more than two International Trade Centers, the participation fee will be determined by DOC and stated in the written notification of acceptance. It would be calculated on a full cost recovery basis. Successful applicants will be required to enter into a Memorandum of Agreement (MOA) with ITA within 10 days of written notification of acceptance into the program. The participation fee (by check or credit card) is due within 30 days of written notification of acceptance into the program.
The MOA constitutes an agreement between ITA and the show organizer specifying which responsibilities for international promotion and export assistance services at the trade shows are to be undertaken by ITA as part of the IBP and, in turn, which responsibilities are to be undertaken by the show organizer. Anyone requesting application information will be sent a sample copy of the MOA along with the application and a copy of this
Selection as an IBP partner does not constitute a guarantee by DOC of the show's success. IBP partnership status is not an endorsement of the show except as to its international buyer activities. Non-selection of an applicant for IBP partnership status should not be viewed as a determination that the event will not be successful in promoting U.S. exports.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
The Office of Management and Budget (OMB) has approved the information collection requirements of the application to this program (Form OMB 0625-0143) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
For further information please contact: Vidya Desai, Acting Director, International Buyer Program (
International Trade Administration, Department of Commerce.
Notice and call for applications.
The U.S. Department of Commerce (DOC), International Trade Administration (ITA) announces that it will begin accepting applications for the International Buyer Program (IBP) Select service for calendar year 2017 (January 1, 2017, through December 31, 2017). This announcement sets out the objectives, procedures and application review criteria for IBP Select. Under IBP Select, ITA recruits international buyers to U.S. trade shows to meet with U.S. suppliers exhibiting at those shows. The main difference between IBP and IBP Select is that IBP offers worldwide promotion, whereas IBP Select focuses on promotion and recruitment in up to five international markets. Specifically, through the IBP Select, the DOC selects domestic trade shows that will receive DOC assistance in the form of targeted promotion and recruitment in up to five foreign markets, export counseling to exhibitors, and export counseling and matchmaking services at the trade show. This notice covers selection for IBP Select participation during calendar year 2017.
Applications for IBP Select must be received by Friday, January 8, 2016.
The application form can be found at
Vidya Desai, Acting Director, International Buyer Program, Trade Promotion Programs, International Trade Administration, U.S. Department of Commerce, 1300 Pennsylvania Ave. NW., Ronald Reagan Building, Suite 800M—Mezzanine Level—Atrium North, Washington, DC 20004; Telephone (202) 482-2311; Facsimile: (202) 482-7800; Email:
The IBP was established in the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. 100-418, title II, § 2304, codified at 15 U.S.C. 4724) to bring international buyers together with U.S. firms by promoting leading U.S. trade shows in industries with high export potential. The IBP emphasizes cooperation between the DOC and trade show organizers to benefit U.S. firms exhibiting at selected events and provides practical, hands-on assistance such as export counseling and market analysis to U.S. companies interested in exporting. Shows selected for the IBP Select will provide a venue for U.S. companies interested in expanding their sales into international markets.
Through the IBP, the DOC selects trade shows that DOC determines to be
ITA is accepting applications for IBP Select from trade show organizers of trade events taking place between January 1, 2017, and December 31, 2017. Selection of a trade show for IBP Select is valid for one event. A trade show organizer seeking selection for a recurring event must submit a new application for selection for each occurrence of the event. For events that occur more than once in a calendar year, the trade show organizer must submit a separate application for each event.
There is no fee required to submit an application. For IBP Select in calendar year 2017, ITA expects to select approximately 8 events from among the applicants. ITA will select those events that are determined to most clearly support the statutory mandate in 15 U.S.C. 4721 to promote U.S. exports, especially those of small- and medium-sized enterprises, and that best meet the selection criteria articulated below. Once selected, applicants will be required to enter into a Memorandum of Agreement (MOA) with the DOC, and submit payment of the $6,000 2017 participation fee (by check or credit card) within 30 days of written notification of acceptance into IBP Select. The MOA constitutes an agreement between the DOC and the show organizer specifying which responsibilities for international promotion and export assistance services at the trade shows are to be undertaken by the DOC as part of the IBP Select and, in turn, which responsibilities are to be undertaken by the show organizer. Anyone requesting application information will be sent a sample copy of the MOA along with the application form and a copy of this
Selection as an IBP Select show does not constitute a guarantee by DOC of the show's success. IBP Select participation status is not an endorsement of the show except as to its international buyer activities. Non-selection of an applicant for IBP Select status should not be viewed as a determination that the event will not be successful in promoting U.S. exports. Eligibility: 2017 U.S. trade events with 1,350 or fewer exhibitors are eligible to apply, through the show organizer, for IBP Select participation. First-time events will also be considered. Exclusions: U.S. trade shows with over 1,350 exhibitors will not be considered for IBP Select. General Evaluation Criteria: ITA will evaluate applicants for IBP Select using the following criteria:
(a) Export Potential: The trade show promotes products and services from U.S. industries that have high export potential, as determined by DOC sources, including industry analysts' assessment of export potential, ITA best prospects lists, and U.S. export analysis.
(b) Level of International Interest: The trade show meets the needs of a significant number of overseas markets and corresponds to marketing opportunities as identified by ITA. Previous international attendance at the show may be used as an indicator.
(c) Scope of the Show: The event must offer a broad spectrum of U.S. made products and services for the subject industry. Trade shows with a majority of U.S. firms as exhibitors are given priority.
(d) U.S. Content of Show Exhibitors: Trade shows with exhibitors featuring a high percentage of products produced in the United States or products with a high degree of U.S. content will be preferred.
(e) Stature of the Show: The trade show is clearly recognized by the industry it covers as a leading event for the promotion of that industry's products and services both domestically and internationally, and as a showplace for the latest technology or services in that industry.
(f) Level of Exhibitor Interest: There is significant interest on the part of U.S. exhibitors in receiving international business visitors during the trade show. A significant number of U.S. exhibitors should be new-to-export or seeking to expand their sales into additional export markets.
(g) Level of Overseas Marketing: There has been a demonstrated effort by the applicant to market prior shows overseas. In addition, the applicant should describe in detail the international marketing program to be conducted for the event, and explain how efforts should increase individual and group international attendance.
(h) Level of Cooperation: The applicant demonstrates a willingness to cooperate with ITA to fulfill the program's goals and adhere to the target dates set out in the MOA and in the event timetables, both of which are available from the program office (see the
(i) Delegation Incentives: Waived or reduced (by at least 50%) admission fees are required for international attendees who are participating in IBP Select. Delegation leaders also must be provided complimentary admission to the event. In addition, show organizers should offer a range of incentives to delegations and/or delegation leaders recruited by the DOC overseas posts. Examples of incentives to international visitors and to organized delegations include: Special organized events, such as receptions, meetings with association executives, briefings, and site tours; or complimentary accommodations for delegation leaders.
Review Process: ITA will vet all applications received based on the criteria set out in this notice. Vetting will include soliciting input from ITA industry analysts, as well as domestic and international field offices, focusing primarily on the export potential, level of international interest, and stature of the show. In reviewing applications, ITA will also consider sector and calendar diversity in terms of the need to allocate resources to support selected events.
Application Requirements: Show organizers submitting applications for 2017 IBP Select are required to submit: (1) A narrative statement addressing each question in the application, OMB 0625-0143 (found at
The statutory program authority for ITA to conduct the IBP is 15 U.S.C. 4724. ITA has the legal authority to enter into MOAs with show organizers under the provisions of the Mutual Educational and Cultural Exchange Act of 1961 (MECEA), as amended (22 U.S.C.s 2455(f) and 2458(c)). MECEA allows ITA to accept contributions of funds and services from firms for the purposes of furthering its mission.
The Office of Management and Budget (OMB) has approved the information collection requirements of the application to this program (0625-0143) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
For further information please contact: Vidya Desai, Acting Director, International Buyer Program (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public workshop.
The Pacific Fishery Management Council (Council) and the NMFS Northwest and Southwest Fisheries Science Centers (NWFSC and SWFSC, respectively) will hold a public workshop to review and critique its groundfish stock assessment process in 2015. The Groundfish Stock Assessment Process Review Workshop is open to the public.
The Groundfish Stock Assessment Process Review Workshop will commence at 8:30 a.m. PT, Wednesday, December 9, 2015 and continue until 5:30 p.m. or as necessary to complete business for the day. The workshop will reconvene at 8:30 a.m. PT, Thursday, December 10, 2015 and continue until 5:30 p.m. or as necessary to complete business for the day
The Groundfish Stock Assessment Process Review Workshop will be held at Room 203, Fishery Sciences Building (FSH), University of Washington, 1122 NE Boat Street, Seattle, WA 98105.
Mr. John DeVore, Pacific Council; telephone: (503) 820-2413.
The purpose of the Groundfish Stock Assessment Process Review Workshop webinar is for participants in the Council's 2015 stock assessment process to consider the procedures used in 2015 to assess and update groundfish stock abundance and develop recommendations for improving the process for future assessments and future assessment reviews. No management actions will be decided in this workshop. Any recommendations developed at the workshop will be submitted for consideration by the Council at its March 2016 meeting in Sacramento, CA or its April 2016 meeting in Vancouver, WA (see the Council's Web site at
Although non-emergency issues not identified in the workshop agenda may come before the workshop participants for discussion, those issues may not be the subject of formal action during this workshop. Formal action at the workshop will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson Stevens Fishery Conservation and Management Act, provided the public has been notified of the workshop participants' intent to take final action to address the emergency.
This workshop is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the workshop date.
United States Patent and Trademark Office, Commerce.
Notice of Interim Patent Term Extension.
The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one-year interim extension of the term of U.S. Patent No. 5,808,146.
Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755; or by email to
Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.
On October 22, 2015, Emory University, the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 5,808,146. The patent claims the active ingredient fluciclovine (
Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period
An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 5,808,146 is granted for a period of one year from the original expiration date of the patent.
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) titled, “Report of Terms of Credit Card Plans (FR 2572)”.
Written comments are encouraged and must be received on or before January 25, 2016 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
•
•
•
Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included.
Documentation prepared in support of this information collection request is available at
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection titled, “Financial Well-Being National Survey.”
Written comments are encouraged and must be received on or before January 25, 2016 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
•
•
•
Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included.
Documentation prepared in support of this information collection request is available at
Through prior research, the Bureau has determined that improvement in consumer financial well-being is the ultimate goal of such financial literacy initiatives. In order to inform our identification and development of financial literacy strategies that explicitly seek to improve consumer financial well-being, the Bureau plans to conduct a nationally representative survey to measure adult financial well-being and related concepts, as well as an oversample of adults age 62 and older to gather additional data relevant to the needs and experiences of older consumers. The specific goals of the survey are to (1) measure the level of financial well-being of American adults and key sub-populations; (2) quantitatively test previously developed hypotheses about the specific types of knowledge, behavior, traits and skills that may support higher levels of financial well-being; and (3) produce fully de-identified public use data files that will allow external researchers to examine additional questions about financial well-being and its drivers.
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, “Homeownership Counseling Amendments to the Real Estate Settlement Procedures Act (Regulation X) 12 CFR 1024.”
Written comments are encouraged and must be received on or before January 25, 2016 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
•
•
•
Documentation prepared in support of this information collection request is available at
This amendment to Regulation X requires lenders to provide mortgage applicants a list of certified homeownership counselors at or soon after the time of their application. This requirement is meant to help applicants be informed about the process of applying for a mortgage, and receive additional non-biased guidance if desired.
Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.
Defense Travel Management Office, DoD.
Notice of revised non-foreign overseas per diem rates.
The Defense Travel Management Office is publishing Civilian Personnel Per Diem Bulletin Number 300. This bulletin lists revisions in the per diem rates prescribed for U.S. Government employees for official travel in Alaska, Hawaii, Puerto Rico, the Northern Mariana Islands and Possessions of the United States when applicable. AEA changes announced in Bulletin Number 194 remain in effect. Bulletin Number 300 is being published in the
Ms. Sonia Malik, 571-372-1276.
This document gives notice of revisions in per diem rates prescribed by the Defense Travel Management Office for non-foreign areas outside the contiguous United States. It supersedes Civilian Personnel Per Diem Bulletin Number 299. Per Diem Bulletins published periodically in the
Technical and Adult Education (OCTAE), Office of Career, Department of Education.
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before December 24, 2015.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Braden Goetz, 202-245-7405.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of application.
MAG Energy Solutions, Inc. (Applicant or MAG E.S.) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Comments, protests, or motions to intervene must be submitted on or before December 24, 2015.
Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to
Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).
On March 30, 2011, DOE issued Order No. EA-306-A to MAG E.S., which authorized the Applicant to transmit electric energy from the United States to Canada as a power marketer for a five-year term using existing international transmission facilities. That authority expires on April 6, 2016. On November 3, 2015, MAG E.S. filed an application with DOE for renewal of the export authority contained in Order No. EA-306 for an additional five-year term.
In its application, MAG E.S. states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that MAG E.S. proposes to export to Canada would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by MAG E.S. have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments and other filings concerning MAG E.S.'s application to export electric energy to Canada should be clearly marked with OE Docket No. EA-306-B. An additional copy is to be provided directly to both Ruta Kalvaitis Skucas, Pierce Atwood LLC., 900 17th Street NW., Suite 350, Washington, DC 20006 and Simon Pelletier, MAG Energy Solutions, Inc., 999 de Maisonneuve Boulevard West, Suite 875, Montreal, Quebec H3A 3L4 Canada.
A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.
Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at
Environmental Protection Agency (EPA).
Notice; public comment period.
The Environmental Protection Agency (EPA) is announcing a 60-day public comment period for the draft document titled, “External Review Draft Integrated Science Assessment for Sulfur Oxides—Health Criteria” (EPA/600/R-15/066). The draft document was prepared by the National Center for Environmental Assessment (NCEA) within the EPA's Office of Research and Development as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for sulfur dioxide (SO
EPA is releasing this draft document to seek review by the Clean Air Scientific Advisory Committee (CASAC) and the public (meeting date and location to be specified in a separate
The 60-day public comment period begins on November 24, 2015, and ends on January 25, 2016. Comments must be received on or before January 25, 2016.
The “External Review Draft Integrated Science Assessment for Sulfur Oxides—Health Criteria” will be available primarily via the Internet on EPA's Integrated Science Assessment for Sulfur Dioxide (Health Criteria) home page at
For information on the public comment period, contact the ORD Docket at the EPA Headquarters Docket Center; telephone: 202-566-1752; facsimile: 202-566-9744; or email:
For technical information, contact Dr. Tom Long, NCEA; telephone: 919-541-1880; facsimile: 919-541-1818; or email:
Section 108(a) of the Clean Air Act directs the Administrator to identify certain pollutants which, among other things, “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare” and to issue air quality criteria for them. These air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air. . . .” Under section 109 of the Act, EPA is then to establish NAAQS for each pollutant for which EPA has issued criteria. Section 109(d) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. EPA is also required to review and, if appropriate, revise the NAAQS, based on the revised air quality criteria (for more information on the NAAQS review process, see
Sulfur oxides are one of six criteria pollutants for which EPA has established NAAQS. Periodically, EPA reviews the scientific basis for these standards by preparing an ISA (formerly called an Air Quality Criteria Document). The ISA, in conjunction with additional technical and policy assessments, provides the scientific basis for the EPA's decisions on the adequacy of the current NAAQS and the appropriateness of possible alternative standards. The CASAC, an independent science advisory committee whose review and advisory functions are mandated by Section 109(d)(2) of the Clean Air Act, is charged (among other things) with independent scientific review of the EPA's air quality criteria.
On May 10, 2013 (78 FR 27387), EPA formally initiated its current review of the air quality criteria for the health effects of sulfur oxides and the primary (health-based) SO
The “External Review Draft Integrated Science Assessment for Sulfur Oxides—Health Criteria” will be discussed at a public meeting for review by CASAC and the public. In addition to the public comment period announced in this notice, the public will have an opportunity to address CASAC. A separate
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2013-0357, by one of the following methods:
•
•
•
•
•
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, November 19, 2015, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communication Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to
Written comments should be submitted on or before December 24, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page <
The Commission is making this submission to the Office of Management and Budget for approval to add SDARS licensees to this information collection.
Federal Communications Commission.
Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by Igor Ovchinnikov, Irina Rzaeva, and Denis Nekipelov, hereinafter “Complainants,” against Michael Hitrinov (“Hitrinov”), Empire United Lines Co., Inc. (“EUL”) and CarCont Ltd. (“CarCont”), hereinafter “Respondents.” Complainants state that they are individuals residing in the Russian Federation. Complainants allege that Respondent EUL is a New York corporation and a licensed non-vessel-operating common carrier, Respondent CarCont is a company in Finland, and Respondent Hitrinov is the owner of both EUL and CarCont.
Complainants allege that Respondents have violated the Shipping Act, 46 U.S.C. 40301, 40302, 40501, 40701, 41102, 41104, 41106, and the Commission's regulations at 46 CFR part 515, in connection with shipment of 3 vehicles. Complainants allege that each Complainant purchased a vehicle, which vehicles were shipped to Finland but never released or delivered because of unpaid loans due Respondents by the seller of the vehicles, affiliates G-Auto Sales, Inc. and Effect Auto Sales Inc. Complainant Igor Ovchinnikov seek damages in excess of $28,960. Complainant Irina Rzaeva seek damages in excess of $32,101. Complainant Denis Nekipelov seek damages in excess of $19,920.
Complainants request that: “(1) Respondents be required to answer the charges herein; (2) that after due hearing, an order be made commanding said Respondent to pay to Complainants by way of reparations for the unlawful conduct . . . with interest and attorney's fees or such other sum as the Commission may determine to be proper as an award of reparation; (3) that the Commission issue an Order holding that the Respondents . . . violated the Shipping Act of 1984; (4) that the Commission Order the Respondents to provide Empire United Lines Co., Inc.'s house bills of lading for the shipments described herein; and (5) that the Commission issue such other and further order or orders as the Commission determines to be just and proper.”
The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by November 17, 2016, and the final decision of the Commission shall be issued by May 16, 2017.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 9, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
Presidential Transition, General Services Administration.
Notice of availability of the General Services Administration 2016 Presidential Transition Directory.
The Presidential Transition Directory Web site is designed to help candidates in the 2016 Presidential election get quick and easy access to key resources about the federal government structure and key policies related to Presidential Transition. The creation of the Presidential Transition Directory is mandated by the Presidential Transition Act of 1963, as amended.
The GSA Presidential Transition Team at
The Presidential Transition Directory (
Federal Acquisition Service; General Services Administration (GSA).
Notice of request for comments regarding a new request for an OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding OMB Control No: 3090-00XX; Simplifying Federal Award Reporting.
Submit comments on or before: January 25, 2016.
Submit comments identified by Information Collection 3090-00XX; Simplifying Federal Award Reporting by any of the following methods:
•
•
Mr. Kenneth Goldman, GSA, at telephone 202-779-2265.
The President's Management Agenda includes objectives for creating a twenty-first century government that delivers better results to the American people in a more efficient manner. Leveraging information technology capabilities to reduce reporting burden is key to achieving these goals. Section 5 of the Digital Accountability and Transparency Act (Pub. L. 113-101) requires a pilot program to develop recommendations for standardizing reporting, eliminating unnecessary duplication, and reducing compliance costs for recipients of Federal awards. The pilot participants are required to provide requested reports as well as the cost to collect the data via the pilot. The proposed pilot program will provide an alternative submission method for existing Federal Acquisition Regulation (FAR) requirements, and assess the pilot results against the existing FAR-required method.
Public comments are particularly invited on: Whether this collection of information will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Please cite OMB Control No. 3090-XXXX, Simplifying Federal Award Reporting, in all correspondence.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS)
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the information collection entitled
Written comments must be received on or before January 25, 2016.
You may submit comments, identified by Docket No. CDC-2015-0106 by any of the following methods:
•
•
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing
Improving the Impact of Laboratory Practice Guidelines (LPGs): A New Paradigm for Metrics—College of American Pathologists, REVISION (OMB Control No. 0920-1067, Expiration 05/31/16)—Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC).
The Centers for Disease Control and Prevention is funding three 5-year projects collectively entitled “Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics”. An “LPG” is defined as written recommendations for voluntary, standardized approaches for medical laboratory testing that takes into account processes for test selection, sample procurement and processing, analytical methods, and results reporting for effective diagnosis and management of disease and health conditions. LPGs may be disseminated to, and used by, laboratorians and clinicians to assist with test selection and test result interpretation. The overall purpose of these cooperative agreements is to increase the effectiveness of LPGs by defining measures and collecting information to inform better LPG creation, revision, dissemination, promotion, uptake, and impact on clinical testing and public health. The project will explore how these processes and their impediments and facilitators differ among various intended users of LPGs. Through this demonstration project, CDC seeks to understand how to customize LPG creation and promotion to better serve these intended users of LPGs. An important goal is to help organizations that sponsor the development of LPGs create a sustainable approach for continuous quality improvement to evaluate and improve an LPG's impact through better collection of information.
The CDC selected three organizations that currently create and disseminate LPGs to support activities under a cooperative agreement funding mechanism to improve the impact of their LPGs. The American Society for Microbiology, the Clinical and Laboratory Standards Institute, and the College of American Pathologists (CAP), will each use their LPGs as models to better understand how to improve uptake and impact of these and future LPGs. Only the CAP submission will be described in this notice.
The CAP project will address two LPGs that are important to clinical testing: immunohistochemistry test validation (IHC) and an algorithm for diagnosing acute leukemia (ALA). As part of the completed survey collections that was conducted under OMB Control Number 0920-1067, the intended users of the CAP's IHC LPG included pathologists, clinical laboratory directors, and laboratory managers overseeing the IHC staining department; the intended users of the CAP's ALA LPG were pathologists and hematologists overseeing testing for acute leukemia. For this revision request, CDC is proposing information collections to conduct qualitative studies of the survey respondents of the IHC post-survey with the intent to include representation from the laboratory professionals who submitted the IHC post-survey results (pathologists, clinical laboratory directors, and laboratory managers).
Prior to entering into this cooperative agreement project with the CDC, the CAP had already completed a baseline IHC LPG information collection from laboratories that used IHC testing. Because of this prior baseline assessment, the CAP only needed to collect post-dissemination data. This has been completed using the information approved under OMB Control Number 0920-1067. Similarly, the CAP also completed an ALA baseline survey under this clearance.
We are submitting a revision request to allow for a fuller exploration of the factors that underlie the reasons why laboratorians adhere to the College of American Pathologists' laboratory practice guideline for IHC. We propose to conduct telephone interviews that will explore the impediments and facilitators that affect uptake and use of the CAP IHC LPG, both generally and concerning specific recommendations. This will be followed by two focus groups, arranged by peer group of pathologists and non-pathologists (referred to as laboratory directors and managers for the purpose of estimating burden), which will allow us to collect information on the current usage of CAP's tools and resources (toolkit) to facilitate implementation of the IHC guideline for its future improvement. To the extent possible, we will include non-adopters of the CAP's IHC LPG, but this fraction won't be known until the information collection occurs. We propose to collect information for the telephone interviews and focus groups combined, from 64 of the IHC post-survey respondents which include pathologists and non-pathologist laboratory directors and laboratory managers.
For this request, the CAP will collect information via telephone interviews from 40 laboratorians. The time it will take each respondent to complete the interview is 20 minutes. Because the CAP anticipates that as many as 121 individuals may need to be contacted to reach 40 individuals who will voluntarily participate, and the burden for those individuals who will not go on to participate (81) in the telephone interview is one minute, the anticipated total burden for individuals who decline participation is 1.35 hours (81 minutes). The telephone interview respondents will be targeted from two primary segments: (1) Laboratories exclusively using CAP Proficiency Testing (PT) products, and (2) laboratories identified by Centers for Medicare and Medicaid Services billing codes that perform IHC testing but are not enrolled in CAP PT products. The telephone interview respondents will be randomly sampled from the submitted post-survey results and will be cross-checked for appropriate distribution of laboratory type and size. Because there are fewer of them, all of the non-CAP PT customer respondents will be included. The CAP estimates that the individuals who complete the telephone interview will be comprised of 20 pathologists, 10 laboratory directors, and 10 laboratory managers and will each take 20 minutes and the 40 respondents combined will take approximately 13 hours (800 minutes) total burden.
The two in-person focus group sessions will include some of the probe questions from the telephone interview survey and a specific subset concentrating on evaluating CAP's current tools and resources (toolkit). It is anticipated that 200 individuals will be contacted to determine their availability to participate in one of two focus group sessions and each will take no longer than five minutes to read and respond to the invitation letter (~17 hours or 1,000 minutes total). Among the 200 individuals contacted, only the 24 who are selected to participate in a focus group session will each be asked to read and submit a signed consent form prior to the session (5 minutes each) (2 hours or 120 minutes total). Twelve participants will be selected to participate in each of the two focus groups (pathologist peers and laboratory director/manager peers) and will last no more than 90 minutes each (36 hours or 2,160 minutes total). Thus, the total
Including both telephone interviews and focus group sessions, the total new burden for this revision request will be an additional ~68 hours (321 individuals) at $4,421 total, compared with the original OMB approved burden of 1,570 hours (4,435 individuals) at $97,460 total.
There are no costs to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled “Monitoring and Reporting System for DELTA FOCUS Awardees”. CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.
Written comments must be received on or before January 25, 2016.
You may submit comments, identified by Docket No. CDC-2015-0104 by any of the following methods:
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation,
Monitoring and Reporting System for DELTA FOCUS Awardees, (OMB Control No. 0920-0968, expiration 5/31/2016)—Extension—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).
Intimate Partner Violence (IPV) is a serious, preventable public health problem that affects millions of Americans and results in serious consequences for victims, families, and communities. IPV occurs between two people in a close relationship. The term “intimate partner” describes physical, sexual, or psychological harm by a current or former partner or spouse. IPV can impact health in many ways, including long-term health problems, emotional impacts, and links to negative health behaviors. Given these factors, the Family Violence Prevention and Services Act (42 U.S.C. 10401) provides an important opportunity for the advancement of public health and reduction of IPV. Support and guidance for programs addressing IPV have been provided through cooperative agreement funding and technical assistance administered by CDC's National Center for Injury Prevention and Control (NCIPC). CDC seeks to continue collecting information needed to monitor cooperative agreement programs funded under Domestic Violence Prevention Enhancement and Leadership through Alliances, Focusing on Outcomes for Communities United with States DELTA FOCUS (FOA CDC-RFA-CE13-130).
Information to be collected will provide crucial data for program performance monitoring and provide CDC with the capacity to respond in a timely manner to requests for information about the program from the Department of Health and Human Services (HHS), the White House, Congress, and other sources. Awardees will report progress and activity information to CDC on an annual schedule using the Program Management Information System (PMIS) consisting of fillable electronic templates and submitted via Grant Solutions.
CDC will use the information collected to monitor each awardee's progress and to identify facilitators and challenges to program implementation and achievement of outcomes. Monitoring allows CDC to determine whether an awardee is meeting performance goals and to make adjustments in the type and level of technical assistance provided to them, as needed, to support attainment of their objectives. CDC's monitoring and evaluation activities also allow CDC to provide oversight of the use of federal funds, and to identify and disseminate information about successful prevention and control strategies implemented by awardees. These functions are central to the NCIPC's broad mission of reducing the burden of injury and violence. Finally, the information collection allows CDC to monitor the increased emphasis on partnerships and programmatic collaboration, and is expected to reduce duplication of effort, enhance program impact and maximize the use of federal funds.
This is an extension request for three years. Participation in the information collection is required as a condition of funding. There are no costs to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the reopening of the nomination period for individuals qualified to serve as members of the Community Preventive Services Task Force (CPSTF). The nomination period originally closed on November 9, 2015.
Nomination packages must be received by December 8, 2015. Complete nomination packages must be submitted by the deadline in order to be considered. Individuals who submitted a nomination package during the original nomination period do not need to re-submit their nomination package to be considered.
Nomination packages should be submitted electronically to
Donyelle Russ, Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS E-69, Atlanta, Georgia 30329. Phone (404) 498-3971, email:
On September 25, 2015 HHS/CDC published a notice in the
Nomination packages must be submitted electronically, and should include:
(1) The nominee's current curriculum vitae;
(2) A brief biographic sketch of the nominee;
(3) The nominee's contact information, including mailing address, email address, and telephone number; and
(4) A brief explanation of how the nominee meets the qualification requirements and how he/she would contribute to the CPSTF. The information provided should also attest to the nominee's willingness to serve as a member of the CPSTF.
HHS/CDC will later ask persons under serious consideration for CPSTF membership to provide detailed information that will permit evaluation of possible significant conflicts of interest.
To obtain diverse perspectives, HHS/CDC encourages nominations of all races, genders, ages and persons living with disabilities. Interested individuals can self-nominate. Organizations and individuals may nominate one or more persons qualified for membership on the CPSTF. Federal employees are not eligible to be CPSTF members. Individuals nominated prior to this round, who continue to have interest in serving on the CPSTF, should be re-nominated.
To qualify for the CPSTF and support its mission, a nominee must, at a minimum, demonstrate knowledge, experience, and national leadership in the following areas:
• The critical evaluation of research or policy, and/or in the methods of evidence review; and
• Research, evaluation, or implementation of community and/or health system-based programs, policies, or services to improve population health.
Strongest consideration will be given to individuals with expertise and experience:
• That is applied, with practical applications for public health action;
• That addresses broad public health considerations, or is beyond one or two highly defined areas;
• In state and/or local health departments; and
• With policy.
In the current round of nominations, the strongest consideration will also be given to people with expertise and experience in systematic review methods, minority health, and aging. The CPSTF will also benefit from members with expertise and experience in the following areas: Youth populations; environmental health; injury (in particular substance abuse and violence prevention); media, communications, and marketing; public health nursing; and economic analysis.
Candidates with experience and skills in any of these areas should highlight them in their nomination materials.
All nominated individuals will be considered for CPSTF membership.
Applicants must have no substantial conflicts of interest, whether financial, professional, or intellectual, that would impair the scientific integrity of the work of the CPSTF and must be willing to complete regular conflict of interest disclosures.
Applicants must have the ability to work collaboratively with a team of diverse professionals who support the mission of the CPSTF. Applicants must have adequate time to contribute substantively to the work products of the CPSTF.
Appointments to the CPSTF will be made on the basis of qualifications as outlined above (see Qualification Requirements) and the current expertise needs of the CPSTF.
The CPSTF was established in 1996 by the U.S. Department of Health and Human Services (HHS) to identify population health interventions that are scientifically proven to save lives, increase lifespans, and improve quality of life. The CPSTF produces recommendations (and identifies evidence gaps) to help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers and organizations, employers, schools and research organizations.
The CPSTF (
The CPSTF bases its recommendations on rigorous, replicable systematic reviews of the scientific literature, which do all of the following:
• Evaluate the strength and limitations of published scientific studies about community-based health promotion and disease prevention programs, services, and policies;
• Assess whether the programs, services, and policies are effective in promoting health and preventing disease, injury, and disability;
• Examine the applicability of these programs, services, and policies to varied populations and settings; and
• Conduct economic analyses of recommended interventions.
These systematic reviews are conducted, with CPSTF oversight, by scientists and subject matter experts from HHS/CDC in collaboration with a wide range of government, academic, policy, and practice-based partners.
The CPSTF conducts three, two-day meetings each year that are open to the public. In addition, a significant portion of the CPSTF's work occurs between meetings during conference calls and via email discussions. Member duties include overseeing the process of prioritizing Task Force work, participating in the development and refinement of systematic review methods, serving as members of individual review teams, and issuing recommendations and findings to help inform the decision making process about policy, practice, research, and research funding in a wide range of U.S. settings. The estimated workload for CPSTF members is approximately 168 hours a year in addition to the three in-person meetings. The members are all volunteers and do not receive any compensation beyond support for travel to in-person meetings.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon: Guidance for Industry.” We developed the draft guidance to assist food manufacturers that wish to voluntarily label their food product or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered (GE) Atlantic salmon.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 25, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist the office in processing your request. See the
We are announcing the availability of a draft guidance for industry entitled “Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
On November 19, 2015, FDA approved a new animal drug application (NADA) related to AquAdvantage Salmon, a GE Atlantic salmon. This is FDA's first approval of an NADA in support of a GE animal for use as food. According to information in the NADA, AquAdvantage Salmon is genetically engineered to reach market size in a shorter period than non-GE farm-raised Atlantic salmon. FDA's Center for Veterinary Medicine reviewed the NADA and made a determination concerning the safety and effectiveness of the new animal drug in AquAdvantage Salmon.
In terms of labeling of food derived from AquAdvantage Salmon, the law requires, among other things, that the label includes a name that accurately describes the basic nature of a food and any other information that is considered material with regard to consequences that may result from the use of the food. In a 1992 policy on foods derived from new plant varieties and a 2001 draft guidance on voluntary labeling of food from GE plants, we explained that: Name changes are appropriate when a food from a GE plant is
In the process of deciding whether or not to require additional labeling of AquAdvantage Salmon, FDA considered whether food from AquAdvantage Salmon is materially different from non-GE, farm-raised Atlantic salmon. As part of our evaluation, we assessed data and information submitted in response to our August 26, 2010,
Based on our review of the sponsor's data and information, and other information available to the Agency (
Recognizing that some consumers are interested in whether a food contains GE Atlantic salmon and some manufacturers may want to respond to this consumer interest, we developed this draft guidance to assist food manufacturers that wish to voluntarily label their food product or ingredients (for humans or animals) as either containing or not containing products from GE Atlantic salmon. FDA's main concern within the context of this guidance is that any voluntary labeling be truthful and not misleading.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This draft guidance contains proposed collections of information. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a 60-day notice in the
Persons with access to the Internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Voluntary Labeling Indicating Whether
Submit either electronic or written comments on the guidance at any time. Fax written comments on the collection of information by December 24, 2015.
To ensure that comments on the information collection are received, the Office of Management and Budget (OMB) recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of this guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Section 403 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343) generally governs the labeling of foods. Under section 403(a)(1) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular.
Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides that labeling is misleading if, among other things, it fails to reveal facts that are material in light of representations made or suggested in the labeling, or material with respect to consequences that may result from the use of the food to which the labeling relates under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual.
In the
In the 1992 Policy, we addressed, among other things, the labeling of foods derived from new plant varieties, including plants developed by bioengineering. In the 1992 Policy, we explained that we were not establishing special labeling requirements for foods from bioengineered plants as a class of foods because we did not find any basis for concluding that foods from bioengineered plants, as a class, differ from other foods in any meaningful or uniform way, or that foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.
In the
We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In addition, this guidance does not preempt State food labeling requirements that are consistent with the Federal requirements described in the guidance and that are not otherwise expressly preempted by the FD&C Act.
This final guidance contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
After publishing the 60-day notice requesting public comment, section 3507 of the PRA (44 U.S.C. 3507) requires Federal Agencies to submit the proposed collection to OMB for review and clearance. In compliance with 44 U.S.C. 3507, we have submitted the following proposed collection of information to OMB for review and clearance. FDA is issuing this final guidance subject to OMB approval of the collection of information. If the collection is approved, FDA will publish a notice in the
As noted, in the
The guidance entitled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” is intended to assist manufacturers that wish to voluntarily label their foods (human or animal) as being made with or without genetic engineering or the use of genetically engineered ingredients, to ensure that such labeling is truthful and not misleading. The information that the manufacturers will collect is documentation of handling practices so that they can truthfully label their products to indicate, if they so choose, whether the food has or has not been developed using genetic engineering.
In general, we anticipate that manufacturers claiming that a product is not developed using genetically engineered material would substantiate the claim. We suggest that manufacturers document practices and procedures to substantiate a claim that a food was not developed using genetic engineering. Examples of documentation that we anticipate will demonstrate practices and procedures are recordkeeping, and certifications or affidavits from farmers, processors, and others in the food production and distribution chain. We are neither suggesting that firms maintain a certain set list of documents nor are we suggesting that anything less or different would likely be considered unacceptable. Rather, we are leaving it to each firm's judgment to maintain appropriate documentation to demonstrate that the food was produced using traditional methods.
As noted, in the
(Comment 1) Most comments agreed that labeling food products as genetically engineered or non-genetically engineered would result in costs due to segregation, testing, or third-party validation, in addition to label changes. However, some comments said the producers that choose to label their products as non-genetically engineered and the consumers that choose to purchase these products should incur these costs. Other comments said that these costs should be borne by the growers, manufacturers, processors, and
(Response) We disagree that it would be necessary to incur costs due to segregation, testing, or third-party validation to substantiate a claim that a food was not developed using genetic engineering. We also note that the question of who should bear the paperwork burden is not within the scope of the guidance.
(Comment 2) One comment stated that we underestimated the number of small firms that will choose to label their product as not genetically engineered, but will not attempt to make an organic claim.
(Response) We disagree that we underestimated the number of respondents in the 2001 60-day
(Comment 3) Numerous comments pointed out that mandatory labeling would have high costs for additional activities such as segregation, testing, labeling, quality control, and certification. One comment estimated that these costs could be as high as 6 to 17 percent of the farmgate price.
(Response) The paperwork reduction analysis only estimates the paperwork burden associated with
FDA estimates the burden of this collection of information as follows:
We have updated the number of recordkeepers and respondents to reflect new information on the number of food products that are labeled using the terms “biotechnology” and “GMO” (genetically modified organism) since the 2001 issuance of the 60-day notice and draft guidance. We estimate a recordkeeping burden, to retain paperwork to substantiate that the food or ingredient is produced without genetic engineering, only for products that are not also already labeled using the term “organic.” We did not include products that are labeled “organic” in the estimated annual recordkeeping burden because, according to a final rule in the
We based our revised estimates of the recordkeeping burden (table 1 of this document) on data from Labelbase by FoodEssentials. Labelbase is a custom online system for accessing a consumer packaged goods product data; the database contains more than 250,000 product labels that can be searched by keyword, ingredient, nutrient, allergen, label claim, or food additive, for example. Using this database, we have identified 540 food manufacturers who produce 2,160 products with the term “bioengineered” or “GMO” on their labels; this estimate includes manufacturers of human food and pet food. In addition, the National Center for Appropriate Technology's National Sustainable Agriculture Information Center maintains on its Web site a list of Organic Livestock Feed Suppliers. Using this list, we have identified 54 livestock feed suppliers that would be likely to include a statement about bioengineering on the label of their products and thus would have documentation to substantiate their claim.
Of the 2,160 human food and pet food products that we have identified as using the term “bioengineered” or “GMO” on their labels (presumably used in a context to designate foods that are not bioengineered), 1,140 of these products (285 manufacturers) also use the term “organic” on the label; 1,020 products do not use the term “organic” on the label (2,160 − 1,140 = 1,020 products not organics; 540−285 = 255 manufacturers of not organic products). In addition, the 54 livestock feed suppliers are also organic producers, thus the 216 products attributed to these manufacturers already are considered to be labeled “organic.” Thus, there are 1,020 products made by 255 human food and pet food manufacturers that would need to substantiate that their product or ingredient was not genetically engineered.
We estimate that the burden of maintaining the documentation is a one-time burden; the document to substantiate that the product or ingredient was produced without genetic engineering only needs to be generated once and then kept on file. To annualize this one-time burden, we divide by 3 because paperwork burden collections are approved on a 3-year cycle (255/3 = 85). Thus, we estimate in table 1 that, on average, 85 manufacturers annually will collect and keep information that substantiates their label claim for four products (1,020 products/3 = 340 products/85 manufacturers = 4 products per manufacturer).
We estimate this one-time recordkeeping burden to be 1 hour per product that makes use of a labeling claim which results in a burden of 1 hour for a total annualized recordkeeping burden of 340 hours (85 manufacturers × 4 records per manufacturer × 1 hour per record). In the 2001 notice, we estimated $53,040 as “operating and maintenance costs” associated with this recordkeeping burden. These costs were reported in error and have been removed from table 1. We estimate no capital costs or operating and maintenance costs associated with this recordkeeping burden.
We do not estimate any reporting burden or third party disclosure burden associated with this information collection. Manufacturers who want to make use of this voluntary labeling claim option are considered to be those that already have such wording on their products' labels. We do not expect that this guidance will cause labels already in the marketplace to need to be re-worded.
Persons with access to the Internet may obtain the guidance at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Coast Guard, DHS.
Request for applications.
The Coast Guard seeks applications for membership on the Merchant Mariner Medical Advisory Committee. The Merchant Mariner Medical Advisory Committee provides advice and recommendations to the Secretary on matters related to medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners' documents; medical standards and guidelines for the physical qualifications of operators of commercial vessels; medical examiner education; and medical research. Applicants selected for service on the Merchant Mariner Medical Advisory Committee via this solicitation will not begin their respective term until August 8, 2016.
Completed applications should reach the Coast Guard on or before January 25, 2016.
Applicants should send a cover letter expressing interest in an appointment to the Merchant Mariner Medical Advisory Committee that also identifies which membership category the applicant is applying under, along with a resume detailing the applicant's experience via one of the following methods:
•
•
•
Lieutenant Ashley Holm, Alternate Designated Federal Officer of the Merchant Mariner Medical Advisory Committee, Commandant, Mariner Credentialing Program Policy Division (CG-CVC-4), U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7501 Washington, DC 20593-7501,
The Merchant Mariner Medical Advisory Committee was established under Section 210 of the Coast Guard
The Merchant Mariner Medical Advisory Committee is expected to meet at least twice a year at various locations around the country. It may also meet intercessionally for extraordinary purposes. Working groups may also meet to consider specific tasks as required.
The Coast Guard will consider applications for seven positions that expire on August 8, 2016. These positions include two professional mariners with knowledge and experience in mariners' occupational requirements, and five health care professionals with particular expertise, knowledge, or experience regarding the medical examinations of merchant mariners or occupational medicine.
The members appointed will serve a term of office of five years. The members are limited to serving no more than two consecutive terms. All members serve without compensation from the Federal Government; however, members may be reimbursed for travel and per diem depending on fiscal budgetary constraints.
Members of the Merchant Mariner Medical Advisory Committee will be appointed and serve as Special Government Employees as defined in section 202(a) of Title 18 United States Code. As candidates for appointment as Special Government Employees, applicants are required to complete Confidential Financial Disclosure Reports (OGE Form 450). Coast Guard may not release the reports or the information in them to the public except under an order issued by a Federal court or as otherwise provided under the Privacy Act (5 U.S.C. 552a). Only the Designated Coast Guard Ethics Official or his designee may release a Confidential Financial Disclosure Report. Applicants can obtain this form by going to the Web site of the Office of Government Ethics (
Registered lobbyists are not eligible to serve on Federal advisory committees in an individual capacity. Registered lobbyists are lobbyists required to comply with provisions contained in the Lobbying Disclosure Act of 1995 (2 U.S.C. 1605; Pub. L. 104-65; as amended by Title II of Pub. L. 110-81).
The Merchant Mariner Medical Advisory Committee members are appointed in their individual capacity and would be designated as a Special Government Employee as defined in 202(a) of Title 18, U.S.C. See “Revised Guidance on Appointment of Lobbyist to Federal Advisory Committees, Boards and Commissions” (79 FR 47482, August 13, 2014).
The Department of Homeland Security does not discriminate in selection of Committee members on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and genetic information, age, membership in an employee organization, or any other non-merit factor. The Department of Homeland Security strives to achieve a widely diverse candidate pool for all of its recruitment actions.
If you are interested in applying to become a member of the Committee, send your cover letter and resume to Lieutenant Ashley Holm, Designated Alternate Federal Officer of the Merchant Mariner Medical Advisory Committee by email or mail according to instructions in the
All email submittals will receive email receipt confirmation.
To visit our online docket, go to
Coast Guard, DHS.
Notice of availability.
The Coast Guard announces the availability of the Merchant Mariner Medical Advisory Committee's response to Task Statement 1, “Navigation and Vessel Inspection Circular 04-08 Revision Working Group.” This document recommends various changes to NVIC 04-08, “Medical and Physical Evaluation Guidelines for Merchant Mariner Credentials,” which the Coast Guard uses when making decisions on mariner credentialing. The Coast Guard has not adopted this document as policy, but will consider it in future policy development.
Task Statement 1 and the Merchant Mariner Medical Advisory Committee's response to the task are available on the Coast Guard's Web site at:
If you have questions on this notice, email
The Merchant Mariner Medical Advisory Committee (the Committee) is authorized under 46 United States Code 7115 and operates in accordance with the Federal Advisory Committee Act (Title 5 U.S.C., Appendix). The Committee advises the Secretary on matters related to (a) medical certification determinations for issuances of licenses, certificates of registry, and merchant mariners' documents; (b) medical standards and guidelines for the physical qualifications of operators of commercial vessels; (c) medical examiner education; and (d) medical research.
The Committee voted to accept Task Statement 1 during the second public meeting held on May 8-9, 2012 in Martinsburg, WV. This task requested
Task Statement 1 required the following inputs. First, it required the working group to review the introduction and Enclosures 1, 2, 5, and 6 of NVIC 04-08 to ensure compliance with existing Coast Guard regulations in the Code of Federal Regulations. Second, it required the working group to review all medical conditions listed in Enclosures 3 and 4 of the NVIC and perform the following actions:
Subsequently, a working group was established. The working group was comprised of individual members of MEDMAC and the public, although the composition of the working group changed over time. The Committee voted to accept the response to Task Statement 1 provided by the working group during the sixth public meeting held on September 29-30, 2014 in Piney Point, MD. All working group meetings were open to the public.
The response to Task Statement 1 is in the form of a revised NVIC 04-08. This revision includes both the introduction to NVIC 04-08 as well as revised versions of each of the enclosures. In accordance with the task statement, the working group has made revisions to each enclosure, but made substantial revisions to enclosures 3 and 4. These enclosures, entitled “Vision and Hearing Standards” and “Guidance on Specific Medical Conditions,” provide detailed guidelines that can help the Coast Guard make fitness determinations for mariners to maintain their credentials.
The Merchant Mariner Medical Advisory Committee's response to Task Statement 1 is a work product of the Committee and therefore is not an official Coast Guard policy and may not be cited as an official agency position. The Coast Guard may use the response, or portions of the response, for development of future policy.
This notice is issued under the authority of 5 U.S.C. 552(a), 46 U.S.C. 7101
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until January 25, 2016.
All submissions received must include the Office of Management and Budget (OMB) Control Number 1615-0047 in the subject box, the agency name, and Docket ID USCIS-2006-0068. To avoid duplicate submissions, please use only
(1)
(2)
(3)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Laura Dawkins, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377. (This is not a toll-free number.) Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information, by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This document designates “Difficult Development Areas” (DDAs) and “Qualified Census Tracts” (QCTs) for purposes of the Low-Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42 (26 U.S.C. 42). The United States Department of Housing and Urban Development (HUD) makes new DDA and QCT designations annually. As previously announced, the 2016 metropolitan DDA designations use for the first time Small Area Fair Market Rents (SAFMRs), rather than metropolitan-area Fair Market Rents (FMRs), for designating metropolitan DDAs. Compared to previous designations, this notice: (1) Describes a strengthening of the data quality standard HUD uses in designating the 2016 QCTs, (2) extends from 365 days to 730 days the period for which the 2016 lists of QCTs and DDAs are effective for projects located in areas not on a subsequent list of DDAs or QCTs but having submitted applications while the area was a 2016 QCT or DDA, and (3) establishes the effective date of the new QCTs and DDAs as July 1, 2016 rather than January 1.
For questions on how areas are designated and on geographic definitions, contact Michael K. Hollar, Senior Economist, Economic Development and Public Finance Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 Seventh Street SW., Room 8234, Washington, DC 20410-6000; telephone number 202-402-5878, or send an email to
This notice designates DDAs for each of the 50 states, the District of Columbia, Puerto Rico, American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands. The designations of DDAs in this notice are based on modified Fiscal Year (FY) 2015 Small Area Fair Market Rents (SAFMRs), FY2015 income limits, and 2010 Census population counts, as explained below.
This notice also designates QCTs based on new income and poverty data released in the American Community Survey (ACS). HUD relies on the most recent three sets of ACS estimates to ensure that anomalous estimates, due to sampling, do not affect the QCT status of tracts.
Data from the 2010 Census on total population of metropolitan areas and nonmetropolitan areas are used in the designation of DDAs. The Office of Management and Budget (OMB) first published new metropolitan area definitions incorporating 2000 Census data in OMB Bulletin No. 03-04 on June 6, 2003, and updated them periodically through OMB Bulletin No. 10-02 on
Data from the 2010 Census on total population of census tracts, metropolitan areas, and the nonmetropolitan parts of states are used in the designation of QCTs. The FY2015 income limits used to designate QCTs are based on these MSA definitions with modifications to account for substantial differences in rental housing markets (and in some cases median income levels) within MSAs. This QCT designation uses the OMB metropolitan area definitions published in OMB Bulletin No. 10-02 on December 1, 2009, without modification for purposes of evaluating how many census tracts can be designated under the population cap, but uses the HUD-modified definitions and their associated area median incomes for determining QCT eligibility.
Because the 2010 Decennial Census did not include questions on respondent household income, HUD uses ACS data to designate QCTs. The ACS tabulates data collected over 5 years to provide estimates of socioeconomic variables for small areas containing fewer than 20,000 persons, such as census tracts. Due to anomalies in estimates from year-to-year, HUD incorporates three sets of ACS tabulations to ensure that anomalous estimates do not affect QCT status.
The U.S. Department of the Treasury (Treasury) and its Internal Revenue Service (IRS) are authorized to interpret and enforce the provisions of the LIHTC found at IRC Section 42. The Secretary of HUD is required to designate DDAs and QCTs by IRC Section 42(d)(5)(B). In order to assist in understanding HUD's mandated designation of DDAs and QCTs for use in administering IRC Section 42, a summary of the section is provided. The following summary does not purport to bind Treasury or the IRS in any way, nor does it purport to bind HUD, since HUD has authority to interpret or administer the IRC only in instances where it receives explicit statutory delegation.
The LIHTC is a tax incentive intended to increase the availability of low-income housing. IRC Section 42 provides an income tax credit to owners of newly constructed or substantially rehabilitated low-income rental housing projects. The dollar amount of the LIHTC available for allocation by each state (credit ceiling) is limited by population. Each state is allowed a credit ceiling based on a statutory formula indicated at IRC Section 42(h)(3). States may carry forward unallocated credits derived from the credit ceiling for one year; however, to the extent such unallocated credits are not used by then, the credits go into a national pool to be redistributed to states as additional credit. State and local housing agencies allocate the state's credit ceiling among low-income housing buildings whose owners have applied for the credit. Besides IRC Section 42 credits derived from the credit ceiling, states may also provide IRC Section 42 credits to owners of buildings based on the percentage of certain building costs financed by tax-exempt bond proceeds. Credits provided under the tax-exempt bond “volume cap” do not reduce the credits available from the credit ceiling.
The credits allocated to a building are based on the cost of units placed in service as low-income units under particular minimum occupancy and maximum rent criteria. In general, a building must meet one of two thresholds to be eligible for the LIHTC; either: (1) 20 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 50 percent of the Area Median Gross Income (AMGI), or (2) 40 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 60 percent of AMGI. A unit is “rent-restricted” if the gross rent, including an allowance for tenant-paid utilities, does not exceed 30 percent of the imputed income limitation (
The LIHTC reduces income tax liability dollar-for-dollar. It is taken annually for a term of 10 years and is intended to yield a present value of either: (1) 70 Percent of the “qualified basis” for new construction or substantial rehabilitation expenditures that are not federally subsidized (as defined in IRC Section 42(i)(2)), or (2) 30 percent of the qualified basis for the cost of acquiring certain existing buildings or projects that are federally subsidized. The actual credit rates are adjusted monthly for projects placed in service after 1987 under procedures specified in IRC Section 42. Individuals can use the credits up to a deduction equivalent of $25,000 (the actual maximum amount of credit that an individual can claim depends on the individual's marginal tax rate). For buildings placed in service after December 31, 2007, individuals can use the credits against the alternative minimum tax. Corporations, other than S or personal service corporations, can use the credits against ordinary income tax, and, for buildings placed in service after December 31, 2007, against the alternative minimum tax. These corporations also can deduct losses from the project.
The qualified basis represents the product of the building's “applicable fraction” and its “eligible basis.” The applicable fraction is based on the number of low-income units in the building as a percentage of the total number of units, or based on the floor space of low-income units as a percentage of the total floor space of residential units in the building. The eligible basis is the adjusted basis attributable to acquisition, rehabilitation, or new construction costs (depending on the type of LIHTC involved). These costs include amounts chargeable to a capital account that are incurred prior to the end of the first taxable year in which the qualified low-income building is placed in service or, at the election of the taxpayer, the end of the succeeding taxable year. In the case of buildings located in designated DDAs or designated QCTs, eligible basis can be increased up to 130 percent from what it would otherwise be. This means that the available credits also can be increased by up to 30 percent. For example, if a 70 percent credit is available, it effectively could be increased to as much as 91 percent.
IRC Section 42 defines a DDA as an area designated by the Secretary of HUD that has high construction, land, and utility costs relative to the AMGI. All designated DDAs in metropolitan areas (taken together) may not contain more than 20 percent of the aggregate population of all metropolitan areas, and all designated areas not in metropolitan areas may not contain more than 20 percent of the aggregate population of all nonmetropolitan areas.
IRC Section 42(d)(5)(B)(v) allows states to award an increase in basis up
In developing the list of DDAs, HUD compared housing costs with incomes. HUD used 2010 Census population for ZCTAs, and nonmetropolitan areas, and the MSA definitions, as published in OMB Bulletin No. 10-02 on December 1, 2009, with modifications, as described below. In keeping with past practice of basing the coming year's DDA designations on data from the preceding year, the basis for these comparisons is the FY2015 HUD income limits for very low-income households (very low-income limits, or VLILs), which are based on 50 percent of AMGI, and modified FMRs based on the FY2015 FMRs used for the Housing Choice Voucher (HCV) program. For metropolitan DDAs, HUD used SAFMRs based on 3 annual releases of ACS data, to avoid statistical anomalies which affect estimates for some ZCTAs. For non-metropolitan DDAs, HUD used the final FY2015 FMRs as published on October 3, 2014 (79 FR 59786) and updated on January 12, 2015 (80 FR 1511).
In formulating the FY2015 FMRs and VLILs, HUD modified the current OMB definitions of MSAs to account for substantial differences in rents among areas within each current MSA that were in different FMR areas under definitions used in prior years. HUD formed these “HUD Metro FMR Areas” (HMFAs) in cases where one or more of the parts of newly defined MSAs that previously were in separate FMR areas had 2000 Census based 40th-percentile recent-mover rents that differed, by 5 percent or more, from the same statistic calculated at the MSA level. In addition, a few HMFAs were formed on the basis of very large differences in AMGIs among the MSA parts. All HMFAs are contained entirely within MSAs. All nonmetropolitan counties are outside of MSAs and are not broken up by HUD for purposes of setting FMRs and VLILs. (Complete details on HUD's process for determining FY2015 FMR areas and FMRs are available at
HUD's unit of analysis for designating metropolitan DDAs consists of ZCTAs, whose SAFMRs are compared to metropolitan VLILs. For purposes of computing VLILs in metropolitan areas, HUD considers entire MSAs, in cases where these were not broken up into HMFAs for purposes of computing VLILs; and HMFAs within the MSAs that were broken up for such purposes. Hereafter in this notice, the unit of analysis for designating metropolitan DDAs will be called the ZCTA, and the unit of analysis for nonmetropolitan DDAs will be the nonmetropolitan county or county equivalent area. The procedure used in making the DDA calculations follows:
1. For each metropolitan ZCTA and each nonmetropolitan county, HUD calculated a ratio. HUD used a modified FY2015 two-bedroom SAFMR for ZCTAs, the final FY2015 two-bedroom FMR as published for non-metropolitan counties, and the FY2015 four-person VLIL for this calculation. The modified FY2015 two-bedroom SAFMRs for ZCTAs differ from the final FY2015 SAFMRs in 5 ways.
First, three years of median rents from the American Community Survey (ACS) were deflated and averaged. Three years of ACS releases are averaged to avoid anomalies that occur due to statistical sampling in some ZCTAs. The modified SAFMRs rely on the 2006-2010, 2007-2011 and 2008-2012 5-year ACS estimates. Only rents with margins of error less than 50 percent of the rent estimate were considered.
a. The numerator of the ratio, representing the development cost of housing, was the area's FY2015 FMR, or SAFMR in metropolitan areas. In general, the FMR is based on the 40th-percentile gross rent paid by recent movers to live in a two-bedroom apartment.
b. The denominator of the ratio, representing the maximum income of eligible tenants, was the monthly LIHTC income-based rent limit, which was calculated as 1/12 of 30 percent of 120 percent of the area's VLIL (where the VLIL was rounded to the nearest $50 and not allowed to exceed 80 percent of the AMGI in areas where the VLIL is adjusted upward from its 50 percent-of-AMGI base).
2. The ratios of the FMR, or SAFMR, to the LIHTC income-based rent limit were arrayed in descending order, separately, for ZCTAs and for nonmetropolitan counties.
3. The DDAs are those with the highest ratios cumulative to 20 percent of the 2010 population of all metropolitan areas and all nonmetropolitan areas. For purposes of applying this population cap, HUD excluded the population in areas designated as 2016 QCTs. Thus, an area can be designated as a QCT or DDA, but not both.
In identifying DDAs, HUD applied caps, or limitations, as noted above. The cumulative population of metropolitan DDAs cannot exceed 20 percent of the cumulative population of all metropolitan areas, and the cumulative population of nonmetropolitan DDAs cannot exceed 20 percent of the cumulative population of all nonmetropolitan areas.
In applying these caps, HUD established procedures to deal with how to treat small overruns of the caps. The remainder of this section explains those procedures. In general, HUD stops selecting areas when it is impossible to choose another area without exceeding the applicable cap. The only exceptions to this policy are when the next eligible excluded area contains either a large absolute population or a large
In developing this list of QCTs, HUD used 2010 Census 100-percent count data on total population, total households, and population in households; the median household income and poverty rate as estimated in the 2007-2011, 2008-2012 and 2009-2013 ACS tabulations; the FY2015 Very Low-Income Limits (VLILs) computed at the HUD Metropolitan FMR Area (HMFA) level
HUD uses the HMFA-level AMGIs to determine QCT eligibility because the statute, specifically IRC Section 42(d)(5)(B)(iv)(II), refers to the same section of the IRC that defines income for purposes of tenant eligibility and unit maximum rent, specifically IRC Section 42(g)(4). By rule, the IRS sets these income limits according to HUD's VLILs, which, starting in FY2006 and thereafter, are established at the HMFA level. Similarly, HUD uses the entire MSA to determine how many eligible tracts can be designated under the 20 percent population cap as required by the statute (IRC Section 42(d)(5)(B)(ii)(III)), which states that MSAs should be treated as singular areas. The QCTs were determined as follows:
1. To be eligible to be designated a QCT, a census tract must have 50 percent of its households with incomes below 60 percent of the AMGI or have a poverty rate of 25 percent or more. Due to potential statistical anomalies in the ACS 5-year estimates, one of these conditions must be met in at least 2 of the 3 evaluation years for a tract to be considered eligible for QCT designation. HUD calculates 60 percent of AMGI by multiplying by a factor of 1.2 the HMFA or nonmetropolitan county FY2015 VLIL adjusted for inflation to match the ACS estimates. For example, the FY2015 VLILs were adjusted for inflation to 2012 dollars to compare with the median income estimate from the 2008-2012 ACS estimates. The inflation-adjusted 2012 VLIL was then deflated to 2011 for comparison with the 2007-2011 ACS estimates and inflated to 2013 to compare with the 2009-2013 ACS estimates.
2. For each census tract, whether or not 50 percent of households have incomes below the 60 percent income standard (income criterion) was determined by: (a) Calculating the average household size of the census tract, (b) applying the income standard after adjusting it to match the average household size, and (c) comparing the average-household-size-adjusted income standard to the median household income for the tract reported in each of the three years of ACS tabulations (2007-2011, 2008-2012 and 2009-2013). HUD did not consider estimates of median household income to be statistically reliable unless the margin of error was less than half of the estimate (or a Margin of Error Ratio, MoER, of 50 percent or less). If at least two of the three estimates were not statistically reliable by this measure, HUD determined the tract to be ineligible under the income criterion due to lack of consistently reliable median income statistics across the 3 ACS tabulations. In prior designations of QCTs, HUD accepted ACS data with MoERs of up to, but not including 100 percent. The higher data quality standard used for the 2016 QCTs is consistent with current thinking about the reliability of ACS data.
3. For each census tract, the poverty rate was determined in each of the three releases of ACS tabulations (2007-2011, 2008-2012 and 2009-2013) by dividing the population with incomes below the poverty line by the population for whom poverty status has been determined. As with the evaluation of tracts under the income criterion, HUD uses a higher data quality standard for evaluating ACS poverty rate data in designating the 2016 QCTs than HUD used in previous designations. HUD did not consider estimates of the poverty rate to be statistically reliable unless both the population for whom poverty status has been determined and the number of persons below poverty had MoERs of less than 50 percent of the respective estimates. In prior designations of QCTs, HUD accepted ACS data with MoERs of up to, but not including 100 percent. If at least two of the three poverty rate estimates were not statistically reliable, HUD determined the tract to be ineligible under the poverty rate criterion due to lack of reliable poverty statistics across the ACS tabulations.
4. QCTs are those census tracts in which 50 percent or more of the households meet the income criterion in at least two of the three years evaluated, or 25 percent or more of the population is in poverty in at least two of the three years evaluated, such that the population of all census tracts that satisfy either one or both of these criteria does not exceed 20 percent of the total population of the respective area.
5. In areas where more than 20 percent of the population resides in
a. The income and poverty criteria are each averaged over the three ACS tabulations (2007-2011, 2008-2012 and 2009-2013). Statistically reliable values that did not exceed the income and poverty rate thresholds were included in the average.
b. Eligible tracts are placed in one of two groups based on the averaged values of the income and poverty criteria. The first group includes tracts that satisfy both the income and poverty criteria for QCTs for at least two of the three evaluation years. The second group includes tracts that satisfy either the income criterion or the poverty criterion in at least two of three years, but not both. A tract must qualify by at least one of the criteria in at least two of the three evaluation years to be eligible, although it does not need to be the same criterion.
c. Tracts in the first group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the first group are ranked from highest to lowest by the average of the poverty rates. The two ranks are averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.
d. Tracts in the second group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the second group are ranked from highest to lowest by the average of the poverty rates. The two ranks are then averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.
e. The ranked first group is stacked on top of the ranked second group to yield a single, concatenated, ranked list of eligible census tracts.
f. Working down the single, concatenated, ranked list of eligible tracts, census tracts are identified as designated until the designation of an additional tract would cause the 20 percent limit to be exceeded. If a census tract is not designated because doing so would raise the percentage above 20 percent, subsequent census tracts are then considered to determine if one or more census tract(s) with smaller population(s) could be designated without exceeding the 20 percent limit.
As stated in OMB Bulletin 10-02, defining metropolitan areas:
OMB establishes and maintains the definitions of Metropolitan . . . Statistical Areas, . . . solely for statistical purposes. . . . OMB does not take into account or attempt to anticipate any non-statistical uses that may be made of the definitions[.] In cases where . . . an agency elects to use the Metropolitan . . . Area definitions in nonstatistical programs, it is the sponsoring agency's responsibility to ensure that the definitions are appropriate for such use. An agency using the statistical definitions in a nonstatistical program may modify the definitions, but only for the purposes of that program. In such cases, any modifications should be clearly identified as deviations from the OMB statistical area definitions in order to avoid confusion with OMB's official definitions of Metropolitan . . . Statistical Areas.
Following OMB guidance, the estimation procedure for the FMRs and income limits incorporates the current OMB definitions of metropolitan areas based on the CBSA standards, as implemented with 2000 Census data, but makes adjustments to the definitions, in order to separate subparts of these areas in cases where FMRs (and in a few cases, VLILs) would otherwise change significantly if the new area definitions were used without modification. In CBSAs where subareas are established, it is HUD's view that the geographic extent of the housing markets are not yet the same as the geographic extent of the CBSAs, but may approach becoming so as the social and economic integration of the CBSA component areas increases.
The geographic baseline for the FMR and income limit estimation procedure is the CBSA Metropolitan Areas (referred to as Metropolitan Statistical Areas or MSAs) and CBSA Non-Metropolitan Counties (nonmetropolitan counties include the county components of Micropolitan CBSAs where the counties are generally assigned separate FMRs). The HUD-modified CBSA definitions allow for subarea FMRs within MSAs based on the boundaries of “Old FMR Areas” (OFAs) within the boundaries of new MSAs. (OFAs are the FMR areas defined for the FY2005 FMRs. Collectively, they include the June 30, 1999, OMB definitions of MSAs and Primary MSAs (old definition MSAs/PMSAs), metropolitan counties deleted from old definition MSAs/PMSAs by HUD for FMR-setting purposes, and counties and county parts outside of old definition MSAs/PMSAs referred to as nonmetropolitan counties). Subareas of MSAs are assigned their own FMRs and Income Limits when the subarea 2000 Census Base FMR differs significantly from the MSA 2000 Census Base FMR (or, in some cases, where the 2000 Census base AMGI differs significantly from the MSA 2000 Census Base AMGI). MSA subareas, and the remaining portions of MSAs after subareas have been determined, are referred to as “HUD Metro FMR Areas (HMFAs),” to distinguish such areas from OMB's official definition of MSAs.
In the New England states (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont), HMFAs are defined according to county subdivisions or minor civil divisions (MCDs), rather than county boundaries. However, since no part of an HMFA is outside an OMB-defined, county-based MSA, all New England nonmetropolitan counties are kept intact for purposes of designating Nonmetropolitan DDAs.
For the convenience of readers of this notice, the geographical definitions of designated Metropolitan DDAs are included in the list of DDAs.
DDAs are designated annually as updated income and FMR data are made public. QCTs are designated annually as new income and poverty rate data are released.
The 2016 lists of QCTs and DDAs are effective:
(1) for allocations of credit after June 30, 2016; or
(2) for purposes of IRC Section 42(h)(4), if the bonds are issued and the building is placed in service after June 30, 2016.
If an area is not on a subsequent list of QCTs or DDAs, the 2016 lists are effective for the area if:
(1) the allocation of credit to an applicant is made no later than the end of the 730-day period after the applicant submits a complete application to the LIHTC-allocating agency, and the submission is made before the effective date of the subsequent lists; or
(2) for purposes of IRC Section 42(h)(4), if:
(a) the bonds are issued or the building is placed in service no later than the end of the 730-day period after the applicant submits a complete application to the bond-issuing agency, and
(b) the submission is made before the effective date of the subsequent lists,
An application is deemed to be submitted on the date it is filed if the application is determined to be complete by the credit-allocating or bond-issuing agency. A “complete application” means that no more than de minimis clarification of the application is required for the agency to make a decision about the allocation of tax credits or issuance of bonds requested in the application.
In the case of a “multiphase project,” the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the project received its first allocation of LIHTC. For purposes of IRC Section 42(h)(4), the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the first of the following occurred: (a) The building(s) in the first phase were placed in service, or (b) the bonds were issued.
For purposes of this notice, a “multiphase project” is defined as a set of buildings to be constructed or rehabilitated under the rules of the LIHTC and meeting the following criteria:
(1) The multiphase composition of the project (
(2) The aggregate amount of LIHTC applied for on behalf of, or that would eventually be allocated to, the buildings on the site exceeds the one-year limitation on credits per applicant, as defined in the Qualified Allocation Plan (QAP) of the LIHTC-allocating agency, or the annual per-capita credit authority of the LIHTC allocating agency, and is the reason the applicant must request multiple allocations over 2 or more years; and
(3) All applications for LIHTC for buildings on the site are made in immediately consecutive years.
Members of the public are hereby reminded that the Secretary of Housing and Urban Development, or the Secretary's designee, has legal authority to designate DDAs and QCTs, by publishing lists of geographic entities as defined by, in the case of DDAs, the Census Bureau, the several states and the governments of the insular areas of the United States and, in the case of QCTs, by the Census Bureau; and to establish the effective dates of such lists. The Secretary of the Treasury, through the IRS thereof, has sole legal authority to interpret, and to determine and enforce compliance with the IRC and associated regulations, including
For the convenience of readers of this notice, interpretive examples are provided below to illustrate the consequences of the effective date in areas that gain or lose DDA status. The examples covering DDAs are equally applicable to QCT designations.
(Case A) Project A is located in a 2016 DDA that is NOT a designated DDA in 2017 or 2018. A complete application for tax credits for Project A is filed with the allocating agency on November 15, 2016. Credits are allocated to Project A on October 30, 2018. Project A is eligible for the increase in basis accorded a project in a 2016 DDA because the application was filed BEFORE January 1, 2017 (the assumed effective date for the 2017 DDA lists), and because tax credits were allocated no later than the end of the 730-day period after the filing of the complete application for an allocation of tax credits.
(Case B) Project B is located in a 2016 DDA that is NOT a designated DDA in 2017 or 2018. A complete application for tax credits for Project B is filed with the allocating agency on December 1, 2016. Credits are allocated to Project B on March 30, 2019. Project B is NOT eligible for the increase in basis accorded a project in a 2016 DDA because, although the application for an allocation of tax credits was filed BEFORE January 1, 2017 (the assumed effective date of the 2017 DDA lists), the tax credits were allocated later than the end of the 730-day period after the filing of the complete application.
(Case C) Project C is located in a 2016 DDA that was not a DDA in 2015. Project C was placed in service on November 15, 2015. A complete application for tax-exempt bond financing for Project C is filed with the bond-issuing agency on January 15, 2016. The bonds that will support the permanent financing of Project C are issued on September 30, 2016. Project C is NOT eligible for the increase in basis otherwise accorded a project in a 2016 DDA, because the project was placed in service BEFORE July 1, 2016.
(Case D) Project D is located in an area that is a DDA in 2016, but is NOT a DDA in 2017 or 2018. A complete application for tax-exempt bond financing for Project D is filed with the bond-issuing agency on October 30, 2016. Bonds are issued for Project D on April 30, 2018, but Project D is not placed in service until January 30, 2019. Project D is eligible for the increase in basis available to projects located in 2016 DDAs because: (1) One of the two events necessary for triggering the effective date for buildings described in Section 42(h)(4)(B) of the IRC (the two events being bonds issued and buildings placed in service) took place on April 30, 2018, within the 730-day period after a complete application for tax-exempt bond financing was filed, (2) the application was filed during a time when the location of Project D was in a DDA, and (3) both the issuance of the bonds and placement in service of Project D occurred after the application was submitted.
(Case E) Project E is a multiphase project located in a 2016 DDA that is NOT a designated DDA or QCT in 2017. The first phase of Project E received an allocation of credits in 2016, pursuant to an application filed July 15, 2016, which describes the multiphase composition of the project. An application for tax credits for the second phase of Project E is filed with the allocating agency by the same entity on July 15, 2017. The second phase of Project E is located on a contiguous site. Credits are allocated to the second phase of Project E on October 30, 2017. The aggregate amount of credits allocated to the two phases of Project E exceeds the amount of credits that may be allocated to an applicant in one year under the allocating agency's QAP and is the reason that applications were made in multiple phases. The second phase of Project E is, therefore, eligible for the increase in basis accorded a project in a 2016 DDA, because it meets all of the conditions to be a part of a multiphase project.
(Case F) Project F is a multiphase project located in a 2016 DDA that is NOT a designated DDA in 2017 or 2018. The first phase of Project F received an allocation of credits in 2016, pursuant to an application filed July 15, 2016, which does not describe the multiphase composition of the project. An application for tax credits for the second
This notice involves the establishment of fiscal requirements or procedures that are related to rate and cost determinations and do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 40 CFR 1508.4 of the regulations of the Council on Environmental Quality and 24 CFR 50.19(c)(6) of HUD's regulations, this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any policy document that has federalism implications if the document either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the document preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the executive order. This notice merely designates DDAs as required under IRC Section 42, as amended, for the use by political subdivisions of the states in allocating the LIHTC. This notice also details the technical method used in making such designations. As a result, this notice is not subject to review under the order.
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before December 24, 2015.
•
•
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and
The applicant requests a permit to import one captive-bred male tiger (
The applicant requests a permit to import 16 captive-bred African penguins (
The applicant requests a permit to import three captive-bred lion-tailed macaques (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival: barasingha (
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Bureau of Indian Affairs, Interior.
Notice.
This notice announces the extension of the Class III gaming compact between the Yankton Sioux Tribe and the State of South Dakota.
November 24, 2015.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, (202) 219-4066.
An extension to an existing tribal-state Class III gaming compact does not require approval by the Secretary if the extension does not include any amendment to the terms of the compact. See 25 CFR 293.5. The Yankton Sioux Tribe and the State of South Dakota have reached an agreement to extend the expiration of their existing Tribal-State Class III gaming compact until April 19, 2016. This publishes notice of the new expiration date of the compact.
Bureau of Reclamation, Interior.
Notice.
The Bureau of Reclamation (Reclamation) has forwarded the following Information Collection Request to the Office of Management and Budget (OMB) for review and approval: Recreation Use Data Reports, OMB Control Number: 1006-0002. As part of its continuing effort to reduce paperwork and respondent burdens, Reclamation invites State, local, or tribal governments that manage recreation sites at Reclamation projects; concessionaires, and not-for-profit organizations who operate concessions on Reclamation lands; and the public, to comment on this information collection.
OMB has up to 60 days to approve or disapprove this information collection request, but may respond after 30 days; therefore, public comments must be received on or before December 24, 2015.
Send written comments to the Desk Officer for the Department of the Interior at the Office of Management and Budget, Office of Information and Regulatory Affairs, via facsimile to (202) 395-5806, or email to
Mr. Jerome Jackson at (303) 445-2712. You may also view the information collection request at
Reclamation collects agency-wide recreation and concession information to fulfill congressional reporting requirements pursuant to current public laws, including Public Law 89-72, as amended through 106-580, Federal Water Project Recreation Act of 1965; and Public Law 102-575, Title XXVIII, Reclamation Recreation Management Act of 1992. In addition, collected
A
We invite comments concerning this information collection on:
(a) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical use;
(b) The accuracy of our burden estimate for the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Reclamation will display a valid OMB control number on the forms.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determinations (“IDs”) (Order No. 105 and 106), which terminated the investigation as to the remaining three respondents in the investigation. The Commission has determined to set January 20, 2016 as the date by which to determine whether to grant the petition for review of Order Nos. 43 and 83 by intervenor Dentons US LLP.
Sidney A. Rosenzweig, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2532. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on September 23, 2014, based on a complaint filed by RevoLaze, LLC and TechnoLines, LLC, both of Westlake, Ohio. 79 Fed. Reg. 56828 (Sept. 23, 2014). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of the importation into the United States, the sale for importation, and the sale within the United States after importation of certain laser abraded denim garments. The complaint alleged
On October 1, 2015, the complainants moved to terminate H&M based upon a withdrawal of the complaint. See 19 CFR 210.21(a). The Commission investigative attorney (“IA”) supported the motion. On October 20, 2015, the ALJ granted the motion as an ID (Order No. 105). She found that the complainants complied with Commission Rule 210.21(a) and that good cause for withdrawal had been shown. Order No. 105 at 2.
Also on October 1, 2015, the complainants moved to terminate Eroglu on the basis of a settlement.
One respondent was previously found to be in default.
No petitions for review of the foregoing terminations (including as to the defaulting party) were filed. The Commission has determined not to review the IDs. The Commission notes that in granting termination as to Eroglu in Order No. 106, the ALJ observed the “unconventional state of the Agreements” demonstrating the settlement between the complainants and Eroglu. Order No. 106 at 2. That characterization is accurate, but the Commission finds that in view of the unique circumstances of this investigation, the ALJ's determination to terminate the investigation as to Eroglu was appropriate.
However, previously in the investigation, the then-presiding ALJ disqualified complainants' former counsel Dentons US LLP (“Dentons”) in a non-ID order. Order No. 43 (May 7, 2015). Subsequently, the ALJ granted (as an ID) Dentons' motion to intervene regarding its disqualification, Order No. 82 (Aug. 7, 2013), but denied (as an order) Dentons' motion for reconsideration of Order No. 43 as well as Dentons' request for leave to seek interlocutory review before the Commission, Order No. 83 (Aug. 7, 2015);
In response to the issuance of Order No. 106, which terminated the investigation before the ALJ, on October 27, 2015, Dentons filed a petition for Commission review of Order Nos. 43 and 83.
Commission Rule 210.42 does not impose a deadline upon the Commission for ruling on Dentons' petition for review, which arises from previously unreviewable orders in the investigation. The target date for completion of the investigation is September 26, 2016. The Commission has determined that Order Nos. 43 and 83 shall become the determination of the Commission on January 20, 2016, unless the Commission shall have ordered review of those orders or certain issues therein or by order has changed that date.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge (“ALJ”) has issued a Final Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief should the Commission find a violation of section 337, as amended, 19 U.S.C. 1337. The ALJ recommended a general exclusion order directed to footwear products that infringe the asserted trademarks, and recommended cease and desist orders directed against those respondents found to infringe. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
Clint A. Gerdine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission is interested in further development of the record on the public interest in its investigations. Accordingly, members of the public are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on November 17, 2015. Comments should address whether issuance of an exclusion order and/or cease and desist orders in this investigation could affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) indicate the extent to which like or directly competitive articles are produced in the United States or are otherwise available in the United States, with respect to the articles potentially subject to the recommended orders;
(iv) indicate whether Complainant, Complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended orders within a commercially reasonable time; and
(v) explain how the recommended orders would impact consumers in the United States.
Written submissions must be filed no later than by close of business on December 28, 2015.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to Commission rule 210.4(f), 19 CFR 210.4(f). Submissions should refer to the investigation number (“Inv. No. 337-TA-936”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document (or portion thereof) to the Commission in confidence must request confidential treatment unless the information has already been granted such treatment during the proceedings. All such requests should be directed to the Secretary of the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under authority of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has found a violation of section 337 in this investigation and has (1) issued a limited exclusion order prohibiting importation of infringing marine sonar imaging systems, products containing the same, and components thereof and (2) issued cease and desist orders directed to the domestic respondents. The investigation is terminated.
Panyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-3042. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on August 21, 2014, based on a complaint filed by Johnson Outdoors lnc. of Racine, Wisconsin and Johnson Outdoors Marine Electronics, Inc. of Eufaula, Alabama (collectively, “Johnson Outdoors”). 79 FR 49536 (Aug. 21, 2014). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain marine sonar imaging systems, products containing the same, and components thereof by reason of infringement of one or more of claims 1, 2, 17, 25, 26, 31, 32, 35, 36, 41-43, 53, and 56 of U.S. Patent No. 7,652,952 (“the '952 patent”); claims 1, 5, 7, 8, 21, 22, 24, 25, 28, and 29 of U.S. Patent No. 7,710,825 (“the '825 patent”); and claims 14, 18, 21-23, 25, and 33 of U.S. Patent No. 7,755,974 (“the '974 patent”).
On January 30, 2015, the parties entered into a stipulation that the domestic industry requirement was met. The parties also agreed to a stipulation regarding importation of Garmin accused products. That same day, Johnson Outdoors filed two unopposed motions for summary determination: (1) That Garmin's importation and sales satisfy the importation requirement and (2) that Johnson Outdoors satisfies the
On July 13, 2015, the ALJ issued his final ID, finding a violation of section 337 by Garmin in connection with claims 14, 18, 21, 22, 23, and 33 of the '974 patent. The ID found no violation of section 337 in connection with the asserted claims of the '952 and '825 patents; and claim 25 of the '974 patent. Specifically, the ID found that the Commission has subject matter jurisdiction,
On July 27, 2015, Garmin filed a petition for review of the ID. That same day, Johnson Outdoors filed a contingent petition for review of the ID. On August 4, 2015, the parties filed responses to the petitions.
On August 25, 2015, the Commission determined to review the final ID on all issues petitioned. 80 FR 55872-74 (Sept. 17, 2015). Specifically, the Commission asked the parties to discuss any impact on the ID's findings if it were to construe the claim term “mounted to a boat” to mean “proximately secured to the boat in a fixed manner.”
On September 21, 2015, the parties filed written submissions on the issues under review, remedy, the public interest, and bonding. On September 28, 2015, the parties filed reply submissions.
Having examined the record of this investigation, including the final ID, and the parties' submissions, the Commission has determined to modify the ID's construction of the claim term “mounted to a boat,” a claim term recited in each of the asserted claims of the '952, '974, and '825 patents (save for asserted claim 29 of the '825 patent), which the ID construed as “attached to a bottom surface of the boat.” Instead, the Commission adopts the construction proposed by complainants before the ALJ and construes the limitation to mean “proximately secured to the boat in a fixed manner.” The Commission finds that the record evidence supports the ID's findings on infringement and invalidity based on this construction. The Commission has determined to affirm the ID's finding of no violation of section 337 in connection with the asserted claims of the'952 patent, '825 patent, and claim 25 of the '974 patent. The Commission further finds a violation of Section 337 with respect to claims 14, 18, 21-23, and 33 of the '974 patent. The Commission adopts the ID's findings to the extent they are not inconsistent with the Commission opinion issued herewith.
Having found a violation of section 337 in this investigation, the Commission has determined that the appropriate form of relief is: (1) A limited exclusion order prohibiting the unlicensed entry of marine sonar imaging systems, products containing the same, and components thereof that infringe one or more of claims 14, 18, 21, 22, 23, and 33 of the '974 patent that are manufactured by, or on behalf of, or are imported by or on behalf of Garmin or any of its affiliated companies, parents, subsidiaries, agents, or other related business entities, or their successors or assigns; and (2) cease and desist orders prohibiting domestic respondents Garmin International, Inc.; Garmin North America, Inc.; and Garmin USA, Inc. from conducting any of the following activities in the United States: Importing, selling, marketing, advertising, distributing, transferring (except for exportation), and soliciting U.S. agents or distributors for, marine sonar imaging systems, products containing the same, and components thereof covered by claims 14, 18, 21, 22, 23 and 33 of the '974 patent. The proposed cease and desist orders include the following exemptions: (1) If in a written instrument, the owner of the patents authorizes or licenses such specific conduct, or such specific conduct is related to the importation or sale of covered products by or for the United States.
The Commission has also determined that the public interest factors enumerated in section 337(d) and (f) (19 U.S.C. 1337(d) and (f)) do not preclude issuance of the limited exclusion order or cease and desist orders. Finally, the Commission has determined that a bond in the amount of zero is required to permit temporary importation during the period of Presidential review (19 U.S.C. 1337(j)) of marine sonar imaging systems, products containing the same, and components thereof that are subject to the remedial orders. The Commission's orders and opinion were delivered to the President and to the United States Trade Representative on the day of their issuance.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), that a proposed Final Judgment, Asset Preservation Stipulation and Order, and Competitive Impact Statement have been filed with the United States District Court for the District of Columbia in
Copies of the Complaint, proposed Final Judgment and Competitive Impact Statement are available for inspection on the Antitrust Division's Web site at
Public comment is invited within 60 days of the date of this notice. Such comments, including the name of the submitter, and responses thereto, will be posted on the Antitrust Division's Web site, filed with the Court and, under certain circumstances, published in the
The United States of America (“United States”), acting under the direction of the Attorney General of the United States, and the States of Colorado, Idaho, Texas, Washington and West Virginia and the Commonwealths of Pennsylvania and Virginia (collectively, “Plaintiff States”), acting by and through their respective Offices of the Attorney General, bring this civil action to enjoin the proposed acquisition of OneMain Financial Holdings, LLC (“OneMain”) by Springleaf Holdings, Inc. (“Springleaf”) and to obtain other equitable relief.
1. OneMain and Springleaf are the two largest lenders that offer personal installment loans to subprime borrowers in the United States, and the only two with a nationwide branch network. Personal installment loans to subprime borrowers are fixed-rate, fixed-term and fully amortized loan products that appeal to borrowers who have limited access to credit from traditional banking institutions. OneMain and Springleaf specialize in the same products (large installment loans typically ranging from $3,000 to $6,000), target the same customer base, and often operate branches within close proximity to one another.
2. In local markets across Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia, Springleaf and OneMain face limited competition for the provision of personal installment loans to subprime borrowers and serve as each other's closest—and often only—competitor. Elimination of the competition between Springleaf and OneMain would leave subprime borrowers seeking personal installment loans with few choices. This reduction in consumer choice may drive many financially struggling borrowers to much more expensive forms of credit or, worse, leave them with no reasonable alternative. As a result, Springleaf's proposed acquisition of OneMain likely would substantially lessen competition in the provision of personal installment loans to subprime borrowers in numerous local markets, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18.
3. Defendant Springleaf is a Delaware corporation headquartered in Evansville, Indiana. Springleaf is the second-largest provider of personal installment loans to subprime borrowers in the United States, with approximately 830 branches in 27 states. Springleaf has a consumer loan portfolio that totals $4.0 billion.
4. Defendant OneMain, a Delaware limited liability company headquartered in Baltimore, Maryland, is the largest provider of personal installment loans to subprime borrowers in the United States, with 1,139 branch locations in 43 states. OneMain has a consumer loan portfolio that totals $8.4 billion. OneMain is a subsidiary of Defendant CitiFinancial Credit Company (“CitiFinancial”), a Delaware corporation headquartered in Dallas, Texas. CitiFinancial is a holding company that is a wholly owned subsidiary of Citigroup, Inc.
5. Pursuant to a Purchase Agreement dated March 2, 2015, Springleaf agreed to purchase OneMain from CitiFinancial for $4.25 billion.
6. The United States brings this action pursuant to Section 15 of the Clayton Act, 15 U.S.C. 25, as amended, to prevent and restrain Defendants from violating Section 7 of the Clayton Act, 15 U.S.C. 18.
7. The Plaintiff States bring this action under Section 16 of the Clayton Act, 15 U.S.C. 26, to prevent and restrain Springleaf and OneMain from violating Section 7 of the Clayton Act, 15 U.S.C. 18. The Plaintiff States, by and through their respective Offices of the Attorney General, bring this action as
8. The Court has subject matter jurisdiction over this action pursuant to Section 15 of the Clayton Act, 15 U.S.C. 25, and 28 U.S.C. 1331, 1337(a), and 1345. Defendants offer personal installment loans to customers in the United States in a regular, continuous, and substantial flow of interstate commerce. Defendants' activities in the provision of personal installment loans have had a substantial effect upon interstate commerce.
9. Defendants have consented to venue and personal jurisdiction in this District. Therefore, venue in this District is proper under Section 12 of the Clayton Act, 15 U.S.C. 22, and 28 U.S.C. 1391(b) and (c).
10. The average size of a personal installment loan typically falls in the range of $3,000 to $6,000. Personal installment loans to subprime borrowers are closed-end, fixed-rate, fixed-term, and fully amortized loan products. In a fully amortized loan, both principal and interest are paid fully through scheduled installments by the end of the loan term, which typically is between 18 and 60 months in duration. Each monthly payment is the same amount and the schedule of payments is clear. If the borrower makes each scheduled payment, at the end of the loan term, the loan is repaid in full.
11. Personal installment lenders target a unique segment of borrowers who may not be able to obtain cheaper sources of credit from other financial institutions but have enough cash flow to afford the monthly payments of personal installment loans. Borrowers of personal installment loans are considered “subprime” because of blemishes in their credit histories, such as serious delinquencies or defaults. These borrowers likely have been denied credit by a bank in the past and turn to personal installment lenders for the speed, ease, and likelihood of success in obtaining credit. Their borrowing needs vary, for example, from paying for unexpected expenses, such as car repairs or medical bills, to consolidating debts. A typical subprime borrower's annual income is in the range of $35,000 to $45,000.
12. The blemished credit histories of subprime borrowers suggest a higher propensity for default on future loans relative to so-called “prime” borrowers. Personal installment lenders mitigate this credit risk by closely analyzing a borrower's characteristics and ability to repay the loan. The lender examines several categories of information about the borrower, including, among other criteria, credit history, income and outstanding debts, stability of employment, and availability or value of collateral. Lenders typically require borrowers to meet face-to-face at a branch location to close the loan, even if the application begins online. This face-to-face meeting allows the lender to efficiently collect information used in underwriting and verify key documents (reducing the risk of fraud). Subprime borrowers seeking installment loans also value having a branch office close to where they live or work; a nearby branch reduces the borrower's travel cost to close the loan and allows convenient and timely access to loan proceeds. If approved, borrowers immediately obtain the funds at the branch.
13. Local branch presence also helps lenders and borrowers establish close customer relationships during the life of the loan. Local branch employees monitor delinquent payments of existing customers and assist borrowers in meeting their payment obligations to minimize loan loss. Borrowers also benefit from knowing the local branch employees. Borrowers may visit a branch to make payments, refinance their loans, or speak with a branch employee at times of financial difficulties. Lenders place branches where their target borrowers live or work so that it is convenient for their borrowers to come into a branch.
14. The interest rate on a personal installment loan is the largest component of the total cost of a loan. Other costs, such as origination fees, maintenance fees, and closing fees, increase the effective interest rate that a borrower will pay. The Annual Percentage Rate (“APR”) combines the two components, interest rates and fees, to indicate the annual charges associated with the loan. Although the maximum interest rates and fees charged on personal installment loans vary by state, Springleaf and OneMain have a self-imposed interest rate cap of 36 percent on their respective loans.
15. While borrowers consider APR in selecting a loan, subprime borrowers typically focus most on the monthly payment and on the ease and speed of obtaining approval. Subprime borrowers' main concerns are whether the payment will fit into their monthly budget and whether they can obtain the money quickly to meet their needs. For these reasons, negotiations between borrowers and lenders tend to focus more on the amount of the loan, the repayment terms, and collateral requirements than on the rates and fees. When a subprime borrower needs or wants a lower monthly payment, personal installment lenders generally lower the amount of the loan or lengthen the term of the loan.
16. Every state requires personal installment lenders to obtain licenses to offer loans to subprime borrowers. Many states also have regulations governing the interest rates and fees on loans charged by consumer finance companies licensed to operate in the state. Some states impose a maximum rate and fee for all personal installment loans, while others have a tiered-rate system that establishes different interest rates and fees for different loan amounts. State regulations significantly affect the number of personal installment lenders offering loans to subprime lenders in the state.
17. Subprime borrowers turn to personal installment loans when they need cash but have limited access to credit from banks, credit card companies, and other lenders. The products offered by these lenders are not meaningful substitutes for personal installment loans for a substantial number of subprime borrowers.
18. Banks and credit unions offer personal installment loans at rates and terms much better than those offered by personal installment lenders, but subprime borrowers typically do not meet the underwriting criteria of those institutions and are unlikely to be approved. Further, the loan application and underwriting process at banks and credit unions typically take much longer than that of personal installment lenders, who can provide subprime borrowers with funds on a far quicker timetable. For these and other reasons, subprime borrowers would not turn to banks and credit unions as an alternative in the event personal installment lenders were to increase the interest rate or otherwise make their loan terms less appealing by a small but significant amount.
19. Payday and title lenders provide short-term cash, but charge much higher rates and fees, usually lend in amounts well below $1,000, and require far quicker repayment than personal installment lenders. Specifically, rates and fees for these types of short-term cash advances can exceed 250 percent APR with repayment generally due in less than 30 days. Given these key differences, subprime borrowers likely would not turn to payday and title loans as an alternative in the event personal installment lenders were to increase the interest rate or otherwise make their loan terms less appealing by a small but significant amount.
20. Most subprime borrowers also cannot turn to credit cards as an alternative to personal installment loans. Subprime borrowers frequently have difficulty obtaining credit cards, and those who have credit cards have often reached their maximum available credit limits (which are much lower than those given to prime borrowers), or have limited access to additional credit extensions. Although subprime borrowers may use credit cards for everyday purchases, such as groceries or dining out, they typically have insufficient remaining credit to pay for larger expenses such as major car repairs or significant medical bills. Subprime borrowers therefore could not
21. Finally, although online lenders have been successful in making loans to prime borrowers, they face challenges in meeting the needs of and mitigating the credit risk posed by subprime borrowers. Without a local branch presence, online lenders do not maintain close customer relationships, nor can they conduct face-to-face meetings to verify key documents, measures which reduce the risk of fraud and borrower default. Online lenders tend to focus on borrowers with better credit profiles or higher incomes than the borrowers typically served by personal installment lenders with branches in local markets. Furthermore, online lenders are unable to process an application and distribute loan proceeds as quickly as local personal installment lenders. For these reasons, subprime borrowers generally would not turn to loans offered by online lenders in the event lenders offering personal installment loans to subprime borrowers were to increase the interest rate or otherwise make their loan terms less appealing by a small but significant amount.
22. Accordingly, the provision of personal installment loans to subprime borrowers is a line of commerce and a relevant product market within the meaning of Section 7 of the Clayton Act.
23. Subprime borrowers seeking personal installment loans value convenience, which includes quick access to the borrowed funds and minimal travel time. Consequently, subprime borrowers considering a personal installment lender look for a branch near where they live or where they work. While the distance a borrower is willing to travel may vary by geography, the vast majority of subprime borrowers travel less than twenty miles to a branch for a personal installment loan.
24. Personal installment lenders have established local trade areas for their branches. Lenders usually rely on direct mail solicitations as the primary means of marketing and solicit customers who live within close proximity to their branches. Lenders who place branches in the same areas compete to serve the same target borrower base. Borrowers view lenders with branches in close proximity to each other as close substitutes.
25. For these reasons, the overlapping trade areas of competing personal installment lenders form geographic markets where the lenders located within the trade areas compete for subprime borrowers who live or work near the branches. The size and shape of the overlapping trade areas of these branches may vary as the distance borrowers are willing to travel depends on factors specific to each local area. Even so, typically more than three-quarters of the personal installment loans to subprime borrowers made by a given branch are made to borrowers residing within twenty miles of the branch. Personal installment lenders with branches located outside these trade areas usually are not convenient alternatives for borrowers.
26. Springleaf and OneMain have a high degree of geographic overlap between their branch networks. In local areas within and around 126 towns and municipalities in eleven states—Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia—Springleaf and OneMain have branches located within close proximity of one another, often within five miles. In these overlapping trade areas of Springleaf's and OneMain's branches, few other lenders have branches offering personal installment loans to subprime borrowers. In many of these overlapping trade areas, Springleaf and OneMain are the only two personal installment lenders.
27. In local areas within and around 126 towns and municipalities in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia, subprime borrowers of personal installment loans would not seek such loans outside the local areas in the event lenders offering personal installment loans to subprime borrowers were to increase the interest rate or otherwise make their loans less appealing by a small but significant amount. Accordingly, the overlapping trade areas located in the 126 towns and municipalities identified in the Appendix hereto constitute relevant geographic markets within the meaning of Section 7 of the Clayton Act.
28. Springleaf and OneMain are the two largest providers of personal installment loans to subprime borrowers in the United States. Both companies have a long history in the business of providing personal installment loans to subprime borrowers, have built an extensive branch network, and have established close ties to the local communities. Leveraging their years of experience and large customer base, both companies have developed sophisticated risk analytics that allow them to minimize expected credit losses when extending loans to borrowers with blemished credit histories.
29. Compared to Springleaf and OneMain, other lenders that offer personal installment loans to subprime borrowers have much smaller branch footprints and are present in a more limited number of states and local markets. These personal installment lenders may operate in states with regulations that permit higher interest rates and fees, rather than in those with low interest rate caps. State regulations, lack of scale, and other economic factors have limited the competitive presence of these lenders in many states and local areas.
30. In local markets within and around the 126 towns and municipalities in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia identified in the Appendix, the market for the provision of personal installment loans to subprime borrowers is highly concentrated. In the local areas within these states, Springleaf and OneMain are the largest providers of personal installment loans to subprime borrowers, and face little, if any, competition from other personal installment lenders. Even if other providers of personal installment loans to subprime borrowers have a branch presence in these states, these lenders compete in a limited number of local markets or in communities located far from a Springleaf or OneMain branch. As a result, these local markets are highly concentrated.
31. In local markets within and around the 126 towns and municipalities in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia identified in the Appendix, the proposed acquisition would substantially increase concentration in the market for personal installment loans to subprime borrowers. Without the benefit of head-to-head competition between Springleaf and OneMain, subprime borrowers are likely to face higher interest rates or fees, greater limits on the amount they can borrow and restraints on their ability to obtain loans, and more onerous loan terms. The proposed acquisition therefore likely will substantially lessen competition in the provision of personal installment loans to subprime borrowers.
32. Entry of additional competitors into the provision of personal installment loans to subprime borrowers in local markets in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia is unlikely to be timely or sufficient to defeat the likely anticompetitive effects of the proposed acquisition. In some states, the state regulatory rate caps create unattractive markets for entry. In others, lenders face entry barriers in terms of cost and time to establish a local branch presence. Personal installment lenders need experienced branch employees with knowledge of the local market to build a base of customer relationships. A new lender in a local market faces more risks as it does not have knowledge of local market conditions. A lender also must obtain funding and devote resources to building a successful local presence.
33. As a result of these barriers, entry into the provision of personal installment loans to subprime borrowers in the local markets identified above would not be timely, likely, or sufficient to defeat the substantial lessening of competition that likely would result from Springleaf's acquisition of OneMain.
34. The acquisition of OneMain by Springleaf likely would substantially lessen competition in the provision of personal installment loans to subprime borrowers in the relevant geographic markets identified the Appendix, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18.
35. Unless enjoined, the proposed acquisition likely would have the following anticompetitive effects, among others:
a. actual and potential competition between Springleaf and OneMain in the provision of personal installment loans to subprime borrowers in local markets in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia would be eliminated;
b. competition generally in the provision of personal installment loans to subprime borrowers in local markets in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia would be substantially lessened; and
c. prices and other terms for personal installment loans to subprime borrowers in local markets in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia would become less favorable to consumers and access to such loans by subprime borrowers would decrease.
36. Plaintiffs request that the Court:
a. adjudge and decree that Springleaf's proposed acquisition of OneMain is unlawful and in violation of Section 7 of the Clayton Act, 15 U.S.C. 18;
b. preliminarily and permanently enjoin and restrain Defendants and all persons acting on their behalf from entering into any other agreement, understanding, or plan by which Springleaf would acquire OneMain;
c. award Plaintiffs their costs for this action; and
d. grant Plaintiffs such other and further relief as the Court deems just and proper.
DATED: November 13, 2015
Respectfully submitted,
Plaintiff United States of America (“United States”), pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. 16(b)-(h), files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding.
Pursuant to a Stock Purchase Agreement dated March 2, 2015, Springleaf Holdings, Inc. proposes to acquire OneMain Financial Holdings, LLC from CitiFinancial Credit Company, a wholly owned subsidiary of Citigroup, Inc., for approximately $4.25 billion. The proposed merger would combine the two largest providers of personal installment loans to subprime borrowers in the United States.
The United States filed a civil antitrust Complaint on November 13, 2015, seeking to enjoin the proposed acquisition. The Complaint alleges that the acquisition likely would substantially lessen competition for personal installment loans to subprime borrowers in numerous local markets across eleven states, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18. That loss of competition likely would result in a reduction of consumer choice that may drive financially struggling borrowers to much more expensive forms of credit or, worse, leave them with no reasonable alternative.
At the same time the Complaint was filed, the United States filed an Asset Preservation Stipulation and Order and a proposed Final Judgment designed to
The United States and Defendants have stipulated that the proposed Final Judgment may be entered after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof.
Defendant Springleaf Holdings, Inc. (“Springleaf”) is a Delaware corporation with its headquarters in Evansville, Indiana. Springleaf is the second-largest provider of personal installment loans to subprime borrowers in the United States. Springleaf operates approximately 830 branches in 27 states and has a consumer loan portfolio of about $4.0 billion.
Defendant OneMain Financial Holdings, LLC (“OneMain”) is a Delaware limited liability company, headquartered in Baltimore, Maryland. OneMain is the largest provider of personal installment loans to subprime borrowers in the United States. OneMain operates 1,139 branches in 43 states and has a consumer loan portfolio that totals $8.4 billion. OneMain is a subsidiary of CitiFinancial Credit Company, a holding company that is a wholly owned subsidiary of Citigroup, Inc.
Personal installment loans to subprime borrowers are closed-end, fixed-rate, fixed-term, and fully amortized loan products that typically range from $3,000 to $6,000. Both the principal and interest are paid fully through scheduled installments by the end of the loan term, which typically is between 18 and 60 months in duration. Each monthly payment is the same amount and the schedule of payments is clear.
Personal installment lenders target a unique segment of borrowers who may not be able to obtain cheaper sources of credit from other financial institutions but have enough cash flow to afford the monthly payments of personal installment loans. Borrowers of personal installment loans are considered “subprime” because of blemishes in their credit histories, such as serious delinquencies or defaults. These borrowers likely have been denied credit by a bank in the past and turn to personal installment lenders for the speed, ease, and likelihood of success in obtaining credit. Their borrowing needs vary, for example, from paying for unexpected expenses, such as car repairs or medical bills, to consolidating debts. A typical subprime borrower's annual income is in the range of $35,000 to $45,000.
The blemished credit histories of subprime borrowers suggest a higher propensity for default on future loans relative to so-called “prime” borrowers. Personal installment lenders mitigate this credit risk by closely analyzing a borrower's characteristics and ability to repay the loan, including the borrower's credit history, income and outstanding debts, stability of employment, and availability or value of collateral. Lenders typically require borrowers to meet face-to-face at a branch location to close the loan, even if the application begins online. This face-to-face meeting allows the lender to efficiently collect information used in underwriting and verify key documents (reducing the risk of fraud). Subprime borrowers seeking installment loans also value having a branch office close to where they live or work; a nearby branch reduces the borrower's travel cost to close the loan and allows convenient and timely access to loan proceeds. If approved, borrowers immediately obtain the funds at the branch.
Local branch presence also helps lenders and borrowers establish close customer relationships during the life of the loan. Local branch employees monitor delinquent payments of existing customers and assist borrowers in meeting their payment obligations to minimize loan loss. Borrowers also benefit from knowing the local branch employees. Borrowers may visit a branch to make payments, refinance their loans, or speak with a branch employee at times of financial difficulties. Lenders place branches where their target borrowers live or work so that it is convenient for their borrowers to come in to a branch.
The interest rate on a personal installment loan is the largest component of the total cost of a loan, but other fees increase the effective interest rate that a borrower will pay. The Annual Percentage Rate (“APR”) combines the interest rates and fees to indicate the annual charges associated with the loan. Although the maximum interest rates and fees charged on personal installment loans vary by state, Springleaf and OneMain have a self-imposed interest rate cap of 36 percent on their respective loans.
While subprime borrowers consider APR in selecting a loan, they typically focus most on the monthly payment and on the ease and speed of obtaining approval. For these reasons, negotiations between borrowers and lenders tend to focus more on the amount of the loan, the repayment terms, and collateral requirements than on the rates and fees.
Every state requires personal installment lenders to obtain licenses to offer loans to subprime borrowers. Many states also have regulations governing the interest rates and fees on personal installment loans, with some states imposing maximum rates and fees and others utilizing a tiered-rate system that establishes different interest rates and fees for different loan amounts. The nature of state regulations significantly affects the number of personal installment lenders operating in a state.
Subprime borrowers turn to personal installment loans when they need cash but have limited access to credit from banks, credit card companies, and other lenders. As explained in the Complaint, the products offered by these lenders are not meaningful substitutes for personal installment loans for a substantial number of subprime borrowers.
For example, banks and credit unions offer personal installment loans at rates and terms much better than those offered by personal installment lenders, but subprime borrowers typically do not meet the underwriting criteria of those institutions and are unlikely to be approved. Further, the loan application and underwriting process at banks and credit unions typically take much longer than that of personal installment lenders.
Payday and title lenders provide short-term cash, but charge much higher rates and fees, usually lend in amounts well below $1,000, and require far quicker repayment than personal installment lenders. Rates and fees for
Credit cards are also not a viable alternative for most subprime borrowers. Subprime borrowers may have difficulty obtaining credit cards, and those who have credit cards have often reached their credit limits and have limited access to additional credit extensions. Although subprime borrowers may use credit cards for everyday purchases, they typically have insufficient remaining credit to pay for larger expenses such as major car repairs or significant medical bills.
Finally, although online lenders have been successful in making loans to prime borrowers, they face challenges in meeting the needs of and mitigating the credit risk posed by subprime borrowers. Without a local branch presence, online lenders do not maintain close customer relationships, nor can they conduct face-to-face meetings to verify key documents, measures which reduce the risk of fraud and borrower default. Online lenders are also unable to process applications and distribute loan proceeds as quickly as local personal installment lenders.
For all of these reasons, as explained in the Complaint, subprime borrowers generally would not turn to banks and credit unions, payday and title lenders, credit cards, or online lenders in the event lenders offering personal installment loans to subprime borrowers were to increase the interest rate or otherwise make their loan terms less appealing by a small but significant amount. Accordingly, the Complaint alleges that the provision of personal installment loans to subprime borrowers is a line of commerce and a relevant product market within the meaning of Section 7 of the Clayton Act.
As explained in the Complaint, subprime borrowers seeking personal installment loans value convenience, including quick access to borrowed funds and minimal travel time, and look for a branch near where they live or work. While the distance a borrower is willing to travel may vary by geography, the vast majority of subprime borrowers travel less than twenty miles to a branch for a personal installment loan.
Personal installment lenders have established local trade areas for their branches. Lenders usually rely on direct mail solicitations as the primary means of marketing and solicit customers who live within close proximity to their branches. Lenders who place branches in the same areas compete to serve the same target borrower base. Borrowers view lenders with branches in close proximity to each other as close substitutes.
For these reasons, the overlapping trade areas of competing personal installment lenders form geographic markets where the lenders located within the trade areas compete for subprime borrowers who live or work near the branches. The size and shape of the overlapping trade areas of these branches may vary as the distance borrowers are willing to travel depends on factors specific to each local area. Even so, typically more than three-quarters of the personal installment loans to subprime borrowers made by a given branch are made to borrowers residing within twenty miles of the branch. Personal installment lenders with branches located outside these trade areas usually are not convenient alternatives for borrowers.
Springleaf and OneMain have a high degree of geographic overlap between their branch networks. In local areas within and around 126 towns and municipalities in eleven states—Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia—Springleaf and OneMain have branches located within close proximity of one another, often within five miles. In these overlapping trade areas of Springleaf's and OneMain's branches, few, if any, other lenders have branches offering personal installment loans to subprime borrowers.
According to the Complaint, in local areas within and around the 126 towns and municipalities in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia, subprime borrowers of personal installment loans would not seek such loans outside the local areas in the event lenders offering personal installment loans to subprime borrowers were to increase the interest rate or otherwise make their loans less appealing by a small but significant amount. Accordingly, the overlapping trade areas located in the 126 towns and municipalities identified in the Appendix attached to the Complaint constitute relevant geographic markets within the meaning of Section 7 of the Clayton Act.
As alleged in the Complaint, Springleaf and OneMain are the two largest providers of personal installment loans to subprime borrowers in the United States. Both companies have a long history in the business, an extensive branch network, and close ties to the local communities in which they operate. Both companies have used their years of experience and large customer base to develop sophisticated risk analytics that allow them to minimize expected credit losses. Other lenders that offer personal installment loans to subprime borrowers have much smaller branch footprints and are present in fewer states and local markets than Springleaf and OneMain.
In local markets within and around the 126 towns and municipalities in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia identified in the Appendix to the Complaint, the market for the provision of personal installment loans to subprime borrowers is highly concentrated. In these local markets, Springleaf and OneMain are the largest providers of personal installment loans to subprime borrowers, and face little, if any, competition from other personal installment lenders. The Complaint alleges that the proposed acquisition would substantially increase concentration in these local markets and likely would result in subprime borrowers facing higher interest rates or fees, greater limits on the amount they can borrow and restraints on their ability to obtain loans, and more onerous loan terms. The proposed acquisition therefore likely will substantially lessen competition in the provision of personal installment loans to subprime borrowers.
According to the Complaint, entry of additional competitors into the provision of personal installment loans to subprime borrowers in the 126 local markets in Arizona, California, Colorado, Idaho, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and West Virginia identified in the Complaint is unlikely to be timely or sufficient to defeat the likely anticompetitive effects of the proposed acquisition. In some states, the state regulatory rate caps create unattractive markets for entry. In others, lenders face entry barriers in terms of cost and time to establish a local branch presence. Personal installment lenders need experienced branch employees with knowledge of the local market to build a base of customer relationships. A new lender in a local market faces more risks as it does not have knowledge of local market conditions. A lender also must obtain funding and devote resources to building a successful local presence. As a result of these barriers, entry is unlikely to
The divestiture required by the proposed Final Judgment will eliminate the anticompetitive effects of the acquisition by establishing an independent and economically viable competitor in the provision of personal installment loans to subprime borrowers in each of the local markets of concern.
Specifically, Paragraphs IV(A) and IV(B) of the proposed Final Judgment requires Defendants to divest 127 Springleaf branches, which are identified in the Attachment to the proposed Final Judgment, to Lendmark Financial Services or to one or more alternative Acquirers acceptable to the United States. The branches to be divested are located in the local markets within and around the 126 towns and municipalities identified in the Appendix to the Complaint. The divestiture will establish Lendmark or an alternative Acquirer as a new, independent and economically viable competitor in some states and will allow Lendmark or an alternative Acquirer to compete in new local areas and to enhance its competitive presence in others.
The divestiture of the 127 Springleaf branches includes all active loans originated or serviced at those branches, including all historical performance information (including account-level payment histories) and all customers' credit scores and other credit metrics with respect to loans that are active, closed, paid-off, or defaulted that have been originated or serviced at the Divestiture Branches at any point since January 1, 2010. The historical performance information will allow a lender to gain an understanding of local market conditions and to perform risk analytics essential to making personal installment loans to subprime borrowers. In the event that Lendmark is not the Acquirer, Paragraph II(G)(3) provides that Springleaf will further divest, at the Acquirer's option, assets related to back office and technical support that would provide the Acquirer with additional capability and know-how.
Paragraph IV(A) of the proposed Final Judgment requires Springleaf to divest the Divestiture Assets within 120 calendar days after the filing of the Complaint or within five (5) calendar days after satisfaction of all state licensing requirements, whichever is sooner. The United States, in its sole discretion, after consultation with the Plaintiff States, may agree to one or more extensions of the time period, not to exceed sixty (60) calendar days in total. In addition, in the event that Lendmark has initiated the state licensing process in a particular state but has not satisfied the state's licensing requirements before the end of the period specified in Paragraph IV(A), the period to divest the Divestiture Assets of that particular state shall be extended to five (5) calendar days after satisfaction of the state licensing requirements. Paragraph IV(A) also requires Springleaf to use its best efforts to divest the Divestiture Assets as expeditiously as possible.
In the event that Lendmark is unable to acquire the Divestiture Assets in one or more states, Paragraphs IV(B) provides that Springleaf shall divest the remaining Divestiture Assets to an alternative Acquirer(s) acceptable to the United States, in its sole discretion, after consultation with the relevant Plaintiff States. Springleaf shall divest the remaining Divestiture Assets within thirty (30) days after the United States receives notice that Lendmark is not the Acquirer of such Divestiture Assets, or within five (5) days of satisfaction of all state licensing requirements, whichever is sooner. The United States, in its sole discretion, after consultation with the relevant Plaintiff States, may agree to one or more extensions of the time period, not to exceed sixty (60) calendar days in total. Pursuant to Paragraph V(I), Springleaf must divest to a single Acquirer all of the Divestiture Branches located in a particular state.
Paragraph IV(G) prohibits Defendants from entering into non-compete agreements with any employee at any of Defendants' branches or with any regional manager with responsibility for managing any of Defendants' branches for a period of two (2) years from the date of the filing of the Complaint. Defendants also must waive any existing non-compete agreements with such employees. Paragraph IV(G) ensures that competing providers of personal installment loans, including the Acquirer, may hire Defendants' branch employees and regional managers who are experienced in making personal installment loans to subprime borrowers.
Paragraph IV(H) provides for the possibility of a transition services agreement between Springleaf and the Acquirer(s) for a period of up to six (6) months. This provision is necessary because the transfer of loan records and customer information from Springleaf's data system to the Acquirer's data system will require system testing, and the transition may take a period of months after the divestiture. The transition services provided pursuant to such an agreement shall include providing the Acquirer(s) access to a separate information technology environment within Springleaf's information system for loan origination, administration and services. During the term of the transition services agreement, Springleaf shall implement and maintain procedures to preclude the sharing of data between Springleaf and the Acquirer(s). The United States, in its sole discretion, may approve one or more extensions of this agreement for a total of up to an additional six (6) months.
Section X of the proposed Final Judgment provides that the United States may appoint a Monitoring Trustee with the power and authority to investigate and report on Defendants' compliance with the terms of the proposed Final Judgment and the Asset Preservation Stipulation and Order during the pendency of the divestiture. Because satisfaction of the state licensing requirements may take 120 calendar days or longer, a Monitoring Trustee will assist Plaintiffs in monitoring the divestiture process and ensuring Defendants' compliance with the Asset Preservation Stipulation and Order. The Monitoring Trustee shall file monthly reports with the United States and shall serve until the completion of the divestiture and the expiration of any transition services agreement.
In the event that Springleaf does not accomplish the divestiture to either Lendmark or an alternative Acquirer(s) within the periods prescribed in the proposed Final Judgment, pursuant to Section V, the Court shall appoint a Divestiture Trustee selected by the United States and approved by the Court to effect the divestiture. If a Divestiture Trustee is appointed, the proposed Final Judgment provides that Springleaf will pay all costs and expenses of the trustee. After its appointment becomes effective, the Divestiture Trustee will file monthly reports with the Court and the United States setting forth its efforts to accomplish the divestiture. At the end of six (6) months, if the divestiture has not been accomplished, the Divestiture Trustee and the United States will make recommendations to the Court, which shall enter such orders as appropriate, in order to carry out the purpose of the Final Judgment, including extending the trust or the term of the Divestiture Trustee's appointment.
Section 4 of the Clayton Act, 15 U.S.C. 15, provides that any person who
The United States and Defendants have stipulated that the proposed Final Judgment may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest.
The APPA provides a period of at least sixty (60) days preceding the effective date of the proposed Final Judgment within which any person may submit to the United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within sixty (60) days of the date of publication of this Competitive Impact Statement in the
Written comments should be submitted to:
The United States considered, as an alternative to the proposed Final Judgment, a full trial on the merits against Defendants. The United States could have continued the litigation and sought preliminary and permanent injunctions against Springleaf's acquisition of OneMain. The United States is satisfied, however, that the divestiture of assets described in the proposed Final Judgment will preserve competition for personal installment loans to subprime borrowers. Thus, the proposed Final Judgment would achieve all or substantially all of the relief the United States would have obtained through litigation, but avoids the time, expense, and uncertainty of a full trial on the merits of the Complaint.
The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a sixty-day comment period, after which the Court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. 16(e)(1). In making that determination, the Court, in accordance with the statute as amended in 2004, is required to consider:
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
As the United States Court of Appeals for the District of Columbia Circuit has held, under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations set forth in the government's complaint, whether the decree is sufficiently clear, whether enforcement mechanisms are sufficient, and whether the decree may positively harm third parties.
Courts have greater flexibility in approving proposed consent decrees than in crafting their own decrees following a finding of liability in a litigated matter. “[A] proposed decree must be approved even if it falls short of the remedy the court would impose on its own, as long as it falls within the range of acceptability or is `within the reaches of public interest.' ”
Moreover, the Court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its Complaint, and does not authorize the Court to “construct [its] own hypothetical case and then evaluate the decree against that case.”
In its 2004 amendments, Congress made clear its intent to preserve the practical benefits of utilizing consent decrees in antitrust enforcement, adding the unambiguous instruction that “[n]othing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.” 15 U.S.C. 16(e)(2);
There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment.
Dated: November 13, 2015
Respectfully submitted,
This Court has jurisdiction over the subject matter of and each of the parties to this action. The Complaint states a claim upon which relief may be granted against Defendants under Section 7 of the Clayton Act, as amended (15 U.S.C. 18).
As used in this Final Judgment:
A. “Acquirer” means Lendmark or another entity to which Defendants divest the Divestiture Assets.
B. “Springleaf” means Defendant Springleaf Holdings, Inc., a Delaware corporation with its headquarters in Evansville, Indiana, and its
C. “OneMain” means Defendant OneMain Financial Holdings, LLC, a Delaware limited liability company with its headquarters in Baltimore, Maryland, and its
D. “CitiFinancial” means Defendant CitiFinancial Credit Company, a Delaware corporation, with its headquarters in Dallas, Texas, that is a wholly owned subsidiary of Citigroup and the holding company of OneMain.
E. “Lendmark” means Lendmark Financial Services, LLC, a Georgia limited liability company with its headquarters in Covington, Georgia, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees.
F. “Divestiture Branches” means the Springleaf branches identified in the Attachment to this Final Judgment.
G. “Divestiture Assets” means the Divestiture Branches, including, but not limited to:
(1) All real property and improvements, equipment, fixed assets, personal property, office furniture, materials, and supplies; all licenses, permits and authorizations issued by any governmental organization to the extent permitted by such governmental organization; and all contracts, leases and agreements related to the Divestiture Branches.
(2) All active loans originated or serviced at the Divestiture Branches; all insurance and other ancillary products sold in conjunction with such loans; all loan documents, records, files, current and past customer information, accounts, and agreements related to such loans and ancillary products; all historical performance information (including account-level payment histories) and all customers' credit scores and other credit metrics with respect to loans that are active, closed, paid-off, or defaulted that have been originated or serviced at the Divestiture Branches at any point since January 1, 2010.
(3) In the event that Lendmark is not the Acquirer, at the Acquirer's option, all tangible and intangible assets related to Springleaf's back office and technical support for loan origination, underwriting, and servicing at the Divestiture Branches, including, but not limited to, all equipment and fixed assets; all patents, licenses and sublicenses, intellectual property, technical information, computer software and related documentation, know-how, and trade secrets; and all manuals and technical information Springleaf provides to its own employees.
A. This Final Judgment applies to Springleaf, OneMain and CitiFinancial, as defined above, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise.
B. If, prior to complying with Section IV and V of this Final Judgment, Springleaf sells or otherwise disposes of all or substantially all of its assets or of lesser business units that include the Divestiture Assets, it shall require the purchaser to be bound by the provisions of this Final Judgment. Springleaf need not obtain such an agreement from the Acquirer(s) of the assets divested pursuant to this Final Judgment.
A. Springleaf is ordered and directed within 120 calendar days after the filing of the Complaint in this matter, or within five (5) calendar days after satisfaction of all state licensing requirements, whichever is sooner, to divest the Divestiture Assets in a manner consistent with this Final Judgment to Lendmark. The United States, in its sole discretion, after consultation with the Plaintiff States, may agree to one or more extensions of this time period not to exceed sixty (60) calendar days in total, and shall notify the Court in such circumstances. In the event that Lendmark has initiated the state licensing process in a particular state but has not satisfied the state's licensing requirements before the end of the period specified in this Paragraph IV(A), the period shall be extended until five (5) calendar days after satisfaction of the state licensing requirements with respect to those Divestiture Assets. Springleaf agrees to use its best efforts to divest the Divestiture Assets as expeditiously as possible.
B. In the event Lendmark is not the Acquirer of the Divestiture Assets in one or more states, Springleaf or the Monitoring Trustee shall promptly notify the United States of that fact in writing. In such circumstance, within thirty (30) calendar days after the United States receives such notice, or within five (5) days of satisfaction of all state licensing requirements, whichever is sooner, Springleaf shall divest the remaining Divestiture Assets in a manner consistent with this Final Judgment to an alternative Acquirer(s) acceptable to the United States, in its sole discretion, after consultation with the relevant Plaintiff States. The United States, in its sole discretion, after consultation with the relevant Plaintiff States, may agree to one or more extensions of either time period in this Paragraph IV(B), provided that the extension of either time period shall not exceed sixty (60) calendar days in total. The United States shall notify the Court of any such extension of time.
C. In the event that Lendmark is not the Acquirer of the Divestiture Assets in one or more states, Springleaf shall
D. Springleaf shall provide the Acquirer(s) and the United States information relating to the personnel employed at each Divestiture Branch to enable the Acquirer(s) to make offers of employment. Springleaf shall not interfere with any negotiations by the Acquirer(s) to employ any Springleaf employee who works at any Divestiture Branch.
E. Springleaf shall permit prospective acquirers of the Divestiture Assets to have reasonable access to personnel and to make inspections of the Divestiture Branches; access to any and all environmental, zoning, and other permit documents and information; and access to any and all financial, operational, or other documents and information customarily provided as part of a due diligence process.
F. Defendants shall not take any action that would impede in any way the permitting, operation, or divestiture of the Divestiture Assets. Springleaf shall use its best efforts to assist the Acquirer(s) in satisfying any state licensing requirements or obtaining any other needed governmental approvals relating to the acquisition of the Divestiture Assets.
G. For a period of two (2) years from the date of the filing of the Complaint in this matter, Defendants shall not enter into any non-compete agreement with any employee at any of Defendants' branches or with any regional manager with responsibility for managing any of Defendants' branches. Defendants shall waive all obligations under any existing non-compete agreement with any such employee.
H. At the option of the Acquirer(s), Springleaf shall enter into a transition services agreement with the Acquirer(s) for back office and technical support sufficient to meet all or part of the needs of the Acquirer(s) for a period of up to six (6) months. The United States, in its sole discretion, may approve one or more extensions of this agreement for a total of up to an additional six (6) months. The transition services provided pursuant to such an agreement shall include, but are not limited to, providing the Acquirer(s) access to a separate information technology environment within Springleaf's information systems for loan origination, administration and servicing. During the term of the transition services agreement, Springleaf shall implement and maintain procedures to preclude the sharing of data between Springleaf and the Acquirer(s). The terms and conditions of any contractual arrangement intended to satisfy this provision must be reasonably related to market conditions.
I. Unless the United States otherwise consents in writing, the divestiture pursuant to Section IV, or by a Divestiture Trustee appointed pursuant to Section V, of this Final Judgment, shall include the entire Divestiture Assets, and shall be accomplished in such a way as to satisfy the United States, in its sole discretion, after consultation with the relevant Plaintiff States, that the Divestiture Assets can and will be used by the Acquirer(s) as part of a viable, ongoing business involving the provision of personal installment loans to subprime borrowers in the United States. Divestiture of the Divestiture Branches may be made to one or more Acquirer(s), provided that Springleaf must divest to a single Acquirer all of the Divestiture Branches located in a particular state and that, in each instance, it is demonstrated to the sole satisfaction of the United States that the Divestiture Branches will remain viable and the divestiture of such assets will remedy the competitive harm alleged in the Complaint. The divestiture, whether pursuant to Section IV or Section V of this Final Judgment,
(1) shall be made to an Acquirer or Acquirers that, in the United States's sole judgment, after consultation with the Plaintiff States, has the intent and capability (including the necessary managerial, operational, technical and financial capability) of competing effectively in the provision of personal installment loans to subprime borrowers in the United States; and
(2) shall be accomplished so as to satisfy the United States, in its sole discretion, after consultation with the Plaintiff States, that none of the terms of any agreement between the Acquirer(s) and Springleaf gives Springleaf the ability unreasonably to raise the Acquirer's costs, to lower the Acquirer's efficiency, or otherwise to interfere in the ability of the Acquirer(s) to compete effectively.
A. If Springleaf has not divested the Divestiture Assets within the time period specified in Paragraph IV(A) or Paragraph IV(B), Springleaf shall notify Plaintiffs of that fact in writing. Upon application of the United States, the Court shall appoint a Divestiture Trustee selected by the United States and approved by the Court to effect the divestiture of the Divestiture Assets.
B. After the appointment of a Divestiture Trustee becomes effective, only the Divestiture Trustee shall have the right to sell the Divestiture Assets. The Divestiture Trustee shall have the power and authority to accomplish the divestiture to an Acquirer or Acquirers acceptable to the United States, after consultation with the Plaintiff States, at such price and on such terms as are then obtainable upon reasonable effort by the Divestiture Trustee, subject to the provisions of Sections IV, V, and VI of this Final Judgment, and shall have such other powers as this Court deems appropriate. Subject to Paragraph V(D) of this Final Judgment, the Divestiture Trustee may hire at the cost and expense of Springleaf any investment bankers, attorneys, or other agents, who shall be solely accountable to the Divestiture Trustee, reasonably necessary in the Divestiture Trustee's judgment to assist in the divestiture. Any such investment bankers, attorneys, or other agents shall serve on such terms and conditions as the United States approves including confidentiality requirements and conflict of interest certifications.
C. Defendants shall not object to a sale by the Divestiture Trustee on any ground other than the Divestiture Trustee's malfeasance. Any such objections by Defendants must be conveyed in writing to the United States and the Divestiture Trustee within ten (10) calendar days after the Divestiture Trustee has provided the notice required under Section VI.
D. The Divestiture Trustee shall serve at the cost and expense of Springleaf pursuant to a written agreement, on such terms and conditions as the United States approves including confidentiality requirements and conflict of interest certifications. The Divestiture Trustee shall account for all monies derived from the sale of the assets sold by the Divestiture Trustee and all costs and expenses so incurred. After approval by the Court of the Divestiture Trustee's accounting, including fees for its services yet unpaid
E. Springleaf shall use its best efforts to assist the Divestiture Trustee in accomplishing the required divestiture. The Divestiture Trustee and any consultants, accountants, attorneys, and other agents retained by the Divestiture Trustee shall have full and complete access to the personnel, books, records, and facilities of the business to be divested, and Springleaf shall develop financial and other information relevant to such business as the Divestiture Trustee may reasonably request, subject to reasonable protection for trade secret or other confidential research, development, or commercial information or any applicable privileges. Defendants shall take no action to interfere with or to impede the Divestiture Trustee's accomplishment of the divestiture.
F. After its appointment, the Divestiture Trustee shall file monthly reports with the United States and, as appropriate, the Court setting forth the Divestiture Trustee's efforts to accomplish the divestiture ordered under this Final Judgment. To the extent such reports contain information that the Divestiture Trustee deems confidential, such reports shall not be filed in the public docket of the Court. Such reports shall include the name, address, and telephone number of each person who, during the preceding month, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture Assets, and shall describe in detail each contact with any such person. The Divestiture Trustee shall maintain full records of all efforts made to divest the Divestiture Assets.
G. If the Divestiture Trustee has not accomplished the divestiture ordered under this Final Judgment within six (6) months after its appointment, the Divestiture Trustee shall promptly file with the Court a report setting forth (1) the Divestiture Trustee's efforts to accomplish the required divestiture, (2) the reasons, in the Divestiture Trustee's judgment, why the required divestiture has not been accomplished, and (3) the Divestiture Trustee's recommendations. To the extent such report contains information that the Divestiture Trustee deems confidential, such reports shall not be filed in the public docket of the Court. The Divestiture Trustee shall at the same time furnish such report to the United States which shall have the right to make additional recommendations consistent with the purpose of the trust. The Court thereafter shall enter such orders as it shall deem appropriate to carry out the purpose of the Final Judgment, which may, if necessary, include extending the trust and the term of the Divestiture Trustee's appointment by a period requested by the United States.
H. If the United States determines that the Divestiture Trustee has ceased to act or failed to act diligently or in a reasonably cost-effective manner, it may recommend the Court appoint a substitute Divestiture Trustee.
A. Within two (2) business days following execution of a definitive divestiture agreement, Springleaf or the Divestiture Trustee, whichever is then responsible for effecting the divestiture required herein, shall notify Plaintiffs of any proposed divestiture required by Section IV or V of this Final Judgment. If the Divestiture Trustee is responsible, it shall similarly notify Springleaf. The notice shall set forth the details of the proposed divestiture and list the name, address, and telephone number of each person not previously identified who offered or expressed an interest in or desire to acquire any ownership interest in the Divestiture Assets, together with full details of the same.
B. Within fifteen (15) calendar days of receipt by the United States of such notice, the United States, after consultation with the Plaintiff States, may request from Springleaf, the proposed Acquirer(s), any other third party, or the Divestiture Trustee, if applicable, additional information concerning the proposed divestiture, the proposed Acquirer(s), and any other potential Acquirer(s). Springleaf and the Divestiture Trustee shall furnish any additional information requested within fifteen (15) calendar days of the receipt of the request, unless the parties shall otherwise agree.
C. Within thirty (30) calendar days after receipt of the notice or within twenty (20) calendar days after the United States has been provided the additional information requested from Springleaf, the proposed Acquirer(s), any third party, and the Divestiture Trustee, whichever is later, the United States shall provide written notice to Springleaf and the Divestiture Trustee, if there is one, stating whether or not it objects to the proposed divestiture. If the United States provides written notice that it does not object, the divestiture may be consummated, subject only to Springleaf's limited right to object to the sale under Paragraph V(C) of this Final Judgment. Absent written notice that the United States does not object to the proposed Acquirer(s) or upon objection by the United States, a divestiture proposed under Section IV or Section V shall not be consummated. Upon objection by Springleaf under Paragraph V(C), a divestiture proposed under Section V shall not be consummated unless approved by the Court.
Defendants shall not finance all or any part of any purchase made pursuant to Section IV or V of this Final Judgment.
Until the divestiture required by this Final Judgment has been accomplished, Defendants shall take all steps necessary to comply with the Asset Preservation Stipulation and Order entered by this Court. Defendants shall take no action that would jeopardize the divestiture ordered by this Court.
A. Within twenty (20) calendar days of the filing of the Complaint in this matter, and every thirty (30) calendar days thereafter until the divestiture has been completed under Section IV or V, Springleaf shall deliver to the United States an affidavit as to the fact and manner of its compliance with Section IV or V of this Final Judgment. Each such affidavit shall include the name, address, and telephone number of each person who, during the preceding thirty (30) calendar days, made an offer to acquire, expressed an interest in
B. Within twenty (20) calendar days of the filing of the Complaint in this matter, Defendants shall deliver to the United States an affidavit that describes in reasonable detail all actions Defendants have taken and all steps Defendants have implemented on an ongoing basis to comply with Section VIII of this Final Judgment. Defendants shall deliver to the United States an affidavit describing any changes to the efforts and actions outlined in Defendants' earlier affidavits filed pursuant to this section within fifteen (15) calendar days after the change is implemented.
C. Springleaf shall keep all records of all efforts made to preserve and divest the Divestiture Assets until one year after such divestiture has been completed.
A. Upon application of the United States, the Court shall appoint a Monitoring Trustee selected by the United States and approved by the Court.
B. The Monitoring Trustee shall have the power and authority to monitor Defendants' compliance with the terms of this Final Judgment and the Asset Preservation Stipulation and Order entered by this Court, and shall have such other powers as this Court deems appropriate. The Monitoring Trustee shall be required to investigate and report on the Defendants' compliance with this Final Judgment and the Asset Preservation Stipulation and Order and the Defendants' progress toward effectuating the purposes of this Final Judgment.
C. Subject to Paragraph X(E) of this Final Judgment, the Monitoring Trustee may hire at the cost and expense of Springleaf any consultants, accountants, attorneys, or other agents, who shall be solely accountable to the Monitoring Trustee, reasonably necessary in the Monitoring Trustee's judgment. Any such consultants, accountants, attorneys, or other agents shall serve on such terms and conditions as the United States approves including confidentiality requirements and conflict of interest certifications.
D. Springleaf shall not object to actions taken by the Monitoring Trustee in fulfillment of the Monitoring Trustee's responsibilities under any Order of this Court on any ground other than the Monitoring Trustee's malfeasance. Any such objections by Springleaf must be conveyed in writing to the United States and the Monitoring Trustee within ten (10) calendar days after the action taken by the Monitoring Trustee giving rise to Springleaf's objection.
E. The Monitoring Trustee shall serve at the cost and expense of Springleaf pursuant to a written agreement with Springleaf and on such terms and conditions as the United States approves, including confidentiality requirements and conflict of interest certifications. The compensation of the Monitoring Trustee and any consultants, accountants, attorneys, and other agents retained by the Monitoring Trustee shall be on reasonable and customary terms commensurate with the individual's experience and responsibilities. If the Monitoring Trustee and Springleaf are unable to reach agreement on the Monitoring Trustee's or any agent's or consultant's compensation or other terms and conditions of engagement within fourteen (14) calendar days of appointment of the Monitoring Trustee, the United States may, in its sole discretion, take appropriate action, including making a recommendation to the Court. The Monitoring Trustee shall, within three (3) business days of hiring any consultants, accountants, attorneys, or other agents, provide written notice of such hiring and the rate of compensation to Springleaf and the United States.
F. The Monitoring Trustee shall have no responsibility or obligation for the operation of Springleaf's business.
G. Defendants shall use their best efforts to assist the Monitoring Trustee in monitoring Defendants' compliance with their individual obligations under this Final Judgment and under the Asset Preservation Stipulation and Order. The Monitoring Trustee and any consultants, accountants, attorneys, and other agents retained by the Monitoring Trustee shall have full and complete access to the personnel, books, records, and facilities relating to compliance with this Final Judgment, subject to reasonable protection for trade secret or other confidential research, development, or commercial information or any applicable privileges. Defendants shall take no action to interfere with or to impede the Monitoring Trustee's accomplishment of its responsibilities.
H. After its appointment, the Monitoring Trustee shall file reports monthly, or more frequently as needed, with the United States and, as appropriate, the Court, setting forth Defendants' efforts to comply with their obligations under this Final Judgment and under the Asset Preservation Stipulation and Order. To the extent such reports contain information that the Monitoring Trustee deems confidential, such reports shall not be filed in the public docket of the Court.
I. The Monitoring Trustee shall serve until the divestiture of all the Divestiture Assets is finalized pursuant to either Section IV or Section V of this Final Judgment and the expiration of any continuing transition services agreement.
J. If the United States determines that the Monitoring Trustee has ceased to act or failed to act diligently or in a reasonably cost-effective manner, it may recommend the Court appoint a substitute Monitoring Trustee.
A. For the purposes of determining or securing compliance with this Final Judgment, or of any related orders such as any Asset Preservation Order, or of determining whether the Final Judgment should be modified or vacated, and subject to any legally recognized privilege, from time to time authorized representatives of the United States Department of Justice, including consultants and other persons retained by the United States, shall, upon written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division, and on reasonable notice to Defendants, be permitted:
(1) Access during Defendants' office hours to inspect and copy, or at the option of the United States, to require Defendants to provide hard copy or electronic copies of, all books, ledgers, accounts, records, data, and documents in the possession, custody, or control of Defendants, relating to any matters contained in this Final Judgment; and
(2) to interview, either informally or on the record, Defendants' officers, employees, or agents, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by Defendants.
B. Upon the written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division, Defendants shall submit written reports or response to written interrogatories, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested.
C. No information or documents obtained by the means provided in this section shall be divulged by the United States to any person other than an authorized representative of the executive branch of the United States, or the Plaintiff States, except in the course of legal proceedings to which the United States is a party (including grand jury proceedings), or for the purpose of securing compliance with this Final Judgment, or as otherwise required by law.
D. If at the time information or documents are furnished by Defendants to the United States, Defendants represent and identify in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure, and Defendants mark each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure,” then the United States shall give Defendants ten (10) calendar days notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding).
Defendants may not reacquire any part of the Divestiture Assets during the term of this Final Judgment.
This Court retains jurisdiction to enable any party to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions.
Unless this Court grants an extension, this Final Judgment shall expire ten (10) years from the date of its entry.
Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon and the United States's responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest.
Occupational Safety and Health Administration (OSHA), Labor.
Announcement of the renewal of the FACOSH charter and appointment of new members to FACOSH.
The Secretary of Labor has renewed the FACOSH charter and appointed six individuals to serve on FACOSH.
On September 30, 2015, President Barack Obama signed Executive Order (E.O.) 13708 continuing certain federal advisory committees, including FACOSH, until September 30, 2017 (80 FR 60271 (10/15/2015)). In response, the Secretary of Labor (Secretary) renewed and filed the FACOSH charter on October 14, 2015. FACOSH will terminate on September 30, 2017, unless the President continues the committee. (The FACOSH charter is available to read or download on the FACOSH page on OSHA's Web page at
FACOSH is authorized by 5 U.S.C. 7902, section 19 of the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 668), and E.O. 11612, as amended, to advise the Secretary on all matters relating to the occupational safety and health of federal employees. This includes providing advice on how to reduce and keep to a minimum the number of injuries and illnesses in the federal workforce and how to encourage each federal Executive Branch department and agency to establish and maintain effective occupational safety and health programs.
FACOSH is comprised of 16 members; eight who represent federal agency management and eight from labor organizations that represent federal employees. The Secretary has appointed or re-appointed the following individuals to serve on FACOSH:
• Mr. William Dougan, National Federation of Federal Employees (Reappointment). Term expires December 31, 2018;
• Ms. Nan Thompson Ernst, American Federation of State, County and Municipal Employees. Term expires December 31, 2016;
• Ms. Deborah Kleinberg, Seafarers International Union (Reappointment). Term expires December 31, 2018; and
• Ms. Irma Westmoreland, National Nurses United (Reappointment). Term expires December 31, 2018.
Federal agency management representatives:
• Mr. Gregory Parham, U.S. Department of Agriculture (Reappointment). Term expires December 31, 2018; and
• Mr. Charles Rosenfarb, U.S Department of State. Term expires December 31, 2018.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice pursuant to 5 U.S.C. 7902; 5 U.S.C. App. 2; 29 U.S.C. 668; E.O. 13708 (80 FR 60271 (10/5/2015) and 12196 (45 CFR 12629 (2/27/1980)); 41 CFR part 102-3; and Secretary of Labor's Order No. 1-2012 (77 FR 3912 (1/25/2012)).
In accordance with the purposes of Sections 29 and 182b of the Atomic Energy Act (42 U.S.C. 2039, 2232b), the Advisory Committee on Reactor Safeguards (ACRS) will hold a meeting on December 3-5, 2015, 11545 Rockville Pike, Rockville, Maryland.
Procedures for the conduct of and participation in ACRS meetings were published in the
Thirty-five hard copies of each presentation or handout should be provided 30 minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the Cognizant ACRS Staff one day before meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the Cognizant ACRS Staff with a CD containing each presentation at least 30 minutes before the meeting.
In accordance with Subsection 10(d) of Public Law 92-463 and 5 U.S.C. 552b(c), certain portions of the December 4th meeting may be closed, as specifically noted above. Use of still, motion picture, and television cameras during the meeting may be limited to selected portions of the meeting as determined by the Chairman. Electronic recordings will be permitted only during the open portions of the meeting.
ACRS meeting agendas, meeting transcripts, and letter reports are available through the NRC Public Document Room at
Video teleconferencing service is available for observing open sessions of ACRS meetings. Those wishing to use this service should contact Mr. Theron Brown, ACRS Audio Visual Technician (301-415-8066), between 7:30 a.m. and 3:45 p.m. (ET), at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Request for comment and public meeting.
On August 27, 2015, the U.S. Nuclear Regulatory Commission (NRC) received from Zion
Submit comments by December 24, 2015. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
John Hickman, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001, telephone: 301-415-3017, email:
Please refer to Docket ID NRC-2015-0265 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0265 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
Zion
In September 1996, ZNPS Unit 2 was permanently shut-down after approximately 23 years of operation. In February 1997, ZNPS Unit 1 was permanently shut-down after approximately 24 years of operation. In early 1998, in accordance with section 50.82(a)(1)(i) and (ii) of title 10 of the
By letter dated December 19, 2014 (ADAMS Accession No. ML15005A336), and supplemented on February 26, 2015 (ADAMS Accession No. ML15061A281), ZS submitted the License Termination Plan (LTP) for ZNPS in accordance with 10 CFR 50.82(a)(9). The LTP includes a site characterization to ensure that final radiation surveys (FRS) cover all areas where contamination existed, remains, or has the potential to exist or remain; identification of remaining dismantlement activities; plans for site remediation; a description of the FRS plan to confirm that ZNPS will meet the release criteria in 10 CFR part 20, subpart E; dose-modeling scenarios that ensure compliance with the radiological criteria for license termination; an estimate of the remaining site-specific decommissioning costs; and a supplement to the Defueled Safety Analysis Report and the Environmental Report describing any new information or significant environmental change associated with proposed license termination activities. The Zion LTP is currently being reviewed by the NRC.
By letter dated August 27, 2015 (ADAMS Accession No. ML15243A029), ZS submitted a request for approval to remove a portion of the site from the part 50 License Nos. DPR-39 and DPR-48. Specifically, ZS intends to remove and release the radiologically non-impacted portions of the site from its part 50 licenses in accordance with 10 CFR 50.83(b), “Release of part of a power reactor facility or site for unrestricted use.” This request is the subject of this notice.
The NRC is requesting public comments on the ZNPS partial site release. The NRC will conduct a public meeting to discuss the partial site release and receive comments on Tuesday, December 1, 2015, from 7:00 p.m. until 8:30 p.m., Central Time, at the Courtyard Chicago Waukegan/Gurnee, located at 3800 Northpoint Boulevard, Waukegan, IL 60085. For additional information regarding the meeting, see the NRC's Public Meeting Schedule Web site at
For the Nuclear Regulatory Commission.
November 23, 30, December 7, 14, 21, 28, 2015.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of November 23, 2015.
9:30 a.m. Briefing on Equal Employment Opportunity and Civil Rights Outreach (Public Meeting) (Contact: Larniece McKoy Moore: 301-415-1942).
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of December 7, 2015.
9:00 a.m. Hearing on Construction Permit for SHINE Medical Isotope Production Facility: Section 189a. of the Atomic Energy Act Proceeding (Public Meeting) (Contact: Steven Lynch: 301-415-1524).
This meeting will be webcast live at the Web address—
9:30 a.m. Briefing on Project AIM 2020 (Public Meeting) (Contact: John Jolicoeur 301-415-1642).
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of December 21, 2015.
There are no meetings scheduled for the week of December 28, 2015.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Nuclear Regulatory Commission.
Biweekly notice.
Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from October 27, 2015, to November 9, 2015. The last biweekly notice was published on November 10, 2015.
Comments must be filed by December 24, 2015. A request for a hearing must be filed January 25, 2016.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lynn M. Ronewicz, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1927, email:
Please refer to Docket ID NRC-2015-0261 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0261, facility name, unit number(s), application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of Title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
A State, local governmental body, federally-recognized Indian tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by December 28, 2015. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions for leave to intervene set forth in this section, except that under § 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. A State, local governmental body, Federally-recognized Indian tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by January 25, 2016.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment does not represent any physical change to plant systems, structures, or components (SSC), or to procedures established for plant operation. The proposed amendment would not increase the likelihood of a malfunction of any plant SSC. Therefore, initial conditions associated with, and systems credited for mitigating the consequences of accidents previously evaluated remain unchanged.
Therefore, the proposed amendment does not involve a significant increase in the probability or the consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any previously evaluated?
Response: No.
The proposed amendment does not involve a physical alteration of the plant. No new or different types of equipment will be installed and there are no physical modifications to existing equipment associated with the proposed amendment. Similarly, the proposed amendment would not physically change any plant systems, structures, or components involved in the mitigation or any postulated accidents. Thus, no new initiators or precursors of a new or different kind of accident are created. Furthermore, the proposed amendment does not create the possibility of a new failure mode associated with any equipment or personnel failures.
Therefore, the proposed amendment would not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed amendment does not represent any physical change to plant systems, structures, or components, or to procedures established for plant operation. The proposed amendment does not affect the inputs or assumptions of any of the design basis analyses and current design limits will continue to be met. The proposed amendment does not alter or create a new mode of plant operation or configuration. Margins of safety are not significantly reduced.
Therefore, operation of the facility in accordance with the proposed change to TS 5.6.3 does not involve a significant reduction in the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
No physical changes to the facility will occur as a result of this proposed amendment. The proposed change will not alter the physical design. The current TS SR note could make Fermi 2 susceptible to potential water hammer in the RHR system if a subsystem is operating in the shutdown cooling mode of RHR in Mode 3 and is required to swap from the shutdown cooling to LPCI [low pressure coolant injection] mode of RHR. The proposed LAR will eliminate the risk for cavitation of the pump and voiding in the suction piping, thereby avoiding potential to damage the RHR system, including water hammer.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change does not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant. Accordingly, the change does not introduce any new accident initiators, nor does it reduce or adversely affect the capabilities of any plant structure, system, or component to perform their safety function. Deletion of the TS SR note is appropriate because current TS could put the plant at risk for potential cavitation of the pump and voiding in the suction piping, resulting in potential occurrence of water hammer and damage the RHR system.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed change conforms to NRC regulatory guidance regarding the content of plant technical specifications. The proposed change does not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed TS changes add flexibility in the selection of fuel rod cladding materials for use at CNS and MNS. The proposed change of adding a cladding material does not result in an increase to the probability or consequences of an accident previously evaluated. TS 4.2.1 addresses the fuel assembly design, and currently specifies that “Each assembly shall consist of a matrix of either ZIRLO® or Zircaloy fuel rods . . .”. The proposed change will add Optimized ZIRLO
The NRC has previously approved use of Optimized ZIRLO
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed TS changes add flexibility in the selection of fuel rod cladding materials for use at CNS and MNS. Optimized ZIRLO
3. Does the proposed change involve a significant reduction in the margin of safety?
Response: No.
The proposed change will not involve a significant reduction in the margin of safety because it has been demonstrated that the material properties of the Optimized ZIRLO
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change will not result in any significant increase in the probability or consequences of an accident previously evaluated. The auxiliary feedwater system mitigates the consequences of any event with a loss of normal feedwater. By prohibiting a plant maneuver when there are no operable auxiliary feedwater pumps, the plant will not be placed into a less safe condition where the probability could be increased, consequences could be exacerbated, or different consequences could result for an accident previously evaluated.
The proposed enhancements and administrative changes are modifications to existing actions that have no potential to impact the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change does not involve physical modification of the plant. No new or different type of equipment will be installed. The proposed change will require prompt action to restore at least one auxiliary feedwater pump to operable status when all three are inoperable. Restricting a power maneuver until at least one auxiliary feedwater pump has been restored to operable status will preclude entry into a less safe condition with no auxiliary feedwater available for accident mitigation. This change will not have an adverse effect on equipment required for accident mitigation.
The proposed enhancements and administrative changes are modifications to existing actions that have no potential to impact equipment required for accident mitigation.
3. Does the proposed change involve a significant reduction in a margin of safety?
The proposed change does not involve a significant reduction in a margin of safety. No plant equipment or accident analyses will be affected. Additionally, the proposed change will not relax any criteria used to establish safety limits, safety system settings, or the bases for any limiting conditions for operation. Safety analysis acceptance criteria are not affected. Plant operation will continue within the design basis.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change allows a change to certain required end states when the Technical Specification (TS) Completion Times (CTs) for remaining in power operation are exceeded. Most of the requested TS changes are to permit an end state of hot shutdown (Mode 4) rather than an end state of cold shutdown (Mode 5) contained in the current TS. The request was limited to: (1) Those end states where entry into the shutdown mode is for a short interval, (2) entry is initiated by inoperability of a single train of equipment or a restriction on a plant operational parameter, unless otherwise stated in the applicable TS, and (3) the primary purpose is to correct the initiating condition and return to power operation a [as] soon as is practical. Risk insights from both the qualitative and quantitative risk assessments were used in specific TS assessments. Such assessments are documented in Section 5.5 of CE NIPSD-1186, Rev 0, “Technical Justification for the Risk-Informed Modification to Selected Required Action End States for CEOG [Combustion Engineering Owners Group] Member PWRs [Pressurized Water Reactors].” They provide an integrated discussion of deterministic and probabilistic issues, focusing on specific TSs, which are used to support the proposed TS end state and associated restrictions. Therefore, the probability of an accident previously evaluated is not significantly increased, if at all. The consequences of an accident after adopting proposed TSTF-422 are no different
Therefore, this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Allowing a change to certain required end states when the TS CTs for remaining in power operation are exceeded,
Therefore, this change does not create the possibility of a new or different kind of accident from an accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change allows, for some systems, entry into hot shutdown rather than cold shutdown to repair equipment, if risk is assessed and managed. The CEOG's [Combustion Engineering Owners Group] risk assessment approach is comprehensive and follows NRC staff guidance as documented in Regulatory Guides (RGs) 1.174 and 1.177. In addition, the analyses show that the criteria of the three-tiered approach for allowing TS changes are met. The risk impact of the proposed TS changes was assessed following the three-tiered approach recommended in RG 1.177. A risk assessment was performed to justify the proposed TS changes. The net change to the margin of safety is insignificant.
Therefore, this change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change to the Updated Safety Analysis Report (USAR) allows the use of the methodology from ANSI/ANS-58.14-2011,
The USAR accident analyses assume the proper functioning of systems in demonstrating the adequacy of the plant's design. The methodology of ANSI/ANS-58.14-2011 is intended to assure equipment is classified correctly and in accordance with the CLB. This change, therefore, does not change the intended function of any plant equipment nor does this change affect or increase the probability of equipment malfunction which could increase the probability or consequences of an accident previously evaluated in the USAR.
The proposed change does not degrade the performance of a system assumed to function in the accident analyses. Also, this change does not increase the challenges to safety systems assumed to function in the accident analysis such that safety system performance is degraded below the design basis without compensating effects.
FCS is licensed to the requirements of 10 CFR 50.67 and 10 CFR 20. These licensed limits are maintained by radiological barrier performance which is unaffected by this change. Hence, there will be no change in radiological barrier performance that would increase the dose to on-site personnel (10 CFR 20) or the public at the site boundary (10 CFR 100.11/10 CFR 50.67).
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated in the USAR.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed amendment allows the use of the NRC approved methodology of ANSI/ANS-58.14-2011 to facilitate proper equipment classification. This standard will be used to confirm that equipment has been properly classified in accordance with the FCS Current Licensing Basis. This approach will not introduce any methods or analytical techniques that could create the possibility of a new or different kind of accident. Application of a classification methodology does not create an accident.
No new unanalyzed interactions between systems or components will be created by the application of ANSI/ANS-58.14-2011. The proposed change does not create a new failure mechanism or new accident initiator. The proposed amendment does not involve a change in methods governing the operation of the plant systems or components.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated in the USAR.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
This proposed amendment revises the CLB to allow the use of ANSI/ANS-58.14-2011 for equipment classification. The proposed change will not modify, change, revise or otherwise affect any current calculations concerning the plant accident analysis or supporting basis for which the Technical Specifications, Technical Specification Bases or USAR safety margins were established. The proposed amendment is consistent with regulatory guidance.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change places the numerical volume of diesel fuel oil and lube oil required to support seven-day operation of the onsite DGs [diesel generators], and the numerical volume equivalent to a six-day supply, in the TS Bases under licensee control. The required volumes of fuel oil equivalent to a seven-day and six-day supply is calculated considering the DG manufacturer's fuel oil consumption rates and worst DG loading resulting from a loss of offsite power coincident with a design basis accident. The numerical volume of lube oil equivalent to a seven-day and six-day supply is based on the DG manufacturer's consumption values for the run time of the DG. The requirement to meet Updated Safety Analysis Report (USAR) diesel loading assumptions, maintain a seven-day supply, and the actions taken when the volume of fuel oil available is less than a seven-day or a six-day supply have not changed. These requirements remain consistent with the assumptions in the accident analyses, and neither the probability nor the consequences of any accident previously evaluated will be affected by the proposed change.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The change does not involve a physical alteration of the plant (
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change places the numerical volume of diesel fuel oil and lubricating oil required to support 7-day operation of an onsite diesel generator, and the numerical volume equivalent to a 6-day supply, in the TS Bases under licensee control. As the basis for the existing limits on diesel fuel oil, and lubricating oil are unchanged, no change is made to the accident analysis assumptions and no margin of safety is reduced as a result of this change.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change provides a short Completion Time to restore an inoperable system for conditions under which the existing Technical Specifications require a plant shutdown to begin within one hour in accordance with Limiting Condition for Operation (LCO) 2.0.1. Entering into Technical Specification Actions is not an initiator of any accident previously evaluated. As a result, the probability of an accident previously evaluated is not significantly increased. The consequences of any accident previously evaluated that may occur during the proposed Completion Times are no different from the consequences of the same accident during the existing one hour allowance. As a result, the consequences of any accident previously evaluated are not significantly increased.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
No new or different accidents result from utilizing the proposed change. The changes do not involve a physical alteration of the plant (
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed change increase[s] the time the plant may operate without the ability to perform an assumed safety function. The analyses in [Westinghouse Electric Company LLC technical report] WCAP-16125-NP-A, “Justification for Risk-Informed Modifications to Selected Technical Specifications for Conditions Leading to Exigent [P]lant Shutdown,” Revision 2, August 2010 [(ADAMS Accession No. ML110070500)], demonstrated that there is an acceptably small increase in risk due to a limited period of continued operation in these conditions and that this risk is balanced by avoiding the risks associated with a plant shutdown. As a result, the change to the margin of safety provided by requiring a plant shutdown within one hour is not significant.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of any accident previously evaluated?
Response: No.
This amendment proposes to increase the post-accident drawdown time for the secondary containment from its current value of 120 seconds, to 10 minutes. No physical modifications are proposed for any system, structure, or component (SSC) designed for the prevention of previously analyzed events. Neither does this amendment request change the operation or maintenance of any of those SSCs; accordingly the amendment does not involve a significant increase in the probability of occurrence of a previously evaluated event.
The increase in the drawdown time does not result in a significant increase in the consequences of a previously analyzed accident because the offsite doses, the main control room dose, and the technical support center dose do not significantly increase. As described in the Technical Evaluation section of this amendment request, the off-site doses for the Low Population Zone (LPZ) and the Exclusion Area Boundary (EAB) increase from 0.75 and 0.34 Rem [Total Effective Dose Equivalent (TEDE)] to 1.10 and 0.61 Rem TEDE, respectively. However, this is still well within the 10 CFR 50.67 limits of 25 Rem for the LPZ and EAB. Regarding the [main control room (MCR)], the increase in drawdown time has very little effect on dose to the MCR operators. Since the HNP MCR is located within the turbine building, MCR doses are due primarily to [main steam isolation valve (MSIV)] leakage which goes to the main condenser and subsequently leaks into the turbine building. Finally, the dose to the [Technical Support Center (TSC)] decreased from 3.9 Rem TEDE to 3.1 Rem TEDE. This is due to the reduction in the assumed unfiltered in-leakage to the TSC. Currently, 10,000 cfm is assumed for the TSC leakage. The new calculation assumed a more realistic value of 1000 cfm.
Therefore, the change in the drawdown time does not represent a significant increase in the consequences of a previously analyzed event.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any previously evaluated?
Response: No.
This Technical Specifications revision request increases the allowed time given the [Standby Gas Treatment System (SGTS)] to drawdown the secondary containment to 0.20 inches of water vacuum from 120 seconds to 10 minutes. No physical modifications are being made to the secondary containment system or to the SGTS as a result of this Tech Spec amendment request. Additionally, other than the increase in the allowed drawdown time to 10 minutes, no changes are being made to the function or operation of the secondary containment. Therefore, its design function of containing fission products released after design basis accidents, such as [loss of coolant accident] LOCA, remains unchanged. Likewise, no changes are being proposed to the function or operation of the SGTS. It remains capable of adequately accomplishing its design function of processing the post accident atmosphere in the secondary containment.
Since no new modes of operation are created, no new accident initiators are created by this amendment request.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
Margins are applied at several levels with respect to the secondary containment safety function and to other functions intended to reduce off-site and on-site dose consequences. One is the control room unfiltered in-leakage rate, which is reduced from 115 cfm to 39 cfm for this analysis. However, results for the last MCR in-leakage test were actually far below 39 cfm. In fact, the in-leakage rate tests for the pressurization mode of the Main Control Room Environmental Control system, performed in April of 2015, indicated rates between 8 and 12 scfm, roughly one third of the assumed in-leakage value. Therefore, although the margin was reduced, a significant amount of margin remains. In-leakage to the Technical Support Center was assumed at 1000 cfm for this calculation. Currently, 10,000 cfm is the assumed in-leakage. Therefore margin is reduced with respect to this parameter. However, 10,000 cfm is an extremely high, unrealistic value. The 1000 cfm in-leakage assumed for this calculation is a reasonable and justifiable value, in fact equal to twice the filtered intake rate. The MSIV leakage rate is assumed at the TS value of 100 scfh, unchanged from the current analysis. As mentioned in the Technical Evaluation section of this submittal, the Volume Correction Factor (VCF) which is a parameter representing control room dose immersion, is assumed at 0.47 as opposed to the current evaluation which assumes a VCF of 0.50. The actual number is, in fact, 0.47, but was previously rounded up conservatively. Therefore, this margin is being eliminated in the current calculation. However, this does not represent a significant reduction in the margin of safety because margin exists in other areas, namely the Control Room in-leakage, TSC in-leakage, and Main Steam Isolation Valve leakage, as discussed above. As described in the Technical Evaluation portion of this submittal, the margins to the 10 CFR 50.67 main control room and offsite dose limits are not significantly reduced. The total MCR doses are virtually unchanged. The off-site doses do increase, but the resultant doses are still a small fraction (< 5%) of the regulatory limit of 25 Rem to the Low Population Zone and 25 Rem to the Exclusion Area Boundary. The doses to the TSC actually decrease from those of the current analysis; the decrease is due to the reduced in-leakage assumption, as previously mentioned.
For all the reasons provided above, this amendment does not represent a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The [Virgil C. Summer Nuclear Station] VCSNS Units 2 and 3 emergency planning inspections, tests, analyses, and acceptance criteria (ITAAC) provide assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations. The proposed changes to remove the copies of [Design Control Document] DCD Table 7.5-1 and [Final Safety Analysis Report] FSAR Table 7.5-201 from Appendix C of the VCSNS Units 2 and 3 [combined license] COLs do not affect the design of a system, structure, or component (SSC) used to meet the design bases of the nuclear plant. Nor do the changes affect the construction or operation of the nuclear plant itself, so there is no change to the probability or consequences of an accident previously evaluated. Removing the copies of the tables from Appendix C of the COLs does not affect prevention and mitigation of abnormal events (
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The VCSNS Units 2 and 3 emergency planning ITAAC provide assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations. The changes do not affect the design of an SSC used to meet the design bases of the nuclear plant, nor do the changes affect the construction or operation of the nuclear plant. Consequently, there is no new or different kind of accident from any accident previously evaluated. The changes do not affect safety-related equipment, nor do they affect equipment which, if it failed, could initiate an accident or a failure of a fission product barrier. In addition, the changes do not result in a new failure mode, malfunction or sequence of events that could affect safety or safety-related equipment.
No analysis is adversely affected. No system or design function or equipment qualification is adversely affected by the changes. This activity will not allow for a new fission product release path, result in a new fission product barrier failure mode, nor create a new sequence of events that would result in significant fuel cladding failures.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The VCSNS Units 2 and 3 emergency planning ITAAC provide assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations. The changes do not affect the assessments or the plant itself. The changes do not adversely interface with safety-related equipment or fission product barriers. No safety analysis, design basis limit or acceptance criterion are challenged or exceeded by the proposed change.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change revises or adds Surveillance Requirement(s) (SRs) that require verification that the Emergency Core Cooling System (ECCS), the Reactor Cooling System (RCS), Residual Heat Removal (RHR) and Reactor Building (RB) Spray System are not rendered inoperable due to accumulated gas and to provide allowances which permit performance of the revised verification. Gas accumulation in the subject systems is not an initiator of any accident previously evaluated. As a result, the probability of any accident previously evaluated is not significantly increased. The proposed SRs ensure that the subject systems continue to be capable to perform their assumed safety function and are not rendered inoperable due to gas accumulation. Thus, the consequences of any accident previously evaluated are not significantly increased.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change revises or adds SRs that require verification that the ECCS, RCS, RHR and RB Spray System are not rendered inoperable due to accumulated gas and to provide allowances which permit performance of the revised verification. The proposed change does not involve a physical alteration of the plant (
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change revises or adds SRs that require verification that the ECCS, RCS, RHR and RB Spray System are not rendered inoperable due to accumulated gas and to provide allowances which permit performance of the revised verification. The proposed change adds new requirements to manage gas accumulation in order to ensure the subject systems are capable of performing their assumed safety functions. The proposed SRs are more comprehensive than the current SRs and will ensure that the assumptions of the safety analysis are protected. The proposed change does not adversely affect any current plant safety margins or the reliability of the equipment assumed in the safety analysis. Therefore, there are no changes being made to any safety analysis assumptions, safety limits or limiting safety system settings that would adversely affect plant safety as a result of the proposed change.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes to the Technical Specifications regarding the Shift Supervisor to Shift Manager title are administrative changes. It has no impact on accident initiators or plant equipment and thus does not affect the probability or consequences of an accident.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change does not involve a change to the design of the physical plant or operations. This is an administrative title change that does not contribute to accident initiation. Therefore, it does not produce a new accident scenario or produce a new type of equipment malfunction.
2. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
Since the change is administrative and changes no previously evaluated accidents or creates no possibility for any new unevaluated accidents to occur, there is no reduction in the margin of safety. This change also does not affect plant equipment or operation and therefore does not affect safety limits or limiting safety systems settings.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
Performing [an] SR that tests the DG is not a precursor of any accident previously evaluated. These changes only affect surveillance testing of mitigative equipment and, therefore, do not have an impact on the probability of an accident previously evaluated.
Relaxing the requirement to maintain PF when paralleled to offsite power does not affect performance of the DG under accident conditions. The performance of the surveillances ensures that mitigative equipment is capable of performing its intended function.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
No new accident scenarios, failure mechanisms, or limiting single failures are introduced as a result of the proposed changes. The systems, structures, and components previously required for the mitigation of a transient remain capable of fulfilling their intended design functions. The proposed changes have no adverse effects on a safety-related system or component and do not challenge the performance or integrity of safety related systems. As such, it does not introduce a mechanism for initiating a new or different accident than those described in the Updated Safety Analysis Report.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed changes do not involve a significant reduction in a margin of safety. The margin of safety is related to the ability of the fission product barriers to perform their design safety functions during and
In addition, the proposed changes involve no changes to safety setpoints or limits established or assumed by the accident analysis. On this and the above basis, no safety margins will be impacted.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commissions related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 29, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated May 29, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 28, 2015.
The Commission's related evaluation of the amendment is contained in a safety evaluation dated November 2, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 9, 2015.
This license amendment request was submitted by PPL Susquehanna, LLC; however, on June 1, 2015, the NRC staff issued an amendment changing the name on the SSES license from PPL Susquehanna, LLC to Susquehanna Nuclear, LLC (ADAMS Accession No. ML15054A066). These amendments were issued subsequent to an order issued on April 10, 2015, to SSES, approving an indirect license transfer of the SSES license to Talen Energy Corporation (ADAMS Accession No. ML15058A073).
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated November 2, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 28, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 28, 2015.
No significant hazards consideration comments received: No.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recently-filed Postal Service notice announcing plans to implement five temporary promotions and associated classification changes. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On November 16, 2015, the Postal Service filed a notice, pursuant to 39 U.S.C. 3622 and 39 CFR part 3010, of plans to implement five temporary promotions and associated classification changes.
The Postal Service's filing consists of a Notice, which the Postal Service
The Postal Service seeks approval for the following five promotions for the periods indicated:
• Emerging and Advanced Technology/Video in Print Promotion (March-August 2016);
• Tactile, Sensory, and Interactive Mailpiece Engagement Promotion (March-August 2016);
• Earned Value Reply Mail Promotion (April-June 2016);
• Mobile Shopping Promotion (July-December 2016); and
• Personalized Color Transpromo Promotion (July-December 2016).
The Postal Service states that its price cap calculation reflects the expiration of the CY 2015 First-Class Mail and Standard Mail promotions and the renewal of those promotions in CY 2016. Notice at 6. The Postal Service asserts that there is no change in the unused price adjustment authority because the Notice is limited to continuing the promotions offered in 2015.
In its Notice, the Postal Service provides a calculation of its new overall price adjustment authority for First-Class Mail and Standard Mail. Combining the unused price adjustment authority with the inflation-based price adjustment authority, the Postal Service calculates that there will be 0.074 percent in unused pricing authority available for First-Class Mail and 0.104 percent available for Standard Mail.
The Postal Service asserts the five temporary promotions do not affect workshare discounts.
1. The Commission establishes Docket No. R2016-2 to consider the planned temporary promotions for market dominant postal products and related classification changes identified in the Postal Service's Notice filed November 16, 2015.
2. Comments on the planned temporary promotions and related classification changes are due no later than December 7, 2015.
3. Pursuant to 39 U.S.C. 505, Elisabeth S. Shellan is appointed to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
4. The Commission directs the Secretary to arrange for prompt publication of this notice in the
By the Commission.
The Presidio Trust.
Notice of public meeting of Presidio Institute Advisory Council.
Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given that a public meeting of the Presidio Institute Advisory Council (Council) will be held from 3:00 p.m. to 4:30 p.m. on Monday, December 14, 2015. The meeting is open to the public, and oral public comment will be received at the meeting. The Council was formed to advise the Executive Director of the Presidio Trust (Trust) on matters pertaining to the rehabilitation and reuse of Fort Winfield Scott as a new national center focused on service and leadership development.
The Trust's Executive Director, in consultation with the Chair of the Board of Directors, has determined that the Council is in the public interest and supports the Trust in performing its duties and responsibilities under the Presidio Trust Act, 16 U.S.C. 460bb appendix.
The Council advises on the establishment of a new national center (Presidio Institute) focused on service and leadership development, with specific emphasis on: (a) Assessing the role and key opportunities of a national center dedicated to service and leadership at Fort Scott in the Presidio of San Francisco; (b) providing recommendations related to the Presidio Institute's programmatic goals, target audiences, content, implementation and evaluation; (c) providing guidance on a phased development approach that leverages a combination of funding sources including philanthropy; and (d)
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange filed a proposal to adopt a new rule to clearly prohibit disruptive quoting and trading activity on the Exchange, as further described below. Further, the Exchange proposes to amend Exchange Rules to permit the Exchange to take prompt action to suspend Members or their clients that violate such rule. This Amendment No. 1 to SR-BATS-2015-101 amends and replaces the original proposal in its entirety.
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange is filing this proposal to adopt a new rule to clearly prohibit disruptive quoting and trading activity on the Exchange and to amend Exchange Rules to permit the Exchange to take prompt action to suspend Members or their clients that violate such rule. The Exchange notes, as further described below, that it previously filed this proposal as File No. SR-BATS-2015-57 and Amendment No. 1 thereto (the “Initial Proposal”). The Exchange received comments on the Initial Proposal and simultaneously with this filing both responded to such comments
As a national securities exchange registered pursuant to Section 6 of the Act, the Exchange is required to be organized and to have the capacity to enforce compliance by its members and persons associated with its members, with the Act, the rules and regulations thereunder, and the Exchange's Rules.
The process described above, from the identification of disruptive and potentially manipulative or improper quoting and trading activity to a final resolution of the matter, can often take several years. The Exchange believes that this time period is generally necessary and appropriate to afford the subject Member adequate due process, particularly in complex cases. However, as described below, the Exchange believes that there are certain obvious and uncomplicated cases of disruptive and manipulative behavior or cases where the potential harm to investors is so large that the Exchange should have the authority to initiate an expedited suspension proceeding in order to stop the behavior from continuing on the Exchange.
In recent years, several cases have been brought and resolved by the Exchange and other SROs that involved allegations of wide-spread market manipulation, much of which was ultimately being conducted by foreign persons and entities using relatively rudimentary technology to access the markets and over which the Exchange and other SROs had no direct jurisdiction. In each case, the conduct involved a pattern of disruptive quoting and trading activity indicative of manipulative layering
The following two examples are instructive on the Exchange's rationale for the proposed rule change.
In July 2012, Biremis Corp. (formerly Swift Trade Securities USA, Inc.) (the “Firm”) and its CEO were barred from the industry for, among other things, supervisory violations related to a failure by the Firm to detect and prevent disruptive and allegedly manipulative trading activities, including layering, short sale violations, and anti-money laundering violations.
In September of 2012, Hold Brothers On-Line Investment Services, Inc. (the “Firm”) settled a regulatory action in connection with the Firm's provision of a trading platform, trade software and trade execution, support and clearing services for day traders.
The Exchange also notes the current criminal proceedings that have commenced against Navinder Singh Sarao. Mr. Sarao's allegedly manipulative trading activity, which included forms of layering and spoofing in the futures markets, has been linked as a contributing factor to the “Flash Crash” of 2010, and yet continued through 2015.
The Exchange believes that the activities described in the cases above provide justification for the proposed rule change, which is described below.
The Exchange proposes to adopt new Rule 8.17 to set forth procedures for issuing suspension orders, immediately prohibiting a Member from conducting continued disruptive quoting and trading activity on the Exchange. Importantly, these procedures would also provide the Exchange the authority to order a Member to cease and desist from providing access to the Exchange to a client of the Member that is conducting disruptive quoting and trading activity in violation of proposed Rule 12.15.
Under proposed paragraph (a) of Rule 8.17, with the prior written authorization of the Chief Regulatory Officer (“CRO”) or such other senior officers as the CRO may designate, the Office of General Counsel or Regulatory Department of the Exchange (such departments generally referred to as the “Exchange” for purposes of proposed Rule 8.17) may initiate an expedited suspension proceeding with respect to alleged violations of Rule 12.15, which is proposed as part of this filing and described in detail below. Proposed paragraph (a) would also set forth the requirements for notice and service of such notice pursuant to the Rule, including the required method of service and the content of notice.
Proposed paragraph (b) of Rule 8.17 would govern the appointment of a Hearing Panel as well as potential disqualification or recusal of Hearing Officers. The proposed provision is consistent with existing Exchange Rule 8.6 and includes the requirement for a Hearing Officer to be recused in the event he or she has a conflict of interest or bias or other circumstances exist where his or her fairness might reasonably be questioned. In addition to recusal initiated by such a Hearing Officer, a party to the proceeding will be permitted to file a motion to disqualify a Hearing Officer. However, due to the compressed schedule pursuant to which the process would operate under Rule 8.17, the proposed rule would require such motion to be filed no later than 5 days after the announcement of the Hearing Panel and the Exchange's brief in opposition to such motion would be required to be filed no later than 5 days after service thereof. Pursuant to existing Rule 8.6(b), if the Hearing Panel believes the Respondent has provided satisfactory evidence in support of the motion to disqualify, the applicable Hearing Officer shall remove himself or herself and request the Chief Executive Officer to reassign the hearing to another Hearing Officer such that the Hearing Panel still meets the compositional requirements described in Rule 8.6(a). If the Hearing Panel determines that the Respondent's grounds for disqualification are insufficient, it shall deny the Respondent's motion for disqualification by setting forth the reasons for the denial in writing and the Hearing Panel will proceed with the hearing.
Under paragraph (c) of the proposed Rule, the hearing would be held not later than 15 days after service of the notice initiating the suspension proceeding, unless otherwise extended by the Chairman of the Hearing Panel with the consent of the Parties for good cause shown. In the event of a recusal or disqualification of a Hearing Officer, the hearing shall be held not later than five days after a replacement Hearing Officer is appointed. Proposed paragraph (c) would also govern how the hearing is conducted, including the authority of Hearing Officers, witnesses, additional information that may be required by the Hearing Panel, the requirement that a transcript of the proceeding be created and details related to such transcript, and details regarding the creation and maintenance of the record of the proceeding. Proposed paragraph (c) would also state that if a Respondent fails to appear at a hearing for which it has notice, the allegations in the notice and accompanying declaration may be deemed admitted, and the Hearing Panel may issue a suspension order without further proceedings. Finally, as proposed, if the Exchange fails to appear at a hearing for which it has notice, the Hearing Panel may order that the suspension proceeding be dismissed.
Under paragraph (d) of the proposed Rule, the Hearing Panel would be authorized to issue a written decision stating whether a suspension order would be imposed. The Hearing Panel would be required to issue the decision not later than 10 days after receipt of the hearing transcript, unless otherwise extended by the Chairman of the Hearing Panel with the consent of the Parties for good cause shown. The Rule would state that a suspension order shall be imposed if the Hearing Panel finds by a preponderance of the evidence that the alleged violation specified in the notice has occurred and that the violative conduct or continuation thereof is likely to result in significant market disruption or other significant harm to investors.
Proposed paragraph (d) would also describe the content, scope and form of a suspension order. As proposed, a suspension order shall be limited to ordering a Respondent to cease and desist from violating proposed Rule 12.15, and/or to ordering a Respondent to cease and desist from providing access to the Exchange to a client of Respondent that is causing violations of Rule 12.15. Under the proposed rule, a suspension order shall also set forth the alleged violation and the significant market disruption or other significant harm to investors that is likely to result without the issuance of an order. The order shall describe in reasonable detail the act or acts the Respondent is to take or refrain from taking, and suspend such Respondent unless and until such action is taken or refrained from. Finally, the order shall include the date and hour of its issuance. As proposed, a suspension order would remain effective and enforceable unless modified, set aside, limited, or revoked pursuant to proposed paragraph (e), as described below. Finally, paragraph (d) would require service of the Hearing Panel's decision and any suspension order consistent with other portions of the proposed rule related to service.
Proposed paragraph (e) of Rule 8.17 would state that at any time after the Office of Hearing Officers served the Respondent with a suspension order, a Party could apply to the Hearing Panel to have the order modified, set aside, limited, or revoked. If any part of a suspension order is modified, set aside, limited, or revoked, proposed paragraph (e) of Rule 8.17 provides the Hearing Panel discretion to leave the cease and desist part of the order in place. For example, if a suspension order suspends Respondent unless and until Respondent ceases and desists providing access to the Exchange to a client of Respondent, and after the order is entered the Respondent complies, the Hearing Panel is permitted to modify the order to lift the suspension portion of the order while keeping in place the cease and desist portion of the order. With its broad modification powers, the Hearing Panel also maintains the discretion to impose conditions upon the removal of a suspension—for example, the Hearing Panel could modify an order to lift the suspension portion of the order in the event a Respondent complies with the cease and desist portion of the order but additionally order that the suspension will be re-imposed if Respondent violates the cease and desist provisions modified order in the future. The Hearing Panel generally would be required to respond to the request in writing within 10 days after receipt of the request. An application to modify, set aside, limit or revoke a suspension
Finally, proposed paragraph (f) would provide that sanctions issued under the proposed Rule 8.17 would constitute final and immediately effective disciplinary sanctions imposed by the Exchange, and that the right to have any action under the Rule reviewed by the Commission would be governed by Section 19 of the Act. The filing of an application for review would not stay the effectiveness of a suspension order unless the Commission otherwise ordered.
The Exchange currently has authority to prohibit and take action against manipulative trading activity, including disruptive quoting and trading activity, pursuant to its general market manipulation rules, including Rule 3.1. The Exchange proposes to adopt new Rule 12.15, which would more specifically define and prohibit disruptive quoting and trading activity on the Exchange. As noted above, the Exchange also proposes to apply the proposed suspension rules to proposed Rule 12.15.
Proposed Rule 12.15 would prohibit Members from engaging in or facilitating disruptive quoting and trading activity on the Exchange, as described in proposed Interpretation and Policies .01 and .02 of the Rule, including acting in concert with other persons to effect such activity. The Exchange believes that it is necessary to extend the prohibition to situations when persons are acting in concert to avoid a potential loophole where disruptive quoting and trading activity is simply split between several brokers or customers.
To provide proper context for the situations in which the Exchange proposes to utilize its proposed authority, the Exchange believes it is necessary to describe the types of disruptive quoting and trading activity that would cause the Exchange to use its authority. Accordingly, the Exchange proposes to adopt Interpretation and Policy .01 and .02, providing additional details regarding disruptive quoting and trading activity. Proposed Interpretation and Policy .01(a), which describes disruptive quoting and trading activity containing many of the elements indicative of layering, would describe disruptive quoting and trading activity as a frequent pattern in which the following facts are present: (a) A party enters multiple limit orders on one side of the market at various price levels (the “Displayed Orders”); and (b) following the entry of the Displayed Orders, the level of supply and demand for the security changes; and (c) the party enters one or more orders on the opposite side of the market of the Displayed Orders (the “Contra-Side Orders”) that are subsequently executed; and (d) following the execution of the Contra-Side Orders, the party cancels the Displayed Orders. Proposed Interpretation and Policy .01(b), which describes disruptive quoting and trading activity containing many of the elements indicative of spoofing, would describe disruptive quoting and trading activity as a frequent pattern in which the following facts are present: (a) A party narrows the spread for a security by placing an order inside the national best bid or offer; and (b) the party then submits an order on the opposite side of the market that executes against another market participant that joined the new inside market established by the order described in (a) that narrowed the spread. The Exchange believes that the proposed descriptions of disruptive quoting and trading activity articulated in the rule are consistent with the activities that have been identified and described in the client access cases described above. The Exchange further believes that the proposed descriptions will provide Members with clear descriptions of disruptive quoting and trading activity that will help them to avoid engaging in such activities or allowing their clients to engage in such activities.
The Exchange proposes to make clear in Interpretation and Policy .02 that, unless otherwise indicated, the descriptions of disruptive quoting and trading activity do not require the facts to occur in a specific order in order for the rule to apply. For instance, with respect to the pattern defined in proposed Interpretation and Policy .01(a) it is of no consequence whether a party first enters Displayed Orders and then Contra-side Orders or vice-versa. However, as proposed, it is required for supply and demand to change following the entry of the Displayed Orders. The Exchange also proposes to make clear that disruptive quoting and trading activity includes a pattern or practice in which some portion of the disruptive quoting and trading activity is conducted on the Exchange and the other portions of the disruptive quoting and trading activity are conducted on one or more other exchanges. The Exchange believes that this authority is necessary to address market participants who would otherwise seek to avoid the prohibitions of the proposed Rule by spreading their activity amongst various execution venues.
In sum, proposed Rule 12.15 coupled with proposed Rule 8.17 would provide the Exchange with authority to promptly act to prevent disruptive quoting and trading activity from continuing on the Exchange. Below is an example of how the proposed rule would operate.
Assume that through its surveillance program, Exchange staff identifies a pattern of potentially disruptive quoting and trading activity. After an initial investigation the Exchange would then contact the Member responsible for the orders that caused the activity to request an explanation of the activity as well as any additional relevant information, including the source of the activity. If the Exchange were to continue to see the same pattern from the same Member and the source of the activity is the same or has been previously identified as a frequent source of disruptive quoting and trading activity then the Exchange could initiate an expedited suspension proceeding by serving notice on the Member that would include details regarding the alleged violations as well as the proposed sanction. In such a case the proposed sanction would likely be to order the Member to cease and desist providing access to the Exchange to the client that is responsible for the disruptive quoting and trading activity and to suspend such Member unless and until such action is taken. The Member would have the opportunity to be heard in front of a Hearing Panel at a hearing to be conducted within 15 days of the notice. If the Hearing Panel determined that the violation alleged in the notice did not occur or that the conduct or its continuation would not have the potential to result in significant market disruption or other significant harm to investors, then the Hearing Panel would dismiss the suspension order proceeding. If the Hearing Panel determined that the violation alleged in the notice did occur and that the conduct or its continuation is likely to result in significant market disruption or other significant harm to investors, then the Hearing Panel would issue the order including the proposed sanction, ordering the Member to cease providing access to the client at issue and suspending such Member unless and until such action is taken. If such Member wished for the suspension to be lifted because the client ultimately responsible for the activity no longer would be provided access to the Exchange, then such Member could apply to the Hearing Panel to have the order modified, set aside, limited or
The Exchange reiterates that it already has broad authority to take action against a Member in the event that such Member is engaging in or facilitating disruptive or manipulative trading activity on the Exchange. For the reasons described above, and in light of recent cases like the client access cases described above, as well as other cases currently under investigation, the Exchange believes that it is equally important for the Exchange to have the authority to promptly initiate expedited suspension proceedings against any Member who has demonstrated a clear pattern or practice of disruptive quoting and trading activity, as described above, and to take action including ordering such Member to terminate access to the Exchange to one or more of such Member's clients if such clients are responsible for the activity. The Exchange recognizes that its proposed authority to issue a suspension order is a powerful measure that should be used very cautiously. Consequently, the proposed rules have been designed to ensure that the proceedings are used to address only the most clear and serious types of disruptive quoting and trading activity and that the interests of Respondents are protected. For example, to ensure that proceedings are used appropriately and that the decision to initiate a proceeding is made only at the highest staff levels, the proposed rules require the CRO or another senior officer of the Exchange to issue written authorization before the Exchange can institute an expedited suspension proceeding. In addition, the Exchange believes that it would use this authority in limited circumstances, when necessary to protect investors, other Members and the Exchange. Further, the Exchange believes that the proposed expedited suspension provisions described above that provide the opportunity to respond as well as a Hearing Panel determination prior to taking action will ensure that the Exchange would not utilize its authority in the absence of a clear pattern or practice of disruptive quoting and trading activity.
The Exchange believes that the proposed rule changes are consistent with Section 6(b) of the Act
Further, the Exchange believes that the proposal is consistent with Sections 6(b)(1) and 6(b)(6) of the Act,
The Exchange further believes that the proposal is consistent with Section 6(b)(7) of the Act,
The Exchange does not believe that the proposed rule changes will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that each self-regulatory organization should be empowered to regulate trading occurring on their market consistent with the Act and without regard to competitive issues. The Exchange is requesting authority to take appropriate action if necessary for the protection of investors, other Members and the Exchange.
As explained above, a similar proposal was filed by the Exchange as File No. SR-BATS-2015-57 and Amendment No. 1 thereto. The Exchange received five comments in response to the Initial Proposal and responded to such comments in the BATS Comment Response Letter.
Within 45 days of the date of publication of this notice in the
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal, as modified by Amendment No. 1, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On October 30, 2015, the International Securities Exchange, LLC (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On November 13, 2015, the Exchange withdrew the proposed rule change (SR-ISE-2015-36).
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On September 22, 2015, Chicago Board Options Exchange, Incorporated (“Exchange” or “CBOE”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
CBOE proposes to amend its rules related to margin requirements. Rule 12.3 sets forth margin requirements, and certain exceptions to those requirements, applicable to security positions of Trading Permit Holders' customers. Rule 12.3(c)(5)(C)(2) currently requires no margin for covered calls and puts. Specifically, that rule provides the following:
• No margin need be required in respect of an option contract, stock index warrant, currency index warrant or currency warrant carried in a short position which is covered by a long position in equivalent units of the
• An underlying stock basket
• No margin is required in respect of a call option on a Standard and Poor's 500 (S&P 500) market index carried in a short position where there is carried for the same account a long position in an underlying open-end index mutual fund (which will be specifically designated by the Exchange) having an aggregate market value at least equal to the underlying value of the S&P 500 contracts to be covered.
According to CBOE, the proposed rule change makes some nonsubstantive changes to Rule 12.3(c)(5)(C)(2). CBOE represents, the proposed rule change letters the provisions listed in the first two bulleted paragraphs above to become subparagraphs (2)(a) and (b) and moves part of the provision in the first bulleted paragraph to proposed subparagraph (2)(c) (as discussed below, the proposed rule change deletes the third bulleted paragraph above). CBOE further represents, the proposed rule change revises the language to be consistent throughout these provisions, including clarifying that the underlying security or one of the other permissible offsets must be carried in the same account as the option position. CBOE notes, the proposed rule change also makes the language more plain English, eliminates repetitive language, and inserts a missing space in proposed subparagraph (b).
CBOE states, the proposed rule change adds circumstances in which covered calls and puts require no margin. According to CBOE, the proposed rule change applies the provision in proposed subparagraph (b) to index mutual funds, index portfolio receipts (“IPRs”),
CBOE states that index ETFs and mutual funds function in a similar manner to underlying stock baskets, as they are intended to replicate the performance of their underlying market indexes. CBOE believes, the types and diversity of products available on the market that track indexes continues to increase and provide additional investment and hedging opportunities. CBOE also believes while an ETF or mutual fund may not meet the definition of an underlying stock basket (for example, some ETFs have a sampling of the securities that comprise the underlying index), it essentially has the same purpose as an underlying stock basket for investors. Therefore, CBOE represents, it closely tracks an underlying index, and thus can function as an offsetting position to an index option overlying the same index in the same way as an underlying stock basket.
According to CBOE, the Board of Governors of the Federal Reserve System (“FRB”) previously indicated that no margin would be required if an index option (on a broad-based stock index with at least a 99% correlation with the S&P 500 index) is covered by an offsetting position in S&P Index Depositary Receipts (SPDRS), but rather such SPDR positions would be treated as cover in accordance with Section 220.5(c)(3) of Regulation T.
The Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
Finally, the Commission believes the non-substantive technical changes will benefit investors by offering more clarity with respect to the margin rules by providing for more consistent and plain English language in the rule.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On October 30, 2015, ISE Gemini, LLC (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On November 13, 2015, the Exchange withdrew the proposed rule change
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The purpose of the proposed rule change is to expand on the Exchange's past representations made in SR-C2-2015-024
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of this filing is to correct certain statements in SR-C2-2015-024.
Notably, within the Purpose section of SR-C2-2015-024, the Exchange incorrectly stated that “[t]he Regulatory Element of these Continuing Education Programs [(
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. This filing relates generally to CE requirements required of all Permit Holders. In addition, the filing is merely a clarification of a previous filing already submitted by the Exchange. Accordingly, the Exchange does not believe that the proposed rule change will impose any burden on competition in the marketplace.
The Exchange neither solicited nor received written comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of filing.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
CBOE proposes to update the status of CBOE's administration of license agreements for Livevol X (“LVX”).
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On August 7, 2015, CBOE Livevol, LLC (formerly CBOE IV, LLC) (“CBOE Livevol”) completed its acquisition of certain technology assets from the entity formerly known as Livevol, Inc. (“Livevol”), including LVX, a front-end order entry and management tool. CBOE had previously submitted a rule filing that, among other things, described the functionality of LVX and proposed applicable fees, which would become operative upon closing of the acquisition of assets from Livevol.
CBOE has made significant progress over the last three months in the complicated process of integrating the acquired Livevol business into CBOE's business and is in the process of distributing its form license agreement to LVX users. However, as LVX has
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed rule change does not discriminate among market participants, as CBOE continues to make LVX available to all market participants in the same manner, and use of LVX continues to be completely voluntary. The LVX functionality available to users remains the same. All LVX users pay the same fees for use of the product, which are set forth in the CBOE Fees Schedule. CBOE expects to license the applications to market participants pursuant to the same contractual terms and conditions set forth in the form license agreement once all LVX users have executed the form agreement. This rule filing has no impact on LVX customers' use of LVX; they may continue to use LVX in the same manner. It merely extends the time by which CBOE expects to complete the process of receiving executed versions of the form agreement from all LVX users. The Exchange notes that this rule filing does not amend the Exchange's rules, fees or systems.
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. This rule filing does not amend the Exchange's rules, fees or systems. CBOE continues to make LVX available to all market participants in the same manner, and use of LVX continues to be completely voluntary. The LVX functionality available to users remains the same. All LVX users currently pay the same fees for LVX as set forth in the CBOE Fees Schedule. CBOE expects to license the applications to market participants pursuant to the same contractual terms and conditions set forth in the form license agreement once all LVX users have executed the form agreement. This rule filing has no impact on LVX customers' use of LVX; they may continue to use LVX in the same manner. It merely extends the time by which CBOE expects to complete the process of receiving executed versions of the form agreement from all LVX users. Market participants continue to have the flexibility to use any order entry and management technology they choose, including LVX.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 30, 2015, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange currently lists and trades shares (“Shares”) of the CurrencyShares® Euro Trust (“Euro Trust” or “FXE”) and the CurrencyShares® Japanese Yen Trust (“Yen Trust” or “FXY,” and together with the Euro Trust, collectively, “Trusts”) under NYSE Arca Equities Rule 8.202.
FXE and FXY hold euros and Japanese yen, respectively, and issue Shares in baskets (“Baskets”) of 50,000 Shares in exchange for deposits of euros or yen, respectively. Each Trust redeems Baskets of Shares and distributes euros or yen, respectively. The Shares of FXE and FXY represent units of fractional undivided beneficial interests in the assets held by the relevant Trust. The investment objective of each Trust is for the Trust's shares to reflect the price in U.S. dollars (“USD”) of the foreign currency held by the Trust, plus accrued interest and minus the expenses and liabilities of such Trust. According to the Exchange, the Shares are intended to provide institutional and retail investors with economic exposure to a particular foreign currency so that they can, for example, hedge foreign currency risk in other portfolio assets or hedge against USD fluctuations more generally.
The Exchange represents that, as sponsor of the Trusts, Guggenheim Specialized Products, LLC (“Guggenheim” or “Sponsor”) receives a management fee that is intended to compensate Guggenheim for its service as Sponsor and to cover certain Trust expenses. The management fee is paid monthly out of a Trust's assets and is calculated as a percentage of the currency held by each Trust. Guggenheim's fee accrues daily at an annual nominal rate of 0.40% of the foreign currency held by the trust.
According to the Exchange, because the accrued but unpaid management fee is subtracted from the assets in calculating each fund's net asset value (“NAV”) on a daily basis,
Like other equity securities, Shares may be loaned by shareholders to other market participants. This securities lending activity can facilitate short selling of Shares, as well as other investment strategies.
According to the Exchange, the Sponsor claims to have identified a strategy (“Strategy”) that permits certain market participants (“Traders”) to profit from the reduction in the NAV of the Shares over time associated with Management Fee Decay, to the purported detriment of the value of the Shares held by shareholders who do not engage in the Strategy. Pursuant to the Strategy, a Trader borrows Shares and then either (1) sells the borrowed Shares, taking a short position in the Shares, or (2) redeems the borrowed Shares for euros or yen, as applicable.
According to the Exchange, the number of units of foreign currency
According to the Exchange, the following two examples—one in which the Trader sells the borrowed Shares short, and the other in which the Trader redeems the borrowed Shares—explain how the Strategy functions.
Before the trade, there are 100 euros in the Euro Trust for each outstanding Share. Assuming a USD/euro exchange rate of $1.10, FXE would be trading at $110 per Share. A Trader borrows 50,000 Shares of FXE and sells them for $5.5 million to obtain a short position of 50,000 Shares. At the same time, to hedge the short exposure to euros, the Trader obtains a long position in euros by entering into a forward contract to purchase in one year 4.98 million euros for $5.478 million. The Trader holds these positions for a year, by which time the FXE has predictably decayed by the 40 basis point management fee, regardless of the change in the USD/euro exchange rate.
Payment of the management fee by the Trust results in the sale of euros, causing the number of euros per Share to fall from 100 euros for each Share to 99.6 euros for each Share. As a result, the Trader can now create 50,000 Shares by depositing only 4.98 million euros, which the Trader can purchase for $5.478 million, and return the borrowed Shares. The $20,000 difference in cost to create 50,000 Shares one year after selling short 50,000 Shares for $5.5 million is profit. The Trader's transaction costs would be the cost of the forward contract, commissions, and any fees charged by the lender.
Before the trade, there are 100 euros in the Euro Trust for each outstanding Share. Assuming a USD/euro exchange rate of $1.10, FXE would be trading at $110 per Share. A Trader borrows 50,000 Shares of FXE and redeems them in exchange for 5 million euros. The Trader uses the proceeds of the redemption as collateral for the stock borrow. The Trader holds this position for a year. Regardless of whether the USD/euro exchange rate rises or falls, the amount of euros per Share held by the Trust will fall because of the Management Fee Decay.
When the Trader redeemed the Shares, there were one hundred euros in the Euro Trust for each outstanding Share. During the year, the Euro Trust has had to sell euros to pay management fees, and therefore there are now only 99.6 euros per outstanding Share in the Euro Trust. As a result, the Trader will only have to deposit 4.98 million euros to create 50,000 Shares of FXE. The 20,000 euros difference between the 5 million euros received from redeeming 50,000 Shares and the 4.98 million euros cost to create 50,000 Shares one year later is the Trader's profit. The Trader's transaction costs would be commissions and any fees charged by the lender.
According to the Exchange, shareholders who do not lend their Shares to Traders subsidize the Strategy employed by the lenders and Traders. The long holder of Shares agrees to pay a management fee for exposure to the underlying currency. When a shareholder lends its Shares, it retains the benefit of exposure to the euros or yen in a Trust. However, according to the Exchange, a Trader that borrows the Shares and redeems or sells its borrowed Shares deprives a Trust of the assets against which the management fee is assessed. The lender retains a long position in the Shares even though the assets reflecting its long position are no longer in a Trust and thus do not bear a proportional cost of managing the assets in a Trust. In this way, according to the Exchange, lenders and Traders that engage in the Strategy are subsidized by long holders of the Shares that do not lend their Shares.
The Exchange represents that the Sponsor continues to bear the cost of providing shareholder services to shareholders that lend Shares to Traders, even though, because Traders sell or redeem these borrowed Shares, there are no assets associated with these borrowed Shares against which a management fee is assessed to support these services. Long holders of Shares that do not lend to Traders are, according to the Exchange, bearing the costs associated with lenders' long positions in Shares that Traders redeem or sell. Through the loan arrangement, the Exchange alleges, the lender and Trader share the economics of the predictable fall in the value of the Shares due to the Management Fee Decay. Long holders of Shares that do not lend their Shares are subsidizing this Strategy through their assets against which the management fee is assessed.
According to the Exchange, this Strategy is not available with asset classes other than exchange-traded products because shares of operating companies do not charge management fees or provide investors with the ability to redeem their shares in exchange for the underlying assets. Thus, shares of a company do not have a decay that is extrinsic to the value of the company or a structure that provides the ability for the holder of a short interest to perfectly hedge its short position.
According to the Exchange, the Strategy discussed above is detrimental to liquidity in the Shares. The Exchange asserts that, because of the large outstanding short positions in the Shares, it is difficult to borrow Shares, particularly for market participants that are not Authorized Participants
The Exchange has filed this proposed rule change to reflect a proposed fee (“ETF Loan Fee”) to be imposed on securities lending and repurchase transactions with respect to the Shares. The Sponsor would receive the proceeds of the ETF Loan Fee, minus an amount equal to 20 percent of the fee, which would be paid to Precidian Investments, LLC (“Precidian” or “Loan Fee Administrator”). Precidian has in turn engaged BNY Mellon to act as “Loan Fee Collection Agent” on its behalf. The Loan Fee Collection Agent would be paid by Precidian and would not further reduce the proceeds paid to the Sponsor. According to the Exchange, Guggenheim would use the net proceeds from the ETF Loan Fee to offset management fees otherwise payable to it by the Trusts or to pay other Trust-related expenses.
According to the Exchange, the Sponsor believes, and has advised the Trustee, that it is in the best interest of the Beneficial Owners to impose an “ETF Loan Fee.”
The procedures proposed by the Trusts would prohibit any shareholder from lending any Shares to another person (“Loan Transaction”), or selling any Shares to another person subject to an agreement to repurchase Shares (“Repurchase Transaction” and, together with a Loan Transaction, collectively, “Permissible Stock Loan”), unless the shareholder notifies the custodian or its designee of the transaction on or prior to the inception of the Permissible Stock Loan. A shareholder engaging in a Permissible Stock Loan (“Loaning Shareholder”) also would be required to notify the custodian or its designee of the termination of the Permissible Stock Loan on or prior to the termination of such transaction. For the pendency of the Permissible Stock Loan, the Loaning Shareholder would be obligated to pay the custodian the ETF Loan Fee with respect to that transaction. For these Loan Transactions, the ETF Loan Fee would accrue from the effective date of the ETF Loan Fee until the Loan Transaction is terminated.
Upon the ETF Loan Fee Effective Date, holders of Shares would be prohibited from lending Shares or selling Shares subject to an agreement to repurchase, without notifying the Loan Fee Collection Agent
According to the Exchange, the ETF Loan Fee is expected to equal Guggenheim's management fee on a per Share basis.
According to the Exchange, once the ETF Loan Fee Collection Agent is notified of a transaction subject to the ETF Loan Fee, it would convey such information to Precidian, which would accrue the ETF Loan Fee on a daily basis and report it to each Trust. On a monthly basis, Precidian or its agent would bill Depository Trust & Clearing Corporation participants based on their loan transactions or the loan transactions of their clients and distribute the net ETF Loan Fee to Guggenheim.
The Exchange represents that, because the proposed ETF Loan Fee is equal to the annual management fee, the proposed ETF Loan Fee should not affect the market in the Shares, including market makers' ability to arbitrage. According to the Exchange, if, for example, FXE Shares are trading at a premium to euros, an arbitrageur, in an attempt to profit from the difference between the price of a euro and a Share of FXE, could sell FXE short, simultaneously buy euros, exchange euros for one or more Baskets of 50,000 FXE Shares, and then close out the short position with the Basket or Baskets of FXE Shares. To minimize market risk, an arbitrageur typically would not carry a position in to the next trading day. Thus, because the short position was closed out the same day, the arbitrageur would not incur the ETF Loan Fee. If FXE Shares are trading at a discount to euros, an arbitrageur could buy one or more Baskets of FXE Shares and simultaneously sell euros short, redeem the FXE Shares for euros at the end-of-day NAV, and close out the euro short position with the euros received on redemption. In this case, because the arbitrageur did not acquire a short position in FXE Shares, no ETF Loan Fee would be incurred. The Exchange also notes that market makers can create new Shares and redeem Shares if needed to facilitate market making activity.
The Exchange believes that the Strategy has had a negative impact on shareholders who do not lend their Shares because lenders of Shares maintain a long exposure to the Trust while profiting from a Strategy that eliminates the assets in trust against which a management fee is assessed. According to the Exchange, these lenders are freeriding on the
The Exchange represents that, as a consequence of the Strategy, the issuer cannot achieve economies of scale necessary to reduce management fees charged to shareholders, which are being paid only by those shareholders who do not lend their Shares. Assessing the ETF Loan Fee would have a positive impact on shareholders that do not lend their Shares because the ETF Loan Fees would be used to offset Trust expenses, bringing down the management fee.
The Exchange states that the ETF Loan Fee would eliminate the economic incentive for market participants to engage in the Strategy. Market participants could still sell FXE and FXY short, but the Traders who borrow those Shares would not be subsidized by those shareholders who do not lend their Shares. According to the Exchange, eliminating the economic distortion created by the Strategy would facilitate pricing of FXE and FXY on parity with the underlying asset (
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposal is consistent with Section 6(b)(5) or any other provision of the Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.
Interested persons are invited to submit written data, views, and arguments regarding whether the proposal should be approved or disapproved by December 15, 2015. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by December 29, 2015. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, which are set forth in the Notice,
1. In general, do commenters believe that the proposal is consistent with the requirements of Section 6 of the Act applicable to a national securities exchange, and in particular, Section 6(b)(5) of the Act, which requires that the rules of a national securities exchange be designed, among other things, to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest and Section 6(b)(8) of the Act, which requires that the rules of an exchange not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act?
2. According to the Exchange, “a Trader that borrows the Shares and redeems or sells its borrowed Shares deprives a Trust of the assets against which the management fee is assessed.”
3. The Exchange states: “Long holders of Shares that do not lend to Traders are bearing the costs associated with lenders' long position in Shares that Traders redeem or sell.” Do commenters agree with this assertion? What, if any, broader policy implications do commenters think this assertion raises?
4. According to the Exchange, the Strategy permits certain Traders to profit from the reduction in the NAV of the Shares over time associated with Management Fee Decay, to the detriment of the value of the Shares held by shareholders who do not engage in the Strategy. The Exchange further represents that, as a consequence of the Strategy, the issuer cannot achieve economies of scale necessary to reduce management fees charged to shareholders, which are being paid only by those shareholders who do not lend their Shares. Assessing the ETF Loan Fee would, the Exchange asserts, have a positive impact on shareholders that do not lend their Shares because the ETF Loan Fees would be used to offset Trust expenses, bringing down the management fee. Do commenters agree with the Exchange's assertions? What, if any, broader policy implications do commenters think these assertions raise?
5. The Exchange asserts that the Strategy discussed above is detrimental to liquidity in the Shares and that the Strategy potentially results wider spreads, harming all investors through higher costs to buy and sell Shares. Based on the trading history of the Shares, do commenters agree with the Exchange's assertions? Are these assertions by the Exchange consistent with the Exchange's statement elsewhere in the Notice that it “believes that imposition of the ETF Loan Fee would not materially impact trading of the Shares”?
6. The Exchange states that eliminating the economic distortion allegedly created by the Strategy would facilitate pricing of FXE and FXY on parity with the underlying asset (
7. Have commenters observed the Strategy being employed with respect to FXE or FXY, and if so, have commenters observed any deleterious effects of the Strategy?
8. The Exchange asserts that the Strategy is not available with asset classes other than exchange-traded products.
9. The Exchange states that the sponsor represents that, “because of large outstanding short positions in the shares . . . it is difficult to borrow shares, particularly for market participants that are not Authorized Participants that are seeking to engage in short selling for trading strategies other than the Strategy.”
10. What are the prevailing securities lending rates that commenters have observed for shares of FXE and FXY? Do commenters have a view regarding whether the Strategy is viable under these observed securities lending rates?
11. The Exchange states that, according to the sponsor, “the ETF Loan Fee is not expected to negatively affect short selling generally, but rather only affect certain types of short selling activities conducted by certain market participants (namely the Strategy) at the expense of long investors.”
12. The proposal would prohibit any holder of the Shares from lending its shares or from entering into an agreement to repurchase the shares unless the holder (a) self-reports to an agent of the sponsor of the Trusts and (b) remits a fee to that agent equal to the sponsor's management fee. What are commenters' views regarding the policy implications of permitting an issuer of securities to place such restrictions on the transfer of shares that it has issued in a public offering and that are listed and traded on a national securities exchange? In particular, are such restrictions consistent with Sections 6(b)(5) and 6(b)(8) of the Act? What are commenters' views on whether a fee based on self-reporting of lending or repurchase activity can be administered in a manner consistent with Section 6(b)(5) of the Act?
Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of an application under Section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from Section 15(a) of the Act and Rule 18f-2 under the Act, as well as from certain disclosure requirements in Rule 20a-1 under the Act, Item 19(a)(3) of Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-07(2)(a), (b), and (c) of Regulation S-X (“Disclosure Requirements”). The requested exemption would permit an investment adviser to hire and replace certain sub-advisers without shareholder approval and grant relief from the Disclosure Requirements as they relate to fees paid to the sub-advisers.
ETF Series Solutions (the “Trust”), a Delaware statutory trust registered under the Act as an open-end management investment company with multiple series, and U.S. Global Investors, Inc., a Texas corporation registered as an investment adviser under the Investment Advisers Act of 1940 (“the “Adviser,” and, collectively with the Trust, the “Applicants”).
The application was filed April 28, 2015, and amended on September 25, 2015.
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on December 14, 2015, and should be accompanied by proof of service on the applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: Susan B. McGee and James L. Love, U.S. Global Investors, Inc., 7900 Callaghan Road, San Antonio, TX 78229; and Michael D. Barolsky, ETF Series Solutions, 615 E. Michigan Street, Milwaukee, WI 53202.
Emerson S. Davis, Senior Counsel, at (202) 551-6868, or Daniele Marchesani, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at
1. The Adviser will serve as the investment adviser to the Funds pursuant to an investment advisory agreement with the Trust (the “Investment Management Agreement”).
2. Applicants request an exemption to permit the Adviser, subject to Board approval, to hire certain Sub-Advisers pursuant to Sub-Advisory Agreements and materially amend existing Sub-Advisory Agreements without obtaining the shareholder approval required under Section 15(a) of the Act and Rule 18f-2 under the Act.
3. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the Application. Such terms and conditions provide for, among other safeguards, appropriate disclosure to Fund shareholders and notification about sub-advisory changes and enhanced Board oversight to protect the interests of the Funds' shareholders.
4. Section 6(c) of the Act provides that the Commission may exempt any person, security, or transaction or any class or classes of persons, securities, or transactions from any provisions of the Act, or any rule thereunder, if such relief is necessary or appropriate in the public interest and consistent with the protection of investors and purposes fairly intended by the policy and provisions of the Act. Applicants believe that the requested relief meets this standard because, as further explained in the Application, the Advisory Agreements will remain subject to shareholder approval, while the role of the Sub-Advisers is substantially similar to that of individual portfolio managers, so that requiring shareholder approval of Sub-Advisory Agreements would impose unnecessary delays and expenses on the Funds. Applicants believe that the requested relief from the Disclosure Requirements meets this standard because it will improve the Adviser's ability to negotiate fees paid to the Sub-Advisers that are more advantageous for the Funds.
For the Commission, by the Division of Investment Management, under delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of California dated 11/17/2015.
Economic Injury (EIDL) Loan Application Deadline Date: 08/17/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth TX 76155.
A. Escobar, Office of Disaster Assistance,
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14541 B and for economic injury is 14542 0.
The States which received an EIDL Declaration # are California.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the objects covered under this notice, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice; correction.
On May 21, 2015, notice was published on pages 29379 and 29380 of the
For further information, including a list of the additional imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and
For further information, including a description of the imported object, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The FAA's B4UFLY smartphone app will provide situational awareness of flight restrictions—including locations of airports, restricted airspace, special use airspaces, and temporary flight restrictions—based on a user's current or planned flight location.
Written comments should be submitted by January 25, 2016.
Send comments to the FAA at the following address: Ronda Thompson, Room 441, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to reinstate a previously discontinued information collection. AC Form 8050-5 is an application for a dealer's Aircraft Registration Certificate which, under 49 United States Code 1404, may be issued to a person engaged in manufacturing, distributing, or selling aircraft.
Written comments should be submitted by January 25, 2016.
Send comments to the FAA at the following address: Ronda Thompson, Room 441, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration, DOT.
Notice.
The Federal Aviation Administration (FAA) announces its findings on the Noise Compatibility Program submitted by the Alaska Department of Transportation & Public Facilities (ADOT&PF) under the provisions of 49 U.S.C. (the Aviation Safety and Noise Abatement Act, hereinafter referred to as “the Act”) and 14 CFR Part 150. These findings are made in recognition of the description of Federal and nonfederal responsibilities in Senate Report No. 96-52 (1980). On July 27, 2015, the FAA determined that the noise exposure maps (NEM) submitted by the ADOT&PF under Part 150 were in compliance with applicable requirements. On November 17, 2015, the FAA approved the Ted Stevens Anchorage International Airport (ANC) and Lake Hood Seaplane Base (LHD) noise compatibility program (NCP). Most of the recommendations of the program were approved.
Leslie Grey, Federal Aviation Administration, Alaskan Region Airports Division, 222 W. 7th Avenue, Annex Building, Rm. A36, Anchorage, Alaska 99513, phone number: 907-271-5453. Documents reflecting this FAA action may be reviewed at this same location by appointment with the above contact.
This notice announces that the FAA has given its overall approval to the NCP for ANC and LHD effective November 17, 2015.
Under Section 47504 of the Act, an airport operator who has previously submitted a NEM may submit to the FAA a NCP which sets forth the measures taken or proposed by the airport operator for the reduction of existing non-compatible land uses and prevention of additional non-compatible land uses within the area covered by the NEM. The Act requires such programs to be developed in consultation with interested and affected parties including local communities, government agencies, airport users, and FAA personnel.
Each airport NCP developed in accordance with Title 14 Code of Federal Regulations (CFR) Part 150 is a local program, not a Federal Program. The FAA does not substitute its judgment for that of the airport operator with respect to which measures should be recommended for action. The FAA's approval or disapproval of each specific measure proposed by an airport sponsor in an Record of Approval (ROA) is determined by applying approval criteria prescribed in 14 CFR 150.35(b):
The Administrator approves programs under this part, if—
(1) It is found that the program measures to be implemented would not create an undue burden on interstate or foreign commerce (including any unjust discrimination) and are reasonably consistent with achieving the goals of reducing existing noncompatible land uses around the airport and of preventing the introduction of additional noncompatible land uses;
(2) The program provides for revision if made necessary by the revision of the noise map; and
(3) Those aspects of programs relating to the use of flight procedures for noise control can be implemented within the period covered by the program and without—
(i) Reducing the level of aviation safety provided;
(ii) Derogating the requisite level of protection for aircraft, their occupants and persons and property on the ground;
(iii) Adversely affecting the efficient use and management of the Navigable
(iv) Adversely affecting any other powers and responsibilities of the Administrator prescribed by law or any other program, standard, or requirement established in accordance with law.
Approval is not a determination concerning the acceptability of land uses under Federal, state, or local law. Approval does not by itself constitute an FAA implementing action. A request for Federal action or approval to implement specific noise compatibility measures may be required, and an FAA decision on the request may require an environmental assessment of the proposed action. Approval does not constitute a commitment by the FAA to financially assist in the implementation of the program nor a determination that all measures covered by the program are eligible for grant-in-aid funding from the FAA. Where Federal funding is sought, requests for project grants must be submitted to the FAA Airports District Office in Anchorage, AK.
ADOT&PF submitted to the FAA on December 19, 2014, the NEM, descriptions, and other documentation produced during the NCP planning study conducted from November 17, 2011 through December 19, 2014. The ANC and LHD NEMs were determined by FAA to be in compliance with applicable requirements on July 27, 2015. Notice of this determination was published in the Federal Register on July 31, 2015.
The ANC and LHD study contains a proposed NCP comprised of actions designed for phased implementation by airport management and adjacent jurisdictions from November 17, 2015 to the year 2020. It was requested that FAA evaluate and approve this material as a NCP as described in Section 47504 of the Act. The FAA began its review of the NCP on July 27, 2015, and was required by provisions of the Act to approve or disapprove the program within 180-days (other than the use of new or modified flight procedures for noise control). Failure to approve or disapprove such program within the 180-day period shall be deemed to be an approval of such program.
The submitted program contained fifteen (15) proposed actions for noise mitigation on and off the airport. The FAA completed its review and determined that the procedural and substantive requirements of the Act and 14 CFR Part 150 have been satisfied. The overall program, therefore, was approved by the FAA effective November 17, 2015.
Outright approval was granted for twelve (12) proposed actions on and/or off the airport. Two of the proposed measures in the NCP were disapproved for purposes of 14 CFR Part 150 because the measures benefit land uses with noise levels below the 65 DNL. Another measure was disapproved because it is eligible for funding as a terminal improvement per the AIP Handbook. However, these measures could be implemented by the Airport Sponsor on a voluntary basis.
These determinations are set forth in detail in a Record of Approval (ROA) signed by the FAA on November 17, 2015. The Record of Approval, as well as other evaluation materials and the documents comprising the submittal, are available for review at the FAA office listed above and at the administrative office of the ADOT&PF. The Record of Approval also will be available on-line at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. Title 49 U.S.C., section 44702 authorizes issuance of air carrier operating certificates. 14 CFR part 135 prescribes requirement for Air Carrier/Commercial Operators. The info collected shows compliance and applicant eligibility.
Written comments should be submitted by January 25, 2016.
Send comments to the FAA at the following address: Ronda Thompson, Room 441, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. 49 U.S.C. 44707 empowers the Administrator of the Federal Aviation Administration (FAA) to provide for the examination and rating of civilian schools giving instruction in flying. This CFR prescribes the requirements for issuing pilot school certificates, provisional pilot school certificates and associated ratings to qualified applicants.
Written comments should be submitted by January 25, 2016.
Send comments to the FAA at the following address: Ronda Thompson, Room 441, Federal Aviation Administration, ASP-110, 950 L'Enfant Plaza SW., Washington, DC 20024.
Ronda Thompson at (202) 267-1416, or by email at:
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requests (ICRs) abstracted below are being forwarded to the Office of Management and Budget (OMB) for review and comment. The ICRs describes the nature of the information collections and their expected burdens. The
Comments must be submitted on or before December 24, 2015.
Ms. Kimberly Toone, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-6132). (These telephone numbers are not toll-free.)
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, sec. 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On September 21, 2015, FRA published a 60-day notice in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30 day notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d);
Below is a brief summary of the information collection activities that FRA will submit for clearance by OMB as required under the PRA:
FRA administers award agreements for both construction and non-construction projects that will result in service benefits or other tangible improvements in rail corridors. These projects include completion of preliminary engineering, environmental research and development, final design, and construction.
To ensure accountability of Federal award recipients through performance and results, including expenditures in support of agreed-upon activities and allowable costs outlined in a FRA Notice of Grant Award (NGA), FRA requires systematic and uniform collection and submission of information, as approved by the OMB. Included in this information collection are reports and documentation mandated by OMB for completion, as well as additional resources to compile evidence relevant to addressing FRA's important policy challenges, promoting cost-effectiveness in FRA programs, and providing effective oversight of programmatic and financial performance. This justification draws on innovative FRA program designs to use sophisticated practices in delivering Federal financial assistance and encourage continuous improvements in service delivery.
FRA issues and manages awards in compliance with Title 2 of the Code of Federal Regulations (CFR): Grants and Agreements. This justification includes one document package for collection over the entire lifecycle of the award process, in adherence to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (78 FR 78589, Dec. 26, 2013; 79 FR 75871, Dec. 19, 2014). All non-research awards are subject to the application, reporting, closeout, and other processes described in this justification.
Additionally, the collection detailed in this justification represents a combination of previous FRA collection requests, including: OMB Control Number 2130-0578, OMB Control Number 2130-0580, OMB Control Number 2130-0584, and OMB Control Number 0587. Combining these collections under a new collection enables FRA to consolidate documentation under one collection, which allows for efficiency and provides a uniform period until expiration of this justification request.
Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520.
Alcohol and Tobacco Tax and Trade Bureau (TTB); Treasury.
Notice and request for comments.
As part of our continuing effort to reduce paperwork and respondent burden, and as required by the Paperwork Reduction Act of 1995, we invite comments on the proposed or continuing information collections listed below in this notice.
We must receive your written comments on or before January 25, 2016.
As described below, you may send comments on the information collections listed in this document using the “Regulations.gov” online comment form for this document, or you may send written comments via U.S. mail or hand delivery. TTB no longer accepts public comments via email or fax.
•
•
•
Please submit separate comments for each specific information collection listed in this document. You must reference the information collection's title, form or recordkeeping requirement number, and OMB number (if any) in your comment.
You may view copies of this document, the information collections listed in it and any associated instructions, and all comments received in response to this document within Docket No. TTB-2015-0001 at
Michael Hoover, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; telephone 202-453-1039, ext. 135; or email
The Department of the Treasury and its Alcohol and Tobacco Tax and Trade Bureau (TTB), as part of their continuing effort to reduce paperwork and respondent burden, invite the general public and other Federal agencies to comment on the proposed or continuing information collections listed below in this notice, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of the relevant information collection. All comments are part of the public record and subject to disclosure. Please do not include any confidential or inappropriate material in your comments.
We invite comments on: (a) Whether this information collection is necessary for the proper performance of the agency's functions, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the information collection's burden; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the information collection's burden on respondents, including through the use of automated
Currently, we are seeking comments on the following forms, recordkeeping requirements, or questionnaires:
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule implements a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. All related care within 90 days of hospital discharge from the joint replacement procedure will be included in the episode of care. We believe this model will further our goals in improving the efficiency and quality of care for Medicare beneficiaries with these common medical procedures.
These regulations are effective on January 15, 2016, and applicable on April 1, 2016 when the first model performance period begins.
Claire Schreiber,
Gabriel Scott,
This
Because of the many terms to which we refer by acronym, abbreviation, or short form in this final rule, we are listing the acronyms, abbreviations and short forms used and their corresponding terms in alphabetical order.
The purpose of this final rule is to implement a new payment model called the Comprehensive Care for Joint Replacement (CJR) model under the authority of the Center for Medicare and Medicaid Innovation (CMMI). Section 1115A of the Social Security Act (the Act) authorizes CMMI to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. The intent of the CJR model is to promote quality and financial accountability for episodes of care surrounding a lower-extremity joint replacement (LEJR) or reattachment of a lower extremity procedure.
We have previously used our statutory authority under section 1115A of the Act to test bundled payment models such as the Bundled Payments for Care Improvement (BPCI) initiative. Bundled payments, for multiple services in an episode of care, hold participating organizations financially accountable for an episode of care. They also allow participants to receive payment, in part, based on the reduction in expenditures for Medicare arising from their care redesign efforts.
We believe the CJR model will further the mission of CMMI and the Secretary's goal of increasingly paying for value rather than for volume,
The CJR model requires the participation of hospitals in multiple geographic areas that might not otherwise participate in the testing of bundled payments for episodes of care for LEJR procedures. Other episode-based, bundled payment models being tested by the Centers for Medicare & Medicaid Services (CMS), such as the BPCI initiative, are voluntary in nature. Interested participants must apply to such models to participate. To date, we have not tested an episode payment model with bundled payments in which providers are required to participate. We recognize that realizing the full potential of new payment models will require the engagement of an even broader set of providers than have participated to date, providers who may only be reached when new payment models are applied to an entire class of providers of a service. As such, we are interested in testing and evaluating the impact of a bundled payment approach for LEJR procedures in a variety of circumstances, especially among those hospitals that may not otherwise participate in such a test.
This model will allow CMS to gain experience with making bundled payments to hospitals who have a variety of historic utilization patterns; different roles within their local markets; various volumes of services; different levels of access to financial, community, or other resources; and various levels of population and health provider density including local variations in the availability and use of different categories of PAC providers. We believe that by requiring the participation of a large number of hospitals with diverse characteristics, the CJR model will result in a robust data set for evaluation of this bundled payment approach, and will stimulate the rapid development of new evidence-based knowledge. Testing the model in this manner will also allow us to learn more about patterns of inefficient utilization of health care services and how to incentivize the improvement of
This final rule implements a model focused on episodes of care for LEJR procedures. We chose LEJR episodes for the CJR model because as discussed in depth in section III.C. of this final rule, these are high-expenditure, high utilization procedures commonly furnished to Medicare beneficiaries,
The following is a summary of the comments received on the proposed model as a whole, including the authority for the model and general comments on CMS' implementation of the CJR model at this time and our responses.
We believe that both section 1115A and the Secretary's existing authority to operate the Medicare program authorize the CJR model as we have proposed and are finalizing it. Section 1115A of the Act authorizes the Secretary to test payment and service delivery models intended to reduce Medicare costs while preserving quality. The statute does not
Moreover, the Secretary has the authority to establish regulations to carry out the administration of Medicare. Specifically, the Secretary has authority under both sections 1102 and 1871 of the Act to implement regulations as necessary to administer Medicare, including testing this Medicare payment and service delivery model. We note that while CJR will be a model, and not a permanent feature of the Medicare program, the model will test different methods for delivering and paying for services covered under the Medicare program, which the Secretary has clear legal authority to regulate. The proposed rule went into great detail about the provisions of the proposed CJR model, enabling the public to fully understand how the proposed model was designed and could apply to affected providers. We acknowledge section 1115A(d)(2) of the Act, which states that there shall be no administrative or judicial review of, among other things, “the selection of organizations, sites, or participants to test . . . models selected,” as well as the commenter's concern that this provision would preclude a participant hospital from appealing its selection as a participant in the CJR model. However, it is precisely because the model will impose new requirements upon participant hospitals that we undertook notice and comment rulemaking to implement it.
In response to the comment indicating that we misread section 1115A(a)(5) of the Act, we believe that the commenter misunderstood the reference to that provision in the proposed rule. The reference to section 1115A(a)(5) of the Act was made in the context of the discussion of selecting certain MSAs within which we will test the model. We do not rely on section 1115A(a)(5) of the Act specifically as the authority for a model in which participation is not voluntary; rather, as noted previously, we rely on section 1115A of the Act as a whole, as well as the Secretary's existing authority to carry out her duties and administer the Medicare program.
We disagree with commenters that implementing the CJR model will negatively affect beneficiaries' appeal rights. We note that normal claims processes will continue under this model, including beneficiary and provider appeal rights. We also refer readers to section III.C.9. of this final rule for discussion of hospital appeals procedures under the CJR model.
With regard to the comment about CMS sidestepping safeguards designed to prevent imposing haphazard models prior to appropriate vetting and testing, we reiterate that we have undertaken rulemaking to solicit comprehensive public input on all aspects of the CJR model. In addition, as previously noted, the CJR model has been designed to limit selection bias, which will allow for more robust evaluation results across a variety of providers.
We note that this is a new model, not an expansion of an existing model. We disagree with the commenters who believe that we have reversed the order of testing and expansion of Innovation Center models. As permitted by section 1115A of the Act, we are testing the CJR model within specified limited geographic areas. The fact that the model will require the participation of certain hospitals does not mean it is not an initial model test. If the model is successful such that it meets the statutory requirements for expansion, and the Secretary determines that expansion is warranted, we would undertake rulemaking to implement the expansion, as required by section 1115A(c) of the Act.
In the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24414 through 24418), we solicited public comments regarding policy and operational issues related to a potential expansion of the BPCI initiative in the future. We explained that as we initiated discussions about potential expansion, we continued to value stakeholder
Although BPCI and the CJR model both include testing episode payment for LEJR episodes of care, CJR differs from BPCI in significant ways, as detailed throughout this final rule. Providers elected to participate in BPCI, and were given a choice of various design features, such as the clinical episodes included and the episode length. The CJR model was designed in part based on feedback and experience from BPCI, and will provide additional information on the impact of episode payment for LEJR episodes across a variety of hospitals, including those who may not have elected to participate in the model. As previously discussed in this section, it is necessary to require participation in the CJR model in order to avoid the selection bias inherent to any voluntary model. When the CJR model begins on April 1, 2016, we will be testing both episode payment models concurrently for a period of time, as well as many other payment and service delivery models, in order to gain information about the most successful strategies to improve the quality of care and reduce spending. The different design features of BPCI and the CJR model will aid us in evaluating the success of episode-based payment across a range of provider types and in a range of geographic areas. As evaluation results addressing the impact of each model on Medicare quality and cost become available, the Secretary will review this information to determine whether the findings from the evaluation of the model demonstrate that it meets all criteria for expansion, consistent with the requirements of section 1115A(c) of the Act, and that, based on these findings and other pertinent factors, expansion is warranted.
LEJR procedures are currently paid under the IPPS (IPPS) through one of two Medicare Severity-Diagnosis Related Groups (MS-DRGs): MS-DRG 469 (Major joint replacement or reattachment of lower extremity with Major Complications or Comorbidities (MCC)) or MS-DRG 470 (Major joint replacement or reattachment of lower extremity without MCC). Under the CJR model, as described further in section III.B of this final rule, episodes will begin with admission to an acute care hospital for an LEJR procedure that is assigned to MS-DRG 469 or 470 upon beneficiary discharge and paid under the IPPS and will end 90 days after the date of discharge from the acute care hospital. This episode of care definition offers operational simplicity for providers and CMS. The episode will include the LEJR procedure, inpatient stay, and all related care covered under Medicare Parts A and B within the 90 days after discharge, including hospital care, PAC, and physician services.
We have finalized that participant hospitals will be the episode initiators and bear financial risk under the CJR model. In comparison to other health care facilities, hospitals are more likely to have resources that will allow them to appropriately coordinate and manage care throughout the episode, and hospital staff members are already involved in hospital discharge planning and PAC recommendations for recovery, key dimensions of high quality and efficient care for the episode. We require all hospitals paid under the IPPS in selected geographic areas to participate in the CJR model, with limited exceptions. Eligible beneficiaries who elect to receive care at these hospitals will automatically be included in the model. We have selected geographic areas based on a stratified random sampling methodology within strata using the following criteria: historical wage adjusted episode payments and population size. Our geographic area selection process is detailed further in section III.A of this final rule.
We will test the CJR model for 5 performance years. We have finalized an alternative start date for the model from the timeline set forth in the proposed rule. As discussed in further detail in section III.C.2.a. of this final rule, the first performance year for the CJR model will begin on April 1, 2016 and end on December 31, 2016. During these performance years we will continue paying hospitals and other providers and suppliers according to the usual Medicare FFS payment systems. However, after the completion of a performance year, the Medicare claims payments for services furnished to the beneficiary during the episode, based on claims data, will be combined to calculate an actual episode payment. The actual episode payment is defined as the sum of related Medicare claims payments for items and services furnished to a beneficiary during a CJR episode. The actual episode payment will then be reconciled against an established CJR target price that is stratified based on the beneficiary's fracture status, with consideration of additional payment adjustments based on quality performance, post-episode spending, and policies to limit hospital financial responsibility. The amount of this calculation, if positive, will be paid to the participant hospital. This payment will be called a reconciliation payment. If negative, we will require repayment from the participant hospital. Medicare will require repayment of the difference between the actual episode payments and the CJR target price from a participant hospital if the CJR target price is exceeded.
We will make reconciliation payments to participant hospitals that achieve quality outcomes and cost efficiencies relative to the established CJR target prices in all performance years of the model. We will also phase in the requirement that participant hospitals whose actual episode payments exceed the applicable CJR target price pay the difference back to Medicare beginning in performance year 2. Under this final rule, Medicare will not require repayment from hospitals for performance year 1 for actual episode payments that exceed their target price in performance year 1.
We will also limit how much a hospital can gain or lose based on its actual episode payments relative to target prices. We have also put in place additional policies to further limit the risk of high payment cases for all participant hospitals and for special categories of participant hospitals as described in section III.C. of this final rule.
The CJR model is informed by other models and demonstrations currently and previously conducted by CMS and will explore additional ways to enhance coordination of care and improve the quality of services through bundled payments. We recently announced the Oncology Care Model (OCM), a new voluntary payment model for physician practices administering chemotherapy. Under OCM, practices will enter into payment arrangements that include financial and performance accountability for episodes of care surrounding chemotherapy administration to cancer patients. We plan to coordinate with other payers to align with OCM in order to facilitate enhanced services and care at participating practices. More information on the OCM can be found on CMMI's Web site at:
Under the authority of section 1866C of the Act, we conducted a 3-year demonstration, the ACE Demonstration. The demonstration used a prospective global payment for a single episode of care as an alternative approach to payment for service delivery under traditional Medicare FFS. The episode
We are currently testing the BPCI initiative. The BPCI initiative is comprised of four related payment models, which link payments for multiple services that Medicare beneficiaries receive during an episode of care into a bundled payment. Under the initiative, entities enter into payment arrangements with CMS that include financial and performance accountability for episodes of care. Episodes of care under the BPCI initiative begin with either—(1) An inpatient hospital stay; or (2) PAC services following a qualifying inpatient hospital stay. The BPCI initiative is evaluating the effects of episode-based payment approaches on patient experience of care, outcomes, and cost of care for Medicare FFS beneficiaries. Each of the four models tests LEJR episodes of care. While final evaluation results for the models within the BPCI initiative are not yet available, we believe that CMS' experiences with BPCI support the design of the CJR model. Under section 1115A(c) of the Act, the Secretary may, taking into consideration an evaluation conducted under section 1115A (b)(4) of the Act, “through rulemaking, expand (including implementation on a nationwide basis) the duration and the scope of a model that is being tested under” CMMI's authority. CJR is not an expansion of BPCI, and BPCI may be expanded in the future. We published a discussion item soliciting public comment on a potential future expansion of one or more of the models within BPCI in the FY2016 IPPS rule, 80 FR 24414 through 24418. CJR will not be an expansion or modification of BPCI; nor does it reflect comments received in response to the proposed rule for the 2016 IPPS Rule. CJR is a unique model that tests a broader, different group of hospitals than BPCI. It is necessary to provide CMS with information about testing bundled payments to hospitals that are required to participate in an APM. For a discussion of why we are requiring hospitals to participate in the CJR model, see section III.A. of this final rule.
The CJR model's design was informed to a large degree by our experience with BPCI Model 2. BPCI's Model 2 is a voluntary episode payment model in which a qualifying acute care hospitalization initiates a 30, 60 or 90 day episode of care. The episode of care includes the inpatient stay in an acute care hospital and all related services covered under Medicare Parts A and B during the episode, including PAC services. More information on BPCI Model 2 can be found on CMMI's Web site at:
Further information of why elements of the OCM, the ACE Demonstration, and BPCI Model 2 were incorporated into the design of the CJR model appears later in this final rule.
We are excluding from participation in CJR certain hospitals participating in the risk-bearing phase of BPCI Models 2 and 4 for LEJR episodes, as well as acute care hospitals participating in BPCI Model 1. We are not excluding beneficiaries in CJR model episodes from being included in other Innovation Center models or CMS programs, such as the Medicare Shared Savings Program (Shared Savings Program), as detailed later in this final rule. We will account for overlap, that is, where CJR beneficiaries are also included in other models and programs, to ensure the financial policies of CJR are maintained and results and spending reductions are attributed to the correct model or program.
We are adopting two hospital-level quality of care measures for the CJR model. Those measures include a complications measure and a patient experience survey measure. We will use these measures in the model pay-for-performance payment methodology, as well as to test the success of the model in achieving its goals under section 1115A of the Act and to monitor for beneficiary safety. We intend to publicly report this information on the
We will share data with participant hospitals upon request throughout the performance period of the CJR model to the extent permitted by the HIPAA Privacy Rule and other applicable law. We will share upon request both raw claims-level data and claims summary data with participants. This approach will allow participant hospitals without prior experience analyzing claims to use summary data to receive useful information, while allowing those participant hospitals who prefer raw claims-level data the opportunity to analyze claims. We will provide hospitals with up to 3 years of retrospective claims data upon request that will be used to develop their target price, as described in section III.C. of this final rule. In accordance with the HIPAA Privacy Rule, we will limit the content of this data set to the minimum data necessary for the participant hospital to conduct quality assessment and improvement activities and effectively coordinate care of its patient population.
Under the CJR model, beneficiaries retain the right to obtain health services from any individual or organization qualified to participate in the Medicare program. Under the CJR model, eligible beneficiaries who receive services from a participant hospital will not have the option to opt out of inclusion in the model. We require participant hospitals to supply beneficiaries with written information regarding the design and implications of this model as well as their rights under Medicare, including their right to use their provider of choice. We will also make a robust effort to reach out to beneficiaries and their advocates to help them understand the CJR model.
We also will use our existing authority, if necessary, to audit participant hospitals if claims analysis indicates an inappropriate change in delivered services. Beneficiary protections are discussed in greater depth in section III.E. of this final rule.
We will hold participant hospitals financially responsible for CJR LEJR episodes as participants in the model as discussed in section III.C.6. of this final
Several of the Medicare program policy waivers outline the conditions under which SNFs and physicians could furnish and bill for certain services furnished to CJR beneficiaries where current Medicare programs rules will not permit such billing. We draw the attention of SNFs and physicians to these waivers, which are included in section III.C.11.b.(5). of this final rule.
As shown in our impact analysis, we expect the CJR model to result in savings to Medicare of $343 million over the 5 performance years of the model. We note that a composite quality score will be calculated for each hospital in order to determine eligibility for a reconciliation payment and whether the hospital qualifies for quality incentive payments that will reduce the effective discount percentage experience by the hospital at reconciliation for a given performance year.
More specifically, in performance year 1 of the model, we estimate a Medicare cost of approximately $11 million, as hospitals will not be subject to downside risk in the first year of the model. As we introduce downside risk beginning in performance year 2 of the model, we estimate Medicare savings of approximately $36 million. In performance year 3 of the model, we estimate Medicare savings of $71 million. In performance years 4 and 5 of the model, we will move from target episode pricing that is based on a hospital's experience to target pricing based on regional experience, we estimate Medicare savings of $120 million and $127 million, respectively.
As a result, we estimate the net savings to Medicare to be $343 million over the 5 performance years of the model. We anticipate there will be a broader focus on care coordination and quality improvement for LEJR episodes among hospitals and other providers and suppliers within the Medicare program that will lead to both increased efficiency in the provision of care and improved quality of the care provided to beneficiaries.
We note that under section 1115A(b)(3)(B) of the Act, the Secretary is required to terminate or modify a model unless certain findings can be made with respect to savings and quality after the model has begun. If during the course of testing the model it is determined that termination or modification is necessary, such actions will be undertaken through rulemaking as necessary.
This final rule finalizes the implementation of a new innovative health care payment model under the authority of section 1115A of the Act. Under the model, called the CJR model, acute care hospitals in certain selected geographic areas will receive bundled payments for episodes of care where the diagnosis at discharge includes a lower extremity joint replacement (LEJR) or reattachment of a lower extremity that was furnished by the hospital. The bundled payment will be paid retrospectively through a reconciliation process; hospitals and other providers and suppliers will continue to submit claims and receive payment via the usual Medicare FFS payment systems. All related care covered under Medicare Part A and Part B within 90 days after the date of hospital discharge from the joint replacement procedure will be included in the episode of care. We believe this model will further our goals of improving the efficiency and quality of care for Medicare beneficiaries for these common medical procedures.
We have changed the acronym of this model to “CJR” and have updated all references in this rule and the regulations to reflect this change.
We received approximately 400 timely pieces of correspondence containing multiple comments on the CJR proposed rule. We note that some of these public comments were outside of the scope of the proposed rule. These out-of-scope public comments are mentioned but not addressed with the policy responses in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading.
The CJR model is different from BPCI because it would require participation of all hospitals (with limited exceptions) throughout selected geographic areas, which would result in a model that includes varying hospital types. However, a discussion of BPCI is relevant because its design informs and supports the proposed CJR model. The BPCI model is voluntary, and under that model we pay a bundled payment for an episode of care only to entities that have elected to participate in the model. We are interested in testing and evaluating the impact of an episode payment approach for LEJRs in a variety of other circumstances, including among those hospitals that have not chosen to voluntarily participate because we have not tested bundled payments for these hospitals previously. This would allow CMS and participants to gain experience testing and evaluating episode-based payment for LEJR procedures furnished by hospitals with a variety of historic utilization patterns; roles within their local markets; volume of services provided; access to financial, community, or other resources; and population and health care provider density. Most importantly, participation of hospitals in selected geographic areas will allow CMS to test bundled payments without introducing selection bias such as the selection bias inherent in the BPCI model due to self-selected participation.
Under the CJR model, as described further in section III.B. of this final rule, episodes will begin with admission to an acute care hospital for an LEJR procedure that is paid under the IPPS through Medical Severity Diagnosis-Related Group (MS-DRG) 469 (Major joint replacement or reattachment of lower extremity with MCC) or 470 (Major joint replacement or reattachment of lower extremity without MCC) and end 90 days after the date of discharge from the hospital. For the CJR model, we proposed that hospitals would be the only episode initiators. For purposes of CJR, the term “hospital” means a hospital as defined in section 1886(d)(1)(B) of the Act. This statutory definition of hospital includes only acute care hospitals paid under the IPPS. We proposed that all acute care hospitals in Maryland would be
The following is a summary of the comments received and our responses.
We proposed to designate IPPS hospitals as the episode initiators to ensure that all Medicare FFS LEJR services furnished by participant hospitals in selected geographic areas to beneficiaries who do not meet the exclusion criteria (specified in section III.B.3. and section III.C.7. of this final rule) are included in the CJR model. Given that our proposal that the LEJR episode begins with an admission to a hospital paid under the IPPS that results in a discharge assigned to MS-DRG 469 or 470, we further believed that utilizing the hospital as the episode initiator is a straightforward approach for this model because the hospital furnishes the LEJR procedure. In addition, we noted our interest in testing a broad model in a number of hospitals under the CJR model in order to examine results from a more generalized payment model. Thus, we believed it is important that, in a model where hospital participation is not voluntary, all Medicare FFS LEJR episodes that begin at the participant hospital in a selected geographic area should be included in the model for beneficiaries that do not meet the exclusion criteria specified in section III.B.3. of this final rule and are not LEJR BPCI episodes that we are excluding as outlined in this section and also in section III.C.7 of this final rule. This is best achieved if the hospital is the episode initiator. Finally, as described in the following sections that present our proposed approach to geographic area selection, this geographic area selection approach relies upon our definition of hospitals as the entities that initiate episodes. We sought comment on our proposal to define the episode initiator as the hospital under CJR. However, commenters generally commented on our proposal to define the episode initiator as the hospital in tandem with comments regarding the proposal that the hospital also be the entity financially responsible for the episode of care under CJR. As such, comments regarding the proposed
BPCI Model 2 participants that have entered into agreements with CMS to bear financial responsibility for an episode of care include acute care hospitals paid under the IPPS, health systems, physician-hospital organizations, physician group practices (PGPs), and non-provider business entities that act as conveners by coordinating multiple health care providers' participation in the model. Thus, our evaluation of BPCI Model 2 will yield information about how results for LEJR episodes may differ based on differences in which party bears financial responsibility for the episode of care. For the CJR model, we proposed to make hospitals financially responsible for the episode of care.
Although we proposed that hospitals would bear the financial responsibility for LEJR episodes of care under CJR, because there are LEJR episodes currently being tested in BPCI Model 1, 2, 3 or 4, we believed that participation in CJR should not be required if it would disrupt testing of LEJR episodes already underway in BPCI models. Therefore, we proposed certain exceptions for instances where IPPS hospitals located in an area selected for the model are active participant hospitals or episode initiators for LEJR episodes as of July 1, 2015, and exceptions for LEJR episodes initiated by other providers or suppliers under certain BPCI models.
The following is a summary of the comments received and our responses.
We considered requiring treating physicians (orthopedic surgeons or
Although the BPCI initiative allows a PGP and PAC providers to have financial responsibility for episodes of care, the physician groups and PAC providers electing to participate in BPCI have done so because their business structure supports care redesign and other infrastructure necessary to bear financial responsibility for episodes and is not necessarily representative of the typical group practice or PAC provider. Most of the PGPs in BPCI are not bearing financial responsibility, but are participating in BPCI as partners with convener organizations, which enter into agreements with CMS on behalf of health care providers, through which they accept financial responsibility for the episode of care. The PAC providers in BPCI are not at risk for episodes that include more than just the post-anchor hospital discharge period. The incentive to invest in the infrastructure necessary to accept financial responsibility for the entire CJR episode of care, starting at admission to an acute care hospital for an LEJR procedure that is paid under the IPPS MS-DRG 469 or 470 and ending 90 days after the date of discharge from the hospital, would not be present across all PGPs and PAC providers. Thus we do not believe it would be appropriate to designate PGPs or PAC providers to bear the financial responsibility for making repayments to CMS under the CJR model where participation is mandatory, rather than voluntary in nature, potentially causing this model to be less likely to succeed. We may consider, through future rulemaking, other episode of care models in which PGPs or PAC providers are financially responsible for the costs of care.
While we proposed that the participant hospital be financially responsible for the episode of care under CJR, we agreed that effective care redesign for LEJR episodes requires meaningful collaboration among acute care hospitals, PAC providers, physicians, and other providers and suppliers within communities to achieve the highest value care for Medicare beneficiaries. We believe it may be essential for key providers and suppliers to be aligned and engaged, financially and otherwise, with the hospitals, with the potential to share financial responsibility with those hospitals. As such, CJR participant hospitals may enter into relationships with other entities in order to manage the episode of care or distribute risk. We refer readers to section III.C.10 of this final rule for further discussion of financial arrangements between participant hospitals and other providers and suppliers. Depending on a hospital's current degree of clinical integration, new and different contractual relationships among hospitals and other health care providers and suppliers may be important, although not necessarily required, for CJR model success in a community. We acknowledge that financial incentives for other providers and suppliers may be important aspects of the model in order for hospitals to partner with these providers and suppliers and incentivize certain strategies to improve episode efficiency.
As noted in the proposed rule (80 FR 41261), in addition to providers and
We have multiple years of experience with several types of large voluntary episode payment models where we have successfully collaborated with participants on implementation of episode payment in a variety of settings for multiple clinical conditions. We believe the relatively narrow scope of the model (LEJR episodes only), the phasing in of full financial responsibility over multiple years of the model, and our plan to engage with hospitals to help them succeed under this model through the provision of claims data, will aid hospitals in succeeding under the CJR model. As discussed in section III.C.2. of this final rule, we are also finalizing that the model's first performance period will begin April 1, 2016, instead of on January 1, 2016 as originally proposed. The longer notice of the final model policies before implementation will provide hospitals with more time to prepare for participation by identifying care redesign opportunities, beginning to form financial and clinical partnerships with other providers and suppliers, and using data to assess financial opportunities under the model.
We acknowledge commenters' concern that some hospitals not in a selected MSA may desire to participate in the CJR model. We also note that CMS will continue to test voluntary bundled payment models, including those already undergoing testing through the BPCI initiative, which offered several open periods over the past few years where interested hospitals and other organizations could join. We expect that many providers will continue to engage in initiatives such as BPCI, and may also participate in other emerging models in the coming years. The coexistence of voluntary initiatives such as BPCI alongside new models in which providers are required to participate will provide CMS, providers, and beneficiaries with multiple opportunities to benefit from various care redesign and payment reform initiatives. We will also continue
We disagree that requiring participation in the CJR model could create confusion and competing incentives for hospitals already participating in voluntary initiatives. We note that simultaneous testing of multiple bundled payment models is appropriate in many situations, depending on the care targeted under each model. Section III.C.7. of this final rule lays out our policies for accounting for overlap between models and contains discussion of the potential synergies and improved care coordination we expect will ensue through allowing for hospitals and beneficiaries to be engaged in more than one initiative simultaneously.
We appreciate that not all hospitals will have contractual arrangements with providers and suppliers furnishing services to beneficiaries during LEJR episodes. However, this final rule lays out the various financial arrangements that will be permitted under the CJR model, to allow hospitals the opportunity to engage with other providers and suppliers and to form clinical and financial partnerships. Section III.C.10. of this final rule details the requirements for these financial arrangements. Although hospitals will not be required to form financial relationships with other providers and suppliers, we expect many will do so in order to help align the clinical and financial incentives of key providers and suppliers caring for CJR model beneficiaries.
Finally, we do not see how participation in the CJR model, in and of itself, would lead to beneficiary harm and that if beneficiary harm were to occur, that CMS would be responsible. First, and most importantly, we note that under the model, providers and suppliers are still required to provide all medically necessary services, and beneficiaries are entitled to all benefits that they would receive in the absence of the model. Second, we note that we have employed many payment systems, such as IPPS, and payment models, such as BPCI and ACOs, that include similar economic incentives to promote efficiency, and we have not determined that beneficiaries have been harmed by those systems and models. Third, we note that CMS has numerous tools and monitoring plans which are both specific to this model and common to all FFS Medicare. These include audits, monitoring of utilization and outcomes within the model, and the availability of Quality Improvement Organization (QIOs) and 1-800-MEDICARE for reporting beneficiary concerns, among other protections. The CJR model includes monitoring to ensure beneficiary access, choice, and quality of care is maintained under the model. We refer readers to section III.F. of this final rule for discussion of beneficiary protections and monitoring under the CJR model. The model pricing structure, discussed in III.C. of this final rule, also includes features to protect against such potential harm, such as responsibility for post-episode spending increases, stop-gain policies that set a maximum threshold a hospital can earn for savings achieved during episodes, and other policies as detailed in that section. In summary, we note that this payment model does not constrain the practice of medicine and we do not expect clinical decisions to be made on the basis of the payment amount.
In determining which hospitals to include in the CJR model, we considered whether the model should be limited to hospitals where a high volume of LEJRs are performed, which would result in a more narrow test on the effects of an episode-based payment, or whether to include all hospitals in particular geographic areas, which would result in testing the effects of an episode-based payment approach more broadly across an accountable care community seeking to coordinate care longitudinally across settings. Selecting certain hospitals where a high volume of LEJRs are performed may allow for fewer hospitals to be selected as model participants, but still result in a sufficient number of CJR episodes to
In determining the geographic unit for the geographic area selection for this model, we considered using a stratified random sampling methodology to select—(1) Certain counties based on their Core-Based Statistical Area (CBSA) status, (2) certain zip codes based on their Hospital Referral Regions (HRR) status; or (3) certain states. We address each geographic unit in turn.
We considered selecting certain counties based on their CBSA status. A CBSA is a core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration within that core. Counties are designated as part of a CBSA when the county or counties or equivalent entities are associated with at least one core (urbanized area or urban cluster) of at least 10,000 in population, plus adjacent counties having a high degree of social and economic integration with the core as measured through commuting ties with the counties associated with the core. There are 929 CBSAs currently used for geographic wage adjustment purposes across Medicare payment systems.
The choice of a geographical unit based on CBSA status could mean selection of a CBSA, an MSA, or a CSA. We proposed basing the selection on an MSA, which we will discuss later in this section.
We proposed that counties not in an MSA would not be subject to the selection process. These counties not subject to selection would include the μSA counties and the counties without a core urban area of at least 10,000. These areas are largely rural areas and have a limited number of qualifying LEJR cases. Relatively few of these areas would be able to qualify for inclusion based on the minimum number of LEJR episodes in year requirement discussed later in this section.
We considered, but ultimately decided against, using CSA designation instead of MSAs as a potential unit of selection. Under this scenario, we would look at how OMB classifies counties. We would first assess whether a county has been identified as belonging to a CSA, a unit which consists of adjacent MSAs or μSAs or both. If the county was not in a CSA, we would determine if it was in an MSA that is not part of a larger CSA. Counties not associated with a CSA or an MSA would be unclassified and excluded from selection. These unclassified areas would include the counties in a state that were either not a CBSA (no core area of at least 10,000) or associated with a μSA (core area of between 10,000 and 50,000) but unaffiliated with a CSA.
Whether to select on the basis of CSA/MSAs or just on MSAs was influenced by a number of factors. We considered the following factors:
• CSAs, by definition, have a significantly lower degree of interchange between component parts than the interchange experienced within an MSA. Thus, we did not believe that using CSAs would be necessary in order to capture referral patterns. A case study examination of the geographic areas included in CSAs with respect to the health care markets of those areas and their respective parts helped to validate our conclusion.
• We assessed the anticipated degree to which LEJR patients would be willing to travel for their initial hospitalization.
• We assessed the extent to which surgeons are expected to have admitting privileges in multiple hospitals located in different MSAs.
• We considered the degree to which we desire to include hospitals within μSAs that are part of a larger CSA.
After examining these factors, we concluded that that the anticipated risk for patient shifting and steering between MSAs within a CSA was not severe enough to warrant selecting CSAs given CMS' preference for smaller geographic units. However, because MSAs are units with significant levels of social and commercial exchange and due to the mobility of patients and providers within MSAs, we believed that selecting complete MSAs is preferable to selecting metropolitan divisions of MSAs for inclusion in the CJR model. We use the metropolitan divisions to set wage indices for its prospective payment systems (PPSs). Of the 388 MSAs, there are 11 MSAs that contain multiple metropolitan divisions. For example, the Boston-Cambridge-Newton, MA-NH MSA is divided into the following metropolitan divisions:
• Boston, MA.
• Cambridge-Newton-Framingham, MA.
• Rockingham County-Strafford County, NH.
The Seattle-Tacoma-Bellevue, WA MSA is divided into the following metropolitan divisions:
• Seattle-Bellevue-Everett, WA.
• Tacoma-Lakewood, WA.
We proposed selecting entire MSAs rather than sub-divisions within an MSA.
We next considered selecting HRRs. HRRs represent regional health care markets for tertiary medical care. There are 306 HRRs with at least one city where both major cardiovascular surgical procedures and neurosurgery are performed. HRRs are defined by determining where the majority of patients were referred for major cardiovascular surgical procedures and for neurosurgery.
We also considered selecting states for the CJR model. However, we concluded that MSAs as a geographic unit are preferable over states for the CJR model. As stated in section III.A.4.b. of the proposed rule, we anticipate that hospitals that would otherwise be required to participate in the CJR model would be excluded from the model because their relevant LEJR episodes are already being tested in BPCI. If we were to select states as the geographic unit, there is a potential that an entire state would need to be excluded because a large proportion of hospitals in that state are episode initiators of LEJR episodes in BPCI. In contrast, if we excluded a specific MSA due to BPCI participation, as discussed in the next section, we could still select another MSA within that same state. Likewise, if we chose states as the geographic unit, we would automatically include hospitals in all rural areas within the state selected. If MSAs are selected for the geographic unit, we anticipate that fewer small rural hospitals would be included in the model. Using a unit of selection smaller than a state would allow for a more deliberate choice about the extent of inclusion of rural or small population areas. Selecting states rather than MSAs would also greatly reduce the number of independent geographic areas subject to selection under the model, which would decrease the statistical power of the model evaluation. Finally, MSAs straddle state lines where providers and Medicare beneficiaries can easily cross these boundaries for health care. Choosing states as the geographic unit would potentially divide a hospital market and set up a greater potential for patient shifting and steering to different hospitals under the model. The decision that the MSA-level analysis was more analytically appropriate was based on the specifics of this model and is not meant to imply that other levels of selection would not be appropriate in a different model such as the proposed HHVBP model.
For the reasons previously discussed, we proposed to require all IPPS hospitals to participate in the CJR model (with limited exceptions as previously discussed in section III.A.2. of the proposed rule) if located in an MSA selected through a stratified random sampling methodology (outlined in section III.A.3.b. of the proposed rule) to test and evaluate the effects of an episode-based payment approach for an LEJR episodes. We proposed to determine that a hospital is located in an area selected if the hospital is physically located within the boundary of any of the counties in that MSA where the counties are determined by the definition of the MSA as of the date the selection is made. In response to comments, we are clarifying that we will determine physical location using the address associated with the CCN of the hospital. Although MSAs are revised periodically, with additional counties added or removed from certain MSAs, we proposed to maintain the same cohort of selected hospitals throughout the 5 performance years of the model with limited exceptions as described later in this section. Thus, we proposed that, if after the start of the model, new counties are added to one of the selected MSAs or counties are removed from one of the selected MSAs, those re-assigned counties would retain the same CJR status they had at the beginning of the initiative. We believed that this approach will best maintain the consistency of the participants in the model, which is crucial for our ability to evaluate the results of the model. We retain the possibility of adding a hospital that is opened or incorporated within one of the selected counties after the selection is made and during the period of performance. (See section III.C.4. of the proposed rule for discussion of how target prices will be determined for such hospitals.) Hospitals in selected counties that do not have any LEJR cases that qualify for CJR, due to their participation in the BPCI initiative as a hospital initiator in an LEJR episode, will become subject to CJR at the time their participation in BPCI ends and their episodes become eligible for CJR. Although we considered including hospitals in a given MSA based on whether the hospitals were classified into the MSA for IPPS wage index purposes, this process would be more complicated, and we could not find any compelling reasons favoring this approach. For example, we assign hospitals to metro divisions of MSAs when those divisions exist. See our previous discussion of this issue. In addition, there is the IPPS process of geographic reclassification by which a hospital's wage index value or standardized payment amount is based on a county other than the one where the hospital is located. For the purpose of this model, it is simpler and more straightforward to use the hospital's physical location as the basis of assignment to a geographic unit. This decision would have no impact on a hospital's payment under the IPPS. We sought comment on our proposal to include participant hospitals for the CJR model based on the physical location of the hospital in one of the counties included in a selected MSA.
The following is a summary of the comments received and our responses.
We chose MSAs as the unit of selection to balance the following considerations: The scope for shifting patients in or out of selected areas, our ability to observe the impact of the model in a variety of circumstances, and our preference to not use a geographic unit larger than strictly necessary to evaluate the model. We acknowledge that there are inevitably tradeoffs among these criteria. With respect to the choice of CSA versus MSA, a far greater number of commenters were concerned with the inclusion of rural providers than were concerned with their or their competitor's markets crossing the borders of MSAs within a CSA. By definition, CSAs have a lesser degree of the employment interchange than an MSA and basing the geographic unit of selection on a CSA would entail the possibility of selecting µSAs within CSAs. On balance, we believe it is appropriate to limit the extent of rural participation in CJR by confining it to rural areas within MSAs. We are sympathetic to concerns related to the experience of hospitals that are located near the borders between MSAs, but believed that those concerns did not outweigh these other considerations. In contrast, the density of populations and providers at the borders of these markets was one of the reasons that we decided to not proceed with allowing selection to be done based on metropolitan divisions for those 11 MSAs that were so sub-divided. Metropolitan divisions are very likely to have hospitals whose referral markets straddle divisions and their use as a unit would have had been problematic. After weighing the comments we continue to believe that MSAs are the most appropriate compromise position for the choice of geographic unit of selection.
Finally, we note that separate commenters stated that a hospital in a CJR selected county could be either at both a competitive advantage (for example, by providing an opportunity to attract physicians through gainsharing), or a competitive disadvantage (for example, by causing physicians to shift patients to nearby hospitals). We believe that both phenomena may occur and that the ability of a hospital to use the opportunities presented to it under the CJR model to strengthen its relationship with other providers and potentially achieve savings will vary by the hospital's specific circumstances and capabilities. We do not see a strong argument for why these types of effects necessitate a change to the geographic unit used for this model.
Comments related to requests for exclusion of particular hospitals are addressed in the next section, MSA Selection Methodology. Financial protections for hospitals are addressed later in section III.C.8. of this final rule.
We proposed to select the MSAs to include in the CJR model by stratifying all of the MSAs nationwide according to certain characteristics.
Prior to assigning an MSA to a selection stratum, we examined whether the MSA met specific proposed exclusion criteria. MSAs were evaluated sequentially using the following 4 exclusion criteria: First, MSAs in which fewer than 400 LEJR episodes (determined as discussed in section III.B.2. of this final rule) occurred from July 1, 2013 through June 30, 2014 were removed from possible selection. The use of the 400 LEJR cases in a year was based on a simple one-sided power calculation to assess the number of episodes that would be needed to detect a 5 percent reduction in episode expenditures. Cases in hospitals paid under either the critical access hospital (CAH) methodology or the Maryland All-Payer Model are not included in the count of eligible episodes. This criterion removed 156 MSAs from possible selection.
Second, MSAs were removed from possible selection if there were fewer than 400 non-BPCI LEJR episodes in the MSA in the reference year. For the purposes of this exclusion, the number of BPCI episodes was estimated as the number of potentially eligible cases during the reference year that occurred in acute care hospitals participating in BPCI Model 1, or in phase 2 of BPCI Models 2 or 4 as of July 1, 2015 and the number of LEJRs in the reference year associated with these hospitals was examined. This criterion removed an additional 24 MSAs from potential selection.
Third, MSAs were also excluded from possible selection if the MSA was dominated by BPCI Models 1, 2, 3, or 4 episodes to such a degree that it would impair the ability of participants in either the CJR model or the BPCI models to succeed in the objectives of the initiative or impair the ability to set accurate and fair prices. We anticipate that some degree of overlap in the two models will be mutually helpful for both models. There are two steps to this exclusion. First, we looked at the number of LEJR episodes at BPCI Model 1, 2 or 4 initiating hospitals and second,
Finally, MSAs were removed if, after applying the previous three criteria they remained eligible for selection, but more than 50 percent of estimated eligible episodes during the reference year were not paid under the IPPS system. The purpose of this rule was to assess the appropriateness of MSAs that contained both Maryland and non-Maryland counties. No MSAs were eliminated on the basis of this rule. Please refer to the appendix for this final rule for the status of each MSA based on these exclusion criteria, available at
The following is a summary of the comments received and our responses.
After we made the previously stated changes, some MSAs previously eligible for selection would now be considered excluded. Additionally, two of the MSAs previously excluded would now be eligible for selection due to hospitals withdrawing from BPCI and the MSAs now having more than 400 eligible cases. Eight MSAs that were selected in the proposed rule would be classified as excluded on the basis of these updated exclusion rules.
We considered a variety of alternative approaches to address the changes in the eligibility of MSAs. First, we considered proceeding with the list of 75 MSAs as initially selected and using the exclusion rules as initially proposed. Second, we considered removing the 8 selected MSAs that would now be excluded on the basis of the updated BPCI participation numbers. Third, we considered replacing the 8 MSAs by randomly selecting new MSAs from the remaining MSAs in the relevant strata. However, we believed that it would preferable, although not required, to give the selected MSAs a consistent period of time between selection and the start of the model. Fourth, we contemplated creating a revised list of eligible MSAs and randomly selecting a new group of 75 MSAs. Given the concern of many commenters about the start date of the model, we were reluctant to create a completely new list of selected MSAs. We believe that making a new selection would be regarded unfavorably by impacted MSAs and hospitals and should be avoided if possible. In order to be responsive to concerns regarding the growth of BPCI after the publication of the proposed rule and the increase in PGP participation in BPCI, we are proceeding with the second option.
The function of the stratification approach was to ensure that our selection of MSAs covered a range of efficiency levels and population sizes and allowed us to target our sampling percentages so as to oversample in the less efficient areas. Regarding the selected MSAs now eliminated, they are distributed fairly evenly throughout the distribution of average episode payments. From the least expensive to the most expensive quartiles, the number selected and now eliminated are, in order, 2/15 (13 percent), 2/19 (11 percent), 3/30 (15 percent), and 1/22 (5 percent). We also believe that the removal of these 8 MSAs from the model will not preclude us from undertaking a rigorous statistical evaluation of the model.
Given the aforementioned information, we believe that the relatively minor reduction in statistical power due to not re-selecting MSAs is outweighed by the desire to give affected participant hospitals equal time to prepare for the model. We are removing the 8 MSAs as noted in Table 1.
We next contemplated whether to apply additional MSA-level exclusion rules. We investigated a potential new rule whereby an MSA would be excluded based on the percent of the MSA's qualifying LEJR episodes associated with Phase 2 Model 2 PGP initiators. We did not believe that there was as strong of an argument for excluding MSAs on the basis of the percent of patients treated by a BPCI physician given that the hospital is the financially accountable entity in CJR. We examined two possible cut off points (>65 percent and >50 percent) to assess which MSAs would be eliminated if we were to exclude MSAs where a specific percent of an MSA's otherwise qualifying LEJR cases was attributable to a BPCI PGP. At 65 percent, no selected MSAs not otherwise excluded were impacted. 8 MSAs that were previously selected had more than 50 percent of their LEJRs performed by BPCI PGPs. Five of these 8 MSAs are already eliminated due to the revised exclusion rule 2. For markets with more than 400 non-BPCI cases but more than 50 percent BPCI PGP penetration, the number of the CJR eligible patients was between 556 and 1834 indicating that there was a sizable number of cases. Consequently, we did not find this new exclusion rule necessary.
Commenters provided a variety of rationales for why they believed it was undesirable or unfair to include low volume providers in the model. These reasons include, but are not limited to, observations that—
• Low-volume providers are less likely to be proficient at taking care of these patients in an efficient cost-effective manner and they will be less likely to achieve savings;
• Low-volume hospitals will be disproportionately impacted by outlier cases and will have less predictable cost and quality outcomes making it difficult for them to manage the model effectively. In addition, low volume providers are likely to see a greater proportion of hip fractures and non-planned procedures;
• Low-volume hospitals will have less control over and ability to impact the behavior of other providers. The pool of collaborating providers such as orthopedic surgeons in most rural communities may be limited and small hospitals may not have the market position to successfully influence others' behavior;
• Hospitals with a limited number of Medicare hip and knee procedures may not have sufficient incentive to invest the time and resources necessary to develop the infrastructure and partnerships required to effectively manage these episodes of care and may not find the opportunity to improve patient outcomes significant enough to engage referring physicians and PAC partners for redesign;
• Low volume providers may be more financially vulnerable and with fewer resources to design and carry out initiatives or make effective responses to the financial incentives in the model. A commenter noted concerns with hospital margins, and the possibility for the reductions in revenue as a result of the loss of volume or loss of margin under CJR could result in additional hospital closures.
Due to these concerns, commenters requested a variety of solutions including (1) the exclusion of hospitals based on a volume cut off variously defined by volume of eligible LEJR cases, LEJR cases within specific MS-DRGs and total hospital volume, (2) making the model voluntary for low volume providers, (3) extending the protections afforded to SCH, MDH and RRC to additional categories of hospitals including hospitals electing to be treated as rural under § 412.103, and (4) the provision of additional protections or payment adjustments beyond what was included in the proposed rule.
As stated in relation to comments requesting that CJR operate as a voluntary model, the inclusion of low volume hospitals in the CJR model is consistent with the goal of evaluating the impact of bundled payment and care redesign across a broad spectrum of hospitals with varying levels of infrastructure, care redesign experience, market position, and other considerations and circumstances. The design of the CJR model and the inclusion of low volume providers within the model reflects our interest in testing and evaluating the impact of a bundled payment approach for LEJR procedures in a variety of circumstances, especially among those hospitals that may not otherwise participate in such a test. The inclusion of these providers allows CMS to better appreciate and understand how the model operates as a general payment approach and its impact on a wide range of hospitals. Many LEJR surgeries are performed in low volume settings, thus, the impact of the CJR model on low volume hospitals is of great interest to the evaluation of this initiative.
We acknowledge that providers with low volumes of cases may not find it in their financial interests to make
With respect to challenges that hospitals may experience related to identifying eligible patients and following them over the course of their episodes, we acknowledge that concern. However, we consider the improved tracking and communication with other providers and suppliers that is likely to occur as a result of hospital efforts in CJR to be a benefit of the model that will improve the coordination of patient care and possibly improve patient outcomes.
The CJR model will require hospitals within selected geographic areas to participate (unless otherwise excluded as set forth in this final rule). The inclusion of additional voluntarily participating hospitals outside of these selected areas would constitute a major change to the model that was not considered in the proposed rule. Providers who wished to participate in a voluntary episode model had the opportunity under the BPCI initiative.
In determining if an MSA was eligible for selection, we first examined whether the MSA met any of the four exclusion criteria as formulated in the proposed rule. This process resulted in a pool of 196 MSA from which we then selected 75 for inclusion in CJR via stratified random selection.
In this final rule, we revised the exclusion rules as defined later in this section, with the purpose of assessing whether any of the 75 selected MSAs would be considered not eligible for selection based on applying the new criteria.
Specifically, the second exclusion rule, which eliminates MSAs with fewer than 400 non-BPCI CJR eligible cases, is modified with the following additions (1) the determination of the count of patients associated with a BPCI Phase 2 initiating hospital is based on the participation in BPCI as of October 1, 2015 rather than July 1, 2015 and (2) the count of BPCI episodes to be removed from the count of eligible episodes takes into consideration patients who would have been attributed to a BPCI Model 2 initiating PGP in Phase 2 for an LEJR episode as of October 1, 2015. The third exclusion rule, wherein MSAs were excluded based on the percent of the MSA's LEJR population associated with either a BPCI hospital, SNF or HHA in an MSA, was changed to be based on episodes associated with participation in BPCI as of October 1, 2015 rather than July 1, 2015.
As a result of updating the list of BPCI participants to those entering the model in October 2015 and including Phase 2 PGPs in the calculation of the number of cases in the MSA, 8 MSAs out of the 75 MSAs that were previously selected are now deemed not eligible for selection and are consequently no longer required to participate in CJR. These previously selected and now excluded MSAs are shown in Table 1. The remaining 67 MSAs selected in the proposed rule will be required to participate in CJR.
Numerous variables were considered as potential strata for classifying MSAs included in the model. However, our proposal was intended to give priority to transparency and understandability of the strata. We proposed creating selection strata based on the following two dimensions: MSA average wage-adjusted historic LEJR episode payments and MSA population size.
We were interested in being able to classify and divide MSAs according to their typical patterns of care associated with LEJR episodes. As a straightforward measure of LEJR patterns of care, we selected the mean MSA episode payment, as defined in the proposed rule. MSAs vary in their average episode payments. The average episode payments in an area may vary for a variety of reasons including—(1) In response to the MS-DRG case mix and thus the presence of complicating conditions; (2) readmission rates; (3) practice patterns associated with type of PAC provider(s) treating beneficiaries; (4) variations of payments within those PAC providers, and (5) the presence of any outlier payments.
The measure of both mean episode payments and median episode payments within the MSA was considered. We proposed to stratify by mean because it would provide more information on the variation in episode payments at the high end of the range of payments. We are interested in the lower payment areas for the purpose of informing decisions about potential future model expansion. However, the CJR model is expected to have the greatest impact in areas with higher average episode payments.
The average episode payments used in this analysis were calculated based on the proposed episode definition for CJR using Medicare claims accessed through the Chronic Conditions Warehouse for 3 years with admission dates from July 1, 2011 through June 30, 2014. Episode payments were wage-adjusted using the FY 2014 hospital wage index contained in the FY 2014 IPPS Final Rule, downloaded at
The second dimension proposed for the CJR selection strata is the number of persons in the MSA. In deciding how best to incorporate the dimensions of urban density and availability of medical resources, a variety of measures were considered, including overall population in the included counties, overall population in the core area of the MSA, population over the age of 65 in the MSA, the number of hospital beds and the number of Medicare FFS LEJR procedures in a year. The reason we decided to include this dimension in the strata definition is that these factors are believed to be associated with the availability of resources and variations in practice and referral patterns by the size of the healthcare market. When examined, these alternative measures were all very highly correlated with one another, which allowed the use of one of these measures to be able to substitute for the others in the definition of the stratum. From these alternative approaches, we choose to use MSA population. In operationalizing this measure, MSAs were classified according to their 2010 census population.
The two proposed domains, MSA population and MSA historic LEJR episode spending, were examined using a K-Means factor analysis. The purpose of this factor analysis was to inform the process of which cut points most meaningfully classify MSAs. Factor analysis attempts to identify and isolate the underlying factors that explain the data using a matrix of associations. Factor analysis is an interdependence technique. Essentially, variables are entered into the model and the factors (or clusters) are identified based on how the input variables correlate to one another. The resulting clusters of MSAs produced by this methodology suggested natural cut points for average episode payments at $25,000 and $28,500. While not intentional, these divisions correspond roughly to the 25th and 75th percentiles of the MSA distribution. Cut points based on these percentiles seemed reasonable from statistical and face validity perspectives in the sense that they created groups that included an adequate number of MSAs and a meaningful range of costs.
As a result of this analysis, we classified MSAs according to their average LEJR episode payment into four categories based the on the 25th, 50th and 75th percentiles of the distribution of the 196 potentially selectable MSAs as determined in the exclusion rules as applied in the proposed rule (80 FR 41198). This approach ranks the MSAs relative to one another and creates four equally sized groups of 49. The population distribution was divided at the median point for the MSAs eligible for potential selection as determined and defined in the proposed rule. This resulted in MSAs being divided into two equal groups of 98. The characteristics of the resulting strata are shown in Table 2.
Please refer to the addenda for this final rule for information on the non-excluded MSAs, their wage adjusted average LEJR episode spending, their population and their resultant group assignment at:
In addition to the two dimensions we proposed to use for the selection groups previously discussed, a variety of possible alternative measures and dimensions were considered. Many of these variables are considered to be important but it was believed that it was important to have a fairly straightforward and easily understandable stratum definition. Simplicity, by definition, required that only the most important variables would be used. If a market characteristic under consideration was correlated with one of the chosen dimensions or it was believed that variations in the characteristic could be adequately captured by random selection within the strata, is was not prioritized for inclusion.
Some of the factors considered that we did not propose as dimensions are—
• Measures associated with variation in practice patterns associated with LEJR episodes. In considering how to operationalize this measure, a number of alternatives were considered including total PAC LEJR payments in an MSA, percent of LEJR episodes with a SNF claim in an MSA, percent of LEJR episodes with an initial discharge to HHA, percent of LEJR episodes with an Inpatient rehabilitation facility (IRF) claim, and percent of LEJR episodes with claims for two or more types of PAC providers;
• Measures associated with relative market share of providers with respect to LEJR episodes;
• Healthcare supply measures of providers and suppliers in the MSA including counts of IRF beds, SNF beds, hospital beds, and number of orthopedic surgeons;
• MSA level demographic measures such as; average income, distributions of population by age, gender or race, percent dually eligible, percent of population with specific health conditions or other demographic composition measures; and
• Measures associated with the degree to which a market might be more capable or ready to implement care redesign activities. Examples of market level characteristics that might be associated with anticipated ease of implementation include the MSA-level EHR meaningful use levels, managed care penetration, ACO penetration and experience with other bundling efforts.
It should be noted that, while these measures were not proposed to be part of the selection strata, we acknowledge that these and other market-level factors may be important to the proper understanding of the evaluation of the impact of CJR. It is the intention that these and other measures will be considered in determining which MSAs are appropriate comparison markets for the evaluation as well as considered for possible subgroup analysis or risk adjustment purposes. The evaluation will include beneficiary, provider, and market level characteristics in how it examines the performance of this proposed model.
Analyses of the necessary sample size to facilitate a robust statistical analysis of CJR's effects led us to conclude that we needed to include between 50 and 100 MSAs of the 384 MSAs with eligible LEJR episodes to participate in CJR and we proposed to select 75 MSAs. As previously discussed, the proposed revision of the MSA exclusion rules resulted in 8 of the previously selected MSAs now being considered excluded, leading to their removal from the model. The resulting number of selected MSAs, 67, is still within the acceptable range for an MSA count as determined by our analysis. The number and method of selection of these original 75 MSAs from the 8 proposed groups is addressed in the following section. In finalizing this approach, we are undertaking a test in as few markets as possible while still allowing us to be confident in our results and to be able to generalize from the model to the larger national context. We discuss the assumptions and modeling that went into our proposal later in this section.
In calculating the necessary size of the model, a key consideration was ensuring that the model would have sufficient power to be able to detect the desired size impact. The larger the anticipated size of the impact, the fewer MSAs we would have to sample in order to observe it. However, a model sized to be able to only detect large impacts runs the risk of not being able to draw conclusions if the size of the change is less than anticipated. The measure of interest used in estimating sample size requirements for the CJR model was wage-adjusted total episode spending. To measure wage-adjusted total episode spending, we used the 3 year data pull also used for the average regional episode spending estimation that covers LEJR episodes with admission dates from July 1, 2011 through June 30, 2014. For the purposes of the sample size calculation the impact estimate assumed we wanted to be able to detect a 2 percent reduction in wage adjusted episode spending after 1 year of experience. This amount was chosen because it is the anticipated amount of the discount we proposed to apply to target prices in CJR.
The next consideration in calculating the necessary sample size is the degree of certainty we will need for the statistical tests that will be performed. In selecting the right sample size, there are two types of errors that need to be considered “false negatives” and “false positives”. A false positive occurs if a statistical test concludes that the model was successful when it was, in fact, not. A false negative occurs if a statistical test fails to find statistically significant evidence that the model was successful, but it was, in fact, successful. In considering the minimum sample size needs of a model, a standard guideline in the statistical literature suggests calibrating statistical tests to generate no more than a 5 percent chance of a false positive and selecting the sample size to ensure no more than a 20 percent
A third consideration in the sample size calculation was the appropriate unit of selection and whether it is necessary to base the calculation on the number of MSAs, the number of hospitals, or the number of episodes. As discussed later in this section, we are proposing to base the sample size calculation at the MSA level.
The CJR model is a nested comparative study, which has two key features. First, the unit of assignment (to treatment and comparison groups) is an identifiable group; such groups are not formed at random, but rather through some physical, social, geographic, or other connection among their members. Second, the units of observation are members of those groups. In such designs, the major analytic problem is that there is an expectation for a positive correlation (intra-class correlation (ICC)) among observations of members of the same group (MSA). The ICC reflects an extra component of variance attributable to the group above and beyond the variance attributable to its members. This extra variation will increase the variance of any aggregate statistic beyond what would be expected with random assignment of beneficiaries or hospitals to the treatment group.
In determining the necessary sample size, we need to take into consideration the degrees of freedom. As part of this process, we examined the number of beneficiaries, the number of hospitals, and the number of MSAs and the level of correlation in episode payments between each level. For example, while each beneficiary has their own episode expenditure level, there are commonalities between those expenditure amounts at the hospital level, based on hospital-specific practice and referral patterns. The number of degrees of freedom needed for any aggregate statistic is related to the number of groups (MSAs or hospitals), not the number of observations (beneficiary episodes). If we were to base the determination of the size of the model on beneficiary episodes where correlation exists, we would have an inflated false positive error rate and would overstate the impact of the model. We empirically examined the level of correlation between beneficiaries and hospitals and between hospitals and MSAs and determined that the correlation was high enough to be of concern and necessitate an MSA level unit of selection.
Using the previous assumptions, a power calculation was run which indicated we would need between 50 and 150 treatment MSAs to be able to reliably detect a 2 percent reduction in payments after 1 year. The lower end of this range assumed that our evaluation approach could substantially reduce variation through regression adjustment and other types of statistical modeling. We anticipated that we would have adequate statistical power based on prior research results, but wanted to ensure that we did not have to achieve the “best possible” results from such modeling in order to draw conclusions. In order to allow for some degree of flexibility we proposed the selection of 75 MSAs. We narrowed the acceptable range to between 50 and 100 MSAs rather than 50 to 150 MSAs, based on the assumption that we will be able to substantially improve our estimates through modeling, and then chose a number near the middle of this reduced range. Due to the revised exclusion rules, we are proceeding with 67 MSAs, which we believe will provide adequate statistical power.
In assessing to what degree regression adjustment and other statistical adjustments could reduce the number of MSAs needed to generate statistically reliable results, it should be noted that calculations are based on the actual Medicare payments associated with episodes. Thus, the variation in payments associated with MS-DRG case mix, or other reasons are already captured in the methodology.
As previously discussed, we selected 75 MSAs from our proposed 8 selection groups and subsequently reduced this number to 67. In performing the initial MSA selection, we examined and considered a number of possible approaches including equal selection in each of the eight groups, equal selection in the four payment groups, selection proportionate to the number of MSAs in each group, and a number of approaches that differentially weighted the payment categories.
After consideration, we proposed a methodology that proportionally under-weighted more efficient MSAs and over-weighted more expensive MSAs was the most appropriate approach to fulfilling the overall priorities of this model to increase efficiencies and savings for LEJR cases while maintaining or improving the overall quality of care. This approach made MSAs in the lowest spending category less likely to be selected for inclusion. We thought this appropriate because the MSAs in the lowest expenditure areas have the least room for possible improvement and are already performing relatively efficiently compared to other geographic areas, which means that experience with the model in these areas may be relatively less valuable for evaluation purposes. At the same time, we believed it was important to include some MSAs in this group in order to assess the performance of this model in this type of circumstance. We also believed it was appropriate for higher payment areas to be disproportionately included because they are most likely to have significant room for improvement in creating efficiencies. We expect more variation in practice patterns among the more expensive areas. There are multiple ways an MSA can be more relatively expensive, including through outlier cases, higher readmission rates, greater utilization of physician services, or through PAC referral patterns. A larger sample of MSAs within the higher payment areas will allow for us to observe the impact of the CJR model on areas with these various practice patterns in the baseline period.
The method of disproportionate selection between the strata used was to choose 30 percent of the MSAs in the two groups in the bottom quarter percentile of the payment distribution, 35 percent of the MSAs in the two groups in the second lowest quartile, 40 percent in the third quartile, and 45 percent in the highest episode payment quartile. This proportion resulted in the selection of the 75 originally selected MSAs out of the 196 eligible. The number of MSAs originally chosen as well as the final selection counts within the eight selection groups is shown in Table 3.
We selected the proposed MSAs for the CJR model through random selection. In the proposed method of selection, each MSA was assigned to one of the eight selection groups previously identified. Based on this sampling methodology, SAS Enterprise Guide 7.1 software was used to run a computer algorithm designed to randomly select MSAs from each strata. SAS Enterprise Guide 7.1 and the computer algorithm used to conduct selection represents an industry standard for generating advanced analytics and provides a rigorous, standardized tool by which to satisfy the requirements of randomized selection. The key SAS commands employed include a “PROC SURVEYSELECT” statement coupled with the “METHOD=SRS” option used to specify simple random sampling as the sample selection method. A random number seed was generated for each of the eight strata by using eight number seeds corresponding to birthdates and anniversary dates of parties present in the room. The random seeds for stratum one through eight were as follows: 907, 414, 525, 621, 1223, 827, 428, 524. Note that no additional stratification was used in any of the eight groupings so as to produce an equal probability of selection within each of the eight groups. For more information on this procedure and the underlying statistical methodology, please reference SAS support documentation at:
The selection of an MSA means that all hospitals are included whose address associated with their CCN is physically located anywhere within the counties that make up the MSA. By definition, the entire county is included in an MSA and hospitals that are in the relevant counties will be impacted even if they are not part of the core urban area.
We stated in the proposed rule, should the methodology we propose in this rule change as a result of comments received during the rulemaking process, it could result in different areas being selected for the model. In such an event, we would apply the final methodology and announce the selected MSAs in the final rule. Therefore we sought comment from all interested parties in every MSA on the randomized selection methodology proposed in this section.
The following is a summary of the comments received and our responses.
With respect to the request to test the model in a limited pool of MSAs prior to testing it in the full set of selected MSAs, we believe that the testing of this model broadly is crucial to achieving the model's desired objectives and does not believe that proceeding in a few test MSAs prior to testing it in a broader set of MSAs would yield the same degree of information in the same time period.
We set forth this final policy in § 510.100 and § 510.105.
CJR model is an episode payment model, focused on incentivizing health care providers to improve the efficiency and quality of care for an episode of care as experienced by a Medicare beneficiary by bundling payment for services furnished to the beneficiary for an episode of care for a specific clinical condition over a defined period of time. Key policies of such a model include the definition of episodes of care. Episodes of care have two significant dimensions—(1) A clinical dimension that describes what clinical conditions and associated services comprise the episode; and (2) a time dimension that describes the beginning, middle, and end of an episode. We present our proposals, summarize public comments and provide our responses, and finalize the policies for these two dimensions of CJR episodes in this section.
As discussed previously in section I.A. of this final rule, we identified LEJR episodes, primarily hip and knee replacements, as the focus of this model. In the proposed rule, we stated our belief that a straightforward approach for hospitals and other providers to identify Medicare beneficiaries in this payment model is important for the care redesign that is required for model success, as well as to operationalize the proposed payment and other model policies.
The vast majority of LEJRs are furnished in the inpatient hospital setting, with a small fraction of partial knee replacements occurring in the hospital outpatient department (HOPD) setting. Most of the Current Procedural Terminology (CPT) codes that physicians report for LEJR are on the hospital OPPS inpatient only list. The CY 2015 OPPS inpatient only list is Addendum E of the CY 2015 Hospital Outpatient Prospective Payment—Final Rule with Comment Period, which is available on the CMS Web site at:
We noted further that LEJRs are paid for under the IPPS through the following two Medicare Severity-Diagnosis Related Groups (MS-DRGs):
• MS-DRG 469 (Major joint replacement or reattachment of lower extremity with Major Complications or Comorbidities (MCC)).
• MS-DRG 470 (Major joint replacement or reattachment of lower extremity without MCC).
Multiple International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) procedure codes that describe LEJR procedures and other less common lower extremity procedures group to these MS-DRGs, with their percentage distribution within the IPPS MS-DRGs 469 and 470 for the past 4 years outlined in Table 5.
Additionally, we noted that there are various types of claims-based information available to CMS, hospitals, and other providers, that could be used to identify beneficiaries in the model who receive LEJRs, including the MS-DRGs for the acute care hospitalization for the procedure, the ICD-9-CM procedure code on the hospital claim, or the CPT code(s) reported by the orthopedic surgeon who furnishes the surgical procedure. While we could utilize ICD-9-CM procedure codes or CPT codes to identify beneficiaries included in the model, over 85 percent of procedures that group to MS-DRGs 469 and 470 are hip or knee replacements. Additionally, the hospitals that would be participating in this model receive payment under the IPPS, which is not determined by CPT codes and is based on clinical conditions and procedures that group to MS-DRGs. Finally, our review of the other low volume procedures that group to these same MS-DRGs, aside from total or partial hip and knee replacements, did not suggest that there is significant clinical or financial heterogeneity within these two MS-DRGs such that we would need to define care for included beneficiaries by ICD-9-CM procedure codes.
Therefore, we proposed that an episode of care in the CJR model would be triggered by an admission to an acute care hospital stay (hereinafter “the anchor hospitalization”) paid under MS-DRG 469 or 470 under the IPPS during the model performance period. This approach offers operational simplicity, for providers and CMS, and is consistent with the approach taken by the BPCI initiative to identify beneficiaries whose care is included in the LEJR episode for that model. We sought public comments on this proposal to define the clinical conditions that are the target of CJR.
The following is a summary of the comments received and our responses.
Many commenters recommended that CMS define the clinical conditions in the model as episodes specific to elective total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures. The commenters stated that this group of beneficiaries is more homogeneous than beneficiaries undergoing emergent joint replacement procedures for hip fractures or undergoing the other low volume procedures that map to the MS-DRGs. Given that CMS did not propose risk adjustment under the model based on procedure or patient characteristics, the commenters contended that limiting the model to these clinical conditions, that represent about 85 percent of beneficiaries discharged for the two MS-DRGs, would provide a sufficient number of cases to test LEJR episode payment and allow hospitals to create efficient, effective clinical pathways for these beneficiaries. The commenters also observed that CMS' quality measures, specifically the THA/TKA readmissions and complications measures, as well as the voluntary data collection for patient-reported outcomes, would represent only the quality of care for beneficiaries undergoing elective THA and TKA procedures. Several commenters recommended that CMS only include episodes in the model for beneficiaries discharged from MS-DRG 469 or 470 whose data would be used to determine the model's quality measures for the participant hospital.
The commenters suggested several different approaches to defining the clinical conditions included in the model as elective THA or TKA. One approach would be to eliminate from the model beneficiaries with reported ICD-9-CM procedure codes other than THA or TKA, and then further exclude some remaining beneficiaries with ICD-9-CM codes for hip fracture on their claim for the anchor hospitalization. Other commenters asserted that CMS should exclude the beneficiaries receiving the low volume procedures as well as those receiving partial hip arthroplasty (PHA) procedures. The commenters pointed out that almost all of the beneficiaries receiving PHA would have hip fractures and observed that the average Medicare episode payment for beneficiaries undergoing PHA was similar to beneficiaries discharged from MS-DRG 469 or 470 with hip fracture diagnoses, almost twice the payment for beneficiaries undergoing elective THA and TKA. Several commenters presented analyses that demonstrated that beneficiaries with hip fracture, regardless of their discharge from MS-DRG 469 or 470, when compared to beneficiaries with elective procedures, experience twice as high readmissions and PAC utilization rates, as well as higher morbidity and mortality.
The commenters in favor of excluding clinical conditions involving hip fractures from the model stated that the number of hip fracture cases treated by individual hospitals can vary significantly on an annual basis, both due to random variation and practice or population changes. Moreover, different hospitals provide care for different percentages of beneficiaries with hip fracture and, according to some commenters, academic medical centers and small hospitals care for disproportionate percentages of these cases for reasons of medical complexity and the urgent nature of the procedure, respectively, because beneficiaries who fall and experience a hip fracture are commonly transported to their local hospital for emergent treatment. Furthermore, in addition to the variation a hospital itself may experience regarding the percentage of hip fracture cases, which could lead to the hospital-specific historical data used for a portion of the target price to not be reflective of the health care needs of the hospital's episode population in a given performance year, some commenters observed that the increasing percentage of the target price contributed by regional data exacerbated their concerns. Hospitals in a region that care for a disproportionately high percentage of hip fracture patients compared to the regional average would be disadvantaged due to the more intense service needs of hip fracture patients, whereas hospitals caring for a disproportionately low percentage of hip fracture patients compared to the regional average would be advantaged. The commenters contended that excluding clinical conditions involving hip fractures from the CJR model would ensure homogeneity in the beneficiaries in the model such that hospitals would be treated fairly with respect to episode pricing based on the hospital-specific and regional historical CJR episode data for only those beneficiaries undergoing elective THA and TKA.
We are also finalizing our proposal to include clinical conditions represented by discharge from both MS-DRG 469 and 470 in the CJR model. We believe that providing separate prices for episodes anchored by the two different MS-DRGs accounts for the differences in typical health care needs of the two groups of beneficiaries, specifically the higher IPPS payment for the anchor hospitalization for beneficiaries discharged under MS-DRG 469, as well as the pattern of service utilization for this group of beneficiaries in the 90 days following discharge.
Additionally, we are finalizing our proposal to include any lower extremity joint procedure that results in discharge from MS-DRG 469 or 470 in the CJR
We note that our final policy to include all clinical conditions that result in a discharge from MS-DRGs 469 or 470 in the CJR model allows us to continue to rely on MS-DRGs to define the clinical conditions included in the LEJR episode being widely tested under the CJR model, consistent with the BPCI methodology to define clinical conditions included in 48 different episodes based on the MS-DRGs for the anchor hospitalization. This approach provides greater certainty from the perspective of participant hospitals or CMS regarding the clinical conditions included in episodes, since the discharge MS-DRG is the defining parameter, and includes the greatest number of beneficiaries with similar clinical conditions in the CJR model test.
Because most LEJR procedures are on the OPPS inpatient list and CMS has, therefore, determined that Medicare beneficiaries require an inpatient hospitalization for payment of these procedures to hospitals, we are not changing the current inpatient only list designation of these LEJR procedures for the CJR model. CJR is an episode payment model, not a model designed to test different sites of services for procedures that CMS has thus far determined may not be safely performed on Medicare beneficiaries in the outpatient setting. Therefore, we are finalizing our proposal that the CJR model will continue to focus around an inpatient hospitalization for these major surgical procedures that result in a discharge from MS-DRG 469 or 470, and a procedure furnished in the outpatient setting will not be included in the model.
The final policies for defining the clinical conditions are set forth in § 510.100 and § 510.200.
For purposes of this model, as in BPCI, given the frequent comorbidities experienced by Medicare beneficiaries and the generally elective nature of LEJR, we are interested in testing inclusive episodes to incentivize comprehensive, coordinated patient-centered care for the beneficiary throughout the episode. We proposed to exclude only those Medicare items and services furnished during the episode that are unrelated to LEJR procedures based on clinical justification. During our experience with BPCI implementation, we reviewed a number of narrow episode definitions for LEJR episodes that were recommended by BPCI participants and other interested parties during the design phase for this project. We concluded that these narrow definitions commonly exclude many services that may be linked to the LEJR, as LEJR beneficiaries, on average, are at higher risk for more clinical problems than Medicare beneficiaries who have not recently undergone such procedures.
Therefore, we proposed that all CJR episodes, beginning with the admission for the anchor hospitalization under MS-DRG 469 or 470 through the end of the proposed episode, include all items and services paid under Medicare Part A or Part B with the exception of certain exclusions that would be excluded because they are unrelated to the episode. The items and services ultimately included in the episode after the exclusions are applied are called related items and services. As discussed in sections III.C.4. and III.C.6. of this final rule, Medicare spending for related items and services would be included in the historical data used to set target prices, as well as in the calculation of actual episode spending that would be compared against the target price to assess the performance of participant hospitals. In contrast, Medicare spending for unrelated items and services (excluded from the episode definition) would not be included in the historical data used to set target prices or in the calculation of actual episode spending.
We proposed that related items and services included in CJR episodes would be the following items and services paid under Medicare Part A or Part B, after the exclusions are applied:
• Physicians' services.
• Inpatient hospital services (including readmissions), with certain exceptions discussed later in this section.
• Inpatient psychiatric facility (IPF) services.
• Long Term Care Hospital (LTCH) services.
• IRF services.
• SNF services.
• HHA services.
• Hospital outpatient services.
• Independent outpatient therapy services.
• Clinical laboratory services.
• Durable medical equipment (DME).
• Part B drugs.
• Hospice.
We noted that under our proposed definition of related services included in the episode, the episode could include certain per-member-per-month model payments, as discussed in section III.C.7.d. of this final rule.
We proposed to exclude from CJR drugs that are paid outside of the MS-DRG, specifically hemophilia clotting factors (§ 412.115), identified through HCPCS code, diagnosis code, and revenue center on IPPS claims. Hemophilia clotting factors, in contrast to other drugs that are administered during an inpatient hospitalization and paid through the MS-DRG, are paid separately by Medicare in recognition that clotting factors are costly and essential to appropriate care for certain beneficiaries. Thus, in the proposed rule we stated our belief that there are no efficiencies to be gained in the variable use of these high cost drugs when particular beneficiaries receive LEJR procedures who have significantly different medical needs for clotting factors under an episode payment model, so we proposed to exclude these high cost drugs from the actual historical episode expenditure data used to set target prices and from the hospital's actual episode spending that is reconciled to the target price. Similarly, we proposed to exclude IPPS new technology add-on payments for drugs, technologies, and services from CJR episodes, excluding them from both the actual historical episode expenditure data used to set target prices and from the hospital's actual episode spending that is reconciled to the target price. This proposal would apply to both the anchor hospitalization
We followed a number of general principles in determining other proposed excluded services from the CJR episodes in order to promote coordinated, high-quality, patient-centered care. Based on the broad nature of these episodes, we proposed to identify excluded (unrelated) services rather than included (related) services based on the rationale that all Part A and Part B services furnished during the episode are related to the episode, unless they are unrelated based on clinical justification as described in more detail later in this section. In developing our proposals for exclusions for this model, we stated our belief that no Part A services, other than certain excluded hospital readmissions during the episode as described in this section, furnished post-hospital discharge during the episode should be excluded, as post-hospital discharge Part A services are typically intended to be comprehensive in nature. We also stated our belief that no claims for services with diagnosis codes that are directly related to the LEJR procedure itself (for example, loosening of the joint prosthesis) based on clinical judgment, and taking into consideration coding guidelines, should be excluded. Furthermore, we stated our belief that no claims for diagnoses that are related to the quality and safety of care furnished during the episode, especially the anchor hospitalization under MS-DRG 469 or 470, should be excluded, such as direct complications of post-surgical care during the anchor hospitalization. Examples of diagnoses that would not be excluded on this basis include surgical site infection and venous thromboembolism. Finally, in the proposed rule we stated our belief that no claims for services for diagnoses that are related to preexisting chronic conditions such as diabetes, which may be affected by care furnished during the episode, should be excluded. However, severe exacerbations of chronic conditions (for example, some surgical readmissions) that are unlikely to be affected by care furnished during the episode should be excluded; thus, when a beneficiary is admitted to the hospital during the episode for these circumstances, we would not consider it to be a related readmission for purposes of CJR. We also stated our belief that services for clinical conditions that represent acute clinical conditions not arising from an existing chronic clinical condition or complication of LEJR surgery occurring during an episode of care, which would not be covered by the previous principles about included services, should be excluded.
To operationalize these principles for CJR, we proposed to exclude unrelated inpatient hospital admissions during the episode by identifying MS-DRGs for exclusion. We proposed to exclude unrelated Part B services based on the ICD-9-CM diagnosis code (or their International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) equivalents when ICD-10-CM codes are implemented) that is the principal diagnosis code reported on claims for services furnished during the episode. More specifically, we proposed to exclude specific inpatient hospital admissions and services consistent with the LEJR episode definition (also triggered by MS-DRGs 469 and 470) that is currently used in BPCI Model 2. We note that the list of exclusions was initially developed over 2 years ago for BPCI through a collaborative effort of CMS staff, including physicians from medical and surgical specialties, coding experts, claims processing experts, and health services researchers. The list has been shared with thousands of entities and individuals participating in one or more phases of BPCI, and has undergone refinement over that time in response to stakeholder input about specific diagnoses or MS-DRGs for exclusion, resulting in only minimal changes over the last 2 years. Thus, the BPCI list of exclusions for LEJR procedures has been vetted broadly in the health care community; refined based on input from a wide variety of providers, researchers and other stakeholders; and successfully operationalized in the BPCI models. We proposed its use in CJR based on our confidence related to our several of years of experience that this definition is reasonable and workable for LEJR episodes, for both providers and CMS.
With respect to the proposed inpatient hospital admission exclusions for this model, we proposed that all medical MS-DRGs for readmissions be included in CJR episodes as related services, with the exception of oncology and trauma medical MS-DRGs. We proposed that admissions for oncology and trauma medical MS-DRGs be excluded from CJR episodes. Readmissions for medical MS-DRGs are generally linked to the hospitalization for the LEJR procedure as a complication of the illness that led to the surgery, a complication of treatment or interactions with the health care system, or a chronic illness that may have been affected by the course of care. We refer readers to section III.D. of this final rule for background and discussion of the complication rate measure proposed for CJR that includes common medical complications resulting from the previously stated circumstances following LEJR procedures and that may result in related hospital readmissions. For readmissions for medical MS-DRGs, the selection of the primary diagnosis code is not clear-cut, so in the proposed rule we stated our belief that all should be included because providers should focus on comprehensive care for beneficiaries during episodes. We proposed to include all disease-related surgical MS-DRGs for readmissions, such as hip/knee revision, in CJR episodes. We also proposed to include readmissions for all body system-related surgical MS-DRGs as they are generally related to complications of the LEJR procedures. An example of a readmission of this type would be for an inferior vena cava filter placement for treatment of thromboembolic complications of the LEJR. We proposed to exclude hospital admissions for chronic disease surgical MS-DRGs, such as prostatectomy (removal of the prostate gland), as they are unrelated to the clinical condition that led to the LEJR and they would not have been precipitated by the LEJR. Finally, we proposed that hospital admissions for acute disease surgical MS-DRGs, such as appendectomy, be excluded because they are highly unlikely to be related to, or precipitated by, LEJR procedures and would not be affected by LEJR episode care redesign.
With respect to the LEJR proposed diagnosis code exclusions for Part B services for this model, we proposed that ICD-9-CM codes be excluded or included as a category and as identified by code ranges. We proposed that disease-related diagnoses, such as osteoarthritis of the hip or knee, are included. We also proposed that body system-related diagnoses are included because they relate to complications that may arise from interactions with the health care system. An example of this would be pressure pre-ulcer skin changes. Additionally, we proposed that all common symptom diagnoses are included because providers have significant discretion to select these as principal diagnosis codes. We proposed that acute disease diagnoses, such as severe head injury, are excluded. Finally, we proposed that chronic disease diagnoses be included or excluded based on specific clinical and coding judgment as described previously with respect to the original development of the exclusions for LEJR episodes under BPCI, taking into consideration whether the condition was likely to have been affected by the LEJR procedure and recovery period and whether substantial services were likely to have been provided for the chronic condition during the episode. Thus, chronic kidney disease and cirrhosis would be included in the episode, but glaucoma and chemotherapy would be excluded.
Proposed exclusions from CJR episodes were based on care for unrelated clinical conditions represented by MS-DRGs for readmissions during the episode and ICD-9 CM codes for Part B services furnished during the episode after discharge from the anchor hospitalization. The complete lists of proposed excluded MS-DRGs for readmissions and proposed excluded ICD-9-CM codes for Part B services are posted on the CMS Web site at
In the proposed rule, we noted that as CMS moves to implement ICD-10-CM we would make the CJR exclusions that would map to the final ICD-9-CM exclusions for CJR available in the ICD-10-CM format as well. We proposed that all Part A and B-covered items and services that would not be excluded based on the exclusions list are included in the episode. Furthermore, we proposed to update the exclusions list without rulemaking on an annual basis, at a minimum, to reflect annual changes to ICD-CM coding and annual changes to the MS-DRGs under the IPPS, as well as to address any other issues that are brought to our attention by the public throughout the course of the model test.
We would first develop potential exclusions list revisions of MS-DRGs for readmissions and ICD-9-CM (or ICD-10-CM, as applicable) diagnosis codes for Part B services based on our assessment against the following standards:
• We would not exclude any items or services that are—
++ Directly related to the LEJR procedure itself (such as loosening of the joint prosthesis) or the quality or safety of LEJR care (such as post-surgical wound infection or venous thromboembolism); and
++ For chronic conditions that may be affected by the LEJR procedure or post-surgical care (such as diabetes). By this we mean that where a beneficiary's underlying chronic condition would be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care must be managed differently as a result of the chronic condition, then those items and services would be related and would be included in the episode.
• We would exclude items and services for—
++ Chronic conditions that are generally not affected by the LEJR procedure or post-surgical care (such as removal of the prostate). By this we mean that where a beneficiary's underlying chronic condition would not be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care need not be managed differently as a result of the chronic condition, then those items and services would not be related and would not be included in the episode; and
++ Acute clinical conditions not arising from existing episode-related chronic clinical conditions or complications of LEJR surgery from the episode (such as appendectomy).
We proposed to post the potential revised exclusions, which could include additions to or deletions from the exclusions list, to the CMS Web site to allow for public input on our planned application of these standards, and then adopt changes to the exclusions list with posting to the CMS Web site of the final revised exclusions list after our consideration of the public input.
We sought comment on our proposals for identifying excluded readmissions and Part B-covered items and services, as well as our proposed process for updating the exclusions list.
The following is a summary of the comments received and our responses.
A number of other commenters recommended that CMS exclude all hospice services from the CJR episode definition, except for the post-episode spending calculation that analyzes all Part A and Part B spending for model beneficiaries, both for consistency with BPCI and to ensure no incentives for underutilization of the hospice benefit were created by the CJR model. The commenters asserted that all hospice services were unrelated to the LEJR episode, and encouraged CMS to exclude hospice services in order to ensure timely access to hospice for CJR model beneficiaries.
Medicare hospice care is palliative care for individuals with a prognosis of living 6 months or less if the terminal illness runs its normal course. As referenced in § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3 that is, the individual's prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course. When an individual is terminally ill, many health problems are brought on by underlying condition(s), as bodily systems are interdependent. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a Medicare certified hospice program and those services include: nursing care; physical therapy; occupational therapy; speech-language pathology therapy; medical social services; home health aide services (now called hospice aide services); physician services; homemaker services; medical supplies (including drugs and biologics); medical appliances; counseling services (including dietary counseling); short-term inpatient care (including both respite care and care necessary for pain control and acute or chronic symptom management) in a hospital, nursing facility, or hospice inpatient facility; continuous home care during periods of crisis and only as necessary to maintain the terminally ill individual at home; and any other item or service which is specified in the plan of care and for which payment may otherwise be made under Medicare, in accordance with Title XVIII of the Act. The services offered under the Medicare hospice benefit must be available, as needed, to beneficiaries 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act).
The regulations at § 418.54(c) stipulate that the comprehensive hospice assessment must identify the patient's physical, psychosocial, emotional, and spiritual needs related to the terminal illness and related conditions, and address those needs in order to promote the hospice patient's well-being, comfort, and dignity. The comprehensive assessment must take into consideration the following factors: The nature and condition causing admission (including the presence or lack of objective data and subjective complaints); complications and risk factors that affect care planning; functional status; imminence of death; and severity of symptoms (§ 418.54(c)). Additionally, the hospice CoPs at § 418.56(c) require that the hospice must provide all reasonable and necessary services for the palliation and management of the terminal illness, related conditions and interventions to manage pain and symptoms. Therapy and interventions must be assessed and managed in terms of providing palliation and comfort without undue symptom burden for the hospice patient or family. In the December 16, 1983 Hospice final rule (48 FR 56010 through 56011), regarding what is related versus unrelated to the terminal illness, we stated: “. . . we believe that the unique physical condition of each terminally ill individual makes it necessary for these decisions to be made on a case-by-case basis. It is our general view that hospices are required to provide virtually all the care that is needed by terminally ill patients.”
Thus, hospice services furnished to CJR model beneficiaries should be included in the episode definition for the CJR model, regardless of the specific diagnosis of the beneficiary, because hospices are to provide virtually all care that is needed by terminally ill patients. If a CJR beneficiary was receiving hospice services during an episode, either because the beneficiary was enrolled in hospice prior to surgery and continued in hospice following surgery or the beneficiary enrolled in hospice following surgery that initiated the CJR model episode, we believe that hospice services would encompass care related to the LEJR episode and should, therefore, be included in the episode definition. As previously noted, given the comprehensive nature of the hospice benefit and the fact that body systems are interdependent at end of life, virtually all care needed by the terminally-ill individual would be related to the terminal prognosis and thus the responsibility of the hospice. As previously noted, hospices are required, per the Hospice CoPs at § 418.56(c), to provide all reasonable and necessary services for the palliation and management of the terminal illness, related conditions, and interventions to manage pain and symptoms. For patients that underwent LEJR procedures as part of the CJR model that have also elected the Medicare hospice benefit, hospice services would need to adapt and respond to the care needs of the CJR beneficiary following surgery. As in the case of other medically necessary services that would improve a beneficiary's quality of care and quality of life, we expect that CJR model beneficiaries will receive clinically appropriate referrals to hospice in a timely manner. Furthermore, we also believe hospice services could contribute to episode efficiency through improved comprehensive care coordination and management for CJR model beneficiaries that have a terminal prognosis. As previously stated, hospices are required to provide comprehensive care coordination and management per the hospice CoPs at 418.56. As discussed in sections III.F.3. and 5. of this final rule, we will be monitoring for access to care and delayed care and will take actions as described if problems are found. Therefore, we are finalizing our proposal to include hospice services in the CJR model episode definition.
With regard to the commenters' request for data regarding hospice use and the CJR model, we note that the evaluation approach described in IV.D. of this final rule will yield utilization information on CJR beneficiaries' episodes for specific types of providers and services. As discussed in section IV.E. of this final rule, we plan to evaluate the CJR model on an annual basis and release internal periodic summaries to offer useful insight, with
We will not establish a new process to review innovative technologies and make individual determinations regarding their exclusion from the CJR model episode definition, as recommended by some commenters. Because the CJR model is a retrospective reconciliation model that pays all providers and suppliers under the regular Medicare program throughout the episode of care, we believe it is more appropriate to rely on the existing processes under the Medicare program to make determinations about separate payment for new technology items and services. If those existing processes identify new technologies that would qualify for add-on payments under the IPPS or transitional pass-through payment under the OPPS, we will exclude them from the CJR model episode definition to ensure that access to new technology items and services for beneficiaries is not influenced by their care being include in the CJR model. We note that the evaluation
Several commenters suggested that CMS adopt an episode definition for the CJR model that is flexible and condition-specific. A commenter questioned the role of the beneficiary's health care provider in evaluating relatedness to the episode under the proposal and recommended that CMS permit the beneficiary's health care provider to make determinations of relatedness of services to the episode on a case-by case basis specific to a beneficiary's unique clinical condition. A few commenters suggested that CMS' proposed episode definition was more consistent with a total cost of care model by including beneficiaries with chronic conditions and excluding so few services. These commenters stated that if CMS finalizes such a broad definition, risk adjustment would be necessary in order to ensure fair payment to participant hospitals. Some commenters contended that CMS should include in the episode definition only services that are directly related to the procedure and complications for which the hospital could be held accountable. In the view of some commenters, CMS should exclude all chronic conditions from the episode definition, especially when the LEJR episode is unavoidable, such as in trauma cases. Examples provided by commenters of chronic conditions that should be excluded include diabetes and renal failure. Other commenters recommended that CMS only exclude care for unrelated chronic conditions and acute medical conditions such as urinary tract infection and dehydration occurring later than 30 days following discharge from the anchor hospitalization or otherwise shorten the episode duration of the model to 30 days. They claimed that holding the participant hospital accountable through the episode definition for chronic conditions two months after surgery is unfair. A commenter recommended that CMS include all readmissions for the first 30 days following discharge from the anchor hospitalization and thereafter only those hospital readmissions for the subsequent 60 days that are directly related to the LEJR procedures. Overall, a number of commenters expressed concern that unless CMS narrowed the proposed CJR model episode definition to exclude more services or diagnoses or shortened the episode duration, hospitals may be more cautious about treating patients with complex medical status, especially if CMS also does not risk adjust the target prices for the episode based on beneficiary characteristics and specific procedures.
A commenter stated that the proposed episode definition was not sufficiently broad for frail patients, especially those with multiple illnesses who may have had a hip fracture. The commenter contended that providers should be paid to provide comprehensive care and treat the whole person, who can have many different types of interrelated health care needs when he or she is acutely ill due to a hip fracture in the face of serious underlying chronic conditions. The commenter stated that the CJR model would contribute to the fracturing of comprehensive care for vulnerable beneficiaries by excluding some services from the episode definition, even if those services are for clinical conditions that appear to be clinically unrelated to the LEJR episode, and claimed that the solution to this challenge is moving people with complex medical needs into a patient-centered medical home or comprehensive ACO. The commenter stressed that any existing medical home or ACO arrangements that apply to CJR model beneficiaries should be respected by the participant hospital managing the CJR episode, so as to not disrupt or otherwise interfere with comprehensive care for beneficiaries with complex medical needs.
As discussed in the proposed rule and confirmed by the commenters, beneficiaries undergoing LEJR procedures have frequent comorbidities where their management may be affected by the surgery and post-operative recovery period. We do not believe it would be appropriate given the frequent comorbidities experienced by Medicare beneficiaries and the generally elective nature of LEJR to utilize a narrow episode definition for CJR that includes only those services directly related to the LEJR procedure or the quality or safety of the LEJR care, as we are interested in testing inclusive episodes to incentivize comprehensive, coordinated patient-centered care for the beneficiary throughout the episode. The care for many chronic conditions and the development of acute medical conditions may be affected by the LEJR procedure or post-surgical care throughout the post-surgical recovery period that extends significantly beyond 30 days following hospital discharge, a point in time where beneficiaries are usually still receiving PAC services, often including SNF services, and have not returned to their level of presurgical function. Therefore, we do not believe it would be appropriate to define services for chronic conditions and acute medical conditions as related to the CJR
We appreciate the concerns expressed by commenters about holding participant hospitals financially responsible for broad LEJR episodes extending 90 days post-discharge from the anchor hospitalization. We note that we are finalizing 90 days post-discharge from the anchor hospitalization as we proposed for the reasons discussed later in this section. Additionally, we refer readers to section III.C.4.b. of this final rule for the final policy that will risk stratify the target prices based on the presence or absence of a hip fracture for CJR model beneficiaries. We believe that this risk stratification policy addresses the commenters' concerns that beneficiaries with chronic conditions are likely to need more costly care throughout the CJR model episode that would have been inadequately paid under our proposal because these beneficiaries are those most likely to be present in the population receiving LEJR procedures emergently due to a hip fracture. Beneficiaries with chronic conditions are more likely to initiate CJR episodes due to hip fracture than beneficiaries without chronic condition who more likely undergo elective THA or TKA, so the typically higher historical spending for chronically ill beneficiaries will be reflected in the historical CJR episodes used to risk stratify target prices for hip fracture patients. In contrast, beneficiaries undergoing elective THA or TKA are less likely to have chronic conditions, so their typically lower historical spending will be reflected in the historical CJR episodes used to risk stratify target prices for LEJR patients without hip fracture. Thus, risk stratification of target prices based on a beneficiary's hip fracture status should account for patient-specific expenditure variation both directly resulting from more intense care due to the hip fracture itself, as well as indirectly resulting from the higher prevalence of chronic conditions that must be treated and managed in beneficiaries with hip fracture. We also believe that risk stratification based on a model beneficiary's hip fracture status will help to ensure that participant hospitals continue to treat these medically complex patients because target prices for these episodes will reflect the more costly care that these beneficiaries are likely to require based on historical experience.
Additionally, while we agree with the commenter that the ongoing and acute health care needs of medically complex beneficiaries may be addressed through a patient-centered medical home or ACO, many of these vulnerable beneficiaries currently are not included in such models or programs. In the case of other beneficiaries who are included in medical home or ACO models or programs, they may have specific, new care management needs arising from an LEJR procedure that may be best managed by the participant hospital that has substantial expertise in coordinating and managing care throughout LEJR episodes because of the hospital's participation in the CJR model, while the ACO or patient-centered medical home may have less specific expertise in managing beneficiaries recovering from major orthopedic surgery. We expect that participant hospitals, accountable for LEJR episode quality and cost performance under this model, will work closely with all providers and other organizations with which a model beneficiary has established relationships, toward the mutual goal of high quality, well-coordinated care that maximizes the rate of a beneficiary's return of function following surgery.
We are finalizing our proposal to include all Medicare Part A and B items and services in the CJR model episode definition, except for excluded services identified by the CJR model exclusions list, with modification to additionally exclude OPPS transitional pass-through payments for devices.
Several commenters requested further justification of CMS's proposals to include all body system-related surgical MS-DRGs and medical MS-DRGs except oncology and trauma medical MS-DRGs in the CJR episode definition. Several commenters requested further rationale for CMS' proposal to include all PAC services in the episode following an excluded readmission. Another commenter requested clarification on the inclusion of communication, cognitive, and swallowing-related diagnoses in the LEJR episode and CMS' intent in bundling services the commenter believes to be unrelated. The commenter also requested information about how providers could submit clinical justification when an exclusion of therapy services from the CJR model episode is needed. Finally, several commenters expressed support for excluding patients from the model with acute disease diagnoses such as head injury, based on their conclusion that CMS proposed to exclude these beneficiaries due to CMS' proposed exclusion of Part B claims reporting acute disease diagnoses, such as severe head injury.
We do not believe that Part B claims including ICD-9-CM diagnosis codes for rheumatoid arthritis should be excluded from CJR model episodes. This chronic condition is likely to be affected by care during the procedure and recovery period and, therefore, we would consider claims reporting these diagnoses codes to be related to the LEJR episode. With regard to the commenter's concerns about delays in timely treatment as a result of high treatment costs and reduced access to joint replacement procedures for beneficiaries with rheumatoid arthritis, we refer readers to sections III.F.3. and 5. of this final rule for discussion of our plans to monitor for access to care and delayed care due to the potential of the CJR model to direct patients away from more expensive services at the expense of outcomes and quality. We will also not exclude claims for substance abuse and mental health services that are not available in beneficiary claims data because these services are clinically related to LEJR episodes. Claims for substance abuse and mental health services include care for clinical conditions that are related to the CJR episode because these conditions may be affected by the LEJR procedure or post-surgical care. With regard to the commenters' requests that we exclude elective procedures such as cataract surgery, hernia repair, gallbladder procedures, and transurethral resection of the prostate from the CJR model episode definition, while we believe these procedures will be uncommon during the post-surgical recovery period for CJR model beneficiaries that extends 90 days following discharge from the anchor hospitalization, we will not exclude them as unrelated because all of the procedures may be related to care furnished during the post-surgical recovery period. Our exclusion methodology does not allow us to identify those procedures that are truly elective; that is, the condition was present and surgery was planned prior to the LEJR procedure and scheduled during the 90-cay post-hospital discharge period.
While we agree with the commenter that chemotherapy services should be excluded from the CJR model episode, our exclusion methodology for Part B services does not rely upon ICD-9-CM procedure codes but instead upon ICD-9-CM (or equivalent ICD-10-CM) diagnosis codes reported on Part B claims. We note that the Part B payment systems, including those for physicians' services, Part B drugs, and institutional services, reject claims that do not report valid ICD-9-CM diagnosis codes. Therefore, we believe that our proposal to base Part B exclusions only on ICD-9 diagnosis codes and not additionally upon ICD-9 procedure codes should allow us to identify and exclude from the CJR episodes all Part B claims for chemotherapy administration services. Providers and suppliers do not report ICD-9-CM (or equivalent ICD-10-CM) procedure codes on Part B claims because they are paid for their chemotherapy and other services on the basis of the CPT or HCPCS codes that describe those services. However, these Part B claims must also include ICD-9-CM (or equivalent ICD-10-CM) diagnosis codes. CMS requires ICD-9-CM (or equivalent ICD-10-CM) procedure codes to be reported only on Part A claims, which are excluded from the CJR model on the basis of readmission MS-DRG rather than ICD-9 (or equivalent ICD-10) codes, so adding ICD-9-CM (or equivalent ICD-10-CM) procedure codes to the Part B exclusions list is not necessary.
As we stated in the proposed rule, for readmissions to medical MS-DRGs the selection of the primary diagnosis code is not clear-cut so we believe they should all be included in the episode definition so that providers focus on comprehensive care to beneficiaries in episodes. We reiterate our belief that readmissions to medical MS-DRGs are generally linked to the hospitalization for the procedure as a complication of the illness that led to the surgery, a complication of treatment or interactions with the health care system, or a chronic illness that may have been affected by the course of care. Moreover,
We did not propose to exclude any PAC services in the 90-day post-hospital discharge period, even when those PAC services follow an excluded readmission. As Part A services are generally intended to be comprehensive in nature and because the beneficiary in a CJR model episode would still be in the post-operative recovery period following LEJR surgery, we believe any PAC services provided during the episode would be related to the LEJR procedure. Regardless of the reason for the hospitalization immediately preceding the initiation of PAC services, the PAC provider would need to address the beneficiary's post-surgical recovery from the LEJR procedure, even if the PAC services immediately followed an unrelated readmission to the hospital.
We did not propose to exclude claims for Part B services for communication, cognitive, or swallowing-related diagnoses from the CJR model episode definition because we believe these diagnoses are due either to chronic conditions whose care may be affected by the LEJR procedure or post-surgical care or to complications of the procedure, such as stroke, that result in these diagnoses. Therefore, we consider all Part B claims reporting these diagnoses in the principal diagnosis field to be related to the CJR episode. Providers are unable to submit clinical justification or other special requests for services to be designated as unrelated to the episode if one of these diagnoses is in the principal diagnosis field on claims. The CJR model is testing LEJR episode payment and we need consistency in the scope of the episode for the model. We will include all related Part A and Part B services as identified in this final rule in the calculation of episode target prices based on historical CJR episode data and in the calculation of actual episode spending for a model performance year.
Finally, in response to the commenters who supported the exclusion of beneficiaries with acute disease diagnoses, such as head injury, from the CJR model, we want to clarify that we did not propose to exclude these beneficiaries from the model. Instead, we proposed to exclude Part B claims reporting acute disease diagnoses from the episode because we consider these services to be unrelated under the episode definition. Therefore, we will not include claims for Part B services reporting excluded acute disease ICD-9-CM (or equivalent ICD-10-CM) diagnosis codes in calculating target prices based on historical CJR episodes or in calculating actual episode spending that will be compared to the episode's target price in the CJR model.
We are finalizing our proposal to exclude the specific list of MS-DRGs for readmissions and ICD-9-CM (or equivalent ICD-10-CM) diagnosis codes that is posted on the CMS Web site at:
Another commenter recommended that the CJR episode include a warranty for complications associated with surgery and other treatment, that is, if complications occur, they should be treated at no additional cost to the patient or Medicare.
Our proposal not to exclude claims for diagnoses related to the quality and safety of care during the episode is the basis for our excluded list of MS-DRGs for readmissions and ICD-9-CM (or equivalent ICD-10-CM) diagnosis codes for Part B services and, therefore, this list would not apply to the anchor hospitalization itself where hospital-acquired conditions that were not present on admission could be reported.
As discussed in sections III.C.5. and 6. of this final rule, the model evaluation will examine changes in utilization, as well as outcomes and quality, in order to assess the impact of the CJR model on the aims of improved care quality and efficiency as well as well as reduced health care costs. We refer readers to section IV. of this final rule for further information on the planned evaluation. We have an ongoing process to review claims data regarding potential candidates for additions to the list of hospital-acquired conditions, so we do not believe there is a need to specifically identify CJR episodes for analysis because the IPPS claims included in CJR episodes would already be considered in the ongoing process used by CMS in the Hospital-Acquired Condition Reduction Program.
In response to the commenter who recommended for the CJR model that if complications due the LEJR procedure occur, they should be treated at no additional cost to the patient or Medicare, we note that because the CJR model uses a retrospective payment approach, we will rely on the existing Medicare program policies under the Hospital-Acquired Condition Reduction Program that define the specific circumstances in which Medicare will not make additional payment for a condition occurring after surgery. When these circumstances occur for CJR model beneficiaries in episodes, the existing Medicare program policies apply and Medicare would not provide additional payment. We do not believe it would be appropriate to establish policies specific to the CJR model regarding Medicare nonpayment for other complications, and we further note that some complications may not be preventable. The final pay-for-performance methodology for the CJR model as discussed in section III.C.5. of this final rule provides strong financial incentives for participant hospitals to coordinate and manage care to reduce complications, as the THA/TKA Complications measure (NQF #1550) contributes half of the available points for the hospital's composite quality score that determines the hospital's eligibility for reconciliation payments and quality incentive payments.
Commenters who supported an exclusions list update process outside of rulemaking did not suggest specific revisions to our proposed criteria for updating the exclusions, namely that:
• We would not exclude any items or services that are—
++ Directly related to the LEJR procedure itself (such as loosening of the joint prosthesis) or the quality or safety of LEJR care (such as post-surgical wound infection or venous thromboembolism); and
++ For chronic conditions that may be affected by the LEJR procedure or post-surgical care (such as diabetes). By this we mean that where a beneficiary's underlying chronic condition would be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care must be managed differently as a result of the chronic condition, then those items and services would be related and would be included in the episode.
• We would exclude items and services for—
++ Chronic conditions that are generally not affected by the LEJR procedure or post-surgical care (such as removal of the prostate). By this we mean that where a beneficiary's underlying chronic condition would not be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care need not be managed differently as a result of the chronic condition, then those items and services would not be related and would not be included in the episode; and
++ Acute clinical conditions not arising from existing episode-related chronic clinical conditions or complications of LEJR surgery from the episode (such as appendectomy).
Thus, we continue to believe these criteria provide the appropriate clinical review framework for updates to the CJR model exclusions. Finally, we believe that our proposed process to post the potential revised exclusions, which could include additions to or deletions from the exclusions list, to the CMS Web site to allow for public input on our planned application of these standards, and then adopt changes to the exclusions list with posting to the CMS Web site of the final revised exclusions list after our consideration of the public input, is consistent with the recommendation of commenters that we use a transparent process reflective of robust opportunity for public input. Conducting this update process outside of rulemaking based on the criteria set forth in this final rule will allow us the greatest flexibility to update the exclusions as changes to the MS-DRGs and ICD diagnosis codes, upon which our exclusions rely, are released. This process will also allow us to respond quickly to any episode definition issues that arise during implementation of the model across the broad array of participant hospitals in the selected MSAs. We would widely publicize the opportunity for review and public input through the CMS Web site and listservs. We also note that any changes to our overall approach to identifying excluded services or to our criteria for evaluating services for exclusion would be addressed through rulemaking. Therefore, we are finalizing our proposal to update the exclusions list annually, at a minimum, using the process as described.
With ICD-10-CM implementation beginning in October 2015, we are making available the final CJR model Part B exclusions list in ICD-10-CM format as additional worksheet tabs to the final exclusions list posted on the CMS Web site at:
To develop the ICD-10-CM exclusions list, we began with the list of final CJR ICD-9-CM code ranges. From that list of ranges, we generated an expanded list of all excluded ICD-9-CM codes. We then compared the list of excluded ICD-9-CM codes against both the ICD-9-CM-to-ICD-10-CM and ICD-10-CM-to-ICD-9-CM General Equivalence Mappings (GEMs) available at:
• In the ICD-9-CM-to-ICD-10-CM GEM file, ICD-9-CM code 85110 (Cortex (cerebral) contusion with open intracranial wound, unspecified state of consciousness) maps to ICD-10-CM code S0190XA (Unspecified open wound of unspecified part of head, initial encounter), but there is not a corresponding map from S019XA to 85110 in the ICD-10-CM-to-ICD-9-CM GEM.
• In the ICD-10-CM-to-ICD-9-CM GEM file, ICD-10-CM code A0101 (Typhoid meningitis) maps to ICD-9-CM code 020 (Typhoid), but there is not a corresponding map from 020 to A0101 in the ICD-9-CM to-ICD-10-CM GEM.
After compiling the results from both GEM files, we created a list of every billable ICD-10-CM code and whether each billable ICD-10-CM code matched to an excluded ICD-9-CM code. We then moved from the list of individual codes to a list of ICD-10-CM three-digit categories (for example, ICD-10-CM code A0101 (Typhoid meningitis) is in ICD-10-CM category A01 (Typhoid and paratyphoid fevers)) to present the final CJR exclusions. We excluded ICD-10-CM categories in which 100 percent of billable ICD-10-CM codes matched to an excluded ICD-9-CM code. There are 574 such categories, and we consider these CD-10-CM categories excluded based on a direct mapping from ICD-9-CM (see the “Excluded Part B ICD10 Direct” worksheet tab in the final exclusions list file). We did not exclude ICD-10-CM categories in which no billable ICD-10-CM codes matched to an excluded ICD-9-CM code. There are 1,258 categories, and we consider these categories not excluded based on a direct mapping from ICD-9-CM. For those 71 categories in which only some billable ICD-10-CM codes in the category matched to an excluded ICD-9-CM code after mapping, we excluded 48 ICD-10-CM categories where all of the ICD-10-CM codes in the category met one or more of our two final criteria for updating the excluded codes on the exclusions list as described previously in this section (see the “Excluded Part B ICD10 Medical” worksheet tab in the final exclusions list file). Specifically, the 48 ICD-10-CM categories that are excluded on this basis include ICD-10-CM codes that meet one or more of the following two criteria:
• Chronic conditions that are generally not affected by the LEJR procedure or post-surgical care (such as removal of the prostate). By this we mean that where a beneficiary's underlying chronic condition would not be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care need not be managed differently as a result of the chronic condition, then those items and services would not be related and would not be included in the episode.
• Acute clinical conditions not arising from existing episode-related chronic clinical conditions or complications of LEJR surgery from the episode (such as appendectomy).
We did not exclude the 23 other ICD-10-CM categories in which only some billable ICD-10-CM codes in the category matched to an excluded ICD-9-CM code after mapping because the ICD-10-CM codes in these categories met one or more of the following criteria:
• Directly related to the LEJR procedure itself (such as loosening of the joint prosthesis) or the quality or safety of LEJR care (such as post-surgical wound infection or venous thromboembolism).
• For chronic conditions that may be affected by the LEJR procedure or post-surgical care (such as diabetes). By this we mean that where a beneficiary's underlying chronic condition would be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care must be managed differently as a result of the chronic condition, then those items and services would be related and would be included in the episode.
When constructing prices for CJR, we will exclude Part B services from target prices and from performance year episodes based on the final excluded ICD-9-CM code ranges and final excluded ICD-10-CM code categories as appropriate, based on the applicable version of ICD diagnosis coding at the time the services was furnished.
In addition, we have addressed changes to the CJR model exclusion list that result from revisions for the FY 2016 IPPS. From FY 2015 to FY 2016, there were few changes to IPPS MS-DRGs that appear on the MS-DRG excluded readmissions list for the CJR model. Specifically, the FY 2016 IPPS update contains changes to existing MS-DRGs 237 and 238, Major Cardiovascular Procedures with MCC and without MCC, respectively, which are on the exclusions list for CJR episodes. For discharges after October 1, 2015, inpatient stays that previously would have been assigned to MS-DRG 237 or 238 will be assigned to one of the following MS-DRGs:
• 268 Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC.
• 269 Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC.
• 270 Other Major Cardiovascular Procedures with MCC.
• 271 Other Major Cardiovascular Procedures with CC.
• 272 Other Major Cardiovascular Procedures without CC/MCC.
We also note that the list of excluded readmissions posted with the proposed rule inadvertently omitted MS-DRGs 490 and 491, which were eliminated in the FY 2015 IPPS Final Rule and from which MS-DRGs 518, 519, and 520 were created in FY 2015. We are adding MS-DRGs 490 and 491 to the list of excluded readmissions posted with this final rule as we will exclude readmissions in MS-DRGs 490 and 491 for the purposes of calculating CJR target prices.
Additional information on the new MS-DRGs is provided in the FY 2016 IPPS final rule (80 FR 49371 through 49390, available at:
We are finalizing our proposal, with modification to remove the term “independent” preceding outpatient therapy services, that related items and services included in CJR episodes, defined by all of the clinical conditions requiring an admission to an IPPS hospital that results in a discharge from MS-DRG 469 or 470 would be the following items and services paid under Medicare Part A or Part B, after the final exclusions are applied:
• Physicians' services.
• Inpatient hospital services (including readmissions), with certain exceptions, as discussed later in this section.
• IPF services.
• LTCH services.
• IRF services.
• SNF services.
• HHA services.
• Hospital outpatient services.
• Outpatient therapy services.
• Clinical laboratory services.
• DME.
• Part B drugs.
• Hospice.
Medicare spending for related items and services will be included in the historical data used to set episode target prices, as well as in the calculation of actual episode spending that would be compared against the target price to assess the performance of participant hospitals. In contrast, Medicare spending for unrelated items and services (excluded from the episode definition) will not be included in the historical data used to set target prices or in the calculation of actual episode spending.
Additionally, we are finalizing our proposal to exclude inpatient hospital readmissions based on the list of excluded MS-DRGs and Part B services that report an excluded ICD-9-CM (or equivalent ICD-10-CM) diagnosis code as the principal diagnosis based on the list posted on the CMS Web site at:
We will first develop potential exclusions list revisions of MS-DRGs for readmissions and ICD-9-CM (or equivalent ICD-10-CM) diagnosis codes for Part B services based on our assessment against the following standards:
• We would not exclude any items or services that are—
++ Directly related to the LEJR procedure itself (such as loosening of the joint prosthesis) or the quality or safety of LEJR care (such as post-surgical wound infection or venous thromboembolism); and
++ For chronic conditions that may be affected by the LEJR procedure or post-surgical care (such as diabetes). By this we mean that where a beneficiary's underlying chronic condition would be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care must be managed differently as a result of the chronic condition, then those items and services would be related and would be included in the episode.
• We would exclude items and services for—
++ Chronic conditions that are generally not affected by the LEJR procedure or post-surgical care (such as removal of the prostate). By this we mean that where a beneficiary's underlying chronic condition would not be affected by the LEJR procedure, or where the beneficiary's LEJR or post-LEJR care need not be managed differently as a result of the chronic condition, then those items and services would not be related and would not be included in the episode; and
++ Acute clinical conditions not arising from existing episode-related chronic clinical conditions or complications of LEJR surgery from the episode (such as appendectomy).
We will post the potential revised exclusions, which could include additions to or deletions from the exclusions list, to the CMS Web site to allow for public input on our planned application of these standards, and then adopt changes to the exclusions list with posting to the CMS Web site of the final revised exclusions list after our consideration of the public input. Through the process for public input on potential revised exclusions and then posting of the final revised exclusions, we will also provide information to the public about when the revisions would take effect and to which episodes they would apply. These parameters could vary, depending on the relationship of exclusion list changes to annual ICD-CM or MS-DRG changes or to other issues brought to our attention by the public. While these revised exclusions may correspond to the time when we provide new target prices for a performance year, depending on the timing of when they would take effect and to which episodes they would apply, we would recalculate target prices as necessary.
The final definitions are set forth in § 510.2 which has been revised to remove proposed (b)(3) for inpatient hospital readmission services because hospital readmissions are already referenced in (b)(2). The remaining provisions under § 510.2(b) have been renumbered accordingly. The final policies for included services, excluded services, and updating the lists of excluded services are set forth in § 510.200(b), (d), and (e). We note that § 510.200(d)(3) has been renumbered to § 510.200(d)(4) and § 510.200(d)(3) added to state, “Transitional pass-through payments for medical devices as defined in § 419.66 of this chapter.” In addition, § 510.200(b)(10) has been modified to read “Outpatient therapy services.”
While we proposed to identify LEJR episodes by an acute care hospitalization for MS-DRG 469 and 470, we recognize that the beneficiary's care for an underlying chronic condition, such as osteoarthritis, which ultimately leads to the surgical procedure, typically begins months to years prior to the surgical procedure. Because of the clinical variability leading up to the joint replacement surgery and the challenge of identifying unrelated services given the multiple chronic conditions experienced by many beneficiaries, we did not propose to begin the episode prior to the anchor hospitalization (that is, the admission that results in a discharge under MS-DRG 469 or 470). In the proposed rule, we stated our belief that the opportunities for care redesign and improved efficiency prior to the inpatient hospitalization are limited for an episode payment model of this type that focuses on a surgical procedure and the associated recovery once the decision to pursue surgery has been made, rather than an episode model that focuses on decision-making and management of a clinical condition itself (such as osteoarthritis).
We proposed to begin the episode with an inpatient anchor hospitalization for MS-DRG 469 or MS-DRG 470 in
We proposed that the defined population of Medicare beneficiaries whose care will be included in CJR meet the following criteria upon admission to the anchor hospitalization. We noted that these criteria are also consistent with Model 2 of BPCI, as well as most other Innovation Center models that do not target a specific subpopulation of beneficiaries. We proposed that the LEJR episodes for all beneficiaries in the defined population will be included in CJR (although we proposed that certain episodes may be canceled for purposes of determining actual episode payments for reasons discussed later in this final rule), and we refer readers to section III.F.2. of this final rule for further discussion of beneficiary notification and a beneficiary's ongoing right under CJR to obtain health services from any individual or organization qualified to participate in the Medicare program.
• The beneficiary is enrolled in Medicare Part A and Part B throughout the duration of the episode.
• The beneficiary's eligibility for Medicare is not on the basis of End Stage Renal Disease (ESRD).
• The beneficiary must not be enrolled in any managed care plan (for example, Medicare Advantage, Health Care Prepayment Plans, cost-based health maintenance organizations).
• The beneficiary must not be covered under a United Mine Workers of America health plan, which provides healthcare benefits for retired mine workers.
• Medicare must be the primary payer.
Our proposal for inclusion of beneficiaries in CJR is as broad as feasible, representing all those LEJR episodes for which we believe we have comprehensive historical Medicare payment data that allow us to appropriately include Medicare payment for all related services during the episode in order to set appropriate episode target prices. For beneficiaries whose care we proposed to exclude from the model, we are unable to capture or appropriately attribute to the episode the related Medicare payments because of Medicare's payment methodology. For example, if a beneficiary is enrolled in a Medicare Advantage plan, Medicare makes capitated payments (and providers do not submit complete claims data to CMS), so we would not have a way to identify and attribute the portion of those payments related to an LEJR episode. More information on setting bundled payment target prices for episodes under CJR is available in section III.C.4.b. of this final rule. Including the broadest feasible array of Medicare beneficiaries' admissions in the model would provide CMS with the most robust information about the effects of this model on expenditures and quality for beneficiaries of the widest variety of ages and comorbidities, and allow the participant hospitals the greatest opportunity to benefit financially from systematic episode care redesign because most Medicare beneficiaries undergoing an LEJR procedure will be included in the model and, therefore, subject to the policies we proposed.
We sought comment on our proposal on when to begin the CJR episode, as well as to identify the care included for beneficiaries.
The following is a summary of the comments received and our responses.
Several orthopedic surgeons commented that physician treatment and care management begin prior to surgery, with the physician continuing to manage care during surgery, following surgery, and throughout the entire PAC period. These commenters were concerned that beginning the episode with the hospital admission would result in beneficiaries choosing and initiating care plans designed with their treating physicians and later, when hospitalized, the beneficiaries would receive conflicting care plans and, ultimately, experience adverse outcomes.
Many commenters recommended starting the episode earlier than the hospital admission. Some commenters recommended starting the episode once the decision to pursue surgery is made, and some recommended specific timeframes that ranged between four to eight weeks prior to the surgery. Some commenters provided examples of presurgical services that they have found improve patient outcome and satisfaction, improve care quality, and reduce costs, such as comprehensive patient evaluations to assess a beneficiary's overall condition and chronic comorbid conditions; pre‐surgical counseling for non‐medical pain management; home safety reviews; post‐discharge planning; patient and caregiver education; weight loss programs; and physical therapy. Some commenters requested that CMS consider additional program rule waivers for the CJR model, beyond those specifically proposed, to facilitate the provision of various preoperative services and incentives that are not allowed or payable under current Medicare rules.
A few commenters were concerned that starting the episode with the hospital admission may lead to participants shifting costs to just prior to the start of the episode to receive payments for those services in addition to the bundle. To minimize gaming, they recommended starting the episode once the surgery has been elected and prior to the hospital admission, which is consistent with many private sector models.
We appreciate commenters' suggestions of pre-surgical services and
We believe that using the date of admission as the start of the episode is appropriate as hospitals are unlikely to shift related services earlier than when is clinically indicated. With respect to expanding the waivers to presurgical services that are not currently covered or payable, we have finalized several waivers of Medicare program rules as discussed in section III.C.11. of this final rule specifically to assist participant hospitals in efficient and effective care coordination and care management for CJR beneficiaries, and we do not believe it would be consistent with the model design or otherwise necessary for the model test to implement waivers for the preoperative period. While we appreciate commenters' interest in providing additional presurgical services that may enhance care coordination and care management, the waivers of Medicare program rules are only available if the beneficiary is in the episode at the time a service under the waiver is furnished. We believe that allowing waivers in the preoperative period prior to the anchor hospitalization, based on an expectation that a beneficiary will be in a CJR Model episode, would not be appropriate as there is no guarantee that the beneficiary will actually initiate a CJR Model episode and qualify for services furnished under a waiver.
For purposes of the CJR model, we continue to believe that beginning the episode with the anchor hospitalization is most appropriate due to the clinical variability leading up to the joint replacement surgery and the challenge of distinguishing between related and unrelated services. We also believe that beginning the episode with the anchor hospitalization, and not prior to admission, would be easier to administer and provide more consistent episodes for testing the CJR Model. Therefore, we are finalizing our proposal to begin the episode with admission to an inpatient anchor hospitalization for MS-DRG 469 or MS-DRG 470 in accordance with the methodology described.
Many commenters recommended that if we did not exclude high risk cases, we must develop more robust risk adjustment to account for socioeconomic, clinical, or other risk factors that are out of the hospital's control and impact patients' health and recovery. Some commenters were concerned that without accurate risk adjustment, hospitals will have an incentive to avoid higher-risk LEJR candidates. A commenter cited a study that found significant differences in Medicare spending per beneficiary during the 90-day episode based on various patient characteristics, such as type of LEJR surgery; emergency versus scheduled surgery; hip fractures versus degenerative conditions; patients age 85 or older; patients with multiple comorbidities, and patients who were dual eligible. The commenter asserted that robust risk adjustment based on the risk profile of each hospital's patients is essential for the CJR model because individual hospitals will not have enough enrollment to spread their risk. A few commenters recommended that at least the initial implementation of the Model should exclude vulnerable populations with complicated or intensive care needs until the CJR model demonstrates sufficient quality outcomes and has developed accurate risk adjustments and patient safeguards to ensure high-quality care for populations that the commenters believe could face serious care disadvantages in the CJR model.
We refer readers to section III.C.4.b. of this final rule for the final policy that will risk stratify the target prices based on the presence or absence of a hip fracture for CJR model beneficiaries. We believe that this risk stratification policy addresses many of the commenters' concerns that beneficiaries with serious conditions, acute diseases, and chronic conditions are likely to need more costly care throughout the CJR model episode that would have been inadequately paid under our proposal because these beneficiaries are those most likely to be present in the population receiving LEJR procedures emergently due to a hip fracture.
We refer readers to section III.C.3. of this final rule for discussion of the effect on reconciliation payments on services furnished by non-participating and opt-out physicians and to section III.C.10.a. of this final rule for discussion of issues related to gainsharing payments and alignment payments.
• The beneficiary is enrolled in Medicare Part A and Part B throughout the duration of the episode.
• The beneficiary's eligibility for Medicare is not on the basis of ESRD.
• The beneficiary must not be enrolled in any managed care plan (for example, Medicare Advantage, Health Care Prepayment Plans, cost based health maintenance organizations).
• The beneficiary must not be covered under a United Mine Workers of America health plan, which provides healthcare benefits for retired mine workers.
• Medicare must be the primary payer.
The final policies for beginning an episode are set forth in § 510.210(a). The final policies for beneficiary inclusion are set forth in § 510.205.
We proposed that once the episode begins for a beneficiary whose care is included, the episode continues until the end as described in the next section of this final rule, unless the episode is canceled because the beneficiary no longer meets the same inclusion criteria proposed for the beginning of the episode at any point during the episode. When an episode is canceled, we proposed that the services furnished to beneficiaries prior to and following the episode cancellation will continue to be paid by Medicare as usual but we will not calculate actual episode spending that would otherwise under CJR be reconciled against the target price for the beneficiary's care (see section III.C.6. of the proposed rule). As discussed in section III.C.11.a. of the proposed rule, if the beneficiary is in the episode at the time the service under the waiver is furnished, the waiver is available, even if the episode is later canceled.
In the proposed rule, we stated our belief that it would be appropriate to cancel the episode when a beneficiary's status changes during the episode such that they no longer meet the criteria for inclusion because the episode target price reflects full payment for the episode, yet we would not have full Medicare episode payment data for the beneficiary to reconcile against the target price.
In addition, we proposed that the following circumstances would also cancel the episode:
• The beneficiary is readmitted to an acute care hospital during the episode and discharged under MS-DRG 469 or 470 (in this case, the first episode would be canceled and a new LEJR episode would begin for the beneficiary).
• The beneficiary dies during the anchor hospitalization.
• The beneficiary initiates an LEJR episode under BPCI Models 1, 2, 3 or 4.
In the case of beneficiary death during the anchor hospitalization, we stated our belief that it would be appropriate to cancel the episode as there are limited efficiencies that could be expected during the anchor hospitalization itself. In the case of beneficiary readmission during the first
We sought comment on our proposals to cancel episodes once they have begun but prior to their end.
The following is a summary of the comments received and our responses.
We expect some limited circumstances where participant hospitals will have limited ability to coordinate care. However, we believe that participant hospitals will be incentivized to seek creative solutions that do not rely on in-person services, and we are finalizing our proposal that all other beneficiary episodes would remain in the CJR model, regardless of where the beneficiary is located. Payment for beneficiaries in these circumstances will be reflected in the target prices based on historical utilization.
• The beneficiary is readmitted to a participant hospital during the episode and discharged under MS-DRG 469 or 470.
• The beneficiary initiates an LEJR episode under BPCI Models 1, 2, 3 or 4.
We are modifying our proposal for canceling an episode when a beneficiary dies during an anchor hospitalization. Under our final policy, the following circumstance would also cancel an episode:
• The beneficiary dies at any time during the episode.
The final policies for cancellation of an episode are set forth in § 510.210(b). We note that § 510.210(b)(4) has been revised to state that an episode is canceled if the beneficiary dies during the episode.
LEJR procedures are typically major inpatient surgical procedures with significant associated morbidity and a prolonged recovery period that often is marked by significant PAC needs, potential complications of surgery, and more intense management of chronic conditions that may be destabilized by the surgery. In light of the course of recovery from LEJRs for Medicare beneficiaries, we proposed that an episode in the CJR model end 90 days after discharge from the acute care hospital in which the anchor hospitalization (for MS-DRG 469 or 470) took place. Hereinafter, we refer to the proposed CJR model episode duration as the “90-day post-discharge” episode. To the extent that a Medicare payment for included services spans a period of care that extends beyond the episode duration, we proposed that these payments would be prorated so that only the portion attributable to care during the fixed duration of the episode is attributed to the episode spending.
We noted that for the vast majority of beneficiaries undergoing a hip or knee joint replacement, a 90-day post-
In proposing the 90-day post-discharge duration for LEJR episodes in CJR, we took into consideration the literature regarding the clinical experiences of patients who have undergone THA or TKA procedures. In 2007-2008, the 30-day all-cause readmission rate for primary THA among Medicare beneficiaries was 8.5 percent, while the 90-day all-cause readmission rate was 11.9 percent, indicating that while the rate of readmission begins to taper after 30 days, readmissions continue to accrue throughout this 90 day window.
• Surgical site infections (18.8 percent).
• Prosthesis issues (7.5 percent).
• Venous thromboembolism (6.3 percent).
• Bleeding (6.3 percent).
• Orthopedic related (5.1 percent).
• Pulmonary (3.2 percent).
• Cardiac (2.4 percent).
• CNS or CVA (2.4 percent).
• Ileus or Obstruction (2.3 percent).
• Sepsis (2.1 percent).
In addition, the authors concluded that “readmissions after surgery were associated with new post-discharge complications related to the procedure and not exacerbation of prior index hospitalization complications, suggesting that readmissions after surgery are a measure of post-discharge complications.” Finally, with regard to the potential for readmission for joint replacement revision within a 90-day post-discharge episode, in a twelve-year study on Medicare patients conducted by Katz, et al., the risk of revision after THA remained elevated at approximately 2 percent per year for the first eighteen months and then 1 percent per year for the remainder of the follow-up period.
In order to address the complication rates associated with elective primary total hip or knee arthroplasty, we developed an administrative claims-based measure (for a detailed description of the measure see section III.D. of the proposed rule). During the development of the Hospital-level Risk-Standardized Complication Rate (RSCR) following elective primary THA or TKA or both, complications of elective primary total hip or knee replacement were identified to occur within specific timeframes.
Other factors further supporting a 90-day post-discharge episode duration are the elevated risk of readmission throughout this time period, as well as the fact that treatment for pneumonia is considered by American Thoracic Society guidelines to be “health care-associated” if it occurs up to 90 days following an acute care hospitalization of at least 2 days.
We also refer readers to a study by the Assistant Secretary for Planning and Evaluation (ASPE) in the U.S. Department of Health and Human Services that assessed the mean payments for acute care, PAC, and physician services grouped in the MS-DRG 470.
Finally, payment and length of stay analyses found the average length of stay in PAC during a 90-day post-discharge episode for MS-DRG 470 to be 47.3 days, indicating that a longer period post-discharge of 90 days is reasonable as a proposal to end the episode of care.
Other tests of bundled payment models for hip and knee replacement have used 90-day post-discharge episodes.
We also considered proposing a 60-day post-discharge episode duration, but the full transition of care following LEJR would exceed this window for some beneficiaries, especially those who are discharged to an institutional PAC provider initially and then transition to home health or outpatient therapy services for continued rehabilitation. According to a report from ASPE on Medicare beneficiaries receiving PAC following major joint replacement in 2006, 13 percent first receive SNF services and then receive HHA services—with a total mean episode duration of 56.8 days.
Therefore, in order to be inclusive of most possible durations of recovery, and services furnished to reach recovery, we proposed the 90-day post-discharge episode duration for CJR. We stated our belief that beneficiaries will benefit from aggressive management and care coordination throughout this episode duration, and hospitals will have opportunities under CJR to achieve efficiencies from care redesign during the 90-day post-discharge episode period.
We sought comment on our proposal to end the episode 90 days after the date of discharge from the anchor hospitalization, as well as on the alternative we considered of ending the CJR episode 60 days after the date of discharge.
The following is a summary of the comments received and our responses.
A few commenters supported a 90-day episode duration, but recommended that we revise the 90-day post-discharge episode duration to begin from the date of surgery instead of discharge, thereby aligning the episode with the MPFS global surgical period and billing policies. A commenter who appeared to believe that CMS proposed to begin the CJR episode immediately after discharge from the anchor hospitalization and extend the episode 90 days post-hospital discharge, rather than upon admission for the anchor hospitalization as CMS actually proposed, asserted that beginning the episode after hospital discharge would make it difficult to understand and account for patient acuity changes within the episode in the post-discharge period as the hospital length-of-stay is related to the PAC acuity of the beneficiary following hospital discharge, especially if the beneficiary has comorbidities. In other words, the commenter believed that beneficiaries with comorbidities would be more likely to have longer anchor hospitalizations and associated higher intensity of PAC services, yet CMS would not understand these relationships if the anchor hospitalization was not included in the episode.
Several commenters supported a 60-day post-discharge episode duration because LEJR patients are nearly fully recovered within 60 days. Some commenters asserted that PAC services associated with LEJR rarely occur after 60 days post-discharge; some commenters cited data that the majority of services for patients with LEJR surgery occur within two months of discharge with only a 6.2 percent change in the total cost of an episode between a 60-day episode and a 90-day episode. Some of these commenters asserted that a 60-day episode would be sufficient to evaluate quality and cost, and a longer duration would increase the financial risk for hospitals without providing significant value to CMS. Some commenters asserted that a 90-day duration increases the risk that unrelated random events that occur well after surgery will disadvantage the hospitals by unfairly impacting participants' performance.
Some commenters recommended a hybrid approach, with every service within the first 30 days post-discharge assumed to be related unless specifically excluded, and services in days 31-90 included only if they meet specified criteria for relatedness.
Some commenters recommended that the episode end prior to 60 days post-discharge. A commenter recommended an episode length of 45 to 60 days, asserting that hospital admissions past the 45 to 60 day window would be for chronic medical admissions that are unrelated to the LEJR procedure. A few commenters recommended that we limit the episode to 30 days citing various rationales, such as: A SNF stay must commence within 30 days of a hospitalization; 30 days better aligns with other quality improvement initiatives such as readmissions; analyses by Medicare Payment Advisory Commission (MedPAC) and the Congressional Budget Office that found that the majority of a bundled payment's episode costs are incurred during the first 30 days; and hospitals may find it difficult to manage follow-up care after 30 days if patients have more than one residence. Several commenters asserted that multiple factors can exacerbate comorbidities in the period beyond 30 days post-operatively, and a model of longer duration that broadly defines related services could result in participant hospitals being more cautious about selecting patients for LEJR and complex patients being discouraged from seeking LEJR procedures in a participant hospital. A few of these commenters noted that Tennessee and Arkansas only include 30 days post-discharge for unrelated chronic conditions in their bundled payment episodes. A commenter shared its experience that, while nearly all patients are diligent about keeping 14-day and 30-day post-operative appointments, those with good outcomes are less likely to return for appointments at 90 days and beyond, resulting in potentially skewed outcomes as patients with complications are much more likely to keep a follow-up appointment at 90 days.
Some commenters recommended giving participant hospitals the flexibility to define the episode duration, either as a duration for all of a participant hospital's LEJR episodes, or to choose a duration based on a patient's clinical condition and comorbidities. A couple of commenters
Other commenters suggested even longer episode durations. A commenter recommended increasing the episode duration to 150 days post-discharge to promote better long-term results and reduce the likelihood of delaying care beyond the end of the episode, specifically urging CMS to adopt a longer episode period for certain clinically-complex subpopulations with predictably longer recovery timeframes. For outcome and quality measurement purposes, some commenters recommended that participant hospitals be held accountable for a longer period, with suggestions of six months, a year, and even two to three years. A commenter recommended increasing the episode duration to two years to better manage the improvements for the entirety of the treatment. A commenter recommended increasing the episode duration to five years to account for the late effects of sub-optimal implant selection.
Due to the concentration of Medicare spending in the earlier part of the episode, we also believe that a 90-day episode duration only nominally increases the hospital's financial risk when compared to 30 or 60 days. While we understand that uncommon events during the 90-day episode may occur for an individual beneficiary, resulting in an unanticipated or unavoidable need for costly health care services, we believe that our episode definition that excludes unrelated items and services and our payment policies, namely the adjustment for high payment episodes and stop-loss policies discussed in sections III.C.3. and III.C.8. of this final rule, provide sufficient protections for participant hospitals from undue financial responsibility for the care of unrelated clinical conditions as well as for unusual circumstances. We also believe that shorter episode durations may incur a higher clinical risk for beneficiaries if participants delay services beyond the episode, and the risk to beneficiaries of this response by providers to episode payment that can be minimized by the longer 90-day episode duration that we proposed. We refer readers to sections III.F.3. and 5. of this final rule for discussion of our plans to monitor for access to care and delayed care.
In response to those commenters requesting a hybrid approach where CMS would include a broader set of related services in the 30 days following discharge from the anchor hospitalization and a more limited set of related services from days 31 to 90 because of the closer clinical link of a beneficiary's clinical conditions in the first 30 days to the events during the anchor hospitalization itself, we emphasize that the CJR model is an episode payment model where many Medicare beneficiaries who receive PAC services as part of their post-operative recovery from surgery will also have underlying health conditions that may be affected by the surgery itself and care throughout the recovery period and that require attentive, flexible management if good health outcomes are to be achieved. Because PAC services are designed to be comprehensive in nature, we believe that the same Part A and Part B services should be included throughout the episode duration because PAC providers should broadly address the beneficiary's health care needs in high quality, efficient episodes, even though the anchor hospitalization itself may be more remote from the beneficiary's health needs as the time from hospital-discharge increases. As discussed in section III.A.3. of this final rule, we have identified hospitals as the financially responsible organization for the episode, although episode quality and cost performance will clearly be related in part to the quality and efficiency of care furnished by other providers and suppliers treating the beneficiary throughout the episode. We expect that participant hospitals will develop the care pathways and partnerships with other providers and suppliers necessary for the hospital to be successful in this responsibility, and this model provides a variety of tools that should be helpful to participant hospitals, such as waivers of Medicare program rules, the opportunity to engage in certain financial arrangements, and the ability to offer certain beneficiary incentives (as discussed in sections III.C.11. and III.C.10. of this final rule, respectively).
We appreciate the interest of some commenters in significantly longer episodes than the 90 days post-hospital discharge period we proposed, in order to include the longer recovery period that some beneficiaries may require as well as to account for longer term health outcomes, because the timing or frequency of joint replacement revisions may be related to implant selection, surgical technique, or other aspects of the primary joint replacement procedure. However, as previously noted, we believe that a 90-day post-discharge duration reflects a full continuum of clinical services and transition of care following LEJR procedures for the average CJR beneficiary, and we do not believe it would be an appropriate test of the model to extend the CJR episode duration beyond 90 days post-hospital discharge to reflect the longer recovery needed by some beneficiaries. Moreover, as noted previously in this section, the CJR model focuses on the surgical procedure and the associated recovery, and at this time, we are not testing a model of longer term outcomes. Therefore, we are not going to incorporate a longer time period in the episode, and will not include periods beyond then, other than to monitor the 30-day post-episode period. The 30-day post-episode period is discussed in section III.C.8.d. of this final rule, where we describe the CJR model policy that holds participant hospitals financially responsible for significantly increased Medicare Parts A and B spending in the 30 days immediately following the end of the episode. We note that the
Regarding the request to align the CJR model episode duration with the MPFS by beginning the 90-day duration on the date of surgery, rather than on the date of discharge from the hospital, we do not agree with this suggestion. We believe that the 90-day global surgical period for LEJR procedures under the MPFS lends support for an episode duration under the CJR model that is similar, because beneficiaries have a significant post-operative recovery period throughout which close care coordination and management among treating providers is important to beneficiary return to function. The MPFS global payment policy sets an expectation that the operating surgeon plays a significant role in caring for beneficiaries in the typical case that extends up to 90 days following surgery. However, using this same 90-day accounting methodology under the CJR episode would lead to model episodes including variable post-discharge lengths because the duration of the anchor hospitalization, which can vary substantially, would count toward the 90 days. We are interested in testing under the CJR model an episode duration that is most likely to cover the time for the beneficiary's full recovery and return to the community so we believe that including a standard length of 90 days post-hospital discharge is the best way to ensure that each CJR beneficiary's episode includes the same length of post-hospital discharge recovery in the episode. We do not believe the minor 90-day definitional differences between this model and the MPFS global billing policies for LEJR procedures should create significant problems for physicians collaborating with participant hospitals in the episode care of CJR model beneficiaries.
In response to the commenter concerned that starting the bundle after hospital discharge would make it difficult to account for patient acuity changes post-discharge under the CJR model, we want to emphasize that the CJR model episode actually begins on the day of admission for the anchor hospitalization and extends 90 days post-hospital discharge, with the day of hospital discharge counting as the first day in the 90-day post-hospital discharge period. Thus, the episode includes the full anchor hospital length-of-stay that may affect changes in patient acuity in the post-discharge period. We note that according to this episode duration definition, episodes for individual beneficiaries will have a variable total length that depends on the length of the anchor hospitalization. For example, the average length-of-stay for MS-DRG 470 is 3 days, so the average CJR model episode length for an individual beneficiary would be 92 days. The average length-of-stay for MS-DRG 569 is 6 days, so the average CJR model episode length for an individual beneficiary would be 95 days. Despite their variable total length, all CJR model episodes will include the complete anchor hospitalization and 90 days post-hospital discharge and, therefore, will include all related items and services furnished to the beneficiary throughout the episode, including those provided to address beneficiary acuity changes during the hospitalization and post-discharge period.
The final definitions policies for ending an episode are set forth in § 510.2 and
As described in section II.B. of the proposed rule, we proposed to use the CJR episode payment model to incentivize participant hospitals to work with other health care providers and suppliers to improve quality of care for Medicare beneficiaries undergoing LEJR procedures and post-operative recovery, while enhancing the efficiency with which that care is provided. We proposed to apply this incentive by paying participant hospitals or holding them responsible for repaying Medicare based on their CJR episode quality and Medicare expenditure performance. The following sections describe our final decisions for the—
• Performance years covered by the model, the retrospective methodology that will be applied, and the application of two-sided risk beginning in the second year of the model;
• Adjustments that will be made to payments included in the episode;
• Episode price setting methodology;
• Use of quality performance in the payment methodology;
• Process for reconciliation;
• Adjustments for overlaps with other CMMI models and CMS programs;
• Limits and adjustments on hospitals' financial responsibility;
• Appeal procedures for reconciliation;
• Financial arrangements and beneficiary incentives; and
• Waivers of Medicare program rules.
We proposed that the CJR model would have 5 performance years. The performance years would align with calendar years, beginning January 1, 2016. Table 7 includes details on which episodes would be included in each of the 5 performance years.
Under our proposal, all episodes tested in this model would have begun on or after January 1, 2016 and ended on or before December 31, 2020. We noted that this definition would result in performance year 1 being shorter than the later performance years in terms of the length of time over which an anchor hospitalization could occur under the model. We also noted that some episodes that began in a given calendar year may be captured in the following performance year due to the episodes ending after December 31st (for example, episode beginning in December 2016 and ending in March 2017 would be part of performance year 2). We stated our belief that 5 years would be sufficient time to test the CJR model and gather sufficient data to evaluate whether it improves the efficiency and quality of care for an LEJR episode of care. Further, having fewer than 5 performance years may not provide sufficient time or data for evaluation. The 5-year performance period is consistent with the performance period used for other CMMI models (for example, the Pioneer Accountable Care Organization (ACO) Model).
The following is a summary of the comments received and our responses.
We also received comments suggesting that implementation of the model is premature and that it should be delayed until certain actions or events have occurred, for example, until certain quality measures have been developed, data required under the Improving Medicare Post Acute Care Transformation Act of 2014 (Pub. L. 113-185, enacted October 6, 2014) (IMPACT Act) have been collected or analyzed, or CMS has considered the results of other bundled payment models such as BPCI. For example, several commenters requested a phased implementation of the CJR model, due to the limited evaluation results that have been publicly released to date for BPCI, and to allow for testing and monitoring of the CJR model prior to full implementation. Another commenter asserted that a phased-in approach to implementing CJR is appropriate, given that while episode-based payment models have shown potential to reduce cost, rigorous studies and evaluation data on episode-based payment models are limited. Some commenters expressed the view that CMS' timeline ignores multiple competing mandates that hospitals and other providers have, for example, ICD-10-CM implementation as well as EHR Meaningful Use and other quality-related programs.
In addition, we received a comment urging a delayed start date due to concerns on how requirements with respect to the civil monetary penalty (CMP) law (sections 1128A(a)(5), (b)(1) and (b)(2) of the Act), the Federal Anti-kickback statute (section 1128B(b)(1) and (2) of the Act), or the physician self-referral prohibition (section 1877 of the Act) would apply under the model. For example, a commenter noted that the proposed rule offered insufficient protection from certain statutory and regulatory risks associated with developing coordinated care arrangements among providers and that significant ambiguity and challenges existed with respect to compliance with these requirements.
Commenters also stated that in contrast to our proposed start date for the CJR model, CMS allowed voluntary BPCI participants, who were more likely to be well positioned to participate in an episode-based payment model, at least one year to consider their episode data, yet many of them likely found the program and timing demands challenging. Further, mandating the program, especially for unprepared participants, could result in even greater challenges, and increase the chance of failure and disruption of health care services for Medicare beneficiaries.
Some commenters offered examples of how, in their view, implementing the model by the proposed start date could result in unintended consequences such as reduced access for beneficiaries or lower care quality. For example, commenters suggested that the proposed timeframe could cause hospitals to make care redesign choices that reduced access for beneficiaries or certain kinds of beneficiaries such as those who posed greater risk or that care quality could be compromised because participants would have had insufficient time to implement new care practices.
Given these concerns, commenters generally requested that we delay the start date by a specific period of time, for example, by three months, six months, nine months or a year, with most commenters requesting a delay of nine months to a year. Some
Table 8 includes details on which episodes would be included in each of the 5 performance years under this delay.
Under this revised schedule, all episodes tested in this model will have begun on or after April 1, 2016 and ended on or before December 31, 2020. Additional discussion on how this revised performance year schedule affects the use of quality measures for the model and the timeline for the reconciliation process is included in sections III.C.5. and III.C.6. of this final rule.
We do not agree that a longer delay is needed. Hospital participants will not be financially responsible for repayment to Medicare until the second performance year of the model. In addition, as discussed in section III.C.8. of this final rule, we have further limited financial risk to hospitals in performance years 2 and 3 by lowering stop-loss limits; specifically, from 10 percent to 5 percent in Year 2, and from 20 percent to 10 percent in Year 3. Finally, while we note that commenters are correct that voluntary BPCI participants received claims data prior to taking on risk under the BPCI model, and in some cases had more than a year to prepare for participation in BPCI, we believe that providing claims data to CJR participants in early 2016 and beginning the model April 1, 2016 is appropriate for several reasons. First, we note that under BPCI, voluntary participants in Phase I had the option of receiving claims data for multiple episodes, up to the 48 clinical episodes included in the BPCI initiative. The CJR model will only include one type of episode, and as such we believe it is reasonable for hospitals to begin to analyze data and identify care patterns and opportunities for care redesign for this episode in our stated implementation timeline. We also note that due to the gradual implementation of downside risk, we expect that hospitals would spend the first performance year of the model analyzing data, identifying care pathways, forming clinical and financial relationships with other providers and suppliers, and assessing opportunities for savings under the model, utilizing the quarterly claims data we provide to them. This is similar to the approach we took to allow hospitals to participate in Phase I of BPCI prior to entering Phase II (the risk-bearing phase). As noted in this section, participant hospitals would also be eligible to receive reconciliation payments for performance year 1 if actual spending is below the target price. We believe that our implementation timeline is reasonable, given the financial opportunity for hospitals to earn reconciliation payments for performance year 1 and the gradual transition to financial responsibility.
We are also not persuaded by commenters that implementation of the model is premature or that it should be delayed until results for BPCI or other episode-based payment models are available. While we anticipate that the BPCI model will offer valuable information that should assist CMS in developing bundling payment models, the CJR model will offer additional insights that are not available under the BPCI model; in particular, insights with respect to bundling payment models on a mandatory rather than voluntary basis. Thus, we will be able to observe how a bundling payment model might work with participants that would otherwise not participate in such a model. As such, we expect the results from this model should produce data that are more broadly representative than what might be achieved under a voluntary model. Also, this model tests a different target pricing approach than the one used in BPCI. BPCI uses a purely participant-specific pricing approach, rewarding participants for improving based on their historical performance. While this may incentivize historically less efficient participants to improve, there may not be as much incentive for already efficient participants. The regional target pricing approach for this model, though, would consider a participant hospital's performance relative to its regional peers. As part of this test, we will learn whether our alternative pricing approach in this model will better incentivize participants who are already delivering high quality and efficient care while
We would note that we have released final evaluation results from the ACE demonstration, which determined that the demonstration led to reduced episode spending with no adverse impact on quality of care. Further, we note that the significant level of voluntary participation in BPCI, as well as high participation in LEJR episodes in particular in all BPCI models, signify the potential for financial opportunity for both hospitals and CMS to achieve savings and improve quality of care through an episode-based payment model targeting LEJR procedures. As further evaluation results for BPCI and other models are available, we will make such information available to the public, and if necessary, could incorporate lessons learned into the CJR model. In addition, in section III.F. of this final rule, we detail our plans to monitor care to ensure beneficiaries' access to quality and timely health care is maintained under the CJR model.
While we acknowledge the benefits of having more rigorous evidence to support the success of episode-based payment models, we believe that the aforementioned findings and encouraging preliminary evaluation data from our prior and current bundled payment models and demonstrations support our plan to more broadly test the model's effectiveness at this time. Moreover, the mission of the Innovation Center is to test models of care that reduce spending while maintaining or improving the quality of care furnished to Medicare, Medicaid and CHIP beneficiaries. Testing this model will provide additional information for CMS and providers on successful payment structures and care redesign strategies.
We also disagree that the model should be delayed simply because other similar efforts are currently ongoing. Rather, we would note that it is not uncommon for CMS to test multiple similar models concurrently rather than sequentially. For example, CMS currently has multiple primary care-focused models in testing, the Comprehensive Primary Care Initiative (CPCI) and the Multi-Payer Advanced Primary Care Practice (MAPCP) models. In addition, CMS has a permanent ACO program (the Medicare Shared Savings Program), as well as multiple other ACO models in the testing phase. We believe our decision to test the CJR model at this time is consistent with the approach taken for other models and programs to test payment models that may be similar in design but are targeted at different groups of providers. Such an approach provides CMS with additional information on the potential success of various model and program aspects and design features.
Likewise, we do not agree that the model should be delayed until certain other actions have occurred (for example, after additional quality measures have been developed or data required under the IMPACT Act have been analyzed) or because of the multiple competing mandates faced by hospitals and other providers. Since the Medicare program's inception, providers have and will continue to contend with constantly evolving statutory and administrative requirements that often require them to make concurrent changes in their practices and procedures. We do not believe the CJR model is dissimilar to those requirements.
As stated previously, some commenters urged a delayed start date due to concerns on how requirements with respect to the CMP law (sections 1128A(a)(5), (b)(1) and (b)(2) of the Act), the Federal Anti-kickback statute (section 1128B(b)(1) and (2) of the Act), or the physician self-referral prohibition (section 1877 of the Act) would apply under the model. In response, we would note that for programmatic reasons discussed elsewhere in this final rule
Also as discussed earlier in this section, some commenters pointed to the potential for unintended consequences that could result from our proposed start date, including impediments to beneficiary access and reduced quality of care. As discussed in section III.D of this final rule, we are including quality measures for purposes of evaluating hospitals' performance both individually and in aggregate across the model. Also, as discussed in section III.F of this final rule, we are making final policies and actions to monitor both care access and quality. We believe these features will help ensure that beneficiary access to high quality care is not compromised under the model.
As described in section III.B. of the proposed rule, we proposed that an episode in the CJR model begins with the admission for an anchor hospitalization and ends 90 days post-discharge from the anchor hospitalization, including all related services covered under Medicare Parts A and B during this timeframe, with limited exclusions and adjustments, as described in sections III.B., III.C.3., and III.C.7. of the proposed rule. The episodes would be attributed to the participant hospital where the anchor hospitalization occurred.
We proposed to apply the CJR episode payment methodology retrospectively. Under this proposal, all providers and suppliers caring for Medicare beneficiaries in CJR episodes would continue to bill and be paid as usual under the applicable Medicare payment system. After the completion of a CJR performance year, Medicare claims for services furnished to beneficiaries in that year that were included in the model would be grouped into episodes and aggregated, and participant hospitals' CJR episode quality and actual payment performance would be assessed and compared against episode quality thresholds and target prices, as described in sections III.C.5. and III.C.4. of the proposed rule, respectively. After the participant hospitals' actual episode performance in quality and spending are compared against the previous episode quality thresholds and target prices, we would determine if Medicare would make a payment to the hospital (reconciliation payment), or if the hospital owes money to Medicare (resulting in Medicare repayment). The possibility for hospitals to receive reconciliation payments or be subject to repayment (note: participant hospitals would not be subject to repayment for performance year 1) was further discussed in section III.C.2.c. of the proposed rule.
We considered an alternative option of paying for episodes prospectively by paying one lump sum amount to the hospital for the expected costs of the 90-day episode. However, we believed such an option would be challenging to implement at this time given the payment infrastructure changes for both hospitals and Medicare that would need to be developed to pay and manage prospective CJR episode payments. We noted that a retrospective episode payment approach is currently being utilized under BPCI Model 2. Also, we expressed our belief that a retrospective payment approach can accomplish the objective of testing episode payment in
The following is a summary of the comments received and our responses.
Some commenters expressed support for the proposed retrospective methodology provided that certain conditions existed. For example, a commenter expressed support for this methodology provided that payment reconciliation could be available on a quarterly basis. Another commenter supported the retrospective methodology provided that beneficiaries had access to any provider they chose and were not limited to those with whom a hospital had a contractual arrangement.
Some of the criticisms we received focused on the potential effects of a retrospective model on beneficiaries' costs. For example, some commenters expressed concerns on whether beneficiaries would or even could see cost-sharing reductions when a provider achieves savings under a retrospective model. Another comment suggested that as compared to a prospective model, payments under a retrospective model are more difficult to be incorporated into tools designed to help consumers shop for facilities and providers and reduced pricing predictability for the consumer.
In light of these concerns, many commenters proposed that CMS adopt or eventually transition to some kind of prospective payment model or hybrid model. Commenters suggested that doing so would improve accountability for costs and quality, strengthen risk/reward relationships, better support efforts to transition away from FFS, encourage providers to adhere to evidence-based clinical guidelines, reduce unnecessary or duplicative care, and help participants invest early in supportive resources, such as health information technology, care coordination tools, and infrastructure development to support accountability for quality and costs. A commenter offered the view that information technology solutions are now available that support prospective payment models with minimal burden and disruption to hospitals—concerns that have discouraged the adoption of prospective models.
Some examples of prospective models that were suggested would be for CMS to—
• Establish an extended DRG that includes hospital, physician, and PAC services for some period of time (for example, 30, 60, 90 days);
• Make a prospective payment to hospitals that are then distributed to their partners based on volume, acuity, quality, and efficiency;
• Withhold some percentage of the total payment that would be intended for downstream partners. Hospitals would subsequently distribute these payments to partners based on their ability to meet quality and efficiency targets;
• Move toward a prospectively negotiated case rate to foster collaboration among all clinicians involved in patient care and provide predictable pricing. For example, give facilities a financial incentive to assume the greater risk and uncertainty inherent in a prospective bundle by reducing or eliminating the two percent discount from the payment benchmark or narrowing the definition of “related care” in the 90-day post-discharge; and
• Allow physicians to lead a team where the participating physician and their patient decide which other providers and suppliers would be involved in and what the treatment plan would be for the episode. The team would designate or create a jointly governed management organization that would be paid through new prospective episode codes. Other providers, including the hospital, could be paid by that same organization or through existing Medicare payment systems. Medicare would pay a single bundled
In addition to comments supporting a prospective payment model, we received comments explicitly expressing concern about adopting such a model. For example, a commenter expressed the view that non-hospital providers and suppliers, including physicians and PAC providers, would likely be concerned with a policy that would allow hospitals complete authority to allocate payments among participating providers and suppliers or to be empowered with functions and authorities typically associated with Medicare Administrative Contractors (MACs). Moreover, a prospective payment methodology would exacerbate anti-competitive concerns with respect to the proposed model in general.
We agree with commenters that there are complexities and potential complications associated with a retrospective model and anticipate that further refinements will likely be needed with whatever kind of bundling model that is implemented. Therefore, we do not believe that the complexities and potential complications with our proposed model are significantly different than what occurs with other Medicare payment models, particularly any of the more novel ones. Likewise, we do not believe that such complexities or complications would be mitigated simply by adopting a prospective model. Moreover, both CMS and some of the commenters have noted that adoption of a prospective model could result in potentially significant complexities and logistical issues as well.
We also do not agree with the view suggesting that adoption of a retrospective model could limit the availability of resources for providers to invest in the changes needed to improve care quality and costs. Under our retrospective model, participant hospitals and other providers and suppliers will continue to bill and be paid under FFS Medicare as they would in the absence of the model that should result in a revenue stream comparable to what they would be absent the model, all else equal.
While we agree with the comment stating that beneficiaries will not see a reduction in their cost-sharing for joint replacement services under this model, we do not see this as being unique to the CJR model or a reason to not test it. To the contrary, if successful, our model will improve the quality of care and outcomes for these beneficiaries as well as better control costs of care. For example, if successful, we believe the model could help to limit or mitigate avoidable costs incurred by these beneficiaries such as costs associated with avoidable hospital readmissions. Last, we also do not see the potential challenges of integrating a retrospective payment methodology into sites designed to compare health care options as a reason to not test our proposed model or as being an insurmountable problem.
Based on the comments that we received, we believe there is support for both prospective and retrospective payment models. We also continue to believe that a retrospective payment model can accomplish the objective of testing episode payments with a broad group of hospitals, by including financial incentives that will streamline care delivery while producing less administrative burden for providers than would be possible with a prospective model. Accordingly, we will be implementing a retrospective payment model at this time as we had proposed. We appreciate the various examples of prospective models that commenters suggested for CMS' consideration, and will consider these examples along with other options to potentially be tested in the future.
We proposed to establish a two-sided risk model for hospitals participating in the CJR model. We proposed to provide episode reconciliation payments to hospitals that meet or exceed quality performance thresholds and achieve cost efficiencies relative to CJR target prices established for them, as was defined later in sections III.C.4. and III.C.5. of the proposed rule. Similarly, we proposed to hold hospitals responsible for repaying Medicare when actual episode payments exceed their CJR target prices in each of performance years 2 through 5, subject to certain proposed limitations discussed in section III.C.8. of the proposed rule. Target prices would be established for each participant hospital for each performance year.
We proposed that hospitals will be eligible to receive reconciliation payments from Medicare based on their quality and actual episode spending performance under the CJR model in each of CJR performance years 1 through 5. Additionally, we proposed to phase in the responsibility for hospital repayment of episode actual spending if episode actual spending exceeds their target price starting in performance year 2 and continuing through performance year 5. Under this proposal in performance year 1, participant hospitals would not be required to pay Medicare back if episode actual spending is greater than the target price.
We considered an episode payment structure in which, for all 5 performance years of the model, participant hospitals would qualify for reconciliation payments if episode actual spending was less than the episode target price, but would not be required to make repayments to Medicare if episode actual spending was greater than the episode target price. However, we noted our belief that not holding hospitals responsible for repaying excess episode spending would reduce the incentives for hospitals to improve quality and efficiency. We also considered starting the CJR payment model with hospital responsibility for repaying excess episode spending in performance year 1 to more strongly align participant hospital incentives with care quality and efficiency. However, we stated our view that hospitals may need to make infrastructure, care coordination and delivery, and financial preparations for the CJR episode model, and that those changes can take several months or longer to implement. With this consideration in mind, we proposed to begin hospitals' responsibility for repayment of excess episode spending
In an effort to further ensure hospital readiness to assume responsibility for circumstances that could lead to a hospital repaying to Medicare actual episode payments that exceed the episode target price, we proposed to begin to phase in this responsibility for performance year 2, with full responsibility for excess episode spending (as proposed in the proposed rule) applied for performance year 3 through performance year 5. To carry out this “phase in” approach, we proposed during the first year of any hospital financial responsibility for repayment (performance year 2) to set an episode target price that partly mitigates the amount that hospitals would be required to repay (see section III.C.4.b. of the proposed rule), as well as more greatly limits (as compared to performance years 3 through 5) the maximum amount a hospital would be required to repay Medicare across all of its episodes (see section III.C.8. of the proposed rule).
Most of the comments we received, however, requested that CMS ease the glide path to downside risk by either delaying the requirement for two to three years or by incorporating features to better limit risk, for example, by adjusting stop-loss caps. Some commenters requested that we modify the CJR model to be more like a shared savings model as is used in Shared Savings Program or the Pioneer ACO model. In their view, this option would be particularly attractive to smaller organizations with lower episode volumes that face a higher risk of random episode cost variation or those with limited financial resources.
Some commenters requested these changes because of concerns that hospitals have little or no experience bearing risk and thus need additional time to be ready to do so. Other commenters stated that our proposed timeframe for implementing the model and requiring hospitals to assume risk was simply too aggressive and offered too little time for hospitals to put in place the care procedures and infrastructure needed to be successful in the model and in a position to bear risk. In recommending that CMS delay downside risk, a commenter observed that payment features of other Medicare efforts such as BPCI and the Pioneer ACO model have been refined more than once since their implementation, which suggested that more can be learned about the appropriate framework for a risk model, particularly given that the CJR model is untested.
We disagree with the view that it is unfair to require hospitals to bear risk while beneficiaries retain the ability to choose among providers. As is the case with other new payment models such as the Shared Savings Program, the CJR model is intended to identify ways to improve care quality and better control costs in the Medicare FFS program. While Medicare beneficiaries may choose between Medicare FFS and Medicare Advantage, the majority of beneficiaries—roughly two-thirds in 2015—continue to choose the former. Accordingly, it is in the interest of the Medicare program and its beneficiaries for CMS to identify new models that both maintain beneficiary choice while improving care quality and costs. Also, while we appreciate suggestions to exclude certain kinds of hospitals, for example, small hospitals or hospitals with a low-volume of cases, we believe our methodology for selecting geographic units, as discussed in section III.A.4.of this final rule, as well as additional protections for certain kinds of these hospitals, as discussed in section III.C.8.c. of this final rule sufficiently address these concerns.
We also understand that commenters would like a more gradual transition to downside risk, and in response to the commenters' concerns, CMS has taken steps for hospitals to do so. As discussed in section III.C.8. of this final rule, we are reducing the potential risk to participants in Year 2 by lowering the stop-loss limit from 10 percent to 5 percent (and from 20 percent to 10 percent in Year 3). We believe these actions should assist participants both with respect to preparing for the assumption of risk as well as reducing the level of risk they must initially bear. We do not support the proposal to change the CJR model to a shared savings model as it is inconsistent with our intent of testing whether a bundled payments model will promote quality and financial accountability for episodes of care surrounding an LEJR or reattachment of a lower extremity procedure. Last, we recognize that our model, as would any model or program, will evolve and may require some adjustments over time. To the extent that this occurs with the CJR model, we would make adjustments that were deemed necessary, as we would do with any of these other models and programs; however, we do not believe the potential for model adjustments is a reason to delay the requirement for hospitals to bear risk in the absence of data suggesting that a problem actually exists.
We proposed to calculate the actual episode payment amount by summing together Medicare payments for each non-cancelled CJR episode during the model's performance year for Parts A and B claims for services included in the episode definition, as discussed in section III.B. of this final rule. We proposed three adjustments to this general approach for—(1) Special payment provisions under existing Medicare payment systems; (2) payment for services that straddle the end of the episode; and (3) high payment episodes. We noted there would be further adjustments to account for overlaps with other Innovation Center models and CMS programs; we refer readers to section III.C.7. of the proposed rule.
We did not propose to adjust hospital-specific or regional components of target prices for any Medicare repayment or reconciliation payments made under the CJR model; CJR repayment and reconciliation payments would be not be included per the episode definition in section III.B. of this final rule. We stated in the proposed rule our belief that including reconciliation payments and Medicare repayments in target price calculations would perpetuate the initial set of target prices once CJR performance years are captured in the 3-historical-years of data used to set target
Many of the existing Medicare payment systems have special payment provisions that have been created by regulation or statute to improve quality and efficiency in service delivery. IPPS hospitals are subject to incentives under the HRRP, the Hospital Value-Based Purchasing (HVBP) Program, the Hospital-Acquired Condition (HAC) Reduction Program, and the Hospital Inpatient Quality Reporting Program (HIQR) and Outpatient Quality Reporting Program (OQR). IPPS hospitals and CAHs are subject to the Medicare EHR Incentive Program. Additionally, the majority of IPPS hospitals receive additional payments for Medicare Disproportionate Share Hospital (DSH) and Uncompensated Care, and IPPS teaching hospitals can receive additional payments for Indirect Medical Education (IME). IPPS hospitals that meet a certain requirements related to low volume Medicare discharges and distance from another hospital receive a low volume add-on payment. As previously stated in section III.B.2.b. of this final rule, acute care hospitals may receive new technology add-on payments to support specific new technologies or services that substantially improve the diagnosis or treatment of Medicare beneficiaries and would be inadequately paid otherwise under the MS-DRG system. Also, some IPPS hospitals qualify to be sole community hospitals (SCHs) or MDHs, and they may receive enhanced payments based on cost-based hospital-specific rates for services; whether a SCH or MDH receives enhanced payments may vary year to year, in accordance with § 419.43(g) and § 412.108(g), respectively.
Medicare payments to providers of PAC services, including IRFs, SNFs, IPFs, HHAs, LTCHs, and hospice facilities, are conditioned, in part, on whether the provider satisfactorily reports certain specified data to CMS: The Inpatient Rehabilitation Facility Quality Reporting Program (IRF QRP), the Skilled Nursing Facility Quality Reporting Program (SNF QRP), the Inpatient Psychiatric Facility Quality Reporting Program (IPF QRP), the Home Health Quality Reporting Program (HH QRP), the Long-Term Care Hospital Quality Reporting Program (LTCH QRP), and the Hospice Quality Reporting Program. Additionally, IRFs located in rural areas receive rural add-on payments, IRFs serving higher proportions of low-income beneficiaries receive increased payments according to their low-income percentage (LIP), and IRFs with teaching programs receive increased payments to reflect their teaching status. SNFs receive higher payments for treating beneficiaries with human immunodeficiency virus (HIV). HHAs located in rural areas also receive rural add-on payments.
ASCs have their own Quality Reporting Program (ASC QRP). Physicians also have a set of special payment provisions based on quality and reporting: The Medicare EHR Incentive Program for Eligible Professionals, the Physician Quality Reporting System (PQRS), and the Physician Value-based Modifier Program.
In the proposed rule we stated our intent with the CJR model is not to replace the various existing incentive programs or add-on payments, but instead to test further episode payment incentives towards improvements in quality and efficiency beyond Medicare's existing policies. Therefore, we proposed that the hospital performance and potential reconciliation payment or Medicare repayment be independent of, and not affect, these other special payment provisions.
We proposed to exclude the special payment provisions as discussed previously when calculating actual episode payments, setting episode target prices, comparing actual episode payments with target prices, and determining whether a reconciliation payment should be made to the hospital or funds should be repaid by the hospital.
Not excluding these special payment provisions would create incentives that are not aligned with the intent of the CJR model. Not excluding the quality and reporting-related special payment provisions could create situations where a high-quality or reporting compliant hospital or both receiving incentive payments, or those hospitals that discharge patients to PAC providers that receive incentives for being reporting compliant, may appear to be “high episode payment” under CJR. Conversely, lower quality or hospitals not complying with reporting programs or both that incur payment reduction penalties, or hospitals that discharge to PAC providers that are not reporting compliant, may appear to be “low episode payment” under CJR. Such outcomes would run counter to CJR's goal of improving quality. Also, not excluding add-on payments for serving more indigent patients, having low Medicare hospital volume, being located in a rural area, supporting greater levels of provider training, choosing to use new technologies, and having a greater proportion of CJR beneficiaries with HIV from CJR actual episode payment calculations may inappropriately result in hospitals having worse episode payment performance. Additionally, not excluding enhanced payments for MDHs and SCHs may result in higher or lower target prices just because these hospitals received their enhanced payments in one historical year but not the other, regardless of actual utilization. In the proposed rule we stated our belief that excluding special payment provisions would ensure a participant hospital's actual episode payment performance is not artificially improved or worsened because of payment reduction penalties or incentives or enhanced or add-on payments, the effects of which we are not intending to test with CJR.
In addition to the various incentive, enhanced and add on payments, sequestration came into effect for Medicare payments for discharges on or after April 1, 2013, per the Budget Control Act of 2011 and delayed by the American Taxpayer Relief Act of 2012. Sequestration applies a 2 percent reduction to Medicare payment for most Medicare FFS services.
In order to operationalize the exclusion of the various special payment provisions in calculating episode expenditures, we proposed to apply the CMS Price (Payment) Standardization Detailed Methodology described on the QualityNet Web site at
We sought comment on this proposed approach to treating special payment
A few commenters expressed concern about how hospitals would be paid the special payment adjustments that are removed in calculating episode expenditures. A commenter inquired whether CMS would account for vendor rebates for hip and knee implants and medical devices, because rebates are not uncommon and can impact the cost of an LEJR procedure to a hospital.
As discussed in section III.C.2.b. of this final rule, we are finalizing our proposal such that all providers and suppliers caring for Medicare beneficiaries in CJR episodes will continue to bill and be paid as usual under the applicable Medicare payment system, and determination of any reconciliation payments or repayments to Medicare will be made retrospectively after the end of each performance year. Therefore, special payment adjustments will continue to be paid as usual under the applicable Medicare payment systems, but their effects will be excluded when reconciliation payment and repayment to Medicare determinations are made retrospectively. This final rule will not affect how hospitals are currently paid special payment adjustments.
Payments for hip and knee implants and medical devices will also continue as usual under the applicable Medicare payment systems. For inpatient admissions paid under IPPS, in particular, implants and medical devices not categorized as new technology add-on payment would be included in the MS-DRG payment and would not be reimbursed separately. To mirror the IPPS approach, we will not separately account for vendor rebates in the LEJR episode.
We note that as previously stated, we plan to utilize the CMS Price (Payment) Standardization approach in order to remove the effects of special payment provisions from calculations of historical and performance period episode spending. We will follow the methodology, with modifications as necessary to be consistent with our episode definition in section III.B. of this final rule and to ensure timely reporting of reconciliation results, for the performance year reconciliations, which begin 2 months after the conclusion of a performance year. We will account for the information available at the time due to claims runout, payment system updates, and the calculations necessary to fully implement the standardization methodology. We will utilize the methodology, consistent with our episode definition, for the target price calculations and subsequent reconciliation calculations 14 months after the conclusion of the performance year, in which we incorporate full claims runout and further account for overlap with other models. This approach will provide feedback and reconciliation payments, as available, to hospitals in a timely manner and as accurately as feasible, while ensuring the standardization approach is utilized for the subsequent calculation, which represents the final calculation for a given performance period.
Opt-out physicians are prohibited from billing and receiving payment (either directly or indirectly) from Medicare except for emergency and urgent care services provided the physician has not previously entered into a private contract with the beneficiary. Therefore, we agree that payments for services furnished by physicians who have opted out of Medicare would not be included in target price and actual episode expenditure calculations. However, we estimate only a small portion of physicians furnishing services to beneficiaries captured in the CJR model will have opted out of Medicare, and we estimate that physician services comprise less than 15 percent of the average CJR episode expenditure, and therefore we believe the impact of not capturing expenditures from physicians
Additionally, there may be some participant hospitals with a disproportionately higher share of episodes for which services were furnished by physicians who have opted out of Medicare. Such participant hospitals would experience lower actual episode expenditures because payments for physicians who have opted out of Medicare would not be included. These hospitals' lower actual episode expenditures would be balanced by lower target prices because the payments for physicians who have opted out of Medicare would also be excluded in the historical episode expenditures, though this argument is primarily relevant in the early years of the CJR model before we move to 100 percent regional pricing as discussed in section III.C.4.b.(5) of this final rule. In the later years of this model, participant hospitals with disproportionately greater share of episodes for which services were furnished by Medicare opt-out physicians may unfairly benefit from regional target prices that are primarily based on the inclusion of expenditures for physician services. However, we believe this advantage to be small because physician expenditures comprise only a small portion of the average episode, and we expect very few physicians to opt out of Medicare.
As we proposed a fixed 90-day post-discharge episode as discussed in section III.B. of the proposed rule, we stated our belief that there would be some instances where a service included in the episode begins during the episode but concludes after the end of the episode and for which Medicare makes a single payment under an existing payment system. An example would be a beneficiary in a CJR episode who is admitted to a SNF for 15 days, beginning on Day 86 post-discharge from the anchor CJR hospitalization. The first 5 days of the admission would fall within the episode, while the subsequent 10 days would fall outside of the episode.
We proposed that, to the extent that a Medicare payment for included episode services spans a period of care that extends beyond the episode, these payments would be prorated so that only the portion attributable to care during the episode is attributed to the episode payment when calculating actual Medicare payment for the episode. For non-IPPS inpatient hospital (for example, CAH) and inpatient PAC (for example, SNF, IRF, LTCH, IPF) services, we proposed to prorate payments based on the percentage of actual length of stay (in days) that falls within the episode window. Prorated payments would also be similarly allocated to the 30-day post-episode payment calculation in section III.C.8.d. of this final rule. In the prior example, one-third of the days in the 15-day length of stay would fall within the episode window, so under the proposed approach, one-third of the SNF payment would be included in the episode payment calculation, and the remaining two-thirds (because the entirety of the remaining payments fall within the 30 days after the episode ended) would be included in the post-episode payment calculation.
For HHA services that extend beyond the episode, we proposed that the
There may also be instances where home health services begin prior to the CJR episode start date, but end during the CJR episode. In such instances, we also proposed to prorate HHA payments based on the percentage of days that fell within the episode. Because these services end during the CJR episode, prorated payments for these services would not be included in the 30-day post-episode payment calculation discussed in section III.C.8.d. of the proposed rule. For example, if the patient's start of care date for a home health 60-day claim was February 1, the anchor hospitalization was March 1 through March 4 (with the CJR episode continuing for 90 days after March 4), and the patient resumed home care on March 5 with the 60-day home health claim ending on April 1 (that is, April 1 was the last billable service date), we would divide the 60-day home health claim payment amount by 60 and then multiply that amount by the days from the CJR admission through April 1 (32 days) to prorate the HHA payment. This proposed prorating method for HHA claims is consistent with how partial episode payments (PEP) are paid for on home health claims.
For IPPS services that extend beyond the episode (for example, readmissions included in the episode definition), we proposed to separately prorate the IPPS claim amount from episode target price and actual episode payment calculations as proposed in section III.C.8. of the proposed rule, called the normal MS-DRG payment amount for purposes of this final rule. The normal MS-DRG payment amount would be pro-rated based on the geometric mean length of stay, comparable to the calculation under the IPPS PAC transfer policy at § 412.4(f) and as published on an annual basis in Table 5 of the IPPS/LTCH PPS Final Rules. Consistent with the IPPS PAC transfer policy, the first day for a subset of MS-DRGs (indicated in Table 5 of the IPPS/LTCH PPS Final Rules) would be doubly weighted to count as 2 days to account for likely higher hospital costs incurred at the beginning of an admission. If the actual length of stay that occurred during the episode is equal to or greater than the MS-DRG geometric mean, the normal MS-DRG payment would be fully allocated to the episode. If the actual length of stay that occurred during the episode is less than the geometric mean, the normal MS-DRG payment amount would be allocated to the episode based on the number of inpatient days that fall within the episode. If the full amount is not allocated to the episode, any remainder amount would be allocated to the 30 day post-episode payment calculation discussed in section III.C.8.d. of the proposed rule. The proposed approach for prorating the normal MS-DRG payment amount is consistent with the IPPS transfer per diem methodology.
The following is an example of prorating for IPPS services that extend beyond the episode. If beneficiary has a readmission for MS-DRG 493—lower extremity and humerus procedures except hip, foot, and femur, with complications—into an IPPS hospital on the 89th day after discharge from a CJR anchor hospitalization, and is subsequently discharged after a length of stay of 5 days, Medicare payment for this readmission would be prorated for inclusion in the episode. Based on Table 5 of the IPPS/LTCH PPS Final Rule for FY 2015, the geometric mean for MS-DRG 493 is 4 days, and this MS-DRG is indicated for double-weighting the first day for proration. This readmission has only 2 days that falls within the episode, which is less than the MS-DRG 493 geometric mean of 4 days. Therefore, the normal MS-DRG payment amount associated with this readmission would be divided by 4 (the geometric mean) and multiplied by 3 (the first day is counted as 2 days, and the second day contributes the third day), and the resulting amount is attributed to the episode. The remainder one-fourth would be captured in the post-episode spending calculation discussed in section III.C.8. of the proposed rule. If the readmission occurred on the 85th day after discharge from the CJR anchor hospitalization, and the length of stay was 7 days, the normal MS-DRG payment amount for the admission would be included in the episode without proration because length of stay for the readmission falling within the episode (6 days) is greater than or equal to the geometric mean (4 days) for the MS-DRG.
We considered an alternative option of including the full Medicare payment for all services that start during the episode, even if those services did not conclude until after the episode ended, in calculating episode target prices and actual payments. Previous research on bundled payments for episodes of PAC services noted that including the full payment for any claim initiated during the fixed episode period of time will capture continued service use. However, prorating only captures a portion of actual service use (and payments) within the bundle.
The following is a summary of comments received and our responses.
We agree that costs for inpatient stays may not be equal for each day of an inpatient admission, and the distribution of costs may differ between surgical and non-surgical inpatient stays. We acknowledge there may be different methodologies to calculate how much more costs are incurred on the first day of a stay. However, we will maintain consistency with the IPPS per diem transfer policy that uses a two-times weight for the first day for a subset of MS-DRGs as described in § 412.4(f) and published on an annual basis in Table 5 of the IPPS/LTCH PPS Final Rules. We also note that many surgical readmissions are excluded from the episode definition described in section III.B. of this final rule, which should mitigate the impact of this prorating approach on surgical readmissions that extend beyond the episode.
Given the broad proposed LEJR episode definition and 90-day post-discharge episode duration proposed for CJR, we want to ensure that hospitals have some protection from the variable repayment risk for especially high payment episodes, where the clinical scenarios for these cases each year may differ significantly and unpredictably. We did not believe the opportunity for a hospital's systematic care redesign of LEJR episodes has significant potential to impact the clinical course of these extremely disparate high payment cases.
The BPCI Model 2 uses a generally similar episode definition as proposed for CJR and the vast majority of BPCI episodes being tested for LEJR are 90 days in duration following discharge from the anchor hospitalization. Similarly in the proposed rule, we stated our belief that the distribution of 90-day LEJR episode payment amounts utilizing the BPCI Model 2 episode definition as displayed in Figure 2 provides information that is relevant to policy development regarding CJR episodes.
As displayed, the mean episode payment amount is approximately $26,000. Five percent of all episodes are paid at two standard deviations above the mean payment or greater, an amount that is slightly more than 2 times the mean episode payment amount. While these high payment cases are relatively uncommon, we stated in the proposed rule our belief that incorporation of the full Medicare payment amount for such high payment episodes in setting the target price and correspondingly in Medicare's aggregate actual episode payment that is compared to the target price for the episode may lead in some cases to excessive hospital responsibility for these episode expenditures. This may be especially true when hospital responsibility for repayment of excess episode spending is introduced in performance year 2. The hospital may have limited ability to moderate spending for these high payment cases. Our proposal to exclude IPPS new technology add-on payments and separate payment for clotting factors for the anchor hospitalization from the episode definition limits excessive financial responsibility under this model of extremely high inpatient payment cases that could result from costly hospital care furnished during the anchor hospitalization. However, in the proposed rule we stated our belief that an additional pricing adjustment in setting episode target prices and calculating actual episode payments is necessary to mitigate the hospital responsibility for the actual episode payments for high episode payment cases resulting from very high Medicare spending within the episode during the period after discharge from the anchor hospitalization, including for PAC, related hospital readmissions, and other items and services related to the LEJR episode.
Thus, in order to limit the hospital's responsibility for the previously stated high episode payment cases, we proposed to utilize a pricing adjustment for high payment episodes that would incorporate a high payment ceiling at two standard deviations above the mean episode payment amount in calculating the target price and in comparing actual episode payments during the performance year to the target prices.
Specifically, when setting target prices, we would first identify for each anchor MS-DRG in each region (discussed further in section III.C.4. of this final rule) the episode payment amount that is two standard deviations above the mean payment in the historical dataset used (discussed further in section III.C.4. of the proposed rule). Any such identified episode would have its payment capped at the MS-DRG anchor and region-specific value that is two standard deviations above the mean, which would be the ceiling for purposes for calculating target prices. We note that the calculation of the historical episode high payment ceiling for each region and MS-DRG anchor would be performed after other steps, including removal of effects of special payment provisions and others described in section III.C.4.c. of this final rule.
When comparing actual episode payments during the performance year to the target prices, episode payments for episodes in the performance year would also be capped at two standard deviations above the mean. The high episode payment ceiling for episodes in a given performance year would be calculated based on MS-DRG anchor-specific episodes in each region. We discuss further how the high episode payment ceiling would be applied when comparing episode payments during the performance year to target prices in section III.C.6. of this final rule.
While this approach generally lowers the target price slightly, it provides a basis for reducing the hospital's responsibility for actual episode spending for high episode payment cases during the model performance years. When performing the reconciliation for a given performance year of the model, we would array the actual episode payment amounts for all episodes being tested within a single region, and identify the regional actual episode payment ceiling at two standard deviations above the regional mean actual episode payment amount. If the actual payment for a hospital's episode exceeds this regional ceiling, we would set the actual episode payment amount to equal the regional ceiling amount, rather than the actual amount paid by Medicare, when comparing a hospital's episode spending to the target price. Thus, a hospital would not be responsible for any actual episode payment that is greater than the regional ceiling amount for that performance year. We proposed to adopt this policy for all years of the model, regardless of the reconciliation payment opportunity or repayment responsibility in a given performance year, to achieve stability and consistency in the pricing methodology. We stated in the proposed rule our belief that this proposal provides reasonable protection for hospitals from undue financial responsibility for Medicare episode spending related to the variable and unpredictable course of care of some Medicare beneficiaries in CJR episodes, while still fully incentivizing increased efficiencies for approximately the 95 percent of episodes for which we estimate actual episode payments to fall below this ceiling.
The following is a summary of the comments received and our responses.
Whether a participant hospital receives reconciliation payments or is made responsible to repay Medicare for the CJR model will depend on the hospital's quality and actual payment performance relative to episode quality and target prices. Quality performance and its tie to payments is further discussed in section III.C.5. of this final rule, and the remainder of this section will discuss the proposed approach to establishing target prices.
We proposed to establish CJR target prices for each participant hospital. For episodes beginning in performance years 1, 3, 4, and 5, a participant hospital would have eight target prices, one for each of the following:
• MS-DRG 469 anchored episodes that were initiated between January 1 and September 30 of the performance year, if the participant hospital successfully submits data on the voluntary patient-reported outcome measure proposed in section III.C.5. of the proposed rule.
• MS-DRG 470 anchored episodes that were initiated between January 1 and September 30 of the performance year, if the participant hospital successfully submits data on the proposed voluntary patient-reported outcome measure.
• MS-DRG 469 anchored episodes that were initiated between October 1 and December 31 of the performance year, if the participant hospital successfully submits data on the proposed voluntary patient-reported outcome measure.
• MS-DRG 470 anchored episodes that were initiated between October 1 and December 31 of the performance year, if the participant hospital successfully submits data on the proposed voluntary patient-reported outcome measure.
• MS-DRG 469 anchored episodes that were initiated between January 1 and September 30 of the performance year, if the participant hospital does not successfully submit data on the voluntary patient-reported outcome measure.
• MS-DRG 470 anchored episodes that were initiated between January 1 and September 30 of the performance year, if the participant hospital does not successfully submit data on the proposed voluntary patient-reported outcome measure.
• MS-DRG 469 anchored episodes that were initiated between October 1 and December 31 of the performance year, if the participant hospital does not successfully submit data on the proposed voluntary patient-reported outcome measure.
• MS-DRG 470 anchored episodes that were initiated between October 1 and December 31 of the performance year, if the participant hospital does not successfully submit data on the proposed voluntary patient-reported outcome measure.
For episodes beginning in performance year 2, a participant hospital would have 16 target prices. These would include the same combinations as for the other 4 performance years, but one set for determining potential reconciliation payments, and the other for determining potential Medicare repayment amounts, as part of the phasing in of two-sided risk discussed later in this section. Further discussion on our proposals for different target prices for MS-DRG 469 versus MS-DRG 470 anchored episodes, for episodes initiated between January 1 and September 30 versus October 1 and December 31, and for participant hospitals that do and do not successfully submit data on the proposed patient-reported outcome measure can be found in sections III.C.4.b. and III.C.5. of the proposed rule.
We intend to calculate and communicate episode target prices to participant hospitals prior to the performance period in which they apply (that is, prior to January 1, 2017, for target prices covering episodes initiated between January 1 and September 30, 2017; prior to October 1, 2017 for target prices covering episodes initiated between October 1 and December 31, 2017). We stated in the proposed rule our belief that prospectively communicating prices to hospitals will help them make any infrastructure, care coordination and delivery, and financial refinements they may deem appropriate to prepare for the new episode target prices.
The proposed approach to setting target prices incorporated the following features:
• Set different target prices for episodes anchored by MS-DRG 469 versus MS-DRG 470 to account for patient and clinical variations that impact hospitals' cost of providing care.
• Use 3 years of historical Medicare payment data grouped into episodes of care according to the episode definition in section III.B. of the proposed rule, hereinafter termed historical CJR episodes. The specific set of 3-historical-years used would be updated every other performance year.
• Apply Medicare payment system (for example, IPPS, OPPS, IRF PPS, SNF, MPFS, etc.) updates to the historical episode data to ensure we incentivize hospitals based on historical utilization and practice patterns, not Medicare payment system rate changes that are beyond hospitals' control. Because different Medicare payment system updates become effective at two different times of the year, we would calculate separate target prices for episodes initiated between January 1 and September 30 versus October 1 and December 31.
• Blend together hospital-specific and regional historical CJR episode payments, transitioning from primarily provider-specific to completely regional pricing over the course of the 5 performance years, to incentivize both historically efficient and less efficient hospitals to furnish high quality, efficient care in all years of the model. Regions would be defined as each of the nine U.S. Census divisions.
• Normalize for provider-specific wage adjustment variations in Medicare payment systems when combining provider-specific and regional historical CJR episodes. Wage adjustments would
• Pool together CJR episodes anchored by MS DRGs 469 and 470 to use a greater historical CJR episode volume and set more stable prices.
• Apply a discount factor to serve as Medicare's portion of reduced expenditures from the CJR episode, with any remaining portion of reduced Medicare spending below the target price potentially available as reconciliation payments to the participant hospital where the anchor hospitalization occurred.
Further discussion on each of the individual features can be found in section III.C.4.b. of this final rule. In section III.C.4.c. of this final rule, we also provide further details on the proposed sequential steps to calculate target prices and how each of the pricing features would fit together.
The following is a summary of the comments received and our responses.
For each participant hospital we proposed to establish different target prices for CJR episodes initiated by MS-DRG 469 versus MS-DRG 470. MS-DRGs under the IPPS account for some of the clinical and resource variations that exist and that impact hospitals' cost of providing care. Specifically, MS-DRG 469 is defined to identify, and provide hospitals a higher Medicare payment to reflect the higher hospital costs for, hip and knee procedures with major complications or comorbidities. Therefore, we proposed to risk stratify and calculate separate target prices for each participant hospital for CJR episodes with MS-DRG 469 versus MS-DRG 470 anchor hospitalizations.
We considered risk adjusting the episode target prices by making adjustments or setting different prices based on patient-specific clinical indicators (for example, comorbidities). However, we did not believe there is a sufficiently reliable approach that exists suitable for CJR episodes beyond MS-DRG-specific pricing, and there is no current standard on the best approach. At the time of developing the proposed rule Tennessee, Ohio, and Arkansas are launching multi-payer (including Medicaid and commercial payers, excluding Medicare) bundles and include hip and knee replacement as an episode.
We also considered making risk adjustments based on the participant hospital's average Hierarchical Condition Category (HCC) score for patients with anchor CJR hospitalizations. The CMS-HCC risk adjustment model quantifies a beneficiary's risk by examining the beneficiary's demographics and historical claims data and predicting the beneficiary's total expenditures for Medicare Parts A and B in an upcoming year. However, the CMS-HCC risk adjustment model's intended use is to pay Medicare Advantage (MA) plans appropriately for their expected relative costs. For example, MA plans that disproportionately enroll the healthy are paid less than they would have been if they had enrolled beneficiaries with the average risk profile, while MA plans that care for the sickest patients are paid proportionately more than if they had enrolled beneficiaries with the average risk profile. The CMS-HCC risk adjustment model is prospective. It uses demographic information (that is, age, sex, Medicare/Medicaid dual eligibility, disability status) and a profile of major medical conditions in the base year to predict Medicare expenditures in the next year.
We also considered risk stratifying or setting different prices for different procedures, such as different prices for hip versus knee replacements, but we did not believe there would be substantial variation in episode payments for these clinical scenarios to warrant different prices or adjustments. Moreover, Medicare IPPS payments, which account for approximately 50 percent
The following is a summary of the comments received and our responses.
Most commenters who wrote on the issue suggested risk adjustment or complete exclusion for episodes with hip fractures, partial hip replacements, and emergent (versus non-emergent or elective) procedures. Some commenters provided analysis on hip fractures, in particular, and demonstrated episodes with hip fractures are significantly more expensive than those without hip fractures. Other clinical and demographic dimensions offered for risk adjustment or exclusion include the following: Procedure (total hip [THA] vs. total knee [TKA] vs. partial hip [PHA] vs. ankle vs. limb reattachment); socioeconomic status; patient functional status; age; and comorbidities. Requests from commenters for risk adjustment based on the previously stated dimensions were usually paired with requests to also exclude patients from the CJR model, and we encourage readers to read comments in section III.B.2.a. of this final rule for additional details on the clinical and demographic dimensions requested for risk adjustment or exclusion.
Some commenters who wrote on the issue of risk adjustment disputed CMS' statement in the proposed rule that there is no standard risk adjustment approach widely accepted throughout the nation. They pointed to examples of existing risk adjustment approaches that could be used for CJR episodes, such as Optum's Procedure Episode Grouper (PEG), Truven's Medical Episode Grouper (MEG), Health Care Incentives Improvement Institute's (HCI3) risk adjustment model, CMS's HCCs model, and CMS's risk-adjusted quality/efficiency metric for elective LEJR episodes: Hospital-Level, Risk-Standardized Payment Associated with a 90-Day Episode of Care for Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA).
On the basis of the comments and our further analysis, we agree with commenters that proper risk adjustment is necessary to appropriately incentivize participant hospitals to deliver high quality and efficient care. We acknowledge that a comprehensive risk adjustment methodology beyond just setting different prices by anchor MS-DRGs could more accurately risk adjust episodes for patient-specific clinical and demographic factors that would drive variations in CJR episode expenditures.
We disagree with commenters, though, that there is an already existing, widely accepted risk adjustment methodology for CJR episodes. The HCC model, as discussed earlier in this section, is not designed to predict costs within CJR episodes and may not accurately predict CJR episode expenditures. Commercial claims groupers such as Optum's PEG, Truven's MEG, and HCI3's risk adjustment model utilize different episode definitions from how we will define CJR episodes. Additionally, these commercial groupers have yet to be validated for a Medicare population; we believe there may be a different set of risk factors that predict episode expenditures for Medicare beneficiaries than those used to predict episode expenditures for younger and generally healthier individuals with commercial insurance. We also acknowledge that CMS has designed a risk-adjusted quality/efficiency metric for elective LEJR episodes: Hospital-Level, Risk-Standardized Payment Associated with a 90-Day Episode of Care for Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA). This metric, though, has been developed for a different episode definition; most notably, this risk-adjusted metric excludes emergent episodes while the CJR episode definition does not exclude emergent episodes, as discussed in section III.B. of this final rule.
We do believe that there are opportunities to learn from existing comprehensive risk adjustment models, and we may explore how a comprehensive risk adjustment model such as these may be adapted for the CJR model in the future.
In the meantime, though, we also believe we can improve upon the proposed approach of only setting different target prices by anchor MS-DRG. Specifically, we can account for the impact of hip fracture status (with hip fracture vs. without hip fracture), procedure choice (PHA vs. TKA or THA), and emergence status (emergent vs. non-emergent) on episode expenditures. According to our analysis, though, there was significant correlation between incidence of hip fractures, partial hip procedures, and emergent procedures—94 percent of partial hip replacement episodes and 93 percent of emergent episodes are for patients with hip fractures. Because of the correlation between these three factors, we believe we can account for all three by risk stratifying based on hip fracture status alone. We believe hip fracture status is a more appropriate dimension on which
In light of the comments and our additional analysis, we will modify our proposed policy to risk stratify, or set different target prices, both for episodes anchored by MS-DRG 469 vs. MS-DRG 470 and for episodes with hip fractures vs. without hip fractures. By adding hip fracture status to our risk stratification approach, we believe we can capture a significant amount of patient-driven episode expenditure variation. Additionally, because of the high correlation between incidence of hip fractures, partial hip procedures, and emergent procedures, we do not believe we need to add any procedure-specific and emergent status factors for risk stratification. We still believe, as stated in the proposed rule that PAC intensity would not vary significantly between TKA and THA for beneficiaries without hip fractures.
We will identify episodes with hip fractures using ICD-9-CM or ICD-10-CM diagnosis codes, where the hip fracture diagnosis is the principal diagnosis on the anchor hospitalization claim for an LEJR procedure. Our goal is to identify those CJR episodes where the primary surgical treatment for the hip fracture is an LEJR procedure furnished during the anchor hospitalization. The historical episodes with hip fracture diagnosis codes on the anchor hospitalization claim will be used to set the hip fracture episode target prices under the CJR model, and episodes during the CJR model with hip fracture diagnosis codes on the anchor hospitalization claim will be reconciled at the hip fracture episode target prices.
In order to develop the initial list of ICD-9-CM hip fracture diagnosis codes used to identify those historical episodes with hip fracture for calculating hip fracture episode target prices, to implement changes to the list to account for the transition to the ICD-10-CM diagnosis code set that will be used to identify episodes during the model performance years that will receive fracture episode target prices, and to make other changes as necessary based on annual ICD-10-CM coding changes or to address issues raised by the public throughout the model performance years, we are implementing the following subregulatory process, which mirrors the subregulatory process we will use for the episode definition exclusions list described in section III.B.2 of this final rule. We will use this process on an annual, or more frequent, basis to update the ICD-CM hip fracture diagnosis code list and to address issues raised by the public.
As part of this process, we will first develop the potential ICD-CM hip fracture diagnosis codes based on our assessment according to the following standards:
• The ICD-CM diagnosis code is sufficiently specific that it represents a bone fracture for which a physician could determine that a hip replacement procedure, either a PHA or a THA, could be the primary surgical treatment.
• The ICD-CM diagnosis code is the primary reason (that is, principal diagnosis code) for the anchor hospitalization.
We will then post a list of potential hip fracture diagnosis codes (whether ICD-9-CM diagnosis codes, as necessary to develop initial target prices, or ICD-10-CM diagnosis codes to be utilized during the model performance years) to the CMS Web site at
With public release of this final rule, we are initiating this subregulatory process to develop a final ICD-9-CM hip fracture diagnosis code list that will be used to identify historical anchor hospitalizations for beneficiaries with hip fracture for purposes of determining episode spending in the historical period and developing initial target prices for the model. The potential ICD-9-CM hip fracture diagnosis code list is posted on the CJR Web site at
This policy is codified at § 510.300(a).
We proposed to use 3 years of historical CJR episodes for calculating CJR target prices. The set of 3-historical-years used would be updated every other year. Specifically—
• Performance years 1 and 2 would use historical CJR episodes that started between January 1, 2012 and December 31, 2014;
• Performance years 3 and 4 would use historical episodes that started between January 1, 2014 and December 31, 2016; and
• Performance year 5 would use episodes that started between January 1, 2016 and December 31, 2018.
We considered using fewer than 3 years of historical CJR episode data, but we are concerned with having sufficient historical episode volume to reliably calculate target prices. We also considered not updating the historical episode data for the duration of the model. However, we stated in the proposed rule our belief that hospitals' target prices should be regularly updated on a predictable basis to use the most recent available claims data, consistent with the regular updates to Medicare's payment systems, to account for actual changes in utilization. We are not proposing to update the data annually, given the uncertainty in pricing this could introduce for participant hospitals. We also note that the effects of updating hospital-specific data on the target price could be limited
The following is a summary of the comments received and our responses.
Some commenters also stated that if we do update the historical data, we should include previous reconciliation payments and repayments to Medicare for the participant hospitals. We refer readers to comments and responses to comments in section III.C.3 of this final rule for further discussion on this comment.
Some commenters proposed alternative approaches to getting to target prices other than using and updating historical data. Some commenters suggested using a negotiations/bidding process approach to get to target prices; Medicare would negotiate with or request bids from providers for providing services covered under the CJR episode definition. Some other commenters suggested applying some sort of inflation factor, such as a CMS market basket update, for future years of the model instead of updating the 3 years of historical CJR episode data. These alternatives to using and updating the historical CJR episode data would help prevent a participant hospital from competing against its historical self, even if it is already efficient, in order to qualify for reconciliation payments.
Instead, we proposed to capture changes in nationwide practice patterns by updating every other year the historical CJR episode data used to set target prices. We recognize that this approach of updating the historical episode data every other year effectively assumes a zero percent change in utilization between the latest year of historical episode data and the performance year. We believe this can be a valid estimate for a few years (for example, 2014 as the latest year of historical episode data for 2017 target prices; update historical episode data for 2018 target prices), but it is less likely to hold true for longer periods of time (for example, 2014 as the latest year of historical episode data for 2020 target prices; no update to historical episode data). Therefore, we believe updating the historical episode data is necessary. While updating the historical episode data more frequently (that is, every year, instead of every other year) would lessen our reliance on an assumption of zero percent utilization change, doing so may exacerbate commenters' concerns that already efficient hospitals would have to compete against themselves, as discussed further later in this section.
We appreciate commenters' concerns that it may be unsustainable for already efficient participant hospitals to continuously improve, and that participant hospitals may undertake activities that promote care coordination and improved quality of care but are not directly reimbursed under applicable Medicare FFS payment systems. If we were using 100 percent hospital-specific pricing, updating the historical data used to set target prices without including reconciliation payments would create a lower and harder to achieve target price for participant hospitals that previously increased efficiency. As discussed in section III.C.3 of this final rule, we may revisit in future rulemaking our decision to exclude reconciliation payments and repayment amounts when updating the set of historical years used to set target prices. Additionally, as we transition to regional pricing over the course of the model, participant hospitals will no longer compete against their historical selves but rather strive to outperform their regional peers. Under regional pricing, an already efficient hospital may be able to achieve actual episode expenditures below the regional target price without having to become even more efficient. By performance year 3, when the first update to historical episode data would occur, the majority of the target price would be based on the regional component, not the hospital-specific component, as described in section III.C.4.b.(5) of this final rule.
We appreciate commenters' suggestions on using alternative approaches to setting target prices. We may consider such approaches for future model tests.
We acknowledge that some payment variation may exist in the 3 years of historical CJR episodes due to updates to Medicare payment systems (for example, IPPS, OPPS, IRF PPS, SNF PPS, etc.) and national changes in utilization patterns. Episodes in the third of the 3-historical-years may have higher average payments than those from the earlier 2 years because of Medicare payment rate increases over the course of the 3-historical-years. We do not intend to have CJR incentives be affected by Medicare payment system rate changes that are beyond hospitals' control. In addition to the changes in Medicare payment systems, average episode payments may change year over year due to national trends reflecting changes in industry-wide practice patterns. For example, readmissions for all patients, including those in CJR episodes, may decrease nationally due to improved industry-wide surgical protocols that reduce the chance of infections. We do not intend to provide reconciliation payments to (or require repayments from) hospitals for achieving lower (or higher) Medicare expenditures solely because they followed national changes in practice
To mitigate the effects of Medicare payment system updates and changes in national utilization practice patterns within the 3 years of historical CJR episodes, we proposed to apply a national trend factor to each of the years of historical episode payments. Specifically, we proposed to inflate the 2 oldest years of historical episode payments to the most recent year of the 3-historical-years described in section III.C.4.b.(2) of the proposed rule. We proposed to trend forward each of the 2 oldest years using the changes in the national average CJR episode payments. We also proposed to apply separate national trend factors for episodes anchored by MS-DRG 469 versus MS-DRG 470 to capture any MS-DRG-specific payment system updates or national utilization pattern changes. For example, when using CY 2012-2014 historical episode data to establish target prices for performance years 1 and 2, under our proposal we would calculate a national average MS-DRG 470 anchored episode payment for each of the 3-historical-years. The ratio of the national average MS-DRG 470 anchored episode payment for CY 2014 to that of CY 2012 would be used to trend 2012 MS-DRG 470 anchored episode payments to CY 2014. Similarly, the ratio of the national average MS-DRG 470 anchored episode payment for CY 2014 to that of CY 2013 would be used to trend 2013 episode payments to CY 2014. The previously stated process would be repeated for MS-DRG 469 anchored episodes. Trending CY 2012 and CY 2013 data to CY 2014 would capture updates in Medicare payment systems as well as national utilization pattern changes that may have occurred.
We considered adjusting for regional trends in utilization, as opposed to national trends. However, we stated in the proposed rule our belief that any Medicare payment system updates and significant changes in utilization practice patterns would not be region-specific but rather be reflected nationally.
We sought comment on our proposal to nationally trend historical data to the most recent year of the 3 being used to set the target prices.
The following is a summary of the comments received and our responses.
We proposed to prospectively update historical CJR episode payments to account for ongoing Medicare payment system (for example, IPPS, OPPS, IRF PPS, SNF, MPFS, etc.) updates to the historical episode data and ensure we incentivize hospitals based on historical utilization and practice patterns, not Medicare payment system rate changes that are beyond hospitals' control. Medicare payment systems do not update their rates at the same time during the year. For example, IPPS, the IRF PPS, and the SNF payment system apply annual updates to their rates effective October 1, while the hospital OPPS) and MPFS apply annual updates effective January 1. To ensure we appropriately account for the different Medicare payment system updates that go into effect on January 1 and October 1, we proposed to update historical episode payments for Medicare payment system updates and calculate target prices separately for episodes initiated between January 1 and September 30 versus October 1 and December 31 of each performance year. The target price in effect as of the day the episode is initiated would be the target price for the whole episode. Note that in performance year 5, the second set of target prices would be for episodes that start and end between and including October 1 and December 31 because the fifth performance period of the CJR model would end on December 31, 2020. Additionally, a target price for a given performance year may apply to episodes included in another performance year. For example, an episode initiated in November 2016, and ending in February 2017 would have a target price based on the second set of 2016 target prices (for episodes initiated between October 1 and December 31, 2016), and it would be captured in the CY 2017 performance year (performance year 2) because it ended between January 1 and December 31, 2017. We refer readers to section III.C.3.c. of the proposed rule for further discussion on the definition of performance years.
We proposed to update historical CJR episode payments by applying separate Medicare payment system update factors each January 1 and October 1 to each of the following six components of each hospital's historical CJR payments:
• Inpatient acute.
• Physician.
• IRF.
• SNF.
• HHA.
• Other services.
A different set of update factors would be calculated for January 1 through September 30 versus October 1 through December 31 episodes each performance year. The six update factors for each of the previously stated components would be hospital-specific and would be weighted by the percent of the Medicare payment for which each of the six components accounts in the hospital's historical episodes. The weighted update factors would be applied to historical hospital-specific average payments to incorporate ongoing Medicare payment system updates. A weighted update factor would be calculated by multiplying the component-specific update factor by the percent of the hospital's historical episode payments the component represents, and summing together the results. For example, let us assume 50 percent of a hospital's historical episode payments were for inpatient acute care services, 15 percent for physician services, 35 percent for SNF services, and 0.0 percent for the remaining services. Let us also assume for this example that the update factors for inpatient acute care services, physician services, and SNF services are 1.02, 1.03, and 1.01, respectively. The weighted update factor in this example would be the following: (0.5 * 1.02) + (0.15*1.03) + (0.35*1.01) = 1.018. The hospital in this example would have its historical average episode payments multiplied by 1.018 to incorporate ongoing payment system updates. The specific order of steps, and how this step fits in with others, is discussed further in section III.C.4.c. of this final rule.
Each of a hospital's six update factors would be based on how inputs have changed in the various Medicare payment systems for the specific hospital. Additional details on these update factors will be discussed later in this section.
Region-specific update factors for each of the previously stated components and weighted update factors would also be calculated in the same manner as the hospital-specific update factors. Instead of using historical episodes attributed to a specific hospital, region-specific update factors would be based on all historical episodes initiated at any CJR eligible hospital within the region. For purposes of this rule, CJR eligible hospitals are defined as hospitals that are paid under IPPS and not a participant in BPCI Model 1 or in the risk-bearing period of Models 2 or 4 for LEJR episodes, regardless of whether or not the MSAs in which the hospitals are located were selected for inclusion in the CJR model. CJR episodes initiated at a CJR eligible hospital will for purposes of this rule be referred to as CJR episodes attributed to that CJR eligible hospital.
We considered an alternative option of trending the historical episode payments forward to the upcoming performance year using ratios of national average episode payment amounts, similar to how we proposed to trend the 2 oldest historical years forward to the latest historical year for historical CJR episode payments in section III.C.4.b.(3) of the proposed rule. Using ratios of national average episode payment amounts would have the advantage of also capturing changes in national utilization patterns in addition to payment system updates between the historical years and the performance year. However, such an approach would need to be done retrospectively, after average episode payments can be calculated for the performance year, because it would rely on the payments actually incurred in the performance period, data that would be not be available before the performance period. While the proposed approach of using component-specific weighted update factors may be more complicated than the previously stated alternative to use ratios of national average episode payment amounts, we stated in the proposed rule our belief that the additional complication is outweighed by the value to hospitals of knowing target prices before the start of an episode for which the target price would apply. We sought comment on this proposed approach of updating historical episode payments for ongoing Medicare payment system changes.
We did not propose to separately and prospectively apply an adjustment to account for changes in national utilization patterns between the historical and performance years. If a prospective adjustment factor for national utilization pattern changes were applied, it may only be meaningful in performance years 2 and 4, when the historical data used to calculate target prices would not be updated, but another year of historical data would be available. In any of the other 3 performance years, the latest available historical year of data would already be incorporated into the target prices. Given that we proposed to refresh the historical data used to calculate target prices every 2 years, we did not believe an additional adjustment factor to account for national practice pattern changes is necessary to appropriately incentivize participant hospitals to improve quality of care and reduce episode payments.
The following is a summary of the comments received and our responses.
A couple of commenters also inquired whether the Medicare payment system update factors accounted for changes Medicare FFS payment system changes. A commenter requested we freeze MS-DRG weights for MS-DRGs 469 and 470 if the weights decrease in any given year as part of the annual Medicare FFS IPPS payment system updates.
We also note that we are finalizing a modification to the equations used to calculate update factors for those payment systems that apply annual updates to their rates effective October 1 of each year. In lieu of calculating the update factors for inpatient acute, SNF, and IRF services using the values applicable at the end of latest historical year used to calculate target prices, we will use a blend of the values applicable during the latest historical year. Such a change will account for the payment systems that update payment rates on a fiscal year cycle, ensure we are calculating update factors based on the payment rates that apply to a given period to the extent feasible, and result in more accurate target price calculations. We reflect this change in the sections III.C.4.b.(4)(a),
We believe freezing MS-DRG weights would run counter to our objective to accurately account for the effects of Medicare FFS payment system changes. If we freeze MS-DRG weights and the weights decrease, we may inappropriately overestimate target prices.
We also clarify that BPCI LEJR episodes will be included in the historical data used to calculate the hospital-specific component of target prices. There may be some CJR participant hospitals who were previously participants in BPCI Model 2; there may be some BPCI Model 2 episodes in the historical data initiated by PGPs for which the LEJR procedure took place at the CJR participant hospital; or there may be some BPCI Model 3 episodes in the historical data for which the LEJR procedure took place at the CJR participant hospital. Including the BPCI LEJR episodes from the historical data used to calculate the hospital-specific component of target prices would parallel the previously discussed approach to include BPCI LEJR episodes in the regional component of target prices. Again, as previously discussed for the regional component of target prices, we would not apply the BPCI discount factor to claim payments nor include BPCI reconciliation or repayments for the hospital-specific component of target prices.
The proposed inpatient acute services update factor would apply to payments for services included in the episode paid under the IPPS. This would include payments for the CJR anchor hospitalization and related readmissions at hospitals paid under IPPS, but not payments for related readmissions at CAHs during the episode window. Payments for related readmissions at CAHs would be captured under the update factor for other services in section III.C.4.b.(4)(f) of the proposed rule.
The update factor applied to the inpatient acute services component of each participant hospital and region's historical average episode payments would be based on how inputs for the Medicare IPPS have changed between the latest year used in the historical 3 years of episodes and the upcoming performance period under CJR. We proposed to use changes in the following IPPS inputs to calculate the inpatient acute services update factor: IPPS base rate and average of MS-DRG weights, as defined in the IPPS/LTCH Final Rules for the relevant years. The average MS-DRG weight would be specific to each participant hospital and region to account for hospital and region-specific inpatient acute service utilization patterns. Hospital-specific and region-specific average MS-DRG weights would be calculated by averaging the MS-DRG weight for all the IPPS MS-DRGs included in the historical episodes attributed to each participant hospital and attributed to CJR eligible hospitals in the region, respectively; including MS-DRGs for anchor admissions as well as those for subsequent readmissions that fall within the episode definition. Expressed as a ratio, the inpatient acute services adjustment factor would equal the following:
• The numerator is based on values applicable for the upcoming performance period (PP) for which a target price is being calculated.
• The denominator is based on a blend of values applicable in the latest of the 3 historical years used in the target price (TP) calculations, weighted to account for the values applicable prior to October 1, and values applicable starting October 1 when IPPS updates for the new fiscal year are in effect. Note that this weighting incorporates a modification to our proposed methodology for calculating update factors, as previously discussed in section III.C.4.(b)(4) of this final rule.
Therefore, the inpatient acute services update factor formula is shown as—
The proposed physician services update factor would apply to payments for services included in the episode paid under the MPFS for physician services. We proposed to use changes in the following MPFS inputs to calculate the physician services update factor of each participant hospital and region's historical average episode payments: RVUs; work, practice expense, and malpractice (MP) liability geographic practice cost indices (GPCIs); and national conversion factor, as defined in the MPFS Final Rule for the relevant years. Hospital-specific and region-specific RVU-weighted GPCIs would be calculated to account for hospital and region-specific physician service utilization patterns. Hospital-specific and region-specific RVU-weighted GPCIs would be calculated by taking the proportion of RVUs for work, practice expense, and MP liability for physician services included in the historical episodes and attributed to each participant hospital and attributed to CJR eligible hospitals in the region, respectively, and multiplying each proportion by the relevant GPCI.
Expressed as a ratio, the physician services update factor would equal the following:
• The numerator is based on GPCI values applicable for the upcoming performance period (PP) for which a target price is being calculated.
• The denominator is based on GPCI values applicable at the end of the latest of the 3 historical years used in the target price (TP) calculations.
Therefore, the proposed physician services update factor formula is shown as—
The proposed IRF services update factor applies to payments for services included in the episode paid under the Medicare inpatient rehabilitation facility prospective payment system (IRF PPS). We proposed to use changes in the IRF Standard Payment Conversion Factor, an input for the IRF PPS and defined in the IRF PPS Final Rule for the relevant years, to update Medicare payments for IRF services provided in the episode. The IRF Standard Payment Conversion Factor is the same for all IRFs and IRF services, so there is no need to account for any hospital-specific or region-specific IRF utilization patterns; each participant hospital and region would use the same IRF services update factor.
Expressed as a ratio, the IRF PPS update factor would equal the following:
• The numerator is based on values applicable for the upcoming performance period (PP) for which a target price is being calculated.
• The denominator is based on a blend of values applicable in the latest of the 3 historical years used in the target price (TP) calculations, weighted to account for the values applicable prior to October 1, and values applicable starting October 1 when IRF PPS updates for the new fiscal year are in effect. Note that this weighting incorporates a modification to our proposed methodology for calculating update factors, as previously discussed in section III.C.4.(b)(4) of this final rule.
Therefore, the IRF services update factor formula is shown as—
The proposed SNF services update factor would apply to payments for services included in the episode and paid under the SNF PPS, including payments for SNF swing bed services. The update factor applied to the SNF services component of each participant hospital and region's historical average episode payments would be based on how average Resource Utilization Group (RUG-IV) Case-Mix Adjusted Federal Rates for the Medicare SNF PPS (defined in the SNF PPS Final Rule) have changed between the latest year used in the historical 3 years of episodes and the upcoming performance period under CJR. The average RUG-IV Case-Mix Adjusted Federal Rates would be specific to each participant hospital and region to account for hospital and region-specific SNF service utilization patterns. Hospital-specific and region-specific average RUG-IV Case-Mix Adjusted Federal Rates would be calculated by averaging the RUG-IV Case-Mix Adjusted Federal Rates for all SNF services included in the historical episodes attributed to each participant hospital and attributed to CJR eligible hospitals in the region, respectively. We note that the RUG-IV Case-Mix Adjusted Federal Rate may vary for the same RUG, depending on whether the SNF was categorized as urban or rural.
Expressed as a ratio, the SNF services update factor would equal the following:
• The numerator is based on values applicable for the upcoming
• The denominator is based on a blend of values applicable in the latest of the 3 historical years used in the target price (TP) calculations, weighted to account for values applicable prior to October 1, and values applicable starting October 1 when SNF PPS updates for the new fiscal year are in effect. Note that this weighting incorporates a modification to our proposed methodology for calculating update factors, as previously discussed in section III.C.4.(b)(4) of this final rule.
Therefore, the SNF services update factor formula is shown as—
The proposed HHA services update factor would apply to payments for services included in the episode and paid under the HH PPS, but exclude payments for Low Utilization Payment Adjustment (LUPA) claims (claims with four or fewer home health visits) because they are paid differently and would instead be captured in the update factor for other services in section III.C.4.b.(f) of the proposed rule. The update factor applied to the home health services component of each participant hospital and region's historical average episode payments would be based on how inputs for the Medicare HH PPS have changed between the latest year used in the historical 3 years of episodes and the upcoming performance period under CJR. We proposed to use changes in the HH PPS base rate and average of home health resource group (HHRG) case-mix weight, inputs for the HHA PPS and defined in the HHA PPS Final Rule for the relevant years, to calculate the home health services update factor. The average HHRG case-mix weights would be specific to each participant hospital and region to account for hospital and region-specific home health service utilization patterns. Hospital-specific and region-specific HHA services update factors would be calculated by averaging the HHRG case-mix weights for all home health payments (excluding LUPA claims) included in the historical episodes attributed to each participant hospital and attributed to CJR eligible hospitals in the region, respectively.
Expressed as a ratio, the HHA adjustment factor would equal the following:
• The numerator is based on values applicable for the upcoming performance period (PP) for which a target price is being calculated.
• The denominator is based on values applicable at the end of the latest of the 3 historical years used in the target price (TP) calculations.
Therefore, the proposed HHA services update factor formula is shown as—
The other services update factor would apply to payments for services included in the episode and not paid under the IPPS, MPFS, IRF PPS, or HHA PPS (except for LUPA claims). This component would include episode payments for home health LUPA claims and CJR related readmissions at CAHs. For purposes of calculating the other services update factor, we proposed to use the Medicare Economic Index (MEI), a measure developed by CMS for measuring the inflation for goods and services used in the provision of physician services.
We proposed to calculate CJR episode target prices using a blend of hospital-specific and regional historical average CJR episode payments, including CJR episode payments for all CJR eligible hospitals in the same U.S. Census division as discussed further in section III.C.4.b.(6) of the proposed rule. Specifically, we proposed to blend two-thirds of the hospital-specific episode payments and one-third of the regional episode payment to set a participant hospital's target price for the first 2-performance years of the CJR model (CY 2016 and CY 2017). For performance year 3 of the model (CY 2018), we proposed to adjust the proportion of the hospital-specific and regional episode payments used to calculate the episode target price from two-thirds hospital-specific and one-third regional to one-third hospital-specific and two-thirds regional. Finally, we proposed to use only regional historical CJR episode payments for performance years 4 and 5 of the model (CY 2019 and CY 2020) to set a participant hospital's target price, rather than a blend between the hospital-specific and regional episode payments. The specific order of steps, and how this step fits in with others, is discussed further in section III.C.4.c. of the proposed rule. We welcome comment on the appropriate blend between hospital-specific and regional episode payments and the change in that blend over time.
We considered establishing episode target prices using only historical CJR hospital-specific episode payments for all 5 performance years of the model (that is, episode payments for episodes attributed to the participant hospital, as previously described in section III.C.2. of the proposed rule). Using hospital-specific historical episodes may be appropriate in other models such as BPCI Model 2 where participation is voluntary and setting a region-wide target price could lead to a pattern of selective participation in which inefficient providers decline to participate, undermining the model's ability to improve the efficiency and quality of care delivered by those providers, while already-efficient providers receive windfall gains even if they do not further improve efficiency. Because CJR model participants will be required to participate in the model,
We considered establishing the episode target price using only historical CJR regional episode payments for all 5 performance years of the model. Though regional target pricing would reward the most efficient hospitals for continuing to provide high quality and cost efficient care, we are concerned about providing achievable incentives under the model for hospitals with high historical CJR average episode payments. We stated in the proposed rule our belief that a lower regional price for such hospitals would leave them with little financial incentive in performance year 1, especially without any responsibility to repay payments in excess of the target price as described in section III.C.3. of the proposed rule. Thus, we did not propose to set target prices solely on regional data for the entire duration of the model.
Therefore, we proposed initially to blend historical hospital-specific and regional-historical episode payments and then transition to using regional-only historical episode payments in establishing target prices to afford early and continuing incentives for both historically efficient and less efficient hospitals to furnish high quality, efficient care in all years of the model. Our proposal more heavily weights a hospital's historical episode data in the first 2 years of the model (two-thirds hospital-specific, one-third regional), providing a reasonable incentive for both currently efficient and less efficient hospitals to deliver high quality and efficient care in the early stages of model implementation. Beginning in performance year 3, once hospitals have engaged in care redesign and adapted to the model parameters, we proposed to shift to a more heavily weighted regional contribution (one-third hospital-specific, two-thirds regional in performance year 3) and ultimately to a regional target price for performance years 4 and 5. We stated in the proposed rule our belief that by performance year 4, setting target prices based solely on regional historical data would be feasible because hospitals would have had 3 years under this model to more efficiently deliver high quality care, thereby reducing some of the variation across hospitals. We stated in the proposed rule our belief that transitioning to regional only pricing in the latter years of the model would provide important information about the reduction in unnecessary variation in LEJR episode utilization patterns within a region that can be achieved.
We stated in the proposed rule our belief that transitioning to regional-only pricing in the latter years of the model may provide valuable information regarding potential pricing strategies for successful episode payment models that we may consider for expansion in the future. As discussed previously, substantial regional and hospital-specific variation in Medicare LEJR episode spending currently exists for beneficiaries with similar demographic and health status, so we are proposing that the early CJR model years will more heavily weight historical hospital-specific experience in pricing episode for a participant hospital. Once the hospital has substantial experience with care redesign, we expect that unnecessary hospital-specific variation in episode spending will be minimized so that regional-only pricing would be appropriate as we have proposed. We noted that, like episode payment under the CJR model, Medicare's current payment systems make payments for bundles of items and services, although of various breadths and sizes depending on the specific payment system. For example, the IPPS pays a single payment, based on national prices with geography-specific labor cost adjustments, for all hospital services furnished during an inpatient hospitalization, such as nursing services, medications, medical equipment, operating room suites, etc. Under the IPPS, the national pricing approach incentivizes efficiencies and has, therefore, led to a substantial reduction in unnecessary hospital-specific variation in resource utilization for an inpatient hospitalization. On the other hand, the episode payment approach being tested under BPCI Model 2 relies solely on provider-specific pricing over the lifetime of the model, assuming the number of episode cases is sufficient to establish a reliable episode price, an approach that has potential limitations were expansion to be considered. Thus, we stated in the proposed rule our belief that our proposal for CJR will provide new, important information regarding pricing for even larger and broader bundles of services once unnecessary provider-specific variation has been minimized that would supplement our experience with patterns and pricing under existing payment systems and other episode payment models. We expect that testing of CJR will contribute further information about efficient Medicare pricing strategies that result in appropriate payment for providers' resources required to furnish high quality, efficient care to beneficiaries who receive LEJR procedures. This is essential information for any consideration of episode payment model expansion, including nationally, in the future, where operationally feasible and appropriate pricing strategies, including provider-specific, regional, and national pricing approaches would need to be considered.
We proposed an exception to the blended hospital-specific and regional pricing approach for hospitals with low historical CJR episode volume. We proposed to define hospitals with low CJR episode volume as those with fewer than 20 CJR episodes in total across the 3-historical-years used to calculate target prices. We stated in the proposed rule our belief that calculating the hospital-specific component of the blended target price for these historically low CJR episode volume hospitals may be subject to a high degree of statistical variation. Therefore, for each performance year, we proposed to use 100 percent regional target pricing for participant hospitals who have fewer than twenty historical CJR episodes in the 3-historical-years used to calculate target prices, as described in section III.C.4.b.(2) of the proposed rule. We note that the 3-historical-years used
We also proposed an exception to the blended hospital-specific and regional pricing approach for participant hospitals that received new CCNs during the 24 months prior to the beginning of, or during, the performance year for which target prices are being calculated. These participant hospitals with new CCNs may have formed due to a merger between or split from previously existing hospitals, or may be new hospitals altogether. As a general principle, we aim to incorporate into the target prices all the historical episodes that would represent our best estimate of CJR historical payments for these participant hospitals with new CCNs. For participant hospitals with new CCNs that formed from a merger between or split from previously existing hospitals, we proposed to calculate hospital-specific historical payments using the episodes attributed to the previously existing hospitals. These hospital-specific historical payments would then be blended with the regional historical payments according to the approach previously described in this section. For participant hospitals with new CCNs that are new hospitals altogether, we proposed to use the approach previously described in this section for hospitals with fewer than 20 CJR episodes across the 3-historical-years used to calculate target prices. In other cases, due to an organizational change a hospital may experience a change to an already existing CCN during the 24 months prior to the beginning of, or during, the performance year for which target prices are being calculated. For example, one hospital with a CCN may merge with a second hospital assigned a different CCN, and both hospitals would then be identified under the single CCN of the second hospital. While there may be more than 20 CJR episodes under the second hospital's CCN in total across the 3-historical-years used to calculate target prices, in this scenario our use of only those cases under the second hospital's CCN in calculating hospital-specific historical payments would fail to meet our general principle of incorporating into target prices all the historical episodes that would represent our best estimate of CJR historical payments for these now merged hospitals. In this scenario, we proposed to calculate hospital-specific payments for the remaining single CCN (originally assigned to the second hospital only) using the historical episodes attributed to both previously existing hospitals. These hospital-specific historical payments would then be blended with the regional historical payments according to the approach previously described in this section in order to determine the episode price for the merged hospitals bearing a single CCN.
We sought comment on this proposed approach for blending hospital-specific and regional historical payments.
The following is a summary of the comments received and our responses.
Some commenters recommended that instead of blending regional and hospital-specific historical average CJR episode payments, we use the higher of the two to reward hospitals that are already efficient.
Some commenters recommended that we delay the transition to regional pricing in order to afford more time for hospitals with high historic episode expenditures, some commenters supported our proposal to get to 100 percent regional pricing by year 4, and some others recommended that we accelerate the transition to regional pricing to appropriately reward already efficient participant hospitals.
We believe that only using hospital-specific pricing would not reward already efficient participant hospitals for maintaining high performance; participant hospitals that are already delivering efficient and high quality care would find it challenging to improve upon their own historical performance in order to qualify for reconciliation payments. Similarly, we believe that using the higher of regional and hospital-specific prices would not sufficiently incentivize inefficient participant hospitals to become more efficient; participant hospitals that have historically high episode expenditures would have less of an incentive to become significantly more efficient over the course of the model if they can qualify for reconciliation payments by improving only slightly relative to their own historical performance, while still being less efficient than their regional peers.
We acknowledge the importance of properly accounting for variations in patient-specific clinical characteristics, socioeconomic conditions, and access to care to appropriately incentivize participant hospitals to deliver high quality and efficient care. We refer readers to response to comments in section III.C.4.b.(1) of this final rule for further discussion on risk stratification to account for such variations. We also acknowledge that incorporating a regional component of historical episode data into a participant hospital's target prices may increase the presence of the variations as
In all 5 performance years we proposed to define “region” as one of the nine U.S. Census divisions
We considered
We sought comment on our proposal to define a region as the U.S. Census division for purposes of the regional component of blended target prices under CJR.
The following is a summary of the comments received and our responses.
We considered the approach suggested by commenters—blending the two regional target price components based on the population distribution. However, using 2010 U.S. Census data, we determined that at least 75 percent of the population in the previously mentioned MSAs resides in just one of the U.S. Census divisions that the MSA spans. For simplicity, we will completely group MSAs that span U.S. Census divisions together with the U.S. Census divisions in which the Census estimates the majority of people reside, as shown in Table 9:
We note that some variation in historical CJR episode payments across hospitals in a region may be due to wage adjustment differences in Medicare's payments. In setting Medicare payment rates, Medicare typically adjusts facilities' costs attributable to wages and wage-related costs (as estimated by the Secretary from time to time) by a factor (established by the Secretary) reflecting the relative wage level in the geographic area of the facility or practitioner (or the beneficiary residence, in the case of home health and hospice services) compared to a national average wage level. Such adjustments are essential for setting accurate payments, as wage levels vary significantly across geographic areas of the country. However, having the wage level for one hospital influence the regional-component of hospital-specific and regional blended target prices for another hospital with a different wage level would introduce unintended pricing distortions not based on utilization pattern differences.
In order to preserve how wage levels affect provider payment amounts, while minimizing the distortions introduced when calculating the regional-component of blended target prices, we proposed to normalize for wage index differences in historical episode payments when calculating and blending the regional and hospital-specific components of blended target prices. Calculating blended target prices from historical CJR episodes would help ensure we incentivize hospitals based on historical utilization and practice patterns, not Medicare payment system rate changes that are beyond hospitals' control.
We proposed to normalize for provider-specific wage index variations using the IPPS wage index applicable to the anchor hospitalization (that is, the IPPS wage index used in the calculation of the IPPS payment for the anchor hospitalization). The anchor hospitalization accounts for approximately 50 percent of the total episode expenditures, and the IPPS wage index is applied to IPPS payments in a similar manner as wage indices for other Medicare payment systems are applied to their respective payments.
We proposed to reintroduce the hospital-specific wage variations by multiplying episode payments by the wage normalization factor when calculating the target prices for each participant hospital, as described in section III.C.4.c. of the proposed rule. When reintroducing the hospital-specific wage variations, the IPPS wage index would be the one that applies to the hospital during the period for which target prices are being calculated (for example, FY 2016 wage indices for the target price calculations for episodes that begin between January 1 and September 30, 2016). The specific order of steps, and how this step fits in with others, is discussed further in section III.C.4.c. of the proposed rule. We sought comment on our proposal to normalize for wage index differences using participant hospitals' wage indices in order to calculate blended target prices.
The following is a summary of the comments received and our responses.
In response to commenters, we will modify our proposal and normalize for wage indices at the claim level for both historical episode expenditures and actual episode expenditures in each performance year by using the wage index normalization algorithm included in the CMS Price (Payment) Standardization Detailed Methodology discussed in section III.C.3 of this final rule, the same methodology we finalized to exclude the various special payment provisions in calculating episode expenditures. By normalizing claims for wage indices in the historical episode expenditure data at the claim level, we will accurately account for wage indices and labor shares for various providers and suppliers under the different Medicare FFS payment systems. This will be a more accurate way than what we proposed to achieve the same goal of accounting for wage index differences so that we incentivize based on practice patterns and not Medicare FFS wage adjustment differences. We will also normalize claims for wage indices in performance year data, as we discuss further in response to comments in section III.C.6.a. of this final rule.
We believe it is still important to reintroduce wage index variations near the end of the target price calculation methodology. Participant hospitals may use their reconciliation payments to invest in care coordination or care delivery infrastructure, and we expect that the costs for such investments would vary by geography due to differences in local wages. For example, we expect that hiring a care coordinator would cost a participant hospital more in the New York metro region than in a rural part of New Mexico. If we do not reintroduce wage index variations into target price calculations, we would calculate reconciliation and repayment amounts that would not capture labor cost variation throughout the country, and participant hospitals in higher labor cost regions may see relatively less financial incentive to invest in improved care quality and efficiency. We intend to incentivize all hospitals to reduce episode spending under the CJR model, regardless of local labor cost variations.
We will use the proposed approach to reintroduce wage index variations—apply the participant hospital's wage index to episode spending, using 0.7 as the labor share. While commenters are correct that the IPPS labor share can be 0.688 or 0.620, depending on the participant hospital's wage index, the labor share for PAC providers also varies across Medicare FFS payment systems: ~0.695 for SNF PPS and IRF PPS, and ~0.785 for HH PPS. Given this range for the labor share across Medicare FFS payment systems, we believe that using 0.7 is an appropriate estimate of the labor share for reintroducing wage index variations. Additionally, as commenters pointed out, PAC providers have their own wage indices. Because wage index variations are reintroduced near the end of the target price calculation methodology and after other features, such as blending, pooling, and update factors are applied, we do not believe there is a simple approach to reintroduce wage index variations at the claim level. We acknowledge that using the participant hospital's wage index and 0.7 as the labor share would only be an approximation of the wage index variations, but this approximation would not change whether a participant hospital qualifies for reconciliation
We proposed to pool together CJR episodes anchored by MS-DRGs 469 and 470 for target price calculations to use a greater historical CJR episode volume and set more stable target prices. We note that we would still calculate separate target prices for episodes anchored by MS-DRGs 469 versus 470, described later in this section.
To pool together MS-DRG 469 and 470 anchored episodes, we proposed to use an anchor factor and hospital weights. The anchor factor would equal the ratio of national average historical MS-DRG 469 anchored episode payments to national average historical MS-DRG 470 anchored episode payments. The national average would be based on episodes attributed to any CJR eligible hospital. The resulting anchor factor would be the same for all participant hospitals. For each participant hospital, a hospital weight would be calculated using the following formula, where episode counts are participant hospital-specific and based on the episodes in the 3-historical-years used in target price calculations:
A hospital-specific pooled historical average episode payment would be calculated by multiplying the hospital's hospital weight by its combined historical average episode payment (sum of MS-DRG 469 and 470 anchored historical episode payments divided by the number of MS-DRG 469 and 470 historical episodes).
The calculation of the hospital weights and the hospital-specific pooled historical average episode payments would be comparable to how case mix indices are used to generate case mix-adjusted Medicare payments. The hospital weight essentially would count each MS-DRG 469 triggered episode as more than one episode (assuming MS-DRG 469 anchored episodes have higher average payments than MS-DRG 470 anchored episodes) so that the pooled historical average episode payment, and subsequently the target price, is not skewed by the hospital's relative breakdown of MS-DRG 469 versus 470 anchored historical episodes.
The hospital-specific pooled historical average payments would be modified by blending and discount factors, as described in section III.C.4.c. of the proposed rule. Afterwards, the hospital-specific pooled calculations would be “unpooled” by setting the MS-DRG 470 anchored episode target price to the resulting calculations, and by multiplying the resulting calculations by the anchor factor to produce the MS-DRG 469 anchored target prices.
We would calculate region-specific weights and region-specific pooled historical average payments following the same steps proposed for hospital-specific weights and hospital-specific pooled average payments. Instead of grouping episodes by the attributed hospital as is proposed for hospital-specific calculations, region-specific calculations would group together episodes that were attributed to any CJR eligible hospital located within the region. The hospital-specific and region-specific pooled historical average payments would be blended together as discussed in section III.C.4.b.(3) of the proposed rule. The specific order of steps, and how this step fits in with others, is discussed further in section III.C.4.c. of the proposed rule.
We considered an alternative option of independently setting target prices for MS-DRG 470 and 469 anchored episodes without pooling them. However, hospital volume for MS-DRG 469 was substantially less than for MS-DRG 470. In 2013 across all IPPS hospitals, there were more than 10 times as many MS-DRG 470 anchored episodes as compared to MS-DRG 469 anchored episodes.
The following is a summary of the comments received and our responses.
Additionally, hospital and regional weights will be calculated using the following formula:
When setting an episode target price for a participant hospital, we proposed to apply a discount to a hospital's hospital-specific and regional blended historical payments for a performance period to establish the episode target price that would apply to the participant hospital's CJR episodes during that performance period and for which the hospital would be fully, or partly, accountable for episode spending in relationship to the target price, as discussed in section III.C.3. of the proposed rule. We expect participant hospitals to have significant opportunity to improve the quality and efficiency of care furnished during episodes in comparison with historical practice, because this model would facilitate the alignment of financial incentives among providers caring for beneficiaries throughout the episode. This discount would serve as Medicare's portion of reduced expenditures from the CJR episode, with any episode expenditure below the target price potentially available as reconciliation payments to the participant hospital where the anchor hospitalization occurred. We proposed to apply a 2 percent discount for performance years 1 through 5 when setting the target price. We stated our belief in the proposed rule that applying a 2 percent discount in setting the episode target price allows Medicare to partake in some of the savings from the CJR model, while leaving considerable opportunity for participant hospitals to achieve further episode savings below the target price that they would be paid as reconciliation payments, assuming they meet the quality requirements as discussed in section III.C.5 of the proposed rule.
The proposed 2 percent discount is similar to the range of the discounts used for episodes in the ACE demonstration.
The proposed 2 percent discount also matches the discount used in the BPCI Model 2 90-day episodes, and is less than the discount used in BPCI Model 2 30-day and 60-day episodes (3 percent). Hundreds of current BPCI participants have elected to take on responsibility for repayment in BPCI Model 2 with a 2 to 3 percent discount. Because many BPCI participants volunteered to participate in a bundled payment model with a discount, we stated in the proposed rule our belief that a discount percent that is within, and especially a discount of 2 percent that is at the lower end of, the BPCI discount range would allow CJR participant hospitals to create savings for both themselves and Medicare.
As stated previously in section III.C.3. of the proposed rule, we proposed to phase in the financial responsibility of hospitals for repayment of actual episode spending that exceeds the target price starting in performance year 2. In order to help hospitals transition to taking on this responsibility, we proposed to apply a reduced discount of one percent in performance year 2 for purposes of determining the hospital's responsibility for excess episode spending, but maintain the 2 percent discount for purposes of determining the hospital's opportunity to receive reconciliation payment for actual episode spending below the target price. For example, under this proposal in performance year 2, a hospital that achieves CJR actual episode payments below a target price based on a 2 percent discount would retain savings below the target price, assuming the quality thresholds for reconciliation payment eligibility are met (discussed in section III.C.5. of the proposed rule) and the proposed performance year stop-gain limit (discussed in section III.C.8. of the proposed rule) does not apply. Medicare would hold responsible for repayment hospitals whose CJR actual episode payments exceed a target price based on a one percent discount, assuming the proposed performance year 2 stop-loss limit (discussed in section III.C.8. of the proposed rule) does not apply. Hospitals that achieve CJR actual episode payments between a 2 percent-discounted target price and 1 percent-discounted target price would neither receive reconciliation payments nor be held responsible for repaying Medicare. The decision on which percent-discounted target price applies will be made by evaluating actual episode payments in aggregate after the completion of performance year 2, and the same percent-discounted target price would apply to all episodes that are initiated in performance year 2. We proposed to apply this reduced one percent discount for purposes of hospital repayment responsibility only in performance year 2 and apply the 2 percent discount for excess episode spending repayment responsibility for performance years 3 through 5. Under this proposal, the discount for determination of reconciliation payment for episode actual spending below the target price would not deviate from 2 percent through performance years 1 through 5.
In section III.C.5. of the proposed rule, we proposed voluntary submission of data for a patient-reported outcome measure. We proposed to incent participant hospitals to submit data on this measure by reducing the discount percentage by 0.3 percentage points for successfully submitting data, as defined in section III.D. of the proposed rule. By successfully submitting data on this metric for episodes ending in performance years 1, 2, 3, 4, and or 5, we would adjust the discount percentage in the corresponding year(s) as follows:
• For episodes beginning in performance year 2, set the discount percentage in a range from 2 percent to 1.7 percent for purposes of determining the hospital's opportunity to receive reconciliation payment for actual episode spending below the target price, and set the discount percentage in a range from 1 percent to 0.7 percent for purposes of determining the amount the hospital would be responsible for repaying Medicare for actual episode spending above the target price.
• For episodes beginning in performance years 3 through 5, set the discount percentage in a range from 2 percent to 1.7 percent for purposes of reconciliation payment and Medicare repayment calculations.
The determination of whether the hospital successfully submitted data on the patient-reported outcome measure cannot be made until after the performance year ends and data is reported. Therefore, participant hospitals would be provided target prices for both scenarios whether the successfully submit data or not and such determination will happen at the time of payment reconciliation (discussed further in section III.C.6. of the proposed rule).
We sought comment on our proposed discount percentage of 2 percent for CJR episodes, our proposal to reduce the discount to 1 percent on a limited basis in performance year 2, and our proposal to reduce the discount by 0.3 percentage points for successfully reporting patient-reported outcomes data in the corresponding year.
The following is a summary of the comments received and our responses.
Each participant hospital may qualify for a quality incentive payment. The quality incentive payment would not be a separate payment stream, but rather it would alter a hospital's effective discount factor used to calculate its target prices. Depending on a participant hospital's quality performance, in performance years 1, 4, and 5, the quality incentive payments could result in effective discount factors ranging from 3 percent to 1.5 percent. In performance years 2 and 3, the quality incentive payments could result in effective discount factors for purposes of calculating reconciliation payments ranging from 3 percent to 1.5 percent, and for purposes of calculating repayment amounts from 2 percent to 0.5 percent. We note that the lower effective discount factors for calculating repayment amounts in performance years 2 and 3 reflect the reduction by 1 percentage point in discount factor to phase in downside risk.
If hospitals' quality performance during the CJR model mirrors historical quality performance, we expect the majority of the participant hospitals to qualify for an effective discount factor of 2 percent each performance year for purposes of reconciliation payment calculations, the same discount factor proposed for all participant hospitals in the proposed rule. By using a range of discount factors, we will offer more participant hospitals an opportunity to qualify for reconciliation payments, and we will be able to better reward the highest quality participant hospitals.
We refer readers to responses to comments in section III.C.5 of this final rule for more details on quality incentive payments, effective discount factors, the link between quality and payment, and how participant hospitals may perform based on historical quality performance.
The discount factor will serve as Medicare's portion of reduced expenditures from the CJR episode. We acknowledge that there are other potential mechanisms, including shared savings methodologies, to provide savings to Medicare while also incentivizing participant hospitals. However, we also believe that a discount model, as proposed, can also incentivize participant hospitals to deliver high quality and efficient care while also providing savings to Medicare. We appreciate commenters' suggestions and we may consider alternative methodologies, such as shared savings, in the future.
Additionally, we believe there may be low investment opportunities for participant hospitals to achieve high quality and efficiency and qualify for reconciliation payments in this model. For example, participant hospitals may refer to high quality and efficient PAC providers when appropriate, and updates to discharge and referral patterns may be informed using already publicly available quality data and historical episode expenditure data provided by CMS and discussed in section III.E. of this final rule. PAC expenditures account for a significant proportion of historical CJR episode expenditures (approximately 30 percent
We also reiterate that as discussed in section III.C.5.b. of this final rule, the quality measures selected for this model are already in use for mandatory CMS quality reporting programs, such as the IQR program. Hospitals will not experience an additional reporting burden under this model for such measures. In addition, while we are including testing of a voluntary patient-reported outcomes measures, as discussed in section III.C.5.b.2. of this final rule, reporting of this measure will be voluntary. We do not believe there is any required additional burden on participant hospitals to report quality data.
Given the success of participants in a similar model, the possibility to achieve reconciliation payments with relatively low investment approaches, and the lack of required additional quality reporting burden, we will not make additional upfront payments through mechanisms such as per-beneficiary-per-month payments or additional payments per episode.
In section III.C.4.(b) of the proposed rule we discuss the various features we proposed to incorporate into our approach to set target prices. We refer readers to that section for more information on rationale and alternatives considered for each feature. In this section we discuss how the different pricing features, as well as the episode definition (section III.B. of the proposed rule) and adjustments to payments included in the episodes (section III.C.3. of the proposed rule), would fit together and be sequenced to calculate CJR episode target prices for participant hospitals. The following steps would be used to calculate MS-DRG 469 and 470 anchored episode target prices for both January 1 through September 30 and October 1 through December 31 each performance year. The output of each step would be used as the input for the subsequent step, unless otherwise noted.
• (1) Calculate historical CJR episode payments for episodes that were initiated during the 3-historical-years (section III.C.4.b.(2) of the proposed rule) for all CJR eligible hospitals for all Medicare Part A and B services included in the episode. We note that specific Per Beneficiary Per Month (PBPM) payments may be excluded from historical episode payment calculations as discussed in section III.C.7.d. of the proposed rule.
• (2) Remove effects of special payment provisions (section III.C.3.a. of the proposed rule).
• (3) Prorate Medicare payments for included episode services that span a period of care that extends beyond the episode (section III.C.3.b of the proposed rule.).
• (4) Normalize for hospital-specific wage adjustment variation by dividing the episodes outputted in step (3) by the hospital's corresponding wage normalization factor described in section III.C.4.b.(7) of the proposed rule.
• (5) Trend forward 2 oldest historical years of data to the most recent year of historical data. As discussed in section III.C.4.b.(3) of the proposed rule, separate national trend factors would be applied to episodes anchored by MS-DRG 469 versus MS-DRG 470.
• (6) Cap high episode payment episodes with a region and MS-DRG anchor-specific high payment ceiling as discussed in section III.C.3.c. of the proposed rule, using the episode output from the previous step. We have posted region-specific historical average episode payments on the CJR Web site at
• (7) Calculate anchor factor and participant hospital-specific weights (section III.C.4.b.(8) of the proposed rule) using the episode output from the previous step to pool together MS-DRG 469 and 470 anchored episodes, resulting in participant hospital-specific pooled historical average episode payments. Similarly, calculate region-specific weights to calculate region-specific pooled historical average episode payments.
• (8) Calculate participant hospital-specific and region-specific weighted update factors as described in section III.C.4.b.(4) of the proposed rule. Multiply each participant hospital-specific and region-specific pooled historical average episode payment by its corresponding participant hospital-specific and region-specific weighted update factors to calculate participant hospital-specific and region-specific updated, pooled, historical average episode payments.
• (9) Blend together each participant hospital-specific updated, pooled, historical average episode payment with the corresponding region-specific updated, pooled, historical average episode payment according to the proportions described in section III.C.4.b.(5) of the proposed rule. Participant hospitals that do not have the minimum episode volume across the historical 3 years would use 0.0 percent and 100 percent as the proportions for hospital and region, respectively.
• (10) Reintroduce hospital-specific wage variations by multiplying the participant hospital-specific blended, updated, and pooled historical average episode payments by the corresponding hospital-specific wage normalization factor, using the hospital's IPPS wage index that applies to the hospital during the period for which target prices are being calculated (section III.C.4.b.(7) of the proposed rule).
• (11) Multiply the appropriate discount factor, as discussed in section III.C.4.b.(9) of the proposed rule to each participant hospital's wage-adjusted, blended, updated, and pooled historical
• (12) Multiply participant hospitals' target prices for MS-DRG 470 anchored episodes by the anchor factor (section III.C.4.b.(8) of the proposed rule) to calculate hospitals' target prices for MS-DRG 469 anchored episodes.
The previously stated twelve steps would be used to calculate target prices for episodes that begin between January 1 and September 30, as well as for episodes that begin between October 1 and December 31, for each performance year. The target price calculations for the two different time periods each performance year would differ by the IPPS wage index used in step (11) and the update factors used in step (8). By following these twelve steps, we would calculate target prices for each participant hospital for each performance year. We refer readers to section III.C.4.b. of the proposed rule for further details on each of the specific steps.
We sought comment on the proposed approach to sequence and fit together the different pricing features, the episode definition (section III.B. of the proposed rule), and adjustments to payments included in the episodes (section III.C.3. of the proposed rule) to calculate CJR episode target prices for participant hospitals.
The following is a summary of the comments received and our responses.
• (1) Calculate historical CJR episode payments for episodes that were initiated during the 3-historical-years (section III.C.4.b.(2) of this final rule) for all CJR eligible hospitals for all Medicare Part A and B services included in the episode. We note that specific PBPM payments may be excluded from historical episode payment calculations as discussed in section III.C.7.d. of this final rule.
• (2) Remove effects of special payment provisions (section III.C.3.a. of this final rule) and normalize for wage index differences (section III.C.4.b.(7) of this final rule) by standardizing Medicare FFS payments at the claim-level.
• (3) Prorate Medicare payments for included episode services that span a period of care that extends beyond the episode (section III.C.3.b of this final rule.).
• (4) Trend forward 2 oldest historical years of data to the most recent year of historical data. As discussed in section III.C.4.b.(3) of this final rule, separate national trend factors would be applied for each combination of anchor MS-DRG (469 vs. 470) and hip fracture status (with hip fracture vs. no hip fracture).
• (5) Cap high episode payment episodes with a region and MS DRG anchor specific high payment ceiling as discussed in section III.C.3.c. of this final rule, using the episode output from the previous step. We have posted region specific historical average episode payments on the CJR final rule Web site at
• (6) Calculate anchor factor and participant hospital specific weights (section III.C.4.b.(8) of this final rule) using the episode output from the previous step to pool together MS DRG 469 and 470 anchored episodes with and without hip fracture, resulting in participant hospital specific pooled historical average episode payments. Similarly, calculate region specific weights to calculate region specific pooled historical average episode payments.
• (7) Calculate participant hospital specific and region specific weighted update factors as described in section III.C.4.b.(4) of this final rule. Multiply each participant hospital specific and region specific pooled historical average episode payment by its corresponding participant hospital specific and region specific weighted update factors to calculate participant hospital specific and region specific updated, pooled, historical average episode payments.
• (8) Blend together each participant hospital specific updated, pooled, historical average episode payment with the corresponding region specific updated, pooled, historical average episode payment according to the proportions described in section III.C.4.b.(5) of this final rule. Participant hospitals that do not have the minimum episode volume across the historical 3 years would use 0.0 percent and 100 percent as the proportions for hospital and region, respectively. For purposes of this final rule, we will define the output of this step as the pre-discount target price for MS DRG 470 anchored episodes without hip fracture.
• (9) Multiply the output of step (8) by the appropriate anchor factors (step (6) of this target price calculation process and detailed in section III.C.4.b.(8) of this final rule) for MS DRG 469 anchored episodes with hip fracture, MS DRG 469 anchored episodes without hip fracture, and MS DRG 470 anchored episodes with hip fracture. For purposes of this final rule, we will define the outputs of this step as the pre-discount target prices for MS DRG 469 anchored episodes with hip fracture, MS DRG 469 anchored episodes without hip fracture, and MS DRG 470 anchored episodes with hip fracture.
• (10) Multiply the pre-discount target prices for MS DRGs 469 and 470 episodes with and without hip fracture by the appropriate effective discount factor that incorporates any quality incentive payment, as briefly described in section III.C.4.b.(9) of this final rule
The previously stated 10 steps will be used to calculate target prices for episodes that begin between January 1 and September 30 (between April 1 and September 30 for performance year 1), as well as for episodes that begin between October 1 and December 31, for each performance year. The target price calculations for the two different time periods each performance year will differ by the update factors used in the seventh step. By following these ten steps, we will calculate target prices for each participant hospital for each performance year. We refer readers to section III.C.4.b. of this final rule for further details on each of the specific steps.
These final policies are set forth at § 510.300 and § 510.305.
Over the past several years Medicare payment policy has moved away from FFS payments unlinked to quality and towards payments that are linked to quality of care. Through the Affordable Care Act, we have implemented specific IPPS programs like the HVBP program (subsection (o) of section 1886 of the Act), the Hospital Acquired Condition Reduction Program (HACRP) (subsection (q) of section 1886) and the HRRP (subsection (p) of section 1886), where quality of care is linked with payment. We have also implemented the Shared Savings Program, an ACO program that links shared savings payment to quality performance. Since the implementation of the HRRP in October 2012, readmission rates for various medical conditions like THA and TKA (THA/TKA) have improved. Trend analyses show a decrease in readmission rates and specifically with THA/TKA risk-standardized readmissions rates (RSRR) from 5.4 percent (July 2010-June 2011) to 4.8 percent (July 2012-June 2013).
As discussed in section III.C. of this final rule, which outlines the payment structure proposed for the CJR model, each participant hospital would have target prices calculated for MS-DRG 469 and 470 anchored episodes; each anchored episode would include an anchor hospitalization for an LEJR procedure and a 90-day period after the date of discharge from the anchor hospitalization. These episode target prices represent expected spending for all related Part A and Part B spending for such episodes, with a discount applied. Hospitals who achieve actual episode spending below a target price for a given performance period would be eligible for a reconciliation payment from CMS, subject to the proposed stop-gain limit policy as discussed in section III.C.8. of this final rule.
In the proposed rule, we proposed quality performance standards that must also be met in order for a hospital to be eligible to receive a reconciliation payment under CJR. Specifically, we described our proposal to include a performance measure result threshold on select outcomes-based quality measures as a requirement for participants to receive a reconciliation payment if actual episode spending is less than the target price under CJR in a performance year, in addition to a payment adjustment for successful reporting of a voluntary measure in development. Beginning in performance year one and continuing throughout the duration of the model, we proposed to make reconciliation payments only to those CJR hospital participants that met or exceeded a minimum measure result threshold. We also discussed an alternative approach to determining CJR reconciliation payment eligibility and adjusting payment based on a quality score developed from performance on three outcomes-based quality measures and success in reporting the voluntary measurement in development.
In section III.D. of the proposed rule, we proposed three measures to assess quality of care of the hospitals participating in the CJR model. We also proposed voluntary data submission for a patient-reported outcome measure in development. In section III.C.5. of the proposed rule, we proposed using three measures to determine eligibility for a reconciliation payment, as well as proposed rewarding hospitals that voluntarily submit data for the patient-reported outcome measure. We also discussed an alternative approach to determining reconciliation payment eligibility and adjusting payment based on a composite quality score calculated from the three required outcome measures and success on reporting voluntary data on the patient-reported outcome measure.
The CJR model is designed to provide financial incentives to improve coordination of care for beneficiaries that we expect to lead to avoidance of post-surgical complications and hospital readmissions, as well as to improve patient experience through care redesign and coordination. Furthermore, we acknowledge that achievement of savings while ensuring high-quality care for Medicare FFS beneficiaries in LEJR episodes would require close collaboration among hospitals,
• Hospital-level 30-day, all-cause RSRR following elective primary THA and/or TKA (National Quality Forum (NQF)#1551), an administrative claims-based measure.
• Hospital-level RSCR following elective primary THA and/or TKA (NQF #1550), an administrative claims-based measure.
• HCAHPS Survey measure (NQF #0166).
Beginning in performance year 1 and continuing throughout the duration of the model, we proposed to make reconciliation payments only to those CJR participant hospitals that met or exceeded a minimum performance threshold on the measures previously listed. We proposed that hospitals must meet or exceed the measure reporting thresholds and other requirements described in section III.C.5 and III.D. of this final rule on all three measures in order to be eligible for a reconciliation payment.
These three outcome measures were chosen due to their: (1) Alignment with the goals of the CJR model; (2) hospitals' familiarity with the measures due to their use in other CMS hospital quality programs, including programs that tie payment to performance such as HVBP and HRRP; and (3) assessment of CMS priorities to improve the rate of LEJR complications and readmissions, while improving patient experience. In the proposed rule, we stated our belief that the three quality measures we proposed for reconciliation payment eligibility reflected these goals and accurately measured hospitals' level of achievement on such goals.
During our consideration of quality metrics for the CJR model, we examined the feasibility of linking voluntary data submission of patient-reported outcomes, beyond the current three required measures discussed in section III.D.2. of this final rule for use in the model, with the possibility of incentivizing participant hospitals under the episode payment model to participate in this voluntary submission of data. We specifically examined potential patient-reported outcome measures since this type of outcome measure aligns with the CJR model goal of improving LEJR episode quality of care, including a heightened emphasis on patient-centered care where patients provide meaningful input to their care. Furthermore, the availability of patient reported outcome data would provide additional information on a participant hospital's quality performance, especially with respect to a patient's functional status, beyond the current three required measures discussed in section III.D.2. of this final rule for use in the model. We noted that we have a measure in development, the Hospital-Level Performance Measure(s) of Patient-Reported Outcomes Following Elective Primary THA or TKA measure or both (hence forth referred to as “THA/TKA patient-reported outcome-based measure”), that would support the National Quality Strategy domain of patient and family engagement, and could capture meaningful information that would not otherwise be available on patient outcomes that are related to the quality of LEJR episodes under CJR. In the proposed rule, we stated our belief that incorporating this measure into CJR by adjusting the payment methodology for successful voluntary data submission on the THA/TKA patient-reported outcome-based measure (henceforth referred to as “THA/TKA voluntary data”) would provide participant hospitals with valuable information on functional outcomes that would assist them in assessing an important patient-centered outcome, engaging other providers and suppliers in care redesign for LEJR episodes, as well as provide them with the potential for greater financial benefit from improved LEJR episode efficiencies. We did not believe it would be appropriate at this time to hold any participant hospitals financially accountable for their actual THA/TKA voluntary data, as we proposed to require for the three measures described in section III.C.5.b.(5) of this final rule.
Instead, we proposed to adjust the episode payment methodology for participant hospitals that successfully submit THA/TKA voluntary data by reducing the discount percentage used to set the target price from 2.0 percent to 1.7 percent of expected episode spending based on historical CJR episode data, hereinafter referred to as the voluntary reporting payment adjustment. The proposed payment policies with respect to reconciliation payment eligibility and the discount percentage based on hospital voluntary data submission are summarized in Table 10 for performance years 3 through 5 where we proposed that hospitals have full repayment responsibility. The proposed specific percentages that would apply for purposes of the repayment amount and reconciliation payment are outlined for performance years 1 and 2 in the discussion that follows.
We refer readers to section III.D.3.a. of this final rule for further discussion of the THA/TKA patient-reported outcome-based measure and our proposed definition of successful reporting. In addition, we refer readers to section III.C.4.b.(9) of this final rule for discussion of the proposed discount of 2.0 percent (without the voluntary reporting payment adjustment) to establish the target price. In the proposed rule, we stated our belief that a voluntary reporting payment adjustment of 0.3 percent of expected episode spending would, on average, cover the participant hospitals' additional administrative costs of voluntarily reporting patient risk variables and patient-reported reported function for outcome calculation. We estimated the value of this discount
We proposed that the voluntary reporting payment adjustment would be available for all years of the model, unless we find the measure to be unfeasible or have adequately developed the measure such that continued voluntary data collection is no longer needed for measure development during the course of the model. In those situations, we would notify participant hospitals that the voluntary reporting payment adjustment was no longer available as we would cease collecting the data.
We proposed that when we provide the episode target price to each participant hospital at 2 times during the performance year, we would provide different target prices reflecting the 2.0 percent and 1.7 percent discounts. At the time of reconciliation for the performance year, we would determine which participant hospitals successfully reported the THA/TKA voluntary data for that performance year. The effects of this voluntary reporting payment adjustment would vary for each year of the model, depending on the proposed reconciliation payment and repayment policies for that performance year. For hospitals that achieved successful reporting of the THA/TKA voluntary data in performance year 3, 4, or 5, we would use the target price reflecting the 1.7 percent discount (compared with the 2.0 percent discount for nonreporting or unsuccessfully reporting hospitals) to calculate the hospital's reconciliation payment or repayment amount. Based on this comparison, consistent with the proposal described in section III.C.6. of this final rule, we would make a reconciliation payment if actual episode spending was less than the target price (and the thresholds for reconciliation payment eligibility are met for the three required quality measures) or make participant hospitals responsible for repaying Medicare if actual episode spending exceeded the target price. For performance year 2, when we proposed that repayment responsibility would be phased-in, for participant hospitals with successful THA/TKA voluntary data reporting, we would use a target price reflecting the 1.7 percent discount (compared with the 2.0 percent discount for nonreporting or unsuccessfully reporting hospitals) to determine if actual episode spending was below the target price, whereupon the participant hospital would receive a reconciliation payment if the quality thresholds on the three required measures were met. In order to help hospitals transition to taking on repayment responsibility, we proposed to apply a reduced discount of 0.7 percent for successful THA/TKA voluntary data reporting hospitals (compared with 1.0 percent for nonreporting or unsuccessfully reporting hospitals) in performance year 2 for purposes of determining the hospital's repayment responsibility for excess episode spending. For performance year 1, when we proposed that there would be no repayment responsibility, for participant hospitals with successful THA/TKA voluntary data reporting, we would use a target price reflecting the 1.7 percent discount (compared with the 2.0 percent discount for nonreporting or unsuccessfully reporting hospitals) to determine if actual episode spending was below the target price, whereupon the participant hospital would receive a reconciliation payment if the quality thresholds on the three required measures were met. In the proposed rule, we stated our belief that this proposed voluntary reporting payment adjustment would provide the potential for increased financial benefit for participant hospitals due to a higher target price (that reflects a lower discount percentage) that successfully report the measure. Participant hospitals that successfully reported the voluntary data would be subject to a lower repayment amount (except for performance year 1 when hospitals have no repayment responsibility) or a higher reconciliation payment (assuming the thresholds are met on the three required measures for reconciliation payment eligibility), than hospitals that did not successfully report the voluntary data.
In general, we proposed that participant hospitals that met the performance thresholds for the three required quality measures and reduced actual episode spending below the target price, as well as successfully reported the THA/TKA voluntary data, would be eligible to retain an additional 0.3 percent of the reduced episode expenditures relative to participant hospitals that successfully reported the three required quality measures but did not report voluntary data, funds which would offset additional administrative costs that the participant hospitals would incur in reporting on the measure. Additionally, for performance years 2-5 where we proposed that participant hospitals would have payment responsibility, participant hospitals with increased actual episode spending above the target price would not be required to repay 0.3 percent of the increased episode expenditures (relative to participant hospitals that do not report voluntary data), funds that would offset additional administrative costs that the participant hospitals would incur in reporting on the measure. These costs would include the hospital staff time required for training on the measure, as well as then gathering and reporting on multiple patient risk variables from LEJR episode beneficiaries' medical records and locating beneficiaries and administering via phone survey questions on functional status, which would also then be reported to CMS. Thus, we expected that the proposal would encourage reporting by a number of participant hospitals, and it would have the potential to benefit those hospitals that successfully reported on the measure. Therefore, this proposal could financially benefit reporting hospitals that would also collect valuable information on patient functional outcomes that could inform their LEJR care redesign. While this measure remains in development from our perspective to ensure translation of data across care settings and the respective hospital communities during the 90-day post-discharge episode of care, participant hospitals would gain anecdotal, locally relevant information regarding the patient-reported outcomes of their own patients that could inform participant hospitals' continuous quality improvement efforts.
We considered two alternative options to adjust the CJR payment methodology by modifying the required quality measure thresholds for reconciliation payment eligibility for those participant hospitals that successfully submit the THA/TKA voluntary data. First, we considered adjusting the threshold that hospitals must meet on the three required quality measures for reconciliation payment eligibility if reduced episode spending was achieved from the unadjusted 30th percentile threshold to the adjusted 20th percentile threshold for performance years 1, 2, and 3, and from the unadjusted 40th percentile to the adjusted 30th percentile for performance years 4 and 5. Second, we
We sought comment on the proposed voluntary reporting payment adjustment of reducing the discount percentage from 2.0 percent to 1.7 percent for CJR participant hospitals that voluntarily and successfully report on the THA/TKA voluntary data. Given our interest in robust hospital participation in reporting on the THA/TKA voluntary data under CJR, we were specifically interested in information on the additional resources and their associated costs that hospitals would incur to report THA/TKA voluntary data, as well as the relationship of these costs to the potential financial benefit participant hospitals could receive from the proposed reduced discount of 1.7 percent. Based on such information, we would consider whether a change from the proposed discount factor reduction due to successful voluntary data submission would be appropriate. We also sought comment on whether the alternative payment methodology adjustments considered, or combination of adjustments, would more appropriately incentivize CJR participant hospitals to submit THA/TKA voluntary data. In the proposed rule, we stated our belief that development of the THA/TKA patient-reported outcome measure would benefit from reporting by a broad array of participant hospitals, including those that currently deliver high quality, efficient LEJR episode care and those that have substantial room for improvement on quality and or cost-efficiency.
We summarize the public comments we received on the proposed voluntary reporting payment adjustment and provide our responses in section III.C.5.b.(5)(c)(iii) of this final rule. We did not receive public comments on the alternative payment methodology adjustments that we discussed in the proposed rule. Furthermore, in light of our interest in encouraging CJR participant hospital THA/TKA voluntary data reporting, we also considered alternative approaches to collect this information or provide hospitals with funds to help cover their associated administrative costs other than adjustments to the CJR model payment methodology. One alternative would be for hospitals to collect and report on patient pre-operative information collected 0 to 90 days before surgery, while CMS would engage a contractor to collect and report the post-operative information collected 9 to 12 months after surgery. This approach would reduce some of the administrative burden of collection and reporting on hospitals, although participant hospitals would need to provide CMS with certain beneficiary information, including contact information that would be needed for a CMS contractor to contact the beneficiary at a later date. We sought comment on this alternative, including whether hospitals would incur significant additional administrative costs to report on the data prior to surgery and how CMS could best provide funds to offset some of those costs, through an adjustment to the CJR payment methodology or other means. We also sought comment on the information participant hospitals would need to provide to CMS so that a CMS contractor could collect and report the post-operative data, and the most efficient ways for hospitals to provide this information to us. Finally, we considered an approach that would provide hospitals with separate payment outside of an adjustment to the CJR payment methodology to specifically assist in covering their administrative costs of reporting THA/TKA voluntary data, in order to achieve robust hospital participation in reporting. We sought comment on the hospital administrative costs that would be incurred for reporting, as well as on approaches we could take to ensure that hospitals achieved successful reporting under such an approach if separate payment was made. Finally, we expressed our interest in comments regarding the comparative strength of these various alternatives in encouraging hospitals to participate in reporting THA/TKA voluntary data.
We did not receive any public comments on the alternatives we discussed other than adjustments to the payment methodology to collect THA/TKA voluntary data and provide hospitals with funds to cover the required resources. We summarize these comments we received in section III.C.5.b.(5)(c)(iii) of this final rule and provide our responses.
All three proposed outcome measures are risk-adjusted, and we refer readers to section III.D.2. of this final rule for a full discussion of these measures and risk-adjustment methodologies. We believed that risk-adjustment for patient case-mix is important when assessing hospital performance based on patient outcomes and experience and understanding how a given hospital's performance compares to the performance of other hospitals with similar case-mix.
We proposed to use a 3-year rolling performance or applicable period for the Hospital-level 30-day, all-cause RSRR following elective primary THA and/or TKA (NQF #1551) and the Hospital-level RSCR following elective primary THA and/or TKA (NQF #1550) measures. We also specifically proposed to align with the HIQR Program's 3-year rolling performance period for the RSRR and RSCR measures since we believed that a 3-year performance period yields the most consistently reliable and valid measure results (FY 2015 IPPS/LTCH final rule, 79 FR 50208 through 50209). For the HCAHPS Survey measure, we proposed to follow the same performance period as in the HIQR Program (FY 2015 IPPS/LTCH final rule, 79 FR 50259). HCAHPS scores are created from 4 consecutive quarters of survey data; publicly reported HCAHPS results are also based on 4 quarters of data. For the voluntary data collection for the proposed THA/TKA patient-reported outcome-based performance measure, the optimal reporting time period had not been determined at the time of issuance of the CJR model proposed rule. Therefore, we proposed defining the applicable time period as
As discussed in section III.A.2. of this final rule, all CJR participant hospitals will be IPPS hospitals.
To determine performance on the quality measures, we proposed to calculate measure results for all three measures as outlined in the Quality Measures section III.D.2. of this final rule. Performance on the three measures for the CJR model participant hospitals would be compared to the national distribution of measure results for each of these measures obtained through the HIQR Program. The HIQR Program is an IPPS program in which public reporting is a focus of the program for the nation's acute care hospitals, and we proposed using the absolute value of the CJR model participant hospital's result to determine if that participant hospital was eligible for a reconciliation payment. In essence, we intended to take the HIQR Program measure results (also posted publicly) for the proposed measures, identify the proposed threshold, and apply the thresholds as outlined in section III.C.5.b.(5)(c)(iii) of this final rule. In the proposed rule, we stated our belief that it would be reasonable to use the HIQR Program distribution of measure results to identify a measure result threshold because—(1) The hospitals in the HIQR Program represent most acute care hospitals in the nation; (2) the CJR model participant hospitals are a subset of the hospitals in the HIQR Program; and (3) the expectation that the CJR model participant hospitals meet a measure result threshold based on a national distribution of measure results would encourage the CJR model participant hospitals to strive to attain measure results consistent with or better than hospitals across the nation. For a detailed description of how we proposed to determine the measure result thresholds for consideration of a reconciliation payment adjustment, see section III.C.5.b.(3) and III.C.5.b.(5)(c) of this final rule. We would not want to encourage CJR model participant hospitals to strive for measure results or quality of care performance that may be lower than the national measure results. Given that the CJR participant hospitals are a subset of the HIQR Program participant hospitals, they are familiar with these three measures and may have put into place processes that will help to improve quality of care in the LEJR patient population. Finally, once the measure results were calculated, we proposed to use these results to determine eligibility for reconciliation payment, which is discussed in detail in the next section.
We summarize the public comments we received on the proposed calculation of the measure results and application of performance thresholds and provide our responses in sections III.D.2 and III.C.5.b.(5)(c)(iii) of this final rule, respectively.
To be considered to have successfully reported the voluntary data collection and submission for the THA/TKA voluntary data, we proposed that successfully reporting would mean participant hospitals must meet all of the following:
• Submit the data elements listed in section III.D.3.a.(2) of this final rule.
• Data elements listed in section III.D.3.a.(3) of this final rule must be submitted on at least 80 percent of their eligible elective primary THA/TKA patients (patients eligible for pre-operative THA/TKA voluntary data submission are those described in section III.D.3.a.(3) of this final rule); patients eligible for post-operative THA/TKA voluntary data submission are those described in section III.D.3.a.(3) of this final rule and also having a THA/TKA procedure date during the anchor hospitalization at least 366 days prior to the end of the data collection period. Therefore, participant hospitals would not be expected to collect and submit post-operative THA/TKA voluntary data on patients who are fewer than 366 days from the date of surgery.
• THA/TKA voluntary data submission must occur within 60 days of the end of the most recent performance period.
Hospitals that meet these three standards and successfully submit THA/TKA voluntary data would be eligible for the proposed voluntary reporting payment adjustment of reducing the discount percentage from 2.0 percent to 1.7 percent for CJR participant hospitals that voluntarily and successfully report on the THA/TKA voluntary data. We note that we are not finalizing this voluntary reporting payment adjustment proposal as discussed in section III.C.5.b.(5)(c)(iii) of this final rule. However, we continue to believe that encouraging collection and submission of the THA/TKA voluntary data through the CJR model would increase availability of patient-reported outcomes to both participant hospitals that collect and submit data on their own patients in the model (and their patients as well); further development of an outcomes measure that provides meaningful information on patient-reported outcomes for THA/TKA procedures that are commonly furnished to Medicare beneficiaries; provide another quality measure that may be incorporated into the CJR model policy linking quality to payment in future performance years, pending successful development of the measure; and inform the quality strategy of future payment models. Collecting data on at least 80 percent of hospital's eligible THA/TKA patients would provide sufficiently representative data to allow for development and testing of the THA/TKA patient-reported outcome-based performance measure.
We invited public comment on the proposal to calculate measure results for all three measures as outlined in the Quality Measures section III.D.2. of this final rule. We also sought public comment on our proposal for hospitals to meet three requirements, previously outlined, in order to be considered as successfully submitting THA/TKA voluntary data.
We summarize the public comments on the proposals to calculate measure results and determine measure result thresholds and provide our responses in sections III.D.2. and III.C.5.b.(5)(c)(iii) of this final rule, respectively. We summarize the public comments on the proposals for successful THA/TKA
In proposing a methodology for linking payment for LEJR episodes to quality under this model, we considered several alternatives. Specifically, we considered making reconciliation payments to hospitals tied to achievement and improvement in quality performance or, alternatively, establishing minimum quality performance thresholds for selected quality measures from the beginning of the model or a later year, which would reward achievement but not necessarily improvement. While we proposed as discussed section III.C.5.b.(5)(c) of this final rule to establish minimum thresholds for participant hospital performance on three selected quality measures for reconciliation payment eligibility each performance year from the beginning of the model, we also discussed in detail an alternative we considered, which would make quality incentive payments related to hospital achievement and improvement on the basis of a composite quality score developed for each performance year. The composite quality score would affect reconciliation payment eligibility and change the effective discount included in the target price experienced by a participant hospital at reconciliation.
Similar to the proposal described in section III.C.5.b.(5)(c) of this final rule, the alternatives considered would require a determination of participant hospital performance on all three proposed required quality measures, described in section III.D.2. of this final rule, based on the national distribution of hospital measure result performance, but instead of identifying the participant hospital's performance percentile for comparison with a threshold requirement, we would do so for purposes of assigning points toward a hospital composite quality score. Both the hospital-level 30-day, all cause Risk-Standardized Readmission Rate (RSRR) following elective primary THA and/or TKA (NQF #1551) measure and the hospital-level Risk-Standardized Complication Rate (RSCR) following elective primary THA and/or TKA (NQF #1550) measure directly yield rates for which a participant hospital performance percentile could be determined and compared to the national distribution in a straightforward manner. As discussed in section III.D.2.c. of this final rule, we proposed to use the HCAHPS Linear Mean Roll Up (HLMR) score calculated using the HCAHPS Survey measure (NQF #0166). Once the HLMR scores are calculated, the participant hospital performance percentile could also be determined and compared to the national distribution in a straightforward manner. In addition, the alternatives considered would account for the successful submission of voluntary THA/TKA data on the patient-reported outcome measure, as discussed in section III.C.5.b.(2) of this final rule, in the calculation of the composite quality score.
We considered assigning each participant hospital a composite quality score, developed as the sum of the individual quality measure scores described later in this section, which were set to reflect the intended weights for each of the quality measures and the successful submission of THA/TKA voluntary data in the composite quality score. The participant hospital's composite quality score would affect reconciliation payment eligibility and could also provide the opportunity for quality incentive payments under the CJR model. Each quality measure would be assigned a weight in the composite quality score and possible scores for the measures would be set to reflect those weights. A composite quality score for each performance year would be calculated for each participant hospital based on its own performance that would affect reconciliation payment eligibility and the hospital's opportunity to receive quality incentive payments under the model. The composite quality score would also change the effective discount included in the target price experienced by the hospital at reconciliation for that performance year. We would weigh participant hospital performance on each of the three measures and successful submission of voluntary THA/TKA data according to the measure weights displayed in Table 11.
We would assign the lowest weight of 10 percent to the successful submission of THA/TKA data on the patient-reported outcome measure because these data represent a hospital's meaningful participation in advancing the quality measurement of LEJR patient-reported outcomes but not actual outcome performance for LEJR episodes under the CJR model. In the proposed rule, we stated our belief the three required measures that represent LEJR outcomes deserve higher weights in the composite quality score. We would assign a modest weight of 20 percent to the readmissions measure because, while we believed that readmissions are an important quality measure for LEJR episodes, the episode payment methodology under the model already provides a strong financial incentive to reduce readmissions that otherwise would contribute significantly to greater actual episode payments. Furthermore, hospitals generally have already made significant strides over the past several years in reducing readmissions due to the inclusion of this measure in other CMS hospital programs that make payment adjustments based on performance on this measure. We believed that a higher weight than 20 percent would overvalue the contribution of readmissions performance as an indicator of LEJR episode quality in calculating the composite quality score. Furthermore, other CMS hospital programs may also make a payment adjustment based on hospital performance on the readmissions measure, so we would not want this measure to also strongly influence reconciliation payment eligibility and the opportunity for quality incentive payments under the
Under such an approach, we would first score individually each participant hospital on the Hospital-level 30-day, all-cause RSRR using the elective primary THA and/or TKA (NQF #1551) measure; Hospital-level RSCR following using the elective primary THA and/or TKA measure (NQF #1550); and HCAHPS Survey measure (NQF #0166) based on the participant hospital's performance percentile as compared to the national distribution of hospitals' measure performance, assigning scores according to the point values displayed in Table 12. These individual measure scores were set to reflect the measure weights included in Table 11 so they could ultimately be summed without adjustment in calculating the composite quality score.
Given the current national distribution of hospital performance on these measures, in the proposed rule we stated our belief that small point increments related to higher measure performance deciles would be the most appropriate way to assign more points to reflect meaningfully higher quality performance on the measures. The absolute differences for each decile among the three measures reflect the intended weight of the measure in the composite quality score. We would assign any low volume participant hospital without a reportable value for the measure to the 50th performance percentile of the measure, so as not to disadvantage a participant hospital based on its low volume alone because that hospital may in actuality provide high quality care. These three measures are well-established measures in use under CMS hospital programs, so we did not believe that scores below the 30th percentile reflect quality performance such that they should be assigned any individual quality measure score points for LEJR episodes under CJR. However, we also considered reducing scores incrementally across the bottom three deciles in order to provide greater incentives for quality improvement for hospitals that may not believe they can attain the 30th performance percentile on one or more of the three measures and to avoid creating a “cliff” at the 30th performance percentile. We sought comment on this scoring approach to the three required quality measures.
Additionally, we would assign a measure quality score of one point for participant hospitals that successfully submit THA/TKA voluntary data and 0 points for participant hospitals that do not successfully submit these data. Because we would not use the actual THA/TKA voluntary data on the patient-reported outcome measure in assessing LEJR episode quality performance under the model, we believed this straightforward binary approach to scoring the submission of THA/TKA voluntary data for the patient-reported outcome measure development would be appropriate.
We note that the Shared Savings Program utilizes a similar scoring and weighting methodology, which is described in detail in the CY2011 Shared Savings Program Final Rule (see § 425.502). The HVBP and HACRP programs also utilize a similar scoring methodology, which applies weights to various measures and assigns an overall score to a hospital (79 FR 50049 and 50102).
We would sum the score on the three quality measures and the score on successful submission of THA/TKA voluntary data to calculate a composite quality score for each participant hospital. Then we would incorporate this score in the model payment methodology by first, requiring a minimum composite quality score for reconciliation payment eligibility if the participant hospital's actual episode spending is less than the target price and second, by making quality incentive payments that change the effective discount percentage included in the target price experienced by the hospital in the reconciliation process. The payment policies we would apply are displayed in Tables 13, 14, and 15 for the performance years of the model.
Under this approach, the CJR model discount included in the target price without consideration of the composite quality score would be 3.0 percent, not the 2.0 percent described under our payment proposal in section III.C.4.b.(9) of this final rule. In the proposed rule, we stated our belief that a discount percentage of 3.0 percent without explicit consideration of episode quality is reasonable as it is within the range of discount percentages included in the ACE demonstration and it is the Model 2 BPCI discount factor for 30 and 60 day episodes, where a number of BPCI participants are testing LEJR episodes subject to the 3.0 percent discount factor. Hospitals that provide high quality episode care would have the opportunity to receive quality incentive payments that would reduce the effective discount percentage as displayed in Tables 13, 14, and 15. Depending on the participant hospital's actual composite quality score, quality incentive payments could be valued at 1.0 percent to 1.5 percent of the hospital's benchmark episode price (that is, of the expected episode spending prior to application of the discount factor to calculate a target price).
Under this methodology, we would require hospitals to achieve a minimum composite quality score of greater than 5.00 to be eligible for a reconciliation payment if actual episode spending was less than the target price. Participant hospitals with below acceptable quality performance reflected in a composite quality score less than or equal to 5.00 would not be eligible for a reconciliation payment if actual episode spending was less than the target price. A level of quality performance that is below acceptable would not affect participant hospitals' repayment responsibility if actual episode spending exceeds the target price. We believed that excessive reductions in utilization that lead to low actual episode spending and that could result from the financial incentives of an episode payment model would be limited by a requirement that this minimum level of LEJR episode quality be achieved for reconciliation payments to be made. This policy would encourage hospitals to focus on appropriate reductions or changes in utilization to achieve high quality care in a more efficient manner. Therefore, these hospitals would be ineligible to
For hospitals with composite quality scores of less than or equal to 5.00, we also considered a potential alternative approach. Under this approach, we would still permit this group of hospitals to receive reconciliation payments but would impose a quality penalty that would increase their effective discount percentage to 4.0 percent for purposes of calculating the reconciliation payment or recoupment amount in performance years 3 through 5, 4.0 percent for calculating the reconciliation payment and 3.0 percent for calculating the repayment amount in performance year 2, and 4.0 percent for calculating the reconciliation payment in performance year 1 where participant hospitals have no repayment responsibility. A potential advantage of this approach is that it would provide stronger incentives for quality improvement for participant hospitals with low performance on quality, even if they did not expect to be able to reduce actual episode spending below the target price. In addition, this approach would provide financial incentives to improve the efficiency of care even for hospitals that did not expect to meet the minimum quality score for reconciliation payment eligibility, while still providing strong incentives to provide high-quality care. The disadvantage of this approach is that it could provide reconciliation payments even to hospitals that did not achieve acceptable quality performance.
Participant hospitals with an acceptable composite quality score of >5.00 and ≤9.25 would be eligible for a reconciliation payment if actual episode spending was less than the target price because their quality performance was at the acceptable level established for the CJR model. They would not be eligible for a quality incentive payment at reconciliation because their episode quality performance, while acceptable, was not good or excellent. Therefore, these hospitals would be eligible to receive a reconciliation payment if actual episode spending was less than the target price.
Participant hospitals with a good composite quality score of >9.25 and ≤15.20 would be eligible for a quality incentive payment at reconciliation if actual episode spending was less than the target price because their quality performance exceeded the acceptable level required for reconciliation payment eligibility under the CJR model. In addition, they would be eligible for a quality incentive payment at reconciliation for good quality performance that equals 1.0 percent of the participant hospital's benchmark price, thereby changing the effective discount percentage included in the target price experienced by the hospital at reconciliation. Thus, participant hospitals achieving this level of quality for LEJR episodes under CJR would either have less repayment responsibility (that is, the quality incentive payment would offset a portion of their repayment responsibility) or receive a higher payment (that is, the quality incentive payment would add to the reconciliation payment) at reconciliation than they would have otherwise based on a comparison of actual episode spending to the target price that reflects a 3.0 percent discount. Therefore, these hospitals would be eligible to receive a reconciliation payment if actual episode spending was less than the target price and would also receive a quality incentive payment.
Finally, hospitals with an excellent composite score quality score of >15.20 would be eligible to receive a reconciliation payment if actual episode spending was less than the target price because their quality performance exceeded the acceptable level required for reconciliation payment eligibility under the CJR model. In addition, they would be eligible for a higher quality incentive payment at reconciliation for excellent quality performance that equals 1.5 percent of the participant hospital's benchmark price, thereby changing the effective discount percentage included in the target price experienced by the hospital at reconciliation. Thus, participant hospitals achieving this level of quality for LEJR episodes under CJR would either have less repayment responsibility (that is, the quality incentive payment would offset a portion of their repayment responsibility) or receive a higher payment (that is, the quality incentive payment would add to the reconciliation payment) at reconciliation than they would have otherwise based on a comparison of actual episode spending to the target price that reflects a 3.0 percent discount. Therefore, these hospitals would be eligible to receive a reconciliation payment if actual episode spending was less than the target price and would also receive a quality incentive payment.
Under this methodology, the proposed stop-loss and stop-gain limits discussed in section III.C.8. of this final rule would not change. We believed this approach to quality incentive payments based on the composite quality score could have the effect of increasing the alignment of the financial and quality performance incentives under the CJR model to the potential benefit of participant hospitals and their collaborators as well as CMS, although it would substantially increase the complexity of the methodology to link quality and payment. We sought comment on this alternative approach to basing reconciliation payment eligibility and quality incentive payments on the participant hospital's composite quality score under the CJR model, as well as the composite quality scoring ranges applicable to the respective payment policies.
While we described in detail this alternative considered to link quality to payment under CJR, we did not propose this methodology for several reasons. First, the Shared Savings Program and HVBP program utilize many more measures than we proposed for the CJR model. For example, the Shared Savings Program initially incorporated thirty-three measures across four quality domains (79 FR 67916 and 67917). The range of measures in the Shared Savings Program and the HVBP program lends itself to a scoring approach, which can account for many measures and allows providers to achieve a high score despite performing well on some measures but achieving lower performance on others. There is a detailed description of the Shared Savings Program scoring methodology on the CMS Web site at:
Finally, we also considered an approach whereby participant hospitals would not be penalized with regard to their eligibility for reconciliation payments in CJR for failure to meet the specified thresholds for the quality measures in performance year 1 of the model; in other words, we would delay the proposal described in the next section to performance year 2 rather than beginning in performance year 1. We considered calculating participant hospital performance on the required measures for the model, and, if actual episode spending was less than the target price, the participant hospital would receive a full reconciliation payment of savings achieved beyond the target price, regardless of performance on the quality measures. However, we did not believe this would be appropriate for the CJR model, given that two of the measures are administrative claims-based and thus impose no additional reporting burden on hospitals; rather, these two measures are established measures in existing CMS quality programs, and a central goal of the model is improving care for Medicare beneficiaries in LEJR episodes. We noted that the HCAHPS Survey measure (NQF #0166) is also an established measure in the HIQR Program and would not impose additional reporting burden on hospitals.
We summarize the public comments we received on these alternatives considered to link quality and payment and provide our responses in section III.C.5.b.(5)(c)(iii) of this final rule. We note that we will be adopting the composite score methodology for the CJR model, as discussed in our responses to comments in section III.C.5.b.(5)(c)(iii) of this final rule.
For the reasons outlined in the previous section, we did not propose to use similar methodologies to other CMS programs that would tie CJR episode reconciliation payment eligibility and reconciliation payment and Medicare repayment amounts to a composite quality score on specified quality measures, but as discussed later in this section, we instead proposed to simply assess performance or achievement on a quality measure by setting a measure result threshold for each measure beginning in performance year 1 of the model.
We proposed that the CJR measure result threshold would be based on the measure results from the HIQR Program, a nationally-established program, and would use its national distribution of measure results. These are the same measure results posted on
As previously described, we proposed for the CJR model the following three required measures to assess LEJR episode quality of care:
• Hospital-level 30-day, all-cause RSRR following elective primary THA and/or TKA (NQF #1551).
• Hospital-level RSCR following elective primary THA and/or TKA (NQF #1550).
• HCAHPS Survey (NQF #0166).
We also proposed to make a voluntary reporting payment adjustment for CJR participant hospitals who successfully and voluntarily submit data for the THA/TKA patient-reported outcome-based performance measure (henceforth referred to as “THA/TKA voluntary data”) as described in sections III.C.5.b.(2) and III.D.3.a. of this final rule. We proposed that participant CJR hospitals must meet or surpass a specified threshold for each required measure beginning for performance year 1 of the model in order to be eligible for a reconciliation payment if actual episode payments are less than the target price. The calculation of the HCAHPS Survey measure is described in section III.D.2.c. of this final rule. We proposed to use the individual measure results calculated as specified in section III.D. of this final rule for the three required measures to determine hospital eligibility for reconciliation payment for each performance year of the CJR model. Also, as discussed in section III.C.4. of this final rule, which outlines the proposed pricing structure for the CJR model, target prices for MS-DRG 470-anchored episodes and for MS-DRG 469-anchored episodes would be calculated for hospitals participating in the model for an episode of care extending 90 days after discharge from the anchor hospitalization. Participant hospitals that achieve actual episode payment below the specified target price for a given performance period would be eligible for a reconciliation payment, provided that the participant hospital also met episode quality thresholds on the three required measures for the performance period.
We proposed to use the following quality criterion to determine if a participant hospital qualifies for a reconciliation payment based on the episode quality thresholds on the three required measures:
The hospital's measure result is at or above the 30th percentile of the national hospital measure results calculated for all HIQR-Program participant hospitals for each of the three required measures for each performance period (for a detailed description of how we determined the performance period and reconciliation payment eligibility, see section III.C.5. of this final rule).
Using HIQR Program's 3 year rolling period as outlined in section III.D.2.d. (Applicable Time Period) of this final rule, if a participant hospital performed at or above the 30th percentile of all HIQR Program hospitals for each of the three required measures and if actual episode payment was less than the target price for the specified performance year, we would make a reconciliation payment to the hospital. Failure to achieve the threshold on one or more measures would result in the participant hospital not receiving a reconciliation payment regardless of whether the actual episode payment was less than the target price for that performance period. We proposed that for hospitals with insufficient volume to determine performance on an individual measure, these hospitals would be considered to be performing at the threshold level and their results would be publicly posted with all other participant hospitals' measure results (for a detailed summary of public reporting, see section III.D.5. of this final rule). We did not believe it would be appropriate to potentially penalize high quality, efficient hospitals due to their low volume, given that meeting the required quality measure thresholds would be required for reconciliation payment eligibility.
We also proposed for performance years 4 and 5 to increase the measure result threshold to the 40th percentile. We believed that increasing the measure result threshold to the 40th percentile
We proposed to require hospitals to meet the threshold for all three measures for the following reasons. The measures proposed for this model are fully developed, NQF-endorsed, and implemented measures in CMS IPPS programs. These measures are also publicly reported on the
Finally, we proposed to increase the measure result thresholds for the final 2 performance years of the model, to ensure that CJR participant hospitals continue to maintain a high level of quality performance or improve performance on these measures as they gain experience with implementation of this payment model. More specifically, we proposed that in order for a participant hospital to receive a reconciliation payment for actual episode spending that is less than the target price for performance years 4 and 5, the participant hospital's measure result must be at or above the 40th percentile of the national hospital measure results calculated for all HIQR-Program participant hospitals for each of the three required measures for each performance period. As previously noted, we proposed to use the most recently available HCAHPS 4-quarter roll-up to calculate the HLMR. In the proposed rule, we stated our belief that holding the participant hospitals to a set measure result threshold for the first 3 years, and increasing this threshold for performance years 4 and 5, would emphasize the need to maintain and improve quality of care while cost efficiencies are pursued. We sought comment on our proposed approach to incorporating quality performance into eligibility for reconciliation payments under the CJR model for participant hospitals.
Table 16 displays the proposed thresholds that participant hospitals must meet on the various measures over the 5 model performance years.
We sought comment on our proposed methodology to utilize quality measure performance in the payment methodology for CJR, as well as the proposed thresholds for participant hospital reconciliation payment eligibility over the performance years of the model.
As discussed in section III.C.5.b.(2) of this final rule, we stated our belief that hospitals that choose to submit THA/TKA voluntary data should have the potential to benefit financially through an adjustment to the payment methodology of the model. We proposed a voluntary reporting payment adjustment for hospitals that successfully submit the THA/TKA voluntary data by reducing the discount percentage incorporated into the target price from 2.0 percent to 1.7 percent. This voluntary reporting payment adjustment would start in performance year 1 and would be available through performance year 5 of the model for each year that the hospital successfully reports THA/TKA voluntary data. As proposed, reporting THA/TKA voluntary data would not affect eligibility for a reconciliation payment if actual episode payments are less than the target price. Participant hospitals would still need to meet the 30th or 40th percentile threshold, as applicable to the given performance year, on all
We considered, but did not propose, two other alternatives to adjust the payment methodology for participant hospitals that successfully report the THA/TKA voluntary data as described in section III.C.5.b.(2) of this final rule. These alternatives would change the threshold percentile for the three required quality measures or, alternatively, reduce the number of required measures in which the threshold must be met provided that successful THA/TKA voluntary data were reported for a performance year. First, we considered reducing the threshold for reconciliation payment eligibility that participant hospitals must meet on the three required quality measures from the 30th percentile threshold to the 20th percentile threshold for performance years 1, 2, and 3, and from the 40th percentile to the 30th percentile for performance year. Second, we considered only requiring hospitals to meet the 30th percentile threshold on two of three outcome measures for performance years 1, 2, and 3, and the 40th percentile threshold on two of three outcome measures in performance years 4 and 5. Under both of these alternatives, the eligibility for reconciliation payments could change based on the THA/TKA voluntary data. We sought comment on these alternative payment methodology adjustments that could impact reconciliation payment eligibility, unlike the proposed voluntary reporting payment adjustment. We note that the other alternative approaches to encouraging THA/TKA voluntary data reporting for CJR beneficiaries as discussed in section III.C.5.b.(2) of this final rule that would not require adjustments to the CJR payment methodology would also not affect reconciliation payment eligibility.
The following is a summary of the comments received and our responses on the proposals and alternatives discussed in section III.C.5. of the proposed rule, including the proposed threshold methodology for reconciliation payment eligibility, as well as the alternatives considered that would change the proposed threshold requirements for participant hospitals that successfully report voluntary THA/TKA data. As cross-referenced several times earlier in this section, these comments and our responses also discuss a number of other proposals, alternatives considered, and other topics related to linking quality and payment under the CJR model for which we sought public comment.
Several commenters urged CMS to delay implementing the proposed quality performance thresholds for reconciliation payment eligibility until performance year 2, or later, where the performance period for measure data would correspond more fully or completely to performance years under the model. They recommended that the first year or two of the CJR model should be pay-for-reporting and, because the proposed THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) are claims-based measures and the HCAHPS Survey measure (NQF #0166) is currently administered by hospitals, all participant hospitals would be expected to meet the CJR model quality performance requirements, which would only require public reporting in performance year 1 and possibly performance year 2. Several commenters in favor of pay-for-reporting in the first performance year asserted that such an approach would be consistent with other CMS value-based initiatives. A commenter also claimed that a year of pay-for-reporting would allow participant hospitals the time to establish internal systems for analyzing quarterly claims data and provide them with maximal opportunity to achieve savings that could be invested in these systems.
While the current BPCI models do not specifically link payment to quality, the Request for Applications describing the BPCI model design features was released over 4 years ago, in August 2011. We now have two years of experience with BPCI Model 2 Awardees, the model that most closely resembles the CJR model, in the risk-bearing period, and the year 1 BPCI annual evaluation and monitoring report from February 2015 is publicly available on the CMS Web site at:
We note that the quality measures finalized for the model as discussed in section III.D.2. of this final rule rely upon data that hospitals are already submitting and which are already analyzed by CMS for other programs, so we see no reason to adopt a period of pay-for-reporting for the first performance year of the model or longer. In the proposed rule, we considered a similar policy that would not penalize hospitals with regard to their eligibility for reconciliation payments for failure to meet the proposed quality measure thresholds in performance year 1. However, we continue to believe that adopting pay-for-reporting and not pay-for-performance in performance year 1 or longer would be inappropriate given that two of the proposed quality measures are administrative claims-based measures and impose no additional reporting burden on hospitals, the proposed measures are all established measures in existing CMS quality programs, and a central goal of the CJR model is improving care for Medicare beneficiaries in LEJR episodes. In this regard, the CJR model is different from some other CMS value-based initiatives where the data for some measures were newly submitted by providers or newly analyzed by CMS early in the initiative. Furthermore, we do not believe that participant hospitals need a year of pay-for-reporting to develop systems for analyzing episode claims under the model, as we expect hospitals to already be focused on improving their performance on these measures. The two measures finalized for the CJR model are aligned with the goals of the CJR model, are familiar to hospitals based on their use in other CMS hospital programs, and are aligned with CMS priorities to reduce LEJR complications while improving the patient experience. Because the measures reflect these goals and accurately measure hospitals' level of achievement and improvement on quality outcomes that are important to beneficiaries undergoing LEJR procedures, we are finalizing our proposal to implement a pay-for-performance approach in the CJR model in the first performance year by using quality performance in the episode payment methodology.
A number of commenters estimated that under CMS' proposal, more than half of the participant hospitals would be ineligible for reconciliation payments based on their current quality measure performance, even if episode savings were achieved during a performance year. The commenters stated that CMS should not use performance percentiles that would always exclude a predetermined number of participant hospitals from reconciliation payments, and hold hospitals to multiple quality performance standards for the same measure performance under different CMS models and programs. They contended that performance percentiles, as measures of relative performance, do not reflect best practices and, therefore, recommended that CMS require a level of absolute measure performance rather than relative performance when incorporating quality performance into the payment methodology under the CJR model. The commenters did not describe the absolute levels of performance that they would recommend on the quality measures for the CJR model. Several commenters claimed that the use of thresholds for reconciliation eligibility disadvantages small hospitals because only one or two patient instances could change the participant hospital's performance percentile and, therefore, affect the hospital's eligibility for reconciliation payments. Other commenters pointed out that the Shared Savings Program uses quality thresholds, but the methodology accounts for improvement and the program is voluntary, while hospital participation would be required in the CJR model and improvement was not considered in the pay-for-performance methodology CMS proposed.
Other commenters asserted that CMS' proposal linking quality measure performance to eligibility for reconciliation payments failed to reflect the quality of care delivered in the context of the model due to flaws in the proposed approach to determining participant hospital performance in relation to the thresholds. The commenters contended that the proposed methodology to determine performance on quality measures and link performance to reconciliation payment eligibility uses arbitrary distinctions in performance among hospitals that are not borne out by the data or even by CMS's own method of assigning ratings of performance on the
A number of commenters recommended that CMS adopt a threshold methodology that would utilize the confidence intervals used on the
Therefore, the commenters maintained that CMS should modify its proposal and set the quality performance thresholds for reconciliation payment eligibility at “worse than national rate,” rather than at the 30th percentile or above compared to the national rate. Specifically, the commenters suggested if performance on both the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) is statistically “worse than national rate,” then a participant hospital should not be eligible for reconciliation payment. Those hospitals that are deemed “no different than national rate” or “better than national rate” on both measures should automatically be deemed eligible for any potential reconciliation payment. Some commenters further urged CMS to also allow participant hospitals performing “worse than national rate” on one or both quality measures to receive reconciliation payments if CJR model episode savings were achieved as long as the hospital submits a corrective action plan to CMS describing their future strategies to improve quality of care, including contributing a portion of the reconciliation payment to quality performance improvement strategies. These commenters asserted that the quality performance thresholds should provide equal financial opportunity and incentives to all hospital participants.
The commenters claimed that setting quality performance thresholds at the level of “worse than national rate” as displayed on the
Furthermore, we will not make THA/TKA voluntary PRO and limited risk variable data submission mandatory and increase the incentives around their collection in the CJR pay-for-performance methodology as recommended by a commenter. This measure remains under development, and we want to encourage robust hospital reporting to speed measure development, but the measure is not yet ready to have its results incorporated in the CJR model methodology in the manner recommended by the commenter. We refer readers to section III.D.3.a. of this final rule for further discussion of our future plans to incorporate PRO measure results in the CJR pay-for-performance methodology.
We appreciate the suggestions of many commenters that we utilize outcome measure thresholds of “worse than national rate” as displayed on the Hospital Compare Web site to set the thresholds for reconciliation payment eligibility. For purposes of the
Regarding the commenter who suggested that an individual hospital's performance on a measure should be assessed within confidence intervals as the measure was originally specified, tested, and endorsed by the NQF, we note that the THA/TKA Complications measure (NQF #1550) was not endorsed by the National Quality Forum for its use with an interval estimate, since NQF endorses measure specifications and not the use of measures in various programs
We note that “worse than national rate” is the quality performance threshold for reconciliation payment eligibility recommended by many commenters as the statistically certain measure of poor hospital quality performance, yet almost every hospital in the country already exceeds this level on the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551). Nationally, we estimate that only 29 hospitals currently perform at “worse than national rate” on one or more of these measures, a number that is similar to the estimate provided by a commenter. Thus, based on current measure performance only a very small number of hospitals would fail to meet the quality performance thresholds for reconciliation payment eligibility recommended by many commenters. We do not believe that adopting “worse than national rate” as the threshold for reconciliation payment eligibility, or applying no threshold as recommended by some commenters if a hospital “worse than national rate” submits a corrective action plan to CMS, would further encourage quality improvement or maintenance of high performance for participant hospitals in the CJR model, beyond the incentives that already exist in CMS programs.
Either incorporating a “worse than national rate” threshold or applying no threshold would essentially eliminate pay-for-performance under the CJR model, which would not be consistent with our final decision discussed in the prior response to public comments to incorporate a pay-for-performance methodology in the CJR model beginning in performance year 1.
Regarding the recommendations to use interval estimates to identify hospitals with performance “worse than national average” as the most equitable approach to identifying statistically valid poor hospital performance on quality measures, we have previously explained our position on the use of interval estimates when determining payment outcomes for hospital performance on measures. Specifically for the HRRP where we use point estimates for quality measure performance, we acknowledged outcome measures of risk-standardized condition-specific readmission rates to be statistical measures (77 FR 53394). We also recognized that statistical measures will include some degree of variation and stated that other Medicare programs use similar statistical measures as part of their programs, so any consideration of the use of interval estimates with respect to the HRRP may have implications for other programs (77 FR 53394). Despite this reality, we finalized the HRRP methodology for quality measure performance (76 FR 51673), which results in the use of a point estimate for a hospital's excess readmission ratio (77 FR 53394), and we use point estimates in other CMS programs that rely upon statistically-based outcome measures, such as the HVBP Program. (76 FR 26504). We note that over the past several years the HRRP has shown that use of point estimates in the program has still led to improvement in hospital readmission rates.
However, we agree with the commenters that our proposal to set performance thresholds for reconciliation payment eligibility at the 30th percentile does not reflect the statistical certainty of intervals around hospital measures performance results and may not adequately account for the variation that occurs in risk-standardized rates like the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) proposed for use in the CJR model. We also agree with the commenters that setting required measure performance thresholds for reconciliation eligibility may provide insufficient quality and cost episode improvement incentives for some participant hospitals in the CJR model. We estimate that based on their current quality measure performance one-third of participant hospitals would not be eligible for reconciliation payments under our proposed thresholds for the three required quality measures, even if those hospitals achieved savings beyond the target price. While our estimate is lower than the estimate of more than 50 percent of participant hospitals that was provided by some commenters, we agree with the commenters that the proposed methodology would not provide significant quality and cost episode improvement incentives for a substantial percentage of participant hospitals in the CJR model.
We continue to believe there are real, clinically meaningful differences that are important to Medicare beneficiaries in hospital performance on the THA/TKA Complications measure (NQF #1550) finalized for this model, as well as opportunities for improvement, which are not recognized by the statistical certainty approach that we use for the
Some commenters who opposed the use of performance percentiles on quality measures that were included in CMS' threshold proposal also opposed the alternative composite quality score approach for the same reasons, mainly because it would rely on performance percentiles derived from point estimates of quality measure performance to award points toward the composite quality score. However, a number of commenters favored the use of a composite quality score to link quality and payment, rather than thresholds for reconciliation payment eligibility, because the composite quality score would provide an opportunity for more participant hospitals to receive reconciliation payments if episode savings were achieved and would vary a participant hospital's financial reward in direct relationship to its episode quality performance.
Other commenters suggested further refinements to the composite score methodology, including different weighting of the measures. A commenter urged CMS to reconsider the composite score weights discussed in the proposed rule, and establish them as: HCAHPS Survey 25 percent; Complications 50 percent, and Readmissions 25 percent. The commenter reasoned that the Readmissions measure weight should be reduced due to the measure's use in other CMS programs. Finally, the commenter recommended that CMS modify the minimum percentile to receive quality measure score points to the 10th percentile, and add a band for incremental performance between the 10th percentile and the current national average performance, where an increasing proportion of any reconciliation payment from episode savings would be paid. The commenter urged CMS to pay the full reconciliation payment for episode savings beyond the target price to any hospital with quality performance above the national average.
Several commenters, who also recommended additional quality measures, stated that CMS should place greater weight in the composite quality score on ambulation, followed by pain experience and management, and finally followed by the Complications, Readmissions, and HCAHPS Survey measures in descending order of importance when calculating the composite quality score. Another commenter contended that CMS should increase the HCAHPS Survey measure weight and make the submission of THA/TKA voluntary PRO and limited risk variable data mandatory for performance year 2 and subsequent years, to increase the effect of patient experience on the financial opportunity of participant hospitals under the CJR model. A commenter recommended that, rather than participant hospital percentiles of performance compared to the national distribution of hospital measure performance, CMS use hospital-specific metrics that should be able to “top out” with high quality performance. The commenter suggested that CMS could measure performance annually on each measure for every participant hospital, and establish a minimum and maximal optimal measure result for the measure that could guide performance scoring. Finally, a commenter urged CMS to reconsider awarding the 50th percentile of performance for individual measure scores that make up the composite quality score without actual measure results, as CMS would not be assured that those hospitals were providing good quality care.
A number of commenters recommended that CMS vary the discount percentage incorporated in the target price at reconciliation based on the participant hospital's level of quality performance. Other commenters stated that high-performing hospitals on quality should have opportunities for greater reconciliation payments if that high-quality performance is sustained, recommending that CMS include no discount in the target price or a smaller discount percentage for these hospitals than would be used for hospitals with lower levels of quality performance. Finally, several commenters contended that hospitals furnishing care of lower quality should incur financial penalties based on their quality performance.
We agree with many of the commenters that the pay-for-performance methodology under the CJR model should provide the opportunity for financial reward to participant hospitals with an acceptable level of episode quality performance, while also including an incentive for quality improvement if the hospital's current level of quality is low. We also agree with the commenters who stated that the CJR pay-for-performance methodology should provide the potential for increased financial reward for participant hospitals that furnish higher-quality care through payments that would either increase the reconciliation payment to the hospital or reduce the hospital's repayment responsibility depending on the hospital's episode cost performance for the model performance year. However, we do not agree with the commenters who recommended that those hospitals achieving high-quality episode performance should not be expected to improve their episode efficiency because we believe that substantial opportunities to reduce Medicare expenditures in the context of high-quality episode care exist for virtually all participant hospitals. Innovation Center models are generally designed with a focus on both reducing costs and improving the quality of care for model beneficiaries. Therefore, we will continue to incorporate a discount percentage into the target price for every participant hospital as discussed in section III.C.4.b. of this final rule in the methodology for setting target prices for the CJR model.
We also do not agree with the commenters who recommended that hospitals with low-quality performance incur financial penalties under the model, because the model is specifically designed to reward episode quality performance and cost savings. We discussed an alternative under the composite quality score approach in section III.C.5.b.(5)(c)(ii) of the proposed rule that would impose a quality penalty on hospitals with a low composite quality score that would otherwise lead them to be ineligible for reconciliation payments (80 FR 41243 through 41244). Under this alternative, we would reduce the effective discount percentage for these hospitals, thus imposing a 1 percent penalty for their low quality performance, regardless of whether or not episode savings are achieved beyond the target price. We continue to believe that while this approach would provide stronger incentives for quality improvement for participant hospitals with low performance on quality, even if they did not expect to be able to reduce actual episode spending below the target price, it could provide reconciliation payments even to those hospitals that did not achieve acceptable quality performance. Therefore, we believe that the risk to beneficiaries and CMS of these low-quality performing hospitals achieving savings in the context of poor quality care by sharply decreasing utilization to levels that reflect stinting on medically necessary care are so significant that adopting this alternative would not be appropriate. Instead, we will provide the opportunity for quality incentive payments that relate to the participant hospital's overall quality performance and improvement on the model's quality measures as reflected in the hospital's composite quality score that we will calculate for each performance year at the time reconciliation is carried out for that performance year.
As previously discussed, we are not finalizing our proposal to set performance percentile thresholds for reconciliation payment eligibility in the CJR model. Based on public comments that addressed our reconciliation payment eligibility threshold proposal, the alternatives considered, and the objectives of the pay-for-performance methodology under the CJR model, we believe that the composite score methodology that we discussed in the proposed rule that would determine reconciliation payment eligibility and change the effective discount percentage experienced by a participant hospital at reconciliation is the most appropriate pay-for-performance approach to achieve the objectives previously described. While the majority of commenters favored the threshold proposal with modification to adopt much lower quality thresholds of “worse than national average” performance that would result in eligibility of almost all participant hospitals for reconciliation payments if savings were achieved beyond the target price, a substantial percentage of commenters supported the composite score methodology or another approach that would provide greater financial reward to participant hospitals for higher quality performance. The composite score methodology omits the proposed 30th percentile performance minimum standard for all required quality measures as a definitive cut-off point for eligibility for reconciliation payments and replaces it with a quality scoring system that provides hospitals with multiple possible combinations of quality performance that can result in a hospital reaching eligibility for the reconciliation payment, thereby providing opportunity for reconciliation payments to hospitals achieving an acceptable or higher level of overall quality performance. This methodology also provides an incentive structure that acknowledges that high-quality episodes should be rewarded with greater financial opportunity under the CJR model, either through increased reconciliation payments or reduced repayment responsibility, depending upon the participant hospital's episode cost performance during a performance year. We appreciate the support of the commenters who share our view on the merits of the composite score approach.
We discussed in the proposed rule, but did not propose, a composite quality score methodology because at the time we believed that such an approach could diminish the importance of each quality measure given the limited number in the model, that the measures represented clinical goals that should be achievable by all hospitals participating in the model, and that a threshold methodology would provide the most achievable and predictable quality targets for the CJR model that requires participation (80 FR 41244). However, we agree with the commenters that the proposed threshold methodology would not sufficiently incentivize and reward quality improvement and acceptable or high quality performance under the CJR model for a substantial proportion of participant hospitals even if savings beyond the target are achieved. In contrast, the composite quality score methodology will allow performance on each required quality measure to be meaningfully valued in the model's pay-for-performance methodology, incentivizing and rewarding cost savings in relation to the quality of episode care provided by the participant hospital. Despite the small number of final CJR model quality measures, the measures represent both clinical outcomes and patient experience, and each carries substantial value in the composite quality score. Participant hospitals could achieve an acceptable or good composite quality score despite performing well on one of the required measures but achieving lower
In the proposed rule, we presented weights for the proposed quality measures in the composite quality score and note that we need to revise those weights for the final rule given that we are not adopting the THA/TKA Readmissions measure (NQF #1551) for the CJR model. As some commenters encouraged us to assign more weight than we discussed in the proposed rule to measures of patient experience and functional status, we believe it would be most appropriate to redistribute the 20 percent measure weight from the THA/TKA Readmissions measure (NQF #1551) equally to the two required measures we adopted for the model, specifically assigning an additional 10 percent weight each to the THA/TKA Complications measure (NQF #1550) and the HCAHPS Survey measure (NQF #0166). We note that the overall distribution of measure weight in the composite quality score would provide 50 percent weight to health-related conditions that arise following LEJR surgery (through the THA/TKA Complications measure (NQF #1550)) and 50 percent weight to patient experience (through the HCAHPS Survey measure (NQF #0166) and THA/TKA voluntary PRO and limited risk variable data submission). We believe this weighting appropriately balances patient experience with meaningful health outcomes for beneficiaries, by providing equal weight in the composite quality score to both dimensions, consistent with the patient-centered priorities for quality measurement that some commenters urged us to adopt.
The final measure weights in the composite quality score for the CJR model are displayed in Table 17.
Consistent with the scoring of individual measure percentile performance as assigned to a decile, as we discussed in the proposed rule, and our final decision to use performance percentiles for both required quality measures, as discussed earlier in this section, for each model performance year we will assign individual measure performance scores to each participant hospital based on the values in Table 18. These individual measure performance scores have been set to reflect the final measures weights in Table 17 so they can ultimately be summed without adjustment in calculating the composite quality score. The absolute differences for each performance decile among the two measures reflect the intended weight of the measure performance in the composite quality score.
As we further discussed in the proposed rule, we will assign participant hospitals without a measure value to the 50th performance percentile (80 FR 41242). A participant hospital will not have a value for the THA/TKA Complications measure (NQF #1550) if the hospital does not meet the minimum case count of 25 cases in the 3 year measurement period which is required to ensure reliability of the measure result. In section III.D.4. of this final rule, we discuss the 25 case minimum and note that this quality measure case minimum is the same as the minimum used in the HIQR Program (75 FR 50185 and 76 FR 51609). We further note that as described in section III.D.2.a. of this final rule, the THA/TKA Complications measure (NQF #1550) only includes primary elective THA/TKA procedures which are a subset of the LEJR episodes included in the CJR model. As a result, it is possible for a CJR participant hospital to have LEJR episodes but no cases that meet the criteria to be included in the THA/TKA Complications measure (NQF #1550). Regarding the HCAHPS Survey measure (NQF #0166), a participant hospital will not have a reported value for the HCAHPS Survey measure (NQF #0166) if it did not meet the minimum of 100 completed surveys and did not have 4 consecutive quarters of HCAHPS data, which are required to ensure the reliably of the measure. In section III.D.4. of this final rule, we discuss the 100 case minimum and note that this quality measure case minimum is the same as the minimum used in the HVBP Program (76 FR 26502).
Moreover, we note that in rare cases, if CMS identifies an error in the data used to calculate the measure resulting in suppression of the data for public reporting on
Lastly, new hospitals that are identified as participants in the CJR model may not have sufficient data within the measure performance periods to calculate a value for the THA/TKA Complications measure (NQF #1550) or HCAHPS Survey measure (NQF #0166) and would be assigned to the 50th performance percentile of the measure, as applicable.
For hospitals that are in the situations previously described, we will assign participant hospitals without a measure value the 50th performance percentile of the measure result distribution. We intend to publicly report the measure results used to calculate the composite quality score for all participant hospitals. While we understand the concerns of the commenter that we have no actual outcome measure results for certain hospitals, we continue to believe it would be unfair to disadvantage a participant hospital in the pay-for-
Moreover, as we also discussed in the proposed rule, we will not assign individual measure score performance points to a hospital categorized to a performance percentile below the 30th percentile because we do not believe lower performance percentiles reflect quality performance such that they should be assigned any individual quality measure score performance points for LEJR episodes under the CJR model. Although a commenter suggested providing individual quality measure score points to hospitals beginning at the 10th performance percentile, we continue to disagree that performance below the 30th performance percentile reflects sufficient quality on these two well-established measures in CMS hospital programs to award quality measure points. We note, however, that a participant hospital assigned no performance points for one required quality measure could still be eligible for reconciliation payments if episode savings are achieved beyond the target price as long that hospital has achieved a sufficient performance percentile on the other required quality measure.
Additionally, we will assign a measure quality score of two points for participant hospitals that successfully submit THA/TKA voluntary PRO and limited risk variable data and 0 points for participant hospitals that do not successfully submit these data. The requirements for successful data submission in each performance year are discussed in section III.D.3.a. of this final rule. While we discussed awarding 1 point for successful submission in the proposed rule, this was an error because we also stated that the submission of THA/TKA voluntary PRO and limited risk variable data would constitute 10 percent of the composite quality score, which is based on a maximum score of 20 points. Two points is the correct value that reflects 10 percent of the maximum score.
We will sum the performance and, if applicable, improvement scores (as discussed in the following response to comments) on the two required quality measures with the score on the successful submission of THA/TKA voluntary PRO and limited risk variable data to calculate a composite quality score for each performance year for a participant hospital. This composite quality score will then be incorporated into the pay-for-performance methodology for the CJR model that assigns a participant hospital to a quality category at the time of reconciliation for a performance year. We will first require a minimum composite quality score for reconciliation payment eligibility if the participant hospital's actual episode spending is less than the target price and second, make quality incentive payments that change the effective discount percentage included in the target price experienced by the hospital in the reconciliation process. Thus, hospitals with higher composite quality scores may financially benefit from their episode quality performance compared to hospitals with lower quality performance in a different quality category, regardless of whether episode savings are achieved. For example, in performance year 4, actual episode spending for a hospital with an excellent composite quality score would be reconciled to a target price reflecting a 3.0 percent discount factor, but then the participant hospital would receive a quality incentive payment of 1.5 percent of the hospital's pre-discount target price that would either increase the hospital's reconciliation payment if savings were achieved or reduce the hospital's repayment responsibility if actual episode spending exceeded the target price. In contrast, actual episode spending for a hospital with an acceptable composite quality score would be reconciled to a target price reflecting a 3.0 percent discount factor, but then the participant hospital would not receive any quality incentive payment. Thus, the excellent quality performance by the participant hospital in the excellent quality category would provide a financial benefit to that hospital of 1.5 percent of the pre-discount target price, regardless of whether the hospital achieved savings for episodes.
As discussed in the proposed rule regarding the composite quality score alternative approach to pay-for-for performance under the CJR model, the discount for all participant hospitals included in the target prices will be 3.0 percent. We refer readers to section III.C.4.b.(9) of this final rule for further discussion of the discount factor included in the target prices. Hospitals that provide high-quality episode care will have the opportunity to receive quality incentive payments that will reduce the effective discount percentage as displayed in Tables 19, 20, and 21, based on their composite quality score that places each hospital into one of four quality categories, specifically “Below Acceptable,” “Acceptable,” “Good,” and “Excellent.” Three tables are required to display the effective discount percentages for each quality category due to the phase-in of hospital repayment responsibility from no responsibility in performance year 1, to partial responsibility in performance
While the final policy to place participant hospitals into one of four quality categories to determine reconciliation payment eligibility and, if applicable, the value of quality incentive payments is the same as that presented in the proposed rule, the applicable scoring ranges for each quality category discussed in the proposed rule are different from the ranges we are finalizing in Tables 19, 20, and 21 for several reasons. First, we are not finalizing the THA/TKA Readmissions measure (NQF #1551) as part of the CJR model's pay-for-performance methodology, requiring us to redistribute the 20 percent weight in the composite quality score that we had presented for that measure. That redistribution is discussed earlier in this section. Second, our final policy includes quality improvement points in addition to quality performance points in the composite quality score, as discussed in the following response to comments. We estimate based on current quality measure performance that approximately 4 percent and 7 percent of all participant hospitals would qualify for improvement points on the HCAHPS Survey measure (NQF #0166) and the THA/TKA Complications measure (NQF #1550), respectively.
The most significant reason for a change in the scoring ranges for the quality categories in the final rule is due to our strengthening the financial incentives for participant hospitals under the CJR model through the composite quality score pay-for-performance methodology to improve quality performance or maintain high-quality performance for episodes. We agree with the commenters who urged us to ensure that most participant hospitals that achieve savings beyond the discount included in the target price receive reconciliation payments if their episode quality is acceptable and that we provide the potential for significantly greater financial reward for hospitals that achieve or maintain high quality episode performance. Therefore, we have reassessed our quality performance expectations for each quality category by examining the current quality measure performance of participant hospitals in the context of the national measure performance distribution. We have adjusted the final scoring ranges to balance the quality performance required for each quality category with the financial incentives (reconciliation payment eligibility and quality incentive payments) to achieve the quality performance required for the category. In the context of our final composite quality score ranges for each quality category, we estimate that approximately 10 percent of participant hospitals placed in the “Below Acceptable” quality category based on their composite quality score would not be eligible for reconciliation payments based on their current quality measure performance, compared to 14 percent based on the proposed rule composite score measures and ranges. Similarly, we estimate that approximately 12 percent of participant hospitals would be eligible for reconciliation payments through placement in the “Acceptable” quality category but would not receive quality incentive payments based on their current quality performance, compared to 30 percent in this quality category based on the proposed rule measures and score ranges. We estimate that the large majority of participant hospitals, specifically 64 percent, would be placed in the “Good” quality category based on their current quality performance and would, therefore, be eligible for reconciliation payments and for quality incentive payments valued at 1.0 percent of the hospital's benchmark episode price, compared to 46 percent based on the proposed rule measures and score ranges. Finally, we estimate that 14 percent of participant hospitals through placement in the “Excellent” quality category would be eligible for reconciliation payments and for quality incentive payments valued at 1.5 percent of the hospital's benchmark episode price, compared to an estimate of 10 percent based on the proposed rule measures and score ranges. Thus, for each quality performance category, we have slightly lowered our quality performance expectations from our proposed rule discussion of the composite quality score approach, in order to provide participant hospitals with more significant financial incentives to improve their quality and cost performance under the CJR model, as well as their incentives to maintain high-quality performance.
Hospitals will be required to achieve a minimum composite quality of score greater than or equal to 4.0 to be eligible for a reconciliation payment if actual episode spending is less than the target price. Participant hospitals with below acceptable quality performance reflected in a composite quality score less than 4.0 will be assigned to the “Below Acceptable” quality category and will not be eligible for a reconciliation payment if actual episode spending is less than the target price. A level of quality performance that is below acceptable will not affect participant hospitals' repayment responsibility if actual spending exceeds the target price. We believe that the requirement that this minimum level of LEJR episode quality be achieved for reconciliation payments to be made is important to protect beneficiaries from excessive reductions in utilization that may result from the financial incentives in an episode payment model to lower actual episode spending. Under the pay-for-performance methodology of the CJR model, this policy should encourage participant hospitals to focus on appropriate reductions or changes in utilization that lead to high quality, more efficient care. Based on current hospital quality measure performance, approximately ninety percent of participant hospitals would have a composite quality score of greater than or equal to 4.0 and be eligible for reconciliation payments based on acceptable or better quality performance.
Participant hospitals with an acceptable composite quality score of greater than or equal to 4.0 and less than 6.0 will be assigned to the “Acceptable” quality category and be eligible for a reconciliation payment if actual episode spending is less than the target price because their quality performance is at the acceptable level established for the CJR model. They will not be eligible for a quality incentive payment at reconciliation because their episode quality performance, while acceptable, is not good or excellent. Therefore, these hospitals will be eligible to receive a reconciliation payment if actual episode spending is less than the target price.
Participant hospitals with a good composite quality score of greater than or equal to 6.0 and less than or equal to 13.2 will be assigned to the “Good” quality category and be eligible for a quality incentive payment at reconciliation if actual episode spending is less than the target price because their quality performance exceeds the acceptable level required for reconciliation payment eligibility under the CJR model. In addition, they will be eligible for a quality incentive payment at reconciliation for good quality performance that equals 1.0 percent of the participant hospital's benchmark
Finally, hospitals with an excellent composite score quality score of greater than 13.2 will be assigned to the “Excellent” quality category and be eligible to receive a reconciliation payment if actual episode spending is less than the target price because their quality performance exceeds the acceptable level required for reconciliation payment eligibility under the CJR model. In addition, they will be eligible for a higher quality incentive payment at reconciliation for excellent quality performance that equals 1.5 percent of the participant hospital's benchmark price, thereby changing the effective discount percentage included in the target price experienced by the hospital at reconciliation. Thus, participant hospitals achieving this level of quality for LEJR episodes under CJR will either have less repayment responsibility (that is, the quality incentive payment will offset a portion of their repayment responsibility) or receive a higher payment (that is, the quality incentive payment would add to the reconciliation payment) at reconciliation than they would have otherwise based on a comparison of actual episode spending to the target price that reflects a 3.0 percent discount. Therefore, these hospitals will be eligible to receive a reconciliation payment if actual episode spending is less than the target price and would also receive a quality incentive payment.
Under this methodology, the final stop-loss and stop-gain limits discussed in section III.C.8. of the final rule will not change for participant hospitals in different quality categories. Despite the limited number of quality measures adopted for the CJR model at this point in time compared to other programs, such as the Shared Savings Program and HBVP Program that use more measures in a quality scoring methodology, after considering the public comments we believe this approach to quality incentive payments based on the composite quality score will have the effect of increasing the alignment of the financial and quality performance incentives under the CJR model to the potential benefit of participant hospitals and their collaborators as well as CMS, although it substantially increases the
A few commenters recommended that CMS reward quality improvement under the CJR model as long as there is no increase in episode spending, observing that under the statutory authority for the CJR model, one of the three expectations for a model is that it would increase the quality of care without increasing spending. The commenters claimed that setting a target price that always includes a discount over expected episode spending should not be necessary for participant hospitals that demonstrate improvements in quality performance.
As we stated earlier in this section, we are not yet certain in this model test what performance outcomes can be achieved under best practices. Therefore, we believe a refinement to the composite score methodology in order to drive quality improvement for participant hospitals that have historically lagged in quality performance on the CJR model quality measures is appropriate, to supplement the composite score's valuing of quality performance in the pay-for-performance methodology of the model. We agree with the commenters that we should directly reward quality improvement under the CJR model pay-for-performance methodology to encourage participant hospitals currently at all levels of quality performance to improve their performance as they strive to achieve high quality performance outcomes under best practices. Like the commenters, we recognize that the heightened focus on episode cost and quality performance by participant hospitals may lead to substantial year-over-year quality measure improvement over the model performance years, and we agree that improvement should be valued in the pay-for-performance methodology, in addition to the quality measure performance percentile actually achieved by the hospital. However, we disagree with the commenters who suggested that participant hospitals demonstrating quality improvement should not be expected to demonstrate episode cost efficiency in order for quality improvement to be rewarded. Improved quality performance and cost savings are closely linked in the CJR pay-for-performance methodology, as both are major goals of the CJR model.
Therefore, we will refine the composite score methodology discussed in the proposed rule that assigns quality performance points based on performance percentiles for each measure to add the potential for incremental quality improvement points to be awarded for substantial improvement in performance on a required quality measure. We believe that the actual level of quality performance achieved should be most highly valued in the composite quality score to reward those hospitals furnishing high-quality care to CJR model beneficiaries, with a smaller contribution to the composite quality score made by improvement points if measure result improvement is achieved. We acknowledge that just because a hospital shows substantial improvement on a measure result, this does not necessarily mean the episode care is high-quality, yet the improvement spurred by the hospital's participation in the CJR model deserves to be valued as the hospital's performance is moving in a direction that is good for the health of beneficiaries. Valuing improvement is especially important because the CJR model involves such a wide range of hospitals that must participate if they are located in the selected MSAs, and the hospitals will be starting from many different current levels of quality performance. This refinement to the composite quality score methodology will help to provide all participant hospitals with a strong incentive to improve LEJR episode outcomes, including those hospitals with historically lagging quality performance.
Specifically, we will add into the composite quality score 10 percent of the maximum value for one or both of
Because of the uncertainty of statistical measures, as discussed previously in this section, and our annual comparison of a participant hospital's measure result to the national distribution to determine the hospital's performance percentile, we will only award measure quality improvement points where improvement is substantial and reflective of true improvement in quality performance on the individual measure. Thus, in order to be considered for improvement points on one of the measures, a participant hospital must have had a reportable measure performance result for that measure in the prior year. We note that in considering quality improvement points for award in the first model performance year, we will use measure results from the prior year quality measure performance period in determining each participant hospital's measure performance percentile against which we will compare its measure performance percentile for CJR model performance year 1 to determine if quality improvement points should be awarded. For the HCAHPS Survey measure (NQF #0166), the prior year quality measure performance period used will be July 1, 2014 through June 30, 2015. For the THA/TKA Complications measure (NQF #1550), the prior year quality measure performance period used will be April 1, 2012 through March 31, 2015. The measure performance percentiles for performance year 1 will be determined from measure results from the performance year 1 quality measure performance periods as displayed in Table C5 of this final rule.
We are defining substantial as improving 3 deciles or more in comparison to the national distribution of measure results. Improvement of three deciles represents a quality measure result change of over one-third of the range between the 10th percentile and the 90th percentile measure results. The 3 decile threshold to define substantial improvement is based on historical
We note that when a participant hospital is awarded improvement points in addition to performance points on a specific required measure, the sum of these points for the measure will be slightly greater than the measure performance points that would be awarded to a hospital in the performance decile that is one level higher than the participant hospital's actual performance decile. By recognizing quality performance in the CJR model pay-for-performance methodology, supplemented by valuing quality improvement, we believe participant hospitals at all current levels of quality performance, including those historically lagging, will have the greatest incentives to achieve high and/or improved quality of care under the CJR model through strong financial incentives that are linked to quality.
Because the measure is currently under development, we believe our final model payment policies and future plans for use of the measure result in the CJR model provide sufficient incentive and increased financial opportunity to encourage robust reporting by participant hospitals of THA/TKA voluntary PRO and limited risk variable data. For the reasons discussed earlier in this section, we are not finalizing our proposed pay-for-performance threshold methodology to determine a participant hospital's reconciliation payment eligibility if episode savings are achieved beyond the target price. Therefore, we are not finalizing our proposal to reduce the discount percentage to 1.7 percent from 2.0 percent for successful submission of THA/TKA voluntary PRO and limited risk variable data. Instead, under our final policy we are incorporating the successful criterion for submission of THA/TKA voluntary PRO and limited risk variable data into our composite quality score methodology for the CJR model, awarding points to participant hospitals who successfully submit these data that will be added into the calculation of the hospital's composite quality score, consistent with our discussion of the alternative approach to linking quality and payment in the proposed rule as described in detail earlier in this section. We refer readers to section III.D.3.a.(9) of this final rule for our final definition of successful reporting of THA/TKA voluntary PRO and limited risk variable data for each performance year of the CJR model. Furthermore, as the PRO-PM remains under development, we will not require the reporting of THA/TKA voluntary PRO and limited risk variable data for reconciliation payment eligibility. However, the successful reporting of the voluntary data may increase a participant hospital's financial opportunity under the model, which may be greater than the hospital's increased administrative cost to report the data. While the final policy to incorporate successful reporting of THA/TKA voluntary PRO and limited risk variable data into the composite quality score methodology is not directly keyed to addressing the hospital resources required for reporting as would have been true for the voluntary reporting payment adjustment that we proposed, we note that voluntary reporting can only help a hospital qualify for quality incentive payments and unsuccessful reporting will not hurt a participant hospital's eligibility for reconciliation payments.
We have added new definitions to § 510.2, specifically: “Composite quality score” means a score computed for each participant hospital to summarize the hospital's level of quality performance and improvement on specified quality measures, as described in § 510.315; “Quality performance points” are points that CMS adds to a participant hospital's composite quality score for a measure based on the performance percentile scale and for successful data submission of patient reported outcomes; and “Quality improvement points” are points that CMS adds to a participant hospital's composite quality score for a measure if the hospital's performance percentile on an individual quality measure increases from the previous performance year by at least three deciles on the performance percentile scale. We have revised § 510.305(f)(2) and (g)(2) and (3) to reflect the role of the composite quality score in determining reconciliation payment eligibility. The final pay-for-performance methodology is set forth in § 510.315, which has been retitled, “Composite quality scores for determining reconciliation payment eligibility and quality incentive payments,” and revised to set forth the final pay-for-performance methodology of the CJR model as described in this final rule.
We outlined in the proposed rule our proposals for how we intend to reconcile aggregate related Medicare payments for a hospital's beneficiaries in CJR episodes during a performance year against the applicable target price in order to determine if reconciliation payment (or repayment, beginning in performance year 2) is applicable under this model. We refer readers to section III.B. of this final rule for our definition of related services for LEJR episodes under CJR, to section III.C.2.a. of this final rule for our definition of performance years, and to section III.C.4. of this final rule for discussion of our approach to establish target prices.
The proposed rule detailed our proposal to conduct reconciliation by calculating a NPRA for each hospital participant in the model. After the completion of a performance year, we proposed to retrospectively calculate a participant hospital's actual episode performance based on the episode definition. We noted that episode payments for purposes of the CJR model would exclude the effects of special payment provisions under existing Medicare payment systems (section III.C.3.a. of this final rule), be subject to
We proposed to compare each participant hospital's actual episode payment performance to its target prices. We proposed that, as discussed in section III.C.4. of this final rule, a participant hospital would have multiple target prices for episodes ending in a given performance year, based on the MS-DRG anchor (MS-DRG 469 versus MS-DRG 470), the performance year when the episode was initiated, when the episode was initiated within a given performance year (January 1 through September 30 of the performance year, October 1 through December 31 of the performance year, October 1 through December 31 of the prior performance year), and whether the participant hospital successfully submitted THA/TKA voluntary PRO and limited risk variable data. The applicable target price for each episode would be determined using the previously stated criteria, and the difference between each CJR episode's actual payment and the relevant target price (calculated as target price subtracted by CJR actual episode payment) would be aggregated for all episodes for a participant hospital within the performance year, representing the raw NPRA. This amount would be adjusted per the steps discussed later in this section, creating the NPRA.
We proposed to adjust the raw NPRA to account for post-episode payment increases (section III.C.8.e. of this final rule) and stop-loss and stop-gain limits (section III.C.8.b. of this final rule). Any NPRA amount greater than the proposed stop-gain limit would be capped at the stop-gain limit, and any NPRA amount less than the proposed stop-loss limit would be capped at the stop-loss limit.
We did not propose to include any CJR reconciliation payments or repayments to Medicare under this model for a given performance year in the NPRA for a subsequent performance year. We want to incentivize providers to provide high quality and efficient care in all years of the model. If reconciliation payments for a performance year are counted as Medicare expenditures in a subsequent performance year, a hospital would experience higher Medicare expenditures in the subsequent performance year as a consequence of providing high quality and efficient care in the prior performance year, negating some of the incentive to perform well in the prior year. Therefore, we proposed to not have the NPRA for a given performance year be impacted by CJR repayments or reconciliation payments made in a prior performance year. For example, if a CJR hospital receives a $10,000 reconciliation payment in the second quarter of 2017 for achieving episode spending below the target price for performance year 1, that $10,000 reconciliation payment amount would not be included in the performance year 2 calculations of actual episode spending. However, as discussed in section III.C.6.b. of this final rule, during the following performance year's reconciliation process, we proposed to account for additional claims run-out and overlap from the prior performance year, and net that amount with the subsequent performance year's NPRA to determine the reconciliation or repayment amount for the current reconciliation. The following is a summary of comments received and our response.
We also refer readers to response to comments in section III.C.4.b.(7) of this final rule on the importance of reintroducing wage index differences when calculating target prices and reconciliation and repayment amounts. In order to maintain consistency with the target price calculations, we will reintroduce wage index differences when calculating NPRA by applying the participant hospital's wage index and 0.7 as the labor cost share. By mirroring the target price calculation approach for accounting for wage index differences, we can better ensure that any reconciliation amounts or repayments to Medicare are due to differences in practice patterns, not Medicare FFS wage index policy variations.
We proposed to reconcile payments retrospectively through the following reconciliation process. We proposed to reconcile a participant hospital's CJR actual episode payments against the target price 2 months after the end of the performance year. More specifically, we would capture claims submitted by March 1st following the end of the performance year and carry out the NPRA calculation as described previously to make a reconciliation payment or hold hospitals responsible for repayment, as applicable, in quarter 2 of that calendar year.
We considered the suggestion to implement a blended reconciliation approach by withholding a specified percentage of FFS payments and later distributing the remainder of payments to hospitals for disbursement to downstream providers and suppliers. We believe that the operational challenges associated with such an approach would introduce significant administrative burden for hospitals. We also note that, as discussed in section III.C.10. of this final rule, we are finalizing policies that will allow participant hospitals to engage in financial arrangements and relationships with downstream providers and suppliers. We believe these relationships will allow participant hospitals the opportunity to share financial risk with downstream providers and suppliers and engage such entities in efforts to improve quality and efficiency throughout the episode.
To address issues of overlap with other CMS programs and models that are discussed in section III.C.7. of the proposed rule, we also proposed that during the following performance year's reconciliation process, we would calculate the prior performance year's episode spending a second time to account for final claims run-out, as well as overlap with other models as discussed in section III.C.7. of this final rule. This would occur approximately 14 months after the end of the prior performance year. As discussed later in this section, the amount from this calculation, if different from zero, would be applied to the NPRA for the subsequent performance year in order to determine the amount of the payment Medicare would make to the hospital or the hospital's repayment amount. We note that the subsequent reconciliation calculation would be applied to the previous calculation of NPRA for a performance year to ensure the stop loss and stop gain limits discussed in section III.C.8. of this final rule are not exceeded for a given performance year.
For the performance year 1 reconciliation process, we would calculate a participant's, as previously described, and if positive, the hospital would receive the amount as a reconciliation payment from Medicare. If negative, the hospital would not be responsible for repayment to Medicare, consistent with our proposal to phase in financial responsibility beginning in performance year 2. Starting with the CJR reconciliation process for performance year 2, in order to determine the reconciliation or repayment amount, the amount from the subsequent reconciliation calculation would be applied to the NPRA. We proposed that if the amount is positive, and if the hospital meets the minimum quality score required to be eligible for reconciliation, (discussed further in section III.C.5. of this final rule), the hospital would receive the amount as a reconciliation payment from Medicare. If the amount is negative, Medicare would hold the participant hospital responsible for repaying the absolute value of the repayment amount following the rules and processes for all other Medicare debts. Note that given our proposal to not hold participant hospitals financially responsible for repayment for the first performance year, during the reconciliation process for performance year 2 only, the subsequent calculation amount (for performance year 1) would be compared against the performance year 1 NPRA to ensure that the sum of the NPRA calculated for performance year 1 and the subsequent reconciliation calculation for year 1 is not less than zero. For performance years 2 through 5, though, we proposed that Medicare would hold the participant hospital responsible for repaying the absolute value of the repayment amount following the rules and processes for all other Medicare debts. The following table illustrates a simplified example of how the subsequent reconciliation calculation may affect the following year's reconciliation payment. The second column represents the raw NPRA calculated for Performance Year 1, meaning that Hospital A's aggregated episode spending was $50,000 below the target price multiplied by the number of episodes. The third column represents the subsequent reconciliation calculation, indicating that when calculating episode spending during Performance Year 1 a second time, we determined that Hospital A's aggregated episode spending was $40,000 below the target price multiplied by the number of episodes, due to claims runout, accounting for model overlap, or other reasons. The fourth column represents the difference between the subsequent reconciliation calculation and the raw NPRA calculated for Performance Year 1. This difference is then combined with the amount in the fifth column to create the reconciliation
This reconciliation process would account for overlaps between the CJR model and other CMS models and programs as discussed in section III.C.7. of this final rule, and would also involve updating performance year episode claims data. We also note that in cases where a hospital has appealed its quality performance results on the complications and HCAHPS quality measures through the IQR program appeal process, discussed in section III.D. of this final rule, and where such appeal results would result in a different effective discount percentage or quality incentive payment under the CJR model, the subsequent reconciliation calculation will account for these updates as well.
For example, for performance year 1 for the CJR model in 2016, we would capture claims submitted by March 1st, 2017, and reconcile payments for participant hospitals approximately 6 months after the end of the performance year in quarter 2 of calendar year 2017. We would carry out the subsequent calculation in the following year in quarter 2 of calendar 2018, simultaneously with the reconciliation process for the second performance year, 2017. Table 23 provides the reconciliation timeframes for the model. Lastly, we proposed that the reconciliation payments to or repayments from the participant hospital would be made by the MAC that makes payment to the hospital under the IPPS. This approach is consistent with BPCI Model 2 operations.
We proposed this approach in order to balance our goals of providing reconciliation payments in a reasonable timeframe, while being able to account for overlap and all Medicare claims attributable to episodes. We stated that pulling claims 2 months after the end of the performance year would provide sufficient claims run-out to conduct the reconciliation in a timely manner, given that our performance year includes episodes ending, not beginning, by December 31st. We note that in accordance with the regulations at § 424.44 and the Medicare Claims Processing Manual (Pub. L. 100-04), Chapter 1, Section 70, Medicare claims can be submitted no later than 1 calendar year from the date of service. We recognized that by pulling claims 2 months after the end of the performance year to conduct reconciliation, we would not have complete claims run-out. However, we believed that the 2 months of claims run-out would be an accurate reflection of episode spending and consistent with the claims run-out timeframes used for reconciliation in other payment models, such as BPCI Models 2 and 3. The alternative would be to wait to reconcile until we have full claims run out 12 months after the end of the performance year, but we were concerned that this approach would significantly delay earned reconciliation payments under this model. Because we proposed to conduct a second calculation to account for overlap with other CMS models and programs, we proposed to incorporate updated claims data with 14 months run out at that time. However, we did not expect that the updated data should substantially, in and of itself, affect the reconciliation results assuming hospitals and other providers and suppliers furnishing services to Medicare beneficiaries in CJR episodes follow usual patterns of claims submission and do not alter their billing practices due to this model.
We appreciate commenters' concerns and request for more frequent feedback on performance throughout the performance period. However, we continue to believe that an annual reconciliation process is most appropriate for the following reasons. As previously stated in this section, providers and suppliers have a calendar year to submit FFS claims for payment. Implementing a quarterly reconciliation process, as we do for the BPCI models, would mean that many claims may be incomplete at the time of the reconciliation. The BPCI reconciliation process incorporates 3 subsequent reconciliation calculations, and BPCI participants have experienced significant fluctuation in financial results between the initial reconciliation and the subsequent calculations. We believe our proposed annual reconciliation approach will lead to more stable financial results for providers. We also note based on our experience with the BPCI models that a quarterly reconciliation process results in model participants' near constant engagement in the reconciliation and appeals processes. This can potentially take time away from efforts focused on care redesign and coordination with providers and suppliers engaged in furnishing care for beneficiaries under the model. In addition, given our plan to assess hospital performance on quality measures (discussed in section III.C.5. of this final rule), we note that annual reconciliation processes will be necessary in order to calculate an accurate composite quality score for hospital participants, since quality measures are calculated on an annual basis. We also proposed to perform annual reconciliation for consistency with other models and programs such as the Shared Savings Program. As discussed in section III.C.7.e.of this final rule, we will allow for beneficiaries to be assigned to an ACO and have a concurrent CJR episode. We will perform our reconciliation calculations and then make the reconciliation and repayment amounts available to other models and programs in order to account for overlapping beneficiaries. We have aligned our annual reconciliation timeline with the ACO models and program in order to make this information available before the ACO models and program begin their annual financial reconciliation calculations; such a timeline is necessary to be able to account for program and model overlap.
We understand commenters' assertions that annual reconciliation does not allow for frequent feedback on financial performance under the model. We would like to reiterate that we will be providing both line-level and summary claims data to model participants on a quarterly basis, as discussed in section III.E. of this final rule. Such data are intended to provide hospitals with information about their care patterns and to identify opportunities for care redesign and savings. This data will also provide ongoing feedback to hospitals about their performance under the model, by including both raw claims as well as summary data with information about their episode spending and care patterns. Moreover, unlike in BPCI Models 2 and 3, we will be providing model participants with performance year target prices on a prospective basis, as discussed in section III.C.4 of this final rule. Prospective target pricing will provide hospitals with increased certainty about financial targets under the model. Finally, we also considered commenters' requests to conduct interim financial reconciliation calculations on a quarterly basis and provide the results of such calculations to hospitals. Because of the potential for volatility between the interim results and the final reconciliation results, and our concern that such results would not provide additional meaningful information to hospitals not present in the claims data and prospective target prices, we are not pursuing an interim reconciliation process at this time. However, we will continue to consider commenters' suggestions and will consider the feasibility of providing interim results in the future if we believe it could aid hospitals in succeeding under this model and would provide additional information not already present in the previously stated claims data and target prices.
Another commenter requested that CMS further outline the reconciliation and repayment processes, including how reconciliation would be conducted for Periodic Interim Payment (PIP) hospitals. Finally, a commenter requested a more flexible repayment process for hospitals meeting certain eligibility criteria, but did not suggest specific criteria.
In response to these comments we have considered whether it would be appropriate to allow subsequent reconciliations if claims are denied and reprocessed after the second reconciliation. We do not believe this is appropriate for several reasons. First, we note that in the event that the hospital's total episode spending exceeded the target price, we are finalizing policies that limit hospitals' financial responsibility for such spending, as discussed in section III.C.8. of this final rule. Second, the entire purpose of MAC and RAC audits is to ensure that Medicare payments are correctly administered and made only for services delivered in accordance with statute and regulation. If the hospital enters into appropriate collaboration agreements with high quality, responsible, and compliant PAC providers, the 14-month period prior to the second reconciliation provides ample opportunity for the hospital and its collaborators to work together to conduct internal audits and ensure that PAC claims are properly submitted or corrected. We believe it is appropriate for hospitals to continue to share some risk with Medicare even after the final reconciliation, and believe this provides additional incentives for them to work closely with their collaborators to ensure that all services are delivered appropriately. Third, we believe it is important to conclude the reconciliation process in the timeframe we have previously outlined in this section, in order to provide hospitals with financial results and certainty over their performance under the model. Additional subsequent reconciliations could introduce uncertainty for model participants. Finally, we do agree that we have a responsibility to ensure that MACs, RACs, and other auditing entities audit services delivered under the CJR using the rules and regulations governing the CJR model in addition to all other relevant statute, regulation, and guidance. We believe that appropriate contractor training and oversight will protect hospitals from inappropriate denials while protecting beneficiaries from the use of inappropriate services and protecting Medicare from making payments on inappropriate claims. We reiterate the information provided in the proposed rule that when a hospital is eligible for a reconciliation payment, such payment would be made to participant hospitals in a form and manner specified by CMS. In cases where repayment is required, as stated in the proposed rule, CMS will follow the normal Medicare debt processes, such as issuing a demand letter. CMS intends to build on existing processes for making reconciliation payments to hospitals or requiring repayment which are familiar to hospitals. Such processes will rely on electronic and other established processes to the extent possible. We also reiterate that as discussed in section III.C.8. of this final rule, certain hospitals would be afforded additional financial protections. We believe are protections are sufficient and an extended repayment process for such hospitals is not necessary.
With regard to PIP hospitals, we appreciate that commenters point out the different payment processes that apply to such hospitals. PIP hospitals receive biweekly payments based on
The following table illustrates the final timeframe for reconciliation.
This final policy is set forth at § 510.305.
In the proposed rule, we acknowledged that there may be circumstances where a Medicare beneficiary in a CJR episode may also be assigned to an ACO participating in the Shared Savings Program or otherwise accounted for in a payment model being tested by the Innovation Center. Current or forthcoming programs and models with potential overlap with CJR are displayed in Table 24. For purposes of this final rule, “total cost of care” models refers to models in which episodes or performance periods include participant financial responsibility for all Part A and Part B spending, as well as some Part D spending in select cases. We use the term “shared savings” to refer to models in which the payment structure includes a calculation of total savings and CMS and the model participants each retain a particular percentage of that savings. We note that there exists the possibility for overlap between CJR episodes and shared savings programs and models such as the Pioneer ACO Model, other total cost of care models such as the OCM, other Innovation Center payment models such as BPCI, and other models or programs that incorporate per-beneficiary-per-month fees or other payment structures.
In the proposed rule, we outlined the following issues that may arise in such overlap situations that must be addressed under CJR. First, beneficiaries in CJR episodes could also be part of BPCI Model 2 or 3 LEJR episodes or BPCI non-LEJR episodes, and the clinical services provided as part of each episode may overlap entirely or in part. Second, CJR reconciliation payments and repayments that are made under Part A and B and attributable to a specific beneficiary's episode may be at risk of not being accounted for by other models and programs when determining the cost of care under Medicare for that beneficiary. Third, some Innovation Center models make PBPM payments to entities for care coordination and other activities, either from the Part A or B Trust Fund or both, or from the Innovation Center's own appropriation (see section 1115A(f) of the Act). These payments may occur during a CJR episode. Finally, there could be instances when the expected Medicare savings for a CJR beneficiary's episode (represented by the discount percentage) is not achieved by Medicare because part of that savings is paid back to the hospital or another entity under the Shared Savings Program or a total cost of care model in which the beneficiary is also included. We sought comment on our proposals to account for overlap with the Shared Savings Program and other models, including those listed in Table 24 as well as other CMS models or programs.
The following is a summary of the comments received and our responses.
BPCI is an episode payment model testing LEJR episodes, as well as 47 other episodes, in acute or PAC or both settings (Models 1, 2, 3 or 4). As discussed in section III.A. of the proposed rule, we proposed to exclude from selection for participation in the CJR payment model those geographic areas where 50 percent or more of LEJR episodes are initiated at acute care hospitals testing the LEJR episode in BPCI in Models 1, 2 or 4 as of July 1, 2015. In that same section, we proposed that acute care hospitals in selected geographic areas participating in BPCI under Model 1 (acute care only) and those participating as episode initiators for the LEJR episode in Model 2 (acute and PAC from 30 to 90 days post-discharge) or Model 4 (prospective episode payment for the LEJR anchor hospitalization and related readmissions for 30 days post-discharge) be excluded from CJR. We discuss the comments received on this proposal and our responses in section III.A.4. of this final rule.
While we believed these proposals will mitigate the overlap of CJR beneficiaries with BPCI episodes, there may still be instances of model overlap that we need to account for under CJR. These include circumstances when a beneficiary is admitted to a CJR participant hospital for an LEJR procedure where the beneficiary would also be in a BPCI Model 2 episode under a PGP that would initiate the episode under BPCI. In another example, a beneficiary discharged from an anchor hospitalization under CJR could enter a BPCI Model 2 LEJR episode at another hospital for a phased second joint replacement procedure or enter a BPCI Model 3 LEJR episode upon initiation of PAC services at a BPCI PAC provider episode initiator for the LEJR episode. Similarly, a beneficiary in a BPCI Model 2 or Model 3 LEJR episode could be admitted to a CJR participant hospital for a phased second joint replacement. In all such scenarios in which there is overlap of CJR beneficiaries with any BPCI LEJR episodes, we proposed that the BPCI LEJR episode under Models 1, 2, 3, or 4 take precedence and we would cancel (or never initiate) the CJR episode. Because the cancelation (or lack of initiation) would only occur for overlap with BPCI LEJR episodes, we expect that the participant hospital and treating physician would generally be aware of the beneficiary's care pathway that would cancel or not initiate the CJR episode. Therefore, we would exclude the CJR episode from the CJR participant hospital's reconciliation calculations where we compare actual episode payments to the target price under the CJR model. If we were to allow both CJR and BPCI LEJR episodes to overlap, we would have no meaningful way to apply the payment policies in two models with overlapping care redesign interventions and episodes. Participants in BPCI have an expectation that eligible episodes will be part of the BPCI model test, whereas CJR participants would be aware that episodes may be canceled when there is overlap with BPCI episodes as previously discussed in this final rule. We aim to preserve the integrity of ongoing model tests without introducing major modifications (that is, CJR episode precedence) that could make evaluation of existing models more challenging. We considered that there may also be instances of overlap between CJR and BPCI Model 3 LEJR episodes where our proposal to give precedence to all BPCI episodes could lead to undesirable patient steering because the BPCI Model 3 episode does not begin until care is initiated at an episode-initiating PAC provider. It could be possible for a participating CJR hospital to purposefully guide a beneficiary to a BPCI Model 3 LEJR episode initiating PAC provider to exclude that beneficiary's episode from CJR. We considered giving precedence to the CJR episode in overlap with Model 3 beneficiaries because the CJR episode begins with admission for the anchor hospitalization and thus includes more of the episode services. However, we believed the steering opportunities would be limited due to the preservation of beneficiary choice of provider in this model (as discussed in section III.E. of the proposed rule). As outlined in section III.F. of this final rule, CJR hospitals must provide patients with a complete list of all
We sought comment on the proposed approach to address overlap between CJR and BPCI episodes. The following is a summary of the comments we received and our responses.
Some commenters disagreed with our proposed policy to apply precedence to BPCI Model 2 and Model 3 PGPs and PAC providers. Commenters contended that the proposed policy was unfair, given that BPCI participants entered models voluntarily, but hospitals in CJR were not given the opportunity to opt out and would be at risk for episodes where others did not perceive enough opportunity to voluntarily enter into risk agreements under BPCI. Commenters expressed concern that, given the precedence rules, CJR hospitals could potentially lose many episodes to BPCI and may be financially responsible for a low volume of episodes. Some commenters also suggested we apply a minimum threshold to remove hospitals from the CJR model based on BPCI PGP participation.
A commenter disagreed with the proposal for BPCI PAC entities at risk for a shorter episode duration than the CJR proposed episode to be given precedence. Another commenter cited the potential for patient steering issues that could arise due to our proposed policy to give BPCI PGPs precedence over CJR hospitals for LEJR episodes. In particular, the commenter was concerned that the precedence rules would lead to BPCI PGPs capturing lower-risk episodes, leaving CJR hospitals at risk for more high-risk episodes. The commenter suggested we give precedence to CJR episodes over BPCI PGP and PAC episodes to mitigate steering concerns.
Another commenter was concerned about potential confusion when episodes initiated at the same acute care hospital could be in both models; for example, when episodes initiated by a BPCI PGP at a hospital or discharged to a Model 3 PAC are attributed to BPCI while the remaining episodes are a part of CJR. The commenter believed that following both sets of rules (for the BPCI and CJR models) within the same hospital could be confusing for hospitals and partner providers and suppliers, limiting providers' ability to target care redesign efforts toward patients for whom a CJR hospital is financially responsible. Another commenter requested CMS publish a public list of BPCI episode initiators whose episodes would take precedence over CJR episodes.
In response to commenters' requests for additional examples of overlap scenarios, we clarify that LEJR overlap could occur in, but is not limited to, the following situations:
• A beneficiary is admitted to a CJR hospital for an LEJR procedure and discharged to a PAC provider participating in BPCI Model 3 for the LEJR episode; the episode is attributed to the BPCI Model 3 PAC provider.
• A beneficiary is admitted to a CJR hospital for an LEJR procedure by a PGP participating in BPCI Model 2; the episode is attributed to the BPCI Model 2 PGP.
• A beneficiary is admitted to a CJR hospital for an LEJR procedure by a PGP participating in BPCI Model 3; the episode is attributed to the BPCI Model 3 PGP.
• A beneficiary is admitted to a CJR hospital for an LEJR procedure, followed by a second phased LEJR procedure within 90 days of the first procedure. The second LEJR procedure is attributed to a PGP participating in BPCI Model 2 or 3 or is followed by admission to a PAC provider participating in BPCI Model 3 for the LEJR episode. The first LEJR episode would be canceled and the second episode would be attributed to the BPCI provider.
We acknowledge that some CJR hospitals could be financially at risk for a small proportion of LEJR episodes initiated at the hospital if there are high-volume PGPs or PAC providers in their community initiating LEJR episodes under BPCI, yet we continue to believe those hospitals have opportunity under the CJR model. Physicians and PAC providers may already have worked on care redesign for LEJR beneficiaries, and the hospitals have an opportunity to learn from that experience. Having a smaller number of beneficiaries in the CJR model to begin with also places hospitals at less financial risk, which may allow them to more rapidly and nimbly design care pathways, test them, and refine them on a smaller number of beneficiaries and with less resources than if all of the hospital's LEJR beneficiaries were in the CJR model from the start. We also note that, given that many providers' 3-year participation in BPCI would end in 2017 or 2018, in many cases full financial responsibility for all of a participant hospital's LEJR procedures under the CJR model would not be in effect until the conclusion of the BPCI participation period when the CJR participant hospitals could have responsibility for a larger number of episodes. By that point in time, CJR participant hospitals should have several years of experience with LEJR episodes focusing on quality and efficiency, and the larger number of beneficiaries can then be integrated into existing pathways.
While we understand the concerns of some commenters that physician and PAC providers participating in BPCI will focus on low-risk beneficiaries, leaving higher-risk beneficiaries to be the participant hospital's responsibility under the CJR model so that the CJR model beneficiaries in a performance year will not resemble those in the baseline period used to set target prices, there are a number of model design features that make this unlikely. First, as discussed in section III.C.4.b.(1) of this final rule, we are stratifying episodes on the basis of a beneficiary's hip fracture
We appreciate commenters' contention that allowing for both models to coexist for LEJR episodes within the same acute care hospital may be confusing for providers. However, we believe the importance of continuing PGP and PAC participation in BPCI Models 2 and 3 outweighs this risk, and believe that local providers, in the best interest of Medicare beneficiaries and cost and quality success under the two models, will coordinate and collaborate to respond to their circumstances. We also note that while the BPCI and CJR models differ in various ways, the broad goals of the models are the same: Improving quality of care while reducing spending during the episode. We believe it is reasonable for hospitals, PGPs, and PAC providers to engage in care redesign strategies targeted at LEJR episodes in general, regardless of attribution of an LEJR episode to a particular model. Such overlap within the same hospital may incentivize additional coordination between the entities already engaged in care redesign under BPCI and acute care hospitals that will begin such activities as participants in CJR.
In response to the commenter who requested a list of BPCI episode initiators, we refer readers to the publicly available list of current episode initiators in BPCI on the model Web site at
As we noted in the proposed rule, we believe that where there is overlap between BPCI and CJR LEJR episodes, providers would generally be aware of such situations. For example, BPCI PGPs and PAC providers would be aware that a PGP initiating an LEJR episode at a CJR hospital, or an admission to a PAC facility in BPCI Model 3 would cancel the CJR episode. CJR hospitals could maintain a list of BPCI participants in their area. In contrast, if we allow any BPCI non-LEJR episode to cancel all CJR episodes, CJR hospitals may not be aware of the beneficiary's eventual care pathway. For example, CJR hospitals may be unaware of cases in which the CJR LEJR episode is canceled and the non-LEJR BPCI episode takes precedence because a wide range of BPCI clinical episodes and provider types could cancel the CJR episode during the 90 day post-discharge period.
We expect such cases of overlap to be rare given current BPCI participation and the participant CJR model hospitals. We also reiterate that when such overlap occurs, each model (BPCI and CJR) would continue its normal financial reconciliation processes. When overlap occurs, it is possible that savings achieved during one model could also be counted as savings under the other model. In such cases it could be difficult to determine whether savings achieved during an episode were attributable to care redesign activities under BPCI or CJR. However, allowing for overlap between BPCI non-LEJR and CJR episodes will maximize the testing of episodes under both models and encourage providers under BPCI and CJR to engage in care redesign and coordination activities for all beneficiaries attributed to either model. The following examples illustrate potential situations of overlap:
• A beneficiary is admitted to a CJR hospital for an LEJR procedure and later readmitted to the same or a different CJR hospital for a congestive heart failure episode under BPCI.
• A beneficiary is in a BPCI PGP Model 2 episode for chronic obstructive pulmonary disease at a CJR hospital and has an LEJR procedure at the same or a different CJR hospital during the post-anchor hospital discharge period of the BPCI episode.
In both situations, each model would calculate episode spending and perform financial reconciliation as normal.
Under CJR, we proposed to annually, as applicable, make reconciliation payments to or receive repayments from participating CJR hospitals based on their quality performance and Medicare expenditures, as described in section III.C.6. of the proposed rule. While we proposed that these reconciliation payments or repayments would be handled by MACs, the calculation of these amounts would be done separately before being sent through the usual Medicare claims processing systems. Nevertheless, it is important that other models and programs in which providers are accountable for the total cost of care be able to account for the full Medicare payment, including CJR-related reconciliation payments and repayments as described in section III.C.6. of the proposed rule, for beneficiaries who are also in CJR episodes. Accordingly, it is necessary to have beneficiary-specific information on CJR-related reconciliation payments and repayments available when those models and programs make their financial calculations. Thus, in addition to determining reconciliation payments and repayments for the participant hospitals in the CJR model, we proposed to also calculate beneficiary-specific reconciliation payment or repayment amounts for CJR episodes to allow for those other programs and models, as their reconciliation calculation timeframes permit, to determine the total cost of care for overlapping beneficiaries. We would perform the reconciliation calculations for CJR hospitals and make information about the CJR reconciliation or repayment amounts available to other programs and models, such as the Shared Savings Program and Pioneer ACO as well as non-ACO total cost of care models such as CPCi and OCM that begin reconciliation calculations after CJR. For example, this strategy is currently in place to account for overlaps between beneficiaries assigned or aligned to Pioneer and Shared Savings Program ACOs and BPCI model beneficiaries. Beneficiary-specific reconciliation payment or repayment amounts are loaded into a shared repository for use during each program or model's respective reconciliations. However, we note that we proposed not to make separate payments to, or collect repayments from, participating CJR hospitals for each individual episode, but, instead, to make a single aggregate reconciliation payment or repayment determination for all episodes for a single performance year, as discussed in section III.C.6. of the proposed rule. As described in section III.C.6 of the proposed rule, we proposed to conduct reconciliation based on claims data available 2 months after the end of the performance year and a second calculation based on claims data available 14 months after the end of a performance year to account for claims run-out and potential overlap with other models. The rationale for this proposed reconciliation process was to be able to make payments to, and require repayment from, CJR participant hospitals in a timely manner and to be able to account for overlaps in other models and programs. In addition, the timing of the reconciliation was determined giving consideration to when the other total cost of care programs and models conduct their reconciliations so that when they perform their financial calculations, they will have the information necessary to account for beneficiary-specific payments/repayments made under the CJR model as it is consistent with their policies. We intend to report beneficiary-specific payments and repayment amounts made for the CJR model in the CMS Master Database Management (MDM) System that generally holds payments/repayment amounts made for CMS models and programs. Other total cost of care models and programs can use the information on CJR payment/repayment amounts reported in the Master Database Management System in their financial calculations such as in their baseline or benchmark calculations or reconciliations, to the extent that is consistent with their policies.
We sought comment on our proposed approach to ensuring that the full CJR episode payment for a beneficiary is accounted for when performing financial calculations for other total cost of care and episode-based payment models and programs. The following comments and responses refer to the implications of our proposal to ensure other models are able to account for the full CJR episode payment, including any reconciliation payment or repayment amount. As discussed later in this section, many commenters expressed concern about how this policy would affect ACO financial calculations. Because total cost of care models and programs, including the Shared Savings Program and other ACO models, would include the full CJR episode payment (that is, including any reconciliation or repayment amounts) in their annual financial calculations determining the total spending for a beneficiary, most of the savings achieved during a CJR episode would be attributed to the CJR model. As discussed in section III.C.7.e. of this final rule, in some select cases the savings amount represented by the discount percentage could be attributed to a Shared Savings Program or other ACO model entity.
The following is a summary of comments received and our response.
In response to commenters who requested that we fully attribute savings achieved (represented by reconciliation payments) during CJR episodes to the ACO in cases where a beneficiary is assigned to an ACO and initiates a CJR episode at a hospital that is not aligned to the ACO as a participant or provider/supplier, we decline to diverge from the approach we have taken in other episode payment models because we wish to maintain consistency and because such a change would be unworkable, as we discuss later in this section. There are several ways in which CMS potentially could attribute savings achieved during a CJR episode to the ACO in lieu of the CJR hospital, but after considering them, we have concluded that each option has far-reaching and undesirable implications for the policies and operations of both the CJR model and ACOs. The first option would involve making the ACO to which a beneficiary is assigned the financially responsible entity for the CJR episode so that reconciliation payments or repayments would ultimately be the responsibility of the ACO. To accomplish this, we would need to determine a way to make the reconciliation payment to or request the repayment amount from the unrelated CJR hospital on behalf of the ACO. This would mean that the CJR hospital would need to have a financial arrangement with the unrelated ACO to pay the ACO the reconciliation payment or the ACO would need to pay the CJR hospital if payment is due to Medicare. Under this approach, it would be necessary to conduct a separate reconciliation process for beneficiaries attributed to the unrelated ACO and another reconciliation for all other beneficiaries with CJR episodes. This would disrupt our approach to the financial protections discussed in section III.C.8. of this final rule—that is, stop-loss and stop-gain, which are intended to apply to all of a CJR hospital's episodes, because we would need to apply those thresholds separately to the episodes attributed to the unrelated ACO. We believe this, in turn, would be confusing for participant hospitals. We note that this is distinct from our policy to report beneficiary-specific reconciliation amounts in the MDM, as previously discussed in this section, which would occur after performing the reconciliation calculations and applying the stop-loss and stop-gain thresholds for a given hospital across all of its aggregated episodes.
A second approach would be for all models or programs (CJR and the Shared Savings Program or other ACO) to conduct reconciliation activities for all beneficiaries as normal. The attribution of savings for those CJR beneficiaries assigned to an unrelated ACO could be accounted for through the subsequent reconciliation through the following process. Reconciliation payments could be recouped from CJR participant hospitals and paid to the ACOs in cases where a beneficiary was assigned to an ACO and had a CJR episode at an unrelated CJR hospital. However, we decline to adopt this approach because it would introduce significant uncertainty for CJR participant hospitals and could cause large fluctuations in reconciliation and repayment amounts between the initial reconciliation and subsequent calculation. Additional policies would also need to be adopted in order to ensure the financial reconciliation activities for the CJR model and the Shared Savings Program or shared savings models are able to account for such transactions, including further coordination of reconciliation timelines and policies to account for the subsequent reconciliation calculations. At present, we have not made any proposals for such types of financial arrangements between the initiatives that would allow for such transactions.
A final option would be to cancel (or never initiate) a CJR episode for any beneficiary assigned to an unrelated ACO. Beneficiaries assigned to such ACOs would need to be excluded from CJR financial reconciliation calculations. Implementing such a policy would be challenging, given our plan to conduct CJR reconciliation activities prior to ACO financial reconciliations, in which ACOs finalize their list of assigned beneficiaries. It would not be possible to finalize a list of CJR episodes or beneficiaries until after the ACO models or the Shared Savings Program, as applicable, had completed their financial reconciliations. Additionally, CJR participant hospitals would not know until well after episodes were completed whether the hospital was actually responsible for a particular beneficiary's episode under the CJR model. While we note that in some cases a CJR episode could be canceled for other reasons, such as precedence for a BPCI PGP episode as discussed in III.C.7.b, in such cases we believe that CJR hospitals will generally be aware of the possibility of episode cancelation due to BPCI precedence. For example, a CJR hospital may be aware that any time a given PGP furnishes an LEJR procedure to a Medicare beneficiary in the CJR hospital, that beneficiary will most likely be in a BPCI, not CJR, episode. In contrast, the uncertainty of final ACO assignment lists prior to the CJR reconciliation activities could lead to significant unanticipated changes in episode attribution. In addition, the high volume of potential CJR episodes that would be canceled under this approach could potentially limit the scope of the CJR model test. As discussed in section I.A. of this final rule, CJR is intended to be a robust test of episode payment across many types of hospitals.
Because this approach is generally inconsistent with our proposals for the CJR model, we decline to adopt it. In addition, if CMS were to pursue a policy for attributing CJR model episode savings to an ACO in lieu of to the CJR hospital, the ACO—not the hospital—would become the risk-bearing entity for some beneficiaries (those assigned to the ACO), which is inconsistent with our stated policy in section III.A.2. of this final rule to designate hospitals as financially responsible for all CJR episodes. As discussed in detail in section III.A.2. of this final rule, we believe hospitals are the most appropriate entities to manage the care and financial responsibility for CJR episodes. CJR hospitals could be unaware that beneficiaries are assigned to an ACO, given that their episodes would be canceled or attributed to the ACO only in cases where the CJR hospital is not participating in the ACO.
Given the significant complexity such a change would introduce, and the changes in other CJR model and ACO policies and operations that would be required to implement such a change (such as CJR model reconciliation processes, application of financial protections for hospitals, and financial arrangements), we continue to believe it is most appropriate, consistent with the policies of both the CJR model and the Shared Savings Program and other ACO models, and operationally feasible to attribute savings achieved during a CJR episode (that is, reconciliation payments) to the CJR model in all cases. Doing so also attributes these savings to the episode that is most proximate to the beneficiary's care during an LEJR episode. We refer readers to section III.C.7.e. of this final rule for discussion of the CJR discount percentage and attribution of the savings represented by the discount percentage.
We do not agree that our proposal to attribute savings achieved during CJR episodes via reconciliation payments to the CJR participant instead of the ACO incentivizes overutilization of LEJR procedures, penalizes providers taking on risk, or harms population-based health models. First, as discussed in
Coexistence of episode-based payment models and ACOs may lead to improved care redesign and coordination strategies, and ultimately, improved quality of care for beneficiaries. While episode-based payment models such as the CJR model target care during a relatively short time span, models incorporating the total cost of care over a longer time period such as ACOs focus on population health and strategies to improve care coordination across the entire spectrum of care. In order to achieve the agency's goals of better care, smarter spending, and healthier people, CMS must engage providers in a variety of models and rigorously evaluate the results of such models and programs in order to identify specific care redesign strategies and payment mechanisms that are effective in reaching these goals. An important feature of such testing and evaluation is also understanding how various models or programs work alongside other initiatives. For this reason, we believe it is appropriate for CMS to allow for the coexistence of various initiatives such as episode-based payment models and ACOs. Doing so will provide robust information on the results of each model, including information on how particular payment structures fare across a variety of regions and in markets with varying levels of provider participation in other models.
In addition, we note that although there are important structural differences between initiatives such as CJR and the Shared Savings Program or other ACO models, the underlying goals are the same. Both CJR and the ACO initiatives target improved quality of care and reduced spending during a defined period of time. Over time, provider organizations participating in one or both types of models will continue to find ways to work together to better coordinate care for beneficiaries, improve clinical efficiencies and reduce unnecessary utilization of health care services, and succeed financially under various types of payment models and programs.
Finally, while we appreciate commenters' suggestion that we test a different method for overlap with ACOs than that used for the BPCI initiative, we do not intend to test a different savings attribution method at this time. Both BPCI and the CJR model share the common episode-initiating event of an inpatient hospitalization and, in the case of each of these models as designed, we have concluded that the same savings attribution policy is appropriate. As we develop other episode payment models in the future and consider the potential for expansion of successful episode payment models, we will consider the perspectives offered by the commenters on the CJR model in the design of those models as we develop overlap policies or consider changes to existing policies.
For the reasons previously stated, we are finalizing our proposal to attribute savings achieved (via reconciliation payments) during CJR episodes to CJR participant hospitals. We refer readers to section III.C.7.e. of this final rule for discussion of the attribution of savings for the CJR discount percentage.
This policy is set forth at § 510.305.
There are currently five CMS models that pay PBPM payments to providers for new or enhanced services as displayed in Table 17. These PBPM payments vary as to their funding source (Medicare Trust Funds or Innovation Center appropriation), as well as to their payment methodology.
In general, these PBPM payments are for new or enhanced provider or supplier services that share the goal of improving quality of care overall and reducing Medicare expenditures for services that could be avoided through improved care coordination. Some of these PBPM payments may be made for services furnished to a beneficiary that is in another Innovation Center model at the that same time that the beneficiary is in a CJR LEJR episode, but the clinical relationship of services paid by the PBPM payments to the CJR episode will vary. For purposes of CJR, we consider clinically related those services paid by PBPMs that are for the purpose of care coordination and care management of any beneficiary diagnosis or hospital readmission not excluded from the CJR episode definition, as discussed in section III.B.2. of this final rule.
We would determine whether the services paid by PBPM payments are excluded from the CJR episode on a model by model basis based on their funding source and clinical relationship to CJR episodes. If we determine a model's PBPM payments are for new or enhanced services that are clinically related to the CJR episode and the PBPM payment is funded through the Medicare Part A or B Trust Fund, we would include the services paid by the PBPM payment to the extent they otherwise meet the proposed episode definition for the CJR model. That is, we would include the clinically related services paid by a PBPM payment if the services would not otherwise be excluded based on the principal diagnosis code on the claim, as discussed in section III.B.2 of the proposed rule. The PBPM payments for clinically related services would not be excluded from the historical CJR episodes used to calculate target prices when the PBPM payments are present on Part A or Part B claims, and they would not be excluded from calculation of episode actual expenditures during the performance period. PBPM model payments that we determine are clinically unrelated would be excluded, regardless of the funding mechanism or diagnosis codes on claims for those payments. We note that in the case of PBPM model payments, principal diagnosis codes on a Part B claim (which are used to identify exclusions from CJR episodes, as discussed in section III.B. of this final rule), would not denote the only mechanism for exclusion of a service from the CJR episode. All such PBPM model payments we determine are clinically unrelated would be excluded as discussed in this proposal. Finally, all services paid by PBPM payments funded through the Innovation Center's appropriation under section 1115A of the Act would be excluded from CJR episodes, without a specific determination of their clinical relationship to CJR episodes. We believed including such PBPM payments funded under the Innovation Center's appropriation and not included on claims would be operationally burdensome and could significantly delay any reconciliation payments and repayments for the CJR model. In addition, because these services are not paid for from the Medicare Part A or B Trust Fund, we are not confident that they would be covered by Medicare under existing law. Therefore, we believed the services paid by these PBPM payments are most appropriately excluded from CJR episodes. Our proposal for the treatment of services paid through model PBPM payments in CJR episodes would pertain to all existing models with PBPM payments, as well as future models and programs that incorporate PBPM payments. We believed that this proposal is fully consistent with our goal of including all related Part A and Part B services in the CJR episodes, as discussed in section III.B.2. of the proposed rule.
Under this proposal, only one of the active models displayed in Table 17 include services paid by PBPM payments that would not be excluded from CJR episodes. The MAPCP model makes PBPM payments that are funded
We acknowledge there may be new models not included in Table 17 that could incorporate a PBPM payment for new or enhanced services. We would plan to make our determination about whether services paid by a new model PBPM payment that is funded under the Medicare Trust Funds are clinically related to CJR episodes through the same subregulatory approach that we are proposing to use to update the episode definition (excluded MS-DRGs and ICD-10-CM diagnosis codes). We would assess each model's PBPM payment to determine if it would be primarily used for care coordination or care management services for excluded clinical conditions under the LEJR episode definition for CJR based on the standards we proposed to use to update the episode definition that are discussed in section III.B.2 of the proposed rule.
If we determine that the PBPM payment would primarily be used to pay for services to manage an excluded clinical condition, we would exclude the PBPM payment from the CJR episode on the basis that it pays for unrelated services. If we determine that the PBPM payment could primarily be used for services to manage an included clinical condition, we would include the PBPM payment in the CJR episode if the diagnosis code on the claim for the PBPM payment was not excluded from the episode, following our usual process for determining excluded claims for Part B services in accordance with the episode definition discussed in section III.C.2 of the proposed rule. We would post our proposed determination about whether the PBPM payment would be included in the episode to the CMS Web site to allow for public input on our planned application of these standards, and then adopt changes to the overlap list with posting to the CMS Web site of the final updated list after our consideration of the public input.
We sought comment on our proposals to account for Innovation Center model PBPM payments under CJR.
The following is a summary of the comments received and our responses.
This policy is set forth at § 510.200.
In addition to the Medicare Shared Savings Program under section 1899 of the Act, there are several ACO and other Innovation Center models that make or will make, once implemented, providers
We proposed that a beneficiary could be in a CJR episode, as defined in section III.B. of this final rule, by receiving an LEJR procedure at a CJR hospital, and also attributed to a provider participating in a model or program in Table 17. For example, a beneficiary may be attributed to a provider participating in the Pioneer ACO model for an entire performance year, as well as have a CJR episode during the ACO's performance year. Each model incorporates a reconciliation process, where total included spending during the performance period or episode are calculated, as well as any potential savings achieved by the model or program. Given that we proposed to allow for such beneficiary overlap, we stated our belief that it would be important to account for savings under CJR and the other models and programs with potential overlap in order that CMS can apply the respective individual savings-related payment policies of the model or program, without attributing the same savings to more than one model or program. In the proposed rule, we stated our belief that when overlap occurs, it is most appropriate to attribute Medicare savings accrued during the CJR time period (hospitalization plus 90 days post-discharge) to CJR to the extent possible. The CJR episode has a shorter duration and is initiated by a major surgical procedure, requiring an inpatient hospitalization. In contrast, the total cost of care models listed in Table 17 incorporate 6 to 12 month performance periods for participants and, in general, have a broader focus on beneficiary health. Our intention was to ensure that CJR episodes are attributed the full expected savings to Medicare to the extent possible. As such, we proposed the following policies to ensure that other programs and models are able to account for the reconciliation payments paid to CJR hospitals to the extent possible prior to performing their own reconciliation calculations and that, in all appropriate circumstances, the CJR model or the other program or model would make an adjustment for savings achieved under the CJR model and partially paid back through shared savings/performance payments under other initiatives to ensure that the full CJR model savings to Medicare is realized.
We proposed that the total cost of care calculations under non-ACO total cost of care models would be adjusted to the extent feasible to account for beneficiaries that are aligned to participants in the model and whose care is included in CJR in order to ensure that the savings to Medicare achieved under CJR (the discount percentage) are not paid back under these other models through shared savings or other performance-based payment. Thus, the non-ACO total cost of care models would adjust their calculations to ensure the CJR discount percentage is not paid out as savings or other performance-based payment to the other model participants. As previously discussed, we believe that the efficiencies achieved during the CJR episode should be credited to the entity that is closest to that care for the episode of care in terms of time, location, and care management responsibility, rather than the broader entity participating in a total cost of care model that spans a longer duration. We proposed that the non-ACO total cost of care models to which this policy would apply would include CPCi, OCM, and MAPCP. We sought comment on our proposal to account for overlap with those non-ACO total cost of care models and any other current or forthcoming models.
We received no comments on our proposed policy to account for the potential for the discount percentage to be paid out as savings by a non-ACO total cost of care model.
We proposed a different policy for accounting for overlap with Shared Savings Program and other ACO models. We noted that given the operational complexities and requirements of the Shared Savings Program reconciliation process, it would not be feasible for the Shared Savings Program to make an adjustment to account for the discount to Medicare under a CJR episode under existing program rules and processes. Additionally, for programmatic consistency across the Shared Savings Program and other ACO models, given that our ACO models generally are tested for the purpose of informing future potential changes to the Shared Savings Program, in the proposed rule we stated our belief that the ACO model overlap adjustment policy should be aligned with the Shared Savings Program policy. Thus, we proposed that under CJR, we would make an adjustment to the reconciliation amount if available to account for any of the applicable discount for an episode resulting in Medicare savings that is paid back through shared savings under the Shared Savings Program or any other ACO model, but only when a CJR participant hospital also participates in the ACO and the beneficiary in the CJR episode is also assigned to that ACO. This adjustment would be necessary to ensure that the applicable discount under CJR is not reduced because a portion of that discount is accounted for in shared savings to the ACO and thus, indirectly, is paid back to the hospital.
However, we proposed not to make an adjustment under CJR when a beneficiary receives an LEJR procedure at a participant hospital and is assigned
We note that our proposed policy would entail CJR reclaiming from the participant hospital any discount percentage paid out as shared savings under the Shared Savings Program or ACO models only when the hospital is participating in an ACO as a participant or provider/supplier and the beneficiary is assigned to that ACO, while other total cost of care models such as CPCi would adjust for the discount percentage in their calculations to the extent feasible. While it is operationally feasible for smaller total cost of care models in testing, such as CPCi, to make an adjustment to account for any CJR discount percentage paid out as sharing savings or other performance-based payments, the operational complexities and requirements of the large permanent Medicare ACO program, the Shared Savings Program, make it infeasible for that program to make an adjustment in such cases, and in the proposed rule we stated our belief that other ACO models in testing that share operating principles with the Shared Savings Program should follow the same policies as the Shared Savings Program adjustment for certain overlapping ACO beneficiaries. As the landscape of CMS models and programs changes, we may revisit this policy through future rulemaking.
We sought comment on our proposal for adjustments to account for overlap of the discount percentage between CJR and ACO models or programs.
The following is a summary of the comments received and our responses.
For purposes of limiting the instances in which a portion of the discount percentage is doubly counted as savings, we proposed the following. When a beneficiary has a CJR episode and is also assigned to an ACO, it is possible that a portion of the CJR discount percentage could be paid out as savings through the ACO's financial reconciliation. The reconciliation or repayment amounts shared with other models for incorporation into their financial calculations are based on the episode target price, which does not include the spending amount equal to the discount percentage as the discount represents potential savings to Medicare. We proposed that when overlap occurs between CJR hospitals that are participating in an ACO model or program as a participant or provider/supplier, we would make an adjustment to the reconciliation payment (if available) to account for the portion of the discount that was paid to the ACO as shared savings. For example, through the subsequent reconciliation calculation, described in section III.C.6. of this final rule we would reduce a CJR hospital's reconciliation payment by the dollar amount that would have been saved by CMS under the applicable CJR discount percentage, but was determined to have been paid to the ACO as shared savings. In cases where the CJR hospital is not participating in the Shared Savings Program or an ACO model, we would not make such an adjustment. We believe it is reasonable to minimize the situations in which the CJR discount percentage is double counted as savings. We also believe our policy not to make this adjustment in the case of an unrelated ACO is appropriate, given that the ACO may be unaware of the beneficiary's care pathway or that the beneficiary's LEJR episode is included in the CJR model because the CJR hospital and the ACO are not related. We also note that while making an adjustment to a CJR hospital's reconciliation payment is within the scope of the CJR model, adjusting shared savings amounts for ACO entities would necessitate changes to agreements to the Shared Savings Program and other ACO model agreements and methodologies. For the reasons previously stated, we believe unrelated ACOs should not be required to repay the amount of the CJR discount percentage included in the ACO's financial reconciliation.
We do not believe our proposed policy would create a disincentive for health systems to participate in an ACO. Hospitals that are not participating in the Shared Savings Program or other ACO models are treated the same as those participating in an ACO for purposes of determining attribution of savings during the CJR episode represented by the reconciliation payments, as previously discussed in section III.C.7.c. of this final rule. As discussed in that section, after performing the financial reconciliation calculations for CJR, we will put the reconciliation or repayment amounts, as applicable, in a shared repository for other models or programs to use in their own financial calculations. The reconciliation or repayment amounts would be taken into account as if they were FFS payments made for a covered service furnished to a beneficiary, to the extent that such inclusion of payments is consistent with the other model or program's policies. In applying this policy, we will not make a distinction between hospitals or other providers based on participation in an ACO or other initiative. The reconciliation or repayment amounts will be available for all other models or programs to use in their financial calculations as appropriate. In cases where the other initiative includes the CJR reconciliation or repayment amounts in their financial calculations, the savings achieved during an episode would be attributed to CJR, except in cases where the discount percentage is paid out as savings to another model or program participant, as discussed later in this section. In addition, in cases where some or all of the CJR discount percentage is paid out to an ACO hospital through the ACO's financial reconciliation, making an adjustment to the reconciliation payment where available to account for the discount percentage does not penalize the hospital participating in an ACO. Such
This policy is set forth at § 510.305.
As discussed in section III.A. of the proposed rule, we proposed designating as the financially responsible providers in CJR all acute care hospitals paid under the IPPS that are located in the selected geographic areas for this test of 90-day post-discharge LEJR episodes, with the exception of some hospitals that we proposed to exclude because of participation in BPCI (Models 1, 2, or 4) for LEJR episodes. We are interested in ensuring a broad test of episode payment for this clinical condition among different types of hospitals, including those who may not otherwise choose to participate in an episode payment model. Many of the participant hospitals would likely be key service providers in their communities for a variety of medical and surgical conditions extending well beyond orthopedic procedures. We want to gain experience with this model before extending it to hospitals in uncommon circumstances. In addition, we acknowledge that hospitals designated for participation in CJR currently vary with respect to their readiness to function under an episode payment model with regard to their organizational and systems capacity and structure, as well as their beneficiary population served. Some hospitals may more quickly be able to demonstrate high quality performance and savings than others, even though we proposed that the episode target prices be based predominantly on the hospital's own historical episode utilization in the early years of CJR.
We also note that providers may be incentivized to excessively reduce or shift utilization outside of the CJR episode, even with the quality requirements discussed in section III.C.5. of the proposed rule. In order to mitigate any excessive repayment responsibility for hospitals or reduction or shifting of care outside the episode, especially beginning in performance year 2 of the model when we proposed to begin to phase in responsibility for repaying Medicare for excess episode spending, we proposed several specific policies that are also referenced in section III.C.6.b. of the proposed rule.
When hospital repayment responsibility begins in the second performance year of CJR, under this final rule, hospitals would be required to repay Medicare for episode expenditures that are greater than the applicable target price. As discussed in the section III.C.3.c of the proposed rule regarding our proposed pricing adjustment for high payment episodes, hospitals participating in CJR would not bear financial responsibility for actual episode payments greater than a ceiling set at two standard deviations above the mean regional episode payment. Nevertheless, hospitals would begin to bear repayment responsibility beginning in performance year 2 for those episodes where actual episode expenditures are greater than the target price up to the level of the regional episode ceiling. In aggregate across all episodes, the money owed to Medicare by a hospital for actual episode spending above the applicable target price could be substantial if a hospital's episodes generally had high payments. As an extreme example, if a hospital had all of its episodes paid at two standard deviations above the mean regional episode payment, the hospital would need to repay Medicare a large amount of money, especially if the number of episodes was large.
To limit a hospital's overall repayment responsibility for the raw NPRA contribution to the repayment amount under this model, we proposed a 10 percent limit on the raw NPRA contribution to the repayment amount in performance year 2 and a 20 percent limit on the raw NPRA contribution to the repayment amount in performance year 3 and subsequent years. Hereinafter we refer to these proposed repayment limits as stop-loss limits. In performance year 2 as we phase in repayment responsibility, the hospital would owe Medicare under the proposed CJR payment model no more than 10 percent of the hospital's target price for the anchor MS-DRG multiplied by the number of the hospital's CJR episodes anchored by that MS-DRG during the performance year, for each anchor MS-DRG in the model. Ten percent provides an even transition with respect to maximum repayment amounts from performance year 1, where the hospital bears no repayment responsibility, to the proposed stop-loss limit in performance years 3 through 5 of 20 percent. In performance years 3
We had believed that a stop-loss limit of 20 percent is appropriate when the hospital bears full repayment responsibility, based on our assessment of the changes in practice pattern and reductions in quality of care that could lead to significant repayment responsibility under the CJR model, as compared to historical LEJR episode utilization. We estimate that the IPPS payment for the anchor hospitalization makes up approximately 50 percent of the episode target price, and we expect that the anchor hospitalization offers little opportunity for efficiencies to be achieved by reducing Medicare expenditures. In contrast, we expect significant episode efficiencies could be achieved in the 90 days following discharge from the anchor hospitalization through reductions in related hospital readmissions and increased utilization of appropriate lower intensity PAC providers, specifically increased utilization of home health services and outpatient therapy and reduced utilization of SNFs and IRFs. Hospital readmissions and facility-based PAC increase the typical Medicare episode payment by 30 to 45 percent over episodes that do not include these services. The proposed 20 percent stop-loss limit related to the total episode payment corresponds to approximately 40 percent of episode payment for the post-discharge period only, where the major opportunities for efficiency through care redesign occur. Thus, taking into consideration the historical patterns used to set target prices, we believed it is reasonable to hold participant hospitals responsible for repayment of actual episode spending that is up to 20 percent greater than the target price. If a participant hospital's repayment amount due to the raw NPRA would otherwise have exceeded the stop-loss limit of 20 percent (comparable to 40 percent of Medicare payment for the post-discharge period), the hospital's episodes would include much poorer episode efficiency as compared to the hospital's historical episodes, with large proportions of episodes including related readmissions and facility-based PAC, costly services that we do not expect to be necessary for most beneficiaries whose care is well-coordinated and appropriate throughout a high quality LEJR episode.
The following hypothetical example illustrates how the proposed stop-loss percentage would be applied in a given performance year for the episodes of a participant hospital. In performance year 3, a participant hospital had ten episodes triggered by MS-DRG 469, with a target price for these episodes of $50,000. The hospital's episode actual spending for these ten episodes was $650,000. The hospital's raw NPRA that would otherwise be $150,000 ((10 × $50,000)−$650,000) would be capped at the 20 percent stop-loss limit of $100,000 (0.2 × 10 × $50,000) so the hospital would owe CMS $100,000, rather than $150,000. In performance year 3, the same participant hospital also has 100 episodes triggered by MS-DRG 470, with a target price for these episodes of $25,000. The hospital's episode actual spending for these 100 episodes was $2,800,000. The hospital's raw NPRA would be $300,000 ((100 × $25,000)−$2,800,000), an amount that would be due to CMS in full as it would not be subject to the 20 percent stop-loss limit of $500,000 (0.2 × 100 × $25,000).
As illustrated in Figure 4 where we display results from our national model for the proposed CJR performance year 2 policies when the phase-in of repayment responsibility begins and under the assumption that utilization remains constant, we estimate that the 10 percent stop-loss limit would impact the amount of repayment due to the raw NPRA for about 11 percent of hospitals. For performance year 3, the 20 percent stop-loss limit would affect significantly fewer hospitals, only about 3 percent. We note that the stop-loss limit for years 3 through 5 where repayment responsibility is fully implemented is consistent with the BPCI Model 2 policy. While Figure 3 assumes no change in utilization patterns, under the model test we expect that the proposed stop-loss limits could actually affect a smaller percentage of hospitals in each performance year because we expect LEJR episode care redesign incentivized by the model's financial opportunities to generally reduce unnecessary utilization, thereby reducing actual episode spending and, correspondingly, any associated repayment amounts due to the raw NPRA. We note that we would include any post-episode spending amount due to Medicare according to the policy proposed in section III.C.8.d. of the proposed rule in assessing the total repayment amount due to the raw NPRA against the stop-loss limit for the performance year to determine a hospital's total payment due to Medicare, if applicable.
We believed a limit on reconciliation payments for CJR would be appropriate for several reasons. Due to the proposed nature of the CJR model during performance year 1, when hospitals have no repayment responsibility for excess episode spending above the target price, CMS bears full financial responsibility for Medicare actual episode payments for an episode that exceed the target price, and we believed our responsibility should have judicious limits. Therefore, we believed it would be reasonable to cap a hospital's reconciliation payment due to the raw NPRA as a percentage of episode payment on the basis of responsible stewardship of CMS resources. In addition, we note that beginning in performance year 1, participant hospitals would be eligible for reconciliation payments due to the NPRA if actual episode expenditures are less than the target price, assuming the proposed quality thresholds are met. This proposal for reconciliation payments due to the NPRA provides a financial incentive to participant hospitals from the beginning of the model to manage and coordinate care throughout the episode with a focus on ensuring that beneficiaries receive the lowest intensity, medically appropriate care throughout the episode that results in high quality outcomes. Therefore, we also believed it would be reasonable to cap a hospital's reconciliation payment due to the raw NPRA based on concerns about potential excessive reductions in utilization under the CJR model that could lead to beneficiary harm.
In determining what would constitute an appropriate reconciliation payment limit due to the raw NPRA, we believed it should provide significant opportunity for hospitals to receive reconciliation payments for greater episode efficiency that includes achievement of quality care and actual episode payment reductions below the target price, while avoiding creating significant incentives for sharply reduced utilization that could be harmful to beneficiaries. Thus, for all 5 performance years of the model, we proposed a limit on the raw NPRA contribution to the reconciliation payment of no more than 20 percent of the hospital's target prices for each MS-DRG multiplied by the number of the hospital's episodes for that MS-DRG. Hereinafter we refer to this proposed reconciliation payment limit as the stop-gain limit. This proposed stop-gain limit is parallel to the 20 percent stop-loss limit proposed for performance year 3 and beyond. We believed that a parallel stop-gain and stop-loss limit is important to provide proportionately similar protections to CMS and participant hospitals for their financial
As illustrated in Figure 3 where we displayed results from our national model for the proposed CJR performance year 2 policies under the assumption that utilization remains constant, we estimate that the 20 percent stop-gain limit would impact the reconciliation payment amount due to the raw NPRA of almost no hospitals. We note that a stop-gain limit of 20 percent is consistent with BPCI Model 2 policy. While Figure 3 assumes no change in utilization patterns, under the model test we expect that the proposed stop-gain limit could actually affect a few hospitals in each performance year because we expect LEJR episode care redesign incentivized by the model's financial opportunities to generally reduce unnecessary utilization, thereby reducing actual episode spending and, correspondingly, increasing any associated reconciliation payment amounts due to the raw NPRA. Nevertheless, we believed the proposed stop-gain limit of 20 percent provides substantial opportunity for hospitals to achieve savings over the target price without excessive reductions in utilization, and those savings would be paid back to hospitals fully in most cases without being affected by the stop-gain limit. We sought comment on our proposal to adopt a 20 percent stop-gain limit for all performance years of CJR.
We note that we plan to monitor beneficiary access and utilization of services and the potential contribution of the stop-gain limit to any inappropriate reduction in episode services. We refer readers to section III.F. of the proposed rule for our proposals on monitoring and addressing hospital performance under CJR.
The following is a summary of the comments received and our responses.
Additionally, we acknowledge the comment that hospitals need to achieve a certain percent savings, representing the Medicare discount before they are able to receive a reconciliation payment and be subject to the stop-gain limits. As discussed in section III.C.4.b.(9) of this final rule, we are modifying our policy in this final rule so as to use lower discount factors for purposes of determining the hospital's responsibility for excess episode spending not only in performance year 2, but also in performance year 3. Additionally, as discussed in section III.C.5. of this final rule, we are modifying the proposed rule so as to provide different levels of quality incentive payments that would modulate participant hospitals' effective target price discount factor based on their quality performance. We expect participant hospitals to have significant opportunity to improve the quality and efficiency of care furnished during episodes in comparison with historical practice, because this model would facilitate the alignment of financial incentives among providers and suppliers caring for beneficiaries throughout the episode. This discount would serve as Medicare's portion of reduced expenditures from the episode, with any episode expenditure below the target price potentially available as reconciliation payments to the participant hospital where the anchor hospitalization occurred.
As discussed in section III.C.3. of the proposed rule, we proposed that participant hospitals would be subject to repayment responsibility for episode actual spending in excess of the applicable target price beginning in performance year 2. Hospitals participating in CJR would not be responsible for actual episode payments greater than a ceiling set at two standard deviations above the mean regional episode payment as described earlier in this section. Additionally, we proposed a 10 percent limit on the raw NPRA contribution to the repayment amount in performance year 2 and a 20 percent limit on the raw NPRA contribution to the repayment amount in performance year 3 and beyond, as described in the previous section of this final rule.
Though our proposals provide several safeguards to ensure that participant hospitals have limited repayment responsibility due to the raw NPRA, we are proposing additional protections for certain groups of hospitals that may have a lower risk tolerance and less infrastructure and support to achieve efficiencies for high payment episodes. Specifically, we are proposing additional protections for rural hospitals, SCHs, Medicare Dependent Hospitals and Rural Referral Centers (RRCs). We note that these categories of hospitals often have special payment protections or additional payment benefits under Medicare because we recognize the importance of preserving Medicare beneficiaries' access to care from these hospitals. In MedPAC's Report to the Congress in June 2012, MedPAC examined issues related to rural Medicare beneficiaries and found that “The primary objective of rural special payments is to ensure that Medicare does its part to support the financial viability of rural providers that are necessary for beneficiaries' access to care. Some form of special payments will be needed to maintain access in areas with low population density where providers inevitably have low patient volumes and lack economies of scale.”
We proposed that a rural hospital would have additional protections under the stop-loss limit proposal. For the purpose of this model, we are proposing to define a rural hospital as an IPPS hospital that is either located in a rural area in accordance with § 412.64(b) or in a rural census tract within an MSA defined at § 412.103(a)(1) or has reclassified to rural in accordance with § 412.103. Such rural hospitals would have additional protections under the stop-loss limit proposal. Consistent with the findings in MedPAC's June 2012 Report to the Congress, we believed rural hospitals may have a lower risk tolerance and less infrastructure and support to achieve efficiencies for high payment episodes, particularly if they are the only rural hospital in an area.
Our preliminary analysis examining national spending for MS-DRGs 469 and 470 from October 1, 2013 to September 30, 2014 showed that MS-DRGs 469 and 470 cases represent a slightly higher proportion of cases and spending for rural hospitals than the national average (for example, MS-DRG 470 episode spending represents 12 percent of IPPS spending for rural hospitals and represents 9 percent of IPPS spending nationally).
Additionally, we proposed to provide additional protections for SCHs as defined in § 412.92, Medicare Dependent Hospitals as defined in § 412. 108 and RRCs as defined in § 412.96. Hospitals paid under the IPPS can qualify for SCH status if they meet one of the following criteria:
• Located at least 35 miles from other like hospitals.
• Located in a rural area, located between 25 and 35 miles from other like hospitals, and no more than 25 percent of residents or Medicare beneficiaries who become hospital inpatients in the hospital's service area are admitted to other like hospitals located within a 35-mile radius of the hospital or the hospital has fewer than 50 beds and would meet the 25 percent criterion if not for the fact that some beneficiaries or residents were forced to seek specialized care outside of the service area due to the unavailability of necessary specialty services at the hospital.
• Hospital is rural and located between 15 and 25 miles from other like hospitals but because of local topography or periods of prolonged severe weather conditions, the other like hospitals are inaccessible for at least 30 days in each of 2 out of 3 years.
• Hospital is rural and the travel time between the hospital and the nearest like hospital is at least 45 minutes.
If an IPPS hospital qualifies to be a SCH, the hospital can be paid the higher of the federal payment rate paid to IPPS hospitals or a cost-based hospital-specific rate as described in § 412.78. Under OPPS, a rural SCH can receive a 7.1 percent add on payment for most services with certain exceptions, in accordance with § 419.43(g). These criteria to qualify for SCH status demonstrate that SCHs are likely to be the sole hospital in an area. Furthermore, additional payments
MDHs are defined as a hospital that meets the following criteria:
• Located in a rural area.
• Has 100 beds or less.
• Is not a SCH.
• Sixty percent of the hospital's inpatient days or discharges were attributable to individuals entitled to Medicare Part A benefits during specified time periods as provided in § 412.108.
MDHs also qualify for special additional payments under the IPPS where an MDH can receive the higher of a payment under the federal standard rate for IPPS hospitals or the payment under federal standard rate for IPPS hospitals plus 75 percent of the difference in payments between a cost based hospital-specific rate and the federal standard rate as described in § 412.108(c). These criteria demonstrate that MDHs are small, rural hospitals that have a high Medicare case mix percentage and receive additional payments under the IPPS to ensure financial stability and preserve beneficiary access to care to these hospitals. Thus, we believed these factors demonstrate that we should provide additional safeguards from hospital responsibility for repayment in order to preserve access to care. We note that we proposed to exclude these payment enhancements for MDHs, as described in section III.C.3.a. of the proposed rule.
RRCs are defined as IPPS hospitals with at least 275 beds that meet the following criteria:
• Fifty percent of the hospital's Medicare patients are referred from other hospitals or from physicians who are not on the staff of the hospital.
• At least 60 percent of the hospital's Medicare patients live more than 25 miles from the hospital.
• At least 60 percent of all services the hospital furnishes to Medicare patients are furnished to patients who live more than 25 miles from the hospital.
• For specified period of time, the hospital has a case-mix that equals the lower of the median case mix index (CMI) value for all urban hospitals nationally; or the median CMI value for urban hospitals located in its region, excluding those hospitals receiving indirect medical education payments.
• Its number of discharges is at least—
++ 5,000 (or 3,000 for an osteopathic hospital); or
++ The median number of discharges for urban hospitals in the census region in which it is located, set by the CMS through IPPS rulemaking.
• Additionally, a hospital must meet one of the following criteria:
++ More than 50 percent of its active medical staff are specialists who meet the conditions specified at§ 412.96(c)(3).
++ At least 60 percent of all discharges are for inpatients who reside more than 25 miles from the hospital.
++ At least 40 percent of all inpatients treated are referred from other hospitals or from physicians who are not on the hospital's staff.
For these reasons, we proposed a stop-loss limit of 3 percent of episode payments for these categories of hospitals in performance year 2 and a stop-loss limit of 5 percent of episode payments for performance years 3 through 5. More specifically, in performance year 2, a rural hospital, SCH, RRC or MDH that is a participant hospital would owe Medicare due to the raw NPRA no more than 3 percent of the hospital's target price for the anchor MS-DRG multiplied by the number of the hospital's CJR episodes with that anchor MS-DRG in the performance year. Additionally, in performance years 3 through 5, a rural hospital, SCH, RRC or MDH that is a participant hospital would owe Medicare due to the raw NPRA no more than 5 percent of the hospital's target price for the anchor MS-DRG multiplied by the number of the hospital's CJR episodes with that anchor MS-DRG in the performance year. We believed a different stop-loss limit policy is warranted given the different spending patterns and the unique hospital characteristics for these groups of hospitals as described earlier. We believed this proposal strikes an appropriate balance between protecting hospitals that often serve as the only access of care for Medicare beneficiaries and having these hospitals meaningfully participate in the model. We note that this proposal does not impact the proposed stop-gain policy for these categories of hospitals. Rural hospitals, SCHs, MDHs and RRCs would still have the opportunity to participate in full gains at 20 percent similar to other hospitals.
Hospitals can apply for SCH, MDH and RRC status through their MACs and Regional Office at any time. MACs maintain the list of SCHs, MDHs, and RRCs in the CMS Provider Specific File, which they update on a quarterly basis. The special hospital designations recorded in the Provider Specific File are used in Medicare claims pricing to ensure that these hospitals are paid according to their special hospital designation. Additionally, CMS can identify which hospitals are considered rural for the purpose of this policy, using the Provider Specific File to identify physical geographic location of a hospital and the MACs to identify whether an urban hospital has reclassified to rural under § 412.103 or located in a rural census tract of an MSA defined under § 412.103(a)(1). Thus, we proposed to identify rural hospitals, MDHs, SCHs and RRCs at the time of reconciliation using the Provider Specific File updated in December of the end of the performance year and information from the MACs, and those hospitals would be subject to the 3 percent stop-loss limit policy for that performance year 2, and 5 percent stop-loss limit policy in performance years 3 through 5. For example, to identify the hospitals that would receive a 3 percent stop-loss limit for performance year 2, we would use the Provider Specific File updated in December 2017. We note that the special Medicare payment designation of MDH status has been extended through FY 2017 by legislation under the MACRA. As a result, the proposed additional protections for hospital responsibility for repayment for MDHs would only apply to the extent that MDH status exists under Medicare.
We note that we also considered excluding rural hospitals, SCHs, MDHs and RRCs from the CJR model altogether due to our concerns of placing significant responsibility for actual episode payment above the target price on these hospitals. Additionally, we were also concerned that from an evaluation perspective, we would not have sufficient sample size of CJR episodes from these categories of hospitals to have significant results of how these groups of hospitals perform under this model. We weighed our reasons for excluding these hospitals with the potential qualitative information we would gain from payment innovation tests on rural hospitals in this model. We concluded that because the CJR model strives to test episode payment for a broad variety of hospitals, it would be preferable to include these hospitals in the CJR model and provide additional protections from a large repayment responsibility. We welcome public comment on our proposed stop-loss limit for rural hospitals, SCHs, MDHs and RRCs and on our alternative consideration to exclude these hospitals entirely from the CJR model.
We are finalizing our proposal to provide for a lower stop-loss limit for rural hospitals, RRCs, MDHs and SCHs and codifying this policy at § 510.305(e)(1)(v)(E). Additionally, we are finalizing to provide a stop-gain limit that correspond to the finalized stop-loss limits for other hospitals in the model such that the stop-gain limit is 5 percent in Performance Years 1 and 2, 10 percent in Performance Year 3 and 20 percent in Performance Years 4 and 5 that would apply to all hospitals in
We noted that while the proposed CJR episode would extend 90-days post-discharge from the anchor hospitalization, some hospitals may have an incentive to withhold or delay medically necessary care until after an episode ends to reduce their actual episode payments. We did not believe this would be likely, especially given the relatively long episode duration. However, in order to identify and address such inappropriate shifting of care, we proposed to calculate for each performance year the total Medicare Parts A and B expenditures in the 30-day period following completion of each episode for all services covered under Medicare Parts A and B, regardless of whether the services are included in the proposed episode definition (section III.B. of the proposed rule), as is consistent with BPCI Model 2. Because we base the proposed episode definition on exclusions, identified by MS-DRGs for readmissions and ICD-9-CM diagnosis codes for Part B services as discussed in section III.B. of the proposed rule, and Medicare beneficiaries may typically receive a wide variety of related (and unrelated) services during the CJR episode that extends 90 days following discharge from the anchor hospitalization, there is some potential for hospitals to inappropriately withhold or delay a variety of types of services until the episode concludes, without attending carefully to the episode definition, especially for Part B services where diagnosis coding on claims may be less reliable. This inappropriate shifting could include both those services that are related to the episode (for which the hospital would bear financial responsibility as they would be included in the actual episode spending calculation) and those that are unrelated (which would not be included in the actual episode spending calculation), because a hospital engaged in shifting of medically necessary services outside the episode for potential financial reward may be unlikely to clearly distinguish whether the services were related to the episode or not in the hospital's decisions.
This calculation would include prorated payments for services that extend beyond the episode as discussed in section III.C.3.b. of the proposed rule. Specifically, we would identify whether the average 30-day post-episode spending for a participant hospital in any given performance year is greater than three standard deviations above the regional average 30-day post-episode spending, based on the 30-day post-episode spending for episodes attributed to all CJR regional hospitals in the same region as the participant hospital. We proposed that beginning in performance year 2, if the hospital's average post-episode spending exceeds this threshold, the participant hospital would repay Medicare for the amount that exceeds such threshold, subject to the stop-loss limits proposed elsewhere in the proposed rule. We sought comment on this proposal to make participant hospitals responsible for making repayments to Medicare based on high spending in the 30 days after the end of the episode and for our proposed methodology to calculate the threshold for high post-episode spend.
The following is a summary of the comments received and our responses.
Under the CJR model, we proposed that we would determine target prices for episodes of care using the methodology described in section III.C. of the proposed rule. We proposed to institute a reconciliation payment process as described in section III.C.6. of the proposed rule, and we proposed to retrospectively calculate a participant hospital's actual episode performance relative to its target price after the completion of each performance year. The difference between the actual episode spending of each CJR episode and the target price of that episode (calculated as target price subtracted by CJR actual episode payment) would be aggregated for all episodes initiated at a participant hospital during each performance year. This calculation for a participant hospital would be adjusted for post-episode payment increases and stop gain and stop loss limits, as described in section III.C.6.a. of the proposed rule. We proposed to use quality measure percentiles to determine hospital eligibility to receive the reconciliation payment and use the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment, as described in section III.C.5. of the proposed rule. The NPRA would be reflected in a report sent to the participant hospital called the CJR Reconciliation Report.
We also proposed to institute appeals processes for the CJR model that would allow participant hospitals to appeal matters related to reconciliation and payment (that are previously discussed in this section), as well as non-payment related issues, such as enforcement matters detailed in section III.C.12. of this final rule.
The proposed processes with regard to reconciliation, payment, use of quality measures to determine payment, and stop-loss and stop-gain policies are set forth in detail in sections III.C.5. through 8. of this final rule. In this section, we proposed an appeals process that will apply to the matters addressed in sections III.C.5 through 8. of this final rule, as well as matters not related to payment or reconciliation. These appeals processes will apply to the following payment and reconciliation processes:
• Starting with the CJR Reconciliation Report for performance year 1, if the CJR Reconciliation Report indicates the reconciliation amount is positive, CMS would issue a payment, in a form and manner specified by CMS, for that amount to the awardee within 30 calendar days from the issue date of the CJR Reconciliation Report, unless the participant hospital selects to pursue the calculation error and reconsideration review processes, in which case payment will be delayed as detailed later in this section.
• For performance year 1, if the CJR reconciliation report indicates a repayment amount, the participant hospital would not be required to make payment for that amount to CMS, as we have finalized our proposal not to hold hospitals financially responsible for negative NPRAs for the first performance year. In addition, if it is determined that a CJR hospital has a positive NPRA for performance year 1, and the subsequent calculation for performance year 1 the following year, as described in section III.C.6. of the proposed rule, determines that in aggregate the performance year 1 NPRA and the subsequent calculation amount for performance year 1 is a negative value (adding together the NPRA amount from the reconciliation for performance year 1 as well as the amount determined in the subsequent calculation, which would be detailed on the CJR reconciliation report for performance year 2), the hospital would only be financially responsible for a repayment amount that would net the performance year 1 NPRA and subsequent calculation for performance year 1 to zero. This would be true for performance year 1 only, given our proposal to begin phasing in financial responsibility in year 2 of the model as discussed in section III.C.2.c. of the proposed rule. For performance years 2 through 5 of the model, for example, if there was a positive NPRA for performance year 1 for a given hospital of $3,000, and the subsequent calculation performed in Q2 2018 to account for claims run-out and overlaps determined a repayment amount of $3,500 for claims incurred and overlap during performance year 1, $3,000 would be applied to the CJR reconciliation report for performance year 2. If the positive NPRA for performance year 2 were $5,000, the repayment amount of $3,000 would be netted against the $5,000, and the reconciliation payment for performance year 2 would be $2,000. Given that downside risk has been waived for performance year 1, the remaining $500 would not be added to the CJR reconciliation report for performance year 2. However, beginning with the reconciliation process for performance year 3, any repayment amounts generated through the subsequent calculation process detailed in section III.C.6.b. of this final rule would be netted against any repayment or reconciliation amount on the respective CJR reconciliation reports for performance years 2, 3, 4, and 5. Starting with the reconciliation for performance year 2, if the CJR Reconciliation Report indicates the NPRA is negative, the participant hospital would make payment for the absolute value of that amount to CMS within 30-calendar days from the issue date of the CJR Reconciliation Report, in a form and manner specified by CMS. For example, if there was a positive NPRA for performance year 3 for a given hospital of $1,000, and the subsequent calculation performed in Q2 2019 to account for claims run-out and overlaps determined a repayment amount of $2,500 for claims incurred and overlap during performance year 3, the full $2,500 would be applied to the CJR reconciliation report for performance year 4, subject to the stop loss/stop gain limits detailed in section III.C.8. of this final rule. Thus, if the positive NPRA for performance year 4 were $2,000, the repayment amount of $2,500 would be netted against the $2,000, and a repayment amount for performance year
• The reconciliation or repayment amount may include adjustments, arising from matters from the previous performance year, as necessary to account for subsequent calculations performed for performance years that were specified in earlier CJR Reconciliation Reports, as discussed in section III.C.6. of the proposed rule. For example, we would potentially make determinations of additional monies owed by Medicare to participant hospitals or vice versa in subsequent periods based on the availability of updated Medicare administrative data. These subsequent calculations would be contained in the succeeding reconciliation report. For example, the subsequent calculations applicable to performance year 1 would be contained in the reconciliation report for performance year 2.
• If the participant hospital fails to pay CMS the amount owed by the date indicated in the demand letter, CMS will recoup owed monies from participant hospital's present and future Medicare payments to collect all monies due to CMS. While we proposed that a participant hospital may enter into financial arrangements with CJR collaborators that allow for some risk-sharing, as discussed in section III.C. of the proposed rule, the participant hospital would be solely liable for the repayment of the negative repayment amount to CMS. Where the participant hospital fails to repay CMS in full for all monies owed, CMS would invoke all legal means to collect the debt, including referral of the remaining debt to the United States Department of the Treasury, pursuant to 31 U.S.C. 3711(g).
We proposed the following calculation error process for participant hospitals to contest matters related to payment or reconciliation, of which the following is a non-exhaustive list: The calculation of the participant hospital's reconciliation amount or repayment amount as reflected on a CJR reconciliation report; the calculation of NPRA; the calculation of the percentiles of quality measure performance to determine eligibility to receive a reconciliation payment; and the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment. Participant hospitals would review their CJR reconciliation report and be required to provide written notice of any error, in a notice of calculation error that must be submitted in a form and manner specified by CMS. Unless the participant provides such notice, the reconciliation report would be deemed final within 30 calendar days after it is issued, and CMS would proceed with payment or repayment. If CMS receives a timely notice of an error in the calculation, CMS would respond in writing within 30 calendar days to either confirm or refute the calculation error, although CMS would reserve the right to an extension upon written notice to the participant hospital. We proposed that if a participant hospital does not submit timely notice of calculation error in accordance with the timelines and processes specified by CMS, the participant hospital would be precluded from later contesting any of the following matters contained in the CJR reconciliation report for that performance year: Any matter involving the calculation of the participant hospital's reconciliation amount or repayment amount as reflected on a CJR reconciliation report; any matter involving the calculation of NPRA; the calculation of the percentiles of quality measure performance to determine eligibility to receive a reconciliation payment; and the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment.
In accordance with section 1115A(d) of the Act, there is no administrative or judicial review under sections 1869 or 1878 of the Act or otherwise for the following:
• The selection of models for testing or expansion under section 1115A of the Act.
• The selection of organizations, sites or participants to test those models selected.
• The elements, parameters, scope, and duration of such models for testing or dissemination.
• Determinations regarding budget neutrality under subsection 1115A(b)(3) of the Act.
• The termination or modification of the design and implementation of a model under subsection 1115A(b)(3)(B) of the Act.
• Decisions about expansion of the duration and scope of a model under subsection 1115A(c) of the Act, including the determination that a model is not expected to meet criteria described in paragraph (1) or (2) of such subsection.
We proposed that a participant hospital may appeal an initial determination that is not precluded from administrative or judicial review by requesting reconsideration review by a CMS official. The request for review must be submitted for receipt by CMS within 10 days of the notice of the initial determination, in a form and manner specified by CMS.
We proposed the following dispute resolution process. First, we proposed that only a participant hospital may utilize the dispute resolution process. Second, in order to access the dispute resolution process a participant hospital must have timely submitted a notice of calculation error, as previously discussed, for any matters related to payment. We proposed these matters would include any amount or calculation indicated on a CJR reconciliation report, including calculations not specifically reflected on a CJR reconciliation report but which generated figures or amounts reflected on a CJR reconciliation report. The following is a non-exhaustive list of the matters we proposed would need to be first adjudicated by the calculation error process as previously detailed: Calculations of reconciliation or repayment amounts; calculations of NPRA; and any calculations or percentile distribution involving quality measures that we proposed could affect reconciliation or repayment amounts. If a participant hospital wants to engage in the dispute resolution process with regard to one of these matters, we proposed it would first need to submit a notice of calculation error. Where the participant hospital does not timely submit a notice of calculation error, we proposed the dispute resolution process would not be available to the participant hospital with regard to those matters for the reconciliation report for that performance year.
If the participant hospital did timely submit a notice of calculation error and the participant hospital is dissatisfied with CMS's response to the participant hospital's notice of calculation error, the hospital would be permitted to request reconsideration review by a CMS reconsideration official. The reconsideration review request would be submitted in a form and manner and to an individual or office specified by CMS. The reconsideration review request would provide a detailed explanation of the basis for the dispute and include supporting documentation
• Calculations of NPRA, post-episode spending amount, target prices or any items listed on a reconciliation report.
• The application of quality measures to a reconciliation payment, including the calculation of the percentiles thresholds of quality measure performance to determine eligibility to receive reconciliation payments, or the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment.
• Any contestation based on the grounds that CMS or its representative made an error in calculating or recording such amounts.
Where the matter is unrelated to payment, such as termination from the model, the participant hospital need not submit a notice of calculation error. We proposed to require the participant hospital to timely submit a request for reconsideration review, in a form and manner to be determined by CMS. Where such request is timely received, we proposed CMS would process the request as discussed later in this section.
We proposed that the reconsideration review would be an on-the-record review (a review of briefs and evidence only). The CMS reconsideration official would make reasonable efforts to notify the hospital in writing within 15 calendar days of receiving the participant hospital's reconsideration review request of the date and time of the review, the issues in dispute, the review procedures, and the procedures (including format and deadlines) for submission of evidence (the “Scheduling Notice”). The CMS reconsideration official would make reasonable efforts to schedule the review to occur no later than 30 calendar days after the date of the Scheduling Notice. The provisions at § 425.804(b), (c), and (e) will apply to reviews conducted pursuant to the reconsideration review process for CJR. The CMS reconsideration official would make reasonable efforts to issue a written determination within 30 days of the review. The determination would be final and binding.
We solicited comment on our proposals related to appeals rights under this model. The two-step appeal process for payment matters—(1) Notice of calculation error, and (2) reconsideration review—is used broadly in other CMS models. We sought comment on whether we should develop an alternative appeal process. We are also interested in whether there should be appeal rights for reductions or eliminations of NPRA as a result of enforcement actions, as discussed in section III.C.12. of the proposed rule, and if so, whether the process for such appeals should differ from the processes proposed here.
The following is a summary of the comments received and our responses.
CMS uses the following processes for appeals that we are finalizing in section III.C.9. of this final rule. The procedures for processing and issuing reconciliation payments and repayments require that we submit the payment files for participant hospitals to the payment systems in batches. CMS uses these processes for several reasons. It is administratively more efficient to continue to use MACs to issue payments to all providers and suppliers that furnish services to beneficiaries during a CJR episode, so as not to disrupt the timing of FFS payments that providers and suppliers normally receive. For reconciliation payments and repayments, CMS has developed a process for processing these payments, which is used for other CMS models. This current process is the result of a substantial number of infrastructure changes to payment and recoupment procedures that were made over a period of several years. As a result, we believe it is appropriate to utilize those processes for the CJR model, given that the challenges associated with establishing these processes, as well as the fact that they were created for other CMS models.
The effect of these processes is that the batches are sent at specified intervals. The first batch is sent after the calculation error timeframe closes. The second batch is sent after CMS has responded to the notices of calculation error of participant hospitals and those hospitals choose to not proceed with the dispute resolution process detailed in section III.C.9.b.(3) of this final rule. The final batch is sent after CMS has adjudicated all of the reconsideration reviews for those participant hospitals that selected to utilize the dispute resolution process.
Given these processes, any extension in the timeframe allowed for submission of notices of calculation error delays payment not only to participant hospitals that choose to utilize the calculation error and dispute resolution processes, but even those participant hospitals that choose not to engage in these processes. As such, we believe the need for extending the deadline for submission of notices of calculation error should be balanced with CMS' goal to issue reconciliation payments and repayments promptly, as an extension for these submissions would delay the processing of reconciliation payments for all participant hospitals for a significant period of time. However, we acknowledge the commenters' concerns and the need for participant hospitals to have adequate time to analyze and prepare notices of calculation error.
Therefore, we believe that a longer timeframe for submission of the calculation error form is appropriate for the CJR model, given that CMS is reconciling on an annual basis, as opposed to quarterly for the BPCI initiative. Given that participant hospitals in CJR are likely have a larger subset of data to review on their annual reconciliation reports than their BPCI counterparts who receive quarterly reconciliation reports, we believe it is
With regard to the calculation error process, we are finalizing our proposal with one modification. Participant hospitals may submit a calculation error form to contest matters related to payment or reconciliation, of which the following is a non-exhaustive list: The calculation of the participant hospital's reconciliation amount or repayment amount as reflected on a CJR reconciliation report; the calculation of NPRA; the calculation of the percentiles of quality measure performance to determine eligibility to receive a reconciliation payment; and the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment. Upon receipt of its CJR reconciliation report, the participant hospital may choose to submit a calculation error form. The form must be submitted in a form and manner specified by CMS. Unless the participant provides such notice, the reconciliation report will be deemed final within 45 calendar days after it is issued, and CMS will proceed with payment or repayment. If CMS receives a timely notice of an error in the calculation, CMS will respond in writing within 30 calendar days to either confirm or refute the calculation error, although CMS reserves the right to an extension upon written notice to the participant hospital. If a participant hospital does not submit timely notice of calculation error in accordance with the timelines and processes specified by CMS, the participant hospital is precluded from later contesting any of the following matters contained in the CJR reconciliation report for that performance year: any matter involving the calculation of the participant hospital's reconciliation amount or repayment amount as reflected on a CJR reconciliation report; any matter involving the calculation of NPRA; the calculation of the percentiles of quality measure performance to determine eligibility to receive a reconciliation payment; and the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment.
With regard to the dispute resolution process, we are finalizing our proposal without modification. In accordance with section 1115A(d) of the Act, there is no administrative or judicial review under sections 1869 or 1878 of the Act or otherwise for the following:
• The selection of models for testing or expansion under section 1115A of the Act.
• The selection of organizations, sites or participants to test those models selected.
• The elements, parameters, scope, and duration of such models for testing or dissemination.
• Determinations regarding budget neutrality under subsection 1115A(b)(3) of the Act.
• The termination or modification of the design and implementation of a model under subsection 1115A(b)(3)(B of the Act.
• Decisions about expansion of the duration and scope of a model under subsection 1115A(c), including the determination that a model is not expected to meet criteria described in paragraph (1) or (2) of such subsection.
We are also finalizing our proposal without modification regarding the matters subject to dispute resolution, and the process CMS will use to adjudicate dispute resolution matters. Thus, a participant hospital may appeal an initial determination that is not precluded from administrative or judicial review by requesting reconsideration review by a CMS official. The request for review must be submitted for receipt by CMS within 10 days of the notice of the initial determination, in a form and manner specified by CMS. Only a participant hospital may utilize the dispute resolution process.
In order to access the dispute resolution process, a participant hospital must timely submit a calculation error form, as previously discussed, for any matters related to payment. These matters include any amount or calculation indicated on a CJR reconciliation report, including calculations not specifically reflected on a CJR reconciliation report but which generated figures or amounts reflected on a CJR reconciliation report. The following is a non-exhaustive list of the matters that we are requiring must be first adjudicated by the calculation error process as previously detailed: Calculations of reconciliation or repayment amounts; calculations of NPRA; and any calculations or percentile distribution involving quality measures that we proposed could affect reconciliation or repayment amounts. If a participant hospital wants to engage in the dispute resolution process with regard to one of these matters, the participant hospital must first submit a calculation error form. Where the participant hospital does not timely submit a calculation error form, the dispute resolution process is not available to the participant hospital with regard to those matters for the reconciliation report for that performance year.
If the participant hospital does timely submit a calculation error form and the participant hospital is dissatisfied with CMS's response to the participant hospital's calculation error form, the hospital is permitted to request reconsideration review by a CMS reconsideration official. The reconsideration review request must be submitted in a form and manner and to
• Calculations of NPRA, post-episode spending amount, target prices or any items listed on a reconciliation report.
• The application of quality measures to a reconciliation payment, including the calculation of the percentiles thresholds of quality measure performance to determine eligibility to receive reconciliation payments, or the successful reporting of the voluntary PRO THA/TKA data to adjust the reconciliation payment.
• Any contestation based on the grounds that CMS or its representative made an error in calculating or recording such amounts.
Lastly, we are finalizing our proposal without modification that the reconsideration review is an on-the-record review (a review of briefs and evidence only). The CMS reconsideration official will make reasonable efforts to notify the hospital in writing within 15 calendar days of receiving the participant hospital's reconsideration review request of the date and time of the review, the issues in dispute, the review procedures, and the procedures (including format and deadlines) for submission of evidence (the “Scheduling Notice”). The CMS reconsideration official will make reasonable efforts to schedule the review to occur no later than 30 calendar days after the date of the Scheduling Notice. The provisions at § 425.804(b), (c), and (e) will apply to reviews conducted pursuant to the reconsideration review process for CJR. The CMS reconsideration official will make reasonable efforts to issue a written determination within 30 days of the review. The determination will be final and binding.
This modification is set forth in § 510.310(a)(1). The remainder of the proposal is finalized as proposed and set forth in § 510.310.
As previously noted, in the proposed rule we stated our belief that given the financial incentives of episode payment in CJR, participant hospitals in the model might want to engage in financial arrangements to share reconciliation payments or hospital internal cost savings or both, as well as responsibility for repaying Medicare, with providers and suppliers making contributions to the hospital's episode performance on spending and quality. Such arrangements would allow the participant hospitals to share all or some of the reconciliation payments they may be eligible to receive from CMS, or the participant hospital's internal cost savings that result from care for beneficiaries during a CJR episode. Likewise, such arrangements could allow the participant hospitals to share the responsibility for the funds needed to repay Medicare with providers and suppliers engaged in caring for CJR beneficiaries, if those providers and suppliers have a role in the hospital's episode spending or quality performance. We use the term “CJR collaborator” to refer to such providers and suppliers, who we proposed may include the following:
• SNFs.
• HHAs.
• LTCHs.
• IRFs.
• PGPs.
• Physicians, nonphysician practitioners, and providers or suppliers of therapy services.
We stated our belief that CJR collaborators should have a role in the participant hospital's episode spending or quality performance. Accordingly, we proposed that the CJR collaborator would directly furnish related items or services to a CJR beneficiary during the episode and/or specifically participate in CJR model LEJR episode care redesign activities, such as attending CJR meetings and learning activities; drafting LEJR episode care pathways; reviewing CJR beneficiaries' clinical courses; developing episode analytics; or preparing reports of episode performance under the direction of the participant hospital or a CJR collaborator that directly furnishes related items and services to CJR beneficiaries. We also stated that in addition to playing a role in the participant hospital's episode spending or quality performance, physician, nonphysician, and PGP CJR collaborators must directly furnish services to CJR beneficiaries in order to receive a gainsharing payment as result of their financial arrangement with the participant hospital. We sought comment on our proposed definition of CJR collaborators, as well as our proposed definition of a provider's or supplier's role in the participant hospital's episode spending or quality performance.
We proposed that certain financial arrangements between a participant hospital and a CJR collaborator be termed a “CJR sharing arrangement,” and that the terms of each CJR sharing arrangement be set forth in a written agreement between the participant hospital and the CJR collaborator. We proposed to use the term “Participation Agreement” to refer to such agreements. We proposed that a “CJR sharing arrangement” would be a financial arrangement contained in a Participation Agreement to share only the following: (1) CJR reconciliation payments (as that term is defined in section III.C. of the proposed rule); (2) the participant hospital's internal cost savings (as that term is defined later in this section); and (3) the participant hospital's responsibility for repayment to Medicare, as discussed later in this section. Where a payment from a participant hospital to a CJR collaborator is made pursuant to a CJR sharing arrangement, we proposed to define that payment as a “gainsharing payment.” A gainsharing payment may only be only composed of the following: (1) Reconciliation payments; (2) internal cost savings; or (3) both. Where a payment from a CJR collaborator to a participant hospital is made pursuant to a CJR sharing arrangement, we proposed to define that payment as an “alignment payment.” We proposed that CJR sharing arrangements that provide for alignment payments would not relieve the participant hospital of its ultimate responsibility for repayment to CMS. Many of the programmatic requirements discussed later in this final rule for gainsharing payments and alignment payments are similar to those in Model 2 of the BPCI initiative.
CJR sharing arrangements must be solely related to the contributions of the CJR collaborators to care redesign that achieve quality and efficiency improvements under this model for CJR beneficiaries. All gainsharing payments or alignment payments between participant hospitals and CJR collaborators resulting from these arrangements must be auditable by HHS, as discussed later in this section, to ensure their financial and programmatic integrity. We emphasized that any CJR collaborator that receives a gainsharing payment or makes an alignment payment must have furnished services included in the episode to CJR beneficiaries. Furthermore, the payment arrangements for gainsharing payments or alignment payments contained in a CJR sharing arrangement must be actually and proportionally related to
We considered whether CJR collaborators should be termed “participants” in this model, or whether the term “participant” should refer only to the participant hospitals located in MSAs selected for participation. If CJR collaborators are participants in the model, we proposed that their activities with regard to CJR beneficiaries would be regulated directly by CMS. However, if CJR collaborators are not participants, but rather are participating entities and individuals in the CJR model through signed agreements with participant hospitals, their activities with regard to CJR beneficiaries would be governed by the Participation Agreement between a CJR collaborator and a participant hospital. Given the large number of potential CJR collaborators, the expected varied nature of their respective arrangements with participant hospitals, and the potential administrative burden in reporting information to CMS, we believed the activities of CJR collaborators with regard to CJR beneficiaries would be best managed by participant hospitals. As we discussed earlier in this final rule, one justification for proposing that acute care hospitals be the provider type financially responsible under the CJR model is the position of the hospital with respect to other providers and suppliers, in terms of coordinating care for CJR beneficiaries. Given that position, we proposed that where participant hospitals enter into Participation Agreements that contain CJR sharing arrangements, the participant hospital must also be responsible for ensuring that those providers and suppliers comply with the terms and requirements of the proposed rule. We sought comments on this proposal; specifically, whether CJR collaborators should be termed participants in this model and subject to the applicable requirements, or whether the responsibility for compliance with the model's requirements is better managed by participant hospitals. We were particularly interested in comments that address the advantages and disadvantages of making CJR collaborators participants in the model, and whether there are certain provider or supplier types that CMS should consider including as “participants” in the model.
The following discussion outlines our proposed requirements and responsibilities of participant hospitals that engage in such CJR sharing arrangements. In the proposed rule, we stated our belief that these proposed requirements and responsibilities are essential to ensuring that all CJR sharing arrangements are for the sole purpose of aligning the financial incentives of collaborating providers and suppliers with those of the participant hospital toward the CJR model goals of improved LEJR episode care quality and efficiency. We believed that the rationale for and details of these arrangements must be documented and auditable by HHS, with a direct connection to the arrangements and the participant hospital's episode performance. Finally, we believed that the proposed limitations to the arrangements, as described later in this section, are necessary to ensure the integrity of the CJR model by minimizing incentives for problematic behaviors, such as patient steering. We sought comments on all proposed requirements regarding CJR sharing arrangements.
With respect to whether certain entities or individuals should be prevented from participating in the CJR model, either as participant hospitals or CJR collaborators, we considered whether CMS should conduct screening for program integrity purposes. Many CMS models conduct screening during the application process and periodically thereafter. These screenings examine provider and supplier program integrity history, including any history of Medicare program exclusions or other sanctions and affiliations with individuals or entities that have a history of program integrity issues. Where a screening reveals that a provider or supplier has a history of program integrity issues or affiliations with individuals or entities that have a history of program integrity issues, we may remove that provider or supplier from the model. We utilize these screening processes for many CMS models, including the BPCI initiative.
For several reasons, in the proposed rule we stated our belief that this type of screening for participant hospitals would be inapplicable to the CJR model. Most importantly, this model seeks to evaluate the performance in the model of hospitals located in a particular MSA. We believed it is important that all hospitals that meet the criteria for participation in the model be included. Further, in section III.F. of the proposed rule we proposed that CMS would evaluate the quality of care and institute beneficiary protections via a monitoring plan that in ways that would go beyond some of the efforts of previous or existing CMS models. We solicited comments on this proposal, including whether screening of participant hospitals or CJR collaborators might be appropriate or useful in aiding HHS’ program integrity efforts and identifying untrustworthy parties or parties with program integrity history problems.
We proposed that each CJR sharing arrangement must include and set forth in writing at a minimum—
• A specific methodology and accounting formula for calculating and verifying internal cost savings, if the participant hospital elects to share internal cost savings through gainsharing payments with CJR collaborators. We proposed to define internal cost savings as the measurable, actual, and verifiable cost savings realized by the participant hospital resulting from care redesign undertaken by the participant hospital in connection with providing items and services to beneficiaries within specific CJR episodes of care. Internal cost savings would not include savings realized by any individual or entity that is not the participant hospital. Each CJR sharing arrangement must include specific methodologies for accruing and calculating internal cost savings of the participant hospital, where the hospital intends to share internal cost savings through a CJR sharing arrangement. The specific methodologies for accruing and calculating internal cost savings must be transparent, measurable, and verifiable in accordance with Generally Accepted Accounting Principles (GAAP) and Government Auditing Standards (The Yellow Book). The methodology must set out the specific care redesign elements to be undertaken by the participant hospital or the CJR collaborator or both;
• A description of the methodology and accounting formula for calculating the percentage or dollar amount of a reconciliation payment received from CMS that will be paid as a gainsharing payment from the participant hospital to the CJR collaborator;
• A description of the methodology, frequency or dates of distribution, and accounting formula for distributing and verifying any and all gainsharing payments;
• A description of the arrangement between the participant hospital and the CJR collaborator regarding alignment payments, where the hospital and CJR collaborator agree through a CJR sharing arrangement to share risk for repayment amounts due to CMS, as reflected on a CJR reconciliation report. The description of this arrangement must include safeguards to ensure that such alignment payments are made solely for
• A provision requiring the participant hospital to recoup gainsharing payments paid to CJR collaborators if gainsharing payments were based on the submission of false or fraudulent data;
• Plans regarding care redesign, changes in care coordination or delivery that are applied to the participant hospital or CJR collaborators or both, and any description of how success will be measured;
• Management and staffing information, including type of personnel or contactors that will be primarily responsible for carrying out changes to care under the model;
• The participant hospital must maintain records identifying all CJR collaborators, and the participant hospital's process for determining and verifying the eligibility of CJR collaborators to participate in Medicare; and
• All CJR sharing arrangements must require compliance, from both the participant hospital and the CJR collaborator, with the policies regarding beneficiary notification set forth in section III.F. of the final rule.
With respect to these requirements for Participation Agreements and CJR sharing arrangements, we considered whether we should require participant hospitals and CJR collaborators to periodically report this information to CMS for purposes of enforcement of these proposed regulations. However, we are mindful of the administrative burden in reporting this information as well as the challenges associated with creating a universal collection tool that would account for all the various iterations of financial arrangements into which participant hospitals and CJR collaborators may enter. We sought comment on this proposal as well as whether CMS should require participant hospitals and CJR collaborators to periodically report data such as: Gainsharing payments and/or alignment payments distributed and received; name and identifier (NPI, CCN, TIN) of all CJR collaborators; and any other relevant information related to Participation Agreements and CJR sharing arrangements that would assist HHS with enforcement of these regulations.
We solicited comments about all of the requirements set out in the preceding discussion, including whether additional or different safeguards would be needed to ensure program integrity, protect against abuse, and ensure that the goals of the model are met.
We proposed that the Participation Agreement must obligate the parties to comply, and must obligate the CJR collaborator to require any of its employees, contractors or designees to comply, without limitation, with the following requirements:
• Each individual's or entity's participation in the CJR sharing arrangement is voluntary and without penalty for nonparticipation.
• Any gainsharing payments made pursuant to a CJR sharing arrangement must be made only from the participant hospital to the CJR collaborator with whom the participant hospital has signed a Participation Agreement containing a CJR sharing arrangement. Additionally, we proposed to require the following for all CJR sharing arrangements between a participant hospital and a CJR collaborator that is a PGP:
+ Where a gainsharing payment is made to a CJR collaborator that is a PGP, all monies contained in such a gainsharing payment must be shared only with physician or nonphysician practitioners that furnished a service to a CJR beneficiary during an episode of care in the calendar year from which the Net Payment Reconciliation Amount (NPRA), as that term is defined in section III.C.6. of this final rule, or internal cost savings was generated, either or both of which are the only permitted sources of funds for a gainsharing payment. We further proposed that each CJR sharing arrangement between a participant hospital and a CJR collaborator that is a PGP must stipulate that the PGP may not retain any portion of a gainsharing payment or distribute, by any method, any portion of a gainsharing payment to physician or nonphysician practitioners who did not furnish a service to a CJR beneficiary during an episode of care in the calendar year from which the NPRA or internal cost savings was generated.
• Any alignment payments made pursuant to a CJR sharing arrangement may be made only to the participant hospital from the entity or individual with whom the participant hospital has signed a Participation Agreement containing a CJR sharing arrangement.
• Each CJR sharing arrangement must require that the CJR collaborator be in compliance with all Medicare provider enrollment requirements at § 424.500
• Any internal cost savings or reconciliation payments that the participant hospital seeks to share through CJR sharing arrangements must meet the requirements set forth in the final CJR rule (as finalized) and be administered by the participant hospital in accordance with GAAP. In no event may the participant hospital distribute any amounts pursuant to a CJR sharing arrangement that are not comprised of either internal cost savings or a reconciliation payment, as those terms are defined in this final rule. All amounts determined to be internal cost savings by the participant hospital must reflect actual, internal cost savings achieved by the participant hospital through implementation of care redesign elements identified and documented by the participant hospital. In no case may internal cost savings reflect “paper” savings from accounting conventions or past investment in fixed costs.
• Any alignment payments that the participant hospital receives through a CJR sharing arrangement must meet the requirements set forth in the final CJR rule (as finalized) and be administered by the participant hospital in accordance with GAAP.
• CJR sharing arrangements must not include any amounts that are not alignment payments or gainsharing payments.
• Further, we proposed that each Participation Agreement—
++ Between the participant hospital and a CJR collaborator must obligate the CJR collaborator to provide the participant hospital and HHS access to the CJR collaborator's records, information, and data for purposes of monitoring and reporting and any other lawful purpose. Records, information, and data regarding the CJR sharing arrangement must have sufficient detail to verify compliance with all material terms of the CJR sharing arrangement and the terms of the CJR model;
++ Must require the participant hospital and the CJR collaborator to include in their compliance programs specific oversight of their Participation Agreements and compliance with the requirements of the CJR model;
++ If the participant hospital or CJR collaborator does not have a compliance program, each party must create one and incorporate the provisions described in this part in that program;
++ Must require compliance, from both the participant hospital and the CJR collaborator, with the policies regarding beneficiary notification set
++ Must require the board or other governing body of the participant hospital to have responsibility for overseeing the participant hospital's participation in the model, its arrangements with CJR collaborators, its payment of gainsharing payments and receipt of alignment payments, and its use of beneficiary incentives in the CJR model.
• Participation Agreements must require all CJR collaborators to comply with any evaluation, monitoring, compliance, and enforcement activities performed by HHS or its designees for the purposes of operating the CJR model.
• Each Participation Agreement must require the CJR collaborator to permit site visits from CMS, or one of its designees, for purposes of evaluating the model.
We solicited comments about all of the requirements set out in the preceding discussion, including whether additional or different safeguards would be needed to ensure program integrity, protect against abuse, and ensure that the goals of the model are met.
We proposed the following conditions and restrictions concerning gainsharing payments and alignment payments made pursuant to a CJR sharing arrangement:
• No entity or individual, whether or not a party to a Participation Agreement, may condition the opportunity to give or receive gainsharing payments in CJR on the volume or value of past or anticipated referrals or other business generated to, from, or among a participant hospital, any CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
• Participant hospitals would not be required to share reconciliation payments, internal cost savings, or responsibility for repayment to CMS with other providers and suppliers. However, where a participant hospital elects to engage in those activities, we proposed that such activities be limited to the provisions prescribed in the proposed rule.
• We proposed that gainsharing payments must be distributed on an annual basis, and are required to meet the following criteria:
++ Must be clearly identified and comply with all provisions in the proposed rule, as well as all applicable laws, statutes, and rules;
++ Must not be a loan, advance payments, or payments for referrals or other business; and
++ Must be made by electronic funds transfer (EFT).
• We proposed that alignment payments from a CJR collaborator to a participant hospital may be made at any interval, and are required to meet the following criteria:
++ Must be clearly identified and comply with all provisions in the proposed rule, as well as all applicable laws, statutes, and rules;
++ Must not be issued, distributed, or paid prior to the calculation by CMS of a reconciliation report reflecting a negative NPRA;
++ Must not be a loan, advance payments, or payments for referrals or other business; and
++ Must be made by EFT.
• We proposed that each CJR sharing arrangement stipulate that any CJR collaborator that is subject to any action involving noncompliance with the provisions of the proposed rule, engaged in fraud or abuse, providing substandard care, or have other integrity problems not be eligible to receive any gainsharing payments related to NPRA generated during the time that coincides with the action involving any of the issues previously listed until the action has been resolved in a forum or manner that constitutes a final determination, either by the state or federal court of last resort, as applicable, or by CMS, HHS, or its designees.
• No entity or individual, whether or not a party to a Participation Agreement, may condition the opportunity to make or receive alignment payments in CJR on the volume or value of past or anticipated referrals or other business generated to, from, or among a participant hospital, any CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
• In a calendar year, the aggregate amount of the total gainsharing payments distributed by the participant hospital that are derived from a CJR reconciliation payment may not exceed the amount of the reconciliation payment that the participant hospital received from CMS.
• In a calendar year, the aggregate amount of the total alignment payments received by the participant hospital may not exceed 50 percent of the participant hospital's repayment amount due to CMS. If no repayment amount is due, then no alignment payments may be received by the participant hospital.
• We proposed that the participant hospital must retain at least 50 percent of its responsibility for repayment to CMS, pursuant to the repayment amount reflected in each annual reconciliation report, under the CJR model. Given that the participant hospital will be responsible for developing and coordinating care redesign strategies in response to its participation in the CJR model, we believed it is important that the participant hospital retain a significant portion of its responsibility for repayment to CMS. For example, upon receipt of a reconciliation report indicating that the participant hospital owes $100 to CMS, the participant hospital would be permitted to receive no greater than $50 in alignment payments, in the aggregate, from its CJR collaborators.
• Further, we proposed that a CJR sharing arrangement must limit the amount a single CJR collaborator may make in alignment payments to a single participant hospital. We proposed that a single CJR collaborator not make an alignment payment to a participant hospital that represents an amount greater than 25 percent of the repayment amount reflected on the participant hospital's annual reconciliation report. For example, upon receipt of a reconciliation report indicating that the participant hospital owes $100 to CMS, the participant hospital would be permitted to receive no more than $25 in an alignment payment from a single entity or individual who is a CJR collaborator of the participant hospital.
• Gainsharing payments and alignment payments must not induce the participant hospital, CJR collaborators, or the employees, contractors, or designees of the participant hospital or CJR collaborators to reduce or limit medically necessary services to any Medicare beneficiary.
• Individual physician and nonphysician practitioners, whether or not a party to a CJR sharing arrangement, must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.
• Entities furnishing services to beneficiaries during a CJR episode, whether or not a party to a CJR sharing arrangement, must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.
• Gainsharing methodologies for determining gainsharing payments and alignment payments must not directly account for volume or value of referrals, or business otherwise generated, between or among a participant hospital, any CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
• Gainsharing payments must be derived solely from reconciliation payments or internal cost savings or both.
• The total amount of gainsharing payments for a calendar year paid to an individual physician or nonphysician practitioner who is a CJR collaborator must not exceed a cap. The cap is 50 percent of the total Medicare approved amounts under the Medicare Physician Fee Schedule (MPFS) for services furnished to the participant hospital's CJR beneficiaries during a CJR episode by that physician or nonphysician practitioner. This cap of 50 percent on gainsharing payments to individual physician or nonphysician practitioner is consistent with the same policy for the BPCI initiative. The purpose of this cap is to limit the amount of gainsharing payments an individual practitioner may receive due to his/her provision of services included in the CJR model.
• The total amount of gainsharing payments for a calendar year paid to a PGP that is a CJR collaborator must not exceed a cap. The cap is 50 percent of the sum of the total Medicare approved amounts under the MPFS for services furnished by physician or nonphysician practitioner members of the PGP to the participant hospital's CJR beneficiaries during a CJR episode by those physicians or nonphysician practitioners.
We solicited comments about all of the requirements set out in the preceding discussion, including whether additional or different safeguards would be needed to ensure program integrity, protect against abuse, and ensure that the goals of the model are met.
We proposed to require participant hospitals and CJR collaborators to comply with audit and document retention requirements similar to those required by the Medicare Shared Savings Program, BPCI Model 2, and other Innovation Center models. Specifically, with respect to all Participation Agreements and CJR sharing arrangements, the participant hospital and CJR collaborator must:
• Comply with the retention requirements regarding Participation Agreements and CJR sharing arrangements set forth in subsection III.C.10.(a) of this final rule.
• Maintain and give CMS, the Office of Inspector General of the Department of Health and Human Services (OIG), and the Comptroller General or their designee(s) access to all books, contracts, records, documents, and other evidence (including data related to utilization and payments, quality performance measures, billings, and CJR sharing arrangements related to CJR) sufficient to enable the audit, evaluation, inspection, or investigation of the participant hospital's compliance, as well as the compliance of any CJR collaborator that has a CJR sharing arrangement with the participant hospital, with CJR rules and requirements, the Participation Agreement, the quality of services furnished, the obligation to repay any reconciliation payments owed to CMS, the determination, distribution, receipt, or recoupment of gainsharing payments or alignment payments.
• Maintain such books, contracts, records, documents, and other evidence for a period of 10 years from the last day of the participant hospital's participation in the CJR model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
++ CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the participant hospital or CJR collaborator at least 30 calendar days before the normal disposition date; or
++ There has been a dispute or allegation of fraud or similar fault against the participant hospital or any CJR collaborator in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault.
• Notwithstanding any CJR sharing arrangements, the participant hospital must have ultimate responsibility for adhering to and otherwise fully complying with all provisions of the CJR model.
• OIG Authority is not limited or restricted by the provisions of the CJR model, including the authority to audit, evaluate, investigate, or inspect the participant hospital, CJR collaborators, or any other person or entity or their records, data, or information, without limitation.
• None of the provisions of the CJR model limits or restricts any other government authority permitted by law to audit, evaluate, investigate, or inspect the participant hospital, CJR collaborators, or any other person or entity or their records, data, or information, without limitation.
We solicited comments about all of the requirements set out in the preceding discussion, including whether additional or different safeguards would be needed to ensure program integrity, protect against abuse, and ensure that the goals of the model are met.
The following is a summary of the comments received and our responses.
For the same reason, we are also revising the term “CJR sharing arrangement,” to “sharing arrangement.” Given that a sharing arrangement is contained in a collaborator agreement that has been created solely for the purpose of establishing a financial arrangement between a participant hospital and a CJR collaborator, we believe the inclusion of the acronym CJR in the term for sharing arrangement is unnecessary. Therefore, to avoid confusion, throughout the
Several commenters supported CMS' proposal to define “CJR collaborators” to include only certain providers and suppliers, including that CJR collaborators that are physicians, nonphysicians, or PGPs must furnish services to CJR model beneficiaries. Some of these commenters suggested that these particular provider and supplier types, given the nature of the services they furnish to beneficiaries, have increased commitments to clinical responsibility, to sustainable change, and to a long-term investment in the communities in which they operate, as opposed to entities that do not furnish these types of services to beneficiaries.
By contrast, some commenters expressed disappointment that the list of CJR collaborators did not include individuals such as Infectious Disease Specialists, or entities such as accountable care organizations (ACOs), medical device companies, and other third parties, such as the types of convening organizations participating in other CMMI models. Some of the commenters suggested that CMS should expand the list of potential CJR collaborators to include non-provider or non-supplier entities, particularly given that these entities in many cases have a track record of providing Medicare providers and suppliers participating in other models with support services such as care redesign, data analytics, and general program support. A commenter noted that were device manufacturers allowed to be CJR collaborators, those manufacturers might collaborate with health care providers to make a meaningful contribution to the success of the CJR model and the individual initiatives of participant hospitals. Multiple commenters added that entities like ACOs and conveners might provide such services at a reduced cost through economies of scale—as these organizations could spread the expense of developing this infrastructure over many clients. These commenters also noted that some entities that are not providers or suppliers might be willing to assume a high percentage of downside risk, in order to reduce that risk to participant hospitals.
Additionally, a commenter shared its perspective that CMS failed to indicate whether the proposed list of CJR collaborators is exhaustive, and requested clarification as to whether that was the case. Finally, another commenter requested clarification on the status of episodes in which services are furnished by physicians who opt out of Medicare.
Although we are open to reconsidering the eligibility of additional entities to be CJR collaborators in the future based on the early implementation experience with the CJR model, at this time we will not adopt a final policy that includes additional entities or individuals beyond those listed as CJR collaborators in the proposed rule. As we stated in section III.A. of the proposed rule, we selected acute care hospitals as the financially responsible entity because we are interested in evaluating the impact of bundled payment and care redesign across a broad spectrum of hospitals with varying levels of infrastructure and experience in entering into risk-based reimbursement arrangements. We also stated our belief that it is most appropriate to identify a single type of provider to bear financial responsibility for making repayment to CMS under the CJR model; given that hospitals perform a central role in coordinating episode-related care and ensuring smooth transitions for beneficiaries undergoing LEJR procedures, this role factored in our decision to select IPPS hospitals as the financially responsible entity for this model. Given this structure, we believe that limiting the testing of gainsharing relationships to solely those between hospitals and providers and suppliers enrolled in Medicare is most appropriate because we expect enrolled providers and suppliers to be most directly and specifically engaged with the participant hospitals in care redesign and episode care for beneficiaries who have LEJR surgery at the hospital.
We also note that many of the potential reasons that were suggested by commenters for us to consider allowing individuals and entities other than providers and suppliers to be CJR collaborators eligible for gainsharing payments, such as data analytics and general program support, can be achieved outside of the context of gainsharing through other relationships between the participant hospital and those entities. With the exception of PGPs (as discussed in detail later in this section), we continue to believe that any CJR collaborator that receives a gainsharing payment must have furnished a billable service included in the episode to CJR beneficiaries, that the payment arrangements for gainsharing payments must be actually and proportionally related to the care of beneficiaries in a CJR episode, and that the CJR collaborator must be contributing to the care redesign strategies of the participant hospital. We further note that we operate many models concurrently, and not all providers and suppliers are eligible for participation in all models. Models have
Given our experience to date with the intersection between Medicare ACO programs, Medicare ACO models, and bundled payment models, we believe it important to note that financial arrangements between non-Medicare providers and suppliers, such as ACOs or other third parties, are allowed under existing laws, rules, and regulations, outside of the context of the CJR model. While we agree that the potential for leveraging the economies of scale of services offered by many entities that are not Medicare providers or suppliers may be significant, we do not believe their involvement necessitates CMS allowing for gainsharing relationships between hospitals and these entities at this time. In many circumstances, financial arrangements between hospitals and these entities may be possible outside the context of gainsharing under a sharing arrangement in the CJR model. For example, a hospital may pay an ACO for care coordination services the ACO provides during or after a beneficiary's stay in the hospital, in the event that a hospital and the ACO are collaborating and agree to that arrangement. In the event an ACO provides care coordination services to the hospital, the hospital is not precluded from compensating the ACO for the services. In other words, if an ACO hires a case manager to work in the hospital to focus on beneficiaries in CJR episodes, the hospital may contract with the ACO for those case manager services. However, this payment would be outside of the context of the CJR model and would not fall under the categories of a gainsharing payment or alignment payment, as those terms are defined in this final rule. Further, nothing in this section alters the applicable laws, rules, and regulations that apply to such arrangements. Thus, we are maintaining the conditions set forth in the proposed rule, and finalizing the list of CJR collaborators as proposed. This finalized list of CJR collaborators is an exhaustive list—only entities and individuals that meet the criteria listed in this final rule may be eligible as CJR collaborators.
Finally, with regard to the comment regarding physicians that have opted out of Medicare, we note that as discussed in section III.C.3. of this final rule, there are implications related to reconciliation payment when services are furnished by physicians and nonphysician practitioners that have opted out of Medicare. With regard to sharing arrangements, we are clarifying in this final rule that in order to be a CJR collaborator, an individual must not have opted out of Medicare, meaning that the individual physician or nonphysician practitioner must be either enrolled in Medicare as a “Participating physician/supplier” or as a “Non-participating physician/supplier.” In this model, the payments to physicians and nonphysician practitioners that have opted out of Medicare are not included in a participant hospital's target price and the actual episode spending calculations. Thus, the purpose of this policy is to prevent an individual from receiving a gainsharing payment in the CJR model if he/she has opted out of Medicare.
Several studies have shown that Medicare beneficiaries located in rural areas historically have had identifiable patterns pertaining to hospital choice, with results across multiple studies and decades indicating that rural Medicare beneficiaries tend to choose larger hospitals and those offering a broader scope of services.
We anticipate that CJR beneficiaries located in rural areas are likely to follow this historical trend, and that some patients will seek care from nonrural hospitals. By contrast, other CJR beneficiaries will initiate CJR episodes at rural hospitals. But this trend is unlikely to be unique to CJR beneficiaries, and we expect that rural hospitals already have established relationships, either on their own or through rural health networks, with providers and suppliers that can furnish services to the hospital's patients upon discharge. Thus, we believe it is possible that rural hospitals may identify a small core group of PAC providers where their model beneficiaries commonly seek care following surgery. We will be providing claims data to assist hospitals in identifying potential CJR collaborators, as discussed in section III.E. of this final rule. Finally, one of the purposes of requiring participation in this model of all hospitals in the selected MSAs is to gain information about the challenges and successes achieved by different types of hospitals in the CJR model, and to share strategies related to success.
As to the second question of provider responsibility, we proposed that participant hospitals in the CJR model that enter into sharing arrangements “be responsible for ensuring that those providers and suppliers comply with the terms and requirements of this proposed rule.” We are not suggesting that CJR collaborators be able to escape responsibility for noncompliance with the Medicare Conditions of Participation, or a state or federal law, rule, or regulation merely by entering into a sharing arrangement. Rather, this provision is meant to not only make participant hospitals aware of their responsibility to oversee their CJR collaborators for compliance with the CJR model, but also to inform the participant hospitals of the potential remedial actions that may be taken against them if their CJR collaborators do not comply with all requirements of the CJR model. Specifically, where CMS, HHS, or its designees discovers an instance of noncompliance by a CJR collaborator with the requirements of the CJR model, CMS, HHS, or its designees may take remedial action against the participant hospital, which may include requiring the participant hospital to terminate a collaborator agreement with a CJR collaborator and prohibit further engagement in the CJR model by that CJR collaborator. Furthermore, this provision requires participant hospitals to include in their collaborator agreements provisions requiring compliance from CJR collaborators with the requirements of the CJR model. This provision is discussed further in section III.C.12. of this final rule, in which we detail the enforcement mechanisms that CMS, HHS, or its designees may apply to a participant hospital.
With regard to screening CJR collaborators, we believe the additional administrative burden on participant hospitals and CMS to periodically prepare, collect, and specifically screen lists of CJR collaborators would not substantially enhance the program integrity protections otherwise built into the model design. We note that CMS will be monitoring for inappropriate behavior of participant hospitals through monitoring efforts specifically for this model. We further note that CMS retains all of its existing mechanisms to directly monitor providers and suppliers, even if they are CJR collaborators. We have included a number of enforcement mechanisms in this final rule that will be available to CMS should a participant hospital or CJR collaborator be out of compliance with the model's requirements.
Furthermore, limiting alignment payments as we proposed operates as a safeguard in much the same manner as we discuss later in this section regarding the cap on gainsharing payments. Thus, we do not agree that increasing the limits on alignment payments is appropriate at this time or necessary to test the model.
Finally, we reiterate that beneficiaries included in a CJR episode retain their full rights to choose their providers and suppliers. Participant hospitals and CJR collaborators that engage in sharing arrangements may not adversely impede those rights of the beneficiary. Alignment payments, or the potential for such payments, must not induce the participant hospital, CJR collaborators, or the employees, contractors, or designees of the participant hospital or CJR collaborators to reduce or limit medically necessary services to any Medicare beneficiary. Individual physician and nonphysician practitioners, whether or not a party to a sharing arrangement, must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.
Other commenters acknowledged the necessity for a cap on gainsharing payments, but urged CMS to apply the same cap to the CJR model as is applied to Model 2 of the BPCI initiative, which does not place a cap on gainsharing payments to PGPs. Commenters stated that having different policies between the models could create the potential for an uneven playing field across CJR participant hospitals and BPCI Model 2 episode initiator hospitals. These commenters asserted that the cap on gainsharing payments to PGPs in CJR may work to the detriment of participant hospitals, as compared to hospitals in the same geographic markets that are participating in BPCI. Given the proposed cap on gainsharing payments to PGPs, the commenters stated that participant hospitals in CJR may be placed at a competitive disadvantage within the market, with the potential for PGPs to view hospitals in BPCI Model 2 as more lucrative financial partners.
In addition, some commenters objected to the proposed requirement that only CJR collaborators that actually furnish a service to a CJR beneficiary during an episode of care would be eligible to receive a gainsharing payment. This policy would prohibit, for example, a PGP from distributing any portion of a received gainsharing payment to physicians or nonphysician practitioners who did not furnish a service to the CJR beneficiary during an episode of care. Commenters suggested that such a requirement might be difficult to institute with PGPs and may necessitate group practices amending their particular bylaws and internal contracts. Another commenter acknowledging that CMS' rationale for this proposal was to preserve program integrity and ensure that individuals who did not furnish services to a CJR beneficiary during an episode are not permitted to receive a payment, nevertheless also disagreed with the proposal, stating that billing records do not always capture all of the surgeons who deliver care to each beneficiary, as other PGP members would likely deliver some postoperative services that are not separately recorded and thereby not identifiable from claims data. According to the commenter, only at the PGP level would it be feasible for the group members to most appropriately allocate gainsharing payments.
While we appreciate the distinction being made by the commenters regarding the potential timing differences between internal cost savings and reconciliation payments, as well as that internal cost savings that could be paid to a CJR collaborator would not actually be due to a change in Medicare payment, as would be the
We understand the perspective from some commenters that the cap on gainsharing payments to PGPs may have impacts on revenue sharing within PGPs, particularly for multi-specialty practices. If the CJR model included clinical episodes for many different conditions, such as in the case of a number of BPCI participants who are testing multiple different clinical episodes, we could understand how it might be justified to remove the cap on gainsharing payments to PGPs. However, with CJR, there is only a single episode—LEJR procedures. As such, we believe it is likely that most services to CJR beneficiaries during an episode will be furnished by an identifiable subset of physician and nonphysician practitioners within a PGP. From our experience with other bundled payment models, such as the BPCI initiative, we have found that even in large, multi-specialty PGPs, the majority of services to LEJR patients are furnished by a subset of practitioners.
We proposed that a cap on gainsharing payments made to a PGP that is a CJR collaborator be limited by the aggregate billable services furnished during a calendar year to the participant hospital's CJR beneficiaries during CJR episodes by physicians and nonphysician practitioners that are members of the PGP. This cap on gainsharing payments to PGPs is based on Medicare payments for the services delivered to CJR beneficiaries by PGP members. We also proposed that the only PGP members that could receive all or a portion of the gainsharing payment made to the PGP are those PGP members that furnished a billable service to a CJR beneficiary during a CJR episode. Therefore, we believe that the cap on gainsharing payments as it has been proposed for the CJR model is appropriate, because it ensures that only physicians and nonphysician practitioners within a PGP that may receive all or a portion of a gainsharing payment are those physicians and nonphysician practitioners who actually furnished services to CJR beneficiaries during CJR episodes, and that the amounts those PGP members receive does not exceed the capped amounts that would be applied to those physician and nonphysician practitioners if they were directly engaging with a participant hospital as CJR collaborators.
For example, for a physician or nonphysician practitioner who furnishes billable services in a calendar year to CJR beneficiaries during CJR episodes that amount $1,000 in total Medicare approved amounts under the MPFS, the cap for that physician or nonphysician practitioner would be $500. By comparison, if the physician or nonphysician practitioner furnishes billable services in a calendar year to CJR beneficiaries during CJR episodes that amount $0 in total Medicare approved amounts under the MPFS, the cap for that physician or nonphysician practitioner would be $0. In both scenarios, if the physician or nonphysician practitioner is a PGP member in a PGP that is a CJR collaborator that has a sharing arrangement with a participant hospital, then the maximum gainsharing payment that could be made to the PGP would be the aggregate capped amounts, as previously described, of all physician and nonphysician practitioners that furnished a billable service in a calendar year to a CJR beneficiary during a CJR episode. Similarly, if the physician or nonphysician practitioner has a sharing arrangement directly with a participant hospital (regardless of whether the physician or nonphysician practitioner is a PGP member), the maximum gainsharing payment that could be made to the physician or nonphysician practitioner would be the capped amount, as previously described, for services furnished to the participant hospital's CJR beneficiaries during a CJR episode by that physician or nonphysician practitioner. We believe that the flexibilities inherent in these policies on limits to gainsharing recognize the various levels of engagement from physicians and nonphysician practitioners in a participant hospital's care redesign, and allows for arrangements to be structured accordingly.
Our proposed policies for limits on gainsharing also recognized that the work of care redesign will also likely be carried out by those same physicians caring for model beneficiaries. We further note that MSAs with high proportions of acute care hospitals initiating LEJR episodes in BPCI have not been included in the random selection process for the CJR model, as described in section III.A. of this final rule. This should limit those communities where participant hospitals in CJR and BPCI hospitals initiating LEJR episodes are co-located such that PGPs could consider moving their current practice locations based on financial considerations under a model in testing.
Furthermore, we do not see how allowing all or a portion of a gainsharing payment to be distributed to individual physicians, nonphysician practitioners, or members of PGPs who did not furnish any services to model beneficiaries during a CJR episode is likely to increase the quality of care that was furnished to those beneficiaries or reduce the cost to Medicare. We can, however, see the potential for abuse by allowing such payments to flow freely to any member of a PGP, as PGPs in some markets could potentially funnel portions of a gainsharing payment to practitioners not involved in LEJR care as a means of impacting the referral patterns of those practitioners to particular hospitals or the PGP. As stated previously, the cap on gainsharing payments functions to deter
In summation, the cap on gainsharing payments ensures that only physician and nonphysician practitioners that actually furnish a service to a beneficiary during a CJR episode are eligible for gainsharing payments, and that gainsharing payments made to PGPs are limited to the aggregate capped amounts of each physician or nonphysician practitioner member that furnished a service to a CJR beneficiary. We reiterate that while the cap is only applicable to gainsharing payments made to CJR collaborators who are physicians, nonphysician practitioners, providers or suppliers of outpatient therapy services, and PGPs, CJR collaborators that are SNFs, HHAs, LTCHs, IRFs, physicians, nonphysician practitioners, and providers or suppliers of outpatient therapy services that are CJR collaborators must have furnished a billable service during a CJR episode to a CJR beneficiary during the calendar year in which the internal cost savings was generated or to which the NPRA applied (the latter of which are directly reflected in a reconciliation payment), in order to be eligible to receive a gainsharing payment. As discussed later in this section, CJR collaborators that are PGPs need to have participated in care redesign activities that involved the provision of care to CJR beneficiaries during the calendar year in which the internal cost savings was generated or to which the NPRA applied (the latter of which is directly reflected in a reconciliation payment), in order to be eligible to receive a gainsharing payment. We believe this connection to beneficiaries is likely to be important in aligning the financial incentives of the practitioner with those of the participant hospital, as well as the other providers and suppliers involved in the delivery of care to beneficiaries.
Many commenters offered related comments regarding CMS' proposed gainsharing policies as applied to PGPs. Commenters vigorously requested that CMS remove the provision prohibiting a PGP that is a CJR collaborator from retaining any portion of a gainsharing payment. CMS' proposal would have required the PGP to distribute 100 percent of the gainsharing payment to the PGP's member physicians and nonphysician practitioners that actually furnished a service to a CJR beneficiary during a CJR episode. In opposing this proposed requirement, commenters stressed that PGPs should have the freedom to determine the most appropriate way to distribute gainsharing payments, given the multiple disciplines involved in patient care, and the potential for clinical and financial involvement of the PGP in the care of CJR beneficiaries. Multiple commenters suggested that if CMS were to finalize this proposal without modification that PGPs would likely be discouraged from participating as CJR collaborators in the model.
We considered whether PGPs that are CJR collaborators should be permitted to retain all or a portion of a gainsharing payment. We are concerned by the comments suggesting that some PGPs may be unwilling to engage in care redesign efforts as a CJR collaborator with a participant hospital if the PGP is not permitted to retain a gainsharing payment. We also understand that PGPs might serve a variety of functions that contribute to care redesign and innovations in care furnished to CJR beneficiaries. For example, while a PGP, as an entity, would not furnish a billable service to a CJR beneficiary (that function is performed by the member physician and nonphysician practitioners of the PGP), a PGP that is engaged in care redesign with a participant hospital could serve as an organizing entity for the physician and nonphysician practitioner members of the PGP that are furnishing services to CJR beneficiaries. Further, the PGP might provide care coordination services for CJR beneficiaries or invest in new technologies that improve care for CJR beneficiaries. In this way, a PGP is distinct from the other provider and supplier types eligible to be CJR collaborators in that, although the PGP is a Medicare enrolled entity, it does not furnish billable services to beneficiaries.
Given these considerations, we are persuaded that a PGP that is a CJR collaborator should be permitted to retain all or a portion of a gainsharing payment. Thus, we are finalizing our proposal with a modification to allow PGPs that are CJR collaborators to retain all or a portion of a gainsharing payment that the PGP receives from a participant hospital. We believe that this modification will provide greater financial flexibility to PGPs that are CJR collaborators, and will allow for those PGPs to consider sharing arrangements that contain provisions regarding alignment payments. We note that for purposes of this final rule, a PGP is an entity that furnishes clinical patient care services, including evaluation and management services, or professional surgical services. We do not believe that an entity is a PGP if it merely furnishes supplies or tests to patients.
In order to be eligible to receive a gainsharing payment, the PGP that is a CJR collaborator must meet all of the following:
• The PGP must have at least one member of the PGP that is a physician or nonphysician practitioner, as those terms are defined at § 510.2, that actually furnished a service to a CJR beneficiary during a CJR episode during the calendar year in which the participant hospital's internal cost savings was generated, or to which the NPRA applied (the latter of which is directly reflected in a reconciliation payment), as these funds are the only two sources that may comprise a gainsharing payment;
• The PGP must contribute to a participant hospital's care redesign in CJR and be clinically involved in the care of CJR beneficiaries. The following is a non-exhaustive list of ways in
++ Provide care coordination services to CJR beneficiaries during and/or after inpatient hospital admission;
++ Engage with a participant hospital in developing care redesign strategies, and actually perform a role in implementing such strategies, that are designed to improve the quality of care for LEJR episodes and reduce LEJR episode spending;
++ In coordination with other providers and suppliers (such as the PGP's members, participant hospitals, and PAC providers), implement strategies designed to address and manage the comorbidities of CJR beneficiaries.
Finally, should the PGP wish to distribute all or a portion of a gainsharing payment to its member physicians and nonphysician practitioners, we discuss later in this section, in detail, the requirements for such distributions.
With respect to the determination of gainsharing payments, a commenter stated that gainsharing payments should be founded in quality performance, with each CJR collaborator needing to meet minimum thresholds prior to any gains being distributed. Other commenters suggested that the ability of all CJR collaborators to receive a gainsharing payment should be based on the quality performance of the CJR collaborators both as individuals and as a group—essentially recommending that CMS institute a “quality gate” that would need to be met by all CJR collaborators in order for any single CJR collaborator to receive a gainsharing payment. The suggested methodologies varied as to how quality would be measured—some commenters suggested that selection should be done by CMS while others recommended that participant hospitals should choose quality criteria important to them. Commenters did not suggest particular quality criteria that CMS should consider, and most commenters did not describe how CMS or participant hospitals would select quality criteria.
With regard to the selection of CJR collaborators, while we do not agree with the commenters suggesting that we require participant hospitals to engage as CJR collaborators with all providers and suppliers caring for CJR model beneficiaries, we believe the providers and suppliers that the participant hospital selects as CJR collaborators should be held to certain standards related to the quality of care for CJR model beneficiaries. Thus, we believe it is appropriate to require the participant hospital to create a written set of policies for selecting providers and suppliers for sharing risks and gains as CJR collaborators. Those policies must be related to, and inclusive of, the quality of care to be delivered to beneficiaries during a CJR episode. We believe these criteria could permit selection of CJR collaborators based on their previous demonstration of the ability to furnish high-quality services to beneficiaries receiving LEJR or based on their expected high quality care due to requirements specified in the hospital's collaborator agreement. For example, some participant hospitals may choose to satisfy this requirement by adopting quality criteria that look at a provider/supplier's past performance on certain quality metrics, such as complication rates, whereas other hospitals may choose to adopt quality criteria that rely primarily on satisfaction of forward-looking requirements that the participant hospital expects to lead to improved quality of episode care, such as attending weekly care coordination meetings, contacting CJR beneficiaries frequently, or following specified clinical care pathways. As previously stated, we believe it is important that participant hospitals have the ability to select the CJR collaborators that are willing to engage in the participant hospital's care redesign strategies, as well as provide high-quality care, so that the CJR collaborators are likely to contribute to improvements in episode quality and efficiency. Thus, with regard to the role of quality in the selection of CJR collaborators, we will require the participant hospital to develop a written set of criteria that it will use to determine the selection of all CJR collaborators.
We also believe the quality of care furnished by CJR collaborators to beneficiaries during an episode should be a factor in determining a gainsharing payment, not just the savings created by the CJR collaborator. We believe that requiring participant hospitals to include quality criteria when determining gainsharing payments will incentivize CJR collaborators to provide high quality, medically necessary care that contributes to the quality of episode care. Because the CJR model incorporates pay-for-performance in the payment methodology, rewarding high quality performance and quality improvement with increased financial opportunity for participant hospitals as discussed in section III.C.5. of this final rule, we believe this same principle should carry through to gainsharing payments, to which episode quality and cost performance should be linked. We further believe that requiring the participant hospital to include quality criteria as a factor in the determination of gainsharing payments should prevent low quality providers and suppliers that have not contributed to the quality of episodes that leads to participant hospital financial opportunity from receiving gainsharing payments in this model.
With regard to the role of quality in the determination of gainsharing
In summary, we will require the participant hospital to develop and maintain a written set of policies for selecting its CJR collaborators. Further, this set of policies must contain criteria for selection of CJR collaborators that include criteria related to, and inclusive of, the quality of care to be delivered to beneficiaries by the CJR collaborator during a CJR episode. The selection criteria cannot be based directly or indirectly on the volume or value of referrals or revenue generated by providers or suppliers. All CJR collaborators must have met, or agree to meet, the quality criteria for selection. In the case of selection criteria regarding an individual's or entity's willingness to engage in activities that are expected to improve the quality of care (such as following specified clinical pathways), such activities must be specified in the collaborator agreement as an obligation of the CJR collaborator. We are also adding a requirement that the participant hospital include in its collaborator agreements with CJR collaborators the methodology the participant hospital will use to determine gainsharing payments, and this methodology must be based, at least in part, on criteria related to, and inclusive of, the quality of care to be delivered to beneficiaries during a CJR episode, and not directly on the volume or value of referrals or business generated by providers and suppliers. Finally, we will require participant hospitals, in considering the quality criteria to incorporate as part of their gainsharing methodologies, to use quality criteria that are directly related to CJR episodes of care, so that the criteria used by the participant hospital are relevant to care for beneficiaries in the model. To be eligible to receive a gainsharing payment, a CJR collaborator must meet quality criteria for the calendar year for which the gainsharing payment is determined by the participant hospital. Any CJR collaborator that does not meet the quality criteria described with specificity in the collaborator agreement is not eligible for a gainsharing payment for the calendar year for which the gainsharing payment is being calculated.
Lastly, with regard to the application of a participant hospital's quality criteria prior to the distribution of gainsharing payments, we are clarifying our proposal by changing the word “calculation” to “determination.” As previously discussed, we are requiring that participant hospitals use a methodology to determine gainsharing payments, and that this methodology be explained in detail in all sharing arrangements with CJR collaborators. We expect that this methodology may include calculations, but we are clarifying that while quality criteria must be used when determining the gainsharing payment for each CJR collaborator, the quality criteria are not specifically required to be a part of the calculated amount of the gainsharing payment.
Second, a number of commenters urged CMS to make sharing arrangements mandatory; in effect suggesting that participant hospitals be required to enter into gainsharing relationships. For example, a commenter recommended that CMS require participant hospitals to enter into sharing arrangements with ACOs in the participant hospital's MSA. Another commenter recommended that CMS require participant hospitals to enter into sharing arrangements with all orthopedic physicians credentialed at the hospital, in order to reduce the potential for hospitals to arbitrarily decide whether or not to enter into such arrangements with a physician. Multiple commenters cautioned that participant hospitals may choose to select only the most “efficient” or “cost effective” orthopedic surgeons to enter into sharing arrangements, and thus recommended that CMS require participant hospitals to enter into sharing arrangements with all
Many commenters stated that the proposed sharing arrangement requirements, such as the gainsharing and alignment payment caps, were too limiting. Several commenters noted that certain types of physicians—particularly orthopedic surgeons—serve a critical role in care redesign and creating internal cost savings for a participant hospital and episode savings to Medicare. Thus, these commenters stated, applying the same policies regarding sharing gains and losses to orthopedic surgeons as to other providers and suppliers—such as physical therapists or PAC providers—would be inapplicable. These commenters recommended that CMS allow physicians greater freedom to negotiate sharing arrangements—such as the ability to assume greater financial risk above the 25 percent for alignment payments proposed by CMS in the proposed rule, and removal of the 50 percent cap on gainsharing payments for CJR collaborators that are physicians, nonphysician practitioners, and PGPs.
Several commenters suggested that the proposed caps on gainsharing payments and alignment payments were arbitrary, particularly given the proposed policy that gainsharing payments must be “actually and proportionally related to the care” of beneficiaries in CJR episodes and that the CJR collaborator must be contributing to the care redesign strategies of the participant hospital. Other commenters likewise suggested that the capped limits were arbitrary because they may not reflect the efforts that a physician undertook to meet required quality metrics and reduce episode spending. Rather than setting what they argue is an arbitrary limit, these commenters recommended that CMS should allow providers to determine the distribution amounts.
Some commenters noted that gainsharing structures in the private sector allow for more flexibility and are less prescriptive. Other commenters recommended that the participant hospital should be afforded broad discretion to establish its policies for the distribution of gainsharing payments. For example, a commenter suggested that CMS should remove the requirement that gainsharing payments be made annually, and allow participant hospitals to make this payments at any interval, or at a minimum, twice per year. These commenters also noted that hospitals are likely to be experienced business entities and should be able to make independent financial decisions without a regulatory structure for gainsharing like the one proposed. Further, these commenters suggested that in the absence of gainsharing, the participant hospital would retain the full reconciliation payment, and thus the hospitals are unlikely to make distributions of gainsharing payments unnecessarily.
We appreciate the reasons for the recommendations by some commenters that we require participant hospitals to essentially offer the same gainsharing arrangement to all providers and suppliers of the same type. While we understand the potential benefits of a policy standardizing sharing arrangements to protect against selection of low-cost patients and the resulting patient steering, we believe that participant hospitals may have legitimate reasons to enter into a sharing arrangement with a particular provider or supplier that differs from the hospital's arrangements with other similar providers or suppliers. For example, it is possible there may be instances in which a particular SNF offers certain therapies or has resources that a participant hospital believes will benefit its patients in the model. In these instances, it may be prudent for a hospital to enter into a different sharing arrangement with that SNF, as opposed to other SNFs. Furthermore, participant hospitals may have legitimate reasons to construct different sharing arrangements with CJR collaborators that agree to take on a portion of the participant hospital's financial risk compared to sharing arrangements with CJR collaborators that do not assume downside risk. We believe that the CJR model's policies that require participant hospitals to be financially liable for episodes of care will incentivize participant hospitals to decrease episode spending and increase the quality of care by engaging participant hospitals to seek CJR collaborators that are also supportive of these goals.
We believe that the MedPAC recommendation to require identical per-episode payments for each physician that is a CJR collaborator would likely limit physician commitment to the goals of the model and the model would be less likely to result in reduced episode spending and improved quality of care. Our experience in other models that incorporate gainsharing has indicated that a hospital may have legitimate reasons to construct different sharing arrangements with different physicians, depending on factors such as the involvement of the physician in the hospital's care redesign efforts, adoption of leadership roles requiring direction and instruction of other physicians, and the number and magnitude of disruptions in the physician's existing practice patterns.
We have included safeguards in this final rule to address patient steering, including the requirement that beneficiaries retain their full rights to choose their providers and suppliers, the requirement that hospitals not limit beneficiary choice of providers or suppliers, the cap on gainsharing payments, the requirement that the opportunity to receive gainsharing payments (or the opportunity to make or receive alignment payments) may not be conditioned on the volume or value of past or anticipated referrals or other business generated to, from, or among the participant hospital and any CJR collaborator, the requirement that gainsharing payments be distributed only to CJR collaborators that meet the quality criteria established by the participant hospital, and the
While we appreciate the reasons why some commenters recommended that we require participant hospitals to enter into financial relationships with certain entities and individuals, we do not agree that such a requirement is necessary. We agree with the commenters who supported the voluntary nature of sharing arrangements, and we continue to believe that it is essential that sharing arrangements be voluntary and without penalty for nonparticipation. Although we are not requiring participant hospitals to offer sharing arrangements to all providers or suppliers, we are finalizing our proposal prohibiting hospitals from coercing or requiring individuals or entities to enter into a sharing arrangement, and participant hospitals may not penalize or discriminate against physicians and nonphysician practitioners on the grounds that they are not CJR collaborators. However, in response to these comments, we are also modifying our proposal, discussed in detail later in this section, regarding the selection criteria a participant hospital must use in choosing CJR collaborators. We believe that our final requirement for selection criteria for CJR collaborators responds to the concerns from some commenters regarding how a participant hospital selects it CJR collaborators.
In response to the view of some commenters that the provisions for gainsharing and risk-sharing in the CJR model are overly restrictive, we note that we constructed a framework for financial arrangements in the CJR model that we believe leaves participant hospitals and CJR collaborators relatively unconstrained to develop sharing arrangements in a manner they see fit, provided that all the requirements contained in this final rule are met. We have not proposed that participant hospitals would need to use a particular methodology for determining gainsharing payments or alignment payments, other than placing upper thresholds on those payments and a requirement for quality criteria for gainsharing payments, which we discuss in greater detail previously in this section.
With regard to the provision on the annual distribution of gainsharing payments, given that CMS is not requiring participant hospitals to submit gainsharing methodologies for review or to report gainsharing payments to CMS, we believe that the provision allowing for gainsharing payments on an annual basis is appropriately placed, for purposes of tracking by the participant hospital, as well as facilitating any program integrity matters by CMS, HHS, and its designees. We also believe that annual distributions of gainsharing payments are appropriate because reconciliation within the model will occur on an annual basis. Also, because providers and suppliers will continue to be paid according to the existing FFS processes throughout the duration of the model, CJR collaborators will continue to have sources of revenue other than gainsharing payments, which we believe makes distributions of gainsharing payments more often than once per year unnecessary. Finally, while gainsharing arrangements in the private sector may be less restrictive, as suggested by some commenters, other commenters nonetheless noted that a number of Federal laws are implicated by gainsharing, and thus a more prescriptive set of gainsharing policies is an appropriate reflection of the presence and importance of that legal framework. We agree with those commenters, and emphasize that while we have attempted to avoid making the provisions on sharing arrangements and collaborator agreements unnecessarily complex, we believe that the regulatory requirements for these documents are justified, for reasons such as limiting opportunities for patient steering, preserving beneficiary choice, and protecting Federal healthcare dollars.
We continue to believe that the permissible sharing arrangements under the CJR model should allow participant hospitals substantial and appropriate flexibility to develop these arrangements with the care redesign needs of their beneficiaries in mind to achieve the model objective of quality improvement and reduced episode cost, while providing sufficient protections against the possible risks of beneficiary steering, stinting, and inappropriate reductions in access to care under an episode payment model. Therefore, final policies apply certain limited protections to minimize these risks and reduce the opportunities for providers and suppliers to engage in inappropriate behavior, while allowing participant hospitals sufficient flexibility to achieve success in the model, striking an appropriate balance between these two important objectives. These protections fall into the following several categories:
• Requirements that the basis for selection of CJR collaborators be on criteria related to, and inclusive of, the quality of care to be delivered to beneficiaries during a CJR episode, and that the selection criteria cannot be based directly or indirectly on the volume or value of referrals or revenue generated by providers or suppliers. Further, all CJR collaborators must have met, or agree to meet, the quality criteria for selection.
• Requirements that the basis for, and determination of, gainsharing payments include provisions describing with specificity in the collaborator agreement, including the quality criteria that the participant hospital will use in its determination of gainsharing payments, and that such payments be based on criteria other than the volume or value of past or future referrals, or business otherwise generated.
• Contemporaneous documentation requirements to ensure that collaborator agreements between participant hospitals and CJR collaborators are memorialized in writing and comply with all the provisions of this final rule.
• Limits on the absolute amount of dollars in alignment payments to ensure that such payments are made solely for the purposes permitted under this final rule.
• Restrictions on the types of providers and suppliers that may receive gainsharing payments and provisions requiring that those providers and suppliers have actually furnished a service to a beneficiary and/or been involved in care redesign, as required by this final rule.
• Limits on the absolute amount of dollars an individual practitioner or PGP may receive as gainsharing payments.
• Compliance from participant hospitals and CJR collaborators with the requirements of this final rule.
Finally, for the many reasons previously provided, we disagree with commenters who suggested that we proposed an arbitrary structure for financial arrangements in the CJR model. We acknowledge that any protections will inherently provide some limits on the flexibility of participant hospitals to develop certain financial arrangements, but we believe that the CJR model requirements appropriately balance the need for flexibility and program integrity.
We specify in § 510.505(a) that a PGP that has entered into a collaborator agreement with a participant hospital may distribute all or a portion of any gainsharing payment it receives from the hospital only in accordance with a “distribution arrangement,” which we define as a financial arrangement between a PGP that is a CJR collaborator and a “practice collaboration agent” pursuant to which the PGP distributes some or all of a gainsharing payment. We define a “practice collaboration agent” as a PGP member who has entered into a distribution arrangement with the same PGP of which he or she is a member and who has not entered into a collaborator agreement with a participant hospital. We are defining the terms “PGP member” and “member of a PGP” to mean a physician, nonphysician practitioner, or therapist who is an owner or employee of the PGP and who has reassigned to the PGP his or her right to receive Medicare payment. We note that the fact that an entity employs or contracts with physicians, nonphysician practitioners or therapists does not make the entity a PGP. We are adding commonplace definitions of “physician” and “nonphysician practitioner” and we are defining “therapist” to include physical, occupational, and speech therapists.
We emphasize that a PGP that is a CJR collaborator (hereafter in this section, “a PGP,” unless noted otherwise) is not obligated under this final rule to distribute (make a “distribution payment”) of a gainsharing payment to its PGP members. Upon receipt of a gainsharing payment, the PGP may retain some or all of the gainsharing payment. If the PGP chooses to make distribution payments, it must do so only in accordance with a distribution arrangement. This final rule requires at new § 510.505 that all distribution arrangements must comply with all applicable laws and regulations, including the applicable fraud and abuse laws, and the following criteria:
• All distribution arrangements must be in a writing signed by the PGP and practice collaboration agent.
• Participation in a distribution arrangement must be voluntary and without penalty for nonparticipation.
• The distribution arrangement must require the practice collaboration agent to comply with the requirements set forth in this final rule.
• The opportunity to receive a distribution payment must not be conditioned directly on the volume or value of past or anticipated referrals or other business generated to, from, or among a participant hospital, the PGP, other CJR collaborator, any practice collaboration agents, and any individual or entity affiliated with a participant hospital, CJR collaborator, or practice collaboration agent.
• Methodologies for determining distribution payments must not directly account for volume or value of referrals, or business otherwise generated, between or among the participant hospital, CJR collaborators, practice collaboration agents, and any individual or entity affiliated with a participant hospital, CJR collaborator, or practice collaboration agent.
• A practice collaboration agent is eligible to receive a distribution payment only if the PGP billed for an item or service furnished by the practice collaboration agent to a CJR beneficiary during a CJR episode that occurred during the calendar year in which the participating hospital accrued the internal cost savings or earned the reconciliation payment that comprise the gainsharing payment made to the PGP.
• Where a PGP receives a gainsharing payment from a participant hospital pursuant to a sharing arrangement, all monies contained in such a gainsharing payment must be shared only with the physician or nonphysician practitioners that are PGP members that furnished a service to a CJR beneficiary during an episode of care in the calendar year from which the NPRA, as that term is defined in section III.C.6. of the final rule, or internal cost savings was generated, either or both of which are the only permitted sources of funds for a gainsharing payment.
• The total amount of distribution payments for a calendar year paid to a practice collaboration agent must not exceed 50 percent of the total Medicare approved amounts under the Medicare Physician Fee Schedule (MPFS) for services billed by the PGP and furnished by the practice collaboration agent to the participant hospital's CJR beneficiaries during a CJR episode.
• With respect to the distribution of any gainsharing payment received by a PGP, the total amount of all distribution payments must not exceed the amount of the gainsharing payment.
• All distribution payments must be made through EFTs.
• The practice collaboration agents must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.
• The distribution arrangement must not—
++ Induce a practice collaboration agent to reduce or limit medically necessary services to any Medicare beneficiary; or
++ Reward the provision of items and services that are medically unnecessary.
• The PGP must maintain documentation regarding practitioner distribution arrangements in accordance with § 510.500(e), including the relevant written agreements, documentation of the amount of any distribution payment, the identity of each practice collaboration agent who received a distribution payment, and a description of the methodology and accounting formula for calculating the amount of any distribution payment.
• The PGP may not enter into a distribution arrangement with any member of the PGP that has a collaborator agreement in effect with a participant hospital.
These provisions require distribution payments to be made by a PGP only to individuals who furnished an item or service to a CJR beneficiary during a CJR
To the extent the commenters were advocating that CMS prohibit late payment of amounts owed to CJR collaborators, we believe that the consequences for breach of contract offer sufficient protection. Regarding the commenters' desire to ensure that gainsharing payments are distributed fairly and equitably to CJR collaborators, we believe that the provisions of this final rule adequately address their comment. For example, this final rule prohibits participant hospitals and all CJR collaborators from reducing or limiting medically necessary services, prohibits conditioning the opportunity to receive gainsharing payments on the volume or value of referrals, requires gainsharing payment eligibility to include quality criteria and gainsharing payment determinations to be based on criteria related to the quality of care to be delivered to CJR beneficiaries during episodes, prohibits gainsharing methodologies that directly account for the volume or value of referrals, and caps the amount a physician or nonphysician practitioner can receive in gainsharing payments as a CJR collaborator. Finally, we agree with the commenters that it is important to deter unfair business practices, but the regulation of such practices is outside the scope of our authority. Accordingly, we decline to add a prohibition against unfair business practices. However, we believe that many of the program integrity provisions regarding sharing arrangements will also serve to deter unfair business practices.
We agree with the commenters that transparency is important to ensure program integrity and to assist with evaluation of the model. We have tried, where possible, to ensure transparency regarding sharing arrangements and distribution arrangements without imposing undue administrative burden on the individuals and entities that enter into such arrangements.
Because documenting financial arrangements is consistent with general business practices, we believe that our documentation requirement imposes minimal additional administrative burden on participant hospitals and CJR collaborators. To promote transparency, we are modifying our regulation text to require contemporaneous documentation of collaborator agreements. This will discourage gaming by ensuring that these agreements are entered into before care is furnished to CJR beneficiaries.
We do not agree that it is necessary for participant hospitals to submit periodically to CMS documentation regarding sharing arrangements, lists of CJR collaborators, or documentation regarding all gainsharing payments and alignment payments. We are sensitive to the potential burden of such a reporting requirement. We believe that the goals of transparency and program integrity can be achieved by requiring participant hospitals and CJR collaborators to retain contemporaneous documentation of collaborator agreements, gainsharing payments, and alignment payments for at least 10 years following completion of the arrangement and to allow CMS, HHS, or its designee's access to such records. In addition, we are modifying the regulation text to require each participant hospital to maintain accurate, current, and historical lists of CJR collaborators and to publish on its Web site, on a Web page accessible to the general public, an accurate and current list of all CJR collaborators. The hospital must update its published list of CJR collaborators no less frequently than quarterly. The dollar amounts of any gainsharing payments or alignment payments need not be listed on the participant hospital's Web site.
We note that the participant hospital's records associated with tracking gainsharing payments must reflect whether the participant hospital recouped any gainsharing payments received by a CJR collaborator that contain funds derived from a CMS overpayment on a reconciliation report or because such gainsharing payments were the result of the submission of false or fraudulent data. Similarly, this final rule also requires PGPs to maintain documentation regarding distribution arrangements in accordance with § 510.500(e), including the relevant written agreements, documentation of the amount of any distribution payment, the identity of each practice collaboration agent who received a distribution payment, and a description of the methodology and accounting formula for determining the amount of any distribution payment. We have revised the regulation text to reflect these requirements.
We do not believe that the obligation to maintain accurate current or historical lists of CJR collaborators and documentation regarding all gainsharing payments and alignment payments, imposes any significant additional burden on participant hospitals. Participant hospitals will likely maintain such lists for their own operational purposes whether or not they are required by our regulations to do so. We believe that maintaining an accurate list of all CJR collaborators and documentation regarding all gainsharing payments, alignment payments, and distribution payments is a necessary and appropriate provision for purposes of transparency, keeping beneficiaries informed, and ensuring that such information is auditable by CMS, HHS, or its designees. We also believe that such information will help inform both CMS and the public about collaborator agreements.
We leave open the possibility for future rulemaking on the issue of documentation and reporting for this model. CMS may consider additional documentation requirements, including submission of lists of CJR collaborators and practice collaboration agents to CMS at regular, ongoing intervals.
• The term “Participation Agreement” has been changed to “collaborator agreement”.
• The term “CJR sharing arrangement” has been changed to “sharing arrangement”.
• In order for a physician or nonphysician practitioner to be a CJR collaborator, the physician or nonphysician practitioner must not have opted out of Medicare.
• PGPs that are CJR collaborators may retain all or a portion of a gainsharing payment, provided that the PGP meets all the criteria in this final rule for such retention.
• Sharing arrangements, included in collaborator agreements, must be entered into before care is furnished to CJR beneficiaries under the terms of the arrangement.
• A requirement that the participant hospital develop and maintain a written set of policies for selecting its CJR collaborators. This set of policies must contain criteria for selection of CJR collaborators that include criteria related to, and inclusive of, the quality of care to be delivered to beneficiaries during a CJR episode. The selection criteria cannot be based directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among the participant hospital and CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator. All CJR collaborators must have met, or agree to meet, the quality criteria for selection.
• A requirement that the participant hospital include in its collaborator agreements with CJR collaborators the methodology the participant hospital will use to determine gainsharing payments, and this methodology must be based, at least in part, on criteria related to, and inclusive of, the quality of care to be delivered to beneficiaries during a CJR episode, and not directly on the volume or value of referrals or business otherwise generated by, between or among the participant hospital and CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator
• A requirement that the participant hospital, in considering the quality criteria to incorporate as part of its gainsharing methodologies, use quality criteria that are directly related to CJR episodes of care, so that the criteria used by the participant hospital are relevant to care for beneficiaries in the model. Any CJR collaborator that does not meet the quality criteria described with specificity in the sharing arrangement is not eligible for a gainsharing payment for the calendar year for which the gainsharing payment is being determined.
• Requirements that the participant hospital keep contemporaneous documentation of collaborator agreements.
• A requirement that the participant hospital maintain accurate current and historical lists of CJR collaborators.
• A requirement that the participant hospital publish on its Web site, on a Web page accessible to the general public, accurate current and historical lists of CJR collaborators.
• A participant hospital must not make a gainsharing payment to a CJR collaborator that is subject to any action for noncompliance with this part or the fraud and abuse laws, or for the provision of substandard care in CJR episodes or other integrity problems.
• A regulatory framework has been created to allow PGPs that are CJR collaborators to share all or portions of gainsharing payments with individual practitioners that are members of the PGP. These requirements are set forth in new § 510.505.
With the exception of new § 510.505, the final policies are set forth in
“General.” We are finalizing at § 510.500(a) the following general requirements for all sharing arrangements that a participant hospital may elect to enter into:
• A participant hospital must not make a gainsharing payment or receive an alignment payment except in accordance with a sharing arrangement. Any gainsharing payments or alignment payments made pursuant to a sharing arrangement must be made only from the participant hospital to the CJR collaborator with whom the participant hospital has signed a collaborator agreement containing a sharing arrangement.
• CMS may review any sharing arrangement for compliance with the requirements of this part and to ensure that it does not pose a risk to beneficiary access, beneficiary freedom of choice, or quality of care.
• Notwithstanding any sharing arrangements between the participant hospital and CJR collaborators, the participant hospital must have ultimate responsibility for fully complying with all provisions of the CJR model.
• If a participant hospital enters into a sharing arrangement, it must update its compliance program to include oversight of sharing arrangements and compliance with the requirements of the CJR model.
• The board or other governing body of the participant hospital must have responsibility for overseeing the participant hospital's participation in the model, its arrangements with CJR Collaborators, its payment of gainsharing payments and receipt of alignment payments, and its use of beneficiary incentives in the CJR model.
• Participant hospitals must develop and maintain a written set of policies for selecting its CJR collaborators. This set of policies must contain criteria for selection of CJR collaborators that include criteria related to, and inclusive of, the quality of care to be delivered by the CJR collaborator to beneficiaries during a CJR episode. The selection criteria cannot be based directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among the participant hospital and CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator. All CJR collaborators must have met, or agree to meet, the quality criteria for selection.
“Sharing Arrangements.” We have consolidated at § 510.500(b) the criteria that each sharing arrangement must satisfy. Specifically, each sharing arrangement must comply with the following criteria:
• The sharing arrangement must be set forth in a collaborator agreement that complies with the requirements of § 510.500(c).
• The sharing arrangement must comply with all relevant laws and regulations, including the applicable fraud and abuse laws and all applicable payment and coverage requirements.
• An individual or entity's participation in a sharing arrangement must be voluntary and without penalty for nonparticipation.
• The parties must enter into a sharing arrangement before care is furnished to CJR beneficiaries under the terms of the sharing arrangement.
• To be eligible to receive a gainsharing payment, a CJR collaborator must meet quality criteria for the calendar year for which the gainsharing payment is determined by the participant hospital. The quality criteria must be established by the participant hospital and directly related to CJR episodes of care.
• To be eligible to receive a gainsharing payment or make an alignment payment, a CJR collaborator other than a PGP must directly furnish a billable service to a CJR beneficiary during a CJR episode that occurred in the calendar year in which the savings or loss was created.
• To be eligible to receive a gainsharing payment, a PGP that is a CJR collaborator must meet the following criteria:
++ The PGP must have billed for an item or service that was rendered by one or more members of the PGP to a CJR beneficiary during a CJR episode that occurred during the calendar year in which the participant hospital's internal cost savings was generated, or to which the NPRA applied;
++ The PGP must contribute to a participant hospital's care redesign in the CJR model and be clinically involved in the care of CJR beneficiaries. We set forth in the regulation a non-exhaustive list of ways in which a PGP might be clinically involved in the care of CJR beneficiaries.
• No entity or individual, whether a party to a collaborator agreement or not, may condition the opportunity to make or receive gainsharing payments or to make or receive alignment payments on the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
• Gainsharing payments, if any, must be—
++ Derived solely from reconciliation payments, or internal cost savings, or both;
++ Actually and proportionally related to the care of beneficiaries in a CJR episode;
++ Distributed on an annual basis (not more than once per calendar year); and
++ Not be a loan, advance payments, or payments for referrals or other business.
• Alignment payments from a CJR collaborator to a participant hospital may be made at any interval that is agreed upon by both parties, and must—
++ Not be issued, distributed, or paid prior to the calculation and issuance by CMS of a reconciliation report reflecting a repayment amount; and
++ Not be a loan, advance payments, or payments for referrals or other business.
• A participant hospital must not make a gainsharing payment to a CJR collaborator that is subject to any action for noncompliance with this part or the fraud and abuse laws, or for the provision of substandard care in CJR episodes or other integrity problems.
• In a calendar year, the aggregate amount of all gainsharing payments distributed by a participant hospital that are derived from a CJR reconciliation payment may not exceed the amount of the reconciliation payment the participant hospital receives from CMS.
• In a calendar year, the aggregate amount of all alignment payments received by the participant hospital must not exceed 50 percent of the participant hospital's repayment amount. No alignment payments may be collected by a participant hospital if it does not owe a repayment amount.
• The aggregate amounts of all alignment payments from any one CJR collaborator to a participant hospital must not be greater than 25 percent of the participant hospital's repayment amount.
• A sharing arrangement must not induce the participant hospital, CJR collaborator, or any employees or contractors of the participant hospital or CJR collaborator to reduce or limit medically necessary services to any Medicare beneficiary.
• A sharing arrangement must not restrict the ability of a CJR collaborator to make decisions in the best interests of its patients, including the selection of devices, supplies, and treatments.
• The methodology for determining gainsharing payments must be based, at
• The methodology for determining alignment payments must not directly account for the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
• The total amount of a gainsharing payment for a calendar year paid to an individual physician or nonphysician practitioner who is a CJR collaborator must not exceed 50 percent of the total Medicare approved amounts under the Physician Fee Schedule (PFS) for services furnished to the participant hospital's CJR beneficiaries during a CJR episode by that physician or nonphysician practitioner.
• The total amount of gainsharing payments for a calendar year paid to a PGP that is a CJR collaborator must not exceed 50 percent of the total Medicare approved amounts under the Physician Fee Schedule (PFS) for services that are billed by the PGP and furnished during a calendar year by members of the PGP to the participant hospital's CJR beneficiaries during CJR episodes.
• The participant hospital's determination of internal cost savings must satisfy the following criteria:
++ Internal cost savings are calculated in accordance with generally accepted accounting principles and Government Auditing Standards (The Yellow Book).
++ All amounts determined to be internal cost savings must reflect actual, internal cost savings achieved by the participant hospital through implementation of care redesign elements identified and documented by the participant hospital. Internal cost savings does not include savings realized by any individual or entity that is not the participant hospital.
++ Internal cost savings may not reflect “paper” savings from accounting conventions or past investment in fixed costs.
• All gainsharing payments and any alignment payments must meet the requirements set forth in this section and be administered by the participant hospital in accordance with generally accepted accounting principles. In no event may the participant hospital receive any amounts from a CJR collaborator under a sharing arrangement that are not alignment payments.
• All gainsharing payments and alignment payments must be made through electronic funds transfers.
“Participation Agreements.” We proposed a number of provisions that we believed should be set forth in the sharing arrangement or participation agreement (now termed “collaborator agreement”). We have finalized and consolidated these provisions under § 510.500(c). Specifically, we are finalizing our proposal to require that each collaborator agreement must include and set forth in writing the following:
• The collaborator agreement must contain a description of the arrangement between the participant hospital and the CJR collaborator regarding gainsharing payments and alignment payments. This description must specify the following:
++ The parties to the sharing arrangement.
++ The date of the sharing arrangement.
++ The purpose and scope of the sharing arrangement; ++ The financial or economic terms of the sharing arrangement, including the frequency of payment, and the methodology and accounting formula for determining the amount of any gainsharing payment or alignment payment.
++ Safeguards to ensure that alignment payments are made solely for purposes related to sharing responsibility for funds needed to repay Medicare in the CJR model.
++ Plans regarding care redesign.
++ Changes in care coordination or delivery that is applied to the participant hospital or CJR collaborators or both.
++ A description of how success will be measured.
++ Management and staffing information, including type of personnel or contractors that will be primarily responsible for carrying out changes to care under the model.
• The collaborator agreement must contain a requirement that the CJR collaborator and its employees and contractors must comply with the applicable provisions of this part (including requirements regarding beneficiary notifications, access to records, record retention, and participation in any evaluation, monitoring, compliance, and enforcement activities performed by CMS or its designees) and all other applicable laws and regulations.
• The collaborator agreement must require the CJR collaborator to be in compliance with all Medicare provider enrollment requirements at § 424.500 of this chapter, including having a valid and active TIN or NPI, during the term of the agreement.
• The collaborator agreement must require the CJR collaborator to have a compliance program that includes oversight of the collaborator agreement and compliance with the requirements of the CJR model.
• The collaborator agreement must set forth a specific methodology for accruing, calculating, and verifying the internal cost savings generated by the participant hospital based on the care redesign elements specifically associated with the particular CJR collaborator.
++ The methodology must set out the specific care redesign elements to be undertaken by the participant hospital or the CJR collaborator or both.
++ The methodology must be based, at least in part, on criteria related to, and inclusive of, the quality of care to be delivered to CJR beneficiaries during an episode and must not directly account for the volume or business otherwise generated by, between, or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
++ The specific methodologies for accruing and calculating internal cost savings must be transparent, measurable, and verifiable in accordance with generally accepted accounting principles and Government Auditing Standards (The Yellow Book).
• The collaborator agreement must set forth the quality criteria established by the participant hospital that will be used in determining the gainsharing payment.
• The collaborator agreement must require the participant hospital to recoup gainsharing payments paid to CJR collaborators if gainsharing payments contain funds derived from a CMS overpayment on a reconciliation report, or were based on the submission of false or fraudulent data.
• Any alignment payments made pursuant to a sharing arrangement may be made only to the participant hospital from the entity or individual with whom the participant hospital has signed a collaborator agreement containing a sharing arrangement.
• The collaborator agreement must require the CJR collaborator to comply with the beneficiary notice requirements specified in § 510.405, as applicable.
• Any internal cost savings or reconciliation payments that the participant hospital seeks to share through sharing arrangements must
• Any alignment payments that the participant hospital receives through a sharing arrangement must meet the requirements set forth in this final rule and be administered by the participant hospital in accordance with GAAP.
• Sharing arrangements must not include any amounts that are not alignment payments or gainsharing payments.
• Each collaborator agreement —
++ Between the participant hospital and a CJR collaborator must obligate the CJR collaborator to provide the participant hospital and HHS access to the CJR collaborator's records, information, and data for purposes of monitoring and reporting and any other lawful purpose. Records, information, and data regarding the sharing arrangement must have sufficient detail to verify compliance with all material terms of the sharing arrangement and the terms of the CJR model;
++ Must require the participant hospital and the CJR collaborator to include in their compliance programs specific oversight of their collaborator agreements and compliance with the requirements of the CJR model;
++ If the participant hospital or CJR collaborator does not have a compliance program, each party must create one and incorporate the provisions described in this part in that program; and
++ Must require the board or other governing body of the participant hospital to have responsibility for overseeing the participant hospital's participation in the model, its arrangements with CJR Collaborators, its payment of Gainsharing Payments and receipt of Alignment Payments, and its use of beneficiary incentives in the CJR model.
• Collaborator agreements must require all CJR collaborators to comply with any evaluation, monitoring, compliance, and enforcement activities performed by HHS (including CMS and OIG) and its designees for the purposes of operating the CJR model.
• Each collaborator agreement must require the CJR collaborator to permit site visits from CMS, and its designees, for purposes of evaluating the model.
“Documentation and Maintenance of Records.” We are finalizing at § 510.500(d) our proposal with regard to certain documentation requirements, and we are finalizing at new § 510.500(e) our proposal regarding access to documents and record retention. Under § 510.500(d), we require the following documentation:
• Documentation of any collaborator agreement containing a sharing arrangement must be contemporaneous with the establishment of the arrangement.
• A participant hospital must maintain accurate current and historical lists of all CJR collaborators, including their names and addresses. The participant hospital must update the lists on at least a quarterly basis and publicly report the current and historical lists of CJR collaborators on a public-facing Web page on the participant hospital's Web site.
• The participant hospital and CJR collaborator must maintain contemporaneous documentation of the payment or receipt of any gainsharing payment or alignment payment. The documentation must identify at least the following: The nature of the payment (gainsharing payment or alignment payment); the identity of the parties making and receiving the payment; the date of the payment; the amount of the payment; and the date and amount of any recoupment of all or a portion of a CJR collaborator's gainsharing payment.
++ The participant hospital must keep records of the following:
++ Its process for determining and verifying the eligibility of CJR collaborators to participate in Medicare.
++ Information confirming the organizational readiness of the participant hospital to measure and track internal cost savings.
++ The participant hospital's plan to track internal cost savings.
++ Information on the accounting systems used to track internal cost savings.
++ A description of current health information technology, including systems to track reconciliation payments and internal cost savings.
++ The participant hospital's plan to track gainsharing payments and alignment payments.
++ Whether the participant hospital recouped any gainsharing payments received by a CJR collaborator that contain funds derived from a CMS overpayment on a reconciliation report, or were based on the submission of false or fraudulent data.
• Provide to CMS, the OIG, and the Comptroller General or their designees scheduled and unscheduled access to all books, contracts, records, documents, and other evidence (including data related to utilization and payments, quality criteria, billings, lists of CJR collaborators, sharing arrangements, and distribution arrangements, and other documentation) sufficient to enable the audit, evaluation, inspection, or investigation of the individual's or entity's compliance with CJR requirements, the quality of services furnished, the obligation to repay any reconciliation payments owed to CMS, or the calculation, distribution, receipt, or recoupment of gainsharing payments, alignment payments, or distribution payments.
• Maintain such books, contracts, records, documents, and other evidence for a period of 10 years from the last day of the participant hospital's participation in the CJR model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
++ CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the participant hospital or CJR collaborator at least 30 calendar days before the normal disposition date; or
++ There has been a dispute or allegation of fraud or similar fault against the participant hospital or any CJR collaborator in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault.
We are finalizing without modification our proposal that OIG Authority is not limited or restricted by the provisions of the CJR model, including the authority to audit, evaluate, investigate, or inspect the participant hospital, CJR Collaborators, or any other person or entity or their records, data, or information, without limitation. In addition, we are finalizing without change our proposal that none of the provisions of the CJR model limits or restricts any other government authority permitted by law to audit,
“Distribution Arrangements.” As previously noted, we are finalizing our proposal with a modification to allow PGPs that are CJR collaborators to enter into distribution arrangements for the purposes of distributing all or a portion gainsharing payment with certain PGP members (practice collaboration agents). We note that we are not requiring the PGP to distribute all or a portion of a gainsharing payment to its member physicians and nonphysician practitioners. But where a PGP chooses to make such distributions, this final rule requires at new § 510.505 that all distribution arrangements must comply with all applicable laws and regulations and the following criteria:
• All distribution arrangements must be in writing and signed by the PGP and practice collaboration agent.
• Participation in a distribution arrangement must be voluntary and without penalty for nonparticipation.
• The distribution arrangement must require the practice collaboration agent to comply with the requirements set forth in this part.
• The opportunity to receive a distribution payment must not be conditioned directly or indirectly on the volume or value referrals or business otherwise generated by, between or among a participant hospital, the PGP, other CJR collaborators, any practice collaboration agents, and any individual or entity affiliated with a participant hospital, CJR collaborator, or practice collaboration agent.
• Methodologies for determining distribution payments must not directly account for the volume or value of referrals, or business otherwise generated, by, between or among the participant hospital, CJR collaborators, other CJR collaborators, practice collaboration agents, and any individual or entity affiliated with a participant hospital, CJR collaborator, or practice collaboration agent.
• A practice collaboration agent is eligible to receive a distribution payment only if the PGP billed for an item or service furnished by the practice collaboration agent to a CJR beneficiary during a CJR episode that occurred during the calendar year in which the participating hospital accrued the internal cost savings or earned the reconciliation payment that comprise the gainsharing payment made to the PGP.
• Where a PGP receives a gainsharing payment from a participant hospital pursuant to a sharing arrangement, all monies contained in such a gainsharing payment must be shared only with the physician or nonphysician practitioners that are PGP members that furnished a service to a CJR beneficiary during an episode of care in the calendar year from which the NPRA, as that term is defined in section III.C.6. of the final rule, or internal cost savings was generated, either or both of which are the only permitted sources of funds for a gainsharing payment.
• The total amount of distribution payments for a calendar year paid to an individual physician or nonphysician practitioner who is a practice collaboration agent must not exceed a cap. The total amount of distribution payments for a calendar year paid to a practice collaboration agent must not exceed 50 percent of the total Medicare approved amounts under the Medicare Physician Fee Schedule (MPFS) for services billed by the PGP and furnished by the practice collaboration agent to the participant hospital's CJR beneficiaries during a CJR episode.
• With respect to the distribution of any gainsharing payment received by a PGP, the total amount of all distribution payments must not exceed the amount of the gainsharing payment.
• All distribution payments must be made through electronic funds transfers.
• The practice collaboration agents must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.
• The distribution arrangement must not—
++ Induce a practice collaboration agent to reduce or limit medically necessary services to any Medicare beneficiary; or
++ Reward the provision of items and services that are medically unnecessary.
• The PGP must maintain contemporaneous documentation regarding distribution arrangements in accordance with § 510.500(e), including the relevant written agreements, the date and amount of any distribution payment, the identity of each practice collaboration agent who received a distribution payment, and a description of the methodology and accounting formula for determining the amount of any distribution payment.
• The PGP may not enter into a distribution arrangement with any member of the PGP that has a collaborator agreement in effect with a participant hospital.
In the proposed rule, we stated our belief that the CJR model would incent participant hospitals to furnish services directly and otherwise coordinate services throughout the episode that lead to higher quality care for the beneficiary and lower episode spending. We proposed that one mechanism that may be useful to the participant hospital in achieving these goals would be the provision of certain items and services to the beneficiary during the episode of care. We also considered whether this policy on beneficiary incentives should extend to providers and suppliers, other than the participant hospital, that furnish services during the CJR episode of care. In the proposed rule, we stated our belief that hospitals are better suited than other providers and suppliers to provide beneficiary incentives. Thus, we proposed that participant hospitals could choose to provide certain in-kind patient engagement incentives to the beneficiary, subject to a number of conditions, including the following:
• The incentive must be provided by the participant hospital to the beneficiary during CJR episode of care.
• There must be a reasonable connection between the item or service and the beneficiary's medical care.
• The item or service must be a preventive care item or service or an item or service that advances a clinical goal for a CJR beneficiary, including the following: Increasing the beneficiary's engagement in the management of his or her own health care; adherence to a treatment or drug regimen; adherence to a follow-up care plan; reduction of readmissions and complications resulting from LEJR procedures; and management of chronic diseases and conditions that may be affected by the LEJR procedure.
• Items of technology must comply with certain safeguards, as discussed later in this section.
• The participant hospital must maintain contemporaneous documentation of the incentives provided to beneficiaries for a period of 10 years.
• The cost of the incentives must not be shifted to another federal health care program.
For example, under this proposal, participant hospitals could provide incentives such as post-surgical monitoring equipment to track patient weight and vital signs for post-surgical patients discharged directly to home, but they could not provide theater tickets, which would bear no reasonable connection to the patient's medical care.
In addition to the conditions previously noted, we proposed that participant hospitals would be required to maintain contemporaneous documentation of such items and services furnished whose value exceeds $10, including the date and identity of the beneficiary to whom the item or service was provided. We further proposed that the required documentation be maintained for a period of 10 years.
We also proposed that items and services involving technology provided to beneficiaries may not exceed $1,000 in retail value at the time of donation for any one beneficiary in any one CJR episode. Items of technology exceeding $50 in retail value at the time of donation must remain the property of the participant hospital and must be retrieved from the beneficiary at the end of the episode, with the documentation of the date of retrieval. In addition, we proposed that the amount and nature of the technology must be the minimum necessary to achieve the goals previously noted earlier in this section. Finally, we proposed that beneficiary incentives may not be tied to the receipt of services outside the episode of care and that the cost of the incentives cannot be shifted to a federal health care program. Our proposals regarding beneficiary incentives are consistent with the policies on beneficiary incentives in other CMS models, such as the BPCI initiative.
We sought comment on our proposal for beneficiary incentives under CJR. In addition to general comments on the proposal, we described our interest in comments on whether the $1000 retail value limit on technology items and services is necessary, reasonable, and appropriate. We also solicited comment on whether retrieving technology valued at more than $50 would be too burdensome and whether elimination of that requirement would prevent abuse. We also solicited comment on the documentation requirement for items and services furnished that exceed $10, or whether a different amount would be more appropriate and less burdensome. We welcomed comments on additional program integrity safeguards for these arrangements.
We proposed to set forth the CJR beneficiary incentives policies in § 510.505. However, in this final rule, the beneficiary incentives section has been renumbered to § 510.515. Thus, the following discussion incorporates the final beneficiary incentive policies under the new section number.
The following is a summary of the comments received and our responses.
Several commenters expressed concern about the use of beneficiary incentives in a payment model such as the CJR model that commonly includes a substantial period of PAC services which may be furnished by different provider types during the episode, as opposed to the more traditional use of beneficiary incentives in a wellness environment where such incentives are related to prevention and primary care. The commenters urged CMS to maintain the requirement of a reasonable connection between the service and a beneficiary's medical care and that the service advance a meaningful clinical goal for the beneficiary under the CJR model. The commenters suggested that CMS take two further actions to strengthen the protections against hospitals' misuse of beneficiary incentives to influence the beneficiary's choice of providers and types of care. First, they recommended that CMS include strong and specific language prohibiting the formal or informal use of incentives as a way to steer beneficiaries toward a certain provider or type of services. Second, they urged CMS to additionally require that hospitals offer beneficiary incentives in the same way to all patients and that the hospital make their beneficiary incentive policy publicly available.
We appreciate the concerns of some commenters about the potential misuse of beneficiary incentives to steer beneficiaries toward a certain type of provider or type of services. We believe that requiring beneficiary incentives to be provided only by a participant hospital partially reduces the likelihood that such an incentive would be used to steer a beneficiary toward a specific PAC provider or type of PAC services. We are accepting the commenters' suggestion to add a requirement that beneficiary incentives must not be tied to the receipt of items or services from a particular provider or supplier. We believe this requirement, which will appear at new § 510.515(a)(5), will further reduce the potential for use of beneficiary incentives to steer a beneficiary toward a specific provider or supplier.
While we agree with the commenters who recommended that we explicitly prohibit the use of beneficiary incentives to steer a beneficiary toward a certain type of provider or types of services, we do not believe that hospitals should be required to offer the incentives in the same way to all
We believe that certain aspects of our proposal on beneficiary incentives will help to protect the program and beneficiaries from misuse of such incentives, including the requirements that only a hospital may provide patient incentives, that the incentives must be furnished during an episode of care, and that the item or service is either a preventive care item or service or advances a clinical goal for a CJR beneficiary. Accordingly, we are finalizing the conditions that we proposed in § 510.515(a)(1) and (2), but with some modification. First, we wish to clarify that the items and services may be provided by the hospital through an agent who is under the hospital's direction and control. We note that if a reasonable beneficiary would perceive the item or service as being from the agent rather than the hospital, we would not consider the incentive to have been provided by the hospital. Second, as previously noted, we are clarifying in § 510.515(a)(2) that the items and services must be reasonably connected to medical care provided to a beneficiary during an episode. We are separately incorporating the requirement that the item or service be a preventive care item or service or advance a clinical goal for a beneficiary in a CJR episode in new § 510.515(a)(3). In addition, we are also adding a new § 510.515(a)(4) to set forth the proposed requirement that the item or service must not be tied to the receipt of services outside of the episode of care. To clarify, our proposed requirement that the item or service must not be tied to the receipt of services outside of the episode of care should have also referred to the receipt of items outside of the episode of care. Thus, the new § 510.515(a)(4) requires that the item or service must not be tied to the receipt of items or services outside of the episode of care.
The commenters did not provide specific examples of items and services that would be commonly furnished as beneficiary incentives such that the cumulative documentation burden on the hospital for CJR model beneficiaries would outweigh the potential benefit to the beneficiary of the item or services. However, after considering the comments, we believe a higher retail value threshold of $25 would strike the appropriate balance between beneficiary and program protections and participant hospital administrative burden. This higher threshold will eliminate the documentation burden for some beneficiary incentives. Therefore, at § 510.515(c)(1), we are finalizing our proposed requirement that participant
We recognize that the 10-year retention requirement imposes some administrative burden, but we note that such a 10-year requirement is commonly used in Medicare. We do not believe it would be appropriate to reduce that document retention period for beneficiary incentives furnished under this model.
We understand the administrative burden on hospitals that tracking and retrieval requires, but believe that a higher retrieval threshold is not warranted. For example, given that the majority of CJR episodes will be elective THA or TKA procedures, we believe it would be inappropriate for participant hospitals to furnish items of technology with a retail value of over $100 for beneficiaries' permanent use because the high value of these items could unduly influence the beneficiary to receive services from the hospital, particularly services outside of the CJR episode of care. We do not believe the administrative burden of retrieving items involving technology with a retail value in excess of $100 outweighs the program integrity benefits of retrieval. Therefore, we are finalizing § 510.515(d)(3) to reflect the $100 retail value threshold for retrieval of items of technology.
We decline to exempt items of technology and their retrieval date from the documentation requirements. We believe that documentation is important to ensure that the provision of items of technology is in compliance with program requirements and is not used by a participant hospital to steer beneficiaries toward one provider or type of service or to engage in other abusive conduct. We stress that hospitals must carefully and completely document all of their attempts to retrieve from a beneficiary at the end of an episode items of technology whose retail value exceeds $100, regardless of whether the hospital is ultimately successful in retrieving the technology. Documented, diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement. These policies are set forth in § 510.515(d)(3)(ii).
Hospitals will not be reimbursed by CMS for the cost of items and services furnished to CJR model beneficiaries as beneficiary incentives. Participant hospitals may choose to provide in-kind patient engagement incentives to beneficiaries in CJR model episodes in accordance with the CJR regulations. Items and services of technology furnished as beneficiary incentives may not exceed $1,000 in retail value at the time they are furnished to any one beneficiary in a single CJR model episode.
Finally, we acknowledge that, in light of our proposal to require retrieval of certain items of technology, our use of the word “donate” was imprecise. We intended to refer to the retail value of technology at this time it was “furnished” to a model beneficiary.
• Any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5, United States Code [5 U.S.C. 8901
• Any state health care program, as defined in section 1128(h) [42 U.S.C. 1320a-7(h)], which includes the following:
• A state plan approved under title XIX [42 U.S.C. 1396
• Any program receiving funds under title V [42 U.S.C. 701
• Any program receiving funds under subtitle 1 of title XX [42 U.S.C. 1397
• A state child health plan approved under title XXI [42 U.S.C. 1397aa
We do not believe it would be appropriate to expand this cost-shifting prohibition to other government programs generally or to commercial programs. We question whether we have the authority to expand the cost-shifting prohibition to commercial payers. Moreover, we believe it would be very difficult to enforce such a provision in a meaningful manner.
We are finalizing this proposed condition in § 510.515(a)(7).
We are also finalizing § 510.515(b) regarding the goals of the CJR model. We note that § 510.515(b)(2) is being finalized with modification to avoid redundancy. The provision will refer to beneficiary adherence to “a care plan,” rather than “a follow-up care plan or care,” since a care plan would include follow up and other care. In addition, we are finalizing the proposed documentation requirement for beneficiary incentives with certain changes; it will apply only to those items and services furnished as beneficiary incentives whose retail value exceeds $25, and it requires contemporaneous documentation to be retained for 10 years. As no commenters objected to the proposed limit of $1,000 in retail value for items and services involving technology provided to any one beneficiary in any one CJR episode, we are finalizing this requirement under § 510.515(d)(1). We are also finalizing in revised § 510.515(d)(2) the proposed condition that the items or services involving technology provided to a beneficiary must be the minimum necessary to advance a clinical goal for a CJR beneficiary. Moreover, we are modifying the requirement that items of technology furnished as beneficiary incentives remain the property of the participant hospital and be retrieved from the beneficiary at the end of the model to apply only to those items of technology that exceed $100 in retail value, and finalizing these requirements under § 510.515(d)(3) and paragraph (d)(3)(i). Under § 510.515(d)(3)(ii), documented, diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement. Finally, we are adding new § 510.515(e) to establish the proposed documentation and record retention provision for beneficiary incentives furnished under the CJR model.
The final beneficiary incentive policies are set forth in § 510.515.
In the proposed rule, we stated our belief that it may be necessary and appropriate to provide additional flexibilities to hospitals participating in CJR, as well as other providers that furnish services to beneficiaries in CJR episodes. The purpose of such flexibilities would be to increase LEJR episode quality and decrease episode
As we have stated elsewhere in sections I.A. and III.A.3 of this final rule, our previous and current efforts in testing episode payment models have led us to believe that models where entities bear financial responsibility for total Medicare spending for episodes of care hold the potential to incentivize the most substantial improvements in episode quality and efficiency. As discussed in section III.C. of this final rule, we proposed that hospitals participating in this model be eligible for reconciliation payments based on improved performance starting in performance year 1, and we would phase-in repayment responsibility for excess episode spending starting in performance year 2. In the proposed rule, we stated our belief that where participant hospitals bear repayment responsibility for excess episode spending that surpasses the target price while high quality care is valued, they will have an increased incentive to coordinate care furnished by the hospital and other providers and suppliers throughout the episode to improve the quality and efficiency of care. With these incentives present, there may be a reduced likelihood of over-utilization of services that could otherwise result from waivers of Medicare program rules. Given these circumstances, waivers of certain program rules for providers and suppliers furnishing services to CJR beneficiaries may be appropriate to offer more flexibility than under existing Medicare rules for such providers and suppliers, so that they may provide appropriate, efficient care for beneficiaries. An example of such a program rule that could be waived to potentially allow more efficient LEJR episode care would be the 3-day inpatient hospital stay requirement prior to a covered SNF stay for beneficiaries who could appropriately be discharged to a SNF after less than a 3-day inpatient hospital stay.
In addition, in the proposed rule we stated our belief that waivers of certain Medicare program rules are necessary to make reconciliation payments to or recoup payments from participant hospitals as a result of the NPRA for each performance year as discussed in section III.C.6.a. of this final rule, as well as to exclude beneficiary cost-sharing from these reconciliation payments or repayments.
We welcomed comments on possible waivers under section 1115A of the Act of certain Medicare program rules that surpass those specifically discussed in the proposed rule that might be necessary to test this model. In the proposed rule, we stated that we would consider the comments that are received during the public comment period and our early model implementation experience and may make future proposals regarding program rule waivers during the course of the model test. We noted that we were especially interested in comments explaining how such waivers could provide providers and suppliers with additional ways to increase quality of care and reduce unnecessary episode spending, but that could be appropriately used in the context of CJR where participant hospitals bear full responsibility for total episode spending by performance year 3. We were also interested in receiving comments regarding the timing and manner in which such waivers, were they to be offered, would be implemented. For example, would it be necessary and appropriate to offer program waivers early in the model to allow providers and suppliers adequate time to adjust their care coordination strategies to implement changes permitted by the waivers, despite there being no full repayment responsibility for excess episode spending until performance year 3? What program integrity and beneficiary protection risks could be introduced by waivers of the program rules described later in this section of this final rule and how could we mitigate those risks? What other issues should be considered when making use of waiver authority with respect to program rules? What operational issues do CMS and providers and suppliers furnishing services to beneficiaries in the model need to consider and what processes would need to be in place to implement these alternative program policies? What implications would there be for provider and supplier infrastructure, including IT and other systems and processes? What provider education would be needed? We noted that any waivers included in a final rule would be offered to participant hospitals, but depending on the specifics of each waiver, might be applied to services furnished by providers and suppliers other than the hospital. Where that is the case, we sought input on how we may best educate and disseminate information using methods effective in reaching providers and suppliers. Additionally, we sought comment on how we would appropriately and accurately track the use of waivers by providers and suppliers other than participant hospitals.
Specific program rules for which we proposed waivers under the CJR model to support provider and supplier efforts to increase quality and decrease episode spending and for which we invited comments are included in the sections that follow. We proposed that these waivers of program rules would apply to the care of beneficiaries who are in CJR episodes at the time a service is furnished to a beneficiary under a waiver, even if the episode is later canceled as described in section III.B.3.b of this final rule. If a service is found to have been billed and paid by Medicare under circumstances only allowed by a program rule waiver for a beneficiary not in the CJR model at the time a service under a waiver was furnished, CMS would recoup payment for that service from the provider or supplier who was paid, and require that provider or supplier to repay the beneficiary for any coinsurance previously collected.
The following is a summary of the comments received and our response.
In the proposed rule, we also generally sought comment on any additional Medicare program rules that it may be necessary to waive using our authority under section 1115A of the Act in order to effectively test the CJR model that we could consider in the context of our early model implementation experience to inform any future proposals we may make.
The following is a summary of the comments received and our response.
We refer readers to section III.F.2. of this final rule for a discussion of the discharge planning requirements under the CJR model.
In the proposed rule, we stated our expectation that the broadly defined LEJR episodes with duration of 90 days following hospital discharge as we proposed in section III.B. of this final rule would result in participant hospitals redesigning care by increasing care coordination and management of beneficiaries following surgery. This would require participant hospitals to pay close attention to any underlying medical conditions that could be affected by the anchor hospitalization
In order for Medicare to pay for home health services, a beneficiary must be determined to be “home-bound”. Specifically, sections 1835(a) and 1814(a) of the Act require that a physician certify (and recertify) that in the case of home health services under the Medicare home health benefit, such services are or were required because the individual is or was “confined to the home” and needs or needed skilled nursing care on an intermittent basis, or physical or speech therapy or has or had a continuing need for occupational therapy. A beneficiary is considered to be confined to the home if the beneficiary has a condition, due to an illness or injury, that restricts his or her ability to leave home except with the assistance of another individual or the aid of a supportive device (that is, crutches, a cane, a wheelchair or a walker) or if the beneficiary has a condition such that leaving his or her home is medically contraindicated. While a beneficiary does not have to be bedridden to be considered confined to the home, the condition of the beneficiary must be such that there exists a normal inability to leave home and leaving home requires a considerable and taxing effort by the beneficiary. Absent this condition, it would be expected that the beneficiary could typically get the same services in an outpatient or other setting. Thus, the homebound requirement provides a way to help differentiate between patients that require medical care at home versus patients who could more appropriately receive care in a less costly outpatient setting. Additional information regarding the homebound requirement is available in the Medicare Benefit Manual (Pub 100-02); Chapter 7, “Home Health Services” Section 30.1.1, “Patient Confined to the Home”.
We considered whether a waiver of the homebound requirement would be appropriate under the CJR model, particularly beginning in performance year 2, where hospitals begin to bear repayment responsibility for excess episode spending. Waiving the homebound requirement would allow additional beneficiaries to receive home health care services in their home or place of residence. As previously discussed, physician certification that a beneficiary meets the homebound requirement is a prerequisite for Medicare coverage of home health services, and waiving the homebound requirement could result in lower episode spending in some instances. For example, if a beneficiary is allowed to have home health care visits, even if the beneficiary is not considered homebound, the beneficiary may avoid a hospital readmission. All other requirements for the Medicare home health benefit would remain unchanged. Thus, under such a waiver, only beneficiaries who otherwise meet all program requirements to receive home health services would be eligible for coverage of home health services without being homebound.
However, we did not propose to waive the homebound requirement under CJR for several reasons. Based on the typical clinical course of beneficiaries after LEJR procedures, we stated our belief that many beneficiaries would meet the homebound requirement for home health services immediately following discharge from the anchor hospitalization or following discharge to their home or place of residence from a SNF that furnished PAC services immediately following the hospital discharge, so they could receive medically necessary home health services under existing program rules. Home health episodes are 60 days in duration, and payment adjustments are made for beneficiaries who require only a few visits during the home health episode or who are discharged during the home health episode. For those CJR beneficiaries who could benefit from home visits by a licensed clinician for purposes of assessment and monitoring of their clinical condition, care coordination, and improving adherence with treatment but who are not homebound, we did not believe that paying for these visits as home health services under Medicare is necessary or appropriate, especially given that Medicare payments for home health services are set based on the clinical care furnished to beneficiaries who are truly homebound. Finally, in other CMS episode payment models, such as BPCI, we have not waived the homebound requirement for home health services.
The following is a summary of the comments received and our response.
In the proposed rule, we noted that in BPCI, we have provided a waiver of the “incident to” direct physician supervision requirement in order to allow a physician or NPP participating in care redesign under a participating BPCI provider to bill for services furnished to a beneficiary who does not qualify for Medicare coverage of home health services as set forth under § 409.42 where the services are furnished in the beneficiary's home during the episode after the beneficiary's discharge from an acute care hospital. The “incident to” direct physician supervision requirement is set forth at § 410.26(b)(5), in which services and supplies furnished “incident to” the service of a physician or other practitioner must be provided under the direct supervision (as defined at § 410.32(b)(3)(ii)) of a physician or other practitioner.
In BPCI, the waiver is available only for services that are furnished by licensed clinical staff under the general supervision (as defined at § 410.32(b)(3)(i)) of a physician (or other practitioner), as long as the individual is an employee, leased employee, or independent contractor of the physician (or other practitioner), or of the same entity that employs or contracts with the physician (or other practitioner), and while the services may be furnished by licensed clinical staff they must be billed by the physician (or other practitioner) in accordance with CMS instructions using a HCPCS G-code created by CMS specifically for the BPCI initiative. As discussed in section III.B. of this final rule, participants in the BPCI initiative are permitted to select the duration of an episode as 30 days, 60 days or 90 days. In the case of the “incident to” direct physician supervision waiver under BPCI, the waiver allows physicians and NPPs to furnish the services not more than once in a 30-day episode, not more than twice in a 60-day episode, and not more than three times in a 90-day episode. All other Medicare coverage and payment criteria must be met.
For the CJR model, we proposed to waive the “incident to” direct physician supervision requirement set forth at § 410.26(b)(5), to allow a CJR beneficiary who does not qualify for home health services to receive post-discharge visits in his or her home or place of residence any time during the episode. The waiver would not apply for beneficiaries who would qualify for home health services under the Medicare program, as set forth under § 409.42. Therefore these visits could not be billed for such beneficiaries. We proposed to allow licensed clinicians, such as nurses, either employed by a hospital or not, to furnish the service under the general supervision of a physician, who may be either an employee or a contractor of the hospital. We proposed to allow services furnished under such a waiver to be billed under the MPFS by the physician or NPP or by the hospital to which the supervising physician has reassigned his or her benefits. In the latter scenario, we noted that the post-discharge home visit services would not be “hospital services,” even when furnished by clinical staff of the hospital. While we used the term “licensed clinicians” in the proposed rule to describe the personnel furnishing a post-discharge home visit to CJR model beneficiaries, for purposes of consistency with correct coding guidelines, hereinafter we will instead use the term “clinical staff” as it is defined in the CPT coding guidelines. Specifically, in the “CPT Coding Guidelines, Introduction, Instructions for Use of the CPT Codebook” it says, a “clinical staff member is a person who works under the supervision of a physician or other qualified health care professional, and who is allowed by law, regulation and facility policy to perform or assist in the performance of a specific professional service, but does not individually report that professional service.”
We proposed that up to 9 post-discharge home visits could be billed and paid during each 90-day post-anchor hospitalization CJR episode. Given the average PAC length of stay of approximately 45 days for these episodes and the incentives under CJR to improve efficiency, which may shorten PAC stays, 9 visits would represent a home visit on average of once per week for two-thirds of the 90-day episode duration, the period of time when the typical beneficiary may have concluded PAC in an efficient episode. In the proposed rule, we stated our belief that a home visit of once a week to a non-homebound beneficiary who has concluded PAC and who could also receive services in the physician's office or hospital outpatient department as needed, along with telehealth visits in the home from a physician or NPP as proposed, should be sufficient to allow comprehensive assessment and management of the beneficiary throughout the LEJR episode. We proposed that the service be billed with HCPCS code GXXXX (CJR model, home visit for patient assessment performed by a qualified health care professional for an individual not considered homebound, including, but not necessarily limited to patient assessment of clinical status, safety/fall prevention, functional status/ambulation, medication reconciliation/management, compliance with orders/plan of care, performance of activities of daily living, and making beneficiary connections to community and other services; (for use only in the Medicare approved CJR model); may not be billed for a 30 day period covered by a transitional care management code) and paid at approximately $50 under the MPFS. We proposed that the standard MPFS ratesetting methodologies would establish relative value units (RVUs) based on the resources required to furnish the typical service. We stated that final RVUs under the CY 2016 MPFS for the proposed new HCPCS code for CJR home visits would be included in the CJR final rule. In addition, we proposed to update the values each year to correspond to final values established under the MPFS.
The waiver would not apply with respect to a CJR beneficiary who has qualified, or would qualify, for home health services when the visit was furnished. We discussed our expectation that the visits by clinical staff could include patient assessment, monitoring, assessment of functional status and fall risk, review of medications, assessment of adherence with treatment recommendations, patient education, communication and coordination with other treating clinicians, care management to improve beneficiary connections to community and other services, etc. These post-discharge home visits would remove barriers to follow-up care outside of the
We also proposed to waive current Medicare billing rules in order to allow the separate reporting of these post-discharge home visits during surgical global periods. The MPFS payment for the surgical procedure includes 90 days of post-operative care furnished by the surgeon. Post-operative follow-up care is not separately billable by the surgeon. We note that in the proposed rule we had incorrectly stated that Medicare limits the separate billing of post-operative care when there is a transfer of care to another practitioner. The current construction of the global packages included in MPFS payments reflects a more narrow view of surgical follow-up care that does not encompass broader, more comprehensive models of post-operative care, such as an episode model like CJR. As we have noted in the past, it is also difficult to determine the appropriate valuation of the various components of the current global packages (2015 Physician Fee Schedule 79 FR 67584). We did not believe that the CJR post-discharge home visits, which can include nursing assessments for chronic conditions for which care may be affected by the surgery, would replace or substantially duplicate the kind of post-operative visits involved in furnishing post-operative follow-up care for the global surgery procedure under the MPFS. Instead, we anticipated that the work of these post-discharge visits would be similar to the work furnished by the physician coordinating the patient's overall episode care. Therefore, we proposed to waive the global surgery billing rules to allow the surgeon or other practitioners to furnish and bill for the post-discharge home visits during surgical global periods.
In the proposed rule, we noted that we planned to monitor utilization patterns of post-discharge home visits under CJR to monitor for overutilization and significant reductions in medical home health services. We sought comments on the proposed waiver of the “incident to” direct physician supervision requirement to pay for a maximum number of post-discharge home visits to beneficiaries who do not qualify for home health services by clinical staff under the general supervision of a physician.
The following is a summary of the comments received and our responses.
Some commenters suggested that HHAs furnishing post-discharge home visits could be paid under the MPFS at the same rate as physicians, while other commenters suggested that HHAs should be paid at the HHPPS discipline-specific LUPA rates for the post-discharge home visits. Commenters pointed out that HHAs regularly carry out assessment home visits paid by commercial insurers, and asserted that allowing HHAs to furnish home visits to CJR model beneficiaries who are not in a home health episode would provide opportunities for physician groups to partner with HHAs on needed interventions.
Some commenters recommended that other organizations be allowed to furnish and be paid for home visits to CJR model beneficiaries, including community-based organizations and hospitals. A few commenters asserted that hospitals should be able to send nurses to a CJR beneficiary's home and bill directly for the services, rather than a hospital-based physician billing for those services. Finally, a commenter suggested that nurse practitioners be allowed to bill for the home visits.
• Furnished in a noninstitutional setting to a non-institutional patient.
• An integral, though incidental, part of the services of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness.
• Commonly furnished without charge or included in the bill of a physician (or other practitioner).
• Of a type that are commonly furnished in the office or clinic of a physician (or other practitioner)
• Furnished under direct supervision of the physician or practitioner.
• Furnished by the physician, practitioner with an “incident to” benefit, or auxiliary personnel.
• A physician (or other practitioner) may be an employee or independent contractor.
Although we proposed to waive the direct physician supervision requirement in § 410.26(b)(5) as previously discussed, clinical staff providing post-discharge home visits as “incident to” services would still need to be considered “auxiliary personnel” (employed, contracted, or leased employee of the physician or same employing organization as physician) as required by § 410.26(a)(1) and § 410.26(b)(6). Therefore, it would not be permissible for HHAs, community-based organizations, hospitals, or others to provide post-discharge home visits under the proposed “incident to” direct physician supervision waiver as these entities would not meet the definition of “auxiliary personnel” as outlined in regulation. At this time, we are declining to waive any additional
As a result, we are not providing additional waivers for post-discharge home visits to beneficiaries in the CJR model who otherwise do not qualify for Medicare home health services, other than under our proposal to allow for 9 post-discharge home visits under the “incident to” direct physician supervision waiver. We further note that under BPCI, post-discharge home visits consistent with the goals of episode payment for LEJR procedures are furnished under a similar “incident to” direct physician supervision waiver, and BPCI participants have not expressed concerns that the waiver limits their ability to efficiently provide the necessary visits. This leads us to believe that the limited waiver of only the direct physician supervision requirement for “incident to” post-discharge home visits that we are providing under the CJR model will be sufficient.
In the specific clinical scenario cited by the commenters, we note that there are already several circumstances in which CMS may cover and pay for home infusions under existing Medicare program rules should a beneficiary develop a post-surgical infection that is not preventable following LEJR surgery and that requires treatment with intravenous antibiotics. For example, many post-surgical beneficiaries will be homebound for a period of time, and skilled nursing visits for infusion would be covered under the home health benefit if the beneficiary is homebound and has no willing and able caregiver that could administer such a service. In addition, aDME for an infusion pump would be covered under the DME benefit if the drug being infused is included on the national coverage determination (NCD) for infusion pumps (
The post-discharge home visit will be billed with the HCPCS code displayed in Table 26. This code will be payable for CJR model beneficiaries beginning April 1, 2016, the start date of the first CJR model performance year as discussed in section III.C.2.a. of this final rule. Rather than finalizing the specific RVUs for this new HCPCS code in this final rule, we are finalizing them through reference to the RVUs for another HCPCS G-code paid under the MPFS, which will be released in proximity to this rule. Specifically, the RVUs for this new code will be based upon the same inputs used to determine the CY 2016 payment rate for HCPCS code G9187 (BPCI initiative home visit for patient assessment performed by a qualified health care professional for individuals not considered homebound including, but not limited to, assessment of safety, falls, clinical status, fluid status, medication reconciliation/management, patient compliance with orders/plan of care, performance of activities of daily living, appropriateness of care setting; (for use only in the Medicare-approved BPCI initiative); may not be billed for a 30-day period covered by a transitional care management code), the specific HCPCS G-code currently used to report post-discharge home visits under BPCI. We are crosswalking the RVUs for new HCPCS code G9490 to the RVUs for the existing post-discharge home visit HCPCS G-code for the BPCI model because, given our view of the similarities between these two services in the two different models and the similar HCPCS G-code descriptors, we expect the resources required to be the same so the two codes are assigned the same inputs under the standard MPFS ratesetting methodologies. In summary, we are finalizing the policy in this CJR final rule that the new HCPCS code G9490 for CJR model post-discharge home visits will have the same RVUs as HCPCS code G9187 for BPCI model post-discharge home visits, and we will finalize the RVUs for HCPCS code G9187 in the CY 2016 MPFS final rule.
The final CY 2016 RVUs, geographic practice cost indices and conversion factor that determine the MPFS payment for HCPCS code G9187 will be included in the CY 2016 MPFS final rule. We will annually update the RVUs for HCPCS code G9490 for post-discharge home visits for CJR model beneficiaries by crosswalking the RVUs for HCPCS code G9490 to HCPCS code G9187as part of the annual MPFS update, and information on the update will be included in the MPFS final rule each year.
Beneficiaries will be able to receive post-discharge home visits furnished under the “incident to” direct physician supervision waiver only during the CJR LEJR episode. All other Medicare rules for coverage and payment of services “incident” to a physician's service continue to apply.
The final post-discharge home visit policies are set forth at § 510.600, which has been revised to use the term clinical staff instead of licensed clinician, as well as to eliminate references to licensed clinician and supervising physician employment relationships that are unnecessary because all other “incident to” coverage and payment policies continue to apply. The waiver of certain post-operative billing restrictions under the MPFS global surgery rules is set forth at § 510.615.
We note that we plan to monitor utilization patterns of post-discharge home visits under CJR to monitor for overutilization or significant reductions in home health services. c. Billing and Payment for Telehealth Services
As discussed in the previous section, in the proposed rule, we described our expectation that the CJR model design features would lead to greater interest on the part of hospitals and other providers and suppliers caring for CJR beneficiaries in furnishing services to beneficiaries in their home or place of residence, including physicians' professional services. While physicians and NPPs may furnish and be paid by Medicare for home visits under the MPFS, few visits are actually furnished to Medicare beneficiaries because of the significant physician and NPP resources required for such visits and the general structure of most physician and non-physician practitioner office-based practices. For example, in 2014 only 2.6 million physician or NPP home E/M visits were furnished to Medicare beneficiaries in contrast to almost 250 million office or other outpatient evaluation and management visits furnished by physicians or NPPs. CJR would create new incentives for comprehensive episode care management for beneficiaries, including early identification and intervention regarding changes in health status following discharge from the anchor hospitalization. We discussed our understanding that participant hospitals may want to engage health care professionals in furnishing timely visits to homebound or non-homebound CJR beneficiaries in their homes or places of residence to address concerning symptoms or observations raised by beneficiaries themselves, by clinicians furnishing home health services, or by clinical staff furnishing post-discharge home visits, but physicians and NPPs committed to LEJR care redesign may not be able to revise their practice patterns to meet this home visit need for CJR beneficiaries.
Under section 1834(m) of the Act, Medicare pays for telehealth services furnished by a physician or practitioner under certain conditions even though the physician or practitioner is not in the same location as the beneficiary. The telehealth services must be furnished to a beneficiary located in one of the eight types of originating sites specified in section 1834(m)(4)(C)(ii) of the Act, and the site must satisfy at least one of the requirements of section 1834(m)(4)(C)(i)(I) through (III) of the Act. These sites include the following:
• Offices of physicians or practitioners.
• Hospitals.
• CAHs.
• RHCs
• Federally Qualified Health Centers.
• Hospital-based or CAH-based Renal Dialysis Centers (including satellites).
• SNFs.
• CMHCs.
Generally, for Medicare payment to be made for telehealth services under the MPFS, several conditions must be met, as set forth under § 410.78(b). Specifically, the service must be on the Medicare list of telehealth services and meet all of the following other requirements for payment:
• The service must be furnished via an interactive telecommunications system.
• The service must be furnished to an eligible telehealth individual.
• The individual receiving the services must be in an eligible originating site.
When all of these conditions are met, Medicare pays a facility fee to the originating site and provides separate payment to the distant site practitioner for the service. Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include professional consultations, office visits, office psychiatry services, and any additional service specified by the Secretary, when furnished via a telecommunications system. For the list of approved Medicare telehealth services, see the CMS Web site at
Some literature suggests that technologies that enable health care providers to deliver care to patients in locations remote from providers are being increasingly used to complement face-to-face patient-provider encounters in both urban and rural areas.
In other CMS episode payment models, such as BPCI Models 2 and 3, we determined it was necessary to waive the geographic site requirements of section 1834(m)(4)(C)(i)(I) through (III) of the Act. This waiver allows telehealth services to be furnished to eligible telehealth individuals when they are located at one of the eight originating sites at the time the service is furnished via a telecommunications system but without regard to the site meeting one of the geographic site requirements. For CJR, we proposed a waiver of this same provision as well as waiver of the requirement that the eligible telehealth individual be in an originating site when the otherwise eligible individual is receiving telehealth services in his or her home or place of residence. This waiver would allow providers and suppliers furnishing services to CJR beneficiaries to utilize telemedicine for beneficiaries that are not classified as rural and to allow the greatest degree of efficiency and communication between providers and suppliers and beneficiaries by allowing beneficiaries to receive telehealth services at their home or place of residence. In the proposed rule, we stated our belief that these waivers are essential to maximize the opportunity to improve the quality of care and efficiency for LEJR episodes under CJR.
Specifically, like the telehealth waiver for BPCI, we proposed to waive the geographic site requirements of section 1834(m)(4)(C)(i)(I) through (III) of the Act that limit telehealth payment to services furnished within specific types of geographic areas or in an entity participating in a federal telemedicine demonstration project approved as of December 31, 2000. Waiver of this requirement would allow beneficiaries located in any region to receive services related to the episode furnished via telehealth, as long as all other Medicare requirements for telehealth services are met. Any service on the list of Medicare approved telehealth services and reported on a claim with an ICD-10-CM principal diagnosis code that was not excluded from the CJR episode definition (see section III.B.2. of this final rule) could be furnished to a CJR beneficiary, regardless of the beneficiary's geographic location. Under CJR, this waiver would support care coordination and increasing timely access to high quality care for all CJR beneficiaries, regardless of geography. Additionally, we proposed to waive, only for the purpose of testing the CJR model, the originating site requirements of section 1834(m)(4)(C)(ii)(I) through (VIII) of the Act that specify the particular sites at which the eligible telehealth individual must be located at the time the service is furnished via a telecommunications system. Specifically, we proposed to waive the requirement only when telehealth services are being furnished in the CJR beneficiary's home or place of residence during the episode. Any service on the list of Medicare approved telehealth services and reported on a claim with an ICD-10-CM principal diagnosis code that was not excluded from the CJR episode definition (see section III.B.2. of the final rule) could be furnished to a CJR beneficiary in his or her home or place of residence, unless the service's HCPCS code descriptor precludes delivering the service in the home or place of residence. For example, subsequent hospital care services could not be furnished to beneficiaries in their home since those beneficiaries would not be inpatients of the hospital.
The following is a summary of the comments received and our responses.
Additionally, several commenters recommended that CMS modify the proposed waiver to waive the originating site requirements of the Act to allow telehealth services to be delivered to a model beneficiary when the beneficiary is not in a facility, office, or home. A commenter provided the example of a beneficiary experiencing an acute event while in a car who could pull the car off the road and access needed medical services via telehealth for treatment of his or her condition if CMS applied the proposed waiver to sites other than the home.
We do not agree with commenters who suggested we apply this waiver
The existing set of codes used to report evaluation and management (E/M) visits are extensively categorized and defined by the setting of the service, and the codes describe the services furnished when both the patient and the practitioner are located in that setting. Section 1834(m) of the Act provides for particular conditions under which Medicare can make payments for office visits when a patient is located in a health care setting (the originating sites authorized by statute) and the eligible practitioner is located elsewhere. However, in the proposed rule, we stated that we did not believe that the kinds of E/M services furnished to patients outside of health care settings via real-time, interactive communication technology are accurately described by any existing E/M codes. This would include circumstances when the patient is located in his or her home and the location of the practitioner is at another location. Therefore, in order to create a mechanism to report E/M services accurately under the CJR model, we proposed to create a specific set of HCPCS G-codes to describe the E/M services furnished to CJR beneficiaries in their homes via telehealth when the physician or practitioner is in another location.
Among the existing E/M visit services, we stated that we envision these services would be most similar to those described by the office and other outpatient E/M codes. Therefore, we proposed to structure the new codes similarly to the office/outpatient E/M codes but adjusted to reflect the location as the beneficiary's residence and the virtual presence of the practitioner. Specifically, we proposed to create a parallel structure and set of descriptors currently used to report office or other outpatient E/M services, (CPT codes 99201 through 99205 for new patient visits and CPT codes 99212 through 99215 for established patient visits). For example, in the proposed rule we discussed a HCPCS G-code for a level 3 E/M visit for an established patient would be a telehealth visit for the evaluation and management of an established patient in the patient's home, which requires at least 2 of the following 3 key components:
• An expanded problem focused history.
• An expanded problem focused examination.
• Medical decision making of low complexity.
Counseling and coordination of care with other physicians, other qualified health care professionals or agencies are provided consistent with the nature of the problem(s) and the patient's or family's needs or both. Usually, the presenting problem(s) are of low to moderate severity. Typically, 15 minutes are spent with the patient or family or both via real-time, audio and video intercommunications technology. The preceding text would be included in the code descriptor for the proposed level 3 established patient telehealth E/M visit HCPCS G-code, just as this information is currently included in the code descriptor for the corresponding level 3 established patient office/outpatient E/M CPT code.
In the proposed rule, we noted that we were not proposing a HCPCS G-code to parallel the level 1 office/outpatient visit for an established patient, since that service does not require the presence of the physician or other practitioner. We stated our belief that this would duplicate the home visits for non-homebound beneficiaries previously discussed in this section.
We proposed to develop payment rates for these new telehealth G-codes for E/M services in the patient's home that are similar to the payment rates for the office/outpatient E/M services, since the codes will describe the work involved in furnishing similar services. Therefore, we proposed to include the resource costs typically incurred when services are furnished via telehealth. In terms of the relative resource costs involved in furnishing these services, in the proposed rule we stated our belief that the efficiencies of virtual presentation generally limit resource costs other than those related to the professional time, intensity, and MP risk to marginal levels. Therefore, we proposed to adopt work and MP RVUs associated with the corresponding level of office/outpatient codes as the typical service because the practitioner's time and intensity and MP liabilities when conducting a visit via telehealth are comparable to the office visit. We stated that final RVUs under the CY 2016 MPFS would be included in the CJR final rule. Additionally, we proposed to update these values each year to correspond to final values established under the MPFS.
We considered whether each level of visit typically would warrant support by auxiliary licensed clinical staff within the context of the CJR model. The cost of such staff and any associated supplies, for example, would be incorporated in the practice expense (PE) RVUs under the MPFS. For the lower level visits, levels 1 through 3 for new visits and 2 and 3 for established visits, we did not believe that the visit would necessarily require auxiliary clinical staff to be available in the patient's home. We anticipated these lower level visits would be the most commonly furnished and would serve as a mechanism for the patient to consult quickly with a practitioner for concerns that can be easily described and explained by the patient. We did not propose to include PE RVUs for these services, since we did not believe that virtual visits envisioned for this model typically incur the kinds of costs included in the PE RVUs under the MPFS. For higher level visits, we typically would anticipate some amount of support from auxiliary clinical staff. For example, wound examination and minor wound debridement would be considered included in an E/M visit and would require licensed clinical staff to be present in the beneficiary's home during the telehealth visit in order for the complete service to be furnished. We stated our belief that it would be rare for a practitioner to conduct as complex and detailed a service as a level 4 or 5 E/M home visit via telehealth for CJR beneficiaries in LEJR episodes without licensed clinical staff support in the home.
However, we also noted that the proposed model already includes several avenues for licensed clinical staff to be in the patient's home, either through a separately paid home visit as proposed for the model or through home health services as discussed earlier in this final rule. Therefore, although we considered support by auxiliary clinical staff to be typical for level 4 or 5 E/M visits furnished to CJR beneficiaries in
We noted that because the services described by the HCPCS G-codes for the proposed model, by definition, are furnished remotely using telecommunications technology, they therefore are paid under the same conditions as in-person physicians' services and they do not require a waiver to the requirements of section 1834(m) of the Act. We also noted that because these home telehealth services would be E/M services, all other coverage and payment rules regarding E/M services would continue to apply.
We additionally noted that under the CJR model, this proposal to waive the originating site requirements and create new home visit telehealth HCPCS codes would support the greatest efficiency and timely communication between providers and beneficiaries by allowing beneficiaries to receive telehealth services at their places of residence.
The following is a summary of the comments received and our response.
The final CY 2016 RVUs, geographic practice cost indices and conversion factor that determine the payment rates for the CPT codes will be included in the CY 2016 MPFS final rule.
We will update the RVUs for the CJR model HCPCS telehealth G-codes annually by crosswalking them to the corresponding CPT codes as part of the annual MPFS update, and information on the updates will be included in the MPFS final rule each year.
With respect to home health services paid under the HH PPS, in the proposed rule we emphasized that telehealth visits under this model cannot substitute for in-person home health visits per section 1895(e)(1)(A) of the Act. Furthermore, telehealth services by social workers could not be furnished for CJR beneficiaries who are in a home health episode of care because medical social services are included as home health services per section 1861(m) of the Act and paid for under the Medicare HH PPS. However, telehealth services permitted under section 1834 of the Act and furnished by physicians or other practitioners, specifically physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives, nurse anesthetists, psychologists, and dieticians, could be furnished for CJR beneficiaries who are in a home health episode of care. Finally, sections 1835(a) and 1814(a) of the Act require that the patient has a face-to-face encounter with the certifying physician or an allowed NPP working in collaboration with or under the supervision of the certifying physician before the certifying physician certifies that the patient is eligible for home health services. Under § 424.22(a)(1)(v), the face-to-face encounter can be performed up to 90 days prior to the start of home health care or within 30 days after the start of home health care. Section 424.22(a)(1)(v)(A) also allows a physician, with privileges, who cared for the patient in an acute or PAC setting (from which the patient was directly admitted to home health) or an allowed NPP working in collaboration with or under the supervision of the acute or PAC physician to conduct the face-to-face encounter.
Although sections 1835(a) and 1814(a) of the Act allow the face-to-face encounter to be performed via telehealth, we did not propose that the waiver of the telehealth geographic site requirement for telehealth services and the originating site requirement for telehealth services furnished in the CJR beneficiary's home or place of residence would apply to the face-to-face encounter required as part of the home health certification when that encounter is furnished via telehealth. In other words, when a face-to-face encounter furnished via telehealth was used to meet the requirement for home health certification, the usual Medicare
The following is a summary of the comments received and our responses.
As we further discussed in the proposed rule, under the proposed waiver of the geographic site requirement and originating site requirement, all telehealth services would be required to be furnished in accordance with all Medicare coverage and payment criteria, and no additional payment would be made to cover set-up costs, technology purchases, training and education, or other related costs. The facility fee paid by Medicare to an originating site for a telehealth service would be waived if there is no facility as an originating site (that is, the service was originated in the beneficiary's home). Finally, providers and suppliers furnishing a telehealth service to a CJR beneficiary in his or her home or place of residence during the episode would not be permitted to bill for telehealth services that were not fully furnished when an inability to provide the intended telehealth service is due to technical issues with telecommunications equipment required for that service. Beneficiaries would be able to receive services furnished in accordance with the telehealth waivers only during the CJR LEJR episode.
The following is a summary of the comments received and our response.
We are also finalizing our proposal, without modification, to create 9 HCPCS G-codes to report home telehealth E/M visits furnished under the CJR waiver of telehealth requirements as displayed in Table 27. These codes will be payable for CJR model beneficiaries beginning April 1, 2016. We are also waiving the requirement that the same payment made for comparable office/outpatient visits be made to eligible distant site practitioners for services reported with the new HCPCS G-codes that we are creating for the CJR model to reflect that these CJR model telehealth home visit services do not require significant practice expenses. In addition, we are finalizing our proposal, without modification, that if a level 4 or 5 home telehealth visit is furnished and a post-discharge home visit is not billed on the same claim with the same date of service or the beneficiary is not in a period of authorized home health care, we will require that the physician or NPP furnishing the home telehealth visit document the presence of auxiliary licensed clinical staff in the home or include an explanation in the medical record as to the specific circumstances precluding the need for auxiliary staff for the specific telehealth visit. Finally, providers and suppliers furnishing a telehealth service to a CJR beneficiary in his or her home or place of residence during the episode will not be permitted to bill for telehealth services that were not fully furnished when an inability to provide the intended telehealth service is due to technical issues with telecommunications equipment required for that service.
Under the waiver of the geographic site requirement and originating site requirement for the CJR model, we are finalizing our proposal, without modification, that no additional payment will be made to cover set-up costs, technology purchases, training and education, or other related costs. The facility fee paid by Medicare to an originating site for a telehealth service will be waived if there is no facility as an originating site (that is, the service is originated in the beneficiary's home).
All other requirements for Medicare coverage and payment of telehealth services not otherwise waived in this final rule will continue to apply, including the list of services approved to be furnished by telehealth and the eligible distant site practitioners. Beneficiaries can receive services furnished under the telehealth waivers only during the CJR LEJR episode.
The final telehealth policies are set forth at § 510.605. We have revised § 510.605(a) and (b) to clarify that the telehealth waivers do not apply to the requirements for a face-to-face encounter for home health certification. We have revised § 510.605(c) to specify the two waivers of selected payment provisions, moving the waiver of the facility fee if the telehealth service is provided in the beneficiary's home from proposed § 510.605(b)(2) to § 510.605(c)(1) and adding § 510.605(c)(2) for the waiver of the payment requirements under section 1834(m)(2)(B) for the in-home telehealth visit HCPCS G-codes created for the CJR model. We have renumbered proposed § 510.605(c) to new (d).
We note that we plan to monitor patterns of utilization of telehealth services under CJR to monitor for overutilization or reductions in medically necessary care, and significant reductions in face-to-face visits with physicians and NPPs. We will specifically monitor the distribution of new telehealth home visits, as we anticipate greater use of lower level telehealth visits than higher level telehealth visits for CJR model beneficiaries. Given our concern that auxiliary clinical staff be present for level 4 and 5 visits furnished remotely, we will also monitor whether these visits are billed on the same claim with the same date of service as a post-discharge home visit or during a period of authorized home health care, and, if neither of the prior two conditions are met, whether our final requirement that the physician or NPP document the presence of auxiliary licensed clinical staff in the home or include an explanation in the medical record as to the specific circumstances precluding the need for auxiliary staff for the specific visit is met.
In the proposed rule, we discussed our expectation that the CJR model would encourage participant hospitals and their provider and supplier partners to redesign care for LEJR episodes across the continuum of care extending to 90 days post-discharge from the anchor hospitalization. We stated our belief that hospitals would seek to develop and refine the most efficient care pathways so beneficiaries receive the lowest intensity, clinically appropriate care at each point in time throughout the episode. We understand that in some cases, particularly younger beneficiaries undergoing total knee replacement, certain beneficiaries receiving LEJR procedures may be appropriately discharged from the acute care hospital to a SNF in less than the 3 days required under the Medicare program for coverage of the SNF stay. While total knee arthroplasty (TKA) remains payable by Medicare to the hospital only when furnished to hospital inpatients, we have heard from some stakeholders that these procedures may be safely furnished to hospital outpatients with a hospital outpatient department stay of only 24 hours. Finally, we noted that the current geometric mean hospital length of stay for LEJR procedures for beneficiaries without major complications or comorbidities (MS-DRG 470) is only 3 days and that for MS-DRG 469 for beneficiaries with such complications or comorbidities is 6 days. Thus, in the
The Medicare SNF benefit is for beneficiaries who require a short-term intensive stay in a SNF, requiring skilled nursing or skilled rehabilitation care or both. In accordance with section 1861(i) of the Act, beneficiaries must have a prior inpatient hospital stay of no fewer than 3-consecutive days in order to be eligible for Medicare coverage of inpatient SNF care. We refer to this as the SNF 3-day rule. We note that the SNF 3-day rule has been waived or is not a requirement for Medicare SNF coverage under other CMS models or programs, including BPCI Model 2. BPCI Model 2 awardees that request and are approved for the waiver can discharge Model 2 beneficiaries in less than 3 days from an anchor hospital stay to a SNF, where services are covered under Medicare Part A as long as all other coverage requirements for such services are satisfied.
Currently, FFS Medicare beneficiary discharge patterns to a SNF immediately following hospitalization for an LEJR procedure vary regionally across the country, from a low of approximately 10 percent of Medicare beneficiaries to a high of approximately 85 percent.
Because of the potential benefits we see for participating CJR hospitals, their provider partners, and beneficiaries, we proposed to waive in certain instances the SNF 3-day rule for coverage of a SNF stay following the anchor hospitalization under CJR beginning in performance year 2 of the model, when we proposed that repayment responsibility for actual episode spending that exceeds the target price would begin. We proposed to use our authority under section 1115A of the Act with respect to certain SNFs that furnish Medicare Part A post-hospital extended care services to beneficiaries included in an episode in the CJR model. We stated our belief that this waiver is necessary to the model test so that participant hospitals can redesign care throughout the episode continuum of care extending to 90 days post-discharge from the anchor hospitalization in order to maximize quality and hospital financial efficiency, as well as reduce episode spending under Medicare. However, we did not propose to waive this requirement in performance year 1, when we did not propose that participating hospitals would be responsible for excess actual episode spending. In the proposed rule, we stated our belief that there is some potential for early hospital discharge followed by a SNF stay to increase actual episode spending over historical patterns unless participant hospitals are particularly mindful of this potential unintended consequence. Without participant hospital repayment responsibility in performance year 1, we were concerned that Medicare would be at full risk under the model for increased episode spending because, without a financial incentive to closely manage care, hospitals might be more likely to discharge beneficiaries to SNFs early, leading to increased episode spending for which the hospital would bear no responsibility. Beginning in performance year 2 and continuing through performance year 5, we proposed to waive the SNF 3-day rule because we proposed that participant hospitals would bear responsibility (capped at the proposed stop-loss limit described in section III.C.8. of this final rule) for excess episode actual spending, thereby providing a strong incentive in those years for participant hospitals to redesign care with both quality and efficiency outcomes as priorities. All other Medicare rules for coverage and payment of Part A-covered SNF services would continue to apply to CJR beneficiaries in all performance years of the model.
In addition, because the average length of stay for Medicare beneficiaries hospitalized for LEJR procedures without major complications or comorbidities is already relatively short at 3 days, and in view of our concerns over protecting immediate CJR beneficiary safety and optimizing health outcomes, we proposed to require that participant hospitals may only discharge a CJR beneficiary under this proposed waiver of the SNF 3-day rule to a SNF with an overall rating of three stars or better by CMS based on information publicly available at the time of hospital discharge. Problem areas due to early hospital discharge may not be discovered through model monitoring and evaluation activities until well after the episode has concluded, and the potential for later negative findings alone may not afford sufficient beneficiary protections. CMS
We proposed that the waiver be available for the CJR beneficiary's care. The SNF would insert a Treatment Authorization Code on the claim for a beneficiary in the model where the SNF seeks to the use the waiver. This process would promote coordination between the SNF and the participant hospital, as the SNF would need to be in close communication with the participant hospital to ensure that the beneficiary is in the model at the time the waiver is used. We proposed that where the beneficiary would be eligible for inclusion in a CJR episode of care at the time of hospital discharge, use of the waiver would be permitted where it is medically necessary and appropriate to discharge the beneficiary to a SNF prior to a 3-day inpatient stay.
Beneficiaries would be eligible to receive services furnished under the 3-day rule waiver only during the CJR episode. In the proposed rule, we described our plan to monitor patterns of SNF utilization under CJR, particularly with respect to hospital discharge in less than 3 days to a SNF, to ensure that beneficiaries are not being discharged prematurely to SNFs and that they are able to exercise their freedom of choice without patient steering. We sought comment on our proposal to waive the SNF 3-day stay rule for stays in SNFs rated overall as three stars or better following discharge from the anchor hospitalization in CJR episodes.
The following is a summary of the comments received and our responses.
Given the importance of this waiver to care redesign for LEJR episodes, many commenters recommended that CMS implement the waiver in the first performance year of the model, even though CMS proposed that hospitals would have no repayment responsibility in that year. The commenters asserted that participant hospitals would be focused in the first year of the model on creating and implementing episode care processes and procedures in order to achieve successful quality and episode spending performance. These activities would include establishing or reviewing discharge planning protocols and clinical pathways. The commenters stated that if the waiver were unavailable until performance year 2, hospitals would have to undertake many of these activities again in the second performance year, creating inefficiency and unnecessary administrative burden.
Regarding the commenters' request to make the SNF 3-day stay rule waiver available to participant hospitals in the
The commenters opposing the proposal to allow the waiver to be used only for CJR model beneficiaries' discharges to SNFs with an overall rating of three stars or better recommended that this proposal would create two tiers of separate and unequal care because the percentage of SNFs that meet this requirement in the selected MSAs was so variable. The commenters asserted that participant hospitals located in those MSAs with an adequate supply of three star or greater SNFs, such as where half or more of the SNFs meet the quality requirement, would be able to establish flexible, patient-centered care pathways, where participant hospitals located in those MSAs with an inadequate supply of three star or better SNFs, such as where less than half of the SNFs meet the quality requirement, would need to create more restrictive care pathways driven by CMS's SNF overall star rating requirements. Some commenters estimated that the variation in the percentage of qualifying SNFs in the selected MSAs was 20 percent to 80 percent, and recommended that this variation created an unlevel playing field for hospitals required to participate in the CJR model.
A number of commenters acknowledged the quality rationale for CMS's proposal but stated arguments about why the SNF overall star rating was not appropriate for use as the quality requirement for waiver use. These commenters asserted that the overall star rating provides little information about the quality of care for short stay residents, the category that CJR model beneficiaries would fall into, because few of the assessment questions would apply to them. Some commenters pointed out that the current star rating does not incorporate important measures of quality of care for LEJR episode beneficiaries, such as function, the ability to ambulate, hospital readmissions, and emergency department utilization. Other commenters believe that periodic recalibration activities by CMS that alter SNF scores could lead high quality SNFs working in close partnership with CJR participant hospitals to suddenly become ineligible to treat model beneficiaries under the waiver. These commenters described significant month-to-month fluctuations in SNF overall star ratings for individual SNFs that could be highly disruptive to stable care redesign under the CJR model. Several commenters suggested that SNFs with embedded specialty expertise, such as behavioral health, might be unable to admit CJR model beneficiaries who required that specialized SNF expertise.
Some commenters recommended that CMS provide accommodation for those MSAs with low percentages of qualifying SNFs, but did not specify the parameters that should accompany such accommodation. Other commenters recommended that CMS deem all hospital-owned SNFs eligible for the waiver, regardless of their star rating, or beneficiaries may need to leave their home geographic area. A commenter pointed out that swing beds in CAHs that may function as PAC providers do not have star ratings and, under CMS's proposal, would therefore be ineligible for payment under the SNF 3-day rule waiver for CJR model beneficiaries. The commenter suggested that CMS waive the proposed three star or better requirement when the PAC provider is a CAH swing bed, because these PAC providers can be an excellent choice for rural beneficiaries following an LEJR procedure due to the available resources in the CAH and the proximity of the facility to beneficiary's home.
A number of commenters recommended that CMS modify its proposal to base SNF eligibility on the overall star rating to instead base SNF eligibility on a rating of three stars or better on two of the three criteria used in the overall rating, specifically quality measures and staffing. These commenters recommended that these two criteria are meaningful for LEJR episode patients, while including the state survey criterion (the third criterion in the overall star rating) would lead to large facilities being disadvantaged because state surveyors would be more likely to find deficiencies based on larger numbers of residents. The commenters asserted that different states and different surveyors could lead to unpredictable results on the health inspections criterion for various SNFs that would unfairly affect the overall star rating and, therefore, the ability of SNFs to accept CJR model beneficiaries under the waiver. However, several other commenters pointed out that two of the three criteria used in the SNF overall star rating are self-reported by SNFs without verification, observing that only the annual inspection is derived from assessment by an independent observer.
Several commenters observed that the BPCI SNF quality requirement for use of the waiver is less stringent. BPCI Model 2 Awardees are approved to use the waiver for all of the Awardee's BPCI Model 2 beneficiaries based on their submission of partner SNFs each quarter, where the majority of those
As we stated in the proposed rule, we continue to believe that because of the potential risk of premature hospital discharge before a beneficiary is medically stable and of care stinting that may result from the financial incentives under the CJR model to reduce actual episode spending and generate hospital internal cost savings, we need to ensure that when a CJR beneficiary is discharged to a SNF before having stayed in the hospital for a qualifying 3-day or longer stay, discharges are to SNFs that provide care of at least average overall quality. Balancing beneficiary protection with the potential for participant hospitals to create patient-centered care pathways that improve quality and episode efficiency, we believe it is most appropriate for all CJR beneficiaries discharged from the participant hospital to a SNF in less than 3 days be admitted to a SNF that has demonstrated that it is capable of providing quality care to patients with significant unresolved post-surgical symptoms and problems. Thus, we believe that establishing a quality performance requirement for SNFs accepting each CJR beneficiary under the waiver is important, especially given the geographic distribution and variety of hospitals included in the CJR model, as well as the estimate from a commenter of the significant number of model beneficiaries (20 percent of elective THA and TKA model beneficiaries) that could be eligible for early hospital discharge to a SNF.
We do not believe that adopting the BPCI Model 2 SNF 3-day stay waiver policy in totality is appropriate. Under BPCI Model 2, so long as the participant identifies sufficient partnerships with SNFs with an overall rating of three stars or better, then the 3-day stay requirement is waived for that participant's discharges of BPCI model beneficiaries, even if beneficiaries are admitted to SNFs with an overall star rating of fewer than three stars. In other words, the 3-day stay rule waiver applies at the level of the financially responsible entity. Moreover, BPCI is a voluntary model where participants sign participation agreements with CMS after having assessed the opportunities under the model and chosen to participate, and can select among 48 different clinical episodes. These design features of BPCI reduce the potential risks of decreased access to care and care stinting. In contrast, under the CJR model which requires participation of substantially all IPPS hospitals in the selected MSAs, where the participant hospitals have varying levels of readiness to develop the care pathways and partnerships necessary for high quality and cost performance under an episode payment model, we believe it is necessary and appropriate to apply the waiver at the SNF level. That is, we believe that in the CJR model, it is necessary to ensure that every CJR beneficiary discharged to a covered SNF stay after less than a 3-day anchor hospitalization is discharged to a SNF that provides care of at least average quality.
In terms of establishing the quality requirement for SNFs accepting CJR model beneficiaries under the waiver, while we appreciate the variation in qualifying SNFs under our proposal across the participating MSAs, we need to balance the goal of improved efficiency under an episode payment model through additional access to a covered SNF stay after an anchor hospitalization of less than 3 days with protecting beneficiaries from the risks of care stinting and premature discharge from the hospital that may result from the financial incentives of episode payment. We estimate that although the national average percentage of SNFs rated three stars or better is greater than 60 percent, the percentage of qualifying SNFs in the MSAs selected for this model range from 22 percent to over 80 percent. However, we note that every MSA does have at least one SNF that would qualify for the waiver under our proposal and, therefore, all CJR model beneficiaries would have access to at least one SNF in the MSA of the participant hospital that meets the SNF overall star rating requirement for the waiver.
We believe it is appropriate to restrict access to the waiver for beneficiaries who are eligible for discharge to a medically necessary SNF stay after less than a 3-day anchor hospitalization to discharge to a SNF with an overall star rating of three stars or better in order to ensure SNF quality and, therefore, protect the beneficiary from potential harm that could arise from the financial incentives of the CJR episode payment model. We believe we need to balance the importance of beneficiary access to the waiver with our concerns about sufficient beneficiary protections under this innovative episode payment model that otherwise alters the rules under which Medicare pays hospitals and allows different financial arrangements among providers and suppliers. Problem areas due to early hospital discharge may not be discovered through model monitoring and evaluation activities until well after the episode has concluded, and we do not believe the potential for later negative findings alone provides sufficient beneficiary protections. Thus, we believe it is appropriate to establish a quality requirement for SNFs accepting patients for Part A-covered stays under the waiver, and believe that participant hospitals will need to convey all relevant information to CJR model beneficiaries who require SNF stays and are candidates for discharge from the anchor hospitalization in less than 3 days. If a CJR beneficiary is discharged to a SNF with an overall rating of two stars or less without a preceding 3-day anchor inpatient hospital stay, the SNF stay will not be covered under Medicare Part A, consistent with existing Medicare rules. However, we note that imposing conditions upon a waiver that, in effect, provides for additional coverage of certain SNF stays is not the same as restricting access to certain SNFs. We are not restricting beneficiary choice of SNFs. We believe it is important for beneficiaries to have unrestricted choice of providers under this model as well as access to SNFs with appropriate specialty expertise or located in their immediate community. We refer readers to section III.F.2. of this final rule for further discussion of the beneficiary choice and notification issues under this model, including their applicability to model beneficiaries who may be discharged in less than 3 days to a SNF.
Finally, for the reasons previously discussed regarding our need to balance access to the waiver with beneficiary protections, we are not making any exceptions to the overall star rating requirement for PAC providers without a star rating or hospital-owned SNFs. We note that all existing Medicare program rules will continue to apply to these providers regarding Part A-covered SNF stays, and CJR model beneficiaries will continue to be able to be discharged to these PAC providers for a Medicare-covered stay as long as the preceding inpatient hospital stay extends at least 3 days.
We appreciate the suggestions of commenters regarding alternatives to using the SNF overall star rating to determine the eligibility of a SNF to be paid for CJR model beneficiaries under the waiver based on the quality of SNF care. However, we continue to believe that SNF overall star ratings reflect important differences in quality among SNFs that are applicable to care for CJR model beneficiaries recovering after LEJR surgery. CMS rates nursing homes on three categories: Results from onsite inspections by trained surveyors, performance on certain quality measures, and levels of staffing. We use these three categories to create an overall star rating, which balances facility-reported information with independent observation. While consumers can see and focus on any of the three individual categories, we believe for purposes of this model that the overall star rating that incorporates all three categories of SNF quality performance in an overall rating is the most appropriate choice to determine SNF eligibility for use of the waiver under the CJR model, based on the SNF's record of average or better care as reflected in the most comprehensive SNF quality rating that takes into account all categories of information about SNF quality.
We acknowledge the disruption to partnerships among hospital participants and SNFs that may occur due to the potential for month-to-month changes in a SNF's quality rating and periodic CMS recalibration. We understand the substantial effort necessary for provider collaboration in care redesign and do not want the SNF 3-day stay waiver policies of the CJR model to unnecessarily disrupt or hamper these partnerships. We proposed to require that participant hospitals may only discharge a CJR beneficiary under the proposed waiver of the SNF 3-day rule to a qualified SNF with an overall rating of three stars or better by CMS based on information publicly available at the time of hospital discharge. However, in order to create more stability in our determination of SNF eligibility based on a pattern of quality performance, and in response to comments, we are modifying our proposal. Under our final policy, we will determine a SNF's qualification for payment under the CJR model waiver based on an overall star rating of three stars or better for at least 7 of the 12 preceding months according to the most recent star rating data available for the quarter in which the CJR beneficiary's admission to the SNF occurs. Specifically, we will prepare and make publicly available a list of qualified SNFs for each calendar quarter of the CJR model performance years, based on our examination of the most recent rolling 12-month period of SNF overall star ratings, and the waiver will apply for admissions to SNFs on our list during the relevant calendar quarter, assuming all other requirements for the waiver are met as discussed in this final rule. The use of such a list to determine qualified SNFs who are eligible for payment under the waiver will facilitate the ease of administration of the policy through CMS's shared systems, as well as ensure a common understanding among participant hospitals, SNFs, CJR model beneficiaries and other providers and suppliers about the specific SNFs who are qualified for Medicare Part A payment under the waiver at any given time in the model performance period.
While we will be using the pattern of SNF quality performance reflected over a rolling 12-month period to qualify SNFs for the 3-day stay waiver under the CJR model, similar to our examination of 12 months of SNF overall star ratings for BPCI partner SNFs, in contrast to BPCI Model 2, the CJR model waiver will only permit a Part A-covered SNF stay if the CJR beneficiary receives care at a qualified SNF, defined as a SNF that meets our quality requirements as determined by its inclusion on the applicable quarterly list of qualified SNFs at the time of the CJR beneficiary's admission to that SNF. In this regard, our standard under the CJR model is more stringent than under BPCI Model 2, in order to provide additional beneficiary protections under this model that includes substantially all IPPS hospitals in 67 MSAs, rather than Awardees participating in a voluntary model such as BPCI. As discussed earlier in this section, we believe that stronger beneficiary protections under the CJR model are necessary due to the required, rather than voluntary, hospital participation in the model, which will include hospitals at varying stages of readiness for engagement in the care redesign and partnerships necessary for high quality and cost performance under episode payment.
We expect that the most recent SNF quality data will lag the admission to the SNF under the CJR by several months, at a minimum. As under BPCI Model 2, we will update our determination of SNFs that qualify for the CJR model waiver every quarter, to ensure that we regularly incorporate updated SNF star ratings reflective of the most recent SNF quality performance into our determinations of SNF eligibility to admit CJR model beneficiaries under the waiver. To minimize any confusion about SNF qualification for participant hospitals and SNFs, we will post to the CMS Web site prior to the beginning of each quarter the list of qualified SNFs who may use the waiver for admissions of CJR model beneficiaries with less than a 3-day anchor hospitalization. We believe the use of a rolling 12-month period to assess SNF qualification based on the pattern of overall star ratings appropriately balances our interest in ensuring SNF quality for a beneficiary during a timeframe that is reasonably close to the CJR beneficiary's admission to the SNF, with our interest in encouraging stable, effective arrangements between SNFs that furnish high quality care and participant hospitals in the CJR model.
We expect that SNFs using this waiver to bill for a Part A-covered SNF stay for a CJR beneficiary discharged from a participant hospital after an inpatient stay of less than 3-days will need to work closely with the participant hospital to determine the applicability of the waiver prior to admitting the beneficiary to the SNF because billing will not occur until after the SNF services are rendered. Specifically all of the following requirements will need to be met for the stay to be covered under the waiver:
• The hospitalization does not meet the prerequisite hospital stay of at least 3 consecutive days for Part A coverage of “extended care” services in a SNF. If the hospital stay would lead to covered PAC SNF treatment in the absence of the waiver, then the waiver is not necessary for the stay.
• The discharge is from a participant hospital in the CJR model. Participant hospitals can be confirmed by a posted file on the CMS Web site.
• The beneficiary's discharge is from MS-DRG 469 or MS-DRG 470.
• The beneficiary must have been discharged from the CJR model participant hospital for one of the two specified MS-DRGs within 30 days prior to the initiation of SNF services.
• The beneficiary meets the criteria for inclusion in the CJR model at the time of SNF admission: That is, he or she is enrolled in Part A and Part B, eligibility is not on the basis of ESRD, is not enrolled in any managed care plan, is not covered under a United Mine Workers of American health plan, and Medicare is the primary payer.
• The SNF is qualified to admit CJR model beneficiaries under the waiver on the date of SNF admission based on its overall star rating, which can be confirmed for the applicable date of SNF admission by a posted file on the CMS Web site that identifies qualified SNFs based on their overall star rating of three stars or better for at least 7 of the preceding 12 months. The file will be updated quarterly, reflecting a rolling 12-month period of SNF overall star ratings.
We will provide additional information on the use of this waiver to providers through MLN Matters articles and other methods prior to the beginning of performance year 2. Medicare will not cover and pay under Part A for SNF services under the CJR model SNF 3-day stay rule waiver unless all of the previously stated criteria are met. SNFs who report the treatment authorization code under circumstances where one or more of these criterion are not met will not be paid by Medicare under the waiver.
Beneficiaries will be able to receive a Part A-covered SNF stay furnished in accordance with the SNF 3-day stay rule waiver only during the CJR episode. All other Medicare rules for coverage and payment of Part A-covered SNF services continue to apply.
The final SNF 3-day stay rule policies are set forth at § 510.610, where § 510.610(a) has been revised to clarify that the waiver applies to SNFs on the calendar quarter list of qualified SNFs and subparagraphs (1) and (2) added to reflect CMS's quarterly determination of qualified SNFs based on their overall rating of three stars or better for at least 7 of the 12 months of rolling data and subsequent posting to the CMS Web site of the list of qualified SNFs for the calendar quarter.
In order to make reconciliation payment to or carry out repayment from a participant hospital that results from the NPRA calculation for each performance year as discussed in section III.C.6.a. of this final rule, in the proposed rule we stated our belief that we would need to waive certain Medicare program rules. Therefore, in accordance with the authority granted to the Secretary in section 1115A(d)(1) of the Act, we proposed to waive requirements of the Act for all Medicare Part A and Part B payment systems only to the extent necessary to make reconciliation payments or receive repayments based on the NPRA that reflect the episode payment methodology under the proposed payment model for CJR participant hospitals selected in accordance with CMS's proposed selection methodology. In addition, we did not propose that reconciliation payments or repayments change beneficiary cost-sharing from the regular Medicare program cost-sharing for the related Part A and Part B services that were paid for CJR beneficiaries and aggregated to determine actual episode spending in the calculation of the NPRA. We therefore proposed to waive the requirements of sections 1813 and 1833(a) of the Act to the extent that they would otherwise apply to reconciliation payments or repayments from a participant hospital under the CJR model. We sought comment on our proposed waivers related to repayment and repayment actions as a result of the NRPA calculated.
This waiver is set forth at new § 510.620.
CMS must have certain mechanisms to enforce compliance with the requirements of the model, either by the participant hospital, or by an entity or individual included in the CJR model by furnishing a service to a beneficiary during a CJR episode. The following discussion details the enforcement mechanisms we proposed to make available to CMS for the CJR model.
We proposed an enforcement structure that would be consistent with other CMMI models. We believed that Model 2 of the BPCI initiative is an appropriate model for comparison, given that Model 2 and CJR share many of the same policy characteristics, particularly with respect to episode definition. For example, the participation agreement between CMS and a participant (called an Awardee) in BPCI Model 2 provides that CMS may immediately or with advance notice terminate the awardee's participation in the model or require the Awardee to terminate its agreement (“participant agreement”) with a participating provider or supplier that is not in compliance with BPCI requirements. In such circumstances, CMS may direct the Awardee to terminate its participant agreement with a participating provider or supplier because the Awardee has a participation agreement with CMS, whereas the participating provider or supplier does not. CMS may require termination of the Awardee or a participating provider or supplier if—
• CMS determines that it no longer has the funds to support the BPCI model;
• CMS terminates the model pursuant to section 1115A(b)(3)(B) of the Act; or
• The BPCI awardee or an individual or entity participating in BPCI under the awardee does any of the following:
++ Takes any action that threatens the health or safety of patients; avoids at-risk Medicare beneficiaries, as this term is defined in § 425.20; or avoids patients on the basis of payer status.
++ Is subject to sanctions or final actions of an accrediting organization or federal, state or local government agency that could lead to the inability to comply with the requirements and provisions of the BPCI agreement.
++ Takes or fails to take any action that CMS determines for program integrity reasons is not in the best interests of the BPCI initiative.
++ Is subject to action by HHS (including OIG and CMS) or the Department of Justice to redress an allegation of fraud or significant misconduct, including intervening in a False Claims Act qui tam matter, issuing a pre-demand or demand letter under a civil sanction authority, or similar actions.
Under the terms of the BPCI agreement, upon CMS's termination of the agreement for any of the reasons previously listed in this section, CMS may immediately cease the distribution of positive reconciliation payments to the awardee and the awardee must immediately cease the distribution of any gainsharing payments.
Many CMMI models also allow for CMS to impose remedial actions to address noncompliance by either a participant that has a direct relationship (participation agreement) with CMS, or by any individual or entity participating in the CMMI model pursuant to an agreement with the participant hospital. For example, with respect to the BPCI Model 2, where CMS determines that there may be noncompliance, CMS may take any or all of the following actions:
• Notify the BPCI awardee of the specific performance problem.
• Require the awardee to provide additional data to CMS or its designees.
• Require the awardee to stop distributing funds to a particular individual or entity.
• Require the awardee to forgo the receipt of any positive reconciliation payments from CMS.
• Request a corrective action plan from the awardee.
++ If CMS requests a corrective action plan, then the following requirements apply to awardees in the BPCI initiative:
Under the CJR model, we proposed that CMS would have the enforcement mechanisms detailed in this section available for use against participant hospitals and any entity or individual furnishing a service to a beneficiary during a CJR episode, where the participant hospital or such entity or individual: (1) Does not comply with the CJR model requirements; or (2) is identified as noncompliant via CMS' monitoring of the model or engage in behavior related to any of the reasons previously described that apply to the BPCI initiative. These mechanisms will support the goals of CJR to maintain or improve quality of care. Given that participant hospitals may receive reconciliation payments, and choose to distribute or share those payments with other providers or suppliers (“CJR collaborators”) we believed that enhanced scrutiny and monitoring of participant hospitals and CJR collaborators under the model is necessary and appropriate. Participant hospitals and CJR collaborators will also be subject to all existing requirements and conditions for Medicare participation not otherwise waived under section 1115A(d)(1) of the Act.
We proposed that CMS would have the option to use any one or more of the following enforcement mechanisms for participant hospitals in CJR. We further proposed that these enforcement mechanisms could be instituted and applied in any order, as is consistent with other CMMI models:
• Warning letter—We proposed to give CMS the authority to issue a warning letter to participant hospitals to put them on notice of behavior that may warrant additional action by CMS. This letter would inform participant hospitals of the issue or issues identified by CMS leading to the issuance of the warning letter.
• Corrective Action Plan—We proposed to give CMS the authority to request a corrective action plan from participant hospitals. We proposed the following requirements for corrective action plans:
++ The participant hospital would be required to submit a corrective action plan for CMS approval by the deadline established by CMS.
++ The corrective action plan would be required to address what actions the
++ The corrective action plan could include provisions requiring that the participant hospital terminate collaborator agreements with CJR collaborators that are determined by HHS to be engaging in activities involving noncompliance with the provisions of this final rule, engaged in fraud or abuse, providing substandard care, or experiencing other integrity problems.
++ The participant hospital's failure to comply with the corrective action plan within the specified time period could result in additional enforcement action, including: (1) Termination; (2) automatic forfeiture of all or a portion of any reconciliation payments as that term is defined in section III.C. of the proposed rule; (3) CMS's discretionary reduction or elimination of all or a portion of the hospital's reconciliation payment; or (4) a combination of such actions.
• Reduction or elimination of reconciliation amount—We proposed to give CMS the authority to reduce or eliminate a participant hospital's reconciliation amount based on noncompliance with the model's requirements, negative results found through CMS' monitoring activities, or the participant hospital's noncompliance associated with a corrective action plan. For example, where CMS requires a participant hospital to submit a corrective action plan, the result of the participant hospital's failure to timely comply with that requirement could be a 50 percent reduction in the reconciliation amount due to the participant hospital at the end a performance year, where the participant hospital's reconciliation report reflects a positive reconciliation amount. We solicit comments on whether negative monitoring results and noncompliance with program requirements or corrective action plans should result in automatic forfeiture of all or a portion of positive NPRA, the amount that could be forfeited or reduced, the number of performance periods over which NPRA may be forfeited or reduced per instance or episode of noncompliance, whether the amount should be a fixed percentage of NPRA or a variable amount depending on the nature and severity of the noncompliance, and the criteria CMS should use in deciding the severity of noncompliance.
Where the participant hospital's reconciliation report reflects a repayment amount, forfeiture of a reconciliation amount would not be an option for that performance year. In such a case, we considered whether CMS would require the participant hospital to forfeit a certain percentage of a reconciliation amount in the reconciliation report for a future performance year. However, in the case of a failure to comply with the model's requirements, presence of negative results found through CMS's monitoring activities, or noncompliance associated with a corrective action plan, we believed a policy that would increase the amount of repayment amount on the reconciliation report for the performance year in which the noncompliance occurred by the participant hospital is more likely to result in compliance from the hospital. Therefore, we proposed to add 25 percent to a repayment amount on a reconciliation report, where the participant hospital fails to timely comply with a corrective action plan or is noncompliant with the model's requirements. We sought comments on this forfeiture policy, including the percentage to be added to a repayment amount on a reconciliation report; the number of performance periods over which a reconciliation amount may be forfeited or reduced per instance or episode of noncompliance; whether the amount should be a fixed percentage of a reconciliation amount or repayment amount, as applicable, or a variable amount depending on the nature and severity of the noncompliance; and the criteria CMS should use in deciding the severity of noncompliance.
• Termination from the model—Given the provisions we proposed outlining the participation of hospitals in the model, we believed that, in contrast to other CMS models, termination from the CJR model would contradict the model's design. As a result, in some circumstances termination from the model may be unlikely to be a sufficient mechanism to deter noncompliance by participant hospitals. While we believed termination is a remedy unlikely to be frequently used by CMS in this model, we nonetheless leave open the possibility that in extremely serious circumstances termination might be appropriate, and for that reason, we proposed to include it as an available enforcement option. Where a participant hospital is terminated from the CJR model, we proposed that the hospital would remain liable for all negative NPRA generated from episodes of care that occurred prior to termination. We proposed that CMS may terminate the participation in CJR of a participant hospital when the participant hospital, or a CJR collaborator that has a collaborator agreement with a participant hospital and performs functions or services related to CJR activities, fails to comply with any of the requirements of the CJR model. We further proposed that CMS could terminate the participant hospital's participation in the model, or require a participant hospital to terminate a collaborator agreement with a CJR collaborator for reasons including, but not limited to the following:
• CMS determines that it no longer has the funds to support the CJR model.
• CMS terminates the model pursuant to section 1115A(b)(3)(B) of the Act.
• The CJR participant hospital, or an individual or entity participating in CJR under the participant hospital does any of the following:
++ Takes any action that threatens the health or safety of patients; avoids at-risk Medicare beneficiaries, as this term is defined in § 425.20; or avoids patients on the basis of payer status.
++ Is subject to sanctions or final actions of an accrediting organization or federal, state or local government agency that could lead to the inability to comply with the requirements and provisions of this final rule.
++ Takes or fails to take any action that CMS determines for program integrity reasons is not in the best interests of the CJR model.
++ Is subject to action by HHS (including OIG and CMS) or the Department of Justice to redress an allegation of fraud or significant misconduct, including intervening in a False Claims Act qui tam matter, issuing a pre-demand or demand letter under a civil sanction authority, or similar actions.
++ Is subject to action involving violations of the physician self-referral law, civil monetary penalties law, federal anti-kickback statute, antitrust laws, or any other applicable Medicare laws, rules, or regulations that are relevant to the CJR model.
• Other Enforcement Mechanisms—We seek to incorporate policies regarding enforcement mechanisms that are necessary and appropriate to test the CJR model. Thus, we sought public comment on additional enforcement mechanisms that would contribute to the following goals:
++ Allow CMS to better operate or monitor the model.
++ Appropriately engage and encourage all entities and individuals furnishing a service to a beneficiary during a CJR episode to comply with the requirements and provisions of the CJR model.
++ Preserve the rights of Medicare beneficiaries to receive medically necessary care, to not be endangered by providers and suppliers engaging in noncompliant activities, and to be able to choose from whom they want to receive care.
We sought public comment on these proposals and invited commenters to propose additional safeguards we should consider in the final rule.
The following is a summary of the comments received and our responses.
We leave open the possibility for future rulemaking on the issue of enforcement mechanisms for this model. We believe that providing, at a minimum, a non-exhaustive list of the types of behaviors against which CMS would use each of these enforcement mechanisms could offer useful clarification for participant hospitals and CJR collaborators.
We had proposed that CMS would have the enforcement mechanisms detailed in this section available for use against participant hospitals and any entity or individual furnishing a service to a beneficiary during a CJR episode, where the participant hospital or such entity or individual: (1) Does not comply with the CJR model requirements; or (2) is identified as noncompliant via CMS' monitoring of the model, or (3) engage in behavior related to any of the reasons previously described that apply to the BPCI initiative.
We are finalizing this proposal with a modification to clarify that CMS will enforce the model's requirements against participant hospitals. Given that participant hospitals may receive reconciliation payments, and choose to distribute or share those payments with other providers or suppliers (“CJR collaborators”) we believe that enhanced scrutiny and monitoring of participant hospitals is necessary and appropriate. We also believe that by making the participant hospital responsible for compliance with the CJR model, CMS will be indirectly ensuring CJR collaborators compliance, in addition to any direct monitoring by HHS (including CMS and OIG) of providers and suppliers that are CJR collaborators. However, because entities and individuals that are not participant hospitals are not actually participants in the CJR model, we will hold the participant hospital responsible for their own and their CJR collaborators' compliance with applicable model requirements. Thus, where CMS, HHS, or its designees discovers an instance of noncompliance by a CJR collaborator with the requirements of the CJR model, CMS, HHS, or its designees may take remedial action against the participant hospital, which may include requiring the participant hospital to terminate a collaborator agreement with a CJR collaborator and prohibit further engagement in the CJR model by that CJR collaborator. Participant hospitals and CJR collaborators remain subject to all existing requirements and conditions for Medicare participation not otherwise waived for this model under section 1115A(d)(1) of the Act.
We are finalizing our proposal to give CMS the option to use any one or more of the following enforcement mechanisms for participant hospitals in CJR. These enforcement mechanisms may be instituted and applied in any order, as is consistent with other CMS models:
• Warning letter—We are finalizing our proposal to give CMS the authority to issue a warning letter to participant hospitals to put them on notice of behavior that may warrant additional action by CMS. This letter will inform participant hospitals of the issue or issues identified by CMS leading to the issuance of the warning letter.
• Corrective Action Plan—We are finalizing our proposal to give CMS the authority to request a corrective action plan from participant hospitals. We are finalizing our proposal the following requirements for corrective action plans:
++ The participant hospital will be required to submit a corrective action plan for CMS approval by the deadline established by CMS.
++ The corrective action plan will address what actions the participant hospital must take within a specified time period to correct the issues identified by CMS.
++ The corrective action plan may include provisions requiring that the participant hospital terminate collaborator agreements with CJR collaborators that are determined by CMS, HHS, or its designees to be engaging in activities involving noncompliance with the provisions of this final rule, engaged in fraud or abuse, providing substandard care, or experiencing other integrity problems.
++ The participant hospital's failure to comply with the corrective action plan within the specified time period could result in additional enforcement action, including: (1) Termination; (2) automatic forfeiture of all or a portion, at CMS' discretion, of any reconciliation payments as that term is defined in section III.C. of the proposed rule; or (3) a combination of such actions.
• Reduction or elimination of reconciliation amount—We are finalizing our proposal to give CMS the authority to reduce or eliminate a participant hospital's reconciliation payment based on noncompliance with the model's requirements, negative results found through CMS' monitoring activities, or the participant hospital's noncompliance associated with a corrective action plan (as noted previously). For example, where CMS requires a participant hospital to submit a corrective action plan, the result of the participant hospital's failure to timely comply with that requirement could be a 50 percent reduction in the reconciliation payment due to the participant hospital at the end a performance year, where the participant hospital's reconciliation report reflects a reconciliation payment.
Where the participant hospital's reconciliation report reflects a repayment amount, forfeiture of a reconciliation payment would not be an option for that performance year. Therefore, we are finalizing our proposal to add 25 percent to a repayment amount on a reconciliation report, where the participant hospital fails to timely comply with a corrective action plan or is otherwise noncompliant with the model's requirements. This provision includes noncompliance by CJR collaborators with the model's requirements.
• Termination from the model—Given this model's provisions outlining the participation of hospitals in the model, we believe that, in contrast to other CMS models, termination from the CJR model would contradict the model's design. Nonetheless, we believe it is important for CMS to have this enforcement mechanism as an available option, and thus we are finalizing our proposal that CMS may terminate a participant hospital from the CJR model if the participant hospital, or its CJR collaborator that has a collaborator agreement with a participant hospital and performs functions or services related to CJR activities, fails to comply with any of the requirements of the CJR model or is noncompliant in other respects, which are discussed in detail later in this section. These areas of noncompliance are set forth in regulation at § 510.410(b)(1).
The effect of termination from the model is that the hospital would no longer be a participant hospital in the CJR model. We note, however, that any information collected by CMS in relation to termination of a hospital from the model would be shared with our program integrity colleagues at HHS, the Department of Justice, and their designees. Should a participant hospital, or one of its CJR collaborators, be noncompliant with the requirements of the CJR model or engage in unlawful behavior related to participation in the CJR model, we note that such information could be used in proceedings unrelated to the enforcement mechanisms in this section.
Where a participant hospital is terminated from the CJR model, we are finalizing our proposal that the hospital would remain liable for all repayment amounts from episodes of care that occurred prior to termination. CMS may terminate a participant hospital from the CJR model when the participant hospital, or its CJR collaborator performs functions or services related to CJR activities, fails to comply with any of the requirements of the CJR model. CMS may terminate a participant hospital's participation in the model, or require a participant hospital to terminate a collaborator agreement with a CJR collaborator for reasons including, but not limited to the following:
• The CJR participant hospital, a CJR collaborator that has a collaborator agreement with the participant hospital, or an individual or entity participating in the CJR model under the participant hospital does any of the following:
++ Takes any action that threatens the health or safety of patients; avoids at-risk Medicare beneficiaries, as this term is defined in § 425.20; or avoids patients on the basis of payer status.
++ Is subject to sanctions or final actions of an accrediting organization or
++ Takes any action that CMS determines for program integrity reasons is not in the best interests of the CJR model, or fails to take any action that CMS determines for program integrity reasons should have been taken to further the best interests of the CJR model.
++ Is subject to action by HHS (including OIG and CMS) or the Department of Justice to redress an allegation of fraud or significant misconduct, including intervening in a False Claims Act qui tam matter, issuing a pre-demand or demand letter under a civil sanction authority, or similar actions.
++ Is subject to action involving violations of the physician self-referral prohibition, civil monetary penalties law, federal anti-kickback statute, antitrust laws, or any other applicable Medicare laws, rules, or regulations that are relevant to the CJR model.
Finally, we are clarifying our proposal that CMS may terminate the CJR model for reasons including but not limited to the following:
• CMS determines that it no longer has the funds to support the CJR model.
• CMS terminates the model pursuant to section 1115A(b)(3)(B) of the Act. As provided by section 1115A(d)(2) of the Act, termination of the model is not subject to administrative or judicial review. This provision is set forth in regulation at new § 510.900
In section III.D.1.a. of the proposed rule, we stated that the priorities of the National Quality Strategy
• The Hospital-level risk-standardized complication rate (RSCR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1550) (as referred to as THA/TKA Complications measure (NQF #1550)).
• The Hospital-level 30-day, all-cause risk-standardized readmission rate (RSRR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1551) (as referred to as THA/TKA Readmissions measure (NQF #1551)).
• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure (NQF #0166).
We indicated in the proposed rule that these measures are fully developed for the inpatient hospital settings, are endorsed by the National Quality Forum (NQF), and recommended by the NQF Measure Application Partnership (MAP) with subsequent implementation in the HIQR Program, HVBP Program, and the HRRP (see FY 2015 IPPS/LTCH final rule 79 FR 50031, 50062, 50208 through 50209, and 50259). These measures are also publicly reported on the
We previously stated that an important purpose of the proposed quality measures for the model is to provide transparent information on hospital performance for the care of patients undergoing eligible elective joint replacement surgery, and to ensure that care quality is either maintained or improved. The proposed measures assess the following key outcomes for patients undergoing elective joint replacement surgery:
• Serious medical and surgical complications.
• Unplanned readmissions.
• Patient experience.
In the proposed rule we discussed the impact of THA/TKA procedures on complications and unplanned readmissions. We noted that THA/TKA procedure complications and readmissions result in excess inpatient and PAC spending, and reductions in these undesirable events will improve patient outcomes while simultaneously lowering healthcare spending. To this end, we also stated that the THA/TKA Complications measure (NQF #1550) will inform quality improvement efforts targeted towards minimizing medical and surgical complications during surgery and the postoperative period, and that the THA/TKA Readmissions measure (NQF #1551) captures the additional priorities of care provided in the transition to outpatient settings and communication between patients and providers, during and immediately following inpatient admission. We stated our belief that improved quality of care, specifically achieved through coordination and communication among providers, and with their patients and their caregivers, can favorably influence performance on these measures. We continue to believe improvement in measure performance will also mean improved quality of care and reduced cost.
We also stated in the proposed rule our continued focus on patient experience during hospitalizations, and our belief that the HCAHPS Survey measure (NQF #0166) provides not only the opportunity for patients to share their LEJR hospital experience, but also for hospitals to improve quality of care based on patient experience. For example, the HCAHPS Survey measure (NQF #0166) “categories of patient experience” specifically provides areas (for example, communication with doctors and nurses, responsiveness of hospital staff, pain management) in which a hospital could improve transition of care and increase patient safety (80 FR 41282). We also
• How often the patient believed providers listened carefully to his or her questions?
• Whether the purpose of medications and associated adverse events were explained?
• Whether discussions on post-discharge instructions and plans occurred so that the patient had a clear understanding of how to take medications and an understanding of his or her responsibilities in managing his or her health post-discharge?
In the proposed rule we addressed how these areas of patient experience would be invaluable to improving hospital quality of care. We noted that Manary,
We also briefly addressed the concern regarding the question of whether there is a relationship between patient satisfaction and quality of surgical care. We addressed this question by noting the work of Tsai,
Finally we shared our goal to strive to align as many measures and programs as is feasibly possible, and stated our belief that proposing fully developed measures that are used in other CMS hospital quality programs will minimize the burden on participant hospitals for having to become familiar with new measures, while still allowing us to appropriately capture quality data for the model.
The following is a summary of the many comments received and our responses.
Regarding the concern about the proposed measures being inadequate to determine whether the care provided to the patient was sufficient to promote an adequate recovery and return to activities of daily life, we acknowledge that the proposed measures do not specifically address activities of daily living, but we note that the THA/TKA PRO data collection does include survey instruments (that is, PROMIS and VR-12 surveys) that assess activities of daily life information and pain management. Through this voluntary initiative, we believe we will begin to address this gap in the current measure set for the CJR model.
Regarding the concern about the potential unintended consequences of care shifting by providers to prevent poor performance on the THA/TKA Readmissions measure (NQF #1551), we note from the beneficiary protection perspective that the model allows beneficiaries to choose their providers and suppliers, and has processes where CMS will be monitoring claims data from participant hospitals—for example, to compare a hospital's case mix relative to a pre-model historical baseline, to determine whether complex patients are being systematically excluded. We will also be publishing this data as part of the model evaluation to promote transparency and an understanding of the model's effects. We note from a quality measurement perspective that the readmission measure assesses unplanned readmissions in the 30 days following discharge from an eligible hospitalization. As previously discussed in the context of the HIQR Program (77 FR 53521), the measure uses a 30-day timeframe because it is a clinically meaningful and sufficient time period for hospitals to show the result of their
Regarding the concern that readmissions related to infection, hematoma, and pulmonary embolus following THA or TKA replacement may not be controlled despite adherence to best practices, we acknowledge that we do not expect hospitals to achieve a hospital-level THA/TKA RSRR of zero, but instead expect hospitals to seek and implement processes to improve their annual THA/TKA RSRR. We base this belief on the need to improve THA/TKA RSRRs, based on Medicare FFS administrative claims data from July 1, 2011 to June 30, 2014, which revealed a median RSRR of 4.8 percent with a range of 2.6 percent to 8.5 percent. A range of 2.6 percent to 8.5 percent suggests room for improvement. Further, we note that we measure all-cause readmission, including readmission for conditions such as infection, hematoma, and pulmonary embolus, rather than a narrowly defined set of conditions, to assess performance for several reasons. First, from the patient perspective, readmission for any reason is likely to be an undesirable outcome of care after an acute hospitalization. Secondly, readmissions not directly related to hip/knee replacement may still be a result of the care received during hospitalization for the procedure. For example, a patient who underwent a THA/TKA procedure who develops a hospital-acquired infection may ultimately be readmitted for sepsis. It would be inappropriate to treat this readmission as unrelated to the care the patient received during the index hospitalization. Furthermore, the range of potentially avoidable readmissions also includes those not directly related to the initial hospitalization, such as those resulting from poor communication at discharge or inadequate follow-up. In addition, readmissions for rare reasons completely unrelated to hospital care, such as car accidents involving the patient as a passenger, are likely to be distributed randomly across hospitals and are not expected to introduce bias into the measure results.
We appreciate the concern expressed by the commenter that surgeons may choose not to operate on patients who have comorbid conditions in order to improve the hospital's performance on the readmission measure. We had similar concerns about this potential unintended consequence, and for this reason the THA/TKA Readmissions measure (NQF #1551) risk adjusts for patients' risk factors, thereby taking into account case mix differences across providers. Adjusting for case mix is an important aspect for measuring a RSRR that accurately reflects factors that can confound an outcome rate when not adequately adjusted.
Finally, we do not believe that the proposed measures are insufficient metrics to assess CJR model patients. We note that hospitals are the unit of analysis for this model and that the proposed measures are hospital-level measures. We believe that these hospital-level measures do assess how hospitals provide care for THA/TKA patients since the measures assess complications, which are costly, and assess patients' perspectives on their hospital experience, which also includes patient feedback on communication with doctors, communication with nurses, responsiveness of hospital staff, pain management, communication about medicines, discharge information, cleanliness of the hospital environment, quietness of the hospital environment, and transition to post-hospital care. While we acknowledge that the proposed measures do not include reported functional outcomes, we have proposed the THA/TKA voluntary data submission initiative to begin to assess post-operative functional outcomes. To our knowledge a hospital-level risk-adjusted patient-reported functional outcome measure using a non-proprietary instrument to assess the measure outcome does not exist nor did we receive any suggestions from the public for measures that fit this description. We anticipate including hospital-level risk-adjusted patient-reported functional outcome measure in years 4 and 5 of this model.
Regarding that portion of the comment stating that the THA/TKA complications and readmissions rates are already low, we note that there is still room for improvement related to the complication and readmission rates for primary elective THA/TKA procedures. As previously noted in the preamble the median hospital-level primary elective THA/TKA RSCR's for April 1, 2011 through March 31, 2014 was 3.1 percent with a range from 1.4 percent to 6.9 percent. Similarly, the data on the THA/TKA RSRR for a 3-year period (July 1, 2011 to June 30, 2014) revealed a median RSRR of 4.8 percent with a range of 2.6 percent to 8.5 percent. We believe both sets of data with the median RSCR and RSRR and the associated ranges, rather than suggesting a low rate, suggest room for improvement in preventing complications. Finally, we believe, from a patient's perspective, that readmissions and complications are undesirable outcome of care, and therefore providers should strive to improve all aspects of health care that influence the occurrence of complications and readmissions so that the median RSCR, RSRR, and their ranges consistently improve over time.
We appreciate the suggestion for the Functional Change: Change in Motor Score (NQF #2287), as it helps us to be sure we have considered all possible measures. We note that the suggested measure of Functional Change: Change in Motor Score (NQF #2287) was developed for use in inpatient rehabilitation facilities (IRFs). Specifically, the Functional Change: Change in Motor Score (NQF #2287) measure is based upon the Functional Independence Measure (FIM), which is intended for use with nursing home residents and IRF patients and assesses functional status items relevant to that patient population, including Feeding, Grooming, Dressing Upper Body, Dressing Lower Body, Toileting, Bowel, Expression, Memory, Transfer to/from Bed/Chair/Wheelchair, Transfer to/from Toilet, Locomotion and Stairs. Since the unit of analysis is not acute care hospitals, this measure would not be appropriate for CJR model. We note that the TEP convened by the measure development contractor, which included clinical and technical experts as well as patients, believed the HOOS/KOOS, VR-12 and PROMIS-Global instruments assessed more meaningful pain and function outcomes at 270 to 365 days after elective primary THA/TKA patient population, which led to our proposal of the HOOS/KOOS, VR-12 and PROMIS-Global instruments. Additionally, we note that the suggested Functional Change: Change in Motor Score (NQF #2287) measure does not focus on acute care hospital care of THA/TKA patients, which is important since CJR hospitals are the unit of analysis for this model. We acknowledge the importance of assessing patient-reported functional changes, which is why we also proposed the THA/TKA voluntary data for patient-reported functional outcomes. We note that the voluntary submission of THA/TKA voluntary data for patient-reported functional outcomes using the proposed survey tools will begin to address functional outcomes of ambulation, thereby adding to the HCAHPS Survey measure (NQF #0166), which assesses inpatient pain management.
Regarding the suggestion to use BPCI model 2 measures that assessed all-cause mortality and the emergency department use without hospitalization. We note that these were not measures but instead interim analyses performed to assess these aspects of the model. Since the CJR model is specific to LEJR we chose to identify measures that were not only specific to these procedures but were risk-adjusted and developed for acute care hospitals. We also chose the proposed measures for the reasons outlined in Background sections of III.D.1.a., III.D.2.a., III.D.2.b. and III.D.2.c.
Regarding the suggestions for specific PAC measures (for example, CARE: Improvement in Mobility (NQF #2612) and CARE: Improvement in Self Care (NQF #2613)), and the general comment to add measures that: (1) Address care across the continuum of the CJR model episode of care; (2) are specific to the PAC setting; and (3) and/or are similar to the Total Knee Replacement (TKR) Measures Group found in the PQRS, we note that for this CJR model we restricted our choice of measures to hospital-level measures given that attribution of the model is at the hospital level, and specifically to risk-adjusted hospital-level outcome measures. In addition, although these suggested functional outcome measures assess functional change in the PAC setting and potentially across the continuum of the episode of care, they are not specific to the THA/TKA procedure patients in our 5-year CJR model.
Regarding the suggestion to include an appropriateness measure or a utilization measure, we are unaware of existing consensus guidelines as to what pre-operative level of pain or functional disability justifies elective primary THA or TKA procedures. Therefore, we believe it is premature to create an appropriateness measure without engaging with patients and providers to define appropriateness. Further, while we have developed a measure of Hospital-Level, Risk-Standardized Payment Associated with a 90-Day Episode of Care for Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA), this measure will not have been publicly reported until July 2016 and was therefore not considered for the CJR model at this time. We will consider changes to the quality measure components for the CJR during future rulemaking as appropriate.
Regarding the suggestion to consider device selection in measures, we understand this comment to be about post-marketing surveillance of medical devices used in THA/TKA procedures. We note that the addition of device selection and the ability to capture it through administrative claims codes will impact many other measures and CMS programs. We will evaluate this concern in the future as needed.
Notwithstanding the important changes instituted by the IMPACT Act, we note that current patient function data collected in various PAC PPSs gather patient function data from the provider's perspective, that is, these data are provider-reported, while the proposed THA/TKA voluntary data submission collects functional data from the patient's perspective (that is, patient-reported). We are committed to prioritizing patient-reported outcomes as these data are likely to focus attention on the most patient-centered care feasible. We also note that the PAC data are collected after the THA/TKA procedure and therefore cannot be used to assess the patient's response to this elective intervention. In addition, these data are collected at admission and discharge from PAC settings. Therefore, these data are not captured over a standard time period, and changes in these assessments may not reflect differences in quality of care across providers. Finally, these assessments are administered to patients during the acute recovery phase following these procedures, as they are intended to assess the quality of care provided during the immediate post-operative rehabilitation period. Patient function during this period is usually restricted by the responsible physician for a period of weeks to ensure prosthetic joint stability; patients' activities are then advanced as tolerated over time. Therefore, short-term functional assessments are inadequate for capturing the full patient outcomes after these procedures, and the Technical Expert Panel convened by our measure development contractor strongly urged post-operative data be collected at least 9 months after surgery. For all of these reasons, we believed the proposed voluntary PRO data collection specifications better reflect outcomes meaningful to patients undergoing elective joint replacement surgery and better assess hospital-level quality of care. We also note that depending on the quality measure used and the setting in which the measure is applied, the measure may not allow collection of identical patient function data across all settings, since an applicable patient-related functional data element in one setting may not necessarily be applicable in another setting. For example, if the intent of a patient functional measure is to assess the frequency of post-operative infections for hospitals, the same measure may not be applicable to an IRF or a HHA.
Finally, we note that we are committed to considering the implementation of quality measures that are standardized and interoperable across PAC and hospital settings using standardized patient assessment data.
In section III.D. of the proposed rule (80 FR 41276), we discussed, in detail, the three proposed measures. From a measure perspective, we believe that the proposed measures (80 FR 41276 through 41290) of the THA/TKA Complications measure (NQF #1550), THA/TKA Readmissions (NQF #1551) and the HCAHPS Survey measure (NQF #0166) all accurately reflect the care provided by hospitals and their services as defined in the episode definition proposed in section III.B. of the proposed rule. Additionally, we believe that the proposed THA/TKA voluntary data submission initiative (80 FR 41284 through 41289) is also appropriate for the CJR model. We believe the proposed measures are appropriate because they are risk-adjusted outcome measures which assess important patient outcomes that are consistent with the National Quality Strategy (80 FR 41276), which acknowledges that complications and readmissions are disruptive to patients and caregivers, costly to the healthcare system, and puts patients at additional risk of hospital-acquired infections, and specifically recognizes that readmissions are also a major source of patient and family stress and may contribute substantially to loss of functional ability, particularly in older patients. We believe through the HCAHPS Survey measure (NQF #0166), CMS programs continue to highlight the importance of assessing patient experience of care. While we acknowledge that the current set of proposed measures do not include assessment of patient-reported functional outcomes in PAC settings, we note that the CJR model episode of care has acute care hospitals as the unit of analysis for this model. To our knowledge a hospital-level, risk-adjusted patient-reported outcome functional measure does not exist for ready use in the CJR model. We believe that the THA/TKA voluntary PRO data submission initiative begins to address this gap in available patient-reported outcome functional measures through this model. While the proposed outcome measures and the THA/TKA voluntary PRO data submission initiative are not all inclusive of all CJR model episode of care settings, these measures address the concerns of patients. Also, since this is a test model we believe the current measures begin to inform us of ways to improve future models. We also have indicated that we will be reviewing the quality measure landscape for measures that can provide further insight on hospital-level quality of care for THA/TKA procedures.
In section III.D.5. of the proposed rule, we stated our belief that the display of measure results is an important way to educate the public on hospital performance and increase the transparency of the model, and therefore proposed, for the model, to display quality measure results on the
As stated in the proposed rule (80 FR 41278 through 41280), THA and TKA are commonly performed procedures for the Medicare population that improve quality of life. We indicated that between 2009 and 2012, there were 337,419 total hip arthroplasty (THA) procedures and 750,569 total knee arthroplasty (TKA) procedures for Medicare FFS patients 65 years and older,
In order to address these concerns and our reasons for proposing the Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) (NQF #1550) measure, we shared historical information about this measure regarding its development, implementation in CMS programs, and its public display. Briefly, we indicated in the proposed rule (80 FR 41278) that the median hospital-level RSCR 2008 was 4.2 percent, with a range from 2.2 percent to 8.9 percent in hospitals and that we believe variation in complication rates suggests that there are important differences in the quality of care delivered across hospitals, and therefore room for quality improvement. In response to noted 2008 variation in complication rates, we developed, in 2010, the proposed measure of Hospital-Level RSCR Following Elective Primary THA and/or TKA, which attained National Quality Forum endorsement (NQF #1550) and recommendations from the NQF Measure Application Partnership (MAP) for use in the HIQR Program.
Finally, in the proposed rule we explained what the measure assesses, which is a hospital's risk standardized complication rate. We also specifically shared that the measure focuses on the rate of complications occurring 90 days after elective primary THA and TKA surgery. We explained that the 90-day period begins with the date of the index admission for a specific hospital, and that the index admission is the hospitalization to which the complications outcome is attributed. We also explained that either one or more of the following are considered complications in this measure: Acute myocardial infarction, pneumonia, or sepsis/septicemia within 7 days of admission; surgical site bleeding, pulmonary embolism or death within 30 days of admission; or mechanical complications, periprosthetic joint infection or wound infection within 90 days of admission. To highlight more recent data on THA/TKA procedure complications, we shared a comparison of the median hospital-level RSCRs for hospitals between April 1, 2011 and March 31, 2014 and noted a that there continues to be a performance gap (median RSCR of 3.1 percent with a range from 1.4 percent to 6.9 percent) indicating there is still room for quality improvement.
In the proposed rule (80 FR 41279), we proposed to use Medicare Part A and Part B FFS claims submitted by the participant hospital as the data source to calculate the measure. We also explained that the index admission diagnoses and in-hospital comorbidities are assessed using Medicare Part A claims, and that additional comorbidities prior to the index admission are assessed using Part A inpatient, outpatient, and Part B office visit Medicare claims in the 1 to 2 months prior to the index (initial) admission. Finally, in the proposed rule, we stated that enrollment and post-discharge mortality status are obtained from Medicare's enrollment database which contains beneficiary demographic, benefits/coverage, and vital status information.
In the proposed rule (80 FR 41279), we proposed that the cohort for the THA/TKA Complications measure (NQF #1550) would include Medicare FFS beneficiaries, aged 65 years or older, admitted to non-federal acute care hospitals for elective primary THA or TKA. We explained that THA and TKA procedures eligible for inclusion are defined using ICD-9-CM codes 81.51 and 81.54, respectively. We also proposed that the cohort would include all hospitals included in the model, but also noted the model cohort may differ slightly from the hospital cohort that is currently captured in the measures through the HIQR Program. We noted this difference because the model cohort is a randomly selected group of acute care hospitals and therefore may not include all of the HIQR Program acute care hospitals (for a detailed discussion on selection of hospitals for the model, see section III.A.4. of the proposed rule).
We also proposed inclusion and exclusion criteria (80 FR 41279). We indicated that an index admission is the hospitalization to which the complication outcome is attributed. We also proposed that the measure include the following index admissions for patients:
• Enrolled in Medicare FFS.
• Aged 65 or over.
• Enrolled in Part A and Part B Medicare for the 12 months prior to the date of index admission and during the index admission.
• Having a qualifying elective primary THA/TKA procedure; elective primary THA/TKA procedures are defined as those procedures without any of the following:
++ Femur, hip, or pelvic fractures coded in principal or secondary discharge diagnosis fields of the index admission.
++ PHA procedures with a concurrent THA/TKA.
++ Revision procedures with a concurrent THA/TKA.
++ Resurfacing procedures with a concurrent THA/TKA.
++ Mechanical complication coded in the principal discharge diagnosis field.
++ Malignant neoplasm of the pelvis, sacrum, coccyx, lower limbs, or bone/bone marrow or a disseminated malignant neoplasm coded in the principal discharge diagnosis field.
++ Removal of implanted devices/prostheses.
++ Transfer from another acute care facility for the THA/TKA.
In the proposed rule, we indicated that the THA/TKA Complications measure (NQF #1550) would exclude the following admissions:
• Admissions for patients discharged against medical advice (AMA).
• Admissions for patients with more than two THA/TKA procedure codes during the index hospitalization.
• Consistent with the FY 2016 IPPS/LTCH proposed rule, admissions for patients without at least 90 days post-discharge enrollment in FFS Medicare; this exclusion is an update to the measure signaled in the HIQR Program section of the FY2016 IPPS/LTCH proposed rule (80 FR 24572 through 24574) to ensure that disproportionate Medicare FFS disenrollment does not bias the measure results.
We further explained in the proposed rule that once the exclusion criteria were applied, we randomly select one index admission for patients with multiple index admissions in a calendar year. Therefore, we exclude the other eligible index admissions in that year. Identification and use of a single index admission in a calendar year is done because this measure includes mortality as an outcome and the probability of death increases with each subsequent admission, preventing each episode of care from being mutually independent. Therefore only one index admission is selected to maintain measure integrity.
In the proposed rule, we also noted that THA/TKA Complications measure (NQF #1550) does not capture patients undergoing PHA procedures. We explained why we exclude PHA procedures, and this is primarily because PHA procedures are done for hip fractures and therefore are not elective procedures. We also shared that PHA procedures are typically performed on patients who are older, frailer, and have more comorbid conditions. We noted that although this exclusion is not fully harmonized with MS-DRG 469 and 470, which include PHA procedures, this measure still provides strong incentive for improving and maintaining care quality across joint replacement patients as hospitals typically develop protocols for lower extremity joint arthroplasty that will address perioperative and post-operative care for both total and PHA procedures. As previously cited in our discussion of the Episode Definition of the model (80 FR 41212 through 41219), the frequency of administrative claims data using ICD-9 codes for 2014 indicated that PHA (ICD-9 code: 81.52) accounted for 12 percent of the administrative claims, while Total Hip replacement (ICD-9 code: 81.51) and Total Knee replacement (ICD-9 code: 81.54) accounted for 87 percent of the administrative claims for 2014. We also
We note that we chose to align this measure with the risk-adjustment methodologies adopted for the HIQR Program and the HRRP in accordance with section 1886(b)(3)(B)(viii)(VIII) of the Act (FY 2013 IPPS/LTCH final rule 77 FR 53516 through 53518 and FY 2015 IPPS/LTCH final rule; 79 FR 50024, 50031, and 50202). We also indicated in the proposed rule (80 FR 41279) that the risk-adjustment takes into account the patient case-mix to assess hospital performance. The patient risk factors are defined using the Hierarchical Condition Categories (CC), which are clinically relevant diagnostic groups of ICD-9-CM codes.
In the proposed rule (80 FR 41280), we shared that analogous to how we calculate hospital risk-standardized readmission rates with all readmission measures and risk-standardized mortality rates with the mortality measures used in CMS hospital quality programs, we also calculate the hospital RSCR by producing a ratio of the number of ”predicted” complications (that is, the adjusted number of complications at a specific hospital based on its patient population) to the number of ”expected” complications (that is, the number of complications if an average quality hospital treated the same patients) for each hospital and then multiplying the ratio by the national raw complication rate. As noted in the proposed rule, the THA/TKA Readmissions measure (NQF #1551) uses a 30-day window of follow-up, which is different from the 90-day window of follow-up used in the THA/TKA Complications measure (NQF #1550).
We also indicated that we would use a 3-year rolling performance period to be consistent with that used for the measure as it is implemented in the HIQR Program (FY 2015 IPPS/LTCH final rule, 79 FR 50208 and 50209). For performance year 1 of the model, we proposed that the performance period for the THA/TKA Complications measure (NQF #1550) would be April 2013 through March 2016. Section III.D.4. of this final rule summarizes performance periods for years 1 through 5 of the CJR model.
We sought public comment on this proposal to assess quality performance through implementation of the Hospital-level risk-standardized complication rate (RSCR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1550) measure.
The following is a summary of the comments received and our responses.
NQF is currently undertaking a two-year trial period in which new measures and measures undergoing maintenance review will be assessed to determine if risk-adjusting for sociodemographic factors is appropriate for each measure. For two years, NQF will conduct a trial of a temporary policy change that will allow inclusion of sociodemographic factors in the risk-adjustment approach for some performance measures. At the conclusion of the trial, NQF will determine whether to make this change permanent. Measure developers must submit information such as analyses and interpretations as well as performance scores with and without sociodemographic factors in the risk adjustment model.
Furthermore, ASPE is conducting research to examine the impact of socioeconomic status on quality measures, resource use, and other measures under the Medicare program as directed by the IMPACT Act. We will closely examine the findings of these reports and related Secretarial recommendations and consider how they apply to our quality programs and the CJR model at such time as they are available.
In the proposed rule (80 FR 41280), we stated that the objective of CMS's Hospital-level 30-day, all-cause risk-standardized readmission rate (RSRR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1551) (as referred to as THA/TKA Readmissions measure (NQF #1551)) measure is to assess readmission from any cause within 30 days of discharge from the hospital following elective primary THA and TKA. As previously stated, outcome measures such as complications and readmissions are the priority areas for the HIQR Program, and elective primary THA and TKA are commonly performed procedures that improve quality of life. We also stated our belief that THA and TKA readmissions are disruptive to patients' quality of life, costly to the Medicare program, and that data support that readmission rates can be improved through better care coordination and other provider actions.
In the proposed rule (80 FR 41280), we proposed to use Medicare Part A and Part B FFS claims submitted by the participant hospital as the data source for calculation of the THA/TKA Readmissions measure (NQF #1551). We stated that index admission diagnoses and in-hospital comorbidity data are assessed using Medicare Part A claims and that additional comorbidities prior to the index admission are assessed using Part A inpatient, outpatient, and Part B office visit Medicare claims in the 12 months prior to index (initial) admission. We shared that enrollment status is obtained from Medicare's enrollment database which contains beneficiary demographic, benefit/coverage, and vital status information.
In the proposed rule (80 FR 41281), we indicated that THA/TKA Readmissions measure (NQF #1551) includes Medicare FFS beneficiaries, aged 65 years or older, admitted to non-federal acute care hospitals for elective primary THA or TKA. We explained that the THA and TKA procedures eligible for inclusion are defined using ICD-9-CM codes 81.51 and 81.54, respectively, and proposed that the cohort will include all hospitals included in the model, but the model cohort may differ slightly from the hospital cohort that is currently captured in the measures through the HIQR Program. That is, the model cohort is a randomly selected group of acute care hospitals and therefore may not include all of the HIQR Program acute care hospitals (for a detailed discussion on selection of hospitals for the model see section III.A. of the proposed rule).
In the proposed rule (80 FR 41281), we proposed that an index admission is the anchor hospitalization to which the readmission outcome is attributed. The measure includes the following index admissions for patients:
• Enrolled in Medicare FFS.
• Aged 65 or over.
• Discharged from non-federal acute care hospitals alive.
• Enrolled in Medicare Part A and Part B for the 12 months prior to the date of index admission and during the index admission.
• Having a qualifying elective primary THA/TKA procedure; elective primary THA/TKA procedures are defined as those procedures without any of the following:
++ Femur, hip, or pelvic fractures coded in principal or secondary discharge diagnosis fields of the index admission.
++ PHA procedures with a concurrent THA/TKA.
++ Revision procedures with a concurrent THA/TKA.
++ Resurfacing procedures with a concurrent THA/TKA.
++ Mechanical complication coded in the principal discharge diagnosis field.
++ Malignant neoplasm of the pelvis, sacrum, coccyx, lower limbs, or bone/bone marrow or a disseminated malignant neoplasm coded in the principal discharge diagnosis field.
++ Removal of implanted devices/prostheses.
++ Transfer from another acute care facility for the THA/TKA.
• This measure excludes index admissions for patients—
++ Without at least 30 days post-discharge enrollment in FFS Medicare;
++ Discharged against medical advice (AMA);
++ Admitted for the index procedure and subsequently transferred to another acute care facility; and
++ With more than two THA/TKA procedure codes during the index hospitalization.
Finally, we also indicated that for the purpose of this measure, admissions within 30 days of discharge from an index admission are not eligible to also be index admissions. Thus, no hospitalization will be counted as both a readmission and an index admission in this measure.
In the proposed rule, we also stated that this measure does not capture patients undergoing PHA procedures, as partial hip arthroplasties are primarily done for hip fractures and are typically performed on patients who are older, frailer, and have more comorbid conditions. We also shared that although this exclusion is not fully harmonized with MS-DRG 469 and 470, which include PHA procedures, this measure would still provide strong incentive for improving and maintaining care quality across joint replacement patients. We shared our belief that the THA/TKA Readmissions measure (NQF #1551) provides strong incentive for quality improvement because hospitals typically develop protocols for lower extremity joint arthroplasty that will address perioperative and post-operative care for both total and partial hip arthroplasties, and the same surgeons and care teams frequently perform both procedures. Therefore, quality improvement efforts initiated in response to the THA/TKA Readmissions measure (NQF #1551) are likely to benefit patients undergoing similar elective procedures, such as PHA and revision THA/TKA procedures, and possibly even non-elective THA/TKA procedures, such as fracture-related THA.
In the proposed rule (80 FR 41281), we noted that we chose to align this measure with the risk-adjustment methodologies adopted for Readmissions measure (NQF #1551) under the HIQR Program in accordance with section 1886(b)(3)(B)(viii)(VIII) of the Act, as finalized in FY 2013 IPPS/LTCH PPS final rule (77 FR 53519 through 53521). We also noted that the measure risk-adjustment takes into account patient age and comorbidities to allow a fair assessment of hospital performance. Further, we noted that the measure defines the patient risk factors for readmission using diagnosis codes collected from all patient claims 1 year prior to patient index hospitalization for THA and TKA. We also indicated that as previously noted for the THA/TKA Complications measure (NQF #1550), Parts A and B administrative claims ICD-9 codes are used to inform the risk prediction for each patient; diagnostic codes from PAC settings are included in the measure, but this information is only used to identify a hospital's patient case mix in order to adequately adjust for differences in case mix across hospitals. We stated that use of the Part A and B data does not mean the measures are applicable to PAC settings, only that they use comprehensive data to predict the risk of the outcome and adjust for hospital patient case mix. We noted that the patient diagnosis codes are grouped using Hierarchical Condition Categories (CCs), which are clinically relevant diagnostic groups of ICD-9-CM codes.
In the proposed rule (80 FR 41281), we proposed to calculate hospital risk-standardized readmission rates consistent with the methodology used to risk standardize all readmission measures and mortality measures used in CMS hospital quality programs. We stated that using HLM, we calculate the hospital-level elective primary THA/TKA risk-standardized readmission rate by producing a ratio of the number of “predicted” readmissions (that is, the adjusted number of readmissions at a specific hospital) to the number of “expected” readmissions (that is, the number of readmissions if an average quality hospital treated the same patients) for each hospital and then multiplying the ratio by the national raw readmission rate. We also indicated that use of the 3-year rolling performance period would be consistent with that used for the HIQR Program (FY 2015 IPPS/LTCH final rule 79 FR 50208 and 50209). For performance year one of the model, we proposed that the performance period for the THA/TKA Readmissions measure (NQF #1551) would be July 2013 through June 2016. As noted in the proposed rule for the section on the THA/TKA Complications measure (NQF #1550), there is a 90-day window of follow-up, which is different from the THA/TKA Readmissions measure (NQF #1551). Section III.D.4. of this final rule summarizes performance periods for years 1 through 5 of the model years.
We invited public comments on this proposal to include Hospital-level 30-day, all-cause risk-standardized readmission rate (RSRR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1551) or both in the model to assess quality performance. We also invited public comment on inclusion of other potential quality measures in the model.
The following is a summary of the comments received and our responses.
With respect to some commenters' concerns regarding the overlap of the measures chosen for the CJR model with measures used in other Medicare payment programs, we acknowledge that there is some overlap in quality measures between the CJR model and the HVBP program and HRRP. While we are aware that commenters object to the possibility of scoring hospitals on certain measures under more than one program or model, we note that the measures we are finalizing for the CJR model cover topics of critical importance to quality improvement for THA/TKA patients, namely, post-surgical complications and patient experience during hospitalizations, as well as the CJR model's broader goals of improving care coordination while lowering costs. In light of the CJR model's goals, we believe it is appropriate to provide strong incentives for hospitals to improve these aspects of patient care quality by using the finalized measures under more than one program or model.
We also note that the CJR model is separate and distinct from the HVBP program and HRRP, which have different purposes and policy goals. The CJR model aims to improve the care experience of Medicare patients who receive joint replacements by focusing on coordinated, patient-centered care while also lowering costs. On the other hand, the HVBP Program is an incentive program that redistributes a portion of the Medicare payments made to hospitals based on their performance on various measures. HRRP is an incentive program that links Medicare payments to hospitals based on their performance on readmission measures compared to the national rate for excess readmissions. Therefore, although the measures finalized for the CJR model exist in more than one program, the measures are used and calculated for distinct purposes. Accordingly, we believe that the critical importance of these measures to THA/TKA patient safety and experience warrant their inclusion in more than one program. We will monitor the use of the THA/TKA Complications measure (NQF #1550) and the HCAHPS Survey measure (NQF #0166) in the CJR model, including any unintended consequences of having a measure in more than one program, and
In the proposed rule (80 FR 41282), we proposed to adopt the HCAHPS Survey (NQF #0166) measure. We indicated that the HCAHPS Survey measure (NQF #0166) is a CMS survey and a national, standardized, publicly reported survey of patients' experience of hospital care, and that CMS is the measure steward. We also shared that the HCAHPS Survey measure is endorsed by the NQF (#0166), and stated that the HCAHPS survey (NQF #0166), also known as CAHPS® Hospital Survey, is a survey instrument and data collection methodology for measuring patients' perceptions of their hospital experience. We explained how the HCAHPS survey asks recently discharged patients 32 questions about aspects of their hospital experience that they are uniquely suited to address, where the core of the survey contains 21 items that ask “how often” or whether patients experienced a critical aspect of hospital care. We also indicated that the survey also includes four items to direct patients to relevant questions, five items to adjust for the mix of patients across hospitals, and two items that support Congressionally-mandated reports (see 77 FR 53513 through 53515).
In the proposed rule, we noted that eleven HCAHPS measures (seven composite measures, two individual items and two global items) are currently publicly reported on the
• How well doctors communicate with patients.
• How well nurses communicate with patients.
• How responsive hospital staff are to patients' needs.
• How well hospital staff helps patients manage pain.
• How well the staff communicates with patients about medicines.
• Whether key information is provided at discharge.
• How well the patient was prepared for the transition to post-hospital care.
Lastly, the two individual items address the cleanliness and quietness of patients' rooms, while the two global items report patients' overall rating of the hospital, and whether they would recommend the hospital to family and friends. We proposed to adopt a measure in the model that uses HCAHPS survey data to assess quality performance and capture patient experience of care.
In the proposed rule (80 FR 41282), we explained that the HCAHPS survey is administered to a random sample of adult inpatients between 48 hours and 6 weeks after discharge. As discussed in section III.D.5. of the proposed rule, we noted the following: (1) The HCAHPS survey data is collected on inpatient experience, is not limited to Medicare beneficiaries, and does not distinguish between types of Medicare beneficiaries; (2) patients admitted in the medical, surgical and maternity care service lines are eligible for the survey; the survey is not restricted to Medicare beneficiaries; (3) hospitals may use an approved survey vendor, or collect their own HCAHPS data (if approved by CMS to do so) (for a detailed discussion, see 79 FR 50259); and (4) to accommodate hospitals, the HCAHPS survey can be implemented using one of the following four different survey modes:
• Mail.
• Telephone.
• Mail with telephone follow-up.
• Active Interactive Voice Recognition (IVR).
We also noted that regardless of the mode used, hospitals are required to make multiple attempts to contact patients, and that hospitals may use the HCAHPS survey alone, or include additional questions after the 21 core items discussed previously. We also indicated the timeframes (that is, surveying must begin from 48 hours to 42 days following hospital discharge) and number of patients that hospitals must survey patients monthly throughout the year (80 FR 41282 in section III.D.2.c.(2) and III.D.2.c.(3) of the proposed rule), and that hospitals participating in the HIQR Program must target at least 300 completed surveys over 4 calendar quarters in order to attain the reliability criterion CMS has set for publicly reported HCAHPS scores (see 79 FR 50259). Finally we noted that the survey itself and the protocols for sampling, data collection, coding, and file submission can be found in the current HCAHPS Quality Assurance Guidelines manual, available on the HCAHPS Web site located at:
In the proposed rule (80 FR 41282), we noted that hospitals, or their survey vendors, submit HCAHPS data in calendar quarters (3 months). Consistent with other quality reporting programs, we proposed that HCAHPS scores would be publicly reported on the
In the proposed rule (80 FR 41282), we stated that the HCAHPS survey is broadly intended for patients of all payer types who meet the following criteria:
• Eighteen years or older at the time of admission.
• Admission includes at least one overnight stay in the hospital.
• Non-psychiatric MS-DRG/principal diagnosis at discharge.
• Alive at the time of discharge.
There are a few categories of otherwise eligible patients who are excluded from the sample frame as follows:
• “No-Publicity” patients—Patients who request that they not be contacted.
• Court/Law enforcement patients (that is, prisoners); patients residing in halfway houses are included.
• Patients with a foreign home address (U.S. territories—Virgin Islands, Puerto Rico, Guam, American Samoa, and Northern Mariana Islands are not considered foreign addresses and are not excluded).
• Patients discharged to hospice care (Hospice-home or Hospice-medical facility).
• Patients who are excluded because of state regulations.
• Patients discharged to nursing homes and SNFs.
We also indicted that the HCAHPS survey is intended for short-term, acute care hospitals. Both IPPS and CAHs
In the proposed rule (80 FR 41282 through 41283), we stated that to ensure that HCAHPS scores allow fair and accurate comparisons among hospitals, CMS adjusts for factors that are not directly related to hospital performance but which affect how patients answer survey items. This includes the mode of survey administration and characteristics of patients that are out of a hospital's control. Patient-mix adjustments (also known as case-mix adjustment) control for patient characteristics that affect ratings and that are differentially distributed across hospitals. Most of the patient-mix items are included in the “About You” section of the survey, while others are taken from hospital administrative records. Based on the HCAHPS mode experiment,
• Self-reported general health status (specified as a linear variable).
• Education (specified as a linear variable).
• Type of service (medical, surgical, or maternity care).
• Age (specified as a categorical variable).
• Admission through emergency room (discontinued in 2010).
• Lag time between discharge and survey completion.
• Age by service line interaction.
• Language other than English spoken at home.
Finally, we indicated that once the data are adjusted for patient-mix, there is a fixed adjustment for the mode of survey administration (mail, telephone, mail with telephone follow-up, and active Interactive Voice Response) and information on patient-mix adjustment (risk adjustment) and survey mode adjustment of HCAHPS scores can be found at
In the proposed rule (80 FR 41283), we outlined the methodology used to assess hospitals in the HIQR Program as reasonable for use in the model since this is a survey that many hospitals and patients are familiar with. In determining HCAHPS performance, we proposed to utilize the HLMR score because the HLMR summarizes performance across the 11 publicly reported HCAHPS measures for IPPS hospitals with 100 or more completed HCAHPS surveys in a 4-quarter period. We stated that the HLMR is calculated by taking the average of the linear mean scores (LMS) for each of the 11 publicly reported HCAHPS measures. We noted that the LMS, which was created for the calculation of HCAHPS Star Ratings, summarizes all survey responses for each HCAHPS measure; a detailed description of LMS can be found in HCAHPS Star Rating Technical Notes, at
We proposed that hospitals participating in the model also have at least 100 completed HCAHPS surveys over a given 4-quarter period to be evaluated on HCAHPS for the model.
We noted in the proposed rule that responses to the survey items used in each of the 11 HCAHPS measures described previously are combined and converted to a 0 to 100 linear-scaled score (LMS) as follows:
• “Never” = 0; “Sometimes” = 33
• “No” = 0; and “Yes” = 100 (For items 19 and 20).
• Overall Rating “0” = 0; Overall Rating “1” = 10; Overall Rating “2” = 20; . . . ; Overall Rating “10” = 100 (For item 21).
• “Definitely No” = 0; “Probably No” = 33
• “Strongly Disagree” = 0; “Disagree” = 33
The 0 to 100 linear-scaled HCAHPS scores are then adjusted for patient mix, survey mode, and quarterly weighting, see
The HLMR summarizes performance across the 11 HCAHPS measures by taking an average of each of the LMS of the 11 HCAHPS measures, using a weight of 1.0 for each of the 7 HCAHPS composite measures, and a weight of 0.5 for each of the single item measures (Cleanliness, Quietness, Overall Hospital Rating and Recommend the Hospital). The HLMR is calculated to the second decimal place. Once the HLMR score is determined for a participant hospital, the hospital's percentile of performance can be determined based on the national distribution of hospital performance on the score.
In the proposed rule (80 FR 41283), we proposed to be consistent with the HIQR Program, which uses four quarters of data (79 FR 50259). For the model, we proposed to use the most recently available HCAHPS 4-quarter roll-up to calculate the HLMR score for the initial year of the model. The performance period would assess data on patients discharged from July 1, 2015 through June 30, 2016 for the first year of the model. Section III.D.4. of this final rule summarizes performance periods for years 1 through 5 of the model years.
We invited public comments on this proposal to include HCAHPS Survey measure (NQF #0166) in the model to assess quality performance and capture patient experience of care.
The following is a summary of the comments received and our responses.
We are finalizing our proposal to employ the HCAHPS Survey measure (NQF #0166) as currently implemented. HCAHPS, which was launched in 2006 and has been continuously administered ever since, is familiar to over 4,000 hospitals. Modifications to the standardized implementation protocols would be disruptive to the other programs that employ HCAHPS data, which include the HIQR Program and Hospital Value-Based Purchasing program.
While a patient experience survey customized for only LEJR patients might have a tighter focus, developing and implementing such a measure would require significant resources and take a number of years. Given the relatively small number of patients at a hospital who undergo LEJR, collecting enough completed surveys to attain acceptable levels of reliability for such a measure would also be a challenge. Segregating HCAHPS Surveys from patients who had undergone LEJR surgery would often result in a small number of completed surveys as well as demand modifications in well-established survey implementation protocols. Tracing a patient over a 90-day episode through a number of different types of healthcare providers would be very difficult given the de-identified nature of HCAHPS data. Replacement of the HCAHPS Survey measure (NQF #0166) with a physician-based survey would remove the hospital experience from the model.
We have no reason to believe that patients undergoing LEJR differ in their patient experience compared with other HCAHPS-eligible patients in the same hospital. Similarly, we have no evidence that patients who are excluded from the HCAHPS Survey measure (NQF #0166) because of discharge to nursing homes or SNFs have different experience of care than other inpatients, but we have found that consistently contacting and surveying such patients is difficult. Thus, we believe that the HCAHPS Survey is the most viable and practical measure of patient experience of care available for the model at this time.
With respect to the HCAHPS Linear Mean Roll-up score measure that CMS has proposed for the model, hospitals began receiving HCAHPS Summary Star Rating in their December 2014
The intent of the HCAHPS survey is to provide a standardized survey instrument and data collection methodology for measuring patients' perspectives of hospital care. In order to achieve the goal of fair comparisons across all hospitals that participate in HCAHPS survey, it is necessary to adjust for factors that are not directly related to hospital performance but do affect how patients answer HCAHPS survey items. These factors include the mode of survey administration and the characteristics of patients in participating hospitals, often referred to as patient-mix.
Patient-mix refers to patient characteristics that are not under the control of the hospital that may affect patient reports of hospital experiences. The goal of adjusting for patient-mix is to estimate how different hospitals would be rated if they all provided care to comparable groups of patients. In developing the HCAHPS patient-mix adjustment (PMA) model, we sought important and statistically significant predictors of patients' HCAHPS ratings that also vary meaningfully across hospitals. The following PMA variables are included in the HCAHPS patient-mix models: Service line (medical, surgical, or maternity care), age, education, self-reported health status, language other than English spoken at home, age by service line interactions, and percentile response order, also known as “relative lag time,” which is based on the time between discharge and survey completion. This adjustment approach is grounded in more than ten years of CAHPS research of case-mix/patient-mix adjustment, reflects the input of a wide variety of stakeholders, has been subject to extensive empirical testing, and has been accepted in the peer-reviewed scientific literature.
In general, after all HCAHPS adjustments are applied (patient mix and survey mode), we believe that so-called safety net hospitals, as we understand the term perform similarly to other hospitals. The current adjustment approach that CMS employs is both well-validated and necessary to ensure fair comparisons of HCAHPS scores across hospitals. When these adjustments are applied according to the rules currently in place, the performance of safety net hospitals for the HCAHPS portion of HVBP is typical of hospitals in general.
In May 2005, the HCAHPS survey was endorsed by the National Quality Forum, a national organization that represents the consensus of many healthcare providers, consumer groups, professional associations, purchasers, federal agencies, and research organizations. In December 2005, the federal Office of Management and Budget gave its final approval for the national implementation of the HCAHPS survey for public reporting purposes. The NQF has twice re-endorsed the HCAHPS survey, most recently in 2014. Performance on the HCAHPS survey varies nationally. CMS believes that this variation reflects true differences in patient experience of care, not inherent bias.
In the CJR model, the HCAHPS survey measures and their relative weighting are very similar to the HVBP program. Both the CJR model and the HVBP program use a four-quarter roll-up of HCAHPS scores and set a threshold of 100 completed HCAHPS surveys for hospital participation (76 FR 26502). The two programs are also similar in that their HCAHPS component is created from the data submitted for the HIQR Program, thus requiring no additional data collection or submission. While there are differences in the HCAHPS survey measures used in the HVBP program and the CJR model, the measures are strongly correlated. Given that the HIQR and HVBP programs and the CJR model all employ the same HCAHPS survey data, patient experience quality improvement efforts targeted toward hospital performance on any one of these programs will redound to the benefit of all programs.
We have no reason to believe that patients undergoing LEJR differ in their patient experience compared with other HCAHPS-eligible patients in the same hospital. Similarly, we have no evidence that patients who are excluded from the HCAHPS Survey measure (NQF #0166) because of discharge to nursing homes or SNFs have different experience of care than other inpatients, but we have found that consistently contacting and surveying such patients is difficult. Thus, we believe that the HCAHPS survey is the most viable and practical measure of patient experience of care available for the model at this time. Finally, we are codifying adoption of the HCAHPS Survey measure (NQF #0166) in § 510.400(a)(2).
In the proposed rule (80 FR 41283), in order to align as much as is reasonably possible with other CMS hospital quality and public reporting programs in which these three measures are implemented, we proposed for the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) performance time periods to be consistent with the HIQR Program, HVBP program and HRRP. We noted that these programs use a 3-year rolling performance period (that is, the applicable period; see section III.D.2.b.(6) of the proposed rule) for the Hospital-level 30-day, all-cause risk-standardized readmission rate (RSRR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1551) and the Hospital-level risk-standardized complication rate (RSCR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1550) measures. We proposed a 3-year rolling performance period for the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) because a 3-year performance period yields the most consistently reliable and valid measure results. We also proposed the 3-year rolling performance periods for the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) because hospitals are intimately familiar with these measures. We noted that reconciliation payments to hospitals as part of the CJR model are dependent upon both cost and quality outcome measures, and that making reconciliation payments solely based on cost has the potential to lead to reduced access and stinting of care. We stated that in order to address these possibilities the inclusion of performance on outcome measures is critical to ensure access and high-quality care for patients undergoing these procedures, and that the only way to include reliable quality measures in the model upon which to base reconciliation payments for 2016, is to use measures that have a performance period that precedes the start date of the model. We explained that, from a measure reliability and validity perspective, it is imperative to have at least 4 quarters of data for HCAHPS survey measures and 3 years of data for the THA/TKA readmissions and complications measures. We intentionally chose outcome and patient experience measures for which hospitals that are already financially accountable in other IPPS programs. Consequently, the performance periods are the same periods for the THA/TKA Readmissions and Complications measures between the model, HIQR Program, HVBP program and HRRP. For the HCAHPS survey measures, there is overlap with the performance periods for the model and the HIQR Program.
We stated our belief that it is appropriate and necessary to use performance periods that precede the start date of the model because: (1) There is no downward payment adjustment associated with the model; (2) hospitals are already familiar with these measures as part of the HIQR Program, HVBP program, and HRRP; and (3) hospitals are already held financially accountable for these measures. For the HCAHPS Survey measure (NQF #0166), we would continue to use a 4 quarter performance period as in the HIQR Program, but would not align with the HIQR Program performance period. We shared how we
The following is a summary of the comments received and our responses.
Regarding the concern that hospitals would only have 3 months to improve on the performance for the three proposed measures, we note for the HIQR Program that the THA/TKA Complications measure (NQF #1550) and the THA/TKA Readmissions measure (NQF #1551) were finalized in the FY 2013 IPPS/LTCH Final Rule (77 FR 53534) for implementation in FY 2015, and the most updated HCAHPS Survey measure (NQF #0166) was finalized in FY 2014 IPPS/LTCH final rule (78 FR 50807) and in the HVBP program (76 FR 26502). We therefore believe hospitals have received ample time to identify ways in which to improve their performance on these three measures. Finally, we specifically considered this aspect of the measures knowing that hospitals were familiar with these measures and had more than likely instituted quality improvement activities in order to perform well on these measures.
Regarding the request to use a 12-month performance period, we note that from a measure reliability perspective—(1) A rolling 3-year performance period consistently identifies more eligible index admissions for each hospital as compared to a single year of hospital performance data or a 3-month period of data. Using a larger number of index admissions improves the precision of the estimation of each hospital's results for the THA/TKA Readmissions measure (NQF #1551) and THA/TKA Complications measure (NQF #1550). We note that if we were to have a 12-month performance period, the reliability of these measure results would become questionable; (2) a rolling 3-year performance period provides larger sample sizes, which will allow the calculation of measure results that are better able to more meaningfully distinguish hospital performance; and (3) in order to provide meaningful measures results that use claims data, we believe it is important to use claims data that has completed the appropriate opportunities for appeal and correction through the CMS administrative claims submission process. Without opportunities for hospitals to correct claims errors, the measure results may not be valid and reliable for making quality improvements in hospital processes. For these reasons we believe that having a rolling 3-year performance period is reasonable for the THA/TKA Complications measure (NQF #1550). We note that the THA/TKA Readmissions measure (NQF #1551) is not finalized for the CJR model.
After review of public comments, we are finalizing the three-year rolling performance period as proposed for the THA/TKA Complications measure (NQF #1550). Similarly, for the HCAHPS Survey measure (NQF #0166), we are finalizing our proposal that the HCAHPS survey scores be calculated from 4 consecutive quarters of survey data and that publicly reported HCAHPS results are based on 4 quarters of data (79 FR 50259). Since we are not finalizing the THA/TKA Readmissions measure (NQF #1551), as discussed in section III.D.2.b. of this final rule, we will not be finalizing any applicable period for this measure.
In the proposed rule (80 FR 41284), we stated that part of our goal to move towards outcome measures that assess patient-reported outcomes, we had begun development on a measure to assess improvement in patient-reported outcomes following THA/TKA procedures. We shared that the Hospital-Level Performance Measure(s) of Patient-Reported Outcomes Following Elective Primary Total Hip and/or Total Knee Arthroplasty (hereinafter referred to as ”THA/TKA patient-reported outcome-based measure”) is currently under development. In our proposal, we shared that we specifically chose to focus on THA/TKA procedures since THA/TKAs are important, effective procedures performed on a broad population, and the patient outcomes for these procedures (for example, pain, mobility, and quality of life) can be
In the proposed rule we provided background on measure development, and shared our discovery that in order to complete measure development, we would need access to a nationally representative sample of THA and TKA inpatient surgical procedure patient-reported outcome data set that is also consistently collected at the hospital-level and contains risk variables identified by orthopedists. Further, we noted that our rationale for requesting access to a national THA and TKA inpatient surgical procedures patient-reported data source was twofold—(1) A national data source would provide us with hospital-level data representative of the total number of THA and TKA procedures performed in hospitals, as well as representative data on hospital-level case-mix; and (2) access to a national THA and TKA inpatient surgical procedures patient-reported data source would allow us to assess and identify a set of parsimonious data elements that will minimize the data collection burden by patients, physicians and hospitals. We shared our belief that—(1) Access to such data would allow for completion and testing of the current measure under development so that it could be appropriately used for nationwide hospital performance evaluation; and (2) the model provides a unique opportunity to resolve these measure development issues through the collection of THA and TKA patient-reported outcome data. We stated that access to this data through the model would address the following:
• Current data sources are not consistently collected nor collected in a uniform process and in a standardized format (that is, data elements are not consistently defined across different data sources). We note that currently available data sources tend to be limited to single hospitals or regional registries which are associated with complex data access sharing requirements.
• Current lack of uniform hospital-level data that can be used in measure development.
• Lack of incentive for physicians and hospitals to collect patient-reported outcome data such as that through the model's financial incentives associated with voluntary data submission.
• Current lack of a technically simple and feasible mechanism for hospitals to submit patient-reported data to CMS. This model would help create and optimize such a mechanism, potentially enabling future measure implementation.
Additionally we stated that the voluntary data collection initiative in the model would provide an opportunity to collect data from the patient's perspective, data that is necessary to finalize and test the measure specifications, including the risk model. In the proposed rule, we shared how access to this national representative voluntarily submitted data would enable us to do the following:
• Determine a parsimonious set of risk factors that are statistically adequate for risk adjustment for patient-reported outcome.
• Examine the differences in hospital performance related to different components in the patient-reported outcome (such as functional status, pain, etc.) to finalize the statistical modeling methodology for risk adjustment.
• Evaluate the reliability of the patient-reported outcome measure.
• Examine validity of the patient-reported outcome measure upon finalization of the risk adjustment model via potential testing methods such as face validity testing with national experts, comparing the measure results to similar results based on other data sources if feasible, etc.
We also addressed the importance of encouraging participation with voluntary data submission of patient-reported outcome data, so we proposed to reward voluntary participation in submission of THA/TKA patient-reported outcome-based measure data as outlined in section III.D.3.a. of the proposed rule. We also indicated that we would not publicly report the THA/TKA voluntary data.
Finally, we shared our intention to use a fully tested and completed THA/TKA patient-reported outcome-based measure in CMS models or programs when appropriate. We stated that if there is a decision to implement the fully developed THA/TKA patient-reported outcome-based measure, such as in the CJR model, we would propose to adopt the measure through notice-and-comment rulemaking. We also referenced draft measure specifications in the Downloads section of the Measure Methodology Web page at
The following is a summary of the comments received and our responses. Please note the use of the following acronyms: (1) Patient-reported outcome will be noted as PRO; (2) patient-reported outcome measure (PROM) is a patient-reported outcome survey instrument; and (3) patient-reported outcome-based performance measure will be noted as PRO-PM. These terms are consistent with the National Quality Forum Patient Reported Outcomes (PROs) in Performance Measurement, January 10, 2013 (available at:
In the proposed rule (80 FR 41285), we shared that this measure is under development, and we proposed to reward participant hospitals that volunteer to submit provider- and patient-level data elements. We shared our observation that currently, there is
• Patient-reported data.
• Administrative claims-based data.
• One or both physician-reported and electronic health record data.
As a way to minimize burden on patients, providers, and hospitals we proposed to request that participant hospitals provide administrative claims-based data whenever possible; we also requested that participant hospitals submit either hospital documentation, chart abstraction, or abstraction from the electronic health records. The list of proposed data elements are summarized in the proposed rule (80 FR 41285).
Finally, we stated that as the measure continues to undergo development that the list of data elements may be simplified consistent with our previously stated goal in this section entitled Data Sources, that we intend to identify a uniform set of provider- and patient-level data elements that are accurate, valid and reliable pieces of information that can be used in the determination of improvement in various patient-reported outcomes like those previously listed (that is, pain, mobility, and quality of life). We shared our anticipation that via public comment and experience with the voluntary data submission, that the set of data elements listed previously will be simplified.
In accordance with, and to the extent permitted by, the HIPAA Privacy Rule and other applicable law, we proposed to request that participant hospitals submit the data specified in the request, which we would limit to the minimum data necessary for us to conduct quality assessment and improvement activities. Regarding the process for data collection, we proposed the THA/TKA voluntary data will be submitted to and collected by a CMS contractor in a manner and format similar to existing CMS data submission processes. For example, CMS would supply applicable hospitals with a file template and instructions for populating the file template with data and submitting the data; the hospitals will populate the template, log in to a secure portal, and transmit the file to the appropriate CMS contractor; the CMS contractor would also match the submitted data to Medicare administrative claims-based data and calculate completeness for determination of the reconciliation payment as noted in section III.C.5. of the proposed rule (or validated subscales or abbreviated versions of these instruments). We stated our belief that participation in the submission of THA/TKA—voluntary data will provide the minimum information we would need that would inform us on how to continuously improve the currently specified measure in development.
Finally, we noted that some of these data elements are closely aligned with data elements in electronic clinical quality measures submitted by eligible professionals for the Medicare EHR Incentives Program for Eligible Professionals. Specifically these EHR Incentives Program measures for eligible professionals are: (1) Functional Status Assessment for Knee replacement (CMS 66); and (2) Functional Status Assessment for Hip replacement (CMS 56). We refer reviewers to CMS.gov EHR Incentives Program 2014 Eligible Professional June 2015 zip file update at
The following is a summary of the comments received and our responses. We received many public comments on the Data Sources section and have divided the public comments and our responses into two categories—(1) Public comments not specifically related to the proposed PRO and risk variable data elements (80 FR 41825); and (2) public comments specifically related to the proposed PRO and risk variable data elements.
The following are public comments made that are not specifically on the proposed instruments (80 FR 41825) and our responses.
The following are public comments that specifically address the proposed instruments and our responses include the following:
We also appreciate the public comments that indicated that the proposed required PRO data elements for the voluntary PRO data collection are too burdensome. We acknowledge evidence indicating that the PROMIS-Global and VR-12 are highly correlated.
Regarding the HOOS/KOOS PROMs, we appreciate the consistent comment that the HOOS/KOOS instruments for this specific voluntary PRO data submission proposal are too burdensome. These instruments were recommended by a diverse, nationally convened Technical Expert Panel assisting our contractor with the development of this measure. During review of these instruments, the Technical Expert Panel acknowledged the length of the instruments as a limitation for its use. For reasons outlined in prior responses, the Technical Expert Panel recommended these instruments over shorter, proprietary joint-specific PROM instruments. We noted in review of the public comments, a joint statement from multiple surgical specialty societies indicated new data validating shortened versions of the HOOS/KOOS instruments in THA/TKA patients. Further, the HOOS/KOOS instruments were originally developed to create five specific subscale scores: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL) (
Based upon the fact that the HOOS/KOOS instruments were developed to create specific subscale scores intended for independent scoring as well as additional evidenced-based data supporting the use of meaningful information on THA/TKA PROMs gathered in substantially less burdensome, non-proprietary instruments and broadly supported by the orthopedic community, we believe it is reasonable to replace the previously proposed collection of the full HOOS or KOOS survey with the shorter HOOS Jr. and KOOS Jr. or with the following list of HOOS and KOOS subscales.
For hospitals seeking to voluntarily collect and submit PRO data on THA patients, we would require collection and submission of all of the following for purposes of determining “successful” voluntary patient-reported outcome data collection:
• Either VR-12 or PROMIS-Global [collected both pre-operatively (90 to 0 days prior to the THA procedure) and post-operatively (270 to 365 days after the THA procedure], the revised list of risk variables [Table 28, collected only pre-operatively (90 to 0 days prior to the THA procedure)], and
• Either (A) the HOOS Jr. (6 items total) [collected both pre-operatively (90 to 0 days prior to the THA procedure) and post-operatively (270 to 365 days after the THA procedure] or (B) the original HOOS Pain Subscale (10 items), AND the original HOOS Function, Daily Living Subscale (17 items, for a total of 27 items) [collected both pre-operatively (90 to 0 days prior to the THA procedure) and post-operatively (270 to 365 days after the THA procedure].
For hospitals seeking to voluntarily collect and submit PROM data on TKA patients, we will require collection and submission of all of the following for purposes of determining “successful” voluntary patient-reported outcome data collection:
• Either VR-12 or PROMIS-Global [collected both pre-operatively (90 to 0 days prior to the TKA procedure) and post-operatively (270 to 365 days after the TKA procedure)], the revised list of risk variables [Table 28, collected only pre-operatively (90 to 0 days prior to the TKA procedure)], and
• Either (A) the KOOS Jr. (7 items total) [collected both pre-operatively (90 to 0 days prior to the TKA procedure) and post-operatively (270 to 365 days after the TKA procedure)] or (B) the original KOOS Stiffness Subscale (2 items), AND the original KOOS Pain Subscale (9 items) and the original KOOS Function, Daily Living Subscale (17 items, for a total of 28 items) [collected both pre-operatively (90 to 0 days prior to the TKA procedure) and post-operatively (270 to 365 days after the TKA procedure)].
Finally, the PROM instrument data will be collected both pre-operatively (90 to 0 days prior to the THA/TKA procedure) and post-operatively (270 to 365 days after the THA/TKA procedure); the risk variables (Table 28) will be collected only pre-operatively (90 to 0 days prior to the THA/TKA procedure). The HOOS/KOOS domain of Quality of Life will be captured by the validated generic instruments (VR-12 or PROMIS-Global); the HOOS/KOOS domain of Function, Sports and Recreational Activities includes questions regarding activities (for example, running) that THA/TKA patients are commonly advised to restrict or avoid after surgery and, as such, is less applicable to this patient population.
In the proposed rule (80 FR 41286), we stated that the measure cohort(s) includes Medicare FFS beneficiaries, aged 65 years or older, admitted to non-federal acute care hospitals for elective primary THA or TKA. We also indicated that we would exclude from the cohort patients with fractures and mechanical complications or those undergoing revision procedures. We stated again that THA and TKA patient-reported outcomes will be assessed separately but may be combined into a single composite measure for reporting.
In the proposed rule (80 FR 41286), we stated that the measure cohort inclusion criteria are all patients undergoing elective primary THA/TKA procedures. Exclusion criteria will consist of patients undergoing non-elective procedures (that is, patients with fractures resulting in THA/TKA), as it is unfeasible to routinely capture pre-operative patient-reported assessments in these patients; patients with mechanical complications of prior hip and knee joint procedures and those undergoing revision THA/TKA will also be excluded, as their patient-reported outcomes may be influenced by prior care experiences and therefore may not adequately represent care quality of the hospital performing the revision procedure.
In the proposed rule (80 FR 41286), we stated that the measure will assess change between pre- and post-operative
In the proposed rule (80 FR 41286), we stated that the measure's risk model has yet to be developed. We shared that in order to develop the risk model, final risk variable selection for the risk model will involve empirical testing of candidate risk variables as well as consideration of the feasibility and reliability of each variable. The risk model will account for the hospital level response rate as well as measureable patient-level factors relevant to patient-reported outcomes following elective THA/TKA procedures. We indicated that to the extent feasible, the risk model methodology will adhere to established statistical recommendations.
In the proposed rule (80 FR 41286) we stated that the approach to reporting this measure(s) has yet to be developed. We outlined in the propose rule that the measure will assess change in patient-reported outcomes between the pre-operative (90 to 0 days prior to the elective primary THA/TKA procedure) and post-operative (270 to 365 days following the elective primary THA/TKA procedure) periods.
We invited public comments on this proposal to seek voluntary participation in submitting data for a Hospital-Level Performance Measure of Patient-Reported Outcomes Following Elective Primary Total Hip and/or Total Knee Arthroplasty. We also welcomed comments on the appropriateness of this voluntary data collection for this model and the specific data collection requirements (see section III.D.3.a.(9) of the proposed rule) and data elements proposed.
The following is a summary of the comments received and our responses.
We appreciate commenter's recommendations regarding specific risk variables for collection. We note the commenter's input that several of these variables can be feasibly collected by self-report and will consider this information when finalizing the data elements for collection.
We appreciate the public comments that the proposed list of current required risk variable data elements for the voluntary PRO data collection is too burdensome. Based upon multiple commenters supporting the risk
We will request that all PRO and risk variable data be submitted through a secure file transfer mechanism using a file template. Hospitals will be able to populate the file template according to their own data collection method and format. CMS will plan to augment the risk model development for the future PRO-based measure with administrative claims, enabling many of the proposed risk variables not selected for voluntary collection to be captured without additional data collection burden. The proposed risk variables for which administrative codes or claims data are available will be considered for possible inclusion in the future PRO-based measure risk model. These individual codes will be considered in addition to the publicly available CMS hierarchical condition categories (CCs) that group the more than 15,000 ICD-9 codes into clinically coherent CCs.
In Table 16 of the proposed rule (80 FR 41286 through 41288), we proposed defining performance periods for each year of the model (see Table 29 of this final rule). A performance period for the voluntary THA/TKA data submission, are those timeframes in which an anchor hospital admission occurs for eligible THA/TKA voluntary data submission procedure. For the first year of the CJR model, hospitals voluntarily submitting data will only be requested to submit data for a 3-month period. The 3-month period for THA/TKA voluntary data reporting was identified due to data processing and coordination of other proposed timelines in this model. We stated that data submitted for the first year would be for cases that fulfill the measure specifications described in section III.D.3.a. of the proposed rule, and would be restricted to the pre-operative data elements on cases performed between April 1, 2016 and June 30, 2016. The proposed timing allows matching of the patient-reported data with relevant administrative claims-based data in order to accurately calculate the percent of eligible elective primary THA/TKA patients for which THA/TKA voluntary data was successfully submitted. The April 1st date acknowledges the measure requirement of the 90-day window prior to surgery during which hospitals can collect pre-operative data. The June 30th end date was selected because it correlates with the THA/TKA Readmissions measure (NQF #1551) performance period end date currently implemented for the HIQR program and the HRRP. Both of these dates provide the greatest feasibility for data collection.
We went on to explain how the THA/TKA voluntary data reporting periods would change based on the year of the model and whether the data submitted was related to pre- or post-operative THA/TKA assessments. Specifically, we stated that for year 2, THA/TKA voluntary data reporting would be 3 months of post-operative data for cases performed between April 1, 2016 and June 30, 2016, and 12 months of pre-operative data for cases performed between July 1, 2016 and June 30, 2017. We completed our explanation of the duration of performance periods by indicating for year 3 and subsequent years of the model, the performance periods for submission of voluntary data will consist of 12-month time periods. We finally noted in our proposal that the proposed performance period enables hospitals to receive incentives for data collection starting in performance year-one, even though complete pre-operative and post-operative data collection requires a minimum 9- through 12-month time period. This 9- through 12-month time period, between the procedure and post-operative data collection, was defined through clinician and stakeholder input and provides for both sufficient elapsed time for maximum clinical benefit of THA/TKA procedures on patient-reported outcomes and accommodates common clinical care patterns in which THA/TKA patients return to their surgeon one year after surgery. We invited public comments on our proposal of defining performance year-one episodes for a participating hospital as an anchor hospital admission for an eligible THA/TKA procedure between April 1, 2016 and June 30, 2016, with subsequent year performance time periods each being 12-month periods and starting every July 1st.
We did not receive comments on the proposed THA/TKA voluntary data submission Performance Period in Table 16 of the proposed rule or for Table 29 of this final rule, and will be finalizing the THA/TKA voluntary PRO and limited risk variable data submission Performance Period as proposed with the exception of the performance periods for the first year of the model (that is, 2016). We note in section III.C.2.a. of this final rule that the date of implementation will be delayed until April 1, 2016. Previously, we had proposed for 2016 the data collection periods of April 1, 2016 and June 30, 2016. Due to the delay in the implementation date from January 1, 2016 to April 1, 2016, we similarly implement a three month delay for the THA/TKA voluntary PRO and risk variable data submission Performance Period, with the result that we will collect only 2 months of data in 2016 from July 1, 2016 through August 31, 2016. The finalized THA/TKA voluntary PRO and limited risk variable data submission Performance Periods are provided in Table 30 of this final rule.
In proposed rule (80 FR 41286), we stated that in order for CMS to assess if participant hospitals are eligible for reconciliation payment after receiving the THA/TKA voluntary data, requirements to determine if the submitted data would inform measure development had been identified (80 FR 41288 through 41289). We stated our belief that the following criteria should be used to determine if a participant hospital has successfully submitted
• Submission of the data elements listed in section III.D.3.a.(2) of the proposed rule.
• Data elements listed in section III.D.3.a.(2) of the proposed rule must be submitted on at least 80 percent of their eligible elective primary THA/TKA patients (as described in section III.D.3.a.(3) of the proposed rule).
• THA/TKA voluntary data submission must occur within 60 days of the end of the most recent data collection period.
We proposed that in order to fulfill THA/TKA voluntary data collection criteria for performance year-one, only pre-operative data collection and submission on at least 80 percent of eligible elective primary THA/TKA patients would be required. We further explained that to successfully submit THA/TKA voluntary data for performance years 2 through 5, hospitals would have to submit both pre-operative and post-operative patient reported outcome data on at least 80 percent of eligible elective primary THA/TKA patients. A potential example of the performance periods for which we would like to have THA/TKA voluntary data submitted by participant hospitals were summarized in section III.D.3.a. of the proposed rule.
Table 16 of the proposed rule (80 FR 41287 through 41288) summarized the performance periods for pre-operative and post-operative THA/TKA voluntary data. We also proposed that hospitals volunteering to submit THA/TKA data would be required to submit pre-operative data on all eligible patients and post-operative data elements only on those patients at least 366 days out from surgery. Therefore, hospitals would not be expected to collect and submit post-operative THA/TKA voluntary data on patients who are fewer than 366 days from the date of surgery.
We also stated that a THA/TKA eligible patient is described in section III.D.3.a.(3) of the proposed rule, and noted that this description is important since these patients were those for which we proposed to seek submission of voluntary data. We also selected the requirement of submitting 80 percent of eligible elective primary THA/TKA patients' data because this volume of cases would result in a high probability that we would have a national sample of THA/TKA patient data representative of each hospital's patient case mix. We stated that having 80 percent of the eligible elective primary THA/TKA patients would enable an accurate and reliable assessment of patient-reported outcomes for use in measure development. We noted that data used for outcome measure development must adequately represent the population that is anticipated to be measured, and in this case that population would be those experiencing elective primary THA/TKA inpatient surgical procedures. Data that more accurately reflects the patient outcomes and case mix of the population to be measured would allow, during measure development, a more scientifically accurate and reliable measure. We stated our belief that having 80 percent of eligible elective primary THA/TKA recipient data would result in a more reliable measure that is better able to assess hospital performance than a measure created from a less representative patient sample. Furthermore, we considered setting the requirement at 100 percent of the eligible elective primary THA/TKA patients, but concluded that a requirement of 100 percent data collection may not be feasible for all hospitals or may be excessively burdensome to achieve. Therefore we proposed to set the requirement at 80 percent of the eligible elective primary THA/TKA patients. We believed acquisition of 80 percent of the eligible elective primary THA/TKA patients would provide representative data for measure development while decreasing patient, provider and hospital burden. We sought public comment of these requirements to determine successful voluntary submission of THA/TKA data. We also sought public comment specifically on the requirement for data on 80 percent of the eligible elective primary THA/TKA patients.
The following is a summary of the comments received and our responses.
We appreciate the commenter's suggestion to increase the successful criterion based upon the concern that lowering the successful criterion (that is, the patient-reported outcome instrument response and risk variable submission rates required for successful participation) may produce biased data that are not generalizable to all patients undergoing elective primary THA/TKA procedures at a given hospital. To assess the amount of data bias, the collected and submitted patient-reported outcome and risk variable data will be matched to administrative claims data, which will allow CMS to determine the proportion of a hospital's patients for which the hospitals collected and submitted patient-reported outcome and risk variable data. In addition, it will allow CMS to determine how representative this sampling of patients is of all of the hospital's eligible THA/TKA patients, by comparing the number and type of comorbid conditions, sociodemographic factors, and post-discharge outcome (for example, complication and readmission) rates. This information will be factored into any measure development work that
While there are a few commenters supporting the feasibility of pre- and post-operative patient-reported outcome instrument response rates exceeding 80 percent for elective THA/TKA procedures, we understand that many hospitals may not be able to meet this criterion as proposed in the first year of the CJR model. Therefore, based on public comments we are finalizing a lower criterion for the “successful” voluntary patient-reported outcome and limited risk variable data collection for year 1, which will entail each participating hospital submitting the required pre- and post-operative data elements (see Table 28 for the final list of voluntary patient-reported outcomes and limited risk variable data elements) on either of the following
• 50 percent of eligible procedures during the data collection period; or
• A total of 50 eligible procedures during the data collection period.
Eligible patients (henceforth for purposes of this discussion, patients will be described as procedures) are described in section III.D.3.a. of the proposed rule (80 FR 41286). The post-operative data collected in year 2 will correspond to the pre-operative data collected in year 1 and, similarly, for years 3 through 5. That is, participant hospitals will collect and submit post-operative data for the same cases for which the hospital submitted pre-operative data in the preceding year.
Based upon commenters' input to reduce the successful criterion, including a recommendation specifically to reduce the successful criterion to 50 percent, we believe a '50 percent or 50 eligible procedures' successful criterion in year 1 provides hospitals with flexibility to minimize the data collection burden; using a 50 percent or 50 eligible procedures successful criterion in year 1 will also allow participant hospitals to submit data regardless of their case volume. A 50 percent or 50 eligible procedures successful criterion in year 1 also allows participant hospitals an opportunity for financial reward for this voluntary initiative. We note having the 50 percent or 50 eligible procedures successful criterion in year 1 in conjunction with a simplified list of PROM instruments and list of risk variables (Table 28) markedly decreases the burden of collecting and submitting the THA/TKA voluntary PRO and limited risk variable data. We believe after the first year of the model, hospitals will become more adept at collecting this data, and the public comments indicate that much higher patient-reported outcome data collection rates are feasible. For example, a commenter shared that its institution reported a reliable 85 percent response rate for its PROM data collection. Therefore, we believe it is reasonable to gradually increase the expected response rates to successfully fulfill the THA/TKA voluntary PRO and limited risk variable data collection in years 2 through 5 of the model, as listed in Table 30. We note that the phase-in approach was suggested by a few public commenters. We agree that phasing in of higher percentage eligible procedures with each year is a more realistic expectation for participating hospitals to meet and a more encouraging manner to enhance the THA/TKA voluntary PRO and limited risk variable data submission.
We anticipate completion of measure development for the future hospital-level THA/TKA PRO-PM during or before year 3 of the model. The measure specifications will be finalized in accordance with our standard measure development process set forth in NQF guidance for outcome measures,
We are codifying requirements for successful data submission of THA/TKA patient reported outcomes and limited risk variable data in § 510.400(b).
In the proposed rule (80 FR 41289), we shared our belief that, in addition to the patient-reported functional status outcomes, shared-decision making is an important aspect of care around elective patient-reported outcome procedures such as primary total hip and total knee arthroplasty. We also noted that lower episode expenditures achieved through improved patient-reported outcome efficiency may yield the unintended consequence of a compensatory increase in the number of episodes initiated. We stated that use of shared decision-making prior to episode initiation can serve as an important tool to ensure appropriate care. Though there are no developed measures, we sought feedback on the opportunity to capture quality data related to shared decision-making between patients and providers. Examples of such a measure could include concepts such as a trial of conservative medical therapy prior to elective procedures or broader shared decision-making measures. We invited public comment on whether such a measure concept would be appropriate for the CJR model. If we develop a measure that captures shared decision-making related to elective primary total hip and total knee arthroplasty or both, we would propose through rulemaking or other means to add that measure to the CJR model.
The following is a summary of the comments received and our responses.
In the proposed rule (80 FR 41289), we stated that person-centered shared care plan is an important tool that can help providers across settings collaborate around a customized plan that reflects a patient's goals and offers providers critical information about all of the treatment a beneficiary has received. We shared that health IT solutions are increasingly supporting the exchange of care plan information across settings so that providers and individuals have access to necessary information whenever and wherever it is needed. We also indicated that in the 2015 Edition of certification criteria for health information technology (80 FR 16842), the Office of the National Coordinator for Health Information Technology (ONC) proposed the adoption of a new criterion to ensure health IT can capture, display, and exchange a robust care plan document in accordance with new standards released in the Consolidated Clinical Document Architecture Release 2.1; this proposal has now been finalized (80 FR 62648). While further measure development is needed, we sought comment on the appropriateness of a future quality measure which would assess the use of shared care plans in the care of beneficiaries participating in the CJR model.
The following is a summary of the comments received and our responses.
In the proposed rule (80 FR 41289), we shared our belief that the use of health IT tools is a critical component of effective coordination across settings of care. Under bundled payment models, in which providers across the continuum of care share accountability for the clinical management and total cost of an episode of care, the capacity to share information electronically across disparate provider systems is essential for delivering efficient, safe, high quality care. As discussed in the August 2013 Statement “Principles and Strategies for Accelerating Health Information Exchange” (available at
We shared our belief that use of certified health IT tools and the interoperable exchange of health information is a critical capability for model participants to be able to deliver the high-quality care and effective coordination across settings that will be required to demonstrate success under the model. Moreover, we believe that it will be important to incentivize adoption and use of these enabling technologies among model participants including PAC providers, by linking these activities to participant eligibility to receive reconciliation payments.
While we did not propose to add a measure for certified health IT use for the program's initial performance year, we sought comment on how we might incorporate such a measure beginning in the 2017 performance year. We invited stakeholder comment on the following questions:
• Is successful attestation as part of the EHR Incentive Program for Medicare hospitals in the applicable reporting year the most appropriate quality measure for assessing hospital performance on the use of health IT and interoperable health information in the model?
• Should the model include a performance measure that would be specific to the ability of hospitals to conduct electronic care coordination using certified health IT, for instance, the measure of transitions of care which hospitals currently report on as part of the EHR Incentive Program for Medicare Hospitals?
• What other measures could be used to assess hospital performance on the use of health IT and interoperable health information while minimizing program and provider collection and reporting burden?
We sought public comments on how we might incorporate an electronic measure beginning in the 2017 performance year, and public comments on the questions posed previously in this rule.
We also sought public comment on the appropriateness of quality measures for PAC patients, physicians and facilities that care for THA/TKA surgical procedure patients.
The following is a summary of the comments received and our responses.
Several commenters noted that hospitals have substantially increased their adoption of health IT systems in recent years, and that participants will need to rely on electronic tools, including EHRs, health information exchange services, and other systems, in order to deliver effective care for beneficiaries under the model. Commenters also noted that many hospitals are seeking to address challenges around electronically exchanging patient information with PAC providers. As these PAC providers were not eligible for the EHR Incentive Programs, many have not yet established health IT systems. However, bundling programs such as the CJR model are likely to further incentivize hospitals to develop strategies to share information with these providers to support care coordination across an episode of care.
In the proposed rule (80 FR 41289), we stated that it is important to be transparent and to outline the form, manner and timing of quality measure data submission so that accurate measure results are provided to hospitals, and that timely and accurate calculation of measure results are consistently produced to determine annual reconciliation payment.
We proposed that data submission for Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) (NQF #1550) and Hospital-Level Risk-Standardized Readmission Rate (RSRR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) (NQF #1551) (or both) be accomplished through the existing HIQR Program processes. Since these measures are administrative claims-based measures, hospitals will not need to submit data. We proposed that the same mechanisms used in the HIQR Program to collect HCAHPS Survey measure (NQF #0166) data also be used in the CJR model (79 FR 50259). For the hospitals that voluntarily submit data for the THA/TKA patient-reported outcome-based performance measure, we anticipated, if it is technically feasible, for data submission processes to be broadly similar to those summarized for the HIQR Program for chart abstracted and administrative claims-based measures. We indicated that we would create a template for hospitals to complete with the THA/TKA voluntary data, provide a secure portal for data submission, and provide education and outreach on how
We invited public comment on the proposal to collect quality measure data through mechanisms similar to those used in the HIQR Program.
The following is a summary of the comments received and our responses.
With respect to the HCAHPS Survey measure (NQF #0166), CMS similarly provides hospitals with their confidential preview reports on a quarterly basis, before the results are publicly reported on Hospital Compare Web site (
In the proposed rule (80 FR 41290), we stated our belief that display of quality data is an important way to educate the public on hospital performance. We have used several methods to report quality data to the public, including posting data on the
We stated that the proposed time periods for the THA/TKA Complications measure (NQF #1550), and the THA/TKA Readmissions measure (NQF #1551) are consistent with HIQR Program performance periods for July 2017 public reporting. The HCAHPS Survey measure (NQF #0166) results performance periods as previously stated in section III.D.2.c. of this final rule would not align with the HIQR program. We also stated our belief that the public is familiar with the proposed measures, which have been publicly reported in past releases of Hospital Compare as part of the HIQR Program. Finally, we clarified in the propose rule our intent to minimize confusion and facilitate access to the data on the measures included in the CJR model by proposing to post the data on each participant hospital's performance on each of the 3 proposed quality measures in a downloadable format in a section of the
In addition, we also stated our belief that information about functional status both pre- and post-operatively is important for hip and knee replacements. We are developing a functional status measure that we believe will provide this needed information. The measure, Hospital-Level Performance Measure(s) of Patient-Reported Outcomes Following Elective Primary Total Hip and/or Total Knee Arthroplasty (see section III.D.3. of the proposed rule for a detailed description), requires comprehensive testing before it can be used in a CMS program. As part of the effort to collect data on functional status voluntarily from hospitals, we proposed that hospitals that voluntarily submit data for this measure be acknowledged through the use of a symbol on
We also provide clarification for the performance periods proposed for years 4 and 5 in Table 17 (80 FR 41290) in the proposed rule, and in Table 31 of this final rule, for the THA/TKA Readmissions measure (NQF #1551). In Table 17 of the proposed rule we had indicated a year 4 performance period of: July 1, 2016 through June 30, 2020 and for year 5 July 1, 2017 through June 30, 2016. We note that these proposed time frames are not consistent with prior proposals (80 FR 41290) and would like to clarify that the correct proposed performance periods for the THA/TKA Readmissions measure (NQF #1551) for year 4 is: July 1, 2016 through June 20, 2019; and for year 5: July 1, 2017 through June 30, 2020. We also note that the THA/TKA Readmissions measure (NQF #1550) has not been finalized for this model.
We invited public comments on these proposals to post data for mandatorily required measures on the
The following is a summary of the comments received and our responses.
We will provide participant hospitals a period of 30 days to review and submit corrections to calculations of measure results and determinations of successful patient-reported outcome data submission using a process that is similar to the process currently used for posting results on the
We note that with respect to the claims based THA/TKA Complications measure (NQF #1550), the review and correction process will not include submitting additional corrections related to the underlying claims data we used to calculate the measure result, nor adding new claims to the data extract we used to calculate the measure result. This is because it is necessary to take a static “snapshot” of the claims in order to perform the calculations. For purposes of the CJR model, we would calculate the THA/TKA Complications measure (NQF #1550) result using a static snapshot (that is, data extract) taken at the conclusion of the 90-day period following the last date of discharge used in the applicable performance period. This is consistent with our policy for all claims-based measures used in the HIQR, HVBP, HRRP programs, and the Hospital-Acquired Condition Reduction Program (for example, see 77 FR 53399 through 53401 as this policy is applied for HRRP and 78 FR 50725 through 50727 as this policy is applied in the Hospital-Acquired Condition Reduction Program). We recognize that under our current timely claims filing policy, hospitals have up to 1 year from the date of discharge to submit a claim to us. However, in using claims data to calculate quality measure results for the CJR model, we will create claims data extracts approximately 90 days after the last discharge date in the applicable performance period. For example, for model year one of the CJR model, the last discharge date in the performance period for the THA/TKA Complications measure (NQF #1550) is March 31, 2016, so we would create the data extract on or around June 30, 2016 and use that data to calculate the measure result for the April 1, 2013 to March 31, 2016 performance period. Participant hospitals are already familiar with this 90-day claims “run-out” period, which we apply when creating data extracts for all of our claims-based outcome measures used in the HIQR, HVBP, HRRP Programs, and the Hospital-Acquired Condition Reduction Program (for example, see 77 FR 53399 through 53401 as this policy is applied for HRRP and 78 FR 50725 through 50727 as this policy is applied in the Hospital-Acquired Condition Reduction Program).
This final policy is set forth at § 510.400.
In section III.E. of the proposed rule, we proposed to provide data to the hospital participants of the CJR model. We have experience with a range of efforts designed to improve care coordination for Medicare beneficiaries, including the Medicare Shared Savings Program (Shared Savings Program), Pioneer ACO Model, and BPCI, all of which make certain data available to participants. In section III.C.2. of the proposed rule, we proposed a model to financially incentivize hospitals, through retrospective bundled payments, to engage in care redesign efforts to improve quality of care and reduce spending for the aggregate Part A and B FFS spending for beneficiaries included in the model during the inpatient hospitalization and 90 days post-discharge. Given this, we expressed our belief that it is necessary to provide historical and ongoing claims data representing care furnished during episodes of care for LEJRs to hospitals so that they can, among other things, adequately structure their care pathways, coordinate care for beneficiaries, and estimate acute inpatient and PAC spending within LEJR episodes.
As noted previously, this would not be the first instance in which we have provided claims data to entities participating in a CMS model or program. For example, participants in Shared Savings Program initially receive aggregate information on their historical financial performance as well as quarterly data throughout their tenure in the program. In addition, Shared Savings Program ACOs receive certain beneficiary-identifiable claims information in accordance with our regulations. (For more information, see
Similarly, participants in the Pioneer ACO model can request historical claims data of beneficiaries aligned with the particular Pioneer ACO entity, and the entities continue to receive certain ongoing data regarding the services furnished to those beneficiaries. (For more information, see the CMS Web site
As noted in the proposed rule, based on our experience with these efforts, we believe that providing a similar opportunity for hospitals participating in the CJR model to request data is necessary for participant hospitals to have the relevant information to allow for practice changes supported by CJR and to identify services furnished to beneficiaries receiving LEJRs under the model. Specifically, providing participant hospitals with certain claims and summary information on beneficiaries in accordance with established privacy and security protections would improve their understanding of the totality of care provided during an episode of care. With this greater understanding, we anticipate that hospitals would be better equipped to evaluate their practice patterns and actively manage care delivery so that care for beneficiaries is better coordinated, quality and efficiency are improved, and payments aligned more appropriately to the medically necessary services beneficiaries have a right to receive. We also expect that providing this data to CJR participants will benefit beneficiaries by allowing providers to use the data to improve care coordination activities in areas that may be currently lacking. However, we also noted our expectation that CJR hospitals are able to, or will work toward, independently identifying and producing their own data, through electronic health records, health information exchanges, or other means that they believe are necessary to best evaluate the health needs of their patients, improve health outcomes, and produce efficiencies in the provision and use of services.
Accordingly, we believe that making certain data available to CJR hospitals, as we do with ACOs participating in the Shared Saving Program and Pioneer ACO Model, would help them to monitor trends and make needed adjustments in their practice patterns. In order for CJR participants to understand and track their care patterns, we proposed to provide the participants with beneficiary-level claims data for the historical period used to calculate a CJR hospital's target price as well as ongoing quarterly beneficiary-identifiable claims data in response to their request for such data in accordance with our regulations. Given that the CJR model also proposes to incorporate regional pricing in the calculation of target prices, we also proposed to provide participants with aggregate regional data.
In the proposed rule we noted that, based on our experience with BPCI participants, we recognize that hospitals vary with respect to the kinds of beneficiary claims information that would be most helpful. While many hospitals located in MSAs that are selected for participation in CJR model may have the ability to analyze raw claims data, other hospitals may find it more useful to have a summary of these data. Given this, we proposed to make beneficiary claims information available through two formats.
First, for participant hospitals that lack the capacity to analyze raw claims data, we proposed to provide summary beneficiary claims data reports on beneficiaries' use of health care services during the baseline and performance periods. These reports would allow participant hospitals to assess summary data on their relevant beneficiary population without requiring sophisticated analysis of raw claims data. Such summary reports will provide tools to monitor, understand, and manage utilization and expenditure patterns as well as to develop, target, and implement quality improvement programs and initiatives. For example, if the data provided by CMS to a particular hospital participant reflects that a certain PAC provider admits beneficiaries who then have significantly higher rates of inpatient readmissions than the rates experienced by other beneficiaries with similar care needs at similarly situated PAC providers, that may be evidence that the hospital could consider, among other things, the appropriateness of discharges to that provider, whether other alternatives might be more appropriate, and whether there exist certain care interventions that could be incorporated post-discharge to lower readmission rates.
Therefore, for both the baseline period and on a quarterly basis during a participant hospital's performance period, we proposed to provide participant hospitals with an opportunity to request summary claims data that would encompass the total expenditures and claims for an LEJR episode, including the procedure,
• Inpatient hospital.
• Outpatient hospital.
• Physician.
• Long-term care hospital (LTCH).
• IRF.
• SNF.
• HHA.
• Hospice.
• ASC.
• Part-B drug.
• Durable medical equipment (DME).
• Clinical laboratory.
• Ambulance.
These reports would likely include the following:
• Information such as admission and discharge date from the anchor hospitalization.
• The physician for the primary procedure, Medicare payments during the anchor hospitalization.
• Medicare payments during the PAC phase.
• Medicare payments for physician services would likely be included in these reports.
These summary claims data would reflect all Medicare Part A and Part B expenditures during the 90-day episodes, except for those claim types noted later in this section, as well as excluding expenditures related to those MS-DRGs that we proposed to be specifically excluded from the episode of care, as set forth in section III.B.2. of the proposed rule.
Alternatively, for hospitals with a capacity to analyze raw claims data, we would make more detailed beneficiary-level information available in accordance with established privacy and security protections. These data would enable hospitals to better coordinate and target care strategies for beneficiaries included in CJR episodes. For example, in the BPCI initiative, we provide participants with beneficiary-level claims data for all Part A and Part B services furnished to a beneficiary treated by that BPCI participant for all MS-DRGs included in an episode that the participant has selected for participation (See BPCI: Background on Model 2 for Prospective Participants, page 3 at
These data include services furnished by the participant, as well as services furnished by other entities during the 30-, 60- or 90-day episode. For example, where the entity participating in BPCI is an acute care hospital, we provide beneficiary-level claims data for all Medicare Part A and B services and supplies furnished by the hospital during the inpatient admission, as well as all PAC services furnished to the beneficiary by the hospital or any other providers or suppliers.
The response from entities participating in BPCI has indicated that the availability of these data is necessary to monitor trends and pinpoint areas where care practice changes are appropriate, as well as assess the cost drivers during the acute and PAC periods of the episode. Thus, for the baseline period and on a quarterly basis during a hospital's performance period, we proposed to provide participant hospitals with an opportunity to request line-level claims data for each episode that is included in the relevant performance year, as described in section III.C. of the proposed rule.
For both the proposed summary claims data and the more detailed claims data formats, we proposed that the sets of these files would be packaged and sent to a portal in a “flat” or binary format for the individual participant hospitals to retrieve. Furthermore, the files would contain information on all claims triggered by a beneficiary in a participating CJR hospital.
Finally, we note that beneficiary information that is subject to the regulations governing the confidentiality of alcohol and drug abuse patient records (42 CFR part 2) would not be included in any beneficiary identifiable claims data shared with a hospital under our proposal.
We requested comments on these proposals as well as the kinds of data and frequency of reports that would be most helpful to the hospitals' efforts in coordinating care, improving health, and producing efficiencies.
The following is a summary of the comments received and our responses.
Because we proposed to incorporate regional pricing data in the creation of prices for CJR, as set forth in section III.C.4. of the proposed rule, we noted our belief that it will also be necessary to provide comparable aggregate expenditure data available for all claims associated with MS-DRGs 469 and 470 for the census region in which the participant hospital is located. As noted in section III.C.4.b.(5) of the proposed rule, we proposed that a hospital's target price will be determined based on a blend of its own historical expenditures as well as regional pricing data of all other hospitals in its region. Thus, we also proposed to provide CJR hospitals with aggregate data on the total expenditures during an acute inpatient stay and 90-day post-discharge period for all Medicare FFS beneficiaries whose anchor diagnosis at discharge was either MS-DRG 469 or 470 (and would have initiated a CJR episode if discharged from a CJR hospital) in their census region. These data would not include beneficiary-identifiable claims data, but would provide high-level information on the average episode spending for MS-DRGs 469 and 470 in the region in which the participant hospital is located. We requested comments on these proposals as well as the kinds of aggregate data and frequency of data reports that would be most helpful to the hospitals' efforts in coordinating care, improving health, and producing efficiencies.
The following is a summary of the comments received and our responses.
• Total normalized episode expenditures.
• Normalized episode expenditures within cost categories (anchor inpatient, SNF, HHA, IRF, LTCH readmissions, professional services, other).
• Variability metrics related to the total normalized episode expenditures (standard deviation, 95th percentile, 99th percentile, etc.).
• Episode counts.
• Variability metrics surrounding episode counts (what is the mean number of episodes at a hospital in the region, the standard deviation, the 95th or 99th percentile, etc.).
• Utilization percentages for key services (what percentage of episodes had SNF utilization, IRF, LTCH, HHA, readmissions).
• Percentage of episodes that were non-elective (for example, using the quality metric specification exclusions methodology).
As stated in the proposed rule, we considered various options for the timing of providing baseline data to CJR participant hospitals. We considered provision of data prior to the proposed start date of the model as well as providing data to participants at the point of the first payment reconciliation (described in section III.C.6. of the proposed rule). We proposed to make baseline data available to hospitals participating in CJR no sooner than 60 days after the proposed start date of the model. We noted our recognition that
In the proposed rule, we also discussed which period of baseline data should be shared with hospitals, for example, whether the data should represent a single year, or some longer period such as a 3-year period or more. We expressed our belief that to be most useful, the baseline information should be recent enough to reflect current practices yet of a sufficient duration to reflect trends in those recent practices. For example, 1 year of data would likely reflect a hospital's most current practices, but would not be helpful for purposes of identifying trends. In contrast, 3 years of data could both reflect a hospital's most recent performance and recent performance trends. Moreover, we noted that making data available for a 3-year period aligned with our proposal to set a target price based on a 3-year period of baseline data, which is a factor in assessing CJR hospitals' performance (see section III.C. of this final rule). That is, if a hospital has access to baseline data for the 3-year period used to set its target price, then it would be able to assess its practice patterns, identify cost drivers, and ultimately redesign its care practices to improve efficiency and quality.
We alternatively considered making data available for an even longer historical period—for example, 4 or 5 years. However, we questioned the usefulness of information that is older than 3 years for purposes of changes contemplated for current operations. Accordingly, in our proposed rule, we proposed to make available baseline data for up to a 3-year period. We indicated that we would limit the content of this data set to the minimum data necessary for the participant hospital to conduct quality assessment and improvement activities and effectively coordinate care of its patient population. This period would encompass up to the 3 most recent years for which claims data are available for the hospital and would align with the baseline period we proposed to utilize to establish target prices, as noted previously. We sought comments on our proposal and invited comments on alternative time periods that could better help hospitals evaluate their practice patterns and actively manage care delivery so that care is better coordinated, quality and efficiency are improved, and costs are better controlled.
The following is a summary of the comments received and our responses.
Commenters indicated that data would be needed sooner than was proposed for reasons such as participating hospitals would need the data and time to analyze claims for purposes of identifying opportunities for care redesign, formulate processes and protocols to redesign care, assess the performance of potential partners, develop networks with physicians and PAC providers, and establish necessary clinical and administrative infrastructure. Further, hospitals might not have the in-house resources to analyze the data and thus need to use consulting resources for these purposes. Commenters noted that activities such as these could take several months to complete once the data were made available.
Some commenters also noted that the absence of downside risk does not diminish the need for access to data in advance of the CJR performance period. Moreover, commenters pointed to other CMS/CMMI efforts where data were made available prior to implementation. For example, under the BPCI model, participants received historical claims data feeds prior to the start of the program, and had approximately 12 months from receiving the data prior to enrollment in the program.
Commenters expressed concerns that insufficient time for preparation and lack of data for preparatory analysis, prior to start, could hinder a hospital's ability to effectively coordinate and ensure smooth transitions across the continuum of care for beneficiaries undergoing LEJR procedures. As discussed elsewhere in this final rule, several commenters recommended that the program be delayed so that data could be made available in advance of implementation.
As indicated in our proposed rule, we believe that the availability of periodically updated beneficiary-identifiable claims data will assist hospitals participating in CJR to identify areas where they might wish to change their care practice patterns, as well as
Related to this is the period of claims that would be represented in each update. For example, as stated in our proposed rule, we considered limiting this period to 3 months of data, which aligns with the frequency with which we would make updated claims data available. However, other than this alignment, we did not see additional reasons for artificially limiting the period to this extent. Alternatively, we considered providing an updated dataset as frequently as each quarter that would include data from up to the previous 6 quarters. We noted our belief that this level of cumulative data would offer more complete information and allow better trend comparisons.
Accordingly, we proposed to make beneficiary-identifiable and aggregate claims data available that would represent up to 6 quarters of information upon receipt of a request for such information that meets the requirements of the HIPAA Privacy Rule. We noted that we intended for the data for this model to be consistent with our proposed performance year of (January 1 through December 31). To accomplish this for the first year of CJR (2016), we proposed to provide, upon request and in accordance with the HIPAA Privacy Rule, claims data from January 1, 2016 to June 30, 2017 on as frequently as a running quarterly basis, as claims were available. For each quarter and extending through June 30, 2017, we proposed that participants during that first year would receive data for up to the current quarter and all of the previous quarters going back to January 1, 2016. These datasets would contain all claims for all potential episodes that were initiated in 2016 and capture a sufficient amount of time for relevant claims to have been processed. We noted in our proposed rule that we would limit the content of this data set to the minimum data necessary for the participating hospital to conduct quality assessment and improvement activities and effectively coordinate care of its patient population. We sought comment on our proposal.
The following is a summary of the comments received and our responses.
While some commenters supported the proposal to make data available on a quarterly basis, most of the comments we received on this topic indicated that data would be needed on a more frequent basis—specifically, on a monthly basis. Commenters suggested that monthly data would be needed for hospitals to react more quickly and to make course changes in response to changes in cost, quality, and utilization. A commenter noted that monthly updates would be needed for tracking patients whose highest utilization is in the first 30 days after their surgery. Another commenter suggested that in addition to facilitating hospitals' ability to implement the model, having more frequent data updates would encourage provider engagement in the program. Several comments also noted and requested that we make data available on a monthly basis as is done with the BPCI model.
As stated in our proposed rule, we recognize that there are a number of issues and sensitivities surrounding the disclosure of beneficiary-identifiable health information, and note that a number of laws place constraints on sharing individually identifiable health information. For example, section 1106 of the Act bars the disclosure of information collected under the Act without consent unless a law (statute or regulation) permits for the disclosure. In this instance, the HIPAA Privacy Rule permits this proposed disclosure of individually identifiable health information by us.
We proposed to make participant hospitals financially responsible for services that may have occurred outside of the hospital during the 90-day post-discharge period. Although we expect hospitals to be actively engaged in post-discharge planning and other care during the 90-day post-discharge period for beneficiaries receiving LEJRs, as discussed in section III.A. of the proposed rule, we stated our belief that it was necessary for the purposes of the CJR model to provide participant hospitals with beneficiary-level claims data, either in summary or line-level claim formats for a 3-year historical period as well as on a quarterly basis during the performance period. We believe that these data constitute the minimum information necessary to enable the participant hospital to understand spending patterns during the episode, appropriately coordinate care, and target care strategies toward individual beneficiaries furnished care by the participant hospital and other providers and suppliers.
Under the HIPAA Privacy Rule, covered entities (defined as health care plans, providers that conduct covered transactions, including hospitals, and health care clearinghouses) are barred from using or disclosing individually identifiable health information (called “protected health information” or PHI) in a manner that is not explicitly permitted or required under the HIPAA Privacy Rule. The Medicare FFS program, a “health plan” function of the Department, is subject to the HIPAA Privacy Rule limitations on the disclosure of PHI. The hospitals and other Medicare providers and suppliers are also covered entities, provided they are health care providers as defined by 45 CFR 160.103 and they conduct (or someone on their behalf conducts) one or more HIPAA standard transactions electronically, such as for claims transactions. In light of these relationships, we believe that the proposed disclosure of the beneficiary claims data for an acute inpatient stay plus 90-day post-discharge episode where the anchor diagnosis at discharge was MS-DRG 469 or 470 would be permitted by the HIPAA Privacy Rule under the provisions that permit disclosures of PHI for “health care operations” purposes. Under those provisions, a covered entity is permitted to disclose PHI to another covered entity for the recipient's health care operations purposes if both covered entities have or had a relationship with the subject of the PHI to be disclosed, the PHI pertains to that relationship, and the recipient will use the PHI for a “health care operations” function that falls within the first two paragraphs of the definition of “health care operations” in the HIPAA Privacy Rule (45 CFR 164.506(c)(4)).
The first paragraph of the definition of health care operations includes “conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines,” and “population-based activities relating to improving health or reducing health costs, protocol development, case management and care coordination” (45 CFR 164.501).
Under our proposal, hospitals would be using the data on their patients to evaluate the performance of the hospital and other providers and suppliers that furnished services to the patient, conduct quality assessment and improvement activities, and conduct population-based activities relating to improved health for their patients. When done by or on behalf of a covered entity, these are covered functions and activities that would qualify as “health care operations” under the first and second paragraphs of the definition of health care operations at 45 CFR 164.501. Hence, as previously discussed, we believe that this provision is extensive enough to cover the uses we would expect a participant hospital to make of the beneficiary-identifiable data and would be permissible under the HIPAA Privacy Rule. Moreover, our proposed disclosures would be made only to HIPAA covered entities that have (or had) a relationship with the subject of the information, the information we would disclose would pertain to such relationship, and those disclosures would be for purposes listed in the first two paragraphs of the definition of “health care operations.”
When using or disclosing PHI, or when requesting this information from another covered entity, covered entities must make “reasonable efforts to limit” the information that is used, disclosed or requested the “minimum necessary” to accomplish the intended purpose of the use, disclosure or request (45 CFR 164.502(b)). We believe that the provision of the proposed data elements listed previously would constitute the minimum data necessary to accomplish the CJR model goals of the participant hospital.
The Privacy Act of 1974 also places limits on agency data disclosures. The Privacy Act applies when the federal government maintains a system of records by which information about individuals is retrieved by use of the individual's personal identifiers (names, Social Security numbers, or any other codes or identifiers that are assigned to the individual). The Privacy Act prohibits disclosure of information from a system of records to any third party without the prior written consent of the individual to whom the records apply (5 U.S.C. 552a(b)).
“Routine uses” are an exception to this general principle. A routine use is a disclosure outside of the agency that is compatible with the purpose for which the data was collected. Routine uses are established by means of a publication in the
Notwithstanding these exceptions, in the proposed rule, we stated our belief
In the proposed rule, we also noted that an opt-out method has been used successfully in most systems of electronic exchange of information because it is significantly less burdensome on patients and providers while still providing an opportunity for patients to exercise control over their data. Thus, in our proposed rule, we proposed to use an “opt-out” approach to provide beneficiaries with the opportunity to decline claims data sharing directly through 1-800-Medicare, rather than through the participant hospital. We also proposed to provide advance notification to all Medicare beneficiaries about the opportunity to decline claims data sharing with entities participating in CMS programs and models through CMS materials such as the Medicare & You Handbook. The Handbook would include information about the purpose of the model, describe the opportunity for participants to request beneficiary identifiable claims data for health care operations purposes, and provide instructions on how beneficiaries may decline claims data sharing by contacting CMS directly through 1-800-MEDICARE. The Handbook would also contain instructions on how a beneficiary may reverse his or her preference to decline claims data sharing by contacting 1-800-MEDICARE.
In the proposed rule, we noted one advantage of these strategies was that 1-800-MEDICARE is a communication method to which beneficiaries have familiarity and broad exposure. It also has the capability for beneficiaries to use accessible alternative or appropriate assistive technology, if needed. Also, while many procedures in MS-DRGs 469 and 470 are planned in advance, some are emergent or unplanned procedures. Thus, asking the participant hospital to provide advance notification to the beneficiary, prior to the provision of services, may be inappropriate or impossible in certain circumstances. We indicated that we would continue to maintain a list of beneficiaries who have declined data sharing and ensure that their claims information is not included in the claims files shared with participants. Further, hospitals with patient portals or Blue Button® may have capability to garner patient input prior to discharge through a hospital intervention specific to patient and caregiver education, while also aiding the hospital to meet reporting requirements for other CMS programs, such as Meaningful Use under the EHR Incentive Program for Medicare Hospitals.
Finally, we proposed that participant hospitals in CJR would only be allowed to request beneficiary-identifiable claims data for beneficiaries who: (1) Have been furnished a billable service by the participant hospital corresponding to the episode definitions for CJR; and (2) have not chosen to opt-out of claims data sharing. A beneficiary that chose to opt-out of claims data sharing would only be opting out of the data sharing portion of the model. The decision to opt-out would not otherwise limit CMS' use of the beneficiaries' data, whether the beneficiary can initiate an episode, inclusion in quality measures, or inclusion in reconciliation calculations. Where a beneficiary chose to opt-out of claims data sharing, our data contractor would maintain a list of all HICNs that choose to opt-out of data sharing. We would monitor whether participant hospitals continue to request data on beneficiaries who have opted out of having their data shared and do not intend to make such data available in response to CJR such a hospital's request.
We requested comments on our proposals related to the provision of both aggregate and beneficiary-identifiable data to participant hospitals in CJR. We indicated that we were particularly interested in comments on the kinds and frequency of data that would be useful to hospitals, potential privacy and security issues, the implications for sharing protected health information with hospitals, and the use of a beneficiary opt-out, as opposed to an opt-in, to obtain beneficiary consent to the sharing of their information. We also requested comments on whether it would be helpful to provide any such system of notices, since Medicare claims information and other electronic information is already routinely shared for many other purposes among health care providers and insurers, and generally is subject to HIPAA protections. We also proposed where available, the exchange of CMS beneficiary data with the local electronic health information exchange, a system that allows doctors, nurses, pharmacists, other health care providers and patients to appropriately access and securely share a patient's vital medical information electronically in order to facilitate the hospitals ability to share timely patient data supporting improved patient referral, access, and care coordination across varied service settings.
The following is a summary of the comments received and our responses.
Commenters expressed views that expanding the availability of data would enable collaborators to be in a better position to improve their performance and management of patient care as well as ensure that care decisions are driven by patient needs rather than the potential financial risk of the hospital.
In the case of providers and suppliers (for example, physicians, PAC providers, etc.) that are collaborators with hospitals participating in the model, those providers and suppliers might be eligible to receive data under HIPAA provided that they had a relationship with the beneficiary. However, we do not believe it is appropriate for CMS to provide collaborators these data because hospitals are the entities designated under the model to assume risk and responsibility for a beneficiary's episode of care under the model. Accordingly, as the responsible entity (and as a covered entity under HIPAA), we believe that hospitals should decide what data they need to manage care and care processes with their collaborators and what data they may or may not wish to make available to those collaborators provided they are in compliance with the HIPAA Privacy Rule.
Some commenters suggested that CMS exclude from the model those beneficiaries who elect not to have their data shared. Another commenter recommended that CMS monitor the frequency with which beneficiaries opt out of sharing data and, if it reaches a certain threshold for a CJR participant, exclude those beneficiaries from payment calculations. Further, they requested that CMS seek stakeholder input on how to prevent providers from being disadvantaged by lack of data as well as the appropriate thresholds for excluding beneficiaries when data opt out has reached a certain level.
In consideration of the comments we received and our experience with programs and models such as BPCI, we have decided to provide participating hospitals with as complete data on their beneficiaries as is possible under the law. We believe that making these data available will enhance hospitals' ability to identify existing care patterns that need to be changed or strengthened as well as the kinds of strategies needed to improve their care practices so that they can be most successful under the model. Thus, we have decided to not finalize our initial proposal to allow beneficiaries the choice to opt out of having their data shared at this time. We would note, however, that this does not preclude beneficiaries from exercising their right to request restrictions on the use of their data either with the participant hospital or with CMS, which administers the Medicare FFS program, by contacting 1-800-Medicare, through which they can speak with a customer service representative who can address their concern.
We proposed the CJR model as we believe it is an opportunity to improve the quality of care and that the policies of the model support making care more easily accessible to consumers when and where they need it, increasing consumer engagement and thereby informing consumer choices. For example, under this model we proposed certain waivers that would offer participant hospitals or their collaborators additional flexibilities with respect to furnishing telehealth services, post-discharge home visits, and care in SNFs, as discussed in section III.C.11. of this final rule. We believe that this model will improve beneficiary access and outcomes. Conversely, we do note that these same opportunities could be used to try to steer beneficiaries into lower cost services without an appropriate emphasis on maintaining or increasing quality. We direct readers to sections III.C.5. and III.D. of this final rule for discussion of the methodology for incorporating quality into the payment structure and the measures utilized for this model.
We believe that existing Medicare provisions can be effective in protecting beneficiary freedom of choice and access to appropriate care under the CJR model. However, because the CJR model is designed to promote efficiencies in the delivery of all care associated with LEJR procedures, providers may seek greater control over the continuum of care and, in some cases, could attempt to direct beneficiaries into care pathways that save money at the expense of beneficiary choice or even beneficiary outcomes. As such, we acknowledge that some additional safeguards may be necessary under the CJR model as providers and suppliers are simultaneously seeking opportunities to decrease costs and utilization. We believe that it is important to consider any possibility of adverse consequences to patients and to ensure that sufficient controls are in place to protect Medicare beneficiaries receiving LEJR related services under the CJR model.
We have proposed that hospitals in selected geographic areas will be required to participate in the model, and that individual beneficiaries will not be able to opt out of the CJR model when they receive care from a participant hospital in the model. We stated our belief that it is not appropriate or consistent with other Medicare programs to allow patients to opt out of a payment system that is unique to a particular geographic area. For example, the state of Maryland has a unique payment system under Medicare, but that payment system does not create an alternative care delivery system, nor does it in any way impact beneficiary decisions. We also stated our belief that an inability to opt out of a payment system does not limit beneficiary choice as all covered Medicare services remain available under the model. We stated that we did not believe that an ability to opt out of the payment system was germane to beneficiary decisions because this model does not change beneficiary cost-sharing. We also stated our belief that full notification and disclosure of the payment model and its possible implications is critical for beneficiary understanding and protection, given that under all payment systems it is important to create safeguards for beneficiaries to ensure that care recommendations are based on clinical needs and not inappropriate cost savings. It is also important for beneficiaries to know that they can raise any concerns with their physicians, with 1-800-MEDICARE, or with their local QIOs.
This model does not limit the ability to choose among Medicare providers or the range of services available to the beneficiary. Beneficiaries may continue to choose any Medicare participating provider, or any physician or practitioner who has opted out of Medicare, with the same costs, copayments and responsibilities as they have with other Medicare services regardless of whether the provider or supplier is a participant hospital or has entered into a sharing arrangement with a participant hospital. Physicians and hospitals may identify and recommend “preferred providers,” a term used to include both providers and suppliers, which may include but are not limited to CJR collaborators with sharing arrangements with the participating hospital, as long as such recommendations do not result in violations of current laws or regulations. However, participant hospitals may not restrict beneficiaries to any such list of preferred or recommended providers/suppliers and must clearly advise beneficiaries that their choices are not constrained. Moreover, hospitals may not charge any CJR collaborator a fee to be included on any list of preferred providers or suppliers, nor may the hospital accept such payments, which would be considered to be outside the realm of risk-sharing agreements. Thus, this proposed payment model does not create any restriction of beneficiary freedom to choose providers and suppliers, including surgeons, hospitals, PAC or any other providers or suppliers.
As participant hospitals redesign care pathways, it may be difficult for providers and suppliers to sort individuals based on health care insurance and to treat them differently. We anticipate that care pathway redesign occurring in response to the model will increase coordination of care, improve the quality of care, and decrease cost for all patients, not just for Medicare beneficiaries. This anticipated
We stated our belief that beneficiary notification and engagement is essential because there will be a change in the way participating hospitals are paid. We stated our belief that appropriate beneficiary notification should explain the model, advise patients of both their clinical needs and their care delivery choices, and should clearly specify that any non-hospital provider or supplier holding a risk-sharing agreement with the hospital should be identified to the beneficiary as a “financial partner of the hospital for the purposes of LEJR services.” These policies seek to enhance beneficiaries' understanding of their care, improve their ability to share in the decision making, and ensure that they have the opportunity to consider competing benefits even as they are stated with cost-saving recommendations. We stated our belief that appropriate beneficiary notification should do all of the following:
• Explain the model and how it will or will not impact their care.
• Inform patients that they retain freedom of choice to choose providers and services.
• Explain how patients can access care records and claims data through an available patient portal and through sharing access to caregivers to their Blue Button® electronic health information.
• Advise patients that all standard Medicare beneficiary protections remain in place. These include the ability to report concerns of substandard care to QIOs and 1-800-MEDICARE.
After carefully considering the appropriate timing and circumstances for the necessary beneficiary notification, we proposed in the preamble that participating hospitals must require all providers and suppliers who execute a sharing arrangement with a participant hospital to share certain notification materials, to be developed or approved by CMS, that detail this proposed payment model before they order an admission for joint replacement for a Medicare FFS patient who would be included under the model. Participant hospitals must require this notification as a condition of any sharing arrangement. We also proposed in the preamble that where a participant hospital does not have sharing arrangements with providers or suppliers that furnish services to beneficiaries during a CJR episode of care, or where the admission for joint replacement for a Medicare FFS patient who would be included under the model was ordered by a physician who does not have a sharing arrangement, the beneficiary notification materials must be provided to the beneficiary by the participant hospital. However, we proposed text regulations that would require this notification by the hospital in all instances, a requirement we will keep in this final rule. The purpose of this proposed policy is to ensure that all beneficiaries that initiate a CJR episode receive the beneficiary notification materials, and that they receive such materials as early as possible. We stated our belief that this proposal targets beneficiaries for whom information is relevant, and increases the likelihood that patients will become engaged and seek to understand the model and its potential impact on their care.
We noted that beneficiaries are accustomed to receiving similar notices of rights and obligations from healthcare providers prior to the start of inpatient care. However, we also considered that this information might be best provided by hospitals at the point of admission for all beneficiaries, as hospitals provide other information concerning patient rights and responsibilities at that time. We invited comment on ways in which the timing and source of beneficiary notification could best serve the needs of beneficiaries without creating unnecessary administrative work for providers. We stated our belief that this notification is an important safeguard to help ensure that beneficiaries in the model receive all medically necessary services, but it is also an important clinical opportunity to better engage beneficiaries in defining their goals and preferences as they share in the planning of their care.
The following is a summary of the comments received and our responses.
Other commenters believed that hospitals should be required to define criteria for inclusion in a “preferred network” based in whole or in part on non-financial criteria such as quality metrics, or that hospitals should define and publish the criteria that they use. Other commenters believed that hospitals should be required to offer the same gainsharing contracts to all willing providers or suppliers. Other
Commenters recommended that the Secretary establish minimum criteria such as quality of care, health outcomes, price, accessibility, willingness to work together on evidence-based protocols, and patient experience of care, and that CMS should exercise caution if it permits the recommendation of specific providers, given concerns that the hospital may not have an adequate understanding of the difference between providers or provider types or that the hospital may drive patients to “low cost” providers in order to retain a greater share of the savings while putting beneficiaries at clinical risk by potentially stinting on care. However, commenters noted that hospitals must be able to limit the options stated to patients because the hospital will be financially responsible for costs in the episode.
We believe that allowing hospitals to disclose those providers and suppliers who best contribute to improved efficiency and better outcomes does not limit beneficiary choice, provided that beneficiaries are fully informed of any financial dealings that could create a conflict of interest. We therefore believe that identifying these preferred providers/suppliers is consistent with section 1861(ee)(2)(H) of the Act, as it does not specify or limit qualified providers/suppliers that may provide PAC, and we believe that our requirement that beneficiaries must be notified of financial arrangements is both consistent with and required by that section. We further believe that the proposed requirement to notify beneficiaries of all preferred and non-preferred PAC providers/suppliers, coupled with the requirement to identify CJR collaborators that we are finalizing in this rule, provides beneficiaries with sufficient information to allow them to avoid improper steering or referral.
With respect to content, some commenters believed that the notification should be highly standardized, based on a standard or model notice created by CMS, or even that CMS should create and provide a single notice to all beneficiaries. Other commenters believed that the notice should reflect specifics of the PAC specific network or of the patient, informing beneficiaries of differences in capacity and patient incurred costs among the various settings or explaining the patient's ability to choose their own PAC provider/supplier, even if the hospital is not satisfied with the quality of the provider/supplier that is chosen. Finally, a commenter believed that the model should be considered to be human experimentation and should follow human subject notice requirements.
With respect to form, several commenters opined that beneficiary notification should be permitted on an electronic basis, with proof of receipt by the beneficiary rather than a paper process that requires a beneficiary's signature.
With respect to timing, we proposed that beneficiaries should be notified at the point of admission because it is hospitals that are participants in the model, not physicians. We do not agree that the point of admission is too late, noting that the point of admission is when notice of other patient rights regarding the hospital stay are required by Medicare. However, we acknowledge that earlier notification of the beneficiary is desirable. We concur that a beneficiary fact sheet and/or a standard notification form for voluntary distribution in the physician's office would be helpful, and that physicians should be encouraged to explain the model to prospective patients as early as possible. In addition to the model notification forms for hospitals, physicians, and PAC providers/suppliers that we will develop and publish prior to the start of the model, we will consider developing a model fact sheet as we develop educational materials, and we note that participant hospitals are not precluded from developing such fact sheets for the use of their medical staff. Furthermore, we agree that, in the limited case of physicians who have sharing arrangements with hospitals, we are modifying the regulations text from what we proposed to specify that hospitals must include in any physician sharing arrangement a condition under which the collaborating physician—(1) Agrees to notify the patient of the structure of the CJR model; (2) agrees to inform the patient that the physician is participating in a sharing arrangement; and (3) agrees to deliver that information at the time that a decision for surgery is made. We also will modify our proposal in response to concerns that more PAC-specific notice is necessary. In addition to this physician notification requirement, we will require notification of involvement in a sharing arrangement from any other providers and suppliers engaged in a sharing arrangement with a participant hospital, with that notice of involvement to be delivered before the first time a service related to the joint replacement, such as a PAC SNF stay, is furnished to the beneficiary by that entity. However, in response to comments to preserve participant hospitals' flexibility, as we previously discussed we are not finalizing our proposal that these notices would be approved by CMS, but we will instead develop one or more model notices that participant hospitals and others can use.
With respect to form, we agree with commenters that written communication is not limited to paper, and we note that we did not propose a written signature requirement in regulation. We agree that electronic health records may be used to maintain documentary evidence of written communications, and we have not specified a specific mechanism by which proof of beneficiary notification must be maintained.
We do not agree that a waiver of existing discharge planning requirements is necessary, and we discuss the specification of allowable and non-allowable financial arrangements in section III.C.10. of this proposed rule. However, we will also add additional details concerning financial arrangements to our notice requirements in order to protect beneficiaries while ensuring that hospitals, if desired, may recommend “preferred providers,” that is, high quality PAC providers/suppliers with whom they have relationships (either financial and/or clinical) for the purpose of improving quality, efficiency, or continuity of care. Specifically, in order to address financial concerns deriving from potential conflicts of interest, we will specify that hospitals and collaborators must disclose the existence of sharing arrangements. In order to protect against situations which might expose beneficiaries to unexpected liability, we will also specify that hospitals must provide written notification of any non-covered services which are recommended or considered as part of discharge planning whenever a hospital knows or should have known that such services are non-covered.
Given that participant hospitals would receive a reconciliation payment when they are able to reduce average costs per case and meet quality thresholds, they could have an incentive to avoid complex, high cost cases by referring them to nearby facilities or specialty referral centers. We intend to monitor the claims data from participant hospitals—for example, to compare a hospital's case mix relative to a pre-model historical baseline to determine whether complex patients are being systematically excluded. We will publish these data as part of the model evaluation to promote transparency and an understanding of the model's effects. We also proposed to continue to review and audit hospitals if we had reason to believe that they are compromising beneficiary access to care. For example, where claims analysis indicates an unusual pattern of referral to regional hospitals located outside of the model catchment area or a clinically unexplained increase or decrease in joint replacement surgery rates.
The following is a summary of the comments received on monitoring for access to care, and our responses.
Commenters raised a number of questions about determinations of medical necessity and their effect on access to care. A commenter, quoting our proposed rule in which we stated that gainsharing payments and alignment of payments must not induce collaborators to limit medically necessary services, requested that we articulate who will decide what is medically necessary and how this determination would be made. That commenter recommended that we encourage the use of treatment protocols based on objective criteria. Other commenters urged us to require CJR participant hospitals to demonstrate that they have appropriateness criteria in place to assess beneficiary need for joint replacement.
Commenters had two competing concerns. First, they were concerned that the bundled payment created a risk of patient “dumping,” or inappropriately referring patients to other providers based on financial considerations. They were concerned that surgeons/hospitals will avoid complex/sicker patients not only to avoid the losses associated with expensive cases but also to avoid cases at risk for readmission. Similarly, they stated that hospitals will avoid lower socioeconomic patients unless there is a socioeconomic risk adjustment. Commenters suggested that these risks could be mitigated by adding specific, separate penalties for withholding care or steering patients inappropriately or rejecting patients entirely. These penalties should progress up to and include termination from Medicare.
Second, commenters identified a risk of overutilization. These commenters believed that some physicians and hospitals will provide services to healthier patients who could benefit from less invasive treatments in order to improve their metrics, or increase volume to account for lost revenue, or treat healthier patients, which will result in adjustments to a hospital's patient mix. A commenter asserted that both influences are already in effect, with considerable overutilization of LEJR (based on regional variation) and also with some studies suggesting that “only 1 in 10 patients needing LEJR are getting it.”
Commenters also recommended other steps in addition to a general recommendation for an appropriateness (medical necessity) measure to gauge the appropriateness of care at the beginning of the episode. It was for this reason that commenters urged us to require CJR participant hospitals to demonstrate that they have appropriateness criteria in place to assess beneficiary need for joint replacement. Commenters urged CMS to monitor changes in utilization patterns and case mix as part of the evaluation, and to generally monitor whether barriers to patient access develop in MSAs participating in the CJR program, and to make necessary alterations to the model if complicated hip/knee replacement cases are found to be underserved.
We also agree with commenters that additional specific regulatory detail should be added to address the consequences of systemic underutilization. We proposed that participant hospitals would not be eligible for reconciliation payments if those payments are associated with actions that threaten beneficiary health, and we note that systemic instances of under-delivery of care threaten that health and therefore constitute a reason to withhold reconciliation payments. We also note that we have the authority to revoke provider enrollment in the Medicare program for cause, such as providing substandard care that places beneficiaries at risk that, is, by under-delivering care. As an intermediate step, we further note that we have additional options, such as requiring additional actions under a corrective action plan in order to avoid revocation. However, we reiterate that we do not believe such aggressive measures are necessary, as we believe that such concerns as reputation and patient outcomes provide sufficient motivation for most providers/suppliers.
We do not believe that the additional controls are necessary because we have a number of established mechanisms by which we will monitor for evidence of the underdelivery of care, and by which we can react to and mitigate any identified problems. We will be monitoring data in the process of calculating quality metrics, and we have several reporting mechanisms, such as
The following is a summary of the comments received on monitoring for quality of care, and our responses.
We believe that these safeguards are all enhanced by beneficiary knowledge and engagement. As we discussed in the section on beneficiary notification, we proposed to require that participant hospitals must, as part of discharge planning, account for potential financial bias by providing patients with a complete list of all available PAC options in the service area consistent with medical need, including beneficiary cost-sharing and quality information (where available and when applicable). We expect that the treating surgeons or other treating practitioners, such as physiatrists, will continue to identify and discuss all medically appropriate options with the beneficiary and that hospitals will discuss the various facilities and providers who are available to meet the clinically identified needs. These proposed requirements for CJR participant hospitals would supplement the existing discharge planning requirements under the hospital CoPs. We also specifically note that neither the CoPs nor this proposed transparency requirement preclude hospitals from recommending preferred providers within the constraints created by current law, as coordination of care and optimization of care are important factors for successful participation in this model. We invited comment on this proposal, including additional opportunities to ensure high quality care.
The following is a summary of the comments received regarding provisions to ensure quality during the delivery of PAC services, and our accompanying responses.
Other recommended controls included a requirement that any and all documents used by the hospital during discharge planning must be submitted to (not approved by) CMS, a requirement that any agreement between hospitals and PAC providers should be submitted to (not approved by) CMS, and that CMS should do a random sample audit of these agreements to ensure they comply with current regulations. A commenter recommended that CMS make available to the public the amount hospitals earn from reconciliation payments for a performance year, while another recommended that we should do random face to face interviews post discharge to determine if the patient was steered to a particular provider if such interviews warranted based on changes in utilization rates or if we identify inappropriate or concerning sharing arrangements between a hospital and a PAC provider.
Other commenters wanted us to underscore in the final rule that hospital utilization review committees and physicians who sign discharge orders remain fully accountable to make the determination that a patient discharge is medically appropriate. A commenter believed that part of the discharge process should include an independent determination that medical resources and care required by each beneficiary are available in an available PAC setting.
With respect to comments that we establish basic requirements for care coordination or require specific documentation of care coordination procedures, we agree with commenters that activities such as discharge planning are integral to care coordination. However, we note that it is one function of state agencies and accrediting organizations to ensure that discharge planning is effectively addressed, and that their applications of the CoPs are updated as necessary to establish appropriate standards. We note that CMS has recently proposed updated discharge planning requirements for hospitals through proposed changes to the hospital CoPs.
We do not believe that new requirements, such as CMS receipt of discharge planning documents or public posting of amounts involved in gainsharing, are necessary to ensure appropriate post discharge care. We note that, with the exception of waivers discussed in section III.C.11. of this final rule, all other Medicare rules for coverage and payment continue to apply. However, as discussed elsewhere in this section of this final rule, we have modified proposed § 510.500 to require additional disclosure of CJR sharing arrangements with PAC providers to CMS. Therefore, we believe that sufficient controls are in place to allow us to ensure the quality of the PAC services without requiring additional public disclosure or CMS approval.
We also note that whereas both utilization review activities and discharge planning are required by the hospital CoPs, a review of the appropriateness of post-discharge services is not an activity currently undertaken by hospitals. We agree that the ultimate direction for the care of the patient lies with the physician and patient, and claims for services are subject to appropriate validation and
This model is based in part on an incentive for hospitals to create efficiencies in the delivery of care within a 90-day episode following the joint replacement surgery. Theoretically this could create incentives for hospitals and other CJR collaborators involved in any CJR sharing arrangements to delay services until after that window has closed.
We believe that existing Medicare safeguards are sufficient to protect beneficiaries. First, our experience with other bundled payments such as the BPCI initiative has shown that providers focus on appropriate care first and efficiencies only when those efficiencies can be obtained in the setting of appropriate care. We believe that a 90-day post-discharge episode will sufficiently minimize the risk that services furnished in relation to the beneficiary's LEJR procedure will be necessary beyond the end of the episode duration. To ensure that the length of the episode duration sufficiently minimizes the risk that any LEJR related care will not exceed the time established for the episode, we proposed to establish a 90-day post-discharge duration. We believe that participant hospitals would be unlikely to postpone services beyond a 90-day period because the consequences of delaying care beyond this long episode duration would be contrary to usual standards of care.
However, we also note that additional monitoring would occur as a function of the payment model. We have proposed as part of the payment definition (see section III.C. of the proposed rule) that certain post-episode payments occurring in the 30-day window subsequent to the end of the 90-day episode would be counted as an adjustment against savings. We believe that the inclusion of this payment adjustment would create an additional deterrent to delaying care beyond the episode duration. In addition, the data collection and calculations used to determine this adjustment provide a mechanism to check if providers are inappropriately delaying care. Finally, we note that the proposed quality measures create additional safeguards as they are used to monitor and influence hospital clinical care at the institutional level. We invited public comment on our proposed requirements for notification of beneficiaries and our proposed methods for monitoring participants' actions and ensuring compliance as well as- on other methods to ensure that beneficiaries receive high quality, clinically appropriate care.
The following is a summary of the comments received and our responses.
Commenters suggested that post-episode monitoring should be extended for at least 3 to 6 months after the end of the bundle period or even 5 or more years in order to include the late effects of suboptimal implant selection. As part of PAC monitoring, commenters acknowledged that CMS proposed to look at changes in referral patterns as a result of the model, but also believed that we should evaluate the impact that the model may have on the availability of services in a market.
With respect to monitoring in general, commenters requested that we should be more transparent about monitoring. Specific recommendations were that we should track readmission rates, complication rates, ER visits, observation stays, length-of-stay, changes in patient function, and patient experience, gap between discharge and first PAC use and between discharge and physician follow-up visit, days lapsed between discharge from the hospital to the first PAC use, and days lapsed between hospital discharge and the first physician visit. Some providers also requested that we should incorporate information from/related to reporting requirements of the IMPACT Act into functional monitoring. Commenters also believed that we should perform some baseline monitoring, looking at case mix before and after CJR implementation as well as the rates of joint replacement in MSAs included in the CJR model and MSAs excluded from the model.
Other commenters believe that special controls and audits should be implemented to further protect beneficiaries. A commenter believes that CMS should require providers to submit annual reports that detail original care redesign objectives they agreed to implement, the progress they made in achieving those objectives and how achieving those objectives has been linked to gainsharing rewards. Another believed that we should institute a structured monitoring program to ensure compliance with the patient notice requirements, using a contractor such as a state survey agency, a QIO, or a hospital private accrediting body. Recommended elements of monitoring and control included the submission of any model notice in advance of its use,
We agree that contractors conducting audits or medical review to assess for delays in care or for other purposes may find and deny claims that were incorrectly billed. We also agree that there is a complex interaction between the denial of a service on a claim and its impact on the reconciliation process for the performance year under the CJR model, depending on the provider whose claim is denied, the timing of the adjustment relative to the model reconciliation, the limits of upside and downside risk, and other factors. For example, if a PAC claim is denied after final reconciliation, the hospital will still have incurred a cost approximately equal to the amount that was denied to the PAC provider because those costs would still be included in the calculation of the positive or negative NPRA as calculated in accordance with § 510.305. On the other hand, if the denial occurs prior to reconciliation, the hospital will have lower costs attributed to it as the cost of the service would be removed from the claims history. This will affect the NPRA as if the denied service had never been delivered and benefit the hospital by an amount that is approximately equal to the amount that was denied to the PAC provider. Given this complex interaction that can create diverse and opposing impacts but only in the setting of inappropriate (denied) claims, we do not believe that it is necessary or desirable to exclude services from medical review because they are delivered under the CJR model.
Impacts created by payment changes under this model are entirely internal to HHS operations; coordination with other agencies is not required outside of the usual coordination involved in the publication of all HHS regulatory changes.
The CJR model is intended to enable CMS to better understand the effects of bundled payments models on a broader range of Medicare providers than what is currently being tested under BPCI. Obtaining information that is representative of a wide and diverse group of hospitals will best inform us on how such a payment model might function were it to be more fully integrated within the Medicare program. All CMS models, which would include the CJR model, are rigorously evaluated on their ability to improve quality and reduce costs. In addition, we routinely monitor CMS models for potential unintended consequences of the model that run counter to the stated objective of lowering costs without adversely affecting quality of care. We outlined the proposed design and evaluation methods, data collection methods, key evaluation research questions, and the evaluation period and anticipated reports for the CJR model in the 2016 Comprehensive Care for Joint Replacement proposed rule (80 FR 4198).
Our evaluation approach for the CJR model will have elements in common with the standard Innovation Center evaluation approaches we have taken in other projects such as the BPCI initiative, ACE Demonstration, Pioneer ACO model, and other Innovation Center models. Specifically, the evaluation design and methodology for the CJR model would be designed to compare patterns of care among the CJR providers to patterns of care among non-CJR providers, potentially contrasted with historical differences in care between these two groups of providers.
Our evaluation methodology for this model builds upon the fact that MSAs were selected for participation in the model based on a stratified random assignment. In this approach, researchers evaluate the effects of the model on outcomes of interest by directly comparing MSAs that are randomly selected to participate in the model to a comparison group of MSAs that were not randomly selected for the model (but could have been). Randomized evaluation designs of this kind are widely considered the “gold standard” for social science and medical research because they ensure that the systematic differences are reduced between units that do and do not experience an intervention, which ensures that (on average) differences in outcomes between participating and non-participating units reflect the effect of the intervention.
The removal of the 8 MSAs that were previously selected but are now considered not eligible due the revision to the MSA exclusion rules does not compromise our proposed evaluation approach. The relative ranking of MSAs with respect to episode payments is unchanged by the new exclusions. The selected MSAs remain randomly selected and also remain distributed throughout the payment and population size dimensions. As with other evaluation issues, the methodological approach to examining and drawing conclusions about the impact of the model will be finalized in the Evaluation Contract.
We plan to use a range of analytic methods, including regression and other multivariate methods appropriate to the analysis of stratified randomized experiments to examine each of our measures of interest. Measures of interest could include, for example, quality of and access to care, utilization patterns, expenditures, and beneficiary experience. The evaluation would also include rigorous qualitative analyses in order to capture the evolving nature of the care model interventions.
In our design, we plan to take into account the impact of the CJR model at the geographic unit level, the hospital level, and the patient level. We are also considering various statistical methods
We are considering multiple sources of data to evaluate the effects of the CJR model. We expect to base much of our analysis on secondary data sources such as Medicare FFS claims and required patient assessment instruments such as the Minimum Data Set (MDS) collected for SNF stays, the Patient Assessment Instrument for Inpatient Rehabilitation Facility (IRF-PAI) collected for IRF stays, and the Outcome and Assessment Information Set (OASIS) collected for home health episodes of care. The beneficiary claims data would provide information such as expenditures in total and by type of provider and service as well as whether or not there was an inpatient hospital readmission. The assessment tools would provide information on a beneficiary's functioning (for example, physical, psychological and psychosocial functioning).
In conjunction with the previously stated secondary data sources, we are considering a CMS-administered survey of beneficiaries who received an LEJR during the performance period. This survey would be administered to beneficiaries who either had received an LEJR under the CJR model or were selected as part of a control group. The primary focus of this survey would be to obtain information on the beneficiary's perception of their functional status before and after the LEJR as well as information on their pain and LE joint symptoms, and perceptions on access to care. The administration of this beneficiary survey would be coordinated with administration of the HCAHPS Survey so as to not conflict with or compromise the HCAHPS efforts. Likewise, we are considering a survey administered by CMS and guided interviews conducted by CMS with providers and suppliers including, but not limited to, orthopedic surgeons, initiating hospitals, and PAC providers participating furnishing services to beneficiaries included in the CJR model. These surveys would provide insight on beneficiaries' experience under the model and additional information on the care redesign strategies undertaken by health care providers.
In addition, we are considering CMS evaluation contractor-administered site visits with selected hospitals and PAC providers as well as focus groups with a range of populations such as PAC providers and orthopedic surgeons. We believe that these qualitative methods would provide contextual information that would help us better understand the dynamics and interactions occurring among CJR providers furnishing services included within a CJR episode. For example, these data could help us better understand hospitals' intervention plans as well as how they were implemented and what they achieved. Moreover, in contrast to relying on quantitative methods alone, qualitative approaches would enable us to view model nuances as well as identify factors that are associated with successful interventions and distinguish the effects of multiple interventions that may be occurring within participating providers, such as simultaneous ACO and bundled payment participation.
Our evaluation would assess the impact of the CJR model on the aims of improved care quality and efficiency as well as reduced health care costs. This would include assessments of patient experience of care, utilization, outcomes, Medicare expenditures, provider costs, quality, and access. Our key evaluation questions would include, but are not limited to, the following:
•
•
•
•
•
•
•
++ Characteristics of the models including variations by year and factors such as presence of downside risk?
++ The participating hospital's specific features and ability to carry out their proposed intervention?
++ Characteristics and nature of interaction with partner providers and suppliers including orthopedic surgeons and PAC provider community?
++ Characteristics of the geographic area, such as market concentration or size of city and availability of PAC providers?
++ Characteristics associated with the patient populations served?
As discussed in section III.C.2.a. of this final rule, each of the selected participants in the CJR model would have 5 performance years. The evaluation period would encompass all 5 performance years and up to 2 years after. We plan to evaluate the CJR model on an annual basis. However, we recognize that interim results are subject to issues such as sample size and random fluctuations in practice patterns. Hence, while we intend to have internal periodic summaries to offer useful insight during the course of the effort, a final analysis after the end of the 5 performance years will be important for ultimately synthesizing and validating results.
We sought comments on our design, evaluation, data collection methods, and research questions.
The following is a summary of the comments received and our responses.
• In the category of “utilization,” the following topics were highlighted as of interest to commenters: (1) An examination of utilization shifts between sites of care as well as an examination of the types of patients for which this occurs and if there was an impact on quality, health outcomes, and total spending; and (2) an examination of changes in types of devices being used in total joint replacement procedures compared to historical trends and other markets.
• In the category of “outcomes and quality,” the following topics were highlighted: an examination of the impact of the model on certain vulnerable subpopulations, including low-income individuals, individuals residing in low-access areas, and racial and ethnic minorities.
• In the category of “market impact,” the following topics were highlighted: an assessment of whether hospitals redesign or eliminate service lines; an assessment on the impact of the availability of services in a market; an assessment of the impact, if any, on the financial viability of PAC providers in impacted markets; the shifting of increased costs to other payers; and an exploration of the use of the gainsharing waiver, including the criteria hospitals use to identify preferred partner relationships and an examination of to whom gains are distributed.
• In the area of “patient access,” the following topics were mentioned: an examination of the extent to which beneficiary choice is preserved and whether or not hospitals steer patients towards certain providers; an assessment on the impact of the model on patient access to services including patient travel time; an assessment of the extent to which use of lower cost alternatives or lack of other enhancements to the patient experience led to changes in patient outcomes and satisfaction; and an evaluation of device offerings and patient access to various technologies for joint replacement.
• Within the category of exploring which factors are associated with “variations” in success, the following topics were mentioned: examining whether higher risk candidates for surgery are avoided or lower risk patients are inappropriately targeted for inclusion; an assessment of the impact of simultaneous incentives and participation in other models and programs that may impact the same patients or providers; an assessment of the variation in implementation by hospitals and the extent to which hospitals make a financial commitment to prepare staff and to undertake other activities to improve coordination; and an assessment of the use and impact of telehealth services and related efforts.
• Readmission rates, complication rates, use of emergency room visits and observation stays, length of stay, changes in patient function, and patient experience in the assessment of the stinting of care.
• Number of days between discharge from the hospital to first PAC use, and number of days between hospital discharge and first physician visit to assess timely care coordination.
• Comparison of utilization rates for joint replacement procedures in markets included and excluded to monitor any increase.
• The development and implementation of true longitudinal outcome metrics.
Regarding collaborator agreements, we are requiring that participant hospitals include provisions that require all CJR collaborators to comply with any evaluation, monitoring, compliance, and enforcement activities performed by HHS or its designees for the purposes of operating the CJR model. We intend to be prudent in exercising this requirement but we believe that it is necessary to include, particularly related to the need to assess compliance with model requirements and patient quality of care. We do not anticipate that this will be a significant barrier to CJR collaborators signing agreements.
As stated in section1115A(d)(3) of the Act, Chapter 35 of title 44, United States Code, shall not apply to the testing and evaluation of models under section 1115A of the Act. As a result, the information collection requirements contained in this final rule need not be reviewed by the Office of Management and Budget.
We have examined the impact of this rule as required by Executive Order 12866 and other laws and Executive Orders requiring economic analysis of the effects of final rules.
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability, presents the costs and benefits of the rulemaking.
This final rule is necessary in order to implement and test a new payment and service delivery model under the authority of section 1115A of the Act, which allows the Innovation Center to test innovative payment and service delivery models in order to reduce program expenditures while preserving or enhancing the quality of care furnished to individuals. The underlying issue addressed by the CJR model is that under FFS, Medicare makes separate payments to providers and suppliers for items and services furnished to a beneficiary over the course of a treatment (an episode of care). Because the amount of payment is dependent on the volume of services delivered, this creates incentives for care that is fragmented, unnecessary or duplicative, while impeding the investment in quality improvement or care coordination that will maximize patient benefit. We anticipate the CJR model may reduce costs while maintaining or improving quality where the provision of “bundled services” in which all the services needed for a given episode of care are included in a single payment arrangement that provides incentives to promote high quality and efficient care.
This final rule will create and test the first bundled payment model under the Innovation Center authority in which providers will be required to participate, building on the experience of the current voluntary BPCI and previous ACE efforts. Testing the model in this manner will also allow us to learn more about patterns of inefficient utilization of health care services and how to incentivize improvement in quality for common LEJR procedure episodes. This learning could inform future Medicare payment policy.
Under the CJR model, acute care hospitals in certain selected locations will receive retrospective bundled payments for episodes of care for LEJR or reattachment of a lower extremity. The proposed rule was developed based on the experiences we gained from the implementation of the Bundled Payments and Care Improvement Initiative and the ACE Demonstration to test bundled payments. We believe the model may benefit Medicare beneficiaries through improving the coordination and transition of care, improving the coordination of items and services paid for through Medicare FFS payments, encouraging provider investment in infrastructure and redesigned care processes for high quality and efficient service delivery, and incentivizing higher value care across the inpatient and PAC spectrum spanning the episode of care. It will also provide an opportunity to evaluate the nature and extent of reductions in the cost of treatment by providing financial incentives for providers to coordinate their efforts to provide services to meet patient needs and prevent future costs.
As detailed in Table 33, we estimate a total aggregate impact of $343 million in net Medicare savings over the duration of the model, CYs 2016 through 2020, from the implementation of the CJR model. This reflects the policies finalized in this rule, as well as updates to the data used for the impact analysis. We note that in the impact estimate in the proposed rule we had identified participant hospitals in the proposed selected 75 MSAs, though we inadvertently excluded some of those hospitals in our estimates presented in the proposed rule. For the impact analysis provided in this final rule, we revised our list of participant hospitals to include hospitals in the 67 MSAs selected for CJR and made the identification of hospitals consistent with how we identify hospitals in the selected MSAs in section III.A.3. of this final rule.
We note that we are posting the list of the participant hospitals in the selected MSAs on the CJR final rule Web site at
We note that we are finalizing the start date of this model to begin April 1, 2016 where the first performance year is 9 months and all other performance years begin January 1 and last 12 months. The estimates presented in this final rule reflect the changed start date
Our analysis of the model's effects shows that this final rule will trigger the threshold of “an annual effect on the economy of $100 million or more” under E.O. 12866. Accordingly it will also be a major rule under the Congressional Review Act, and we are required to prepare an analysis that presents the costs and benefits of this final rule. We have prepared an analysis that address benefits and costs that applies to “economically significant” or “major” rules. We solicited comment on the assumptions and analysis presented throughout this regulatory impact section.
The following is a summary of the comments received and our responses.
We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. As previously stated, this final rule triggers these criteria.
Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, pre-empts state law, or otherwise has federalism implications. We do not believe that there is anything in this final rule that either explicitly or implicitly pre-empts any state law, and furthermore we do not believe that this final rule will have a substantial direct effect on state or local governments, preempt states law, or otherwise have a federalism implication.
According to Medicare FFS claims data in 2014, there were approximately 478,000 discharges for MS-DRGs 469 and 470 nationally. Based on the same data for 2014, we estimate that the participant hospitals had approximately 86,000 LEJR episodes (as defined in this model). The number of such procedures has grown in recent years, due both to the aging of the American population and to advances in medical technology and care that have made these operations less physically burdensome on patients and led to faster recovery times.
More uncertain are the total costs of these procedures. The mean estimated 90-day episode payment for LEJR procedures (defined as discharges for MS-DRG 469 and MS-DRG 470) is about $26,000 based on Medicare claims data for FY 2014 where approximately 55 percent of the spending is attributed to hospital inpatient services, 25 percent of spending is attributed to PAC services such as physical therapy (either ambulatory and in a facility) and 20 percent to physician, outpatient hospital and other spending.
We are testing the model in 67 MSAs out of the 196 MSAs initially deemed eligible for selection, as described previously in this final rule. We note that this is a change from the proposed rule where we had selected a proposed 75 MSAs but in this final rule, we are removing 8 MSAs from selection because they did not meet the updated eligibility criteria. Based on the selection methodology finalized in this rule, we estimate that the model will include about 23 percent of all LEJR episodes nationally. We estimate the model will apply to about $1.247 billion in episode spending in 2016 and $2.980 billion in episode spending in 2020 as displayed in Table 33 later in this section. As discussed subsequently in this analysis, this is likely to generate approximately a net amount of $343 million in savings to Medicare over the entire duration of the model. Annual reconciliation payments for each performance year may be greater than or less than the net change as detailed in Table 33 later in this section. In years 2019 and 2020 of the CJR model, we estimate a net change that is greater than the $100 million dollar threshold for economic significance.
There may also be spillover effects in the non-Medicare market, or even in the Medicare market in other areas as a result of this model. Recent research suggests that permanent changes in Medicare payment policy often have substantial effects on non-Medicare payers.
The CJR model is a model involving an innovative mix of financial incentives for quality of care and efficiency gains within FFS Medicare for LEJR episodes. This model represents a new approach for the Medicare FFS program because it applies bundled payments to hospitals that might not otherwise participate in Innovation Center models or Medicare demonstrations and tests bundled payment models for episodes of care for LEJR procedures in multiple geographic areas. As such, we are interested in testing and evaluating the impact of a bundled payment approach for LEJR procedures in a variety of circumstances, especially among those providers that may not have decided to engage in programs or models in which Medicare makes payments differently than Medicare FFS.
As described earlier in this final rule in section III.B. of this final rule, episodes will begin with admission to an acute care hospital for an LEJR procedure that is paid under the IPPS through MS-DRG 469 or 470 and extend 90 days following discharge from the acute care hospital. The episode will include the LEJR procedure, inpatient stay, and all related care covered under Medicare Parts A and B within the 90 days after discharge, including hospital care, PAC, and physician services. Furthermore, we have designated participant hospitals as the episode initiators and to be financially responsible for episode cost under the CJR model. We will require all hospitals paid under the IPPS and physically located in selected geographic areas to participate in the CJR model, with limited exceptions. Eligible beneficiaries who receive care at these hospitals will automatically be included in the model. Geographic areas, based on MSAs, were selected for the model through a stratified random sampling methodology based on the following criteria: historical episode wage-adjusted payment quartiles and population size halves. We anticipate the CJR model may have financial and quality of care effects on non-hospital providers and suppliers that are involved in the care of Medicare beneficiaries with an LEJR episode, improving the coordination of items and services paid for through Medicare FFS, encouraging more provider investment in infrastructure and redesigned care processes for higher quality and more efficient service delivery, and incentivizing higher value care across the inpatient and PAC spectrum spanning the episode of care. However, the CJR model attributes episode spending and makes the retrospective reconciliation payment to or repayment from the participant hospital. Accordingly, our analysis examines the effects on participant hospitals, as they are the providers accountable for the episode payment under this model. Additionally, we will test the CJR model for a performance period beginning April 1, 2016 and ending December 31, 2020 and our estimates cover the duration of the model. We note that in this final rule, we are changing the start date of the model such that the first year of the model will begin April 1, 2016 and have a performance period of 9 months. All other performance years of the model will begin January 1 and have a performance period of 12 months.
As described earlier in this final rule, we will continue paying hospitals and other providers and suppliers according to the usual Medicare FFS payment systems during all performance years. After the completion of a performance year, the Medicare claims payments for services furnished to the beneficiary during the episode, based on claims data, will be combined to calculate an actual episode payment. The actual episode payment is the sum of Medicare Part A and B claims payments for all related items and services furnished to a beneficiary during a CJR episode. The actual episode payment will then be reconciled against an established CJR target price, with consideration of additional payment adjustments based on quality performance and post episode spending. The amount of this calculation, if positive, will be paid to the participant hospital if the hospital has met the quality thresholds finalized in this rule. This payment is the reconciliation payment. If negative, the participant hospital will be required to make repayment to Medicare. We are phasing in the requirement that hospitals whose actual episode payments exceed their CJR target price to pay the difference back to Medicare beginning in performance year 2. Under this requirement, Medicare will not require repayment from hospitals for CJR episode spending above their target price in performance year 1. Lastly, we finalized to limit how much a hospital can gain or lose based on its reconciliation calculation with additional policies to further limit the risk of high payment cases for all participant hospitals and for special categories of hospitals.
Based on the mix of financial and quality incentives, the CJR model could result in a range of possible outcomes for participant hospitals. The effects on hospitals of potential savings and liabilities will have varying degrees.
Table 33 summarizes the estimated impact for the CJR model. Our model estimates that the Medicare program will save $343 million dollars over the 5 performance years (2016 through 2020). Savings to the Medicare program may be greater if providers are able to improve the coordination of care, invest in infrastructure, and redesign care processes to promote high quality and efficient service delivery. Costs to the Medicare program may increase if providers are able to use waivers provided under the model to increase
We used final action Medicare claims data from January 1, 2012 through March 31, 2015 as of October 2015 to simulate the impact that this model will have on Medicare spending for joint replacement episodes. This time period is consistent with the historical period that we are finalizing to use to calculate target prices for performance years 1 and 2 of the model as described in section III.C of this final rule (we note that for performance years 3 and 4, target prices will be calculated based on episodes that start between the period of January 1, 2014 to December 31, 2016. And for performance year 5, target prices will be calculated based on episodes that begin between the period of January 1, 2016 to December 31, 2018.) We applied the methodology provided in this final rule for calculating target prices for all hospitals that will be required to participate in the model, as discussed in section III.A. of this final rule, based on their performance from calendar years 2012 through 2014. Specifically, the estimates in this impact analysis reflect all IPPS hospitals in the selected MSAs and not participating in Model 1 or Phase II of BPCI Models 2 or 4 for the LEJR clinical episode as of October 2015. We identified the anchor hospitalizations based on claims with MS-DRG 469 and MS-DRG 470 and included the related spending that occurred 90 days after discharge. Also as finalized in this rule, we are risk stratifying for episodes with hip fractures for MS-DRG 469 and MS-DRG 470. For the purpose of the risk stratification, we identified anchor hospitalizations for MS-DRG 469 and MS-DRG 470 with hip fractures based on ICD-9-CM diagnosis codes reported on the anchor inpatient hospitalization claim. We removed payments excluded from the episode as not being associated with joint replacement care, as well as removing the IPPS add-on payments including disproportionate share hospital and indirect medical educational payments, new technology payments, uncompensated care payments, hospital value based purchasing payments, and hospital readmission reduction payments associated with the anchor hospitalization. We note that we have other payment exclusions in the calculation of the episode target price, in comparing actual episode payments with target prices, and in determining whether a reconciliation payment should be made to the hospital or repayment from the hospital should be made as described in section III.C. of this final rule. For the purpose of this impact analysis, we have only limited our calculations to remove the IPPS add-on payments reported on the IPPS claims including disproportionate share hospital and indirect medical educational payments, new technology payments, uncompensated care payments, hospital value based purchasing payments, and hospital readmissions reduction payments in calculating estimated target prices and in comparing the target price to actual episode payments. We then excluded episodes where the anchor hospitalization occurred in hospitals that are not paid under the IPPS. As finalized in this rule, we excluded episodes where the patient died during the 90 day episode. With the remaining episodes, we standardized episode payments to remove the variation in spending due to differences in the hospital's wage index. We trended utilization and prices in 2012 and 2013 to match 2014 national performance, and we incorporated the outlier policy to cap spending for high cost outlier episodes such that payments are capped at the MS-DRG anchor value that is two standard deviations above the mean as described in section III.C. of this final rule. After we pooled episodes for MS-DRGs 469 and 470 with and without hip fractures, we calculated average risk-stratified episode prices for each hospital and census region, as well as a hospital-specific weight representing a case mix value for each hospital that is dependent only on episode volume for MS-DRGs 469 and 470 with and without hip fractures, and the national anchor factor. We then calculated blended prices for each hospital, with prices set at two-thirds of the hospital's experience and one-third of the region's average experience for performance years 1 and 2 of the model, as one-third of the hospital's experience and two-thirds of the region's experience as used for performance year 3 of the model, and as the region's average experience for performance years 4 and 5 of the model. We made an exception for hospitals with low historical CJR episode volume defined in this final rule as those with fewer than 20 CJR episodes in total across the 3 historical years, by setting their target price as the region's experience. These average prices were then disaggregated based on the national anchor factor of average episode spending for MS-DRG 470 relative to MS-DRG 469, the computed hospital-specific weight, the hospital's wage index was then applied back to the price, and a Medicare discount was applied.
After calculating risk stratified target prices for MS-DRG 469 and 470 for each hospital appropriate for each performance year, we compared these target prices against actual performance in the 2014 calendar year. We capped actual spending for individual episodes based on the methodology in this final rule for high cost episodes. After incorporating the final policy for high cost episodes, total Medicare FFS spending in the 2014 calendar year for each hospital was reconciled against the target price and total number of episodes for the hospital. The aggregate impacts were then determined by multiplying by the total episodes for each MS-DRG.
As described earlier in this rule, we are finalizing our proposal to rebase the target prices in performance years 3 and 4 based on episodes that start between the period of January 1, 2014 to December 31, 2016 and rebase target prices for performance year 5 based on episodes that start between the period of January 1, 2016 to December 31, 2018.
The difference between each CJR episode's actual payment and the relevant target price (calculated as target price subtracted by CJR episode actual episode payment) will be aggregated for all episodes for a participant hospital within the performance year, creating the NPRA. As finalized in this rule, any positive NPRA amount greater than the stop-gain limit will be capped at the stop-gain limit of 5 percent for performance years 1 and 2 of the model, 10 percent in performance year 3 and 20 percent in performance years 4 and 5. We note this is a change from the proposed rule where we had proposed a stop-gain limit to be capped at 20 percent for each performance year of the model. In addition, any negative NPRA amount exceeding the stop-loss limit will be capped at the stop-loss limit as described in section III.C.8.b. of this final rule. To limit a hospital's overall repayment responsibility under this model, a 5 percent repayment limit in performance year 2, 10 percent repayment limit in performance year 3 and a 20 percent repayment limit in performance years 4 and 5. We note that this is a change from our proposed rule where we had proposed to set a 10
• Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1550).
• Hospital-level 30-day, all-cause risk-standardized readmission rate following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) (NQF #1551).
• HCAHPS survey (NQF #0166).
Additionally, as described earlier in this final rule in section III.C.5., we are not finalizing our proposal that hospitals could qualify for a lower discount from 2 percent to 1.7 percent applied to their target episode price if they voluntarily submit patient-reported outcome measures data. Rather, we are finalizing the use of a composite quality score based on achievement and improvement on the THA/TKA Complications measure (NQF #1550) and the HCAHPS Survey measure (NQF #0116), as well as submission of THA/TKA voluntary PRO data, that will assign hospitals to be below acceptable, acceptable, good, and excellent. Hospitals assigned as ‘below acceptable’ would not be eligible for a reconciliation payment and would be subject to a 3 percent discount. Hospitals assigned as ‘acceptable’ would be eligible for a reconciliation payment and would be subject to a 3 percent discount. Hospitals assigned as ‘good’ would be eligible for a reconciliation payment and would be subject to a 2 percent discount. Lastly, hospitals assigned as ‘excellent’ would be eligible for a reconciliation payment and would be subject to a 1.5 percent discount. We note that in performance year 2 and 3, the discount for repayment would be 1 percentage point less than the discount applied for a reconciliation payment. We have used the following data to model the impact of this policy:
• Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) measure results reported on Hospital Compare in July 2015 based on the performance period of April 1, 2011 through March 31, 2014.
• HCAHPS survey (NQF #0166) reported on Hospital Compare in October 2015 based on the performance period of January 1, 2014 through December 31, 2014. To calculate improvement included in the composite quality score, we used the following data:
• Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) measure results reported on Hospital Compare in July 2014 based on the performance period of April 1, 2010 through March 31, 2013.
• HCAHPS survey (NQF #0166) reported on Hospital Compare in December 2014 based on the performance period of January 1, 2013 through December 31, 2013.
For the purpose of this analysis, we assumed that no hospitals voluntarily submitted patient reported outcome measures because we do not have the data to determine which hospitals in the model would submit this data. However, if we assumed that all hospitals in the model voluntarily submitted patient reported outcome measures, we would estimate that over the 5 performance years of the model, we would save $329 million (or 2.7% of total episode spend), as opposed to the projected estimates of $343 million (or 2.8% of total episode spend) in this final rule.. Hospitals located in selected MSAs were assigned to a performance percentile and assigned the corresponding quality performance score points listed in Table 16 of this final rule, based on their performance in the historical performance data described earlier. Hospitals that did not have a reported measure result were assigned to the 50th performance percentile. Hospitals assigned a quality measure performance percentile for the most recent year that improved by at least three deciles from the prior years' time period were quality improvement points. We used HCAHPS survey (NQF #0166) reported on Hospital Compare in October 2015 based on the performance period of January 1, 2014 through December 31, 2014 and Hospital-level (RSCR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) measure results reported on Hospital Compare in July 2015 based on the performance period of April 1, 2011 through March 31, 2014 to model the hospital's performance in the most recent year. We used HCAHPS survey (NQF #0166) reported on Hospital Compare in December 2014 based on the performance period of January 1, 2013 through December 31,(RSCR)following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) measure results reported on Hospital Compare in July 2014 based on the performance period of April 1, 2010 through March 31, 2013 to calculate the hospital's performance in the prior year for the purpose of modeling a hospital's quality improvement. Composite quality scores, including quality improvement points on the two measures, were calculated for hospitals in selected MSAs, and hospitals were assigned to a quality category of “below acceptable”, “acceptable”, “good” or “excellent” based on their composite quality scores. As discussed in section III.C.5. of this final rule, composite quality scores will affect hospitals' eligibility for reconciliation payments and determine the amount of quality incentive payment a given hospital earns, which will affect hospitals' effective discount percentages at reconciliation.
In order to model payments in this impacts analysis, hospitals assigned as `below acceptable' would not be eligible for a reconciliation payment and would be subject to a 3 percent effective discount percentage; hospitals assigned as ‘acceptable’ would be eligible for a reconciliation payment and would be subject to a 3 percent effective discount percentage; hospitals assigned as ‘good’ would be eligible for a reconciliation payment and would be subject to a 2 percent effective discount percentage, and hospitals assigned as ‘excellent’ would be eligible for a reconciliation payment and would be subject to a 1.5 percent effective discount percentage. We note that for performance years 2 and 3 of the model, for the purpose of repayment, the discount percentage is one percentage point lower than the effective discount percentage assigned for reconciliation payment. Due to limited data, for the purpose of modeling these estimates, we assumed that hospitals in the selected MSAs would have the same composite quality score throughout the 5 year performance period of the model.
To simulate the impact for performance year 1 or April 1 2016 through December 31, 2016, we calculated the NPRA assuming no downside risk to hospitals, and using the target price calculated for performance year 1, that is two-thirds hospital experience and one-third region experience. If the estimated NPRA is negative (that is, in the aggregate, the actual episode payments
To simulate the impact in performance year 2, we calculated the NPRA with the 5 percent stop-loss and stop-gain limits applied, but only requiring repayments from hospitals for total spending that is above a 1 percent discount. Additionally, we accounted for whether hospitals would meet the quality payment incentives based on their performance for the THA/TKA complications rate and HCAHPs survey including eligibility for a reconciliation payment and the quality incentive discount at 2 percent or 1.5 percent. For the simulation in performance year 2, we used the target price calculated for performance year 2 that is two-thirds hospital experience and one-third regional experience. A 5 percent stop-loss limit was applied to repayments, and 3 percent stop-loss limit was applied for rural hospitals, sole community hospitals, Medicare dependent hospitals, and rural referral centers, and a 5 percent stop-gain limit was applied. We note that this is a change from the proposed rule where we proposed to apply a 10 percent stop-loss limit for all hospitals except for rural hospitals, sole community hospitals, Medicare dependent hospitals and rural referral centers.
To simulate the impact in performance year 3, we calculated the NPRA assuming 10 percent stop-gain and stop-loss limit and met the quality incentive scores for a reduced discount and for reconciliation payments, and requiring repayments from hospitals for total spending that is above the 2 percent discount. For the simulation in year 3, we used the target price calculated as one-third of the hospital's experience and two-thirds of the regional experience. We included a 10 percent stop-loss limit on repayments from acute care hospitals included in this analysis, but used a 5 percent stop-loss limit on reconciliation repayments from rural hospitals, sole community hospitals, Medicare dependent hospitals, and rural referral centers. We note that this is a change from the proposed rule where we included a 20 percent stop-gain limit and 20 percent stop-loss limit on repayments for all hospitals with the exception of rural hospitals, sole community hospitals, Medicare dependent hospitals, and rural referral centers
For performance years 4 and 5, the impact estimates were calculated in the same way except that the episode target prices are based on 100 percent of the regional experience and the stop-loss and stop-gain limits are set to 20 percent.
In the CJR model, we have finalized to include a total of 67 MSAs from 8 MSA groupings. IPPS hospitals located within the selected MSAs will be required to participate in this model unless they participate in BPCI as discussed earlier in this final rule in section III.A.
Additionally, we note for these estimates, we did not assume that participation in this model would result in in efficiency or utilization over the course of the model. Since the model provides hospitals with strong incentives to improve efficiency, however, it is plausible that improvement in efficiency (and corresponding reductions in utilization) could occur. If such improvements occurred, however, it would have a limited effect on the net savings generated by the model since the resulting reduction in episode savings would be offset approximately one-for-one by higher net reconciliation payments up to the stop-gain limits. Over the 5 performance years of the model, we estimate $343 million dollars in savings to the Medicare program, out of $12.299 billion in total episode spending.
These estimates contain a significant amount of uncertainty. As a result, this model could produce more significant Medicare savings or could result in additional costs to the Medicare program. The primary source of uncertainty stems from the normal variation in claim cost trends each year coupled with the cap on the repayment made at reconciliation. In addition, this analysis assumes no change in utilization both for the use of services within the bundled episode, as well as no change in total episodes among hospitals. The prospective prices for the CJR model incorporate price updates from the FFS payment systems, but assume no change in utilization for the performance years. If there is a national increase in utilization within each bundle that is independent of this model, then savings to the Medicare program may increase due to greater repayments paid back to Medicare. If there is a national decrease in utilization within each bundle that is independent of this model, then costs to the Medicare program may increase due to greater reconciliation payments paid by Medicare to hospitals. The results will also depend on the cumulative effects over time and across providers on whether and how the model changes either actual medical procedures or the allocations of payments among service providers. We will expect significant
Additionally, although we project savings to Medicare under this model, as stated earlier, we note that under section 1115A(b)(3)(B) of the Act, the Secretary is required to terminate or modify a model unless certain findings can be made with respect to savings and quality after the model has begun. If during the course of testing the model it is determined that termination or modification is necessary, such actions will be undertaken through rulemaking as necessary.
The first performance year of the model is expected to cost the Medicare program $11 million in reconciliation payments made by CMS to hospitals. No repayments from hospitals will be assessed because hospitals are not subject to downside risk in performance year 1. Hospitals that will receive reconciliation payments are the hospitals that provide lower cost care relative to their regional average. As stated earlier, we are finalizing that the first performance year will be 9 months beginning April 1, 2016 through December 31, 2016. The estimate reflects reconciliation payments made for a 9 month performance period.
In the second performance year of the model, participant hospitals on net are expected to pay $36 million to CMS. We are stipulating a 5 percent stop-loss and stop-gain limit for acute care hospitals, with exception for rural hospitals, sole community hospitals, Medicare dependent hospitals, and rural referral center hospitals which will be subject to a 3 percent stop-loss limit. These limits will cap the total amount of repayments paid by hospitals to CMS.
In the third performance year of the model, net reconciliation payments are expected to be $71 million in savings to the Medicare program. The additional savings in performance year 3 compared to performance year 2 can be attributed to the increase in the stop-loss and stop-gain limits to 10 percent for acute care hospitals, with exception for rural hospitals, sole community hospitals, Medicare dependent hospitals, and rural referral center hospitals which will be subject to a 5 percent stop-loss limit.
For performance years 4 and 5 of the model, the episode target price will be based on full regional pricing. This creates great variation between the target price and hospitals own experience. Therefore, the stop-gain and stop-loss limits of 20 percent on reconciliation payments are estimated to have a larger impact. As a result, net payments are expected to be $120 million dollars from hospitals to the Medicare program in the fourth year and $127 million in the fifth year. These estimated savings in years 4 and 5 represent 4.2 percent of total episode spending in those years.
The total savings to the Medicare program after 5 years of the model are expected to be $343 million dollars out of $12.299 billion dollars or 2.8 percent in total episode spending. Due to the uncertainty of estimating this model, actual results could be significantly higher or lower than this estimate.
We can use our experience in previous implementation of bundled payment models to help inform our impact analyses. We have previously used our statutory authority to create payment models such as the BPCI initiative and the ACE Demonstration to test bundled payments. Under the authority of section 1866C of the Act, CMS funded a 3-year demonstration, the ACE Demonstration. The demonstration used a prospective global payment for a single episode of care as an alternative approach to payment for service delivery under traditional Medicare FFS. The episode of care was defined as a combination of Parts A and B services furnished to Medicare FFS beneficiaries during an inpatient hospital stay for any one of a specified set of cardiac and orthopedic MS DRGs. The MS DRGs tested included 469 and 470, which are included in the CJR model. The discounted bundled payments generated an average gross savings to Medicare of $585 per episode for a total of $7.3 million across all episodes (12,501 episodes) or 3.1 percent of the total expected costs for these episodes. After netting out the savings produced by the Medicare Parts A and B discounted payments and some increased PAC costs that were observed at two sites, Medicare saved approximately $4 million, or 1.72 percent of the total expected Medicare spending.
Additionally, we are currently testing the BPCI initiative. Under the initiative, entities enter into payment arrangements with CMS that include financial and performance accountability for episodes of care. Episodes of care under the BPCI initiative begin with either an—(1) Inpatient hospital stay; or (2) PAC services following a qualifying inpatient hospital stay and include tests of LEJR episodes. The BPCI initiative is evaluating the effects of episode based payment approaches on patient experience of care, outcomes, and cost of care for Medicare FFS beneficiaries. Although there is some evidence from BPCI and ACE suggesting that providers may improve their performance, both of these initiatives were voluntary, and the participants that volunteered to participate may be in a better position to reduce episode spending relative to the average provider. We believe that our experiences with BPCI support the design of the CJR Model.
In 2014, approximately 430,000 Medicare beneficiaries had discharges for LEJRs (MS-DRG 469 and MS-DRG 470) nationally. We anticipate that the CJR model may benefit beneficiaries receiving LEJRs because the intent of the model is to test whether providers under this bundled payment system are able to improve the coordination and transition of care, invest in infrastructure and redesigned care processes for high quality and efficient service delivery, and incentivize higher value care across the inpatient and PAC spectrum spanning the episode of care.
We have finalized several quality of care and patient experience measures to evaluate participant hospitals in the CJR model with the intent that it will encourage the provider community to focus on and deliver improved quality care for the Medicare beneficiary. We are finalizing to adopt and publicly report two hospital level quality of care measures for the CJR model. Those measures include a complication measure and a patient experience survey measure. In addition, we are finalizing to voluntarily collect data to develop a hospital-level measure of patient reported outcomes following an elective primary total hip or total knee arthroplasty to be used in future years of the model. We finalized to use these measures to assess the success of the model and to monitor for beneficiary safety. The accountability of participant hospitals for both quality and cost of care provided for Medicare beneficiaries with an LEJR episode provides the hospitals with new incentives to improve the health and well-being of the Medicare beneficiaries they treat.
Additionally, the model does not affect the beneficiary's freedom of choice to obtain health services from any individual or organization qualified to participate in the Medicare program. Under the CJR model, eligible beneficiaries who choose to receive services from a participant hospital will not have the option to opt out of inclusion in the model. Although the CJR model allows hospitals to enter into risk-sharing arrangements with certain other providers and these hospitals may recommended those providers to the
Many controls exist under Medicare to ensure beneficiary access and quality and we will use our existing authority, if necessary, to audit participant hospitals if claims analysis indicates an inappropriate change in delivered services. As described earlier in this final rule, given that participant hospitals will receive a reconciliation payment when they are able to reduce average costs per case and meet quality thresholds, they could have an incentive to avoid complex, high cost cases by referring them to nearby facilities or specialty referral centers. We intend to monitor the claims data from participant hospitals—for example, to compare a hospital's case mix relative to a pre-model historical baseline to determine whether complex patients are being systematically excluded. Furthermore, we also will require providers to supply beneficiaries with written information regarding the design and implications of this model as well as their rights under Medicare, including their right to use their provider of choice.
We are implementing several safeguards to ensure that Medicare beneficiaries do not experience a delay in services. We believe that the longer the episode duration, the lower the risk of delaying care beyond the episode duration, and we believe that a 90 day episode is sufficiently long to minimize the risk that any LEJR related care will be delayed beyond the end of the episode. Moreover, we have finalized as part of the payment definition (see section III.C. of this final rule) that certain post-episode payments occurring in the 30 day window subsequent to the end of the 90-day episode will be counted as an adjustment against savings. Importantly, approaches to saving costs will include taking steps that facilitate patient recovery, that shorten recovery duration, and that minimize post-operative problems that might lead to readmissions. Thus, the model itself rewards better patient care.
Lastly, we note that Medicare payments for services will continue to be made for each Medicare FFS payment system under this model, and will include normal beneficiary copayments, deductibles, and coinsurance. We expect and assume that beneficiary payments will not be affected, as only the hospital will be subject to the reconciliation process. Beneficiaries may benefit if providers are able to systematically improve the quality of care while reducing costs. We welcomed public comments on our estimates of the impact of our proposals on Medicare beneficiaries. We did not receive any comments on our estimates of the impact of our policies on Medicare beneficiaries.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. We estimate that most hospitals and most other providers and suppliers are small entities, either by virtue of their nonprofit status or by qualifying as small businesses under the Small Business Administration's size standards (revenues of less than $7.5 to $38.5 million in any 1 year; NAIC Sector-62 series). States and individuals are not included in the definition of a small entity. For details, see the Small Business Administration's Web site at
For purposes of the RFA, we generally consider all hospitals and other providers and suppliers to be small entities. We believe that the provisions of this final rule relating to acute care hospitals will have some effects on a substantial number of other providers involved in these episodes of care including surgeons and other physicians, SNFs, physical therapists, and other providers.
Although we acknowledge that many of the affected entities are small entities, and the analysis discussed throughout this final rule discusses aspects of the model that may or will affect them, we have no reason to assume that these effects will reach the threshold level of 5 percent of revenues used by HHS to identify what are likely to be “significant” impacts. Although LEJR procedures (MS-DRGs 469 and 470) are among the most common surgical procedures undergone by Medicare beneficiaries, they are only about 5 percent of all acute hospital discharges.
Accordingly, we have determined that this final rule will not have a significant impact on a substantial number of small entities. We solicited public comments on our estimates and analysis of the impact of our proposals on those small entities.
Section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a proposed rule or final rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, a small rural hospital is defined as a hospital that is located outside of an MSA and has fewer than 100 beds. We note that, according to this definition, the CJR model will not include any rural hospitals given that the CJR model will only include hospitals located in MSAs, as discussed in section III.A of this final rule. However, we also note that as discussed in section III.C.8. of this final rule, for purposes of our policy finalized in this rule to include a more protective stop-loss policy for certain hospitals, we are finalizing to define a rural hospital as an IPPS hospital that is either located
Because of our concerns that rural hospitals may have lower risk tolerance and less infrastructure and support to achieve efficiencies for high payment episodes, we are implementing additional financial protections for certain categories of hospitals, including rural hospitals. In performance year 2, a hospital could owe Medicare no more than 5 percent of the target price multiplied by the number of the hospital's LEJR episodes in CJR as we phase in repayment responsibility under the model and in performance year 3, a hospital could owe Medicare no more than 10 percent. In performance year 4 and 5 when full repayment responsibility is in place, no more than 20 percent of the target price multiplied by the number of the hospital's LEJR episodes in CJR could be owed by a hospital to Medicare. However, for rural hospitals, Medicare Dependent Hospitals, RRCs and Sole Community Hospitals, we are implementing a lower stop loss limit policy of 3 percent of episode payments for these categories of hospitals. More specifically, in performance year 2, a rural hospital, MDH, RRC, or SCH could owe Medicare no more than 3 percent of the target price multiplied by the number of the hospital's episodes in CJR. In performance years 3 through 5, such a hospital could owe Medicare no more than 5 percent of the target price multiplied by the number of the hospital's episodes. We are finalizing these additional protections, and we estimate that approximately 9 percent of participant hospitals are rural hospitals, MDHs, RRCs and SCHs that will be subject to these protections.
Because LEJR procedures (MS-DRGs 469 and 470) account for only about 5 percent of all discharges, because relatively few of these procedures are performed at small rural hospitals, and because our model is designed to minimize adverse effects on rural hospitals, we do not believe that rural hospitals will experience significant adverse economic impacts. Accordingly, we conclude that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
We solicited public comments on our estimates and analysis of the impact of our proposals on those small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that is approximately $144 million. This final rule does not include any mandate that would result in spending by state, local or tribal governments, in the aggregate, or by the private sector in the amount of $144 million in any 1 year.
Throughout this final rule, we have identified our policies and alternatives that we have considered, and provided information as to the effects of these alternatives and the rationale for each of the policies. In the proposed rule we solicited and welcomed comments on our proposals, on the alternatives we identified, and on other alternatives that we should consider, as well as on the costs, benefits, or other effects of these. We note that our estimates are limited to the IPPS hospitals that are selected to participate in this model. This final rule will not directly affect hospitals that are not participating in the model. However, it may encourage innovations in health care delivery in other areas or in care reimbursed through other payers. For example, a hospital and affiliated providers may choose to extend their arrangements to all joint replacement procedures they provide, not just those reimbursed by Medicare. Alternatively, a hospital and affiliated providers in one city may decide to hold themselves forth as “centers of excellence” for patients from other cities, both those included and not included in the model. In the proposed rule we welcomed comments that address these or other possibilities. We did not receive any comments on the alternatives considered.
As required by OMB Circular A-4 under Executive Order 12866 (available at
The preceding analysis, together with the remainder of this preamble, provides the Regulatory Impact Analysis of a rule with a significant economic effect. As a result of this final rule, we estimate of the financial impact of the CJR model for CYs 2016 through 2020 will be net federal savings of $343 million over a 5 year period. The annualized change in payments based on a 7 percent and 3 percent discount rate, results in net federal monetary transfer from the participant IPPS hospitals to the federal government of $63 million and $65 million respectively.
In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, under the authority at section 1115A of the Social Security Act, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV as follows:
Secs. 1102, 1115A, and 1871 of the Social Security Act (42 U.S.C. 1302, 1315(a), and 1395hh).
(a)
(b)
(1) The participants in the Comprehensive Care for Joint Replacement model.
(2) The episodes being tested in the model.
(3) The methodology for pricing and payment under the model.
(4) Quality performance standards and quality reporting requirements.
(5) Safeguards to ensure preservation of beneficiary choice and beneficiary notification.
For the purposes of this part, the following definitions are applicable unless otherwise stated:
(1) Skilled nursing facility (SNF).
(2) Home health agency (HHA).
(3) Long-term care hospital (LTCH).
(4) Inpatient rehabilitation facility (IRF).
(5) Physician.
(6) Nonphysician practitioner.
(7) Provider or supplier of outpatient therapy services.
(8) Physician group practice (PGP).
LTCH stands for long-term care hospital.
(1) A physician assistant who satisfies the qualifications set forth at § 410.74(a)(2)(i) and (ii) of this chapter.
(2) A nurse practitioner who satisfies the qualifications set forth at § 410.75(b) of this chapter.
(3) A clinical nurse specialist who satisfies the qualifications set forth at § 410.76(b) of this chapter.
(4) A certified registered nurse anesthetist (as defined at § 410.69(b)).
(5) A clinical social worker (as defined at § 410.73(a)).
(6) A registered dietician or nutrition professional (as defined at § 410.134).
(1) Outpatient physical therapy services as defined in § 410.60 of this chapter.
(2) Outpatient occupational therapy services as defined in § 410.59 of this chapter.
(3) Outpatient speech-language pathology services as defined in § 410.62 of this chapter.
(1) Is located in a rural area as defined under § 412.64 of this chapter.
(2) Is located in a rural census tract defined under § 412.103(a)(1) of this chapter.
(3) Has reclassified as a rural hospital under § 412.103 of this chapter.
(1) Physical therapist.
(2) Occupational therapist.
(3) Speech-language pathologist.
(a)
(b)
(1) The hospital is an episode initiator for an LEJR episode in the risk-bearing period of Models 2 or 4 of BPCI.
(2) The hospital is participating in Model 1 of BPCI.
(3) These exclusions cease to apply as of the date that the hospital no longer meets any of the conditions specified in this paragraph.
(a)
(b)
(c)
(1) Had fewer than 400 episodes between July 1, 2013 and June 30, 2014.
(2) Had fewer than 400 non-Model 1, 2, or 4 BPCI episodes as of October 1, 2015.
(3) Failed either or both of the following rules regarding participation in BPCI:
(i) More than 50 percent of eligible episodes initiated in a BPCI Model 2 or 4 initiating hospital.
(ii) More than 50 percent of eligible episodes that included SNF or HHA services, where the SNF or HHA services were furnished by a BPCI Model 3 initiating HHA or SNF.
(4) For MSAs including both Maryland and non-Maryland counties, more than 50 percent of eligible episodes were initiated at a Maryland hospital.
(a)
(b)
(1) Physicians' services.
(2) Inpatient hospital services (including hospital readmissions).
(3) IPF services.
(4) LTCH services.
(5) IRF services.
(6) SNF services.
(7) HHA services.
(8) Hospital outpatient services.
(9) Outpatient therapy services.
(10) Clinical laboratory services.
(11) DME.
(12) Part B drugs and biologicals.
(13) Hospice services.
(14) PBPM payments under models tested under section 1115A of the Act.
(c)
(d)
(1) Hemophilia clotting factors provided in accordance with § 412.115 of this chapter.
(2) New technology add-on payments, as defined in part 412, subpart F of this chapter.
(3) Transitional pass-through payments for medical devices as defined in § 419.66 of this chapter.
(4) Items and services unrelated to the anchor hospitalization, as determined by CMS. Excluded services include, but are not limited to, the following:
(i) Inpatient hospital admissions for MS-DRGs that group to the following categories of diagnoses:
(A) Oncology.
(B) Trauma medical.
(C) Chronic disease surgical, such as prostatectomy.
(D) Acute disease surgical, such as appendectomy.
(ii) Medicare Part B services, as identified by the principal ICD-CM diagnosis code on the claim (based on the ICD-CM version in use during the performance year) that group to the following categories of diagnoses:
(A) Acute disease diagnoses, such as severe head injury.
(B) Certain chronic disease diagnoses, as specified by CMS on a diagnosis-by-diagnosis basis depending on whether the condition was likely to have been affected by the LEJR procedure and recovery period or whether substantial services were likely to be provided for the chronic condition during the episode. Such chronic disease diagnoses are posted on the CMS Web site and may be revised in accordance with paragraph (e) of this section.
(iii) Certain PBPM payments under models tested under section 1115A of the Act. PBPM model payments that CMS determines to be primarily used for care coordination or care management services for clinical conditions in excluded categories of diagnoses, as described in this paragraph.
(A) The list of excluded PBPM payments is posted on the CMS Web site and are revised in accordance with paragraph (e) of this section.
(B) Notwithstanding the foregoing, all PBPM model payments funded from CMS' Innovation Center appropriation are excluded from the episode.
(5) Certain incentive programs and add on payments under existing Medicare payment systems in accordance with § 510.300(b)(6) of this chapter.
(6) Payments for otherwise included items and services in excess of 2 standard deviations above the mean regional episode payment in accordance with § 510.300(b)(5) of this chapter.
(e)
(2) On an annual basis, or more frequently as needed, CMS updates the list of excluded services to reflect annual coding changes or other issues brought to CMS's attention.
(3) CMS applies the following standards when revising the list of excluded services for reasons other than to reflect annual coding changes:
(i) Items or services that are directly related to the LEJR procedure or the quality or safety of LEJR care would be included in the episode.
(ii) Items or services for chronic conditions that may be affected by the LEJR procedure or post-surgical care would be related and included in the episode.
(iii) Items and services for chronic conditions that are generally not affected by the LEJR procedure or post-surgical care would be excluded from the episode.
(iv) Items and services for acute clinical conditions not arising from existing, episode-related chronic clinical conditions or complications of LEJR surgery would be excluded from the episode.
(v) PBPM payments under CMS models determined to be primarily used for care coordination or care management services for clinical conditions in excluded categories of diagnoses, as described in § 510.200(d), would be excluded from the episode.
(4) CMS posts the following to the CMS Web site:
(i) Potential revisions to the exclusion to allow for public comment; and
(ii) An updated exclusions list after consideration of public comment.
(a) Episodes tested in the CJR model include only those in which care is furnished to beneficiaries who meet all of the following criteria upon admission to the anchor hospitalization:
(1) Are enrolled in Medicare Parts A and Part B.
(2) Eligibility for Medicare is not on the basis of end stage renal disease, as described in § 406.13 of this chapter.
(3) Are not enrolled in any managed care plan (for example, Medicare Advantage, health care prepayment plans, or cost-based health maintenance organizations).
(4) Are not covered under a United Mine Workers of America health care plan.
(5) Have Medicare as their primary payer.
(b) If at any time during the episode a beneficiary no longer meets all of the criteria in this section, the episode is canceled in accordance with § 510.210(b).
(a)
(b)
(1) Ceases to meet any criterion listed in § 510.205.
(2) Is readmitted to any participant hospital for another anchor hospitalization.
(3) Initiates an LEJR episode under BPCI.
(4) Dies.
(a)
(1) MS-DRG assigned at discharge for anchor hospitalization and presence of hip fracture diagnosis for anchor hospitalization—
(i) MS-DRG 469 with hip fracture;
(ii) MS-DRG 469 without hip fracture;
(iii) MS-DRG 470 with hip fracture; or
(iv) MS-DRG 470 without hip fracture.
(2)
(3)
(4) Adjustments for quality performance, as specified in § 510.305(g).
(5)
(i) On an annual basis, or more frequently as needed, CMS updates the list of ICD-CM hip fracture diagnosis codes to reflect coding changes or other issues brought to CMS' attention.
(ii) CMS applies the following standards when revising the list of ICD-CM hip fracture diagnosis codes.
(A) The ICD-CM diagnosis code is sufficiently specific that it represents a bone fracture for which a physician could determine that a hip replacement procedure, either a PHA or a THA, could be the primary surgical treatment.
(B) The ICD-CM diagnosis code is the primary reason (that is, principal diagnosis code) for the anchor hospitalization.
(iii) CMS posts the following to the CMS Web site:
(A) Potential ICD-CM hip fracture diagnosis codes for public comment; and
(B) A final ICD-CM hip fracture diagnosis code list after consideration of public comment.
(b)
(i) Episodes beginning in 2012 through 2014 for performance years 1 and 2.
(ii) Episodes beginning in 2014 through 2016 for performance years 3 and 4.
(iii) Episodes beginning in 2016 through 2018 for performance year 5.
(2) Specifically, the blend consists of the following:
(i) Two-thirds of the participant hospital's own historical episode payments and one-third of the regional historical episode payments for performance years 1 and 2.
(ii) One-third of the hospital's own historical episode payments and two-thirds of the regional historical episode payments for performance year 3.
(iii) Regional historical episode payments for performance years 4 and 5.
(3)
(4)
(5)
(6)
(7)
(c)
(1)
(2)
(i) Not applicable in performance year 1, as the requirement for hospital repayment under the CJR model is waived in performance year 1;
(ii) In performance years 2 and 3, 2.0 percent; and
(3)
(d)
(i) Determine appropriate ways to increase the coordination of care.
(ii) Improve quality.
(iii) Enhance efficiencies in the delivery of care.
(iv) Otherwise achieve the goals of the CJR model described in this section.
(2)
(ii) The minimum data necessary to achieve the goals of the CJR model, as determined by CMS, may be provided under this section for a participant hospital's baseline period and no less frequently than on a quarterly basis throughout the hospital's participation in the CJR model.
(a)
(b)
(c)
(d)
(2) CMS—
(i) Calculates the NPRA for each participant hospital in accordance with paragraph (e) of this section including the adjustments provided for in paragraph (e)(1)(iv) of this section; and
(ii) Assesses whether hospitals meet specified quality requirements under § 510.315.
(e)
(1)
(i) Determines actual episode payments for each episode included in the performance year (other than episodes that have been canceled in accordance with § 510.210(b)) using claims data that is available 2 months after the end of the performance year. Actual episode payments are capped at the amount determined in accordance with § 510.300(b)(5) for the performance year.
(ii) Multiplies each episode target price, after applying any reduction to the discount percentage as provided in § 510.315(f) by the number of episodes included in the performance year (other than episodes that have been canceled in accordance with § 510.210(b)) to which that episode target price applies.
(iii) Aggregates the amounts computed in paragraph (e)(1)(ii) of this section for all episodes included in the performance year (other than episodes that have been canceled in accordance with § 510.210(b)).
(iv) Subtracts the amount determined under paragraph (e)(1)(i) of this section from the amount determined under paragraph (e)(1)(iii) of this section.
(v) Makes the following adjustments:
(A)
(B)
(
(
(
(
(C)
(
(
(
(
(D)
(f)
(ii) Subject to paragraph (f)(1)(iii) of this section, for performance years 2 through 5, results from the subsequent reconciliation calculation for a prior year's reconciliation, as described in paragraph (h)(6)(i) of this section, are applied to the current year's NPRA in order to determine the reconciliation or repayment amount.
(iii) The reconciliation or repayment amount may be adjusted as provided in § 510.410(b)(5).
(2)
(3)
(g)
(2) If the hospital's composite quality score described in § 510.315 is acceptable (defined as greater than or equal to 4.00), good (defined as greater than or equal to 6.0 and less than or equal to 13.2), or excellent (defined as greater than 13.2), and the hospital is determined to have a positive NPRA under § 510.305(e)), the hospital is eligible for a reconciliation payment.
(3) If the hospital's composite quality score described in § 510.315 is below acceptable, defined as less than 4.00 for a performance year, the hospital is not eligible for a reconciliation payment.
(4) If the hospital is found to be engaged in an inappropriate and systemic under delivery of care, the quality of the care provided must be considered to be seriously compromised and the hospital must be ineligible to receive or retain a reconciliation payment for any period in which such under delivery of care was found to occur.
(h)
(1) Information on the participant hospital's composite quality score described in § 510.315.
(2) The total actual episode payments for the participant hospital.
(3) The NPRA.
(4) Whether the participant hospital is eligible for a reconciliation payment or must make a repayment to Medicare.
(5) The NPRA and subsequent reconciliation calculation amount for the previous performance year, as applicable.
(6) The reconciliation payment or repayment amount.
(i)
(B) The subsequent reconciliation calculation accounts for cases in which a portion of the CJR discount percentage is paid out to an ACO as shared savings by reducing the reconciliation payment amount for a CJR hospital, if available, by the amount of the discount percentage paid out to the ACO as shared savings. This adjustment is only made when the participant hospital is a participant or provider/supplier in the ACO and the beneficiary in the CJR episode is assigned to one of the following ACO models or program:
(
(
(
(
(C) The additional calculation occurs concurrently with the reconciliation process for the most recent performance year. If the result of the subsequent calculation is different than zero, CMS applies the stop-loss and stop-gain limits in paragraph (e) of this section to the calculations in aggregate for that performance year (the initial reconciliation and the subsequent calculation) to ensure the amount does not exceed the stop-loss or stop-gain limits. CMS then applies the subsequent calculation amount to the NPRA for the most recent performance year in order to determine the reconciliation amount or repayment amount for the most recent performance year. Because hospitals will not have financial repayment responsibility for performance year 1, for the performance year 2 reconciliation report only, the subsequent calculation amount (for performance year 1) is applied to the performance year 1 NPRA to ensure that the combined amount is not less than 0. If the combined performance year 1 NPRA and subsequent calculation for performance year 1 is less than 0, the subsequent calculation amount would be capped at the value that would result in a net amount of 0 for the combined performance year 1 NPRA and subsequent calculation.
(a)
(1) Unless the participant hospital provides such notice, the CJR reconciliation report is deemed final 45 calendar days after it is issued.
(2) If CMS receives a timely notice of a calculation error, CMS responds in writing within 30 calendar days to either confirm that there was an error in the calculation or verify that the calculation is correct, although CMS reserves the right to an extension upon written notice to the participant hospital.
(3) If a participant hospital does not submit timely notice of a calculation error in accordance with the timelines and processes specified by CMS, then CMS deems final the CJR reconciliation report and proceeds with the payment or repayment processes, as applicable.
(4) Only participant hospitals may use the dispute resolution process described in this part.
(b)
(2) The reconsideration review request must provide a detailed explanation of the basis for the dispute and include supporting documentation for the participant hospital's assertion that CMS or its representatives did not accurately calculate the NPRA, the reconciliation payment, or the repayment amount in accordance with § 510.305.
(3) If CMS does not receive a request for reconsideration from the participant hospital within 10 calendar days of the issue date of CMS's response to the participant hospital's notice of calculation error, then CMS's response to the calculation error is deemed final and CMS proceeds with reconciliation payment or repayment processes, as applicable, as described in § 510.305.
(4) A CMS reconsideration official notifies the participant hospital in writing within 15 calendar days of receiving the participant hospital's review request of the following:
(i) The date, time, and location of the review.
(ii) The issues in dispute.
(iii) The review procedures.
(iv) The procedures (including format and deadlines) for submission of evidence.
(5) The CMS reconsideration official takes all reasonable efforts to schedule the review to occur no later than 30 days after the date of receipt of the notification.
(6) The provisions at § 425.804(b), (c), and (e) of this chapter are applicable to reviews conducted in accordance with the reconsideration review process for CJR.
(7) The CMS reconsideration official issues a written determination within 30 days of the review. The determination is final and binding.
(c)
(d)
(1) The selection of models for testing or expansion under section 1115A of the Act.
(2) The selection of organizations, sites, or participants to test those models selected.
(3) The elements, parameters, scope, and duration of such models for testing or dissemination.
(4) Determinations regarding budget neutrality under section 1115A(b)(3) of Act.
(5) The termination or modification of the design and implementation of a model under section 1115A(b)(3)(B) of Act.
(6) Decisions about expansion of the duration and scope of a model under section 1115A(c) of the Act, including the determination that a model is not
(a)
(b)
(1) The hospital's quality performance points for the hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty measure (NQF #1550) described in § 510.400(a)(1). This measure is weighted at 50 percent of the composite quality score.
(2) The hospital's quality performance points for the Hospital Consumer Assessment of Healthcare Providers and Systems Survey measure (NQF #0166) described in § 510.400(a)(2). This measure is weighted at 40 percent of the composite quality score.
(3) Any additional quality improvement points the hospital may earn as a result of demonstrating improvement on either or both of the quality measures in paragraphs (b)(1) and (2) of this section, as described in paragraph (d) of this section.
(4) If applicable, 2 additional points for successful THA/TKA voluntary data submission of patient-reported outcomes and limited risk variable data, as described in § 510.400(b). Successful submission is weighted at 10 percent of the composite quality score.
(c)
(1) For the hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty measure (NQF #1550) described in § 510.400(a)(1), CMS assigns the participant hospital measure value to a performance percentile and then quality performance points are assigned based on the following performance percentile scale:
(i) 10.00 points for ≥90th.
(ii) 9.25 points for ≥80th and <90th.
(iii) 8.50 points for ≥70th and <80th;
(iv) 7.75 points for ≥60th and <70th.
(v) 7.00 points for ≥50th and <60th.
(vi) 6.25 points for ≥40th and <50th.
(vii) 5.50 points for ≥30th and <40th.
(ix) 0.0 points for <30th.
(2) For the Hospital Consumer Assessment of Healthcare Providers and Systems Survey measure (NQF #0166) described in § 510.400(a)(2), CMS assigns the participant hospital measure value to a performance percentile and quality performance points are assigned based on the following performance percentile scale:
(i) 8.00 points for ≥90th.
(ii) 7.40 points for ≥80th and <90th.
(iii) 6.80 points for ≥70th and <80th.
(iv) 6.20 points for ≥60th and <70th.
(v) 5.60 points for ≥50th and <60th.
(vi) 5.00 points for ≥40th and <50th.
(vii) 4.40 points for ≥30th and <40th.
(ix) 0.0 points for <30th.
(d)
(e)
(1) A participant hospital will not have a measure value for the—
(i) Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty measure (NQF #1550) described in § 510.400(a)(1) if the hospital does not meet the minimum 25 case count; or
(ii) Hospital Consumer Assessment of Healthcare Providers and Systems Survey measure (NQF #0166) described in § 510.400(a)(2) if the hospital does not meet the minimum of 100 completed survey and does not have 4 consecutive quarters of HCAHPS data.
(ii) For either of the measures described in paragraphs (e)(1) or (2) of this section, if CMS identifies an error in the data used to calculate the measure and suppresses the measure value.
(f)
(1) A 1.0 percentage point reduction to the applicable discount factor for participant hospitals with good quality performance, defined as composite quality scores that are greater than or equal to 6.0 and less than or equal to 13.2.
(2) A 1.5 percentage point reduction to the applicable discount factor for participant hospitals with excellent quality performance, defined as composite quality scores that are greater than 13.2.
The CJR model does not replace any existing Medicare incentive programs or add-on payments. The target price and NPRA for a participant hospital are independent of, and do not affect, any incentive programs or add-on payments under existing Medicare payment systems.
(a)
(b)
(1)
(2)
(3)
(i) The first day of the IPPS stay is counted as 2 days.
(ii) If the actual length of stay that occurred during the episode is equal to or greater than the MS-DRG geometric mean, the normal MS-DRG payment is fully allocated to the episode.
(iii) If the actual length of stay that occurred during the episode is less than the geometric mean, the normal MS-DRG payment amount is allocated to the episode based on the number of inpatient days that fall within the episode.
(iv) If the full amount is not allocated to the episode, any remainder amount is allocated to the post-episode spending calculation (defined in § 510.2).
(a)
(1) Hospital-level risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty.
(2) Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
(b)
(1) For each eligible procedure all eleven risk variable data elements are required to be submitted. The eleven risk variables are as follows:
(i) Date of birth.
(ii) Race.
(iii) Ethnicity.
(iv) Date of admission to anchor hospitalization.
(v) Date of eligible THA/TKA procedure.
(vi) Medicare Health Insurance Claim Number.
(vii) Body mass index.
(viii) Use of chronic (≥90 day) narcotics.
(ix) Total painful joint count.
(x) Quantified spinal pain.
(xi) Single Item Health Literacy Screening (SILS2) questionnaire.
(2) Hospitals must also submit the amount of requested THA/TKA patient-reported outcomes data required for each year of the model in order to be considered successful in submitting voluntary data.
(i) The amount of requested THA/TKA patient-reported outcomes data to submit, in order to be considered successful will increase each subsequent year of the model over the 5 years of the model.
(ii) A phase-in approach that determines the amount of requested THA/TKA patient-reported outcomes data to submit over the 5 years of the program will be applied so that in year 1 successful submission of data would mean CMS received all requested THA/TKA patient-reported outcomes and limited risk variable data on both of the following:
(A) Greater than or equal to 50 percent of eligible procedures or greater than or equal to 50 eligible patients during the data collection period.
(B) Submission of requested THA/TKA PRO and limited risk variable data is completed within 60 days of the most recent performance period.
(3) For years 1 through 5 of the model an increasing amount of data is requested by CMS for each performance period as follows:
(i) Year 1 (2016). Submit pre-operative data on primary elective THA/TKA procedures for ≥50% or ≥50 eligible procedures performed between July 1, 2016 and August 31, 2016, unless CMS requests a more limited data set, in which case, submit all requested data elements.
(ii) Year 2 (2017). Submit—
(A) Post-operative data on primary elective THA/TKA procedures for ≥50% or ≥50 eligible procedures performed between July 1, 2016 through August 31, 2016; and
(B) Pre-operative data on primary elective THA/TKA procedures for ≥60% or ≥75 procedures performed between September 1, 2016 through June 30, 2017, unless CMS requests a more limited data set, in which case, submit all requested data elements.
(iii) Year 3 (2018). Submit—
(A) POST-operative data on primary elective THA/TKA procedures for ≥60% or ≥75 procedures performed between September 1, 2016 and June 30, 2017; and
(B) Pre-operative data on primary elective THA/TKA procedures for ≥70% or ≥100 procedures performed between July 1, 2017 and June 30, 2018, unless CMS requests a more limited data set, in which case, submit all requested data elements.
(iv) Year 4 (2019). Submit—
(A) Post-operative data on primary elective THA/TKA procedures for ≥70% or ≥100 procedures performed between July 1, 2017 and June 30, 2018; and
(B) Pre-operative data on primary elective THA/TKA procedures for ≥80% or ≥200 procedures performed between July 1, 2018 and June 30, 2019, unless CMS requests a more limited data set, in which case, submit all requested data elements.
(v) Year 5 (2020). Submit—
(A) Post-operative data on primary elective THA/TKA procedures for ≥80% or ≥200 procedures performed between July 1, 2018 and June 30, 2019 and
(B) Pre-operative data on primary elective THA/TKA procedures for ≥80% or ≥200 procedures performed between July 1, 2019 and June 30, 2020, unless CMS requests a more limited data set, in which case, submit all requested data elements.
(c)
(1) Makes the quality measurement results calculated for the complication and patient survey quality measures described in paragraph (a) of this section for each participant hospital in each performance year publicly available on the CMS Web site in a form and manner as determined by CMS;
(2) Shares each participant hospital's quality metrics with the hospital prior to display on the Web site; and
(3) Does not publicly report the voluntary patient-reported outcomes and limited risk variable data during this model, but does indicate whether a hospital has voluntarily submitted such data.
(a)
(1) As part of discharge planning and referral, participant hospitals must inform beneficiaries of all Medicare participating post-acute care providers in an area and must identify those post-acute care providers with whom they have sharing arrangements. Participant hospitals may recommend preferred providers and suppliers, consistent with applicable statutes and regulations. Participant hospitals may not limit beneficiary choice to any list of providers or suppliers in any manner other than that permitted under applicable statutes and regulations. Participant hospitals must respect patient and family preferences when they are expressed.
(2) Participant hospitals may not charge any CJR collaborator a fee to be included on any list of preferred providers or suppliers, nor may the participant hospital accept such payments.
(b)
(i) A detailed explanation of the model and how it might be expected to affect the beneficiary's care.
(ii) Notification that the beneficiary retains freedom of choice to choose providers and services.
(iii) Explanation of how patients can access care records and claims data through an available patient portal, and how they can share access to their Blue Button® electronic health information with caregivers.
(iv) A statement that all existing Medicare beneficiary protections continue to be available to the beneficiary. These include the ability to report concerns of substandard care to Quality Improvement Organizations and 1-800-MEDICARE.
(v) A list of the providers and suppliers with whom the participant hospital has a collaborator agreement.
(2)
(3)
(4)
(i) If the hospital knows or should have known that the beneficiary is considering or has decided to receive a non-covered post-acute service or other non-covered associated service or supply, the hospital must notify the beneficiary that the service would not be covered by Medicare.
(ii) If the hospital is discharging a beneficiary to a SNF prior to the occurrence of a 3 day hospital stay, and the beneficiary is being transferred to or is considering a SNF that would not qualify under the SNF 3-day waiver in § 510.610, the hospital notify the beneficiary in accordance with paragraph (b)(4)(i) of this section that the beneficiary will be responsible for costs associated with that stay except those which would be covered by Medicare Part B during a non-covered inpatient SNF stay.
(a)
(b)
(i) Fails to comply with any applicable requirements of this part or is identified as noncompliant through monitoring by HHS (including CMS and OIG) of the CJR model, including but not limited to the following:
(A) Avoiding potentially high cost patients.
(B) Targeting potentially low cost patients.
(C) Failing to provide medically appropriate services or systematically engaging in the over or under delivery of appropriate care.
(D) Failing to provide beneficiaries with complete and accurate information, including required notices.
(E) Failing to allow beneficiary choice of medically necessary options, including non-surgical options.
(F) Failing to follow the requirements related to collaborator agreements;
(ii) Has signed a collaborator agreement with a CJR collaborator if the agreement is noncompliant with the requirements of this part;
(iii) Takes any action that threatens the health or safety of patients;
(iv) Avoids at-risk Medicare beneficiaries, as this term is defined in § 425.20;
(v) Avoids patients on the basis of payer status;
(vi) Is subject to sanctions or final actions of an accrediting organization or federal, state, or local government agency that could lead to the inability to comply with the requirements and provisions of this part;
(vii) Takes any action that CMS determines for program integrity reasons is not in the best interests of the CJR model, or fails to take any action that CMS determines for program integrity reasons should have been taken to further the best interests of the CJR model;
(viii) Is subject to action by HHS (including OIG and CMS) or the Department of Justice to redress an allegation of fraud or significant misconduct, including intervening in a False Claims Act qui tam matter, issuing a pre-demand or demand letter under a civil sanction authority, or similar actions; or
(ix) Is subject to action involving violations of the physician self-referral law, civil monetary penalties law, federal anti-kickback statute, antitrust laws, or any other applicable Medicare laws, rules, or regulations that are relevant to the CJR model.
(2) Remedial actions include the following:
(i) Issue a warning letter to the participant hospital.
(ii) Require the participant hospital to develop a corrective action plan, commonly referred to as a CAP.
(iii) Reduce or eliminate a participant hospital's reconciliation payment.
(iv) Require a participant hospital to terminate a collaborator agreement with a CJR collaborator and prohibit further engagement in the CJR model by that CJR collaborator.
(v) Terminate the participant hospital's participation in the CJR model.
(3) CMS may add 25 percent to a repayment amount on a participant hospital's reconciliation report if all of the following criteria are satisfied:
(i) CMS has required a corrective action plan from a participant hospital.
(ii) The participant hospital is not due a positive reconciliation payment but instead owes a repayment amount to CMS.
(iii) The participant hospital fails to timely comply with the corrective action plan or is noncompliant with the model's requirements.
(a)
(2) A participant hospital must not make a gainsharing payment or receive an alignment payment except in accordance with a sharing arrangement. Any gainsharing payments or alignment payments made in accordance with a sharing arrangement must be made only from the participant hospital to the CJR collaborator with whom the participant hospital has signed a collaborator agreement containing a sharing arrangement.
(3) CMS may review any sharing arrangement for compliance with the requirements of this part and to ensure that it does not pose a risk to beneficiary access, beneficiary freedom of choice, or quality of care.
(4) The participant hospital has ultimate responsibility for fully complying with all provisions of the CJR model.
(5) If a participant hospital enters into a sharing arrangement, it must update its compliance program to include oversight of sharing arrangements and compliance with the requirements of the CJR model.
(6) The board or other governing body of the participant hospital must have responsibility for overseeing the participant hospital's participation in the CJR model, its arrangements with CJR collaborators, its payment of gainsharing payments and receipt of alignment payments, and its use of beneficiary incentives in the CJR model.
(7) Participant hospitals must develop and maintain a written set of policies for selecting providers and suppliers for sharing gains and risk as CJR collaborators. This set of policies must contain criteria for selection of CJR collaborators related to, and inclusive of, the quality of care to be delivered by the CJR collaborator to beneficiaries during a CJR episode. The selection criteria cannot be based directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator. All collaborator agreements must require the CJR collaborator to have met, or agree to meet, the quality criteria for selection.
(b)
(1) The sharing arrangement must be set forth in a collaborator agreement that complies with the requirements of paragraph (c) of this section.
(2) The sharing arrangement must comply with all relevant laws and regulations, including the applicable fraud and abuse laws and all applicable payment and coverage requirements.
(3) An individual or entity's participation in a sharing arrangement must be voluntary and without penalty for nonparticipation.
(4) The parties must enter into a sharing arrangement before care is furnished to CJR beneficiaries under the terms of the sharing arrangement.
(5)(i) To be eligible to receive a gainsharing payment, a CJR collaborator must meet quality criteria for the calendar year for which the gainsharing payment is determined by the participant hospital. The quality criteria must be established by the participant hospital and directly related to CJR episodes of care.
(ii) To be eligible to receive a gainsharing payment or make an alignment payment, a CJR collaborator other than a PGP must directly furnish a billable service to a CJR beneficiary during a CJR episode that occurred in the calendar year in which the savings or loss was created.
(iii) To be eligible to receive a gainsharing payment, a PGP that is a CJR collaborator must meet the following criteria:
(A) The PGP must have billed for an item or service that was rendered by one or more members of the PGP to a CJR beneficiary during a CJR episode that occurred during the calendar year in which the participant hospital's internal cost savings was generated, or to which the NPRA applied, the latter of which is contained in a reconciliation payment.
(B) The PGP must contribute to a participant hospital's care redesign in the CJR model and be clinically involved in the care of CJR beneficiaries. The following is a non-exhaustive list of ways in which a PGP might be clinically involved in the care of CJR beneficiaries:
(
(
(
(6) No entity or individual, whether a party to a collaborator agreement or not, may condition the opportunity to make or receive gainsharing payments or to make or receive alignment payments on the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
(7) Gainsharing payments, if any, must be—
(i) Derived solely from reconciliation payments, or internal cost savings, or both;
(ii) Actually and proportionally related to the care of beneficiaries in a CJR episode;
(iii) Distributed on an annual basis (not more than once per calendar year);
(iv) Not be a loan, advance payments, or payments for referrals or other business; and
(v) Be clearly identified and comply with all provisions in this part, as well as all applicable laws, statutes, and rules.
(8) Alignment payments from a CJR collaborator to a participant hospital may be made at any interval that is agreed upon by both parties, and must—
(i) Not be issued, distributed, or paid prior to the calculation by CMS of a repayment amount reflected in a reconciliation report; and
(ii) Not be a loan, advance payments, or payments for referrals or other business.
(9) A participant hospital must not make a gainsharing payment to a CJR collaborator that is subject to any action for noncompliance with this part or the fraud and abuse laws, or for the
(10) In a calendar year, the aggregate amount of all gainsharing payments distributed by a participant hospital that are derived from a CJR reconciliation payment may not exceed the amount of the reconciliation payment the participant hospital receives from CMS.
(11) In a calendar year, the aggregate amount of all alignment payments received by the participant hospital must not exceed 50 percent of the participant hospital's repayment amount. No alignment payments may be collected by a participant hospital if it does not owe a repayment amount.
(12) The aggregate amount of all alignment payments from any one CJR collaborator to a participant hospital must not be greater than 25 percent of the participant hospital's repayment amount.
(13) A sharing arrangement must not induce the participant hospital, CJR collaborator, or any employees or contractors of the participant hospital or CJR collaborator to reduce or limit medically necessary services to any Medicare beneficiary.
(14) A sharing arrangement must not restrict the ability of a CJR collaborator to make decisions in the best interests of its patients, including the selection of devices, supplies, and treatments.
(15) The methodology for determining gainsharing payments must be based, at least in part, on criteria related to, and inclusive of, the quality of care to be delivered to CJR beneficiaries during an episode and must not directly account for the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
(16) The methodology for determining alignment payments must not directly account for the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
(17) The total amount of a gainsharing payment for a calendar year paid to an individual physician or nonphysician practitioner who is a CJR collaborator must not exceed 50 percent of the total Medicare approved amounts under the Physician Fee Schedule (PFS) for services furnished to the participant hospital's CJR beneficiaries during a CJR episode by that physician or nonphysician practitioner.
(18) The total amount of gainsharing payments for a calendar year paid to a PGP that is a CJR collaborator must not exceed 50 percent of the total Medicare approved amounts under the Physician Fee Schedule for services that are billed by the PGP and furnished during a calendar year by members of the PGP to the participant hospital's CJR beneficiaries during CJR episodes.
(19) The participant hospital's determination of internal cost savings must satisfy the following criteria:
(i) Internal cost savings are calculated in accordance with generally accepted accounting principles and Government Auditing Standards (The Yellow Book).
(ii) All amounts determined to be internal cost savings must reflect actual, internal cost savings achieved by the participant hospital through implementation of care redesign elements identified and documented by the participant hospital. Internal cost savings does not include savings realized by any individual or entity that is not the participant hospital.
(iii) Internal cost savings may not reflect “paper” savings from accounting conventions or past investment in fixed costs.
(20) All gainsharing payments and any alignment payments must meet the requirements set forth in this section and be administered by the participant hospital in accordance with generally accepted accounting principles. In no event may the participant hospital receive any amounts from a CJR collaborator under a sharing arrangement that are not alignment payments.
(21) All gainsharing payments and alignment payments must be made through EFT.
(c)
(1) The collaborator agreement must contain a description of the sharing arrangement between the participant hospital and the CJR collaborator regarding gainsharing payments and alignment payments. This description must specify the following:
(i) The parties to the sharing arrangement.
(ii) The date of the sharing arrangement.
(iii) The purpose and scope of the sharing arrangement.
(iv) The financial or economic terms of the sharing arrangement, including the frequency of payment, and the methodology and accounting formula for determining the amount of any gainsharing payment or alignment payment.
(v) Safeguards to ensure that alignment payments are made solely for purposes related to sharing responsibility for funds needed to repay Medicare in the CJR model.
(vi) Plans regarding care redesign.
(vii) Changes in care coordination or delivery that is applied to the participant hospital or CJR collaborators or both.
(viii) A description of how success will be measured.
(ix) Management and staffing information, including type of personnel or contractors that will be primarily responsible for carrying out changes to care under the CJR model.
(2) The collaborator agreement must contain a requirement that the CJR collaborator and its employees and contractors must comply with the applicable provisions of this part (including requirements regarding beneficiary notifications, access to records, record retention, and participation in any evaluation, monitoring, compliance, and enforcement activities performed by CMS or its designees) and all other applicable laws and regulations.
(3) The collaborator agreement must require the CJR collaborator to be in compliance with all Medicare provider enrollment requirements at § 424.500 of this chapter, including having a valid and active TIN or NPI, during the term of the agreement.
(4) The collaborator agreement must require the CJR collaborator to have a compliance program that includes oversight of the collaborator agreement and compliance with the requirements of the CJR model.
(5) The collaborator agreement must set forth a specific methodology for accruing, calculating, and verifying the internal cost savings generated by the participant hospital based on the care redesign elements specifically associated with the particular CJR collaborator.
(i) The methodology must set out the specific care redesign elements to be undertaken by the participant hospital or the CJR collaborator or both.
(ii) The methodology must be based, at least in part, on criteria related to, and inclusive of, the quality of care to be delivered to CJR beneficiaries during an episode and must not directly account for the volume or value of referrals or business otherwise generated by, between or among the participant hospital, CJR collaborators, and any individual or entity affiliated with a participant hospital or CJR collaborator.
(iii) The specific methodologies for accruing and calculating internal cost savings must be transparent, measurable, and verifiable in accordance with generally accepted
(6) The collaborator agreement must set forth the quality criteria established by the participant hospital that will be used in determining the gainsharing payment.
(7) The collaborator agreement must require the participant hospital to recoup gainsharing payments paid to CJR collaborators if gainsharing payments contain funds derived from a CMS overpayment on a reconciliation report, or were based on the submission of false or fraudulent data.
(d)
(2) A participant hospital must maintain accurate current and historical lists of all CJR collaborators, including names and addresses of each CJR collaborator. The participant hospital must update the lists on at least a quarterly basis and publicly report the current and historical lists of CJR collaborators on a public-facing Web page on the participant hospital's Web site.
(3) The participant hospital and CJR collaborator must maintain contemporaneous documentation of the payment or receipt of any gainsharing payment or alignment payment. The documentation must identify at least the following: The nature of the payment (gainsharing payment or alignment payment); the identity of the parties making and receiving the payment; the date of the payment; the amount of the payment; and the date and amount of any recoupment of all or a portion of a CJR collaborator's gainsharing payment.
(4) The participant hospital must keep records of the following:
(i) Its process for determining and verifying the eligibility of CJR collaborators to participate in Medicare.
(ii) Information confirming the organizational readiness of the participant hospital to measure and track internal cost savings.
(iii) The participant hospital's plan to track internal cost savings.
(iv) Information on the accounting systems used to track internal cost savings.
(v) A description of current health information technology, including systems to track reconciliation payments and internal cost savings.
(vi) The participant hospital's plan to track gainsharing payments and alignment payments.
(vii) Whether the participant hospital recouped any gainsharing payments received by a CJR collaborator that contain funds derived from a CMS overpayment on a reconciliation report, or were based on the submission of false or fraudulent data.
(e)
(1) Provide to CMS, the OIG, and the Comptroller General or their designees scheduled and unscheduled access to all books, contracts, records, documents, and other evidence (including data related to utilization and payments, quality criteria, billings, lists of CJR collaborators, sharing arrangements, and distribution arrangements, and the documentation required under paragraph (d) of this section) sufficient to enable the audit, evaluation, inspection, or investigation of the individual's or entity's compliance with CJR requirements, the quality of services furnished, the obligation to repay any reconciliation payments owed to CMS, or the calculation, distribution, receipt, or recoupment of gainsharing payments, alignment payments, or distribution payments.
(2) Maintain all such books, contracts, records, documents, and other evidence for a period of 10 years from the last day of the participant hospital's participation in the CJR model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
(i) CMS determines that there is a special need to retain a particular record or group of records for a longer period and notifies the participant hospital at least 30 calendar days before the normal disposition date; or
(ii) There has been a dispute or allegation of fraud or similar fault against the participant hospital or any CJR collaborator, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault.
(a)
(2) All distribution arrangements must comply with the provisions of paragraph (b) of this section and all applicable laws and regulations, including the fraud and abuse laws.
(b)
(2) Participation in a distribution arrangement must be voluntary and without penalty for nonparticipation.
(3) The distribution arrangement must require the practice collaboration agent to comply with the requirements set forth in this part.
(4) The opportunity to receive a distribution payment must not be conditioned directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among the participant hospital, PGP, other CJR collaborators, practice collaboration agents, and any individual or entity affiliated with a participant hospital, CJR collaborator, or practice collaboration agent.
(5) Methodologies for determining distribution payments must not directly account for volume or value of referrals, or business otherwise generated, by, between or among the participant hospital, PGP, other CJR collaborators, practice collaboration agents, and any individual or entity affiliated with a participant hospital, CJR collaborator, or practice collaboration agent.
(6) A practice collaboration agent is eligible to receive a distribution payment only if the PGP billed for an item or service furnished by the practice collaboration agent to a CJR beneficiary during a CJR episode that occurred during the calendar year in which the participating hospital accrued the internal cost savings or earned the reconciliation payment that comprise the gainsharing payment made to the PGP.
(7) When a PGP receives a gainsharing payment from a participant hospital in accordance with a sharing arrangement, all monies contained in such a gainsharing payment must be shared only with the physician or nonphysician practitioners that are PGP members that furnished a service to a CJR beneficiary during an episode of care in the calendar year from which the NPRA, as that term is defined in this part, or internal cost savings was generated, either or both of which are the only permitted sources of funds for a gainsharing payment.
(8) The total amount of distribution payments for a calendar year paid to a practice collaboration agent must not exceed 50 percent of the total Medicare approved amounts under the Physician Fee Schedule for services billed by the PGP and furnished by the practice collaboration agent to the participant hospital's CJR beneficiaries during a CJR episode.
(9) With respect to the distribution of any gainsharing payment received by a
(10) All distribution payments must be made through EFT.
(11) The practice collaboration agents must retain their ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.
(12) The distribution arrangement must not—
(i) Induce a practice collaboration agent to reduce or limit medically necessary services to any Medicare beneficiary; or
(ii) Reward the provision of items and services that are medically unnecessary.
(13) The PGP must maintain contemporaneous documentation regarding distribution arrangements in accordance with § 510.500(e), including the relevant written agreements, the date and amount of any distribution payment, the identity of each practice collaboration agent who received a distribution payment, and a description of the methodology and accounting formula for determining the amount of any distribution payment.
(14) The PGP may not enter into a distribution arrangement with any member of the PGP that has a collaborator agreement in effect with a participant hospital.
(a)
(b)
(a)
(1) The incentive must be provided directly by the participant hospital or by an agent of the hospital under the hospital's direction and control to the beneficiary during a CJR episode of care.
(2) The item or service provided must be reasonably connected to medical care provided to a beneficiary during an episode.
(3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as listed in paragraph (b) of this section, for a beneficiary in a CJR episode by engaging the beneficiary in better managing his or her own health.
(4) The item or service must not be tied to the receipt of items or services outside the CJR episode of care.
(5) The item or service must not be tied to the receipt of items or services from a particular provider or supplier.
(6) The availability of the items or services must not be advertised or promoted except that a beneficiary may be made aware of the availability of the items or services at the time the beneficiary could reasonably benefit from them.
(7) The cost of the items or services must not be shifted to another federal health care program, as defined at section 1128B(f) of the Act.
(b)
(1) Beneficiary adherence to drug regimens.
(2) Beneficiary adherence to a care plan.
(3) Reduction of readmissions and complications resulting from LEJR procedures.
(4) Management of chronic diseases and conditions that may be affected by the lower extremity joint replacement procedure.
(c)
(2) The documentation must be contemporaneous with the provision of the items and services and must include at least the following:
(i) The date the incentive is provided.
(ii) The identity of the beneficiary to whom the item or service was provided.
(3) The participant hospital must retain the required documentation in accordance with paragraph (e) of this section.
(d)
(2) Items or services involving technology provided to a beneficiary must be the minimum necessary to advance a clinical goal, as listed in paragraph (b) of this section, for a beneficiary in a CJR episode.
(3) Items of technology exceeding $100 in retail value must—
(i) Remain the property of the participant hospital; and
(ii) Be retrieved from the beneficiary at the end of the CJR episode. The participant hospital must document all retrieval attempts, including the ultimate date of retrieval. Documented, diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement.
(e)
(1) Provide to CMS, the OIG, and the Comptroller General or their designee(s) scheduled and unscheduled access to all books, contracts, records, documents, and other evidence sufficient to enable the audit, evaluation, inspection, or investigation of the participant hospital's compliance with CJR requirements for beneficiary incentives.
(2) Maintain all such books, contracts, records, documents, and other evidence for a period of 10 years from the last day of the participant hospital's participation in the CJR model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
(i) CMS determines that there is a special need to retain a particular record or group of records for a longer period and notifies the participant hospital at least 30 calendar days before the normal disposition rate; or
(ii) There has been a dispute or allegation of fraud or similar fault against the participant hospital, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault.
(a)
(b)
(1) The home visit is furnished during the episode to a beneficiary who has been discharged from an anchor hospitalization.
(2) The home visit is furnished at the beneficiary's home or place of residence.
(3) The beneficiary does not qualify for home health services under sections 1835(a) and 1814(a) of the Act at the time of any such home visit.
(4) The visit is furnished by clinical staff under the general supervision of a physician or non-physician practitioner. Clinical staff are individuals who work under the supervision of a physician or other qualified health care professional, and who are allowed by law, regulation, and facility policy to perform or assist in the performance of a specific professional service, but do not individually report that professional service.
(5) No more than 9 visits are furnished to the beneficiary during the episode.
(c)
(d)
(a)
(1) May be furnished via telehealth under existing requirements; and
(2) Are included in the episode in accordance with § 510.200(b).
(b)
(1) May be furnished via telehealth under existing requirements; and
(2) Are included in the CJR episode in accordance with § 510.200(b).
(c)
(2) CMS waives the payment requirements under section 1834(m)(2)(B) to allow the distant site payment for telehealth home visit HCPCS codes unique to this model to more accurately reflect the resources involved in furnishing these services in the home by basing payment upon the comparable office visit relative value units for work and malpractice under the Physician Fee Schedule.
(d)
(a)
(1) CMS determines the qualified SNFs for each calendar quarter based on a review of the most recent rolling 12 months of overall star ratings on the Five-Star Quality Rating System for SNFs on the Nursing Home Compare Web site. Qualified SNFs are rated an overall of 3 stars or better for at least 7 of the 12 months.
(2) CMS posts to the CMS Web site the list of qualified SNFs in advance of the calendar quarter and the waiver only applies for a beneficiary who has been discharged from an anchor hospitalization if the SNF is included on the applicable calendar quarter list for the date of the beneficiary's admission to the SNF.
(b)
(a)
(b)
(c)
(a)
(b)
CMS may terminate the CJR model for reasons including but not limited to the following:
(a) CMS determines that it no longer has the funds to support the CJR model.
(b) CMS terminates the model in accordance with section 1115A(b)(3)(B) of the Act. As provided by section 1115A(d)(2) of the Act, termination of the model is not subject to administrative or judicial review.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
Upon application from the U.S. Navy (Navy), we (the National Marine Fisheries Service) are issuing regulations under the Marine Mammal Protection Act (MMPA) to govern the unintentional taking of marine mammals incidental to training and testing activities conducted in the Northwest Training and Testing (NWTT) Study Area from November 2015 through November 2020. These regulations allow us to issue Letters of Authorization (LOAs) for the incidental take of marine mammals during the Navy's specified activities and timeframes, set forth the permissible methods of taking, set forth other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, and set forth requirements pertaining to the monitoring and reporting of the incidental take. These regulations also allow us to authorize modifications to watchstander requirements for observed behavior of marine mammals during Major Training Events (MTEs) in the Hawaii-Southern California Training and Testing (HSTT), Atlantic Fleet Training and Testing (AFTT), Mariana Islands Training and Testing (MITT), and Gulf of Alaska Training (GOA) study areas. Modifications to the Navy watchstander requirements include a revision to regulatory text in current regulations governing the taking and importing of marine mammals during training and/or testing activities in these study areas. There are no MTEs associated with Navy training and testing activities in the NWTT Study Area.
To obtain an electronic copy of the Navy's application or other referenced documents, visit the internet at:
John Fiorentino, Office of Protected Resources, NMFS, (301) 427-8477.
A copy of the Navy's LOA application, which contains a list of the references used in this document, may be obtained by visiting the internet at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
The National Defense Authorization Act of 2004 (NDAA) (Pub. L. 108-136) removed the “small numbers” and “specified geographical region” limitations indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (section 3(18)(B) of the MMPA): “(i) any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild [Level A Harassment]; or (ii) any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered [Level B Harassment].”
On December 19, 2013, NMFS received an application (version (v)1 dated December 18, 2013) from the Navy requesting two LOAs for the take of 25 species of marine mammals incidental to Navy training and testing activities to be conducted in the NWTT Study Area over 5 years. On October 1, 2014, the Navy submitted a revised LOA application (v2 dated September 26, 2014) to reflect updates to exposure estimates based on emergent changes to specific types of training activities which were addressed in the Navy's supplemental EIS/OEIS for the NWTT Study Area. The revised application also provided an update to the effects analysis for Guadalupe fur seals (summarized in the Analysis of Guadalupe Fur Seal Exposures section of the proposed rule, which published on June 3, 2015 (80 FR 31737)) to more realistically reflect potential impacts from offshore Navy training and testing events. On November 7, 2014, the Navy submitted a revised LOA application (v3 dated November 7, 2014) to address: (a) An inadvertent error in the recommended mitigation zone for mine countermeasure and neutralization training events; (b) removal of the time delay firing underwater explosive training activity; (c) correction or clarification of certain mitigation measures applied to testing, and (d) revised mitigation for pinniped haulouts. On November 21, 2014, the Navy submitted a revised LOA application (v4 dated November 7, 2014) to correct inadvertent errors in the exposure calculations. On April 2, 2015, the Navy submitted a final revision to the LOA application (v5 dated April 2, 2015) (hereinafter referred to as the LOA application) to incorporate and update population density estimates for the Hood Canal stock of harbor seals and remove the ship strike mortality request.
The Navy is requesting separate 5-year LOAs for training and testing activities to be conducted from 2015 through 2020. The NWTT Study Area is composed of established maritime operating and warning areas in the eastern north Pacific Ocean region, to include the Strait of Juan de Fuca, Puget Sound, and Western Behm Canal in southeastern Alaska. The Study Area includes the existing Northwest Training Range Complex, the Keyport Range Complex, Carr Inlet Operations Area, Southeast Alaska Acoustic Measurement Facility (SEAFAC), and Navy pierside locations where sonar maintenance or testing may occur (see Figure 1-1 of the LOA application for a map of the NWTT Study Area). The activities conducted within the NWTT Study Area are classified as military readiness activities. The Navy states that these activities may expose some of the marine mammals present within the NWTT Study Area to sound from underwater acoustic sources and explosives. The Navy is requesting authorization to take 25 marine mammal species by Level B (behavioral) harassment; 5 of those marine mammal species may be taken by injury (Level A harassment). The Navy is not requesting mortality takes for any species.
The Navy's LOA application and the NWTT FEIS/OEIS contain acoustic thresholds that, in some instances, represent changes from what NMFS has used to evaluate the Navy's activities for previous authorizations. The revised thresholds, which the Navy developed in coordination with NMFS, are based on the evaluation and inclusion of new information from recent scientific studies; a detailed explanation of how they were derived is provided in the NWTT FEIS/OEIS Criteria and Thresholds for U.S. Navy Acoustic and Explosive Effects Analysis Technical Report (available at
NOAA is currently in the process of developing Acoustic Guidance on thresholds for onset of auditory impacts from exposure to sound, which will be used to support assessments of the effects of anthropogenic sound on marine mammals. To develop this Guidance, NOAA is compiling, interpreting, and synthesizing the best information currently available on the effects of anthropogenic sound on marine mammals, and is committed to finalizing the Guidance through a systematic, transparent process that involves internal review, external peer review, and public comment.
In December 2013, NOAA released for public comment a “Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals: Acoustic Threshold Levels for Onset of Permanent and Temporary Threshold Shifts” (78 FR 78822). The Draft Guidance was generally consistent with the Navy's PTS/TTS criteria used in the NWTT FEIS/OEIS and detailed within Finneran and Jenkins (2012). Prior to the finalization of this guidance by NOAA, the Navy suggested revisions to the criteria (
Finneran (2015) proposed new weighting functions and thresholds for predicting PTS/TTS in marine mammals. The methodologies presented within this paper build upon the methodologies used to develop the criteria used within the Navy's NWTT FEIS/OEIS (Finneran and Jenkins, 2012) and incorporate relevant auditory research made available since 2012. While Finneran and Jenkins (2012) presented a conservative approach to development of auditory weighting functions where data was limited, Finneran (2015) synthesizes a wide range of auditory data, including newly available studies, to predict refined auditory weighting functions and corresponding TTS thresholds across the complete hearing ranges of functional hearing groups. Finneran (2015) also developed updated threshold shift growth functions to facilitate the development of new PTS thresholds.
During the development process of NOAA's Draft Guidance, NOAA chose to incorporate Finneran (2015) into its Draft Guidance prior to its finalization. As a result, the Navy's proposal (Finneran 2015) was submitted for peer review by external subject matter experts, in accordance with the process previously conducted for NOAA's Draft Guidance. Peer review comments were received by NOAA in April 2015. NOAA subsequently developed a Peer Review Report, which was published on its Web site on July 31, 2015. The published report documents the Navy's proposal (Finneran 2015) that underwent peer review, the peer-review comments, and NOAA's responses to those comments. NOAA then incorporated this information into revised Draft Guidance which was published in the
If the proposed criteria in Finneran (2015) were adopted by NOAA, incorporated into its Final Guidance, and applied to the Navy in the future, predicted numbers of PTS/TTS would change for most functional hearing groups. However, because Finneran (2015) relies on much of the same data as the auditory criteria presented in the Navy's NWTT FEIS/OEIS, these changes would not be substantial, and in most cases would result in a reduction in the predicted impacts. Predicted PTS/TTS would be reduced over much to all of their hearing range for low-frequency cetaceans and phocids. Predicted PTS/TTS for mid-frequency and high-frequency cetaceans would be reduced for sources with frequencies below about 3.5 kHz and remain relatively unchanged for sounds above this frequency. Predicted auditory effects on otariids would increase for frequencies between about 1 kHz and 20 kHz and decrease for frequencies above and below these points, although otariids remain the marine mammals with the least sensitivity to potential PTS/TTS. Overall, predicted auditory effects within this rulemaking would not change significantly.
In summary, NOAA's continued evaluation of all available science for the Acoustic Guidance could result in changes to the acoustic criteria used to model the Navy's activities for this rulemaking, and, consequently, the enumerations of “take” estimates. However, at this time, the results of prior Navy modeling described in this rule represent the best available estimate of the number and type of take that may result from the Navy's use of acoustic sources in the NWTT Study Area. Further, consideration of the
NMFS is also authorizing modifications to watchstander requirements, which do not affect current mitigation measures, for observed behavior of marine mammals during MTEs in the HSTT, AFTT, MITT, and GOA study areas. With these modifications the Navy would no longer be required to report individual marine mammal sighting information when mitigation is not being implemented during the MTEs. After 5 years of collecting marine mammal sighting data for all animals sighted during MTEs, NMFS and the Navy have determined that without the ability to obtain species information this data set does not provide for any meaningful analysis beyond that which may be possible using mitigation-related observations alone. The Navy and NMFS have thoroughly investigated several potential uses for the data prior to reaching this conclusion. Additionally, this reporting requirement places an undue administrative burden on ships watch teams, which was undue given the limited value of the information collected, as was described during the Adaptive Management Process. The Navy will continue to collect marine mammal sighting data during MTEs for every instance when any form of mitigation is employed such as powering down or securing sonar, maneuvering the ship, or delaying an event—in other words, in instances where animals are closer to the sound source around which mitigation measures are implemented. This data is useful in supporting mitigation effectiveness analyses and also may be helpful in supporting an understanding of the frequency with which marine mammals (generally, not by species) may be encountered or detected in close proximity to a particular source (
The proposed rule (80 FR 31738, June 3, 2015) and NWTT FEIS/OEIS include a complete description of the Navy's specified training and testing activities incidental to which NMFS is authorizing take of marine mammals in this final rule. Sonar use and underwater detonations are the stressors most likely to result in impacts on marine mammals that could rise to the level of harassment. Detailed descriptions of these activities are provided in the NWTT FEIS/OEIS and LOA application (
The Navy routinely trains in the NWTT Study Area in preparation for national defense missions. Training activities and exercises covered in the Navy's LOA request are briefly described below, and in more detail within Chapter 2 of the NWTT FEIS/OEIS. Training activities are categorized into eight functional warfare areas (anti-air warfare; amphibious warfare; strike warfare; anti-surface warfare; anti-submarine warfare; electronic warfare; mine warfare; and naval special warfare). The Navy determined that the following stressors used in these warfare areas are most likely to result in impacts on marine mammals:
• Anti-surface warfare (impulsive sources [underwater detonations])
• Anti-submarine warfare (non-impulsive sources [active sonar], impulsive underwater detonations)
• Mine warfare (non-impulsive sources, impulsive underwater detonations)
The Navy's activities in anti-air warfare, electronic warfare, and naval special warfare do not involve stressors that could result in harassment of marine mammals. Therefore, these activities are not discussed further. The analysis and rationale for excluding these warfare areas are contained in the NWTT FEIS/OEIS.
Testing activities covered in the Navy's LOA request are briefly described below, and in more detail within Chapter 2 of the NWTT FEIS/OEIS. The Navy researches, develops, tests, and evaluates new platforms, systems and technologies. Many tests are conducted in realistic conditions at sea, and can range in scale from testing new software to operating portable devices to conducting tests of live weapons (such as the Service Weapon Test of a torpedo) to ensure they function as intended. Testing activities may occur independently of or in conjunction with training activities.
Many testing activities are conducted similarly to Navy training activities and are also categorized under one of the primary mission areas described above. Other testing activities are unique and are described within their specific testing categories. Because each test is conducted by a specific component of the Navy's research and acquisition community, which includes the Navy's Systems Commands and the Navy's scientific research organizations, the testing activities described in the LOA application are organized first by that particular organization as described below and in the order as presented.
The Navy describes and analyzes the effects of its testing activities within the NWTT FEIS/OEIS. In its assessment, the Navy concluded that acoustic stressors from the use of underwater acoustic sources and underwater detonations resulted in impacts on marine mammals that rose to the level of harassment as defined under the MMPA. Therefore, the LOA application for the NWTT Study Area provides the Navy's assessment of potential effects from these stressors in terms of the various activities that produce them.
The individual commands within the research and acquisition community included in the NWTT FEIS/OEIS and in the LOA application are:
• Naval Sea Systems Command (NAVSEA). Within NAVSEA are the following field activities:
○ Naval Undersea Warfare Center (NUWC) Division, Keyport
○ Naval Surface Warfare Center, Carderock Division (NSWCCD), Detachment Puget Sound
○ NSWCCD Southeast Alaska Acoustic Measurement Facility (SEAFAC)
○ Puget Sound Naval Shipyard and Intermediate Maintenance Facility
○ Various NAVSEA program offices
• Naval Air Systems Command (NAVAIR)
The Navy uses a variety of sensors, platforms, weapons, and other devices to meet its mission. Training and testing with these systems may introduce acoustic (sound) energy into the environment. This section describes and organizes sonar systems, ordnance, munitions, targets, and other systems to facilitate understanding of the activities in which these systems are used. Underwater sound is described as one of two types for the purposes of the LOA application: Impulsive and non-impulsive. Sonar and similar sound producing systems are categorized as non-impulsive sound sources. Underwater detonations of explosives and other percussive events are impulsive sounds.
Modern sonar technology includes a variety of sonar sensor and processing systems. The simplest active sonar emits sound waves, or “pings,” sent out in multiple directions and the sound waves then reflect off of the target object in multiple directions. The sonar source calculates the time it takes for the reflected sound waves to return; this calculation determines the distance to the target object. More sophisticated active sonar systems emit a ping and then rapidly scan or listen to the sound waves in a specific area. This provides both distance to the target and directional information. Even more advanced sonar systems use multiple receivers to listen to echoes from several directions simultaneously and provide efficient detection of both direction and distance. The Navy rarely uses active sonar continuously throughout activities. When sonar is in use, the pings occur at intervals, referred to as a duty cycle, and the signals themselves are very short in duration. For example, sonar that emits a 1-second ping every 10 seconds has a 10-percent duty cycle. The Navy's largest hull-mounted mid-frequency sonar source nominally emits a 1-second ping every 50 seconds representing a 2% duty cycle. The Navy utilizes sonar systems and other acoustic sensors in support of a variety of mission requirements. Primary uses include the detection of and defense against submarines (anti-submarine warfare) and mines (mine warfare); safe navigation and effective communications; use of unmanned undersea vehicles; and oceanographic surveys. Sources of sonar and other active acoustic sources include surface ship sonar, sonobuoys, torpedoes, range pingers, and unmanned underwater vehicles.
Most ordnance and munitions used during training and testing events fall into three basic categories: Projectiles (such as gun rounds), missiles (including rockets), and bombs. Ordnance can be further defined by their net explosive weight, which considers the type and quantity of the explosive substance without the packaging, casings, bullets, etc. Net explosive weight (NEW) is the trinitrotoluene (TNT) equivalent of energetic material, which is the standard measure of strength of bombs and other explosives. For example, a 12.7-centimeter (cm) shell fired from a Navy gun is analyzed at about 9.5 pounds (lb) (4.3 kilograms (kg)) of NEW. The Navy also uses non-explosive ordnance in place of high explosive ordnance in many training and testing events. Non-explosive ordnance look and perform similarly to high explosive ordnance, but lack the main explosive charge.
Naval forces depend on effective defensive countermeasures to protect themselves against missile and torpedo attack. Defensive countermeasures are devices designed to confuse, distract, and confound precision-guided munitions. Defensive countermeasures analyzed in the LOA application include acoustic countermeasures, which are used by surface ships and submarines to defend against torpedo attack. Acoustic countermeasures are either released from ships and submarines, or towed at a distance behind the ship.
The Navy divides mine warfare systems into two categories: Mine detection and mine neutralization. Mine detection systems are used to locate, classify, and map suspected mines, on the surface, in the water column, or on the seafloor. The Navy analyzed the following mine detection systems for potential impacts to marine mammals:
• Towed or hull-mounted mine detection systems. These detection systems use acoustic and laser or video sensors to locate and classify suspect mines. Fixed and rotary wing platforms, ships, and unmanned vehicles are used for towed systems, which can rapidly assess large areas.
• Airborne Laser Mine Detection Systems. Airborne laser detection systems work in concert with neutralization systems. The detection system initially locates mines and a neutralization system is then used to relocate and neutralize the mine.
• Unmanned/remotely operated vehicles. These vehicles use acoustic and video or lasers to locate and classify mines and provide unique capabilities in nearshore littoral areas, surf zones, ports, and channels.
Mine neutralization systems disrupt, disable, or detonate mines to clear ports and shipping lanes, as well as littoral, surf, and beach areas in support of naval amphibious operations. Mine neutralization systems can clear individual mines or a large number of mines quickly. The Navy analyzed the following mine neutralization systems for potential impacts to marine mammals:
• Towed influence mine sweep systems. These systems use towed equipment that mimic a particular ship's magnetic and acoustic signature triggering the mine and causing it to explode.
• Towed mechanical mine sweeping systems. These systems tow a sweep wire to snag the line that attaches a moored mine to its anchor and then uses a series of cables and cutters to sever those lines. Once these lines are cut, the mines float to the surface where Navy personnel can neutralize the mines.
• Unmanned/remotely operated mine neutralization systems. Surface ships and helicopters operate these systems, which place explosive charges near or directly against mines to destroy the mine.
• Projectiles. Small- and medium-caliber projectiles, fired from surface ships or hovering helicopters, are used to neutralize floating and near-surface mines.
• Diver emplaced explosive charges. Operating from small craft, divers put explosive charges near or on mines to destroy the mine or disrupt its ability to function.
Explosive charges are used during mine neutralization system training activities; however, only non-explosive mines or mine shapes would be used.
In order to better organize and facilitate the analysis of about 300 sources of underwater non-impulsive sound or impulsive energy, the Navy developed a series of source classifications, or source bins. This method of analysis provides the following benefits:
• Allows for new sources to be covered under existing authorizations, as long as those sources fall within the parameters of a “bin;”
• Simplifies the data collection and reporting requirements anticipated under the MMPA;
• Ensures a conservative approach to all impact analysis because all sources in a single bin are modeled as the loudest source (
• Allows analysis to be conducted more efficiently, without compromising the results;
• Provides a framework to support the reallocation of source usage (hours/explosives) between different source bins, as long as the total number and severity of marine mammal takes remain within the overall analyzed and authorized limits. This flexibility is required to support evolving Navy training and testing requirements, which are linked to real world events.
A description of each source classification is provided in Tables 1-3. Non-impulsive sources are grouped into bins based on the frequency, source level when warranted, and how the source would be used. Impulsive bins are based on the net explosive weight of the munitions or explosive devices. The following factors further describe how non-impulsive sources are divided:
• Frequency of the non-impulsive source:
○ Low-frequency sources operate below 1 kilohertz (kHz)
○ Mid-frequency sources operate at or above 1 kHz, up to and including 10 kHz
○ High-frequency sources operate above 10 kHz, up to and including 100 kHz
○ Very high-frequency sources operate above 100 kHz, but below 200 kHz
• Source level of the non-impulsive source:
○ Greater than 160 decibels (dB), but less than 180 dB
○ Equal to 180 dB and up to 200 dB
○ Greater than 200 dB
How a sensor is used determines how the sensor's acoustic emissions are analyzed. Factors to consider include pulse length (time source is on); beam pattern (whether sound is emitted as a narrow, focused beam, or, as with most explosives, in all directions); and duty cycle (how often a transmission occurs in a given time period during an event).
There are also non-impulsive sources with characteristics that are not anticipated to result in takes of marine mammals. These sources have low source levels, narrow beam widths, downward directed transmission, short pulse lengths, frequencies beyond known hearing ranges of marine mammals, or some combination of these factors. These sources were not modeled by the Navy, but are qualitatively analyzed in Table 1-4 of the LOA application and in the NWTT FEIS/OEIS. These sources generally meet the following criteria:
• Acoustic sources with frequencies greater than 200 kHz (based on known marine mammal hearing ranges)
• Sources with source levels less than 160 dB
The training and testing activities that the Navy proposes to conduct in the NWTT Study Area are listed in Tables 4-6. Detailed information about each activity (stressor, training or testing event, description, sound source, duration, and geographic location) can be found in the LOA application and in Appendix A of the NWTT FEIS/OEIS. NMFS used the detailed information in the LOA application and in Appendix A of the NWTT FEIS/OEIS to analyze the potential impacts from training and testing activities on marine mammals. The Navy's activities are anticipated to meet training and testing needs in the years 2015-2020.
During the development of the Navy's NWTT Draft, Supplemental and Final EIS/OEIS, 8 proposed life cycle pierside sonar testing events involving surface ships at Naval Station (NS) Everett were incorrectly modeled as 8 life cycle pierside sonar testing events involving submarines at Naval Base Kitsap (NBK)—Bremerton. The Navy identified this error while considering, at the request of NMFS, the overlap of NWTT activities within biologically important areas. Although documents released to the public for comment, including the NWTT Draft, Supplemental and Final EIS/OEIS, the Navy's LOA application, and NMFS' proposed rule qualitatively describe life cycle pierside sonar testing events as occurring at both NBK—Bremerton and Naval Station Everett, the quantitative analysis of impacts on marine mammals that could result from these activities is based on modeling data for more events occurring at NBK—Bremerton and fewer events than
The Navy corrected the error by eliminating 8 life cycle pierside sonar testing events involving submarines and their associated hours at NBK—Bremerton and adding 8 life cycle pierside sonar testing events involving surface ships and their associated hours to Naval Station Everett. This correction results in a reduction of hours in the MF3 bin (submarine sonar) and an addition of hours to the MF1 bin (surface ship sonar). Life cycle pierside sonar testing events involving submarines require use of up to 2 hours of MF3 sonar per event. Life cycle pierside sonar testing events involving surface ships require use of up to 4 hours of MF1 sonar per event. Given this difference between submarine and surface ship life cycle pierside sonar testing, elimination of the 8 submarine events at NBK—Bremerton will result in an overall reduction of 16 MF3 hours and addition of the 8 surface ship events at Naval Station Everett will result in an overall increase of 32 MF1 hours.
These revisions have been incorporated in this final rule (Table 5). Further, the updated predicted exposures resulting from this correction are included in the estimated Take of Marine Mammals section of this rule and depicted in Table 18, and the resulting analysis is discussed in the Analysis and Negligible Impact Determination section of this rule.
Table 4 provides a quantitative annual summary of training activities by sonar and other active acoustic source class analyzed in the Navy's LOA request.
Table 5 provides a quantitative annual summary of testing activities by sonar and other active sources analyzed in the Navy's LOA request.
Table 6 provides a quantitative annual summary of training explosive source classes analyzed in the Navy's LOA request.
Table 7 provides a quantitative annual summary of testing explosive source classes analyzed in the Navy's LOA request.
In addition to potential impacts to marine mammals from activities during which explosives or sonar and other active acoustic sources are used, the Navy also considered potential ship strike impacts to marine mammals, which are discussed below. The Navy concluded that no additional stressors would result in a take and require authorization under the MMPA.
Vessel strikes may occur from surface operations and sub-surface operations (excluding bottom crawling, unmanned underwater vehicles). Vessels used as part of the Navy's NWTT training and testing activities (proposed action) include ships, submarines and boats ranging in size from small, 16-foot (ft.) (5-meter [m]) rigid hull inflatable boats to aircraft carriers with lengths up to 1,092 ft. (333 m). Representative Navy vessel types, lengths, and speeds used in both training and testing activities are shown in Table 8.
Large Navy ships greater than 65 ft. (20 m) generally operate at speeds in the range of 10-15 knots for fuel conservation when cruising. Submarines generally operate at speeds in the range of 8-13 knots during transit and slower for certain tactical maneuvers. Small craft (for purposes of this discussion less than 65 ft. [20 m] in length) have much more variable speeds, dependent on the mission. While these speeds are representative, some vessels operate outside of these speeds due to unique training, testing, or safety requirements for a given event. Examples include increased speeds needed for flight operations, full speed runs to test engineering equipment, time critical positioning needs, etc. Examples of decreased speeds include speeds less than 5 knots or completely stopped for launching small boats, certain tactical maneuvers, target launch or retrievals, etc.
The number of Navy vessels in the Study Area varies based on training and testing schedules. Most activities include either one or two vessels, with an average of one vessel per activity, and last from a few hours up to 2 weeks. Vessel movement and the use of in-water devices as part of the proposed action would be concentrated in certain portions of the Study Area (such as Western Behm Canal [Alaska] or Hood Canal in the inland waters portion of the
The Navy analyzed the potential environmental impacts of approximately 286 ongoing annual Maritime Security Operations events in Puget Sound and the Strait of Juan de Fuca. Included in this activity are approximately 226 annual Transit Protection System training events. These critical events have been occurring since 2006 and exercise the Navy's Transit Protection System, where up to nine escort vessels provide protection during all nuclear ballistic missile submarine (SSBN) transits between the vessel's homeport and the dive/surface point in the Strait of Juan de Fuca or Dabob Bay. During a Transit Protection System event, the security escorts enforce a moving 1,000yard security zone around the SSBN to prevent other vessels from approaching while the SSBN is in transit on the surface. These events include security escort vessels, U.S. Coast Guard personnel and their ancillary equipment and weapons systems. The Transit Protection System involves the movement of security vessels and also includes periodic exercises and firearms training (with blank rounds). Given the relative slow speed of the escorted and blocking vessels and multiple lookouts, no marine mammal vessel strikes are expected as a result of these events.
In addition to Transit Protection System events, the Navy would conduct approximately 60 annual maritime security escort training events with Coastal Riverine Group boats that conduct force protection for designated vessels and movements. These Coastal Riverine Group boat crews train to protect ships while entering and leaving ports. Other missions include ensuring compliance with vessel security zones for ships in port and at anchor, conducting patrols to counter waterborne threats, and conducting harbor approach defense. Special consideration will be given to the presence of marine mammals during training events. Training will be paused until marine mammals have cleared the area, or the training area will be temporarily relocated.
Navy policy (Chief of Naval Operations Instruction 3100.6H) requires Navy vessels to report all whale strikes. That information is collected by the Office of the Chief of Naval Operations Energy and Environmental Readiness Division (OPNAV N45) and cumulatively provided to NMFS on an annual basis. In addition, the Navy and NMFS also have standardized regional reporting protocols for communicating to regional NMFS stranding coordinators information on any Navy vessel strikes as soon as possible. These communication procedures will remain in place for the duration of the LOAs. There are no records of any Navy vessel strikes to marine mammals during training or testing activities in the NWTT Study Area.
Training and testing activities will be conducted in the NWTT Study Area for the reasonably foreseeable future. The description of the location of authorized activities has not changed from what was provided in the proposed rule (80 FR 31737, June 3, 2015; pages 31747-31749) and NWTT FEIS/OEIS (
Twenty-nine marine mammal species are known to occur in the Study Area, including seven mysticetes (baleen whales), 16 odontocetes (dolphins and toothed whales), and six pinnipeds (seals and sea lions). The Description of Marine Mammals in the Area of the Specified Activities section was included in the proposed rule (80 FR 31737, June 3, 2015, 2014; pages 31749-31750). Table 9 of the proposed rule provided a list of marine mammals with possible or confirmed occurrence within the NWTT Study Area, including stock, abundance, and status.
The proposed rule, the Navy's LOA application, and the NWTT FEIS/OEIS include a complete description of information on the status, distribution, abundance, vocalizations, density estimates, and general biology of marine mammal species in the Study Area. In addition, NMFS publishes annual stock assessment reports for marine mammals, including some stocks that occur within the Study Area (
In the Potential Effects of Specified Activities on Marine Mammals section of the proposed rule (80 FR 31737, June 3, 2015; pages 31752-31769), we included a qualitative discussion of the different ways that Navy training and testing activities may potentially affect marine mammals without consideration of mitigation and monitoring measures. That information has not changed and is not repeated here.
Under section 101(a)(5)(A) of the MMPA, NMFS must set forth the “permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.” NMFS' duty under this “least practicable adverse impact” standard is to prescribe mitigation reasonably designed to minimize, to the extent practicable, any adverse population-level impacts, as well as habitat impacts. While population-level impacts are minimized by reducing impacts on individual marine mammals, not all takes have a reasonable potential for translating to population-level impacts. NMFS' objective under the “least practicable adverse impact” standard is to design mitigation targeting those impacts on individual marine mammals that are reasonably likely to contribute to adverse population-level effects.
The NDAA of 2004 amended the MMPA as it relates to military readiness activities and the ITA process such that “least practicable adverse impact” shall include consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the “military readiness activity.” The training and testing activities described in the Navy's LOA application are considered military readiness activities.
In
A population-level impact is an impact on the population numbers (survival) or growth and reproductive rates (recruitment) of a particular marine mammal species or stock. As we noted in the preamble to our general MMPA implementing regulations, not every population-level impact violates the negligible impact requirement. As we explained, the negligible impact standard does not require a finding that the anticipated take will have “no effect” on population numbers or growth rates: “The statutory standard does not require that the same recovery rate be maintained, rather that no significant effect on annual rates of recruitment or survival occurs . . . [T]he key factor is the significance of the level of impact on rates of recruitment or survival. Only insignificant impacts on long-term population levels and trends can be treated as negligible.” See 54 FR 40338, 40341-42 (September 29, 1989). Nevertheless, while insignificant impacts on population numbers or growth rates may satisfy the negligible impact requirement, such impacts still must be mitigated, to the extent practicable, under the “least practicable adverse impact” requirement. Thus, the negligible impact and least practicable adverse impact requirements are clearly distinct, even though both focus on population-level effects.
As explained in the proposed rule, any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to accomplishing one or more of the general goals listed below:
a. Avoid or minimize injury or death of marine mammals wherever possible (goals b, c, and d may contribute to this goal).
b. Reduce the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of MFAS/HFAS, underwater detonations, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing harassment takes only).
c. Reduce the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of MFAS/HFAS, underwater detonations, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing harassment takes only).
d. Reduce the intensity of exposures (either total number or number at biologically important time or location) to received levels of MFAS/HFAS, underwater detonations, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).
e. Avoid or minimize adverse effects to marine mammal habitat (including acoustic habitat), paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
f. For monitoring directly related to mitigation—increase the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation (shut-down zone, etc.).
Our final evaluation of measures that meet one or more of the above goals includes consideration of the following factors in relation to one another: The manner in which, and the degree to which, the successful implementation of the mitigation measures is expected to reduce population-level impacts to marine mammal species and stocks and impacts to their habitat; the proven or likely efficacy of the measures; and the practicability of the suite of measures for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
NMFS reviewed the proposed activities and the suite of proposed mitigation measures as described in the Navy's LOA application to determine if they would result in the least practicable adverse effect on marine mammals. NMFS described the Navy's proposed mitigation measures in detail in the proposed rule (80 FR 31738, June 3, 2015; pages 31771-31780). NMFS worked with the Navy in the development of the Navy's initially proposed measures, and they are informed by years of experience and monitoring. As described in the Mitigation Conclusions below and in responses to comments, and in the NWTT FEIS/OEIS, some additional measures were considered and analyzed, but ultimately not chosen for implementation. However, some area-specific mitigation measures considered by the Navy and NMFS for the Navy's low use of mid-frequency active sonar and other activities in certain areas of particular importance to marine mammals have been clarified or updated below (see
• At least one Lookout during the training and testing activities provided in Table 9;
• Mitigation zones ranging from 70 yards (yd) (64 m) to 2.5 nautical miles (nm) during applicable activities that involve the use of impulsive and non-impulsive sources to avoid or reduce the potential for onset of the lowest level of injury, PTS, out to the predicted maximum range (Table 10).
• For all training activities and for testing activities involving surface ships, vessels shall maneuver to keep at least 500 yd (457 m) away from whales and 200 yd (183 m) away from all other marine mammals (except bow riding dolphins, and pinnipeds hauled out on man-made navigational and port structures and vessels) during vessel movements. These requirements do not apply if a vessel's safety is threatened and to the extent that vessels are restricted in their ability to maneuver (
• For testing activities not involving surface ships (
• The Navy will ensure that towed in-water devices being towed from manned platforms avoid coming within a mitigation zone of 250 yd (229 m) for all training events and testing activities involving surface ships, and a mitigation zone of 100 yd (91 m) for testing activities not involving surface ships (
• Mitigation zones ranging from 200 yd (183 m) to 1,000 yd (914 m) during
• The Navy is clarifying its existing speed protocol: While in transit, Navy vessels shall be alert at all times, use extreme caution, and proceed at a “safe speed” so that the vessel can take proper and effective action to avoid a collision with any sighted object or disturbance, including any marine mammal or sea turtle and can be stopped within a distance appropriate to the prevailing circumstances and conditions.
The Navy has previously placed certain voluntary limitations on their activities in Puget Sound and coastal areas. These limitations have been incorporated into the final rule.
MFAS Training: Currently, the Navy is not conducting nor is it proposing to conduct training with mid-frequency active hull-mounted sonar on vessels while underway in Puget Sound and the Strait of Juan de Fuca. The Navy's process since 2003 requires approval prior to operating mid-frequency active hull-mounted sonar in Puget Sound and the Strait of Juan de Fuca. The Navy will continue the permission and approval process, in place since 2003, through U.S. Pacific Fleet's designated authority for all mid-frequency active hull-mounted sonar on vessels while training underway in Puget Sound and Strait of Juan de Fuca.
Pierside Maintenance/Testing of Sonar Systems: Pierside maintenance and testing of sonar systems within Puget Sound and the Strait of Juan de Fuca will also require approval by U.S. Pacific Fleet's designated authority or System Command designated authority as applicable and must be conducted in accordance with Navy's Protective Measures Assessment Protocol (PMAP) for ship and submarine active sonar use, to include use of lookouts. Use of active sonar for anti-terrorism force protection or for safe navigation within the Puget Sound or Strait of Juan de Fuca, or for testing activities within the Dabob Bay Range is always permitted for safety of ship/national security reasons. This scheme has been functioning appropriately since 2003 and there has been, as reflected in annual reports submitted to NMFS for the Northwest Training Range Complex, limited active sonar use for maintenance and testing across Puget Sound and no use for training purposes has been approved in that timeframe.
Civilian Port Defense Exercise (Maritime Homeland Defense/Security Mine Countermeasure Exercise): Prior to Maritime Homeland Defense/Security Mine Countermeasure Integrated Exercises, the Navy will conduct pre-event planning and training to ensure environmental awareness of all exercise participants. When this event is proposed to be conducted in Puget Sound, Navy event planners will consult with Navy biologists who will contact NMFS (Protected Resources Division, West Coast Marine Species Branch Chief) during the planning process in order to determine likelihood of gray whale or southern resident killer whale presence in the proposed exercise area as planners consider specifics of the event.
Non-Explosive Gunnery Exercises: One gunnery exercise, Small Boat Attack, involves only blank rounds and no targets. However, because of the exercise location in Puget Sound, prior to Small Boat Attack training, the Navy will conduct pre-event planning and training to ensure environmental awareness of all exercise participants. When this event is proposed to be conducted in and around Naval Station Everett, Naval Base Kitsap Bangor, or Naval Base Kitsap Bremerton in Puget Sound, Navy event planners will consult with Navy biologists who will contact NMFS early in the planning process in order to determine the extent marine mammals may be present in the immediate vicinity of proposed exercise area as planners consider the specifics of the event.
Mine Neutralization: The Navy conducts Explosive Ordnance Disposal (EOD) Mine Neutralization events in only two designated locations within the Inland Waters of the NWTT Study Area. A process has been in place requiring approval from U.S. Third Fleet prior to conducting EOD underwater detonations. The Navy will continue the permission and approval process through U.S. Third Fleet for in-water explosives training conducted at Hood Canal or Crescent Harbor.
The Navy will conduct Missile Exercises using high explosives at least 50 nm from shore in the NWTRC Offshore Area. The Navy will conduct BOMBEX (high explosive munitions) events at least 50 nm from shore, and will conduct BOMBEX (non-explosive practice munitions) events at least 20 nm from shore.
The Navy's and NMFS' analysis of effects to marine mammals considers emergent science regarding locations where cetaceans are known to engage in specific activities (
The Navy and NMFS have supported and will continue to support the Cetacean and Sound Mapping project, including providing representation on the Cetacean Density and Distribution Mapping Working Group (CetMap) developing the BIAs, which informed NMFS' identification of BIAs. The same marine mammal density data present in the Navy's Density Database Technical Report (U.S. Department of the Navy, 2014) and used in the analysis for the NWTT FEIS/OEIS and this rule were used in the development of BIAs. The final products, including U.S. West Coast BIAs, from this mapping effort were completed and published in March 2015 (Aquatic Mammals, 2015; Calambokidis
NMFS' Office of Protected Resources routinely considers available information about marine mammal habitat use to inform discussions with applicants regarding potential spatio-temporal limitations on their activities that might help effect the least practicable adverse impact on species or stocks and their habitat. BIAs are useful tools for planning and impact assessments and are being provided to the public via this Web site:
During the April 2014 annual adaptive management meeting in Washington, DC, NMFS and the Navy discussed the BIAs that might overlap with portions of the NWTT Study Area, what Navy activities take place in these areas (in the context of what their effects on marine mammals might be or whether additional mitigation might be necessary), and what measures could be implemented to reduce impacts in these areas (in the context of their potential to reduce marine mammal impacts and their practicability). Upon request by NMFS the Navy prepared an assessment of these BIAs, including the degree of spatial overlap of their action areas and activities as well as an analysis of potential impacts or lack of impacts for each BIA. The Navy determined that there was some very limited, to no direct spatial overlap with the marine mammal feeding and migration areas for the majority of the NWTT Study Area (as depicted in Figures 3.4-2—3.4-4 of the NWTT FEIS/OEIS). There is even less overlap with the actual training and testing activities based on historical training and testing profiles. The majority of overlap involves vessel transit activity rather than actual acoustic training and testing activities. The following paragraphs go into more detail on the spatial and activity overlap with marine mammal feeding and migration areas.
Gray whale areas: There is no direct spatial overlap between the Study Area and four of the offshore gray whale feeding areas—Grays Harbor, WA; Depoe Bay, OR; Cape Blanco and Orford Reef, OR; and Pt. St. George, CA. The NWTT Study Area does overlap with the newly designated offshore gray whale Northwest WA feeding area and the Northern Puget Sound gray whale feeding area. There is no overlap of the gray whale migrations corridor(s) and the NWTT Study Area, with the exception of a portion of the NW coast of Washington approximately from Pacific Beach (WA) and extending north to the Strait of Juan de Fuca.
Humpback whale areas: The offshore Northern WA humpback whale feeding area is located entirely within the Study Area boundaries. The humpback whale feeding area at Stonewall and Hecta Bank only partially overlaps with the Study Area, and the feeding area at Point St. George has extremely limited overlap with the Study Area.
Gray whale areas: The gray whale NW Washington feeding area abuts to the shoreline of the NW coast of WA and lies adjacent to the main shipping channel between the Strait of Juan de Fuca and the Pacific Ocean. There is a small likelihood of Navy vessel movement in the gray whale feeding area mapped along the northern coast of Washington as ships transit to the offshore training and testing areas. Based on approximate historically used locations and the proposed training and testing activities described in the NWTT FEIS/OEIS, there is no direct spatial overlap of any training or testing activities within this feeding area. The majority of activities occur greater than 12 nm offshore, thus significantly reducing the potential for overlap. Furthermore, the Navy's LOA request describes mitigation measures that it will implement to avoid vessel strikes, such as continuing to use extreme caution and a safe speed when transiting, maneuvering to keep at least 500 yards from whales observed in a vessel's path, and not approaching whales head-on, provided it is safe to do so. The Navy will also be required to report any vessel strike. The Navy and NMFS concluded that these mitigation measures in addition to historical training and testing profiles indicate that additional mitigations are not warranted for this feeding area.
Vessel movement associated with both training and testing activities is likely to occur within the gray whale feeding area in Northern Puget Sound. Navy ships cannot avoid transiting through this area in order to exit the Puget Sound. Figure 3.0-5 in the NWTT FEIS/OIES depicts average ship traffic density within the major shipping routes within the Pacific Northwest. Overall vessel traffic near Everett, whose port is within or adjacent to the Northern Puget Sound feeding area, is relatively low compared to other inland water areas. The Navy's proportion of the total vessel traffic is extremely minimal with only 6 surface ships
The following training and testing activities occur at Naval Station Everett which appears to be located within the Northern Puget Sound gray whale feeding area; annual pierside sonar maintenance training, annual life-cycle hull-mounted sonar testing, and Maritime Homeland Defense/Security Mine Countermeasure exercises which could occur once every other year (3 events out of 5 years). Acoustic emissions would propagate into this feeding area from these activities. However it is highly unlikely that gray whales would be within the vicinity of the piers or the shorelines around Naval Station Everett based on historical data of their presence (Calambokidis
Given this area's location in Puget Sound, the vast majority of sound and disturbance in the area will be the result of non-Navy vessel traffic. As such, precluding Navy activity at Naval Station Everett and in Northern Puget Sound would be of little to no biological benefit to the gray whales. Furthermore, given pending overseas deployment needs and individual ship readiness cycles to support those deployments, the time of year when maintenance occurs cannot be proscribed. As for the Maritime Homeland Defense exercise, the location in which it would occur provides realistic conditions necessary to effectively train personnel to protect a major port and the vital assets (ships, cargo) and shipping channels near those ports. This training event, which may include a pierside component, cannot be relocated without losing realism given the ships/cargo and transit lanes requiring protection are in fixed locations. Moreover, as described in the area-specific mitigation section above, the Navy will require approval from designated authorities prior to conducting mine countermeasure and neutralization underwater detonations at Hood Canal or Crescent Harbor, hull-mounted mid-frequency active sonar training on vessels while underway in Puget Sound and the Strat of Juan de Fuca, and pierside maintenance or testing in Puget Sound or the Strait of Juan de Fuca. In summary, the Navy and NMFS conclude that seasonal avoidance of the use of acoustic sources within the Northern Puget Sound feeding area is unlikely to further reduce impacts to gray whales in this area which are already estimated to be extremely low (
The Navy acknowledges that gray whales migrate along the entire western coast of the United States, typically within 15 nm of the shore in the NWTT Study Area, but possibly anywhere over the continental shelf, and that a small subset of the gray whale population may enter Puget Sound during their migrations. Vessel movement associated with virtually all of the training and testing activities proposed in the NWTT FEIS/OEIS will occur and has been occurring in areas potentially used by migrating gray whales for decades; however, the majority of the Navy's vessel traffic and training and testing occur outside the 12 nm line, thus significantly reducing the overlap, since the gray whale migration areas only extend 10 nm offshore. Navy vessels are not the only vessel traffic that these migrating whales may encounter as Navy vessels represent a small fraction of total vessel traffic within the Greater Puget Sound and offshore areas (see Figure 3.0-5 of the NWTT FEIS/OIS). The Figure shows little correlation of impedance or interference to gray whale migration in areas where Navy vessels transit and training and testing activities have historically occurred or are expected to continue into the reasonably foreseeable future in the NWTT Study Area. In fact, with the shipping density data overlapped, it is evident that while shipping traffic is heavy into the Strait of Juan de Fuca, as well as within the shipping lanes of Puget Sound, this traffic does not restrict or interfere with the annual north and south bound migration of gray whales nor their movements in Puget Sound. Some training and most testing activities will include acoustic emissions within or propagating into areas potentially used by migrating gray whales. However, these activities may not always be timed during periods in which the gray whales are present. The Navy has requested a small number of Level B (behavioral) gray whale takes for all activities occurring within the offshore NWTT Study Area. As described in the Navy's LOA application and this final rule, the Navy is seeking authorization for 17 Level B (TTS) takes of gray whales annually (6 from training activities and 11 from testing activities) from activities occurring throughout the offshore Study Area. The Navy's LOA request describes mitigation measures that it will implement to avoid vessel strikes, such as continuing to use extreme caution and a safe speed when transiting, maneuvering to keep at least 500 yards from whales observed in a vessel's path, and not approaching whales head-on, provided it is safe to do so. The Navy will also be required to report any vessel strike. However, the Navy does not find vessel strikes likely to occur given there is no recorded occurrence of vessel strike of any species of marine mammal, including gray whales, by Navy ships during training or testing in the Northwest. Navy mitigation measures for acoustic activities also include avoiding the conduct of acoustic and explosive activities in the immediate vicinity of all marine mammals, including gray whales. Further, as described in the area-specific mitigation section above, the Navy will require approval from designated authorities prior to conducting mine countermeasure and neutralization underwater detonations at Hood Canal
Humpback whale areas: Vessel movement is likely to occur in at least some of the humpback whale BIAs, including the designated humpback whale feeding area mapped at the mouth of the Strait of Juan de Fuca. Historical ship density (majority of which is non-Navy vessels) depicted in Figure 3.0-5 of the NWTT FEIS/OEIS is high in the Northern Washington humpback whale feeding area. However, Navy vessel traffic is extremely minimal in comparison to commercial ship traffic, with typically only 20 ships and submarines homeported in the Puget Sound region. Therefore, Navy vessel traffic is low within this feeding area. There is an extremely low likelihood of any Navy vessel movements occurring within the two southern humpback whale feeding areas, especially given that the Point St. George feeding area only overlaps the very eastern boundary of the Study Area. The Navy's LOA request describes mitigation measures that it will implement to avoid vessel strikes, such as continuing to use extreme caution and a safe speed when transiting, maneuvering to keep at least 500 yards from whales observed in a vessel's path, and not approaching whales head-on, provided it is safe to do so. The Navy will also be required to report any vessel strike. (Note that neither the Navy nor NMFS find vessel strikes likely to occur given there is no recorded occurrence of vessel strike of any species of marine mammal, including gray whales, by Navy ships during training or testing in the Northwest).
Based on a review of the historic activity profiles and the proposed training activities described in the NWTT FEIS/OEIS, there would be no direct spatial overlap of training activities with any designated feeding areas for humpbacks in the offshore portion of the NWTT Study Area. There is a generally low probability of potential acoustic overlap with the specifically identified feeding areas. Any propagation of sound from training activities into the Northern Washington humpback whale feeding area would mostly likely result from hull-mounted sonar maintenance or systems checks as vessels are transiting to other areas within and outside of the NWTT Study Area. The Navy estimates very low impacts to humpback whales from offshore training activities involving sonar, and no impacts from any explosive events. Only 12 total Level B (7 behavioral, 5 TTS) takes of humpback whales are anticipated annually from all training activities combined occurring within the offshore Study Area, not just those areas overlapping with the feeding areas. Requiring Navy vessels to avoid this feeding area and utilize acoustic systems further offshore would position ships into higher dense traffic waters based on commercial shipping density data in that area. In addition to the fact that avoidance would not be expected to notably reduce takes, avoidance of these feeding areas during Navy training could create safety concerns by forcing the Navy to delay maintenance and systems checks until ships are farther from shore and homeport infrastructure that could have assisted in addressing potential technical issues.
For testing activities, there is a chance that countermeasure testing could propagate non-impulsive sound into the Northern Washington humpback whale feeding area adjacent to the Strait of Juan de Fuca. These testing activities would be transitory, last from three to eight hours, and are conducted sporadically in any given geographic location. These countermeasure testing activities may be scheduled for any time of year based upon the availability of assets (ships and/or aircraft) needed to support the tests. Though the Navy does not expect to conduct tests within this feeding area, it would be difficult to ensure that all countermeasure testing was conducted far enough from the site to avoid sound propagation into it since some countermeasure devices propagate mid-frequency sound a long distance, so it is possible that some amount of sound from these measures conducted outside of the area may propagate into the feeding area some limited number of times. Conducting this testing further from port and from support facilities would increase event costs, time, and fuel required to complete them, as well as limit available sites suitable to support the testing requirements and limit Navy's use of the existing Quinault Range Site. Avoidance of this area would negatively impact readiness, while likely only providing a small potential reduction in marine mammal sound exposure.
Occasional shallow water testing with sonobuoys would overlap the Stonewall and Heceta Bank humpback whale feeding area offshore of Oregon. The shallow water features in the area affect bottom reflecting, scattering, and absorption of the sound and typically create a more challenging environment to test sonobuoys in due to other surface sound sources (commercial/recreational boats). These conditions allow aircrews to gain understanding of how noise from other sources will impact underwater signal detection. However, these sonobuoy testing events are infrequent (fewer than 50 per year) and of short-duration (less than a day). These events occur sporadically throughout the year and will not necessarily occur during time periods of humpback whale feeding. It is unlikely that this limited testing of sonobuoys would have any biologically meaningful effect on humpback whale feeding behavior in this area; however, avoidance of this area would negatively impact readiness. The Navy estimates very low impacts to humpback whales from offshore testing activities involving sonar and no impacts from explosive testing. Only 45 Level B (6 behavioral, 39 TTS) takes of humpback whales are anticipated annually from all testing activities occurring within the offshore Study Area, not just those areas overlapping with the feeding areas. Based on the Navy's existing mitigation measures for these activities, the low numbers of potential take to all humpback whales not just those within the feeding areas, the lack of prior ship strikes of humpback whales within the Study Area, and the impacts to readiness from avoiding or relocating activities the Navy and NMFS conclude that further mitigation within the humpback whale feeding areas is not warranted.
In summary, the Navy's and NMFS' analysis indicates that there is generally low use of the BIAs and the modeling supports that there are limited impacts to gray whales and humpbacks throughout the entire NWTT study area. There is the potential for the most overlap between Navy activities within the following threes feeding areas—the Humpback Whale Northern Washington feeding area, Stonewall Heceta Bank feeding area, and the Gray Whale Northern Puget Sound feeding area. Very few takes are expected to result from activities within these feeding areas, and the nature of these activities along with the required mitigation measures would result in the least practicable adverse impacts on the species and their habitat. However, the Navy has agreed to monitor, and provide NMFS with reports of, hull-mounted mid-frequency and high frequency active sonar use during
If additional biologically important areas are identified by NMFS after finalization of this rule and the Navy's NWTT FEIS/OEIS, the Navy and NMFS will use the Adaptive Management process to assess whether any additional mitigation should be considered in those areas. Results of the species-specific assessment of potential impacts to humpback and gray whales in their respective BIAs within the Study Area are included in Chapter 3.4.3 and Chapter 5.3.4.1.11 of the NWTT FEIS/OEIS and in the Species/Group Specific Analysis below. As we learn more about marine mammal density, distribution, and habitat use (and the BIAs are updated), NMFS and the Navy will continue to reevaluate appropriate time-area measures through the Adaptive Management process outlined in these regulations.
Marine protected areas (MPAs) in the National System of MPAs potentially occurring within the Study Area are listed and described in Section 6.1.2 of the NWTT FEIS/OEIS (Marine Protected Areas, Table 6.1-2). As shown in Figure 6.1-1 of the NWTT FEIS/OEIS, proposed Navy training and testing activities in the Study Area do not overlap these MPAs (with the exception of the Olympic Coast National Marine Sanctuary (OCNMS), discussed below). The NWTT FEIS/OEIS has been prepared in accordance with the requirements to avoid harm to the natural and cultural resources of existing National System MPAs. Navy activities, should they occur within or near a MPA, would fully abide by the regulations of the individual MPA (see Table 6.1-2 of the NWTT FEIS/OEIS for information See Section 6.1.2 of the NWTT FEIS/OEIS (Marine Protected Areas) for more information.
To the extent practicable, the Navy currently avoids conducting activities within the OCNMS, and expects this practice to continue. However, some Navy NWTT activities may occur within the OCNMS. The Navy has been conducting training and testing offshore of the coast of Washington for decades. The area provides variable bathymetries, and training and testing challenges to simulate potential operational scenarios. There is relatively small spatial overlap between the NWTT Offshore Area and the OCNMS. For training activities occurring in the Offshore Area, less than 3% would be expected to occur within the OCNMS. Most training events would occur outside the boundaries of the OCNMS. Although the Navy is specifically authorized to conduct certain activities within the OCNMS, the Navy currently conducts very limited training within the OCNMS and does not use explosives within the OCNMS. Non-explosive bombing exercises will also not occur in the OCNMS. The Navy expects this level and type of activity to continue into the reasonably foreseeable future.
While active sonar and ASW activities are authorized within the OCNMS, the Navy uses its Protective Measures Assessment Protocol (PMAP) program to inform all users of active sonar that the OCNMS is within the NWTT Study Area. PMAP informs users that no high explosives are authorized in the OCNMS. The Navy proposes to continue use of PMAP in this manner for awareness and notification. The Navy has also agreed to monitor, and provide NMFS with reports of, hull-mounted mid-frequency and high-frequency active sonar use during training and testing in the OCNMS.
Federal agency actions that are likely to injure sanctuary resources are subject to consultation with the NOAA Office of National Marine Sanctuaries (ONMS) under section 304(d) of the National Marine Sanctuaries Act (NMSA). The Navy and NMFS initiated joint consultation with ONMS through the submittal of a Sanctuary Resource Statement (SRS) on September 8, 2015. Within the Navy's SRS, only a subset of NWTT activities, primarily non-impulsive testing events, were identified as possibly occurring routinely within OCNMS because of the existing Quinault Range which overlaps portions of OCNMS. Furthermore, these events would be spatially and temporarily separated throughout the year as well as from any preceding event. ONMS provided recommended alternatives to the Navy and NMFS to further protect sanctuary resources on October 23, 2015. On November 9, 2015, the Navy and NMFS jointly responded in writing to each of the ONMS recommendations.
Navy personnel shall ensure that NMFS is notified immediately (or as soon as clearance procedures allow) if a stranded marine mammal is found during or shortly after, and in the vicinity of, any Navy training exercise utilizing MFAS, HFAS, or underwater explosive detonations. See
NMFS has carefully evaluated the Navy's proposed mitigation measures—many of which were developed with NMFS' input during the first phase of Navy Training and Testing authorizations—and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. Based on our evaluation of the Navy's proposed measures, as well as other measures considered by NMFS, NMFS has determined that the Navy's proposed mitigation measures (especially when the adaptive management component is taken into consideration (see Adaptive Management, below)) are adequate means of effecting the least practicable adverse impacts on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, while also considering personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
Section 101(a)(5)(A) of the MMPA states that in order to issue an ITA for an activity, NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for LOAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in
The Navy's ICMP is intended to coordinate monitoring efforts across all regions and to allocate the most appropriate level and type of effort for each range complex based on a set of standardized objectives, and in acknowledgement of regional expertise and resource availability. The ICMP is designed to be flexible, scalable, and adaptable through the adaptive management and strategic planning processes to periodically assess progress and reevaluate objectives. Although the ICMP does not specify actual monitoring field work or projects, it does establish top-level goals that have been developed in coordination with NMFS. As the ICMP is implemented, detailed and specific studies will be developed which support the Navy's top-level monitoring goals. In essence, the ICMP directs that monitoring activities relating to the effects of Navy training and testing activities on marine species should be designed to contribute towards one or more of the following top-level goals:
• An increase in our understanding of the likely occurrence of marine mammals and/or ESA-listed marine species in the vicinity of the action (
• An increase in our understanding of the nature, scope, or context of the likely exposure of marine mammals and/or ESA-listed species to any of the potential stressor(s) associated with the action (
• An increase in our understanding of how individual marine mammals or ESA-listed marine species respond (behaviorally or physiologically) to the specific stressors associated with the action (in specific contexts, where possible,
• An increase in our understanding of the impacts of the activity on marine mammal or ESA-listed species habitat;
• An increase in our understanding of how anticipated individual responses to individual stressors or anticipated combinations of stressors, and/or impacts to habitat, may impact either: (1) The long-term fitness and survival of an individual; or (2) the population, species, or stock (
• An increase in our understanding of the effectiveness of mitigation and monitoring measures;
• A better understanding and record of the manner in which the authorized entity complies with the ITA and Incidental Take Statement;
• An increase in the probability of detecting marine mammals (through improved technology or methods), both specifically within the safety zone (thus allowing for more effective implementation of the mitigation) and in general, to better achieve the above goals; and
• A reduction in the adverse impact of activities to further achieve the least practicable level, as defined in the MMPA.
Monitoring would address the ICMP top-level goals through a collection of specific regional and ocean basin studies based on scientific objectives. Quantitative metrics of monitoring effort (
The Navy also developed the Strategic Planning Process for Marine Species Monitoring, which establishes the guidelines and processes necessary to develop, evaluate, and fund individual projects based on objective scientific study questions. The process uses an underlying framework designed around top-level goals, a conceptual framework incorporating a progression of knowledge, and in consultation with a Scientific Advisory Group and other regional experts. The Strategic Planning Process for Marine Species Monitoring would be used to set intermediate scientific objectives, identify potential species of interest at a regional scale, and evaluate and select specific monitoring projects to fund or continue supporting for a given fiscal year. This process would also address relative investments to different range complexes based on goals across all range complexes, and monitoring would leverage multiple techniques for data acquisition and analysis whenever possible. The Strategic Planning Process for Marine Species Monitoring is also available online (
NMFS has received multiple years' worth of annual exercise and monitoring reports addressing active sonar use and explosive detonations within portions of the NWTT Study Area and other Navy range complexes. The data and information contained in these reports have been considered in developing mitigation and monitoring measures for the proposed training and testing activities proposed to occur within the NWTT Study Area. The Navy's annual exercise and monitoring reports may be viewed at:
Additional marine mammal studies are being funded or conducted by the Navy outside of and in addition to the Navy's commitments in the NWTT Study Area and other Navy range complexes. NMFS' summary of the Navy's other regional monitoring efforts was included in the proposed rule (80 FR 31738, June 3, 2015; pages 31781-31783).
Based on discussions between the Navy and NMFS, future Navy compliance monitoring should address ICMP top-level goals through a series of regional and ocean basin study questions with a prioritization and funding focus on species of interest as identified for each range complex. The ICMP will also address relative investments to different range complexes based on goals across all range complexes, and monitoring will leverage multiple techniques for data
Within the NWTT Study Area, the Navy's initial recommendation for species of interest includes blue whale, fin whale, humpback whale, Southern Resident killer whale (offshore portion of their annual movements), and beaked whales. Navy monitoring for NWTT under this LOA authorization and concurrently in other areas of the Pacific Ocean will therefore be structured to address region-specific and species-specific study questions in consultation with NMFS. The following projects will be funded or have been funded to support the NWTT monitoring program:
As an early start to NWTT monitoring, in July 2014 the Navy provided funding ($209,000) to NMFS' Northwest Fisheries Science Center (NWFSC) to jointly participate in a new NWTT-specific study: Modeling the distribution of southern resident killer whales in the Pacific Northwest. The goal of this new study is to provide a more scientific understanding of endangered southern resident killer whale winter distribution off the Pacific Northwest coast. The end product will be a Bayesian space-state model for predicting the offshore winter occurrence of southern resident killer whales. The project will consist of analysis of existing NMFS data (passive acoustic detections, satellite tag tracks) as well as new data collection from fall 2014 through spring 2016, some of which is being accomplished with the Navy's funding. The Navy has also provided NMFS NWFSC funds to support the FY16 fieldwork associated with the larger southern resident killer whale Habitat Model Project to collect biopsy samples, prey remains, fecal, mucus, and regurgitation samples. The goal of this field work is to determine the prey selected by southern resident killer whales throughout their range, but particularly in the coastal waters of the US, mainly from Cape Flattery to the Columbia River).
Details of the study can be found at:
The main tasks the study supports include:
• Identification and classification of marine mammal detections from acoustic recorders.
• Acquisition and field deployment of satellite-linked transmitters to track and determine southern resident killer whales movements.
• Deployment of autonomous underwater acoustic recorders in and adjacent to the coastal and shelf/slope waters of Washington State. Navy funding will allow 10 additional recorders to be purchased and deployed along with four NMFS recorders for a total of 14 deployed recorders.
• Estimation of the probability of Southern Resident killer whale detection on acoustic recorders.
• Development of the state-space occurrence models.
• Development of predicative maps of the seasonal annual occurrence of southern resident killer whales.
• Development a cost efficient strategy for the deployment of acoustic recorders in and adjacent to Pacific Northwest Navy ranges.
• Reporting.
This project began in FY14 and will continue through FY16. Navy provided funding to the Alaska Fisheries Science Center to conduct satellite tagging and behavioral monitoring of sea lions in the Pacific Northwest in proximity to Navy facilities. The goal of the study is to fill in data gaps that exist in identifying the location of local foraging areas and documenting the percentage of time pinniped species are hauled out or utilizing the waters near Puget Sound naval facilities. The objectives of this study include:
• Census data of the adult males that haulout at Naval Station Everett, and Naval Base Kitsap-Bremerton/Bangor to develop minimum population estimates for the inland waters;
• Monthly correction factors from tagging data to correct count data from census locations;
• Geographical distribution and foraging behavior of California sea lion adult males in the inland waters of Washington, specifically relative to Navy installations;
• Migration and foraging behavior of California sea lions in coastal Washington, Oregon, and California.
This project began in FY13 and will continue through FY16. The goal of this effort was to fill critical data gaps regarding the current abundance and population status of marine mammal species within the inland waters of Puget Sound and in relation to Navy training and testing locations. The objectives of this task are to:
• Collect data to estimate the abundance and densities of marine mammals in inland waters of Puget Sound;
• Document the distribution, habitat use, and behaviors of each species observed.
A more detailed description of the Navy's planned projects starting in 2015 (and some continuing from previous years) is available at the Navy's Marine Species Monitoring web portal:
The U.S. Navy is one of the world's leading organizations in assessing the effects of human activities on the marine environment, including marine mammals. From 2004 through 2013, the Navy has funded over $240M specifically for marine mammal research. Navy scientists work cooperatively with other government researchers and scientists, universities, industry, and non-governmental conservation organizations in collecting, evaluating, and modeling information on marine resources. They also develop approaches to ensure that these resources are minimally impacted by existing and future Navy operations. It is imperative that the Navy's Research and Development (R&D) efforts related to marine mammals are conducted in an open, transparent manner with validated study needs and requirements. The goal of the Navy's R&D program is to enable collection and publication of scientifically valid research as well as development of techniques and tools for Navy, academic, and commercial use. Historically, R&D programs are funded and developed by the Office of the Chief of Naval Operations Energy and Environmental Readiness Division and Office of Naval Research (ONR), Code 322 Marine Mammals and Biological Oceanography Program. Since the 1990s, the primary focus of these programs has been on understanding the effects of sound on marine mammals, including physiological, behavioral and ecological effects. ONR's current Marine Mammals and Biology Program thrusts include, but are not limited to: (1) Monitoring and detection research; (2) integrated ecosystem research including sensor and tag development; (3) effects of sound on marine life (such as hearing, behavioral response studies, physiology [diving and stress], and PCAD); and (4) models and databases for environmental compliance.
To manage some of the Navy's marine mammal research programmatic elements, OPNAV N45 developed in
• Providing science-based information to support Navy environmental effects assessments for research, development, acquisition, testing, and evaluation as well as Fleet at-sea training, exercises, maintenance, and support activities.
• Improving knowledge of the status and trends of marine species of concern and the ecosystems of which they are a part.
• Developing the scientific basis for the criteria and thresholds to measure the effects of Navy-generated sound.
• Improving understanding of underwater sound and sound field characterization unique to assessing the biological consequences resulting from underwater sound (as opposed to tactical applications of underwater sound or propagation loss modeling for military communications or tactical applications).
• Developing technologies and methods to monitor and, where possible, mitigate biologically significant consequences to living marine resources resulting from naval activities, emphasizing those consequences that are most likely to be biologically significant.
The integration between the Navy's new LMR R&D program and related range complex monitoring will continue and improve during the applicable period of the rulemaking with results presented in NWTT annual monitoring reports.
The final regulations governing the take of marine mammals incidental to Navy training and testing activities in the NWTT Study Area contain an adaptive management component carried over from previous authorizations. Although better than 5 years ago, our understanding of the effects of Navy training and testing activities (
The reporting requirements associated with this rule are designed to provide NMFS with monitoring data from the previous year to allow NMFS to consider whether any changes are appropriate. NMFS and the Navy would meet to discuss the monitoring reports, Navy R&D developments, and current science and whether mitigation or monitoring modifications are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from the Navy regarding practicability) on an annual or biennial basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.
The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) Results from monitoring and exercises reports, as required by MMPA authorizations; (2) compiled results of Navy funded R&D studies; (3) results from specific stranding investigations; (4) results from general marine mammal and sound research; and (5) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.
In order to issue an ITA for an activity, section 101(a)(5)(A) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring. NMFS described the proposed Navy reporting requirements in the proposed rule (80 FR 31738, June 3, 2015; page 31784). Reports from individual monitoring events, results of analyses, publications, and periodic progress reports for specific monitoring projects will be posted to the Navy's Marine Species Monitoring web portal:
Navy personnel would ensure that NMFS (the appropriate Regional Stranding Coordinator) is notified immediately (or as soon as clearance procedures allow) if an injured, stranded, or dead marine mammal is found during or shortly after, and in the vicinity of, any Navy training exercise utilizing MFAS, HFAS, or underwater explosive detonations. The Navy would provide NMFS with species identification or a description of the animal(s), the condition of the animal(s) (including carcass condition if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photographs or video (if available).
Since the publication of the proposed rule, NMFS has added the following language to address monitoring and reporting measures specific to vessel strike. Most of this language comes directly from the Stranding Response Plan for other Navy Phase 2 rulemakings. This section has also been included in the regulatory text at the end of this document. Vessel strike during Navy training and testing activities in the Study Area is not anticipated; however, in the event that a Navy vessel strikes a whale, the Navy shall do the following:
Immediately report to NMFS (pursuant to the established Communication Protocol) the:
• Species identification (if known);
• Location (latitude/longitude) of the animal (or location of the strike if the animal has disappeared);
• Whether the animal is alive or dead (or unknown); and
• The time of the strike.
As soon as feasible, the Navy shall report to or provide to NMFS, the:
• Size, length, and description (critical if species is not known) of animal;
• An estimate of the injury status (
• Description of the behavior of the whale during event, immediately after the strike, and following the strike (until the report is made or the animal is no longer sighted);
• Vessel class/type and operational status;
• Vessel length;
• Vessel speed and heading; and
• To the best extent possible, obtain a photo or video of the struck animal, if the animal is still in view.
Within 2 weeks of the strike, provide NMFS:
• A detailed description of the specific actions of the vessel in the 30-minute timeframe immediately preceding the strike, during the event, and immediately after the strike (
• A narrative description of marine mammal sightings during the event and immediately after, and any information as to sightings prior to the strike, if available; and use established Navy shipboard procedures to make a camera available to attempt to capture photographs following a ship strike.
NMFS and the Navy will coordinate to determine the services the Navy may provide to assist NMFS with the investigation of the strike. The response and support activities to be provided by the Navy are dependent on resource availability, must be consistent with military security, and must be logistically feasible without compromising Navy personnel safety. Assistance requested and provided may vary based on distance of strike from shore, the nature of the vessel that hit the whale, available nearby Navy resources, operational and installation commitments, or other factors.
The Navy shall submit an annual report of the NWTT monitoring describing the implementation and results of the NWTT monitoring efforts from the previous calendar year. Data collection methods will be standardized across range complexes and study areas to allow for comparison in different geographic locations. Although additional information will be gathered, the protected species observers collecting marine mammal data pursuant to the NWTT monitoring plan shall, at a minimum, provide the same marine mammal observation data required in § 218.145. The report shall be submitted either 90 days after the calendar year, or 90 days after the conclusion of the monitoring year to be determined by the Adaptive Management process.
The NWTT Monitoring Report may be provided to NMFS within a larger report that includes the required Monitoring Plan reports from multiple range complexes and study areas (the multi-Range Complex Annual Monitoring Report). Such a report would describe progress of knowledge made with respect to monitoring plan study questions across all Navy ranges associated with the ICMP. Similar study questions shall be treated together so that progress on each topic shall be summarized across all Navy ranges. The report need not include analyses and content that does not provide direct assessment of cumulative progress on the monitoring plan study questions.
The Navy shall submit preliminary reports detailing the status of authorized sound sources within 21 days after the anniversary of the date of issuance of the LOA. The Navy shall submit detailed reports 3 months after the annual anniversary of the date of issuance of the LOA. The detailed annual reports shall describe the level of training and testing conducted during the reporting period, and a summary of sound sources used (total annual hours or quantity [per the LOA] of each bin of sonar or other non-impulsive source; total annual number of each type of explosive exercises; total annual expended/detonated rounds [missiles, bombs, etc.] for each explosive bin; and improved Extended Echo-Ranging System (IEER)/sonobuoy summary, including total number of IEER events conducted in the Study Area, total expended/detonated rounds (buoys), and total number of self-scuttled IEER rounds. The analysis in the detailed reports will be based on the accumulation of data from the current year's report and data collected from previous reports.
The annual classified exercise reports will also include the amount of hull-mounted mid-frequency and high frequency active sonar use during training and testing activities in the OCNMS and in the months specified for the following three feeding areas (to the extent that active sonar training or testing does occur in these areas): The Humpback Whale Northern Washington feeding area (May through November); the Stonewall and Heceta Bank feeding area (May through November) and the Gray Whale Northern Puget Sound Feeding Area (March through May).
This report will be included as part of the 2020 annual exercise or testing report. This report will provide the annual totals for each sound source bin with a comparison to the annual allowance and the 5-year total for each sound source bin with a comparison to the 5-year allowance. Additionally, if there were any changes to the sound source allowance, this report will include a discussion of why the change was made and include the analysis to support how the change did or did not result in a change in the EIS and final rule determinations. The report will be submitted 3 months after the expiration of the rule. NMFS will submit comments on the draft close-out report, if any, within 3 months of receipt. The report will be considered final after the Navy has addressed NMFS' comments, or 3 months after the submittal of the draft if NMFS does not provide comments.
On June 3, 2015 (80 FR 31738), NMFS published a proposed rule in response to the Navy's request to take marine mammals incidental to training and testing activities in the NWTT Study Area and requested comments, information, and suggestions concerning the request. During the 45-day public
Please see Section 3.4.3.1.18 of the NWTT FEIS/OEIS (Application of the Marine Mammal Protection Act to Potential Acoustic and Explosive Effects) and the Estimated Take of Marine Mammals section of the proposed rule for a description of “take” and note that the overwhelming majority of takes predicted for all species—including those mentioned above by the commenters—are short-term behavioral responses to relatively short-term activities (Level B harassment). Further, the majority of these Level B takes are expected to be in the form of milder responses (
Regarding southern resident killer whales, and as discussed in the Group and Species-Specific Analysis section of this rule, the Navy's acoustic analysis predicts only 2 instances of Level B harassment (behavioral reaction) of southern resident killer whales from sonar and other active acoustic sources during annual training activities in the Study Area. The Navy has not asked for, and NMFS has not authorized, any takes resulting from mortality or injury for southern resident killer whales. No injury or mortality is predicted by the acoustic impact modeling, or anticipated to result from the continuation of Navy training and testing, which has been occurring in the area for decades. The Navy and NMFS considered numerous studies analyzing the impact from chronic noise associated with vessel traffic as well as other threats, and these are cited in the NWTT FEIS/OEIS, Section 3.4.2.4 (General Threats) and Section 3.4.3.1.5 (Physiological Stress). As described in the Biological Opinion, the available scientific information does not provide evidence that exposure to acoustic stressors from Navy training and testing activities will impact the fitness of any individuals of this species. Therefore, exposure to acoustic stressors will not have population or species level impacts.
NMFS considered the distribution of southern resident killer whales in its effects analysis. The majority of the Navy's proposed training and testing activities would not occur in the southern resident killer whale's designated critical habitat (NMFS, 2006). Furthermore, the majority of testing events would occur in Hood Canal, where southern resident killer whales are not believed to be present (southern resident killer whales have not been reported in Hood Canal or Dabob Bay since 1995 [NMFS, 2008c]), while the majority of training activities
As discussed in the Group and Species-Specific Analysis section of this rule, take numbers for ESA-listed mysticetes are also predicted to be low relative to estimated stock abundances, and occasional behavioral reactions are predicted to occur at low received levels and are unlikely to cause long-term consequences for individuals or populations. Furthermore, there is no designated critical habitat for mysticetes in the Study Area.
The number of harbor porpoises behaviorally harassed by exposure to MFAS/HFAS in the Study Area is higher than the other species because of the low Level B harassment threshold (we assume for the purpose of estimating take that all harbor porpoises exposed to 120 dB or higher MFAS/HFAS will be taken by Level B behavioral harassment), which essentially makes the ensonified area of effects significantly larger than for the other species. However, the fact that the threshold is a step function and not a curve (and assuming uniform density) means that the vast majority of the takes occur in the very lowest levels that exceed the threshold (it is estimated that approximately 80 percent of the takes are from exposures to 120 dB to 126 dB), which means that anticipated behavioral effects are not expected to be severe (
Moore and Barlow (2013) have noted a decline in beaked whale populations in a broad area of the Pacific Ocean within the U.S. Exclusive Economic Zone. However, there are scientific caveats and limitations to the data used for that analysis, as well as oceanographic and species assemblage changes on the U.S. Pacific coast not thoroughly addressed. Although Moore and Barlow (2013) have noted a decline in the overall beaked whale population along the Pacific coast, in the small fraction of that area where the Navy has been training and testing with sonar and other systems for decades (the Navy's Southern California (SOCAL) Range Complex), higher densities and long-term residency by individual Cuvier's beaked whales suggest that the decline noted elsewhere is not apparent where Navy sonar use is most intense. Navy sonar training and testing is not conducted along a large part of the U.S. west coast from which Moore and Barlow (2013) drew their survey data. In Southern California, based on a series of surveys from 2006 to 2008 and a high number encounter rate, Falcone
The use of a mean density estimate is consistent with the approach taken by NMFS to estimate and report the populations of marine mammals in the Stock Assessment Reports, and the estimated mean is thus considered the “best available data.” Adjusting the mean estimates as suggested would result in unreasonable take estimates, particularly given the very high coefficients of variation (CVs) associated with most marine mammal density estimates. Note that the CVs in the Navy's marine species density database for the California Current Ecosystem represent the interannual variability in marine mammal occurrence; the CV does not represent uncertainty in the model predicted density estimates. Further, the Navy's acoustic model includes conservative estimates of all parameters (
With regard to the density of northern elephant seals, the area used for calculation was based on all animals in the LeBouef
The Weise
The Commission's suggested novel method of determining a density of pinnipeds based on the presence of tagged animals and then “scaled to the population” may be investigated in the future as the science and methodology evolves. NMFS, along with the Navy, will continue to work with researchers and scientists at NMML in the development of future at-sea analyses.
Regarding the reduction in Guadalupe fur seal takes for the offshore area, the Navy's September 26, 2014 revision to the LOA application included an update to the effects analysis for Guadalupe fur seals to more realistically reflect potential impacts from offshore Navy training and testing activities. The analysis used to modify the Guadalupe fur seal takes is fully described in Analysis of Guadalupe Fur Seal Exposures in the proposed rule (80 FR 31738, June 3, 2015; page 31792).
The Navy's Marine Species Density Database Technical Report, was revised in May 2015 to update the density estimates for harbor seals in the NWTT Study Area. The report is available at
Using a mean haulout correction factor of 1.47 would revise the density estimate from 0.29 seals per km
The technical report is available on the NWTT FEIS/OEIS Web site at:
The acoustic and explosive thresholds were adjusted based on weighting the exposures from the original research from which the thresholds were derived with the Type II weighing functions. The weighted threshold is not derived by a simple amplitude shift. The high-frequency cetacean onset TTS threshold is based on the onset-TTS threshold derived from data in Lucke
As detailed in Finneran and Jenkins (2012), the thresholds presented incorporate new findings since the publication of Southall
Regarding the raw number of exposures presented in the modeling technical report (Navy Marine Species Modeling Team, 2013) and the difference between the non-TTS exposures for harbor porpoise when compared to Dall's porpoise and
Regarding the confusion about TTS and behavioral takes, note that over time, for some events, such as slow moving or stationary sources and stationary animats, PTS and TTS takes increase with multiple pings and increased energy. However, multiple pings would not cause the outer range of the behavioral takes to increase. Therefore, the fixed pool of animals that are taken (PTS + TTS + behavioral) does not change but, over time, some TTS become PTS, and some behavioral takes become TTS. The result of this is that, ultimately, the behavioral takes are reduced and become smaller, eventually fewer than the number of TTS.
Regarding the commenters' first point, NMFS disagrees that the thresholds are unjustified and insufficiently conservative. Please see the discussion presented in the NWTT FEIS/OEIS Section 3.4.2.3.3 (Low-Frequency Cetaceans) and Section 3.4.3.1.11 (Frequency Weighting) to understand the derivation of the thresholds and criteria for low frequency cetaceans. Specifically it was the low- and high-frequency cetacean weighting functions (see Southall
NMFS disagrees with the commenters' second point, as the data used in the analysis included many animals and species at multiple experimental facilities around the world as well as auditory measurements on wild animals that had stranded, in addition to anatomical analyses of the auditory system of mysticetes (Cranford and Krysl (2015); Houser
Regarding the commenters' third point, the most recent publications by Dr. Kastelein are cited and were considered in the analysis presented in the NWTT FEIS/OEIS (see Kastelein
Additionally, TTS represents a physiological metric for a behavioral reaction and that an exposure resulting in TTS has been and is considered an MMPA Level B harassment take. As presented in Section 3.4.3.1.12.1 (Sonar and Other Active Acoustic Sources, Subsection “Harbor Porpoises”) of the NWTT FEIS/OEIS, the Navy and NMFS are aware of the sensitivity of harbor porpoises and have established a sound pressure level of 120 dB re 1 µPa as a threshold for predicting behavioral responses in harbor porpoises and Level B takes pursuant to the MMPA.
The reference to Tougaard
Regarding the commenters' fourth point, NMFS and the Navy have incorporated empirical data on humans (see the NWTT FEIS/OEIS citations to Ward
With regard to the references cited by the commenters: Kastak
NMFS and marine mammal scientists recognize the limitations of controlled experiments using captive animals, but there are no alternative scientific methods to document the onset of TTS, especially in wild animals. It is inaccurate to describe these limitations as deficiencies. Furthermore, commenters are incorrect that the TTS data used in the analysis is from only seven animals in the Navy's research program in the SPAWAR complex. Data used in the analysis and cited in the NWTT FEIS/OEIS also includes results from other species and non-Navy/SPAWAR animals—for example see Lucke
Regarding the Hanalei Bay event, NMFS included an extensive analysis of this event in the Potential Effects section of the proposed rule (80 FR 31738, June 3, 2015; pages 31764-31765. Please see that section for further information regarding NMFS' assessment and consideration of that event. It should be noted that NMFS considered active sonar transmissions a plausible, if not likely, contributing factor in the Hanalei stranding in what may have been a “confluence of events,” including a unique interaction of biological and physical factor—most of which are not expected to occur in the NWTT Study Area or during NWTT activities. The biological factors may have included the presence of an apparently uncommon, deep-diving cetacean species (and possibly an offshore, non-resident group), social interactions among the animals before or after they entered the Bay, and/or unknown predator or prey conditions. The physical factors may have included the presence of nearby deep water, multiple vessels transiting in a directed manner while transmitting active sonar over a sustained period, the presence of surface sound ducting conditions, and/or intermittent and random human interactions while the animals were in the Bay.
This analysis is further corroborated by the healthy, and in some locations, increasing marine mammal populations, where sonar use has been occurring for decades and is frequently in use on an annual basis, such as on instrumented ranges. As noted previously, there is no evidence that Navy activities have had or are having any long-term impact on marine mammal populations or stocks. For more information, see the Long-Term Consequences discussion in the Analysis and Negligible Impact Determination section of this rule.
Any increase in vessel movement, as discussed in Section 3.4.3.4.1 (Impacts from Vessel Strikes) of the NWTT FEIS/OEIS, over the No Action Alternative is still well below areas such as Southern California and Hawaii where the density of large whales and the number of Navy activities is higher than that for the NWTT Study Area and yet strikes to large whales are still relatively rare in the SOCAL and Hawaii Range Complexes. Further, there are fewer Navy vessels for NWTT that are homeported in the Study Area than in the previous years included in the historical record. Additionally, while the number of training and testing activities is likely to increase, it is not expected to result in an appreciable increase in vessel use or transits since multiple activities usually occur from the same vessel. Finally, the Navy is not proposing substantive changes in the locations where vessels have been used over the last decade. In summary, neither the Navy nor NMFS anticipates vessel strikes to marine mammals during training or testing activities within the Study Area, and NMFS is not authorizing mysticete takes (by injury or mortality) from vessel strikes during the 5-year period of the NWTT regulations. However, the Navy has proposed measures (see Mitigation) to mitigate potential impacts to marine mammals from vessel strikes during training and testing activities in the Study Area.
The Navy considered using a dynamic simulation model to estimate strike probability. However, the Navy determined, and NMFS concurs, that the use of historical data was a more appropriate way to analyze the potential for strike. The Navy's strike probability analysis in the NWTT FEIS/OEIS is based upon actual data collected from historical use of vessels, in-water devices, and military expended materials, and the likelihood that these items may have the potential to strike an animal. This data accounts for real world variables over the course of many years, and any model would be expected to be less accurate than the use of actual data.
The suggestion to use the Navy's acoustic effects model to determine the probability of a strike would not provide a more reliable estimate of strike probability given that there are so many unknown but critical values which would be necessary as required inputs. There is no available science regarding the necessary functional parameters for a complex dynamic whale strike simulation model; there are large unknowns regarding the data that would be necessary such as the density, age classes, and behavior of large whales in the NWTT Study Area; and there are no means to validate the output of a model given there is no empirical data (not strikes) to “seed the dynamic simulation.” Therefore, use of historical data from identical activities elsewhere and additional use of a probability analysis remain a more reasonable analytical approach.
The mitigation measures required by this rule are discussed in the NWTT FEIS/OEIS and in the Mitigation section of this rule. In summary, the mitigation measures include the use of visual and acoustic methods to detect marine mammals, procedures to relocate or delay events where marine mammals have been detected, monitoring of event locations and marine mammals before, during, and after events, and the continued reporting of Navy activity and interactions with marine mammals as has been occurring since 2006. Please also note that the rule requires a robust adaptive management program that regularly addresses new information and allows for modification of mitigation and/or monitoring measures as appropriate. The mitigation measures are informed by years of experience and monitoring, which has shown them to be effective. NMFS has determined that the mitigation measures are adequate means of effecting the least practicable adverse impacts on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, while also considering personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
As explained in the NWTT FEIS/OEIS in Section 3.4.3.2.1.1 (Range to Effects), there is no reason to show a PTS range for more than one ping because of the short distances involved, even in the case of the most powerful hull mounted source. The ship moves beyond the PTS zone for each successive ping, and there is no difference in successive pings. Given all the science detailed in the NWTT FEIS/OEIS (see for example Section 3.4.3.2.1.2, Avoidance Behavior and Mitigation Measures as Applied to Sonar and Other Active Acoustic Sources) indicating that marine mammals will behaviorally avoid high levels of sound, the assumption that a marine mammal would not remain alongside a pinging vessel is a simple but reasonable assumption. As presented in the NWTT FEIS/OEIS, while 10 knots was the speed used in modeling the ship's speed of advance, a ship engaged in anti-submarine warfare training or testing would be moving at between 10 and 15 knots. For the majority of marine mammals, the distance to a PTS exposure is within 10 meters of the sonar dome, and that distance is not influenced significantly by differing ocean environments given that the calculated range to a PTS is almost entirely a function involving the physics of spreading loss. The comment's assumption that the distances provided in Tables 3.4-10 and 3.4-11 of the NWTT DEIS/OEIS do not apply to NWTT is incorrect.
Because the Navy conducts training and testing in a variety of environments having variable acoustic propagation conditions, variations in acoustic propagation conditions are considered in the Navy's acoustic modeling and the quantitative analysis of acoustic impacts. Although the Navy pointed out the complexity of acoustic modeling in inland waters, it would be incorrect to conclude that modeling therefore lacked precision. The Navy acoustic modeling makes use of the most accurate information and environmental data available, including the inland waters where these activities would take place.
The Navy's NWTT FEIS/OEIS and supporting technical documents provide the detail to make the analysis fully transparent. Details of this model's processes and the description and derivation of the inputs are presented in the Navy's Determination of Acoustic Effects Technical Report (Marine Species Modeling Team, 2013). As presented in Section 3.4.3.1.14.3 (Navy Acoustic Effects Model) of the NWTT FEIS/OEIS, the model incorporates actual site-specific bathymetric relief, sound speed profiles, wind speed, and bottom properties into the propagation analysis.
• As described in the NWTT FEIS/OEIS in Chapter 5 (Standard Operating Procedures, Mitigation, and Monitoring), a 30-minute wait period more than covers the average dive times of most marine mammals.
• The ability of an animal to dive longer than 30 minutes does not mean that it will always do so. Therefore, the 60-minute delay would only potentially add value in instances when animals had remained under water for more than 30 minutes.
• Navy vessels typically move at 10-12 knots (5-6 m/sec) when operating
• Additionally, the times when marine mammals are deep-diving (
• Given that, the animal would need to have stayed in the immediate vicinity of the sound source for an hour, and considering the maximum area that both the vessel and the animal could cover in an hour, it is improbable that this would randomly occur. Moreover, considering that many animals have been shown to avoid both acoustic sources and ships without acoustic sources, it is improbable that a deep-diving cetacean (as opposed to a dolphin that might bow ride) would choose to remain in the immediate vicinity of the source.
Furthermore, the Navy was aware of the diving behaviors of marine mammals and integrated the data in Watwood and Buonantony (2012) into its modeling. In summary, NMFS believes that it is unlikely that a single cetacean would remain in the safety zone of a Navy sound source for more than 30 minutes, and therefore disagrees with the Commission that a second clearance category of 60 minutes for deep-diving species is necessary. The Navy's acoustic analysis predicts that that injury to deep-diving marine mammals (
NMFS has determined that the mitigation measures required by this rule (especially when the adaptive management component is taken into consideration), including those clarified or updated above (see
The mitigation zones contained in this final rule represent the maximum area the Navy can effectively observe based on the platform of observation, number of personnel that will be involved, and the number and type of assets and resources available. As mitigation zone sizes increase, the potential for reducing impacts decreases. For instance, if a mitigation zone increases from 1,000 to 4,000 yd. (914 to 3,658 m), the area that must be observed increases sixteen-fold, which is not practicable. The mitigation measures contained in this final rule balance the need to reduce potential impacts with the Navy's ability to provide effective observations throughout a given mitigation zone. Implementation of mitigation measures is most effective when the mitigation zone is appropriately sized to be realistically observed. The Navy does not have the resources to maintain additional Lookouts or observer platforms that would be needed to effectively observe mitigation zones of increased size.
With respect to passive acoustic monitoring, all passive acoustic detections will be reported to Lookouts to increase vigilance of the visual surveillance. However, as stated previously, passive acoustic monitoring can neither provide range or bearing to detected animals, and therefore cannot provide locations of these animals.
As discussed in Section 2.5.1.4 (Simulated Training and Testing) and Section 5.3.4.1.2 (Replacing Training and Testing with Simulated Activities) of the NWTT FEIS/OEIS, the Navy uses computer simulation for training and testing whenever possible. However, training in near-coastal environments is an essential component to maintaining military readiness. Computer simulation can provide familiarity and complement live training; however, it cannot provide the fidelity and level of training necessary to prepare naval forces for deployment. Sound propagates differently in shallower water and operators must learn to train in this environment. Additionally, submarines have become quieter through the use of improved technology and have learned to hide in the higher ambient noise levels of the shallow waters of coastal environments. In real world events, it is highly likely Sailors would be working in, and therefore must train in, these types of areas. The littoral water space is also the most challenging area to operate in due to a diverse acoustic environment. It is not realistic or practicable to refrain from training in the areas that are the most challenging and operationally important. Operating in near-costal environments is essential in order to provide realistic training on real world combat conditions with regard to shallow water sound propagation.
The Navy will implement mitigation for all training and testing activities to minimize any potential effects. Further, the Navy does have a particular set of monitoring measures (intended to help reduce the chance of a stranding) that would be applied if a combination of circumstances exist that are thought to make a stranding more likely (
NMFS clarifies that historically, Navy bombing exercises in the NWTT Study area are very infrequent and have occurred greater than 50 nm from shore in order to avoid other users and for marine safety purposes. Conducting these exercises greater than 50 nm from shore has the practical effort of affording environmental protections to certain species such as southern resident killer whale, salmonids, and harbor porpoise that generally are not in these areas. The Navy proposes to continue to conduct bombing and missile exercises with high explosives at least 50 nm off shore in the NWTT study area. In addition, Bombex and other events using non-explosive practice munitions are not anticipated to occur within 20 nm of shore in NWTT Study area, and SINKEX are not proposed to occur in the NWTT Study area.
The active sonar system used by SURTASS LFA is unique to the platforms that use SURTASS LFA. Moreover, this system requires the platforms that carry SURTASS LFA to travel at very slow speeds for the system to be effective. For both of these reasons it is not possible for the Navy to use this system for the platforms analyzed in the NWTT FEIS/OEIS.
NMFS disagrees that using Lookouts as the primary strategy for limiting potential impacts from Navy activities is inadequate. Navy Lookouts are qualified and experienced observers of the marine environment. All Lookouts take part in Marine Species Awareness Training so that they are better prepared to spot marine mammals. Their duties require that they report all objects sighted in the water to the Office of the Deck (OOD) and all disturbances that may be indicative of a threat to the vessel and its crew. Lookouts are on duty at all times, day and night, when a ship or surfaced submarine is moving through the water. Visual detections of marine mammals would be communicated immediately to a watch station for information disseminations and appropriate mitigation action. The number of Lookouts required for each activity represents the maximum level of effort (
The Navy has determined that the use of third-party observers (
In 2010, the Navy initiated a study designed to evaluate the effectiveness of the Navy Lookout team. The University of St. Andrews, Scotland, under contract to the Navy, developed an initial data collection protocol for use during the study. Between 2010 and 2012, trained Navy marine mammal observers collected data during nine field trials as part of a “proof of concept” phase. The goal of the proof of concept phase was to develop a statistically valid protocol for quantitatively analyzing the effectiveness of Lookouts during Navy training exercises. Field trials were conducted in the HRC, SOCAL Range Complex, and Jacksonville Range Complex onboard one frigate, one cruiser, and seven destroyers. Preliminary analysis of the proof of concept data is ongoing. The Navy is also working to finalize the data collection process for use during the next phase of the study. While data was collected as part of this proof of concept phase, those data are not fairly comparable because protocols were being changed and assessed, nor are those data statistically significant. Therefore, it is improper to use these data to draw any conclusions on the effectiveness of Navy Lookouts at this time.
As discussed earlier in this rule in the Mitigation section, the Navy is clarifying its existing speed protocol: While in transit, Navy vessels shall be alert at all times, use extreme caution, and proceed at a “safe speed” so that the vessel can take proper and effective action to avoid a collision with any sighted object or disturbance, including any marine mammal or sea turtle and can be stopped within a distance appropriate to the prevailing circumstances and conditions. Other mitigation measures will be implemented to avoid vessel strikes, such as maneuvering to keep at least 500 yards from whales observed in a vessel's path, and not approaching whales head-on, provided it is safe to do so. The Navy will also be required to report any vessel strike.
Navy ship speed has not been implicated in impacts to marine mammals in the NWTT Study Area. As discussed in the Take Request section and elsewhere in this rule, there has never been a recorded vessel strike of marine mammals during any training or testing activities in the Study Area. There has been only one whale strike in the Pacific Northwest by the Navy since such records have been kept (June 1994-present). In August 2012, a San Diego homeported DDG (destroyer) at-sea about 35 nm west of Coos Bay, Oregon struck a whale (believed to be a minke) while transiting to San Diego from Seattle. A detailed analysis of strike data is contained in Section 6.7 (Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy's proposed actions would not result in any appreciable changes in locations or frequency of vessel activity, and there have been no recorded whale strikes during any training and testing activities in the Study Area. The manner in which the Navy has trained would remain consistent with the range of variability observed over the last decade so the Navy does not anticipate vessel strikes would occur within the Study Area during training events.
Navy vessel transit potentially occurring within biologically important areas in the NWTT Study Area is discussed in the
Section 5.3.4.1.11 of the NWTT FEIS/OEIS (Avoiding Marine Species
NMFS believes that the post-modeling analysis is an effective method for quantifying the implementation of mitigation measures to reduce impacts on marine mammals and the science regarding the avoidance of sound sources by marine mammals which cannot be captured within the modeling process itself, and that the resulting exposure estimates are, nevertheless, a conservative estimate of impacts on marine mammals from the Navy's proposed activities. As explained in the above-referenced documents, as part of the post-modeling analysis the Navy reduced some predicted Level A (PTS) exposures based on the potential for marine mammals to be detected and mitigation implemented, and the potential for marine mammals to avoid a sound source. Given this potential, not taking into account some possible reduction in Level A exposures would result in a less realistic, overestimation of possible Level A takes, as if there were no mitigation measures implemented. For example, with respect to mitigation effectiveness, the period of time between clearing the impact area of any non-participants or marine mammals and weapons release is on the order of minutes, making it highly unlikely that a marine mammal would enter the mitigation zone. Information provided in Section 3.4.3.1.16 (Implementing Mitigation to Reduce Sound Exposures) of the NWTT FEIS/OEIS indicates how much of a reduction each factor represents for specific activities. As explained in the documents referenced above, the adjustments move a percentage of the model predicted Level A (PTS) effects at close range to more likely behavioral effects (Level B harassment) and do not conclude that all modeled mortalities or non-PTS injuries will be avoided. This process represents peer-reviewed and accepted scientific process.
The assignment of mitigation effectiveness scores and the appropriateness of consideration of sightability using detection probability, g(0), when assessing the mitigation in the quantitative analysis of acoustic impacts is discussed in the NWTT FEIS/OEIS (Section 3.4.3.1.16, Implementing Mitigation to Reduce Sound Exposures). Additionally, the activity category, mitigation zone size, and number of Lookouts are provided in the proposed rule (80 FR 31738, June 3, 2015, pages 31772-31773) and NWTT FEIS/OEIS (Section 5, Tables 5.3-2 and 5.4-1). In addition to the information already contained within the NWTT FEIS/OEIS, the Post-Model Quantitative Analysis of Animal Avoidance Behavior and Mitigation Effectiveness for the Northwest Training and Testing Technical Report (
The Navy is in the process of assessing Lookout effectiveness at detecting marine mammals during Navy exercises. Lookouts will not always be effective at avoiding impacts on all species. However, Lookouts are expected to increase the overall likelihood that certain marine mammal species and some sea turtles will be detected at the surface of the water, when compared to the likelihood that these same species would be detected if Lookouts are not used. The continued use of Lookouts contributes to helping reduce potential impacts on these species from training and testing activities. Results from the Lookout effectiveness study will be reviewed and any recommendations for improving Lookout effectiveness will be considered at that time. In summary, NMFS and the Navy believe that consideration of marine mammal sightability and activity-specific mitigation effectiveness is appropriate in the Navy's quantitative analysis in order to provide decision makers a reasonable assessment of potential impacts from the Navy's proposed activities.
The studies referenced by the commenters of North Atlantic right whales (
In the course of training and testing activities, military expended material is released into the marine environment as detailed in the NWTT FEIS/OEIS Chapter 3.1 (Sediments and Water Quality). The NWTT FEIS/OEIS presents a thorough description and analysis in Section 3.1.3 (Environmental Consequences) of amounts and types of specific training materials as well as chemical composition and breakdown processes of expended materials. The analysis concludes that chemical, physical, or biological changes to sediment or water quality, while measurable, are below applicable standards, regulations, and guidelines, and would be within existing conditions or designated uses. Neither state nor federal standards or guidelines would be violated. Further, as discussed in Section 3.4 of the NWTT FEIS/OEIS, military expended materials are not expected to result in mortality, Level A, or Level B harassment of marine mammals. This conclusion is supported by studies referenced in the NWTT FEIS/OEIS that have investigated the fate of the constituents of military expended materials; see for example the discussion presented in Section 3.4.3.7 (Explosion By-Products and Unexploded Ordnance) and citations to Rosen and Lotufo (2010) and University of Hawaii at Manoa (2010).
In addition, Section 3.1 of the NWTT FEIS/OEIS analyzed the impact from explosives, explosive byproducts, and metals using the best available science. The analysis concluded that the impact of explosives, explosion byproducts, and metals on sediment and water quality would be both short- and long-term, and localized. As above, chemical,
Finally, the NWTT FEIS/OEIS analyzed other potential stressors, such as entanglement in cables, wires, and parachutes, in Section 3.4.3.5 (Entanglement Stressors). As discussed in that section, the chance that an individual animal would encounter expended cables or wires is likely low, and it is unlikely that an animal would get entangled even if it encountered a wire. For example, the majority of the “parachutes” expended are 18-inch (in.) diameter cruciform (“X” shaped) decelerators attached with short lines to the top of sonobuoys. These are designed to sink and, given their small size, are very unlikely entanglement hazards for most marine mammals.
With respect to long-term impacts, see the discussion in Section 3.4.3.1.9 of the NWTT FEIS/OEIS (Long-Term Consequences to the Individual and the Population) and the
As discussed in the Analysis and Negligible Impact determination section of this final rule, Chapter 4 of the NWTT FEIS/OEIS contains a comprehensive assessment of potential cumulative impacts, including analyzing the potential for cumulatively significant impacts to the marine environment and marine mammals. The Navy used the best available science and a comprehensive review of past, present, and reasonably foreseeable actions to develop a robust cumulative impacts analysis. The cumulative impacts analysis focused on impacts that are “truly meaningful.” This was accomplished by reviewing the direct and indirect impacts that have the potential to occur on each resource under each of the alternatives. Key factors considered were the current status and sensitivity of the resource and the intensity, duration, and spatial extent of the impacts of each potential stressor. In general, long-term rather than short-term impacts and widespread rather than localized impacts were considered more likely to contribute to cumulative impacts. Those impacts to a resource that were considered to be negligible were not considered further in the analysis. As required under NEPA, the level and scope of the analysis are commensurate with the potential impacts of the action as reflected in the resource-specific discussions in Chapter 3 of the NWTT FEIS/OEIS (Affected Environment and Environmental Consequences). The NWTT FEIS/OEIS considered its activities alongside those of other activities in the region whose impacts are truly meaningful to the analysis.
In addition, NMFS' Biological Opinion concludes that NMFS' proposed rulemaking and LOAs and any take associated with activities authorized by the rulemaking and LOAs are not likely to jeopardize the continued existence of threatened or endangered species (or species proposed for listing) in the action area during any
Additionally, NMFS notes that, even in areas where the Navy uses sonar frequently, such as instrumented ranges, marine mammal populations are present, not diminishing, and in some cases, thriving. NMFS and the Navy relied on actual trends in marine mammal populations and the best available science regarding marine mammals, including behavioral response studies and the satellite tracking of tagged marine mammals in areas of higher sonar use.
NMFS has reporting and monitoring data from the Navy on training and testing events occurring around the U.S. since 2006. For example, results from 2 years (2009-2010) of intensive monitoring by independent scientists and Navy observers in Southern California Range Complex and Hawaii Range Complex recorded an estimated 161,894 marine mammals with no evidence of distress or unusual behavior observed during Navy activities. Additional information and data summarized in the NWTT FEIS/OEIS Section 3.4.4.1 (Summary of Monitoring and Observations During Navy Activities) provide support for the conclusions that it is unlikely there would be any population level or long-term consequences resulting from implementation of final rule.
In addition, there is no scientific basis for the suggestion that animals taken by harassment would have “greater susceptibility to vessel strike.” NMFS considered Nowacek
Regarding ship strike generally, see the Response to Comment 20.
Chapter 4 of the NWTT FEIS/OEIS contains a comprehensive assessment of potential cumulative impacts, including analyzing the potential for cumulatively significant impacts to the marine environment and marine mammals. Specifically, the Navy concluded, and NMFS concurs, that their proposed action is likely to result in generally no more than temporary changes to the noise environment and sediment and water quality. Therefore, there is limited potential for those effects to interact cumulatively with the effects of other past, present, and reasonably foreseeable projects. Implementation of the proposed action, in conjunction with other past, present, and reasonably foreseeable future actions, would not be expected to result in significant cumulative impacts to the environment. As such, the proposed action will not result in cumulative adverse effects that could have a substantial effect on species and populations in the action area.
In addition, we note that the Navy has been training in the same relative area for decades using substantially similar training and testing systems for decades, and coupled with the multitude of other activities taking place in the area, there is no evidence of long term consequences to marine mammal populations or stocks.
While climate change may result in changes in the distribution of marine mammals, it is currently not possible to predict how or under what conditions such changes might occur without engaging in unsupported conjecture. Therefore, it is not possible to reasonably determine what hypothetical future marine mammal distributions may look like as a result of climate change or otherwise factor such changes into an analysis of resulting potential effects and impacts from Navy activities.
The environmental conditions in the NWTT Study Area and the types of activities proposed in the NWTT FEIS/OEIS have no relationship to those present in the Bahamas incident fourteen years ago in unique and warm tropical waters. The environmental conditions otherwise differentiating the Atlantic tropical Bahamas environment present in 2000 from the Pacific Northwest NWTT Study Area include the unique bathymetry of the Bahamas Providence Channels that are steep sided, narrow, and very deep—ranging from approximately 2,000 to 12,000 in depth. On that day in 2000 in the Bahamas, there was also a 200 meter thick layer of near constant water temperature, calm seas, as well as the presence of beaked whales. The Strait of Juan de Fuca, by comparison, is not steep sided, is relatively shallow (approximately 600 feet depth), is unlikely to ever have a uniformly mixed thermocline, and beaked whales are not known to inhabit its waters. Additionally and also unlike the Bahamas, there will be no Navy training or testing activities involving multiple ships using hull mounted tactical mid-frequency active sonar over an extended period of time in a single area.
With regard to the harbor porpoise strandings in Washington State (2003), NMFS has since determined that these strandings were unrelated to Navy sonar use. There was a lack of evidence of any acoustic trauma among the harbor porpoises, and the identification of probable causes (
Lastly, while not referenced by the commenters and not related to active sonar exposure, NMFS considered an investigation into a long-finned pilot whale mass stranding event at Kyle of Durness, Scotland on July 22, 2011 (Brownlow
The NWTT FEIS/OEIS provides an analysis of potential impacts occurring in the NWTT Study Area. While most of the world's coastlines lack coverage by a stranding network, the Navy's analysis of impacts has focused on scientific data collected in and around the Navy range complexes, which are the proposed locations for the continuation of historically occurring training and testing activities including the use of sonar. A summary of the compendium of the research in that regard is presented in NWTT FEIS/OEIS in Section 3.4.4.1 (Summary of Monitoring and Observations During Navy Activities). Unlike the rest of the world's oceans, there has not been an absence of observation where the U.S. Navy has been routinely training and testing for years. In particular and as ongoing for approximately the last 8 years, the Navy, NMFS, and an independent group of scientists have been engaged in implementing a comprehensive monitoring program and associated research that includes monitoring before, during, and after Navy activities on U.S. Navy range complexes. In short, the research and monitoring associated with Navy training and testing activities makes the Navy range complexes different than the remainder of the world's oceans.
For beaked whales in particular, not only have there been no mortalities or strandings associated with Navy sonar use during the past approximately 8 years of monitoring, but to the contrary there has been overwhelming evidence from research and monitoring indicating the continued presence or residence of individuals and populations in Navy range complexes and no clear evidence indicating long-term effects from Navy training and testing in those locations. For example, photographic records spanning more than 2 decades demonstrated re-sightings of individual beaked whales (from two species: Cuvier's and Blainville's beaked whales), suggesting long-term site fidelity to the area west of the Island of Hawaii where intensive swept-channel exercises historically occurred (McSweeney
In the NWTT FEIS/OEIS, the sensitivity of beaked whales is taken into consideration both in the application of Level B harassment thresholds and in how beaked whales are expected to avoid sonar sources at higher levels. No beaked whales were predicted in the acoustic analysis to be exposed to sound levels associated with PTS, other injury, or mortality (note: There is no data from which to develop or set a mortality criterion and there is no evidence that sonar can lead to a direct mortality due to lack of a shock wave). After decades of the Navy conducting similar activities in the NWTT Study Area without incident, NMFS does not expect strandings, injury, or mortality of beaked whales or any other species to occur as a result of training and testing activities. Additionally, through the MMPA rulemaking (which allows for adaptive management), NMFS and the Navy will determine the appropriate way to proceed in the event that a causal relationship were to be found between Navy activities and a future stranding.
NMFS' Office of Protected Resources has thoroughly reviewed the Navy's NWTT FEIS/OEIS and concluded that the impacts evaluated by the Navy are substantially the same as the impacts of NMFS' proposed action to issue regulations (and associated LOAs) governing the take of marine mammals incidental to Navy training and testing activities in the NWTT Study Area from November 2015 through November 2020. In addition, the Office of Protected Resources has evaluated the NWTT FEIS/OEIS and found that it includes all required components for adoption by NOAA including: a discussion of the purpose and need for the action; a listing of the alternatives to the proposed action; a description of the affected environment; a succinct description of the environmental impacts of the proposed action and alternatives, including cumulative impacts; and a listing of agencies and persons consulted, and to whom copies of the FEIS are sent.
Per the cooperating agency commitment, the Navy provided NMFS with early preliminary drafts of the NWTT DEIS/OEIS and the FEIS/OEIS and a designated (and adequate) timeframe within which NMFS could provide comments. The Office of Protected Resources circulated the Navy's preliminary NEPA documents to other interested NOAA line offices and NMFS' regional and science center offices, compiled any comments received, and submitted them to the Navy. Subsequently, the Navy and NMFS participated in comment resolution meetings, in which the Navy addressed NMFS' comments, and in which any outstanding issues were resolved. The Navy has incorporated the majority of NMFS' comments into the FEIS, and adequately addressed those comments that were not incorporated. As a result of this review, the Office of Protected Resources has determined that it is not necessary to prepare a separate Environmental Assessment or EIS to issue regulations or LOAs authorizing the incidental take of marine mammals pursuant to the MMPA, and that adoption of the Navy's NWTT FEIS/OEIS is appropriate. Based on NMFS' review of the FEIS, NMFS has adopted the FEIS under the Council on Environmental Quality's Regulations for Implementing the National Environmental Policy Act (40 CFR 1506.3). Furthermore, in accordance with NEPA, its implementing regulations, and the NOAA's Administrative Order (NAO) 216-6 “Environmental Review Procedures for Implementing the National Environmental Policy Act,” we have prepared a Record Decision (ROD) which addresses NMFS' determination to issue regulations and LOAs to the Navy pursuant to section 101(a)(5)(A) of the MMPA, for the taking of marine mammals incidental to the conduct of Navy's training and testing activities.
In the Estimated Take of Marine Mammals section of the proposed rule, NMFS described the potential effects to marine mammals from active sonar and underwater detonations in relation to the MMPA regulatory definitions of Level A and Level B harassment (80 FR 31738, June 3, 2015, pages 31785-31790). That information has not changed and is not repeated here. It is important to note that, as Level B Harassment is interpreted here and quantified by the behavioral thresholds described below, the fact that a single behavioral pattern (of unspecified duration) is abandoned or significantly altered and classified as a Level B take does not mean, necessarily, that the fitness of the harassed individual is affected either at all or significantly, or that, for example, a preferred habitat area is abandoned. Further analysis of context and duration of likely exposures and effects is necessary to determine the impacts of the estimated effects on individuals and how those may translate to population-level impacts, and is included in the Analysis and Negligible Impact Determination.
Tables 11 and 12 provide a summary of non-impulsive and impulsive thresholds to TTS and PTS for marine mammals. Behavioral thresholds for impulsive sources are summarized in Table 13. A detailed explanation of how these thresholds were derived is provided in the NWTT FEIS/OEIS Criteria and Thresholds Technical Report (
The NWTT FEIS/OEIS considered all training and testing activities proposed to occur in the Study Area that have the potential to result in the MMPA defined take of marine mammals. The potential stressors associated with these activities included the following:
• Acoustic (sonar and other active non-impulse sources, explosives, swimmer defense airguns, weapons firing, launch and impact noise, vessel noise, aircraft noise);
• Energy (electromagnetic devices);
• Physical disturbance or strikes (vessels, in-water devices, military expended materials, seafloor devices);
• Entanglement (fiber optic cables, guidance wires, parachutes);
• Ingestion (munitions, military expended materials other than munitions); and
• Secondary stressors (sediments and water quality).
NMFS has determined that two stressors could potentially result in the incidental taking of marine mammals from training and testing activities within the Study Area: (1) Non-impulsive stressors (sonar and other active acoustic sources) and (2) impulsive stressors (explosives). Non-impulsive and impulsive stressors have the potential to result in incidental takes of marine mammals by harassment, injury, or mortality. NMFS also considered the potential for vessel strikes to impact marine mammals, and that assessment is presented below.
In order to account for the accidental nature of vessel strikes to large whales in general, and the potential risk from any vessel movement within the NWTT Study Area, lethal takes of large whales were originally conservatively requested in the Navy's original LOA application for NWTT training and testing activities over the 5-year period of NMFS' final authorization. However, after further consideration of the Navy's ship strike analysis, the unlikelihood of a ship strike to occur and the fact that there has never been a ship strike to marine mammals in the Study Area, the Navy removed their request for mortality takes from vessel strike in the final LOA application. Therefore, NMFS is not authorizing takes (by injury or mortality) from vessel strikes during the 5-year period of the NWTT regulations, as discussed below.
A detailed analysis of effects due to marine mammal exposures to impulsive and non-impulsive sources in the Study Area is presented in Chapter 6 of the LOA application. Based on the model and post-model analysis described in Chapter 6 of the LOA application, Table 14 summarizes the authorized takes for training activities for a year (a 12-month period) and the summation over a 5-year period (annual events occurring five times and the non-annual event occurring three times). The Civilian Port Defense exercise (Maritime Homeland Defense/Security Mine Countermeasure exercise) is a non-annual event and is analyzed as occurring every other year, or three times during the 5-year period considered in this analysis. Annual totals presented in the tables are the summation of all annual events plus all the proposed non-annual events occurring in a 12-month period as a maximum year.
Table 15 provides the Navy's take request for training activities by species from the acoustic effects modeling estimates. The numbers provided in the annual columns are the totals for a maximum year (
There has never been a recorded vessel strike of marine mammals during any training activities in the Study Area. A detailed analysis of strike data is contained in Section 6.7 (Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy's proposed actions would not result in any appreciable changes in locations or frequency of vessel activity, and there have been no whale strikes during any previous training activities in the Study Area. The manner in which the Navy has trained would remain consistent with the range of variability observed over the last decade so the Navy does not anticipate vessel strikes would occur within the Study Area during training events. Neither the Navy nor NMFS anticipates vessel strikes of marine mammals within the Study Area, nor were takes by injury or mortality resulting from vessel strike predicted in the Navy's quantitative analysis. Therefore, takes by injury or mortality resulting from vessel strikes are not authorized by NMFS in this final rule. However, the Navy has proposed measures (see Mitigation) to mitigate potential impacts to marine mammals from vessel strikes during training activities in the Study Area.
A detailed analysis of effects due to marine mammal exposures to impulsive and non-impulsive sources in the Study Area is presented in Chapter 6 of the LOA application. Based on the model and post-model analysis described in Chapter 6 of the LOA application, Table 17 summarizes the authorized takes for testing activities for an annual (12-month) period and the summation over a 5-year period. There are no non-annual testing events.
Table 18 summarizes the authorized takes for testing activities by species. There are no non-annual testing events. Derivation of these values is described in more detail within Chapter 6 of the LOA application. There are no mortalities predicted for any testing activities based on the analysis of impulsive and non-impulsive sources.
There has never been a recorded vessel strike to marine mammals during any testing activities in the Study Area. A detailed analysis of strike data is contained in Section 6.7 (Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. Testing activities involving vessel movement could mainly occur in the Inland Waters and in Western Behm Canal with some additional testing activities in the offshore region. The majority of vessels used in the Inland Waters and Western Behm Canal are smaller vessels, which are less likely to be involved in a whale strike. The Navy's proposed actions would not result in any appreciable changes in locations or frequency of vessel activity, and there have been no whale strikes during any previous testing activities in the Study Area. The manner in which the Navy has tested would remain consistent with the range of variability observed over the last decade, so neither the Navy nor NMFS anticipates vessel strikes would occur within the Study Area during testing events. Further, takes by injury or mortality resulting from vessel strike were not predicted in the Navy's quantitative analysis. As such, NMFS is not authorizing take by injury or mortality resulting from vessel strike for this final rule. However, the Navy has proposed measures (see Mitigation) to mitigate potential impacts to marine mammals from vessel strikes during testing activities in the Study Area.
The Navy's proposed training and testing activities could potentially affect marine mammal habitat through the introduction of sound into the water column, impacts to the prey species of marine mammals, bottom disturbance, or changes in water quality. Each of these components was considered in Chapter 3 of the NWTT FEIS/OEIS. Based on the information in the Marine Mammal Habitat section of the proposed rule (80 FR 31737, June 3, 2015; pages 31769-31771) and the supporting information included in the NWTT FEIS/OEIS, NMFS has determined that training and testing activities would not have adverse or long-term impacts on marine mammal habitat. In summary, expected effects to marine mammal habitat will include transitory elevated levels of anthropogenic sound in the water column; short-term physical alteration of the water column or bottom topography; brief disturbances to marine invertebrates; localized and infrequent disturbance to fish; a limited number of fish mortalities; and temporary marine mammal avoidance.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
The Navy's specified activities have been described based on best estimates of the maximum amount of sonar and other acoustic source use or detonations that the Navy would conduct. There may be some flexibility in that the exact number of hours, items, or detonations may vary from year to year, but take totals are not authorized to exceed the 5-year totals indicated in Tables 14-18. We base our analysis and NID on the maximum number of takes authorized.
To avoid repetition, we provide some general analysis immediately below that applies to all the species listed in Tables 14-18, given that some of the anticipated effects (or lack thereof) of the Navy's training and testing activities on marine mammals are expected to be relatively similar in nature. However, below that, we break our analysis into species, or groups of species where relevant similarities exist, to provide more specific information related to the anticipated effects on individuals or where there is information about the status or structure of any species that would lead to a differing assessment of the effects on the population.
The Navy's take request is based on its model and post-model analysis. In the discussions below, the “acoustic analysis” refers to the Navy's modeling results and post-model analysis. The model calculates sound energy propagation from sonar, other active acoustic sources, and explosives during naval activities; the sound or impulse received by animat dosimeters representing marine mammals distributed in the area around the modeled activity; and whether the sound or impulse received by a marine mammal exceeds the thresholds for effects. The model estimates are then further analyzed to consider animal avoidance and implementation of highly effective mitigation measures to prevent Level A harassment, resulting in final estimates of effects due to Navy training and testing. NMFS provided input to the Navy on this process and the Navy's qualitative analysis is described in detail in Chapter 6 of its LOA application (
Generally speaking, and especially with other factors being equal, the Navy and NMFS anticipate more severe effects from takes resulting from exposure to higher received levels (though this is in no way a strictly linear relationship throughout species, individuals, or circumstances) and less severe effects from takes resulting from exposure to lower received levels. The
As discussed previously in this document, marine mammals can respond to LF/MFAS/HFAS in many different ways, a subset of which qualifies as behavioral harassment. As described in the proposed rule, the Navy uses the behavioral response function to quantify the number of behavioral responses that would qualify as Level B behavioral harassment under the MMPA. As the statutory definition is currently applied, a wide range of behavioral reactions may qualify as Level B harassment under the MMPA, including but not limited to avoidance of the sound source, temporary changes in vocalizations or dive patterns, temporary avoidance of an area, or temporary disruption of feeding, migrating, or reproductive behaviors. The estimates calculated using the behavioral response function do not differentiate between the different types of potential reactions. Nor do the estimates provide information regarding the potential fitness or other biological consequences of the reactions on the affected individuals. We therefore consider the available scientific evidence to determine the likely nature of the modeled behavioral responses and the potential fitness consequences for affected individuals.
For LF/MFAS/HFAS, the Navy provided information (Table 19) estimating the percentage of the total number of takes by behavioral harassment that would occur within the 6-dB bins (without considering mitigation or avoidance). As mentioned above, an animal's exposure to a higher received level is more likely to result in a behavioral response that is more likely to adversely affect the health of the animal. As illustrated below, the majority (about 80 percent, at least for hull-mounted sonar, which is responsible for a large portion of the sonar takes) of calculated takes from MFAS result from exposures between 150 dB and 162 dB. Less than 0.5 percent of the takes are expected to result from exposures above 174 dB. Specifically, given a range of behavioral responses that may be classified as Level B harassment, to the degree that higher received levels are expected to result in more severe behavioral responses, only a small percentage of the anticipated Level B harassment from Navy activities might necessarily be expected to potentially result in more severe responses, especially when the distance from the source at which the levels below are received is considered (see Table 19). Marine mammals are able to discern the distance of a given sound source, and given other equal factors (including received level), they have been reported to respond more to sounds that are closer (DeRuiter
Although the Navy has been monitoring the effects of LF/MFAS/HFAS on marine mammals since 2006, and research on the effects of MFAS is advancing, our understanding of exactly how marine mammals in the Study Area will respond to LF/MFAS/HFAS is still improving. The Navy has submitted more than 80 reports, including Major Exercise Reports, Annual Exercise Reports, and Monitoring Reports, documenting hundreds of thousands of marine mammals across Navy range complexes, and there are only two instances of overt behavioral disturbances that have been observed. One cannot conclude from these results that marine mammals were not harassed from MFAS/HFAS, as a portion of animals within the area of concern were not seen (especially those more cryptic, deep-diving species, such as beaked whales or
As noted previously, many animals perform vital functions, such as feeding, resting, traveling, and socializing on a diel cycle (24-hour cycle). Behavioral reactions to noise exposure (when taking place in a biologically important context, such as disruption of critical life functions, displacement, or avoidance of important habitat) are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
Durations for non-impulsive activities utilizing tactical sonar sources vary and are fully described in Appendix A of the NWTT FEIS/OEIS. ASW training and testing exercises using MFAS/HFAS generally last for 2-16 hours, and may have intervals of non-activity in between. Because of the need to train in a large variety of situations, the Navy does not typically conduct successive ASW exercises in the same locations. Given the average length of ASW exercises (times of continuous sonar use) and typical vessel speed, combined with the fact that the majority of the cetaceans in the Study Area would not likely remain in an area for successive days, it is unlikely that an animal would be exposed to MFAS/HFAS at levels likely to result in a substantive response that would then be carried on for more than one day or on successive days. Further, as stated above, there are no MTEs proposed in the NWTT Study Area.
Most planned explosive exercises are of a short duration (1-6 hours). Although explosive exercises may sometimes be conducted in the same general areas repeatedly, because of their short duration and the fact that they are in the open ocean and animals can easily move away, it is similarly unlikely that animals would be exposed for long, continuous amounts of time.
As mentioned previously, TTS can last from a few minutes to days, be of varying degree, and occur across various frequency bandwidths, all of which determine the severity of the impacts on the affected individual, which can range from minor to more severe. The TTS sustained by an animal is primarily classified by three characteristics:
1. Frequency—Available data (of mid-frequency hearing specialists exposed to mid- or high-frequency sounds; Southall
2. Degree of the shift (
3. Duration of TTS (recovery time)—In the TTS laboratory studies (see
Based on the range of degree and duration of TTS reportedly induced by exposures to non-pulse sounds of energy higher than that to which free-swimming marine mammals in the field are likely to be exposed during MFAS/HFAS training exercises in the Study Area, it is unlikely that marine mammals would ever sustain a TTS from MFAS that alters their sensitivity by more than 20 dB for more than a few days (and any incident of TTS would likely be far less severe due to the short duration of the majority of the exercises and the speed of a typical vessel). Also, for the same reasons discussed in the Diel Cycle section, and because of the short distance within which animals would need to approach the sound source, it is unlikely that animals would be exposed to the levels necessary to induce TTS in subsequent time periods such that their recovery is impeded. Additionally, though the frequency range of TTS that marine mammals might sustain would overlap with some of the frequency ranges of their vocalization types, the frequency range of TTS from MFAS (the source from which TTS would most likely be sustained because the higher source level and slower attenuation make it more likely that an animal would be exposed to a higher received level) would not usually span the entire frequency range of one vocalization type, much less span all types of vocalizations or other critical auditory cues. If impaired, marine mammals would typically be aware of their impairment and are sometimes able to implement behaviors to compensate (see Acoustic Masking or Communication Impairment section), though these compensations may incur energetic costs.
Masking only occurs during the time of the signal (and potential secondary arrivals of indirect rays), versus TTS, which continues beyond the duration of the signal. Standard MFAS nominally pings every 50 seconds for hull-mounted sources. For the sources for which we know the pulse length, most are significantly shorter than hull-mounted active sonar, on the order of several microseconds to tens of microseconds. For hull-mounted active sonar, though some of the vocalizations that marine mammals make are less than one second long, there is only a 1 in 50 chance that they would occur exactly when the ping was received, and when vocalizations are longer than one second, only parts of them are masked. Alternately, when the pulses are only several microseconds long, the majority of most animals' vocalizations would not be masked. Masking effects from MFAS/HFAS are expected to be minimal. If masking or communication impairment were to occur briefly, it would be in the frequency range of MFAS, which overlaps with some marine mammal vocalizations; however, it would likely not mask the entirety of any particular vocalization, communication series, or other critical auditory cue, because the signal length, frequency, and duty cycle of the MFAS/HFAS signal does not perfectly mimic the characteristics of any marine mammal's vocalizations. The other sources used in Navy training and testing, many of either higher frequencies (meaning that the sounds generated attenuate even closer to the source) or lower amounts of operation, are similarly not expected to result in masking.
NMFS believes that many marine mammals would deliberately avoid exposing themselves to the received levels of active sonar necessary to induce injury by moving away from or at least modifying their path to avoid a close approach. Additionally, in the unlikely event that an animal approaches the sonar vessel at a close distance, NMFS believes that the mitigation measures (
If a marine mammal is able to approach a surface vessel within the distance necessary to incur PTS, the likely speed of the vessel (nominal 10-15 knots) would make it very difficult for the animal to remain in range long enough to accumulate enough energy to result in more than a mild case of PTS. As mentioned previously and in relation to TTS, the likely consequences to the health of an individual that incurs PTS can range from mild to more serious, depending upon the degree of PTS and the frequency band it is in, and many animals are able to compensate for the shift, although it may include energetic costs. Only 11 Level A PTS takes per year are predicted from NWTT training activities and 176 Level A (PTS) takes per year from testing activities.
As discussed previously, marine mammals (especially beaked whales) could potentially respond to MFAS at a received level lower than the injury threshold in a manner that indirectly results in the animals stranding. The exact mechanism of this potential response, behavioral or physiological, is not known. When naval exercises have been associated with strandings in the past, it has typically been when three or more vessels are operating simultaneously, in the presence of a strong surface duct, and in areas of constricted channels, semi-enclosed areas, and/or steep bathymetry. A combination of these environmental and operational parameters is not present in the NWTT action. Further, as stated earlier, there are no MTEs proposed in the Study Area. When this is combined with consideration of the number of hours of active sonar training that will be conducted and the nature of the exercises—which do not typically include the use of multiple hull-mounted sonar sources—we believe that the probability is small that this will occur. Furthermore, given that there has never been a stranding in the Study Area associated with sonar use and based on the number of occurrences where strandings have been definitively associated with military sonar versus the number of hours of active sonar training that have been conducted, we believe that the probability is small that this will occur as a result of the Navy's proposed training and testing activities. Lastly, an active sonar shutdown protocol for strandings involving live animals milling in the water minimizes the chances that these types of events turn into mortalities.
As stated previously, there have been no recorded Navy vessel strikes of any marine mammals during training or testing in the NWTT Study Area to date, nor were takes by injury or mortality resulting from vessel strike predicted in the Navy's quantitative analysis.
Predicted harassment of marine mammals from sonar and other active acoustic sources and explosions during annual training and testing activities are shown in Tables 14-18. The vast majority of predicted exposures (greater than 99 percent) are expected to be Level B harassment (non-injurious TTS and behavioral reactions) from sonar and other active acoustic sources at relatively low received levels (less than 156 dB) (Table 19). As mentioned earlier in the Analysis and Negligible Impact Determination section, an animal's exposure to a higher received level is more likely to adversely affect the health of the animal. Only low numbers of harbor porpoise, Dall's porpoise,
For explosive (impulsive) sources, the acoustic analysis predicts only ten annual exposures that would exceed thresholds associated with Level B (from training or testing activities) and only 2 annual exposures at levels that exceed the threshold for injury (only from training activities). Only harbor porpoise, Dall's porpoise, Northern elephant seal, and harbor seals are predicted to have Level B (TTS) exposures resulting from explosives. The two Level A exposures would be of Dall's porpoise and would be in the form of PTS (Table 12). There are no mortality takes predicted for any marine mammal species for the NWTT activities.
The analysis below may in some cases (
These exposure estimates represent a limited number of takes relative to population estimates for all mysticete stocks in the Study Area. When the numbers of behavioral takes are compared to the estimated stock abundance and if one assumes that each take happens to a separate animal, less than 20 percent of each of these stocks would be behaviorally harassed during the course of a year. Because the estimates given above represent the total number of exposures and not necessarily the number of individuals exposed, it is more likely that fewer individuals would be taken, but a subset would be taken more than one time per year. In the ocean, the use of sonar and other active acoustic sources is transient and is unlikely to repeatedly expose the same population of animals over a short period. Around heavily trafficked Navy ports and on fixed ranges, the possibility is greater for animals that are resident during all or part of the year to be exposed multiple times to sonar and other active acoustic sources. However, as discussed in the proposed rule, because neither the vessels nor the animals are stationary, significant long-term effects from repeated exposure are not expected.
Level B harassment takes are anticipated to be in the form of TTS and behavioral reactions and no injurious
Specific to U.S. Navy systems using low frequency sound, studies were undertaken in 1997-98 pursuant to the Navy's Low Frequency Sound Scientific Research Program. These studies found only short-term responses to low frequency sound by mysticetes (fin, blue, and humpback whales) including changes in vocal activity and avoidance of the source vessel (Clark, 2001; Miller
Specific to mid-frequency sound, studies by Melcón
High-frequency systems are notably outside of mysticetes' ideal hearing and vocalization range and it is unlikely that they would cause a significant behavioral reaction.
Most Level B harassments to mysticetes from sonar in the Study Area would result from received levels less than 156 dB SPL (Table 19). Therefore, the majority of Level B takes are expected to be in the form of milder responses (
As explained above, recovery from a threshold shift (TTS) can take a few minutes to a few days, depending on the exposure duration, sound exposure level, and the magnitude of the initial shift, with larger threshold shifts and longer exposure durations requiring longer recovery times (Finneran
There is no designated critical habitat for mysticetes in the NWTT Study Area. There are also no known specific breeding or calving areas for mysticete species within the Study Area. Some biologically-important seasonal feeding and migration areas for mysticetes (Northern Puget Sound Feeding Area for gray whales; Northwest Feeding Area for gray whales; Northbound Migration Phase A for gray whales; Northbound Migration Phase B for gray whales; Northern Washington Feeding Area for humpback whales; Stonewall and Heceta Bank Feeding Area for humpback whales; and Point St. George Feeding Area for humpback whales (Calambokidis
The potential for the most overlap between Navy activities and the gray and humpback feeding areas will be in the following three feeding areas—the Humpback Whale Northern Washington feeding area, Stonewall Heceta Bank feeding area, and the Gray Whale Northern Puget Sound feeding area. As described in the Navy's and NMFS' analysis discussed in the
Finally, the Navy has previously affirmed that it is not conducting nor is it proposing to conduct training with mid-frequency active hull-mounted sonar on vessels while underway in Puget Sound and the Strait of Juan de Fuca. The Navy's process since 2003 requires approval prior to operating mid-frequency active hull-mounted sonar in Puget Sound and the Strait of Juan de Fuca. The Navy will continue the permission and approval process, in place since 2003, through U.S. Pacific Fleet's designated authority for all mid-frequency active hull-mounted sonar on vessels while training underway in Puget Sound and Strait of Juan de Fuca. Pierside maintenance/testing of sonar systems within Puget Sound and the Strait of Juan de Fuca will also require approval by U.S. Pacific Fleet's designated authority or Systems Command designated authority as applicable, and must be conducted in accordance with PMAP for ship and submarine active sonar use, to include the use of Lookouts. The use of active sonar for anti-terrorism/force protection or for safe navigation within the Puget Sound or Strait of Juan de Fuca is always permitted for safety of ship/national security reasons. These mitigation measures are incorporated within this final rule and continue to minimize sonar use within these areas.
There has never been a recorded vessel strike of a mysticete whale during any active training or testing activities in the Study Area. A detailed analysis of strike data is contained in Chapter 6 (Section 6.7, Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy and NMFS do not anticipate vessel strikes to any marine mammals during training or testing activities within the Study Area, nor were takes by injury or mortality resulting from vessel strike predicted in the Navy's analysis. Therefore, NMFS is not authorizing mysticete takes (by injury or mortality) from vessel strikes during the 5-year period of the NWTT regulations.
The majority of Level B takes are expected to be in the form of mild responses (low-level exposures) and of a generally short duration. Relative to the population size, this activity is anticipated to result only in a limited number of Level B harassment takes. When the number of behavioral takes is compared to the estimated stock abundance and if one assumes that each take happens to a separate animal, less than 8 percent of the California/Oregon/Washington stock would be behaviorally harassed during the course of a year. Because the estimates given above represent the total number of exposures and not necessarily the number of individuals exposed, it is more likely that fewer individuals would be taken, but a subset would be taken more than one time per year. In the ocean, the use of sonar and other active acoustic sources is transient and is unlikely to repeatedly expose the same population of animals over a short period. Around heavily trafficked Navy ports and on fixed ranges, the possibility is greater for animals that are resident during all or part of the year to be exposed multiple times to sonar and other active acoustic sources. However, as discussed in the proposed rule, because neither the vessels nor the animals are stationary, significant long-term effects from repeated exposure are not expected. Overall, the number of predicted behavioral reactions are unlikely to cause long-term consequences for individual animals or populations. The NWTT activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for sperm whales. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of sperm whales. Sperm whales are listed as depleted under the MMPA and endangered under the ESA; however, there is no designated critical habitat in the Study Area.
There has never been a recorded vessel strike of a sperm whale during any active training or testing activities in the Study Area. A detailed analysis of strike data is contained in Chapter 6 (Section 6.7, Estimated Take of Large Whales by Navy Vessel Strike) of the LOA application. The Navy and NMFS do not anticipate vessel strikes to any marine mammals during training or testing activities within the Study Area, nor were takes by injury or mortality resulting from vessel strikes predicted in the Navy's analysis. Therefore, NMFS is not authorizing sperm whale takes (by injury or mortality) from vessel strikes during the 5-year period of the NWTT regulations.
Acoustic analysis (factoring in the post-model correction for avoidance and mitigation) also predicted that 47 Dall's porpoises and 45 harbor porpoises might be exposed to sound levels likely to result in PTS or injury (Level A harassment) from mainly sonar and other active acoustic stressors; only 2 level A takes are predicted to Dall's porpoise from explosives. In the case of all explosive exercises, it is worth noting that the amount of explosive and acoustic energy entering the water, and therefore the effects on marine mammals, may be overestimated, as many explosions actually occur upon impact with above-water targets—nonetheless, here we analyze the effects of the takes authorized. However, sources such as these were modeled as exploding at 1-meter depth. Furthermore, in the case of all explosive exercises, the exclusion zones are considerably larger than the estimated distance at which an animal would be exposed to injurious sounds or pressure waves. Furthermore, in the case of all explosive exercises, the exclusion zones are considerably larger than the estimated distance at which an animal would be exposed to injurious sounds or pressure waves. When the numbers of takes for Dall's porpoise are compared to the estimated stock abundances and if one assumes that each take happens to a separate animal, approximately 33 percent of the Alaska stock and less than 2 percent of the California/Oregon/Washington stock would be harassed (behaviorally) during the course of a year. Because the estimates given above represent the total number of exposures and not necessarily the number of individuals exposed, it is more likely that fewer individuals would be taken, but a subset would be taken more than one time per year.
The number of harbor porpoises—in particular, Northern Oregon/Washington Coast and Northern California/Southern Oregon stocks—behaviorally harassed by exposure to MFAS/HFAS in the Study Area is higher than the other species (and, in fact, suggests that every member of the stock could potentially be taken by Level B harassment multiple times, although it is more likely that fewer individuals are harassed but a subset are harassed more than one time during the course of the year). This is due to the low Level B harassment threshold (we assume for the purpose of estimating take that all harbor porpoises exposed to
Animals that do experience hearing loss (TTS or PTS) may have reduced ability to detect relevant sounds such as predators, prey, or social vocalizations. Some porpoise vocalizations might overlap with the MFAS/HFAS TTS frequency range (2-20 kHz). Recovery from a threshold shift (TTS; partial hearing loss) can take a few minutes to a few days, depending on the exposure duration, sound exposure level, and the magnitude of the initial shift, with larger threshold shifts and longer exposure durations requiring longer recovery times (Finneran
Harbor porpoises have been observed to be especially sensitive to human activity (Tyack
ASW training and testing exercises using MFAS/HFAS generally last for 2-16 hours, and may have intervals of non-activity in between. In addition, the Navy does not typically conduct ASW exercises in the same locations. Given the average length of ASW exercises (times of continuous sonar use) and typical vessel speed, combined with the fact that the majority of the harbor porpoises in the Study Area would not likely remain in an area for successive days, it is unlikely that an animal would be exposed to MFAS/HFAS at levels likely to result in a substantive response (
The harbor porpoise is a common species in the nearshore coastal waters of the Study Area year-round (Barlow, 1988; Green
Considering the information above, the predicted effects to Dall's and harbor porpoises are unlikely to cause long-term consequences for individual animals or the population. The NWTT activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for Dall's and harbor porpoises. Pacific stocks of Dall's and harbor porpoises are not listed as depleted under the MMPA. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of porpoises.
Recovery from a threshold shift (TTS; partial hearing loss) can take a few minutes to a few days, depending on the exposure duration, sound exposure level, and the magnitude of the initial shift, with larger threshold shifts and longer exposure durations requiring longer recovery times (Finneran
Some
Research and observations on
The predicted effects to
Virtually all of the Baird's and
Behavioral responses can range from a mild orienting response, or a shifting of attention, to flight and panic (Richardson, 1995; Nowacek, 2007; Southall
It has been speculated for some time that beaked whales might have unusual sensitivities to sonar sound due to their likelihood of stranding in conjunction with MFAS use. Research and observations show that if beaked whales are exposed to sonar or other active acoustic sources they may startle, break off feeding dives, and avoid the area of the sound source to levels of 157 dB re 1 µPa, or below (McCarthy
Populations of beaked whales and other odontocetes on the Bahamas and other Navy fixed ranges that have been operating for decades, appear to be stable. Behavioral reactions (avoidance of the area of Navy activity) seem likely in most cases if beaked whales are exposed to anti-submarine sonar within a few tens of kilometers, especially for prolonged periods (a few hours or more) since this is one of the most sensitive marine mammal groups to anthropogenic sound of any species or group studied to date and research indicates beaked whales will leave an area where anthropogenic sound is present (Tyack
Based on the findings above, it is clear that the Navy's long-term ongoing use of sonar and other active acoustic sources has not precluded beaked whales from also continuing to inhabit those areas. In summary, based on the best available science, the Navy and NMFS believe that beaked whales that exhibit a significant TTS or behavioral reaction due to sonar and other active acoustic testing activities would generally not have long-term consequences for
NMFS also considered New
No beaked whales are predicted in the acoustic analysis to be exposed to sound levels associated with PTS, other injury, or mortality. After decades of the Navy conducting similar activities in the NWTT Study Area without incident, NMFS does not expect strandings, injury, or mortality of beaked whales to occur as a result of training and testing activities. Stranding events coincident with Navy MFAS use in which exposure to sonar is believed to have been a contributing factor were detailed in the Stranding and Mortality section of the proposed rule. However, for some of these stranding events, a causal relationship between sonar exposure and the stranding could not be clearly established (Cox
The NWTT training and testing activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for beaked whales. None of the Pacific stocks for beaked whales species found in the Study Area are depleted under the MMPA. The degree of predicted Level B harassment is expected to be mild, and no beaked whales are predicted in the acoustic analysis to be exposed to sound levels associated with PTS, other injury, or mortality. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of beaked whales.
All of these takes are anticipated to be in the form of behavioral harassment (TTS and behavioral reaction) and no injurious takes of delphinids from sonar and other active acoustic stressors or explosives are requested or proposed for authorization. Further, the majority of takes are anticipated to be by behavioral harassment in the form of mild responses (low received levels and of a short duration). Behavioral responses can range from alerting, to changing their behavior or vocalizations, to avoiding the sound source by swimming away or diving (Richardson, 1995; Nowacek, 2007; Southall
The predicted effects to delphinids are unlikely to cause long-term consequences for individual animals or populations. The NWTT activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for delphinids. Pacific stocks of delphinid species found in the Study Area are not depleted under the MMPA. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of delphinid species.
All of these takes are anticipated to be in the form of behavioral harassment (TTS and behavioral reaction) and no injurious takes of killer whales from sonar and other active acoustic stressors or explosives are requested or proposed for authorization. Further, the majority of takes are anticipated to be by behavioral harassment in the form of mild responses. The killer whale's size and detectability makes it unlikely that these animals would be exposed to the higher energy or pressure expected to result in more severe effects. Killer whales generally travel in pods and should be visible from a distance in order to implement mitigation measures and reduce potential impacts.
Research and observations show that if killer whales are exposed to sonar or other active acoustic sources they may react in a number of ways depending on their experience with the sound source and what activity they are engaged in at the time of the acoustic exposure. Killer whales may not react at all until the sound source is approaching within a few hundred meters to within a few kilometers depending on the environmental conditions and species. Killer whales that are exposed to activities that involve the use of sonar and other active acoustic sources may alert, ignore the stimulus, change their behaviors or vocalizations, avoid the sound source by swimming away or diving, or be attracted to the sound source. Research has demonstrated that killer whales may routinely move over long large distances (Andrews and Matkin, 2014; Fearnbach
The vocalizations of killer whales fall directly into the frequency range in which TTS would be incurred from the
The southern resident killer whale is the only ESA-listed marine mammal species with designated critical habitat located in the NWTT Study Area (NMFS, 2006). The majority of the Navy's proposed training and testing activities would, however, not occur in the southern resident killer whale's designated critical habitat (NMFS, 2006). For all substressors that would occur within the critical habitat, those training and testing activities are not expected to impact the identified primary constituent elements of that habitat and therefore would have no effect on that critical habitat. Furthermore, the majority of testing events would occur in Hood Canal, where southern resident killer whales are not believed to be present (southern resident killer whales have not been reported in Hood Canal or Dabob Bay since 1995 [NMFS, 2008c]), while the majority of training activities would occur in the offshore portions of the Study Area where they are only present briefly during their annual migration period.
The predicted effects to southern resident killer whale would occur in the Inland Waters area of Puget Sound as a result of the Civilian Port Defense exercise (Maritime Homeland Defense/Security Mine Countermeasures Integrated Exercise) where they could be exposed to sonar and other active acoustic sources that may result in two behavioral reactions annually. NMFS issued a Biological Opinion concluding that training and testing activities are likely to adversely affect, but are not likely to jeopardize, the continued existence of southern resident killer whale and are not likely to result in the destruction or adverse modification of critical habitat in the NWTT Study Area. As described in the Biological Opinion, the available scientific information does not provide evidence that exposure to acoustic stressors from Navy training and testing activities will impact the fitness of any individuals of this species. Therefore exposure to acoustic stressors will not have population or species level impacts.
The NWTT training and testing activities are generally not expected to occur in an area/time of specific importance for reproductive, feeding, or other known critical behaviors for killer whales. Consequently, the activities are not expected to adversely impact annual rates of recruitment or survival of killer whale species and will therefore not result in population-level impacts. As discussed in the
Generally speaking, pinniped stocks in the Study Area are thought to be stable or increasing. Relative to population size, training and testing activities are anticipated to result only in a limited number of takes for the majority of pinniped species. When the numbers of takes are compared to the estimated stock abundances and if one assumes that each take happens to a separate animal, less than 2 percent of each Steller sea lion, California sea lion, northern fur seal, harbor seal (Southeast Alaska [Clarence Strait] only; all other harbor seal stock abundances are unknown), and northern elephant seal stock would be harassed (behaviorally) during the course of a year. Because the estimates given above represent the total number of exposures and not necessarily the number of individuals exposed, it is more likely that fewer individuals would be taken, but a subset would be taken more than one time per year. Takes of depleted (as defined under the MMPA) stocks of northern fur seals (Eastern Pacific) and Guadalupe fur seals (Mexico) represent only 0.7 percent and 0.07 percent of their respective stock.
Research has demonstrated that for pinnipeds, as for other mammals, recovery from a hearing threshold shift (
Research and observations show that pinnipeds in the water may be tolerant of anthropogenic noise and activity (a review of behavioral reactions by pinnipeds to impulsive and non-impulsive noise can be found in Richardson
Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness to those individuals, and would not result in any adverse impact to the stock as a whole. Evidence from areas where the Navy extensively trains and tests provides some indication of the possible consequences resulting from those proposed activities. In the confined waters of Washington State's Hood Canal where the Navy has been training and intensively testing for decades and harbor seals are present year-round, the population level has remained stable suggesting the area's carrying capacity likely has been reached (Jeffries
NMFS has determined that the Level A and Level B harassment exposures to the Hood Canal stock of harbor seals are not biologically significant to the population because (1) the vast majority of the exposures are within the non-injurious TTS or behavioral effects zones and none of the estimated exposures result in mortality; (2) the majority of predicted harbor seal exposures result from testing activities which are generally of an intermittent or short duration and should prevent animals from being exposed to stressors on a continuous basis; (3) there are no indications that the historically occurring activities resulting in these behavioral harassment exposures are having any effect on this population's survival by altering behavior patterns such as breeding, nursing, feeding, or sheltering; (4) the population has been stable and likely at carrying capacity (Jeffries
The Guadalupe fur seal is the only ESA-listed pinniped species found within the NWTT Study Area. Guadalupe fur seals are considered “seasonally migrant” and are present within the offshore portion of the Study Area during the warm season (summer and early autumn) and during that portion of the year may be exposed to sonar and other active acoustic sources associated with training and testing activities. Predicted Level B takes of Guadalupe fur seals in the Study Area represent a negligible percentage of the Mexico stock. Furthermore, critical habitat has not been designated for Guadalupe fur seals.
We believe that factors described above, as well as the available body of evidence from past Navy activities in the Study Area, demonstrate that the potential effects of the specified activity will have only short-term effects on individuals. The NWTT training and testing activities are not expected to occur in an area/time of specific importance for reproductive, feeding, or
As discussed earlier in this final rule, the Navy revised the number of hours and the location of sonar use attributed to life cycle pierside sonar testing events already described as occurring at each of the Navy's installations in the Pacific Northwest. The resulting revised predicted exposures (take) calculations for several species as a result of these corrections are depicted in Table 18.
None of the species/stocks that could be affected by life cycle pierside testing events are listed under the ESA. Gray whale and harbor seal densities are somewhat higher in the vicinity of Naval Station Everett (Possession Sound) than they are near NBK—Bremerton (Sinclair Inlet). While gray whales seasonally occur in the vicinity of Naval Station Everett, they are rarely sighted as far inside Puget Sound as NBK—Bremerton. The net change in annual testing effects reflects these environmental differences. However, the net change represents a less than 5 percent increase in predicted annual Level A harassments and a less than 1 percent increase in predicted annual Level B harassments across all sonar and explosive testing activities proposed to occur within the NWTT Study Area.
The species with the most potential for harassment by this correction—Dall's porpoise, Steller sea lions, California sea lions, harbor seals, and harbor porpoise—are all species/stocks with robust, stable populations. All these species/stocks are also predicted to be affected by pierside surface ship sonar maintenance events at Naval Station Everett, and by life cycle pierside sonar testing events at NBK—Bremerton already accounted for in Navy and NMFS analyses. The longer duration of the testing events is predicted to result in 8 Level A harassment exposures of harbor seals; Level A harassment would not be incurred from the shorter duration training events. In addition, the analysis shows that the longer MF1 testing events could result in 1 Level B harassment (by temporary threshold shift [TTS]) of a gray whale. The shorter duration pierside surface ship sonar maintenance training events at Naval Station Everett would not affect this species, and effects to this species were not predicted for life cycle pierside sonar testing at NBK—Bremerton.
As a result of the correction, the gray whale is the only species with predicted effects at Naval Station Everett that was not predicted to have effects at NBK—Bremerton. If a gray whale were to experience a TTS, its hearing sensitivity would only be affected for a short duration of time (a few minutes to a few days), and any effect on its hearing would be in a very narrow bandwidth equivalent to the exposure. Because marine mammals hear over a large range of frequencies, they are likely to be able to compensate for any temporary reduction in sensitivity over a small frequency band. Therefore, TTS is unlikely to affect their ability to carry out necessary life functions (
The species with the greatest increase in predicted exposures and for which the only instances of Level A takes are predicted are harbor seals from the Washington Northern Inland Waters stock. The net change in annual testing exposures would not alter the conclusions of the analysis presented above for harbor seals in this section or in the NWTT FEIS/OEIS.
In summary, correcting the number of life cycle pierside sonar testing event hours will result in an insignificant increase in overall Level B and Level A takes of a few species within the NWTT Study Area. All populations are healthy and exposures to sound from these events would be short term (no more than 4 hours) and infrequent (a maximum of 8 times per year). These testing events are qualitatively described in documents released to the public as potentially occurring at both NBK—Bremerton and Naval Station Everett. Furthermore, the testing events are similar to pierside surface ship sonar system maintenance training events using MF1 sonar systems also proposed to occur at Naval Station Everett that were quantitatively analyzed in public documents and pose similar potential effects on marine mammals. Therefore, the addition of life cycle pierside sonar testing events to Naval Station Everett and their associated predicted exposures does not reflect a significant departure from or a substantial change in the nature of activities or environmental effects already analyzed as potentially occurring there, and NMFS concludes that no long-term consequences to or significant impacts on marine mammal species/stocks would be expected.
The best assessment of long-term consequences from training and testing activities will be to monitor the populations over time within a given Navy range complex. A U.S. workshop on Marine Mammals and Sound (Fitch
Since 2006 across all Navy Range Complexes (in the Atlantic, Gulf of Mexico, and the Pacific), there have been more than 80 reports; including Major Exercise Reports, Annual Exercise Reports, and Monitoring Reports. For the Pacific since 2011, there have been 29 monitoring and exercise reports (as shown in Table 6-1 of the LOA application) submitted to NMFS to further research goals aimed at understanding the Navy's impact on the environment as it carries out its mission to train and test.
In addition to this multi-year record of reports from across the Navy, there have also been ongoing Behavioral Response Study research efforts (in Southern California and the Bahamas) specifically focused on determining the potential effects from Navy MFAS (Southall
Based on the findings from surveys in Puget Sound and research efforts and monitoring before, during, and after
To summarize, while the evidence covers most marine mammal taxonomic suborders, it is limited to a few species and only suggestive of the general viability of those species in intensively used Navy training and testing areas (Barlow
Training and testing activities proposed in the NWTT Study Area would result in Level B and Level A takes, as summarized in Tables 14-18. Based on best available science, as summarized in this rule and in the NWTT FEIS/OEIS (Section 3.4.4.1), NMFS concludes that exposures to marine mammal species and stocks due to NWTT activities would result in primarily short-term (temporary and short in duration) and relatively infrequent effects to most individuals exposed, and not of the type or severity that would be expected to be additive for the generally small portion of the stocks and species likely to be exposed.
Chapter 4 of the NWTT FEIS/OEIS contains a comprehensive assessment of potential cumulative impacts, including analyzing the potential for cumulatively significant impacts to the marine environment and marine mammals. In addition, the Biological Opinion concludes that the proposed regulations and any take associated with activities authorized by those regulations are not likely to jeopardize the continued existence of threatened or endangered species (or species proposed for listing) in the action area during any single year or as a result of the cumulative impacts of a 5-year authorization. The Biological Opinion includes an explanation of how the results of NMFS' baseline and effects analyses in Biological Opinions relate to those contained in the cumulative impact section of the NWTT FEIS/OEIS.
Marine mammal takes from Navy activities are not expected to impact annual rates of recruitment or survival and will therefore not result in population-level impacts for the following reasons:
• Most acoustic exposures (greater than 99 percent) are within the non-injurious TTS or behavioral effects zones (Level B harassment consisting of generally temporary modifications in behavior) and none of the estimated exposures result in mortality.
• As mentioned earlier, an animal's exposure to a higher received level is more likely to result in a behavioral response that is more likely to adversely affect the health of the animal. For low frequency cetaceans (mysticetes) in the Study Area, most Level B exposures will occur at received levels less than 156 dB. The majority of estimated odontocete takes from MFAS/HFAS (at least for hull-mounted sonar, which is responsible for most of the sonar-related takes) also result from exposures to received levels less than 156 dB. Therefore, the majority of Level B takes are expected to be in the form of milder responses (
• Acoustic disturbances caused by Navy sonar and explosives are short-term, intermittent, and (in the case of sonar) transitory. Moreover, there are no MTEs in the NWTT Study Area. Navy activities are generally unit level. Unit level events occur over a small spatial scale (one to a few 10s of square miles) and with few participants (usually one or two). Single-unit unit level training would typically involve a few hours of sonar use, with a typical nominal ping of every 50 seconds (duty cycle). Even though an animal's exposure to active sonar may be more than one time, the intermittent nature of the sonar signal, its low duty cycle, and the fact that both the vessel and animal are moving provide a very small chance that exposure to active sonar for individual animals and stocks would be repeated over extended periods of time. Consequently, we would not expect the Navy's activities to create conditions of long-term, continuous underwater noise leading to habitat abandonment or long-term hormonal or physiological stress responses in marine mammals.
• Range complexes where intensive training and testing have been occurring for decades have populations of multiple species with strong site fidelity (including highly sensitive resident beaked whales at some locations) and increases in the number of some species. Populations of beaked whales and other odontocetes in the Bahamas, and other Navy fixed ranges that have been operating for tens of years, appear to be stable.
• Years of monitoring of Navy-wide activities (since 2006) have documented hundreds of thousands of marine mammals on the range complexes and
• Years of monitoring of Navy-wide activities on the range complexes have documented no demonstrable instances of injury to marine mammals as a direct result of non-impulsive acoustic sources.
• In at least three decades of the same type of activities, only one instance of injury to marine mammals (March 4, 2011; three long-beaked common dolphin off Southern California) has occurred as a known result of training or testing using an impulsive source (underwater explosion). Of note, the time-delay firing underwater explosive training activity implicated in the March 4 incident is not proposed for the training activities in the NWTT Study Area.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, which includes consideration of the materials provided in the Navy's LOA application and NWTT FEIS/OEIS, and dependent upon the implementation of the mitigation and monitoring measures, NMFS finds that the total marine mammal take from the Navy's training and testing activities in the NWTT Study Area will have a negligible impact on the affected marine mammal species or stocks. NMFS has issued regulations for these activities that prescribe the means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat and set forth requirements pertaining to the monitoring and reporting of that taking.
There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
There are nine marine mammal species under NMFS jurisdiction that are listed as endangered or threatened under the ESA with confirmed or possible occurrence in the NWTT Study Area: North Pacific right whale, blue whale, humpback whale, fin whale, sei whale, gray whale (Western North Pacific stock), sperm whale, killer whale (Eastern North Pacific Southern Resident stock), and Guadalupe fur seal. The Navy consulted with NMFS pursuant to section 7 of the ESA, and NMFS also consulted internally on the issuance of a rule and LOAs under section 101(a)(5)(A) of the MMPA for NWTT activities. NMFS issued a Biological Opinion concluding that the issuance of the rule and subsequent LOAs are likely to adversely affect, but are not likely to jeopardize, the continued existence of the threatened and endangered species (and species proposed for listing) under NMFS' jurisdiction and are not likely to result in the destruction or adverse modification of critical habitat in the NWTT Study Area. The Biological Opinion for this action is available on NMFS' Web site (
NMFS participated as a cooperating agency on the NWTT FEIS/OEIS, which was published on October 2, 2015 and is available on the Navy's Web site:
Some Navy NWTT activities will occur within the Olympic Coast National Marine Sanctuary (OCNMS). Federal agency actions that are likely to injure sanctuary resources are subject to consultation with the NOAA Office of National Marine Sanctuaries (ONMS) under section 304(d) of the National Marine Sanctuaries Act (NMSA) to determine if there are reasonable and prudent alternatives to the proposed action that will protect sanctuary resources. The Navy and NMFS initiated joint consultation with ONMS through the submittal of a Sanctuary Resource Statement (SRS) on August 31, 2015, with follow-up information provided to ONMS on October 1, 2015. The SRS provided by the Navy and NMFS estimated the numbers of marine mammals within the OCNMS that could be exposed, annually, to acoustic transmissions associated with NWTT activities. The impacts of these exposures were predicted as numbers of marine mammals that could experience temporary and permanent threshold shifts and behavioral responses, all of which constitute “injury” as defined by the NMSA. ONMS provided recommended alternatives to the Navy and NMFS to further protect sanctuary resources on October 23, 2015. On November 9, 2015, the Navy and NMFS jointly responded in writing to each of the ONMS recommendations.
The Office of Management and Budget has determined that this final rule is not significant for purposes of Executive Order 12866.
Pursuant to the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration at the proposed rule stage that this rule would not have a significant economic impact on a substantial number of small entities. The Navy is the sole entity that would be affected by this rulemaking, and the Navy is not a small governmental jurisdiction, small organization, or small business, as defined by the RFA. Any requirements imposed by an LOA issued pursuant to these regulations, and any monitoring or reporting requirements imposed by these regulations, would be applicable only to the Navy. NMFS does not expect the issuance of these regulations or the associated LOAs to result in any impacts to small entities pursuant to the RFA. Because this action, if adopted, would directly affect the Navy and not a small entity, NMFS concludes the action would not result in a significant economic impact on a substantial number of small entities.
The Assistant Administrator for Fisheries has determined that there is good cause under the Administrative Procedure Act (5 U.S.C. 553(d)(3)) to waive the 30-day delay in the effective date of the measures contained in the final rule. NMFS is unable to accommodate the 30-day delay of effectiveness due to delays in the release of this rule which resulted from an initial delay in the publication of the proposed rule. That delay occurred when updated species density information became available immediately prior to the release of the proposed rule. As those new data represented the best available science at the time, NMFS determined that it was necessary to incorporate those data, and the resulting analyses, into the proposed rule, which was subsequently delayed due to the added time needed to perform the additional analyses and provide the necessary revisions to the notice of the proposed rule. The Navy is the only entity subject to the regulations, and it has informed NMFS that it requests that this final rule take effect by November 9, 2015, when the regulations issued by NMFS to govern the unintentional taking of marine mammals incidental to the Navy's activities in the Northwest Training Range Complex and the Keyport Range
Exports, Fish, Imports, Incidental take, Indians, Labeling, Marine mammals, Navy, Penalties, Reporting and recordkeeping requirements, Seafood, Sonar, Transportation.
For reasons set forth in the preamble, 50 CFR part 218 is amended as follows:
16 U.S.C. 1361
(f) * * *
(1) * * *
(ii) * * *
(F) Individual marine mammal sighting information for each sighting when mitigation occurred during each MTE:
(f) * * *
(1) * * *
(ii) * * *
(F) Individual marine mammal sighting information for each sighting when mitigation occurred during each MTE:
(g) * * *
(1) * * *
(ii) * * *
(F) Individual marine mammal sighting information for each sighting when mitigation occurred during each MTE:
(f) * * *
(1) * * *
(ii) Individual marine mammal sighting information for each sighting in each exercise when mitigation occurred:
(a) Regulations in this subpart apply only to the U.S. Navy for the taking of marine mammals that occurs in the area outlined in paragraph (b) of this section and that occurs incidental to the activities described in paragraph (c) of this section.
(b) The taking of marine mammals by the Navy is only authorized if it occurs within the NWTT Study Area, which is composed of established maritime operating and warning areas in the eastern North Pacific Ocean region, including areas of the Strait of Juan de Fuca, Puget Sound, and Western Behm Canal in southeastern Alaska. The Study Area includes air and water space within and outside Washington state waters, and outside state waters of Oregon and Northern California. The Study Area includes four existing range complexes and facilities: The Northwest Training Range Complex (NWTRC), the Keyport Range Complex, Carr Inlet Operations Area, and SEAFAC. In addition to these range complexes, the Study Area also includes Navy pierside locations where sonar maintenance and testing occurs as part of overhaul, modernization, maintenance and repair activities at NAVBASE Kitsap, Bremerton; NAVBASE Kitsap, Bangor; and Naval Station Everett.
(c) The taking of marine mammals by the Navy is only authorized if it occurs incidental to the following activities within the designated amounts of use:
(1) Sonar and other Active Sources Used During Training:
(i) Mid-frequency (MF) Source Classes:
(A) MF1—an average of 166 hours per year.
(B) MF3—an average of 70 hours per year.
(C) MF4—an average of 4 hours per year.
(D) MF5—an average of 896 items per year.
(E) MF11—an average of 16 hours per year.
(ii) High-frequency (HF) Source Classes:
(A) HF1—an average of 48 hours per year.
(B) HF4—an average of 384 hours per year.
(C) HF6—an average of 192 hours per year
(iii) Anti-Submarine Warfare (ASW) Source Classes:
(A) ASW2—an average of 720 items per year per year.
(B) ASW3—an average of 78 hours per year.
(2) Sonar and other Active Sources Used During Testing:
(i) Low-frequency (LF) Source Classes:
(A) LF4—an average of 110 hours per year.
(B) LF5—an average of 71 hours per year.
(ii) Mid-frequency (MF):
(A) MF1—an average of 32 hours per year
(B) MF3—an average of 145 hours per year.
(C) MF4—an average of 10 hours per year.
(D) MF5—an average of 273 items per year.
(E) MF6—an average of 12 items per year.
(F) MF8—an average of 40 hours per year.
(G) MF9—an average of 1,183 hours per year.
(H) MF10—an average of 1,156 hours per year.
(I) MF11—an average of 34 hours per year.
(J) MF12—an average of 24 hours per year.
(iii) High-frequency (HF) and Very High-frequency (VHF):
(A) HF1—an average of 161 hours per year.
(B) HF3—an average of 145 hours per year.
(C) HF5—an average of 360 hours per year.
(D) HF6—an average of 2,099 hours per year.
(iv) VHF:
(A) VHF2—an average of 35 hours per year.
(B) [Reserved]
(v) ASW:
(A) ASW1—an average of 16 hours per year.
(B) ASW2—an average of 64 hours per year.
(C) ASW2—an average of 170 items per year.
(D) ASW3—an average of 444 hours per year.
(E) ASW4—an average of 1,182 items per year.
(vi) Acoustic Modems (M):
(A) M3—an average of 1,519 hours per year.
(B) [Reserved]
(vii) Torpedoes (TORP):
(A) TORP1—an average of 315 items per year.
(B) TORP2—an average of 299 items per year.
(viii) Swimmer Detection Sonar (SD):
(A) SD1—an average of 757 hours per year.
(B) [Reserved]
(ix) Synthetic Aperture Sonar (SAS):
(A) SAS2—an average of 798 hours per year.
(B) [Reserved]
(3) Impulsive Source Detonations During Training:
(i) Explosive Classes:
(A) E1 (0.1 to 0.25 pound [lb] NEW)—an average of 48 detonations per year.
(B) E3 (>0.5 to 2.5 lb NEW)—an average of 6 detonations per year.
(C) E5 (>5 to 10 lb NEW)—an average of 80 detonations per year.
(D) E10 (>250 to 500 lb NEW)—an average of 4 detonations per year.
(E) E12 (>650 to 1,000 lb NEW)—an average of 10 detonations per year.
(ii) [Reserved]
(4) Impulsive Source Detonations During Testing:
(i) Explosive Classes:
(A) E3 (>0.5 to 2.5 lb NEW)—an average of 72 detonations per year.
(B) E4 (>2.5 to 5 lb NEW)—an average of 140 detonations (70 sonobuoys) per year.
(C) E8 (>60 to 100 lb NEW)—an average of 3 detonations per year.
(D) E11 (>500 to 650 lb NEW)—an average of 3 detonations per year.
(ii) [Reserved]
Regulations in this subpart are applicable November 9, 2015, through November 8, 2020.
(a) Under Letters of Authorization (LOAs) issued pursuant to § 218.147, the Holder of, and those operating under, the LOA may incidentally, but not intentionally, take marine mammals within the area described in § 218.140, provided the activity is in compliance with all terms, conditions, and requirements of these regulations and the appropriate LOA.
(b) The activities identified in § 218.140(c) must be conducted in a manner that minimizes, to the greatest extent practicable, any adverse impacts on marine mammals and their habitat.
(c) The incidental take of marine mammals under the activities identified in § 218.140(c) is limited to the following species, by the identified method of take and the indicated number of times:
(1) Level B Harassment for all Training Activities:
(i) Mysticetes:
(A) Blue whale (
(B) Fin whale (
(C) Gray whale (
(D) Humpback whale (
(E) Minke whale (
(ii) Odontocetes:
(A) Baird's beaked whale (
(B) Mesoplodont beaked whale (
(C) Cuvier's beaked whale (
(D) Dall's porpoise (
(E) Harbor porpoise (
(F) Harbor porpoise (
(G) Harbor porpoise (
(H) Killer whale (
(I) Killer whale (
(J) Killer whale (
(K)
(L) Northern right whale dolphin (
(M) Pacific white-sided dolphin (
(N) Risso's dolphin (
(O) Short-beaked common dolphin (
(P) Sperm whale (
(Q) Striped dolphin (
(iii) Pinnipeds:
(A) California sea lion (
(B) Steller sea lion (
(C) Guadalupe fur seal (
(D) Harbor seal (
(E) Harbor seal (
(F) Harbor seal (
(G) Northern elephant seal (
(H) Northern fur seal (
(I) Northern fur seal (
(2) Level A Harassment for all Training Activities:
(i) Mysticetes:
(A)-(B) [Reserved]
(ii) Odontocetes:
(A) Dall's porpoise (
(B) Harbor porpoise (
(iii) Pinnipeds:
(A) Harbor seal (
(B) Harbor seal (
(C) [Reserved]
(3) Level B Harassment for all Testing Activities:
(i) Mysticetes:
(A) Blue whale (
(B) Fin whale (
(C) Fin whale (
(D) Gray whale (
(E) Humpback whale (
(F) Humpback whale (
(G) Minke whale (
(H) Sei whale (
(ii) Odontocetes:
(A) Baird's beaked whale (
(B) Baird's beaked whale (
(C) Mesoplodont beaked whale (
(D) Cuvier's beaked whale (
(E) Cuvier's beaked whale (
(F) Dall's porpoise (
(G) Dall's porpoise (
(H) Harbor porpoise (
(I) Harbor porpoise (
(J) Harbor porpoise (
(K) Harbor porpoise (
(L) Killer whale (
(M) Killer whale (
(N) Killer whale (
(O)
(P) Northern right whale dolphin (
(Q) Pacific white-sided dolphin (
(R) Pacific white-sided dolphin (
(S) Risso's dolphin (
(T) Short-beaked common dolphin (
(U) Sperm whale (
(V) Striped dolphin (
(iii) Pinnipeds:
(A) California sea lion (
(B) Steller sea lion (
(C) Guadalupe fur seal (
(D) Harbor seal (
(E) Harbor seal (
(F) Harbor seal (
(G) Harbor seal (
(H) Harbor seal (
(I) Northern elephant seal (
(J) Northern fur seal (
(K) Northern fur seal (
(4) Level A Harassment for all Testing Activities:
(i) Mysticetes:
(A) Gray whale (
(B) [Reserved]
(ii) Odontocetes:
(A)
(B) Dall' porpoise (
(C) Harbor porpoise (
(D) Harbor porpoise (
(E) Harbor porpoise (
(iii) Pinnipeds:
(A) Harbor seal (
(B) Harbor seal (
(C) Harbor seal (
(D) Harbor seal (
(E) Northern elephant seal (
(F) [Reserved]
Notwithstanding takings contemplated in § 218.142 and authorized by an LOA issued under §§ 216.106 and 218.147 of this chapter, no person in connection with the activities described in § 218.140 may:
(a) Take any marine mammal not specified in § 218.142(c);
(b) Take any marine mammal specified in § 218.142(c) other than by incidental take as specified in § 218.142(c);
(c) Take a marine mammal specified in § 218.142(c) if such taking results in more than a negligible impact on the species or stocks of such marine mammal; or
(d) Violate, or fail to comply with, the terms, conditions, and requirements of these regulations or an LOA issued under §§ 216.106 and 218.147.
(a) When conducting training and testing activities, as identified in § 218.140, the mitigation measures contained in the LOA issued under §§ 216.106 and 218.147 of this chapter must be implemented. These mitigation measures include, but are not limited to:
(1)
(i) Lookouts positioned on surface ships will be dedicated solely to diligent observation of the air and surface of the water. Their observation objectives will include, but are not limited to, detecting the presence of biological resources and recreational or fishing boats, observing mitigation zones, and monitoring for vessel and personnel safety concerns.
(ii) Lookouts positioned ashore, in aircraft or on boats will, to the maximum extent practicable and consistent with aircraft and boat safety and training and testing requirements, comply with the observation objectives described in paragraph (a)(1)(i) of this section.
(iii) Lookout Measures for Non-Impulsive Sound:
(A) With the exception of vessels less than 65 ft (20 m) in length or minimally manned vessels, ships using low-frequency or hull-mounted mid-frequency active sonar sources associated with anti-submarine warfare and mine warfare activities at sea will have two Lookouts at the forward position of the vessel. For the purposes of this rule, low-frequency active sonar does not include surface towed array surveillance system low-frequency active sonar.
(B) While using low-frequency or hull-mounted mid-frequency active sonar sources associated with anti-submarine warfare and mine warfare activities at sea, vessels less than 65 ft (20 m) in length or minimally manned vessels will have one Lookout at the forward position of the vessel due to space and manning restrictions.
(C) Ships conducting active sonar activities while moored or at anchor (including pierside or shore-based testing or maintenance) will maintain one Lookout.
(D) Minimally manned vessels conducting hull-mounted mid-frequency testing will employ one Lookout.
(E) Ships, small boats, range craft, or aircraft conducting non-hull-mounted mid-frequency active sonar, such as helicopter dipping sonar systems, will maintain one Lookout.
(F) Surface ships or aircraft conducting high-frequency or non-hull-mounted mid-frequency active sonar activities associated with anti-submarine warfare and mine warfare activities at sea will have one Lookout.
(iv) Lookout measures for impulsive sound (
(A) Aircraft conducting improved extended echo ranging sonobuoy activities will have one Lookout.
(B) Aircraft conducting explosive sonobuoy activities using >0.5 to 2.5-lb net explosive weight (NEW) will have one Lookout.
(C) General mine countermeasure and neutralization activities involving positive control diver placed charges using >0.5 to 2.5 lb NEW will have a total of two Lookouts (one Lookout positioned in each of the two support vessels). All divers placing the charges on mines will support the Lookouts while performing their regular duties. The divers and Lookouts will report all marine mammal sightings to their dive support vessel.
(D) Surface vessels or aircraft conducting small-, medium-, and large-caliber gunnery exercises will have one Lookout. Towing vessels, if applicable, will also maintain one Lookout.
(E) Aircraft conducting missile exercises against a surface target will have one Lookout.
(F) Aircraft conducting explosive bombing exercises will have one Lookout and any surface vessels involved will have trained Lookouts.
(G) During explosive torpedo testing from aircraft one Lookout will be used and positioned in an aircraft. During explosive torpedo testing from a surface ship the Lookout procedures implemented for hull-mounted mid-frequency active sonar activities will be used.
(H) To mitigate effects from weapon firing noise, ships conducting explosive and non-explosive large-caliber gunnery exercises will have one Lookout. This may be the same Lookout used for small, medium, and large-caliber gunnery exercises using a surface target when that activity is conducted from a ship against a surface target.
(v) Lookout measures for physical strike and disturbance:
(A) While underway, surface ships and range craft will have at least one Lookout.
(B) During activities using towed in-water devices towed from a manned platform, one Lookout will be used. During activities in which in-water devices are towed by unmanned platforms, a manned escort vessel will be included and one Lookout will be employed.
(C) Activities involving non-explosive practice munitions (
(D) During non-explosive bombing exercises one Lookout will be positioned in an aircraft and trained Lookouts will be positioned in any surface vessels involved.
(2)
(i) Mitigation zones will be measured as the radius from a source and represent a distance to be monitored.
(ii) Visual detections of marine mammals (or sea turtles) within a mitigation zone will be communicated immediately to a watch station for information dissemination and appropriate action.
(iii) Mitigation Zones for Non-Impulsive Sound:
(A) The Navy shall ensure that hull-mounted mid-frequency active sonar transmission levels are limited to at least 6 dB below normal operating levels if any detected marine mammals (or sea turtles) are within 1,000 yd. (914 m) of the sonar dome (the bow).
(B) The Navy shall ensure that hull-mounted mid-frequency active sonar transmissions are limited to at least 10 dB below the equipment's normal operating level if any detected marine mammals (or sea turtles) are within 500 yd. (457 m) of the sonar dome.
(C) The Navy shall ensure that hull-mounted mid-frequency active sonar transmissions are ceased if any detected cetaceans (or sea turtles) are within 200 yd. (183 m) and pinnipeds are within 100 yd. (91 m) of the sonar dome. Transmissions will not resume until the marine mammal has been observed exiting the mitigation zone, is thought to have exited the mitigation zone based on its course and speed, has not been detected for 30 minutes, the vessel has transited more than 2,000 yd. beyond the location of the last detection, or the Lookout concludes that dolphins are deliberately closing in on the ship to
(D) The Navy shall ensure that low-frequency active sonar transmission levels are ceased if any detected cetaceans (or sea turtles) are within 200 yd. (183 m) and pinnipeds are within 100 yd. (91 m) of the source. Transmissions will not resume until the marine mammal has been observed exiting the mitigation zone, is thought to have exited the mitigation zone based on its course and speed, has not been detected for 30 minutes, or the vessel has transited more than 2,000 yd. beyond the location of the last detection. The pinniped mitigation zone does not apply for pierside sonar in the vicinity of pinnipeds hauled out on or in the water near man-made structures and vessels.
(E) For training, the Navy shall ensure that high-frequency and non-hull-mounted mid-frequency active sonar transmission levels are ceased if any detected marine mammals are within 200 yd. (183 m) of the source. For testing, the Navy shall ensure that high-frequency and non-hull-mounted mid-frequency active sonar transmission levels are ceased if any detected cetaceans are within 200 yd. (183 m) and pinnipeds are within 100 yd. (91 m) of the source. Transmissions will not resume until the marine mammal has been observed exiting the mitigation zone, is thought to have exited the mitigation zone based on its course and speed, the mitigation zone has been clear from any additional sightings for a period of 10 minutes for an aircraft-deployed source, the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a vessel-deployed source, the vessel or aircraft has repositioned itself more than 400 yd. (370 m) away from the location of the last sighting, or the vessel concludes that dolphins are deliberately closing in to ride the vessel's bow wave (and there are no other marine mammal sightings within the mitigation zone). The pinniped mitigation zone does not apply for pierside or shore-based testing in the vicinity of pinnipeds hauled out on or in the water near man-made structures and vessels.
(iv) Mitigation Zones and Procedures for Explosive and Impulsive Sound:
(A) For activities using IEER sonobuoys, mitigation will include pre-exercise aerial observation and passive acoustic monitoring, which will begin 30 minutes before the first source/receiver pair detonation and continue throughout the duration of the exercise. IEER sonobuoys will not be deployed if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone around the intended deployment location. Explosive detonations will cease if a marine mammal, sea turtle, or concentrations of floating vegetation are sighted within a 600-yd. (549 m) mitigation zone. Detonations will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 30 minutes.
(B) A mitigation zone with a radius of 350 yd. (320 m) shall be established for explosive signal underwater sonobuoys using >0.5 to 2.5 lb net explosive weight. Mitigation will include pre-exercise aerial monitoring of the mitigation zone during deployment. Explosive SUS buoys will not be deployed if concentrations of floating vegetation (kelp paddies) are observed within the mitigation zone around the intended deployment location. A SUS detonation will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Detonations will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
(C) A mitigation zone with a radius of 400 yd. (366 m) shall be established for mine countermeasures and neutralization activities using positive control firing devices. For Demolition and Mine Countermeasures Operations, pre-exercise surveys shall be conducted within 30 minutes prior to the commencement of the scheduled explosive event. The survey may be conducted from the surface, by divers, or from the air, and personnel shall be alert to the presence of any marine mammal or sea turtle. Should a marine mammal or sea turtle be present within the survey area, the explosive event shall not be started until the animal voluntarily leaves the area. The Navy will ensure the area is clear of marine mammals for a full 30 minutes prior to initiating the explosive event. Explosive detonations will cease if a marine mammal is sighted in the water portion of the mitigation zone (
(D) A mitigation zone with a radius of 200 yd. (183 m) shall be established for small- and medium-caliber gunnery exercises with a surface target. Vessels will observe the mitigation zone from the firing position. When aircraft are firing, the aircrew will maintain visual watch of the mitigation zone during the activity. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed within the mitigation zone. Firing will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, the mitigation zone has been clear from any additional sightings for a period of 10 minutes for a firing aircraft, the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a firing ship, or the intended target location has been repositioned more than 400 yd. (370 m) away from the location of the last sighting.
(E) A mitigation zone with a radius of 600 yd. (549 m) shall be established for large-caliber gunnery exercises with a surface target. Ships will observe the mitigation zone from the firing position. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 30 minutes.
(F) A mitigation zone with a radius of 2,000 yd. (1.8 km) shall be established for missile exercises up to 500 lb NEW using a surface target. When aircraft are involved in the missile firing, mitigation will include visual observation by the aircrew prior to commencement of the activity within a mitigation zone of 2,000 yd. (1.8 km) around the intended impact location. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will not commence or will cease if a marine
(G) A mitigation zone with a radius of 2,500 yd. (2.3 km) for explosive bombs and a mitigation zone of 1,000 yd (914 m) for non-explosive bombs around the intended impact location shall be established for bombing exercises. Aircraft shall visually survey the target and buffer zone for marine mammals prior to and during the exercise. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Bombing will not commence or will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Bombing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes.
(H) A mitigation zone with a radius of 2,100 yd. (1.9 km) shall be established for torpedo (explosive) testing. Mitigation will include visual observation by aircraft immediately before, during, and after the event of the mitigation zone. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are sighted within the mitigation zone. Firing will not commence or will cease if a marine mammal, sea turtle, or aggregation of jellyfish is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been clear from any additional sightings for a period of 10 minutes or 30 minutes (depending on aircraft type). In addition to visual observation, passive acoustic monitoring shall be conducted by Navy assets, such as passive ship sonar systems or sonobuoys already participating in the activity. These assets would only detect vocalizing marine mammals within the frequency band monitored by Navy personnel. Passive acoustic detections would not provide range or bearing to detected animals, and therefore cannot provide locations of these animals. Passive acoustic detections shall be reported to the Lookout posted in the aircraft in order to increase vigilance of the visual surveillance, and to the person in control of the activity for their consideration in determining when the mitigation zone is determined free of visible marine mammals.
(I) A mitigation zone with a radius of 70 yd. (46 m) within 30 degrees on either side of the gun target line on the firing side shall be established for weapons firing noise during large-caliber gunnery exercises. Mitigation shall include visual observation immediately before and during the exercise. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal or sea turtle is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, the mitigation zone has been clear from any additional sightings for a period of 30 minutes, or the vessel has repositioned itself more than 140 yd. (128 m) away from the location of the last sighting.
(v) Mitigation Zones for Vessels and In-Water Devices:
(A) For all training activities and for testing activities involving surface ships, vessels shall avoid approaching marine mammals head on and shall maneuver to keep at least 500 yd. (457 m) away from observed whales and 200 yd (183 m) away from all other marine mammals (except bow riding dolphins, and pinnipeds hauled out on man-made navigational and port structures and vessels) during vessel movements. These requirements shall not apply if a vessel's safety is threatened and to the extent that vessels are restricted in their ability to maneuver. Restricted maneuverability includes, but is not limited to, situations when vessels are engaged in dredging, submerged activities, launching and recovering aircraft or landing craft, minesweeping activities, replenishment while underway and towing activities that severely restrict a vessel's ability to deviate course.
(B) For testing activities not involving surface ships (
(C) The Navy shall ensure that towed in-water devices being towed from manned platforms avoid coming within a mitigation zone of 250 yd. (230 m) for all training events and testing activities involving surface ships, and a mitigation zone of 100 yd (91 m) for testing activities not involving surface ships (
(vi) Mitigation zones for non-explosive practice munitions:
(A) A mitigation zone of 200 yd. (183 m) shall be established for small-, medium, and large-caliber gunnery exercises using a surface target. Mitigation will include visual observation from a vessel or aircraft immediately before and during the exercise within the mitigation zone of the intended impact location. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed in the mitigation zone. Firing will cease if a marine mammal is sighted within the mitigation zone. Firing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, the mitigation zone has been clear from any additional sightings for a period of 10 minutes for a firing aircraft, the mitigation zone has been clear from any additional sightings for a period of 30 minutes for a firing ship, or the intended target location has been repositioned more than 400 yd. (370 m) away from the location of the last sighting.
(B) A mitigation zone of 1,000 yd. (914 m) shall be established for non-explosive bombing exercises. Mitigation shall include visual observation from the aircraft immediately before the exercise and during target approach within the mitigation zone around the intended impact location. The exercise will not commence if concentrations of floating vegetation (kelp paddies) are observed within the mitigation zone. Bombing will not commence or will cease if a marine mammal is sighted within the mitigation zone. Bombing will recommence if the animal is observed exiting the mitigation zone, the animal is thought to have exited the mitigation zone based on its course and speed, or the mitigation zone has been
(3)
(i) Maritime Homeland Defense/Security Mine Countermeasure Integrated Exercises—The Navy shall conduct pre-event planning and training to ensure environmental awareness of all exercise participants. When this event is proposed to be conducted in Puget Sound, Navy event planners shall consult with Navy biologists who shall contact NMFS during the planning process in order to determine likelihood of gray whale or southern resident killer whale presence in the proposed exercise area as planners consider specifics of the event.
(ii) Small Boat Attack Gunnery Exercises—The Navy shall conduct pre-event planning and training to ensure environmental awareness of all exercise participants. When this event is proposed to be conducted in and around Naval Station Everett, Naval Base Kitsap Bangor, or Naval Base Kitsap Bremerton in Puget Sound, Navy event planners shall consult with Navy biologists who shall contact NMFS early in the planning process in order to determine the extent marine mammals may be present in the immediate vicinity of the proposed exercise area as planners consider the specifics of the event.
(iii) Missile Exercise—The Navy shall conduct Missile Exercises using high explosives at least 50 nm from shore in the NWTT Offshore Area.
(iv) BOMBEX—The Navy shall conduct BOMBEX (high explosive munitions) greater than 50 nm from shore.
(v) BOMBEX (non-explosive practice munitions)—The Navy shall conduct BOMBEX (non-explosive practice munitions) events at least 20 nm from shore and shall not conduct BOMBEX events within the Olympic Coast National Marine Sanctuary.
(vi) Mine Countermeasure and Neutralization Underwater Detonations—The Navy shall require approval from U.S. Third Fleet prior to conducting mine countermeasure and neutralization underwater detonations at Hood Canal or Crescent Harbor.
(vii) Hull Mounted Mid-Frequency Active Sonar Training—The Navy shall require approval from U.S. Pacific Fleet's designated authority prior to conducting hull-mounted mid-frequency active sonar on vessels while training underway in Puget Sound and the Strait of Juan de Fuca.
(viii) Pierside Maintenance or Testing of Sonar Systems—The Navy shall require approval from U.S. Pacific Fleet's designated authority or Systems Command designated authority (as applicable to ship and submarine active sonar use) prior to conducting pierside maintenance or testing in Puget Sound or the Strait of Juan de Fuca.
(b) [Reserved]
(a) The Navy is required to cooperate with the NMFS, and any other Federal, state or local agency monitoring the impacts of the activity on marine mammals.
(b) General Notification of Injured or Dead Marine Mammals—Navy personnel shall ensure that NMFS is notified immediately (or as soon as clearance procedures allow) if an injured, stranded, or dead marine mammal is found during or shortly after, and in the vicinity of, any Navy training exercise utilizing MFAS, HFAS, or underwater explosive detonations. The Navy will provide NMFS with species or description of the animal(s), the condition of the animal(s) (including carcass condition if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photo or video (if available). In the event that an injured, stranded, or dead marine mammal is found by the Navy that is not in the vicinity of, or during or shortly after, MFAS, HFAS, or underwater explosive detonations, the Navy will report the same information as listed above as soon as operationally feasible and clearance procedures allow.
(c) General Notification of Ship Strike—In the event of a ship strike by any Navy vessel, at any time or place, the Navy shall do the following:
(1) Immediately report to NMFS the species identification (if known), location (lat/long) of the animal (or the strike if the animal has disappeared), and whether the animal is alive or dead (or unknown), and the time of the strike.
(2) Report to NMFS as soon as operationally feasible the size and length of animal, an estimate of the injury status (ex., dead, injured but alive, injured and moving, unknown, etc.), vessel class/type and operational status.
(3) Report to NMFS the vessel length, speed, and heading as soon as feasible.
(4) Provide NMFS a photo or video, if equipment is available.
(5) Within 2 weeks of the strike, provide NMFS with a detailed description of the specific actions of the vessel in the 30-minute timeframe immediately preceding the strike, during the event, and immediately after the strike (
(d) Event Communication Plan—The Navy shall develop a communication plan that will include all of the communication protocols (phone trees, etc.) and associated contact information required for NMFS and the Navy to carry out the necessary expeditious communication required in the event of a stranding or ship strike, including as described in the proposed notification measures above.
(e) The Navy must conduct all monitoring and/or research required under the Letter of Authorization including abiding by the NWTT monitoring plan. (
(f) Annual NWTT Monitoring Report—The Navy shall submit an annual report of the NWTT monitoring describing the implementation and results of the NWTT monitoring efforts from the previous calendar year. Data collection methods will be standardized across range complexes and study areas to allow for comparison in different geographic locations. Although additional information will be gathered, the protected species observers collecting marine mammal data pursuant to the NWTT monitoring plan shall, at a minimum, provide the same marine mammal observation data required in this section. The report shall be submitted either 90 days after the calendar year, or 90 days after the conclusion of the monitoring year to be determined by the Adaptive Management process. The NWTT Monitoring Report may be provided to NMFS within a larger report that includes the required Monitoring Plan reports from multiple range complexes and study areas (the multi-Range Complex Annual Monitoring Report). Such a report would describe progress of knowledge made with respect to monitoring plan study questions across all Navy ranges associated with the Integrated Comprehensive Monitoring Program. Similar study questions shall be treated together so that progress on each topic shall be summarized across all Navy ranges. The report need not include analyses and content that does
(g) Annual NWTT Exercise and Testing Reports—The Navy shall submit preliminary reports detailing the status of authorized sound sources within 21 days after the anniversary of the date of issuance of the LOA. The Navy shall submit detailed reports 3 months after the annual anniversary of the date of issuance of the LOA. The detailed annual reports shall describe the level of training and testing conducted during the reporting period, and a summary of sound sources used (total annual hours or quantity [per the LOA] of each bin of sonar or other non-impulsive source; total annual number of each type of explosive exercises; total annual expended/detonated rounds [missiles, bombs, etc.] for each explosive bin; and improved Extended Echo-Ranging System (IEER)/sonobuoy summary, including total number of IEER events conducted in the Study Area, total expended/detonated rounds (buoys), and total number of self-scuttled IEER rounds. The analysis in the detailed reports will be based on the accumulation of data from the current year's report and data collected from previous reports. The annual classified exercise reports will also include the amount of hull-mounted mid-frequency and high frequency active sonar use during training and testing activities in the Olympic Coast National Marine Sanctuary and in the months specified for the following three feeding areas (to the extent that active sonar training or testing does occur in these areas): The Humpback Whale Northern Washington feeding area (May through November); the Stonewall and Heceta Bank feeding area (May through November) and the Gray Whale Northern Puget Sound Feeding Area (March through May).
(h) 5-year Close-out Exercise and Testing Report—This report will be included as part of the 2020 annual exercise or testing report. This report will provide the annual totals for each sound source bin with a comparison to the annual allowance and the 5-year total for each sound source bin with a comparison to the 5-year allowance. Additionally, if there were any changes to the sound source allowance, this report will include a discussion of why the change was made and include the analysis to support how the change did or did not result in a change in the EIS and final rule determinations. The report will be submitted 3 months after the expiration of the rule. NMFS will submit comments on the draft close-out report, if any, within 3 months of receipt. The report will be considered final after the Navy has addressed NMFS' comments, or 3 months after the submittal of the draft if NMFS does not provide comments.
To incidentally take marine mammals pursuant to the regulations in this subpart, the U.S. citizen (as defined by § 216.106) conducting the activity identified in § 218.140(c) (the U.S. Navy) must apply for and obtain either an initial LOA in accordance with § 218.147 or a renewal under § 218.148.
(a) An LOA, unless suspended or revoked, will be valid for a period of time not to exceed the period of validity of this subpart.
(b) Each LOA will set forth:
(1) Permissible methods of incidental taking;
(2) Means of effecting the least practicable adverse impact on the species, its habitat, and on the availability of the species for subsistence uses (
(3) Requirements for mitigation, monitoring and reporting.
(c) Issuance, modification, or renewals of LOAs will be based on a determination that the total number of marine mammals taken by the activity as a whole will have no more than a negligible impact on the affected species or stock of marine mammal(s).
(a) A Letter of Authorization issued under §§ 216.106 and 218.147 of this chapter for the activity identified in § 218.140(c) will be renewed or modified upon request of the applicant, provided that:
(1) The proposed specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for these regulations (excluding changes made pursuant to the adaptive management provision of this chapter), and;
(2) NMFS determines that the mitigation, monitoring, and reporting measures required by the previous LOA under these regulations were adequately implemented.
(b) For LOA modification or renewal requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting (excluding changes made pursuant to the adaptive management provision of this chapter) that do not change the findings made for the regulations or result in no more than a minor change in the total estimated number of takes (or distribution by species or years), NMFS may publish a notice of proposed LOA in the
(c) An LOA issued under §§ 216.106 and 218.147 of this chapter for the activity identified in § 218.144 of this chapter may be modified by NMFS under the following circumstances:
(1) Adaptive Management—NMFS may modify (including add to, change, or remove) the existing mitigation, monitoring, or reporting measures (after consulting with the Navy regarding the practicability of the modifications) if doing so creates a reasonable likelihood of more effectively accomplishing the goals of the mitigation and monitoring set forth in the preamble for these regulations.
(i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, and reporting measures in an LOA include (but are not limited to):
(A) Results from Navy's monitoring from the previous year(s);
(B) Results from other marine mammal and/or sound research or studies; or
(C) Any information that reveals marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.
(ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, NMFS would publish a notice of proposed LOA in the
(2) Emergencies—If NMFS determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in § 218.142(c), an LOA may be modified without prior notification and an opportunity for public comment. Notification would be published in the
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |