Page Range | 33775-34250 | |
FR Document |
Page and Subject | |
---|---|
82 FR 34249 - Continuation of the National Emergency With Respect to Transnational Criminal Organizations | |
82 FR 33894 - Applications for New Awards; Impact Aid Discretionary Construction Grant Program | |
82 FR 33871 - Pacific Islands Pelagic Fisheries; American Samoa Longline Limited Entry Program | |
82 FR 33872 - Procurement List: Proposed deletions | |
82 FR 33911 - Environmental Impact Statements; Notice of Availability | |
82 FR 33910 - Local Government Advisory Committee: Request for Nominations | |
82 FR 33908 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for Exemption Reissuance-Class I Hazardous Waste Injection; Vopak Logistics Services USA Inc. Deer Park, Texas | |
82 FR 33922 - Center for Mental Health Services; Notice of Meeting | |
82 FR 33809 - Protection of Stratospheric Ozone: Determination 33 for Significant New Alternatives Policy Program | |
82 FR 33907 - Proposed CERCLA Administrative Cost Recovery Settlement: Parker Street Waste Site, New Bedford, Massachusetts | |
82 FR 33904 - EPA's Intent To Disclose Confidential Business Information (CBI) Contained in Vehicle Sales Data for Model Years 2015 to the U.S. Energy Information Administration (EIA) for Use in Modeling and Projecting Energy Demand in the Light-Duty Vehicle Sector | |
82 FR 33905 - Clean Water Act Class II: Proposed Administrative Settlement, Penalty Assessment and Opportunity To Comment Regarding JPMorgan Chase Bank, N.A. | |
82 FR 33922 - Committee management; notice of Federal Advisory Committee meeting | |
82 FR 33913 - Medicare, Medicaid and Children's Health Insurance Program (CHIP); Meeting on Behavioral Health Payment and Care Delivery | |
82 FR 33799 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas | |
82 FR 33915 - Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals (QIs): Federal Fiscal Year 2014 and Federal Fiscal Year 2015 through Calendar Year 2015 | |
82 FR 33802 - Drawbridge Operation Regulation; St. Louis River (Duluth-Superior Harbor), Between the Towns of Duluth, MN and Superior, WI | |
82 FR 33803 - Safety Zone; Upper Ohio Valley Italian Heritage Festival/Upper Ohio Valley Italian Heritage Festival Fireworks, Wheeling, WV | |
82 FR 33864 - Public Quarterly Meeting of the Board of Directors | |
82 FR 33868 - Agenda and Notice of Public Meeting of the Maryland Advisory Committee | |
82 FR 33940 - Chicago Rail & Port, LLC- Lease and Operation Exemption-Rail Line of South Chicago Property Development, LLC | |
82 FR 33943 - Notice of OFAC Sanctions Actions | |
82 FR 33880 - Agency Information Collection Activities; Comment Request; Annual Protection and Advocacy of Individual Rights (PAIR) Program Assurances | |
82 FR 33879 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Report of Children in State Agency and Locally Operated Institutions for Neglected or Delinquent Children | |
82 FR 33911 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
82 FR 33939 - Missouri Disaster Number MO-00081 | |
82 FR 33881 - Applications for New Awards; Promise Neighborhoods Program | |
82 FR 33939 - Missouri Disaster Number MO-00082 | |
82 FR 33852 - Touhy Regulations | |
82 FR 33926 - Large Residential Washers; Institution and Scheduling of Safeguard Investigation and Determination That the Investigation Is Extraordinarily Complicated, Amendment | |
82 FR 33927 - Crystalline Silicon Photovoltaic Cells (Whether or Not Partially or Fully Assembled Into Other Products); Institution and Scheduling of Safeguard Investigation and Determination That the Investigation Is Extraordinarily Complicated, Amendment | |
82 FR 33931 - Information Collection: DOE/NRC Form 740M, Concise Note; DOE/NRC Form 741, Nuclear Material Transaction Report; DOE/NRC Form 742, Material Balance Report; DOE/NRC Form 742C, Physical Inventory Listing | |
82 FR 33868 - Notice of Public Meeting of the Texas Advisory Committee | |
82 FR 33869 - Notice of Public Meeting of the California Advisory Committee | |
82 FR 33869 - Notice of Public Meeting of the Alaska Advisory Committee | |
82 FR 33934 - Proposed Collection; Comment Request | |
82 FR 33921 - Submission for OMB Review; Comment Request | |
82 FR 33942 - Notice of Final Federal Agency Actions on Proposed Highway in California | |
82 FR 33804 - Miscellaneous Changes to Trademark Trial and Appeal Board Rules of Practice; Clarification | |
82 FR 33908 - Proposed Information Collection Request; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (Renewal) | |
82 FR 33903 - Notice of Availability of Two Updated Chapters in the Environmental Protection Agency's Air Pollution Control Cost Manual | |
82 FR 33911 - Information Collection; General Services Acquisition Regulation; Information Specific to a Contract or Contracting Action (Not Required by Regulation) | |
82 FR 33933 - Information Collection: NRC Form 4, Cumulative Occupational Exposure History | |
82 FR 33876 - Submission for OMB Review; Comment Request | |
82 FR 33946 - Solicitation of Nominations for Appointment to the VA Prevention of Fraud, Waste, and Abuse Advisory Committee | |
82 FR 33933 - Assessment of the Assumption of Normality (Employing Individual Observed Values) | |
82 FR 33899 - Notice of Staff Attendance at the Southwest Power Pool Regional Entity Trustee, Regional State Committee, Members' Committee and Board of Directors' Meetings | |
82 FR 33901 - Combined Notice of Filings #1 | |
82 FR 33899 - AEP Texas Central Company; AEP Texas North Company; Notice of Request for Waiver | |
82 FR 33901 - Pike County Light and Power Company; Notice of Request for Waiver | |
82 FR 33901 - Apple Blossom Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
82 FR 33899 - Hog Creek Wind Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
82 FR 33902 - Combined Notice of Filings #2 | |
82 FR 33900 - Combined Notice of Filings #1 | |
82 FR 33825 - Filing Instructions for Cross-Service FM Translator Auction Filing Window for AM Broadcasters To Be Open July 26-August 2, 2017; Freeze on FM Translator and Low-Power FM Station Minor Change Applications and FM Booster Applications July 19-August 2, 2017; Availability of Online Tutorial; Clarification of Eligible Applicants | |
82 FR 33929 - Agency Information Collection Activities: Comment Request | |
82 FR 33870 - Manufacturing Extension Partnership Advisory Board | |
82 FR 33909 - Clean Air Act Operating Permit Program; Petitions for Objection to State Operating Permit for Bunge North America, Inc. Destrehan Grain Elevator, Destrehan, St. Charles Parish, Louisiana | |
82 FR 33928 - Information Collection Activities; Comment Request | |
82 FR 33865 - Medicine Bow National Forest, Wyoming, Landscape Vegetation Analysis (LaVA) Project | |
82 FR 33936 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the BOX Fee Schedule | |
82 FR 33938 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Relating to the Listing and Trading of Shares of the EtherIndex Ether Trust Under NYSE Arca Equities Rule 8.201 | |
82 FR 33877 - Arms Sales Notification | |
82 FR 33941 - Petition for Exemption; Summary of Petition Received; CSA Ocean Sciences, Inc. | |
82 FR 33939 - Defense Trade Advisory Group; Notice of Open Meeting | |
82 FR 33927 - Comment Request for the Extension of a Currently Approved Collection: Evaluation of the Employment First State Leadership Mentoring Program (EFSLMP) | |
82 FR 33942 - Petition for Exemption; Summary of Petition Received; Phoenix Air UNMANNED, LLC | |
82 FR 33870 - Notice of Availability of a Final Programmatic Environmental Impact Statement for the West Region of the Nationwide Public Safety Broadband Network | |
82 FR 33806 - Rules of Conduct for Postal Employees | |
82 FR 33923 - Foreign Endangered Species; Receipt of Applications for Permit | |
82 FR 33864 - Notice of Meeting of the National Organic Standards Board | |
82 FR 33946 - Proposed Collection: Comment Request for Forms 945, 945-A, and, 945-X | |
82 FR 33945 - Proposed Information Collection; Comment Request | |
82 FR 33829 - Pecans Grown in the States of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas; Establishment of Reporting Requirements and New Information Collection | |
82 FR 33775 - Walnuts Grown in California; Decreased Assessment Rate | |
82 FR 33856 - Calling Number Identification Service-Caller ID | |
82 FR 33856 - Petition for Partial Reconsideration, or in the Alternative, Suspension of Action in Rulemaking Proceeding | |
82 FR 33926 - Fine Denier Polyester Staple Fiber From Vietnam; Termination of Investigation | |
82 FR 33925 - Citric Acid and Certain Citrate Salts From Belgium, Colombia, and Thailand | |
82 FR 33925 - Fine Denier Polyester Staple Fiber From China, India, Korea, and Taiwan | |
82 FR 33827 - Fisheries of the Northeastern United States; Summer Flounder Fishery; Commercial Quota Harvested for the Commonwealth of Massachusetts | |
82 FR 33867 - Notice for Request for Revision of a Currently Approved Information Collection | |
82 FR 33936 - Proposed Collection; Comment Request | |
82 FR 33935 - Submission for OMB Review; Comment Request | |
82 FR 33880 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Mandatory Civil Rights Data Collection | |
82 FR 33921 - Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant | |
82 FR 33796 - Amendment of Class E Airspace; Medford, OR | |
82 FR 33792 - Amendment of Class E Airspace; Albany, GA | |
82 FR 33837 - Proposed Amendment of Class D and Class E Airspace, Elizabeth City, NC | |
82 FR 33790 - Amendment of Class D and Class E Airspace; Morgantown, WV | |
82 FR 33836 - Proposed Establishment of Class E Airspace; Augusta, AR | |
82 FR 33794 - Amendment of Class E Airspace; Fayetteville, TN | |
82 FR 33833 - Proposed Amendment of Class E Airspace, Seward, NE | |
82 FR 33864 - Submission for OMB Review; Comment Request | |
82 FR 33876 - Submission for OMB Review; Comment Request-Safety Standard for Multi-Purpose Lighters | |
82 FR 33874 - Submission for OMB Review; Comment Request-Procedures for Export of Noncomplying Products | |
82 FR 33874 - Submission for OMB Review; Comment Request-Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
82 FR 33873 - Submission for OMB Review; Comment Request-Consumer Focus Groups | |
82 FR 33875 - Agency Information Collection Activities; Proposed Extension of Approval of Information Collection; Comment Request-Safety Standard for Bicycle Helmets | |
82 FR 33798 - Establishment of Class E Airspace; Ashburn, GA | |
82 FR 33834 - Proposed Amendment of Class E Airspace; Clarinda, IA | |
82 FR 33795 - Amendment of Class E Airspace; Laurel, MS | |
82 FR 33791 - Amendment of Class E Airspace; Orange City, IA | |
82 FR 33807 - Air Plan Approval; Florida: Unnecessary Rule Removal | |
82 FR 33851 - Air Plan Approval; Florida: Unnecessary Rule Removal | |
82 FR 33839 - Covered Securities Pursuant to Section 18 of the Securities Act of 1933 | |
82 FR 33912 - Extension of Funding to Special Olympics | |
82 FR 33785 - Airworthiness Directives; The Boeing Company Airplanes | |
82 FR 33787 - Airworthiness Directives; Airbus Airplanes | |
82 FR 33940 - Petition for Exemption; Summary of Petition Received; Lauren Pelicano: Child Restraint System | |
82 FR 33780 - Airworthiness Directives; Sikorsky Aircraft Corporation Helicopters | |
82 FR 33778 - Airworthiness Directives; Sikorsky Aircraft Corporation Helicopters (Type Certificate Previously Held by Schweizer Aircraft Corporation) | |
82 FR 33782 - Airworthiness Directives; The Boeing Company Airplanes | |
82 FR 33950 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program | |
82 FR 34206 - Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019 |
Agricultural Marketing Service
Forest Service
Rural Housing Service
First Responder Network Authority
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Army Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Health Resources and Services Administration
Substance Abuse and Mental Health Services Administration
Coast Guard
Fish and Wildlife Service
Labor Statistics Bureau
Federal Aviation Administration
Federal Highway Administration
Foreign Assets Control Office
Internal Revenue Service
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 electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Agricultural Marketing Service, USDA.
Interim rule with request for comments.
This rule implements a recommendation from the California Walnut Board (Board) to decrease the assessment rate established for the 2017-18 and subsequent marketing years from $0.0465 to $0.0400 per kernelweight pound of assessable walnuts. The Board is comprised of growers and handlers of walnuts and locally administers the marketing order that regulates the handling of walnuts grown in California. The Board also has a public member who has no financial interest in walnut production or handling. Assessments upon walnut handlers are used by the Board to fund reasonable and necessary expenses of the program. The marketing year begins September 1 and ends August 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Effective July 24, 2017. Comments received by September 19, 2017 will be considered prior to issuance of a final rule.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Terry Vawter, Senior Marketing Specialist, or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This rule is issued under Marketing Order No. 984, as amended (7 CFR part 984), regulating the handling of walnuts grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See the Office of Management and Budget's (OMB) Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California walnut handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate will be applicable to all assessable walnuts beginning on September 1, 2017, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA will rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule decreases the assessment rate established for the Board for the 2017-18 and subsequent marketing years from $0.0465 to $0.0400 per kernelweight pound of assessable walnuts.
The California walnut marketing order provides authority for the Board, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. All members of the Board, except the public member, are growers and handlers of California walnuts. They are familiar with the Board's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2016-17 and subsequent marketing years, the Board recommended, and USDA approved, an assessment rate of $0.0465 per kernelweight pound of assessable walnuts that would continue in effect from year to year unless modified, suspended, or terminated by USDA upon recommendation and information
The Board met on May 31, 2017, and unanimously recommended 2017-18 expenditures of $24,140,000 and a decreased assessment rate of $0.0400 per kernelweight pound of assessable walnuts. In comparison, last year's budgeted expenditures were $23,143,050. The assessment rate of $0.0400 is $0.0065 per pound lower than the rate currently in effect. The quantity of assessable walnuts for the 2017-18 marketing year is estimated at a three-year average of 615,000 tons (inshell) or 553,500,000 kernelweight pounds, which is 62,000 tons more than the 553,000 tons assessed during the 2016-17 marketing year. At the recommended lower assessment rate of $0.0400 per kernelweight pound, the Board should collect approximately $22,140,000 in assessment income, which, when augmented with funds from the Board's monetary reserve, would be adequate to cover its 2017-18 budgeted expenses of $24,140,000.
The following table compares major budget expenditures recommended by the Board for the 2016-17 and 2017-18 marketing years:
The assessment rate recommended by the Board was derived by dividing anticipated expenses by expected volumes of California walnuts certified as merchantable. The 615,000-ton (inshell) estimate for merchantable walnut receipts is an average of the three prior years' shipments.
Section 984.69 of the order authorizes the Board to carry over excess funds into subsequent marketing years as a reserve, provided that funds already in the reserve do not exceed approximately two years' budgeted expenses. The reserve is estimated to be $14,909,800 at the end of the marketing year, well within the authorized reserve amount.
The Board met on May 31, 2017, and unanimously approved using a three prior years' average walnut production volume to formulate the 2017-18 crop estimate. Pursuant to § 984.51(b) of the order, this figure is converted to a merchantable kernelweight basis using a factor of 0.45 (615,000 tons × 2,000 pounds per ton × 0.45), which yields 553,500,000 kernelweight pounds. At $0.0400 per pound, the new assessment rate should generate $22,140,000 in assessment income. The assessment income, plus $2,000,000 from the Board's reserve, will be adequate to cover its budgeted expenses.
The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other available information.
Although this assessment rate is effective for an indefinite period, the Board will continue to meet prior to or during each marketing year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Board meetings are available from the Board or USDA. Board meetings are open to the public, and interested persons are encouraged to express their views at these meetings. USDA will evaluate Board recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Board's 2017-18 budget and those for subsequent marketing years will be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 5,700 growers of California walnuts in the production area and approximately 90 handlers subject to regulation under the marketing order. Small agricultural growers are defined by the Small Business Administration (SBA) as those whose annual receipts are less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to USDA's National Agricultural Statistics Service's (NASS) 2012 Census of Agriculture, approximately 86 percent of California's walnut farms were smaller than 100 acres. Further, NASS reports that the average yield for 2015 was 2.01 tons per acre, and the average price received for 2015 was $1,620 per ton. A 100-acre farm with an average yield of 2.01 tons per acre would, therefore, have been expected to produce about 201 tons of walnuts. At $1,620 per ton, that farm's production would have had an approximate value of $325,620. This is well below the SBA threshold of $750,000; thus, it may be concluded that the majority of California's walnut growers are considered small growers according to SBA's definition.
According to information supplied by the industry, approximately two-thirds of California's walnut handlers shipped merchantable walnuts valued under $7,500,000 during the 2016-17 marketing year and would, therefore, be
This rule decreases the assessment rate established for the Board and collected from handlers for the 2017-18 and subsequent marketing years from $0.0465 to $0.0400 per kernelweight pound of assessable walnuts. The Board unanimously recommended 2017-18 expenditures of $24,140,000 and an assessment rate of $0.0400 per kernelweight pound of assessable walnuts, which is $0.0065 lower than the assessment rate currently in effect. The quantity of assessable walnuts for the 2017-18 marketing year is estimated to be 615,000 tons, 62,000 tons greater than the quantity estimated for the 2016-17 marketing year. Therefore, even at the reduced assessment rate, the Board should collect approximately $22,140,000 in assessment income, which, when combined with $2,000,000 from its reserves, should be adequate to cover its budgeted expenses.
The following table compares major budget expenditures recommended by the Board for the 2016-17 and 2017-18 marketing years:
The Board reviewed and unanimously recommended 2017-18 expenditures of $24,140,000. Prior to arriving at this budget, the Board considered alternative expenditure and assessment levels, as well as a recommendation from the Budget and Personnel Committee (Committee). The Committee considered the estimated income and expenses, given the requests from other committees, such as the Production Research, Market Development, and Grades and Standards Committees. The other committees each deliberated, formulated their own budgets of expenses, and made their recommendations to the Committee. The Committee also considered the recommendations and various assessment rates and expenses, then made a recommendation to the Board. The Board ultimately determined that the recommended levels were reasonable and necessary to properly administer the order.
The assessment rate of $0.0400 per kernelweight pound of assessable walnuts was derived by dividing anticipated expenses of $24,140,000 by expected 2017-18 volumes of California walnuts certified as merchantable. Merchantable walnuts certified for the year are estimated at 553,500,000 kernelweight pounds, which should provide $22,140,000 in assessment income. Assessment income, coupled with $2,000,000 from the Board's reserve funds, should allow the Board to cover its expenses. Unexpended funds may be retained in a financial reserve, provided that funds in the financial reserve do not exceed approximately two years' budgeted expenses. The anticipated reserve should be $14,909,800, which is well within the order's requirement.
According to NASS, the season average grower price for 2015 was $1,620 per ton. Dividing this average grower price by 2,000 pounds per ton provides an inshell price per pound of $0.81. Dividing this inshell price per pound by the 0.45 conversion factor (inshell to kernelweight) established in the order yields a potential 2017-18 price of about $1.80 per kernelweight pound of assessable walnuts.
To calculate the percentage of grower revenue represented by the assessment rate, the assessment rate of $0.0400 per kernelweight pound is divided by the price. The estimated assessment revenue for the 2017-18 marketing year, stated as a percentage of total grower revenue, would be approximately 2 percent.
This action decreases the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to growers. However, decreasing the assessment rate reduces the burden on handlers and may reduce the burden on growers.
In addition, the Board's meeting was widely publicized throughout the California walnut industry, and all interested persons were invited to attend the meeting and encouraged to participate in Board deliberations on all issues. Like all Board meetings, the May 31, 2017, meeting was a public meeting, and all entities, both large and small, were able to express their views on this issue. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order information collection requirements have been previously reviewed by OMB and assigned OMB No.: 0581-0178 (Walnuts Grown in California). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This action imposes no additional reporting or recordkeeping requirements on either small or large California walnut handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the Board's recommendation, and other information, it is found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Marketing agreements, Nuts, Reporting and recordkeeping requirements, Walnuts.
For the reasons set forth in the preamble, 7 CFR part 984 is amended as follows:
7 U.S.C. 601-674.
On and after September 1, 2017, an assessment rate of $0.0400 per kernelweight pound is established for California merchantable walnuts.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding airworthiness directive (AD) 93-17-13 for Schweizer Aircraft Corporation and Hughes Helicopters, Inc. (now Sikorsky Aircraft Corporation) (Sikorsky) Model TH55A, 269A, 269A-1, 269B, and 269C helicopters. AD 93-17-13 required installing tachometer markings and inspecting the lower coupling driveshaft (driveshaft). This new AD requires repetitive inspections of the driveshaft and expands the applicability to include Model 269C-1 helicopters. This AD is prompted by reports of accidents because of driveshaft failures. The actions of this AD are intended to prevent the unsafe condition on these products.
This AD is effective August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of October 20, 1993 (58 FR 51770, October 5, 1993).
For Schweizer or Sikorsky service information identified in this final rule, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
You may examine the AD docket on the Internet at
Blaine Williams, Aerospace Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, 1200 District Avenue, Burlington, Massachusetts 01803; telephone (781) 238-7161; email
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to remove AD 93-17-13, Amendment 39-8684 (58 FR 51770, October 5, 1993) and add a new AD. AD 93-17-13 applied to Schweizer Aircraft Corporation and Hughes Helicopters, Inc. (now Sikorsky) Model TH55A, 269A, 269A-1, 269B, and 269C helicopters. AD 93-17-13 required within 30 days or 100 hours time-in-service (TIS), whichever occurs first and thereafter every 300 hours TIS, visually inspecting for cracks, machining steps, manufacturing tool marks, surface defects, and lack of cleanup during the production grinding operation. AD 93-17-13 also required installing engine and rotor tachometer markings and replacing any unairworthy driveshaft before further flight.
The NPRM published in the
We gave the public the opportunity to participate in developing this AD, but we received no comments on the NPRM.
We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other products of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.
We consider this AD to be an interim action. The design approval holder is developing a replacement driveshaft that will address the unsafe condition identified in this AD. Once the replacement driveshaft is developed, approved, and available, we might consider additional rulemaking.
We reviewed Sikorsky 269C Helicopter Alert Service Bulletin B-307, Basic Issue, dated December 18, 2014, and Sikorsky 269C-1 Helicopter Alert Service Bulletin C1B-043, Basic Issue, dated December 18, 2014 (ASBs). The ASBs call for a one-time visual and magnetic particle inspection of the driveshaft and driveshaft assembly for damage. The ASBs advise that the driveshaft be sent to Sikorsky and replaced if damaged. The inspection is to be accomplished within 25 hours TIS or within 180 days from the ASBs' issue date, whichever comes first. Sikorsky has since revised its maintenance manual to incorporate these inspections every 150 hours TIS.
We also reviewed Schweizer Aircraft Service Bulletin B-257.1, dated May 21, 1993 (ASB B-257.1). ASB B-257.1 calls for a one-time inspection to look for drive-shaft defects; installing declutched limit markings on the engine/rotor tachometer to reinforce operating limits; and prohibiting engine declutched operations above 1600 RPM.
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
The Sikorsky service information calls for the initial inspection to be completed within 180 days or 25 hours TIS. This AD requires that the initial inspection to be completed within 25 hours TIS only. The service information requires contacting Sikorsky if a certain part-numbered driveshaft is installed, emailing information to Sikorsky, and returning damaged parts to Sikorsky; this AD does not.
We estimate that this AD affects 619 helicopters of U.S. Registry and that labor costs average $85 per work hour. Based on these estimates, we expect the following costs:
• We estimate that the visual and magnetic particle inspections of the driveshaft requires 11 work hours for a cost of $935 per helicopter and $578,765 for the U.S. fleet per inspection cycle.
• Replacing the driveshaft, if needed, costs about $4,574 for parts. No additional labor costs are necessary.
• Installing engine and rotor tachometer markings requires 0.5 work-hour for a labor cost of about $43. The cost of parts is minimal.
We consider this AD to be an interim action. The design approval holder is developing a replacement driveshaft that will address the unsafe condition identified in this AD. Once the replacement driveshaft is developed, approved and available, we might consider additional rulemaking.
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.
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 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.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
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 applies to Model TH55A, 269A, 269A-1, 269B, 269C and 269C-1 helicopters,
This AD defines the unsafe condition as failure of a driveshaft. This condition could result in loss of power to the rotor system and subsequent loss of helicopter control.
This AD supersedes AD 93-17-13, Amendment 39-8684 (58 FR 51770, October 5, 1993).
This AD becomes effective August 25, 2017.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Within 25 hours time-in-service (TIS), install engine and rotor tachometer markings in accordance with Part II of Schweizer Aircraft Service Bulletin B-257.1, dated May 21, 1993.
(2) Within 25 hours TIS and thereafter at intervals not to exceed 150 hours TIS:
(i) Visually inspect the driveshaft for corrosion, a pit, a nick, a scratch, a dent, and a crack in accordance with the Accomplishment Instructions, paragraph 3.B.(1) through 3.B.(6) of Sikorsky 269C Helicopter Alert Service Bulletin B-307, Basic Issue, dated December 18, 2014 (269C ASB), or Sikorsky 269C-1 Helicopter Alert Service Bulletin C1B-043, Basic Issue, dated December 18, 2014 (269C-1 ASB), whichever is applicable for your model helicopter, except we do not require that you use a Sikorsky recommended vendor list. If there is any corrosion, a pit, a nick, a scratch, a dent, or a crack, replace the driveshaft before further flight.
(ii) If there is no corrosion and no pits, nicks, scratches, dents, and cracks, magnetic particle inspect the driveshaft for a crack in accordance with paragraph 3.C.(1) of the 269C ASB or 269C-1 ASB, whichever is applicable for your model helicopter. This magnetic particle inspection must be performed by a Level II or higher technician with the National Aerospace Standard 410 or equivalent certification who has performed a magnetic particle inspection within the last 12 months. If there is a crack, replace the driveshaft before further flight.
Compliance with paragraph (a)(1) of AD 93-17-13, Amendment 39-8684 (58 FR 51770, October 5, 1993) before the effective date of this AD is considered acceptable for compliance with the actions specified in paragraph (f)(1) of this AD.
(1) The Manager, Boston Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Blaine Williams, Aerospace Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7161; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
For Schweizer or Sikorsky service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
Joint Aircraft Service Component (JASC) Code: 6300, Main Rotor Drive System.
(1) The Director of the Federal Register approved the incorporation by reference 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 the AD specifies otherwise.
(3) The following service information was approved for IBR on August 25, 2017.
(i) Sikorsky 269C Helicopter Alert Service Bulletin B-307, Basic Issue, dated December 18, 2014.
(ii) Sikorsky 269C-1 Helicopter Alert Service Bulletin C1B-043, Basic Issue, dated December 18, 2014.
(4) The following service information was approved for IBR on October 20, 1993 (58 FR 51770, October 5, 1993).
(i) Schweizer Aircraft Corporation Service Bulletin B-257.1, dated May 21, 1993.
(ii) Reserved.
(5) For Schweizer or Sikorsky service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
(6) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(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), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for Sikorsky Aircraft Corporation (Sikorsky) Model S-92A helicopters. This AD requires installing an engine flame detector bracket assembly and harness assembly. This AD was prompted by reports of false fire warnings. The actions of this AD are intended to prevent an unsafe condition on these products.
This AD is effective August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of August 25, 2017.
For service information identified in this final rule, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
You may examine the AD docket on the Internet at
Kristopher Greer, Aerospace Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, 1200 District Avenue, Burlington, Massachusetts 01803; telephone (781) 238-7799; email
On December 27, 2016, at 81 FR 95066, the
We gave the public the opportunity to participate in developing this AD, but we received no comments on the NPRM.
We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other products of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.
We reviewed Sikorsky S-92 Customer Service Notice 92-094, Revision B, dated June 14, 2016, which provides procedures for installing harness part number (P/N) 92310-04201-041.
We also reviewed Sikorsky Special Service Instructions No. 92-107G, Revision G, dated February 25, 2016, (SSI No. 92-107G) which specifies installing new brackets, P/N 92070-30033-011, 92070-30033-014, and 92070-30033-015, to increase the stability of the No. 2 engine outboard flame detector.
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 reviewed Sikorsky S-92 Alert Service Bulletin (ASB) 92-26-006, Basic Issue, dated February 25, 2016. This service information provides instructions for installing a new bracket by complying with SSI No. 92-107G. We also reviewed S-92 ASB 92-26-007, Basic Issue, dated June 14, 2016. This service information specifies installing harness P/N 92310-04201-041 after or concurrently with the new bracket.
We estimate that this AD affects 50 helicopters of U.S. Registry and that labor costs average $85 per work-hour. Based on these estimates, we expect that installing a new bracket and harness requires 15.25 work hours for a labor cost of about $1,296. Parts cost $100 for a total cost of about $1,396 per helicopter and $69,800 for the U.S. fleet.
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.
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 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.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
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 applies to Sikorsky Aircraft Corporation (Sikorsky) Model S-92A helicopters, serial numbers 920006 through 920298, certificated in any category.
This AD defines the unsafe condition as a false fire warning. This condition could result in an unnecessary emergency landing or ditching.
This AD becomes effective August 25, 2017.
You are responsible for performing each action required by this AD within the
Within 180 hours time-in-service:
(1) For helicopters with a No. 2 engine outboard flame detector bracket assembly (bracket) (either part number (P/N) 92070-30033-014, or both P/N 92070-30033-011 and 92070-30033-015) installed, and with a No. 2 engine flame detector harness assembly (harness) P/N 92310-04201-041 installed: If the harness was installed before the bracket, replace the harness.
(2) For helicopters with a bracket (either P/N 92070-30033-014, or both P/N 92070-30033-011 and 92070-30033-015) installed, and without a harness P/N 92310-04201-041 installed: Remove the harness and install harness P/N 92310-04201-041 by following the Accomplishment Instructions, section 3.C.1, of Sikorsky S-92 Customer Service Notice 92-094, Revision B, dated June 14, 2016 (CSN 92-094).
(3) For helicopters without a bracket (either P/N 92070-30033-014, or both P/N 92070-30033-011 and 92070-30033-015) installed, and with a harness P/N 92310-04201-041 installed:
(i) Install a bracket P/N 92070-30033-014 by following the Instructions, paragraph D, of Sikorsky Special Service Instructions No. 92-107G, Revision G, dated February 25, 2016 (SSI 92-107G).
(ii) Replace the harness.
(4) For helicopters without a bracket (either P/N 92070-30033-014, or both P/N 92070-30033-011 and 92070-30033-015) installed, and without a harness P/N 92310-04201-041 installed:
(i) Install a bracket P/N 92070-30033-014 by following the Instructions, paragraph D, of SSI 92-107G.
(ii) Remove the harness and install harness P/N 92310-04201-041 by following the Accomplishment Instructions, section 3.C.1, of CSN 92-094.
(1) The Manager, Boston Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Kristopher Greer, Aerospace Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, 1200 District Avenue, Burlington, Massachusetts 01803; telephone (781) 238-7799; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
Sikorsky S-92 Alert Service Bulletin 92-26-006, Basic Issue, dated February 25, 2016, and Sikorsky S-92 Alert Service Bulletin 92-26-007, Basic Issue, dated June 14, 2016, which are not incorporated by reference, contain additional information about the subject of this AD. For service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
Joint Aircraft Service Component (JASC) Code: 2612, Fire Detection.
(1) The Director of the Federal Register approved the incorporation by reference 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 the AD specifies otherwise.
(i) Sikorsky S-92 Customer Service Notice 92-094, Revision B, dated June 14, 2016.
(ii) Sikorsky Special Service Instructions No. 92-107G, Revision G, dated February 25, 2016.
(3) For Sikorsky service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkw., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(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.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777 airplanes. This AD was prompted by reports of uncommanded altitude display changes in the mode control panel (MCP) altitude window. This AD requires replacing the existing MCP with a new MCP having a different part number. We are issuing this AD to address the unsafe condition on these products.
This AD is effective August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 25, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Frank Carreras, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6442; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 777 airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
Boeing and FedEx stated that they concur with the contents of the NPRM.
Air Line Pilots Association, International (ALPA), indicated its support for the NPRM but requested that the compliance time in paragraph (g) of the proposed AD be reduced from 60 months to 50 months. The commenter did not provide justification for its request.
We do not agree with the commenter's request to reduce the compliance time. In developing an appropriate compliance time, we considered the safety implications and the availability of required parts. In addition, we also received manufacturer concurrence for the 60-month compliance time. In consideration of all of these factors, we determined that the compliance time, as proposed, represents an appropriate interval in which the MCP parts can be replaced in a timely manner within the fleet, while still maintaining an adequate level of safety. For most ADs, operators are permitted to accomplish the requirements at a time earlier than the specified compliance time; for this AD, an operator may choose to replace the affected MCP at any time up to 60 months after the effective date of this AD. If additional data are presented that would justify a shorter compliance time, we might consider further rulemaking on this issue. We have not changed this AD in this regard.
United Airlines (UAL) requested that the applicability of the proposed AD be limited to only those MCP series parts on which the uncommanded changes in the speed/mach window occurred. The commenter noted that the NPRM did not indicate if the uncommanded changes were reported on all three MCP series parts (MCP-770, MCP-771, and MCP-770C) or only one MCP series part. The commenter suggested that if the uncommanded changes occurred only on one MCP series part, then the applicability of the proposed AD should be limited to that particular MCP series part. The commenter observed that this would reduce the number of MCP parts that need to be replaced or upgraded and reduce the compliance time needs.
We agree that clarification is necessary regarding the affected MCP series parts. Based on the manufacturer's installation review, the unsafe condition has been identified to exist in all three MCP series parts. Therefore, no change to this AD is required regarding this issue.
One commenter, Geoffrey Barrance, noted that the FAA has issued AD 2016-25-01, Amendment 39-18727 (81 FR 94949, December 27, 2016), which addressed uncommanded autopilot engagement before takeoff. The commenter thought that there was a similarity in the root causes (malfunction of the MCP) of the unsafe conditions in AD 2016-25-01 and this final rule. The commenter recommended that the FAA initiate a review of the MCP design, including changes that might have been introduced over the life of these units, to identify if the design was initially susceptible to, or has been subsequently compromised in a way that could result in the unsafe conditions of both ADs.
We infer the commenter may think the unsafe condition associated with AD 2016-25-01 resulted from a similar root cause as the unsafe condition addressed by this AD based on a statement in the Discussion section of the NPRM (80 FR 79735, December 23, 2015) associated with AD 2016-25-01. That statement noted that “the erroneous autopilot engage request is believed to have come from the mode control panel (MCP) and to have been caused by contamination within the MCP.” During the public comment period for the NPRM associated with AD 2016-25-01, Boeing stated that this statement was speculative and requested that the FAA remove it and replace it with a statement that possible failures in the autopilot flight director system can cause an uncommanded engagement of the autopilot. We agreed the replacement statement would be less speculative; however, because the Discussion section of an NPRM is not repeated in the final rule, AD 2016-25-01 was not revised.
We do not agree with the commenter's request because we have determined that there is no similarity in the root cause of the unsafe condition of AD 2016-25-01 and this AD. The unsafe condition identified in AD 2016-25-01 is different from the unsafe condition identified in this final rule. AD 2016-25-01 addresses uncommanded autopilot engagement on the ground, potentially resulting in incorrect stabilizer trim adjustment during takeoff. This final rule addresses uncommanded altitude display changes in the MCP while the autopilot is engaged. We have not changed this AD regarding this issue.
Cathay Pacific Airlines asked why operators are being charged for the parts and labor associated with compliance with the proposed AD if the unsafe condition is the result of a design flaw (the problematic MCP-770 part) that could not be detected during flight tests or the design phase. We infer that the commenter is requesting that either the estimated costs of the proposed AD be revised or the manufacturer's warranty coverage.
We do not agree to revise the cost estimates. We do not control the manufacturer's warranty coverage. We have identified an unsafe condition that must be corrected to ensure that airplanes are operated in an airworthy condition, as required by the Federal Aviation Regulations. We have not changed this AD in regard to this issue.
UAL requested a revision to the estimated costs of the proposed AD because the estimated costs provided are too low. UAL stated that only MCP-770C can be upgraded and all other MCP series parts would need to be replaced. UAL observed that its estimated fleet cost would exceed $8,000,000.
We do not agree with the commenter's request. We acknowledge that the cost estimate does not include the cost of a new MCP. The estimated costs in the NPRM were based on data provided in Boeing Special Attention Service Bulletin 777-22-0034, dated March 3, 2016. The cost section of the NPRM indicated that we have received no definitive data regarding the cost of a new MCP. Although UAL provided a
We reviewed the relevant data, considered the comments received, 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 for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Boeing Special Attention Service Bulletin 777-22-0034, dated March 3, 2016. The service information describes procedures for replacing the existing MCP part with a new MCP part having a different part number, in the glareshield in the flight compartment. 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 203 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
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.
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 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.
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 is effective August 25, 2017.
None.
This AD applies to The Boeing Company Model 777-200, -200LR, -300, -300ER, and 777F series airplanes, certificated in any category, identified in Boeing Special Attention Service Bulletin 777-22-0034, dated March 3, 2016.
Air Transport Association (ATA) of America Code 22; Auto flight.
This AD was prompted by reports of uncommanded altitude display changes in the mode control panel (MCP) altitude window. We are issuing this AD to prevent uncommanded changes to the MCP selected altitude; such uncommanded changes could result in incorrect spatial separation between airplanes, midair collision, or controlled flight into terrain.
Comply with this AD within the compliance times specified, unless already done.
Within 60 months after the effective date of this AD: Replace the existing MCP part with a new MCP part having a different part number, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-22-0034, dated March 3, 2016.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Frank Carreras, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6442; fax: 425-917-6590; email:
(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 the AD specifies otherwise.
(i) Boeing Special Attention Service Bulletin 777-22-0034, dated March 3, 2016.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet:
(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.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This AD was prompted by wire harness chafing on the electro-mechanical actuators (EMAs) for certain spoilers due to insufficient separation with adjacent structure. This AD requires replacement of affected EMAs. We are issuing this AD to address the unsafe condition on these products.
This AD is effective August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 25, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Sean Schauer, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6479; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8 and 787-9 airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
Boeing indicated its support for the intent of the NPRM.
The Air Line Pilots Association, International, (ALPA), supported the intent of the NPRM but asked that the compliance time in the proposed AD be reduced from 40 to 20 months. The commenter stated that the NPRM's 40-month compliance time, combined with the release date of Boeing Service Bulletin B787-81205-SB270030-00, Issue 001, dated October 22, 2015, would provide operators in excess of 56
We do not agree with the commenter's request to reduce the compliance time. In developing an appropriate compliance time for this action, we considered the safety implications, parts availability, and normal maintenance schedules for timely accomplishment of replacement of the EMAs. Further, we arrived at the proposed compliance time with the manufacturer's concurrence. In consideration of all of these factors, we determined that the compliance time, as proposed, represents an appropriate interval in which the EMA can be replaced in a timely manner within the fleet, while still maintaining an adequate level of safety. Most ADs, including this one, permit operators to accomplish the requirements of an AD at a time earlier than the specified compliance time; therefore, an operator may choose to replace the EMA at any time within the 40-month compliance time. If additional data are presented that would justify a shorter compliance time, we may consider further rulemaking on this issue. We have not changed the AD in this regard.
United Airlines (UA) asked that the compliance time in the proposed AD be extended. UA stated that considering the extensive ground time required for implementing the corrective action, additional time is necessary.
We do not agree with the commenter's request to extend the compliance time. UA did not suggest an alternative compliance time. In developing an appropriate compliance time for this action, we considered the safety implications, parts availability, and normal maintenance schedules for the timely accomplishment of the replacement. In consideration of these items, we have determined that a 40-month compliance time will ensure an acceptable level of safety and allow the replacements to be done during scheduled maintenance intervals for most affected operators. We have not changed the AD in this regard.
We reviewed the relevant data, considered the comments received, 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 for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Boeing Service Bulletin B787-81205-SB270030-00, Issue 001, dated October 22, 2015. The service information describes procedures for replacing affected EMAs with new EMAs. 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 19 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
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.
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 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.
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 is effective August 25, 2017.
None.
This AD applies to The Boeing Company Model 787-8 and 787-9 airplanes, certificated in any category, as identified in Boeing Service Bulletin B787-81205-SB270030-00, Issue 001, dated October 22, 2015.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by wire harness chafing on the electro-mechanical actuators (EMAs) for certain spoilers due to insufficient separation with adjacent structure. We are issuing this AD to prevent chafing and consequent wire damage that could result in a potential source of ignition in the flammable leakage zone and a consequent fire or explosion.
Comply with this AD within the compliance times specified, unless already done.
Within 40 months after the effective date of this AD, replace the EMAs with new EMAs, in accordance with the Accomplishment Instructions of Boeing Service Bulletin B787-81205-SB270030-00, Issue 001, dated October 22, 2015.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Sean Schauer, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6479; fax: 425-917-6590; email:
(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 the AD specifies otherwise.
(i) Boeing Service Bulletin B787-81205-SB270030-00, Issue 001, dated October 22, 2015.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
(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 superseding Airworthiness Directive (AD) 2014-08-02 which applied to certain Airbus Model A300 B4-600 and A300 B4-600R series airplanes. AD 2014-08-02 required modifying the profile of stringer run-outs of both wings, including a high frequency eddy current (HFEC) inspection of the fastener holes for defects, and repairs if necessary. This new AD retains the actions required by AD 2014-08-02 and revises the compliance times. This AD was prompted by further analysis in the context of widespread fatigue damage (WFD), which concluded that shorter compliance times are necessary to meet specified requirements to address WFD. We are issuing this AD to address the unsafe condition on these products.
This AD is effective August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 25, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of May 21, 2014 (79 FR 21392, April 16, 2014).
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-08-02, Amendment 39-17826 (79 FR 21392, April 16, 2014) (“AD 2014-08-02”). AD 2014-08-02 applied to certain Airbus Model A300 B4-600 and A300 B4-600R 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 2016-0174, dated August 30, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-600 and A300 B4-600R series airplanes. The MCAI states:
During full-scale fatigue testing, cracks were detected in the bottom wing skin stringers at Rib 14. In addition, operators have also reported finding cracks in the same area on in-service aeroplanes.
This condition, if not detected and corrected, could impair the structural integrity of the wings.
Additional analysis results showed that the improved design of the stringer run-out was necessary for aeroplanes operating beyond the Extended Service Goal 1.
To address this unsafe condition, Airbus issued Service Bulletin (SB) A300-57-6046 Revision 01 to provide modification instructions, and EASA issued AD 2013-0008 (later revised) [which corresponds to FAA AD 2014-08-02], to require the removal of the stringer end run-out plate at stringer 19 on the bottom wing skin and a re-profiling modification of the stringers 10, 11, 12, 17 and 19.
Since that [EASA] AD was issued, further analysis in the context of Widespread Fatigue Damage (WFD), concluded that a threshold reduction is necessary to meet the WFD requirements. Consequently, Airbus revised SB A300-57-6046 accordingly (now at Revision 03).
For the reasons described above, this [EASA] AD retains the requirements of EASA AD 2013-0008R1, which is superseded, but reduces the modification threshold, and introduces a pre-mod High Frequency Eddy Current (HFEC) inspection.
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 considered the comment received. FedEx Express had no objection to the NPRM.
We reviewed the available data, including the comment received, 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 for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Airbus Service Bulletin A300-57-6046, Revision 03, including Appendix 01, dated February 4, 2015. The service information describes procedures to modify the profile of stringer run-outs of both wings, including a HFEC inspection of the fastener holes for defects, and repairs. It also describes new compliance times for completing the modifications. 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 29 airplanes of U.S. registry.
The actions required by AD 2014-08-02, and retained in this AD, take about 63 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $2,360 per product. Based on these figures (accounting for updated work-hour and parts cost estimates), the estimated cost of this AD on U.S. operators is $7,715 per product.
We have received no definitive data that would enable us to provide cost estimates for any on-condition actions specified in this AD. We have no way of determining the number of aircraft that might need these repairs.
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.
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 is effective August 25, 2017.
This AD replaces AD 2014-08-02, Amendment 39-17826 (79 FR 21392, April 16, 2014) (“AD 2014-08-02”).
This AD applies to Airbus Model A300-B4-601, B4-603, B4-620, and B4-622 airplanes, and Model A300-B4-605R and B4-622R airplanes, certificated in any category, except airplanes on which Airbus Modification 10324 or 10325 has been embodied in production.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by an evaluation by the design approval holder indicating that certain wing skin stringers are subject to widespread fatigue damage. We are issuing this AD to prevent cracking in the bottom wing skin stringers, which could result in reduced structural integrity of the wings.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2014-08-02, with revised compliance times and service information. At the time specified in paragraph (g)(1) or (g)(2) of this AD, whichever occurs earlier, modify the profile of stringer run-outs at rib 14 of both wings, including a high frequency eddy current inspection of the fastener holes for defects and all applicable repairs, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6046, Revision 02, dated June 21, 2013; or Revision 03, including Appendix 01, dated February 4, 2015; except as required by paragraph (h) of this AD. Do all applicable repairs before further flight. As of the effective date of this AD, only Airbus Service Bulletin A300-57-6046, Revision 03, including Appendix 01, dated February 4, 2015, may be used.
(1) Before the accumulation of 42,500 total flight cycles, or within 2,000 flight cycles after May 21, 2014 (the effective date of AD 2014-08-02), whichever occurs later.
(2) Before the accumulation of 30,000 total flight cycles, or within 2,000 flight cycles after the effective date of this AD, whichever occurs later.
This paragraph restates the requirements of paragraph (h) of AD 2014-08-02, with revised service information.
(1) Where Airbus Mandatory Service Bulletin A300-57-6046, Revision 02, dated June 21, 2013, specifies to contact Airbus for repair instructions, this AD requires contacting the Manager, ANM-116, International Branch, Transport Airplane Directorate, FAA, or the European Aviation Safety Agency (EASA) (or its delegated agent) for repair instructions and doing those repairs before further flight.
(2) Where Airbus Service Bulletin A300-57-6046, Revision 03, including Appendix 01, dated February 4, 2015, specifies to contact Airbus for appropriate action: Before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (j)(2) of this AD.
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 the service information specified in paragraph (i)(1), (i)(2), or (i)(3) of this AD.
(1) Airbus Service Bulletin A300-57-6046, dated January 18, 1994, which is not incorporated by reference in this AD.
(2) Airbus Service Bulletin A300-57-6046, Revision 01, dated April 18, 2011, which is not incorporated by reference in this AD.
(3) Airbus Service Bulletin A300-57-6046, Revision 02, dated June 21, 2013, which was incorporated by reference in AD 2014-08-02.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2016-0174, dated August 30, 2016, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (l)(4) and (l)(5) 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 August 25, 2017.
(i) Airbus Service Bulletin A300-57-6046, Revision 03, including Appendix 01, dated February 4, 2015.
(ii) Reserved.
(4) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(5) 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.
(6) 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.
This action amends Class E airspace designated as an extension to a Class D surface area by removing the Notice to Airmen (NOTAM) part-time status at Morgantown Municipal Airport-Walter L. Bill Hart Field, Morgantown, WV, and updating the airport's geographic coordinates. Also, this action updates the geographic coordinates of the airport listed in Class D airspace, Class E surface area airspace, and Class E 700 foot airspace. This action enhances the safety and management of instrument flight rules (IFR) operations at the airport.
Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
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 amends Class D and Class E airspace at Morgantown Municipal Airport-Walter L. Bill Hart Field, Morgantown, WV, in support of IFR operations at the airport.
On April 7, 2017, the FAA published in the
This action also makes an editorial change to the associated Class D and E airspace legal descriptions removing the words “(previously called Airport/Facility Directory). Except for this change, the rule is the same as published in the NPRM.
Class D and E airspace designations are published in paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E Airspace designated as an extension to a Class D surface area at Morgantown Municipal Airport-Walter L. Bill Hart Field, Morgantown, WV, by eliminating the NOTAM information from the regulatory text that reads, “This Class E airspace area is effective during the specific dates and time established in advance by Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.” This action also amends Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet or more above the surface by updating the geographic coordinates of the airport to be in concert with the FAA's aeronautical database.
Additionally, this action removes the words “(previously called Airport/Facility Directory)” from the associated
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. 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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the FAA amends 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 the surface to and including 3,700 feet MSL within a 4-mile radius of Morgantown Municipal Airport-Walter L. Bill Hart Field. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
Within a 4-mile radius of Morgantown Municipal Airport-Walter L. Bill Hart Field. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within 1 mile either side of the Morgantown VORTAC 332° radial extending from the 4-mile radius of Morgantown Municipal Airport-Walter L. Bill Hart Field to the Morgantown VORTAC.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Morgantown Municipal Airport-Walter L. Bill Hart Field, and within 3 miles each side of the Morgantown VORTAC 152° radial extending from the 6.5-mile radius to 8.8 miles southeast of the VORTAC, and within 3 miles west of the Morgantown VORTAC 336° radial clockwise to 3 miles east of Morgantown Municipal Airport-Walter L. Bill Hart Field north localizer course extending from the 6.5-mile radius to 15.1 miles north of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace extending up to 700 feet above the surface at Orange City Municipal Airport, Orange City, IA. Airspace reconfiguration is necessary due to the decommissioning of the Orange City non directional radio beacon (NDB), and cancellation of the NDB approach. This action enhances the safety and management of standard instrument approach procedures for instrument flight rules (IFR) operations at the airport.
Effective 0901 UTC, September 14, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Walter Tweedy (prepared by Ron
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 modifies Class E airspace extending up to and including 700 feet above the surface area at Orange City Municipal Airport.
The FAA published in the
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within the 6.4-mile radius of Orange City Municipal Airport, Orange City, IA, and within 2 miles each side of the 165° bearing from the airport extending from the 6.4-mile radius to 10.1 miles south of the airport. The segment each side of the 172° bearing from the Orange City NDB extending from the 6.4-mile radius to 7.4 miles south of the airport is removed due to the decommissioning of the NDB, and cancellation of the NDB approach. The airport coordinates are amended to be in concert with the FAA's aeronautical database. This action enhances the safety and management of the standard instrument approach procedures for IFR operations at the airport.
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, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 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 6.4-mile radius of Orange City Municipal Airport and within 2 miles each side of the 165° bearing from the airport extending from the 6.4-mile radius to 10.1 miles south of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E Airspace Designated as an Extension to a Class D Surface Area by eliminating the Notice to Airmen (NOTAM) part time status for Southwest Georgia Regional Airport, Albany, GA. This action corrects differences between the descriptions of Class D airspace and Class E surface areas and their associated Class E surface area extensions. This action enhances the safety and management of Instrument Flight Rules (IFR) operations.
Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
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 amends Class E airspace designated as an extension to Class D airspace at Southwest Georgia Regional Airport, Albany, GA.
On April 25, 2017, the FAA published in the
Class E airspace designations are published in paragraph 6004 FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E Airspace designated as an extension to a Class D surface area at Southwest Georgia Regional Airport, Albany, GA, by eliminating the NOTAM information from the regulatory text that reads, “This Class E airspace area is effective during the specific dates and time established in advance by Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.” This action brings the airspace description for the airport listed in FAA Order 7400.11A in line with the airspace hours listed in the applicable Chart Supplement.
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. 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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 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 the surface within 1.3 miles each side of Pecan VORTAC 143° radial, extending from the 4.2-mile radius of Southwest Georgia Regional Airport to 1 mile southeast of the VORTAC.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace upward from 700 feet or more above the surface at Fayetteville, TN, as the Kelso non-directional radio beacon (NDB) has been decommissioned, requiring airspace reconfiguration at Fayetteville Municipal Airport. This action enhances the safety and airspace management of instrument flight rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport.
Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on-line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, GA 30320; telephone (404) 305-6364.
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 amends Class E airspace extending upward from 700 feet above the surface at Fayetteville Municipal Airport, Fayetteville, TN, for the continued safety, and management of IFR operations at the airport.
The FAA published a notice of proposed rulemaking (NPRM in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Fayetteville Municipal Airport, Fayetteville, TN, due to the decommissioning of the Kelso NDB and cancellation of the NDB approach. Therefore, these changes are necessary for continued safety and management of IFR operations at the airport. Also, the geographic coordinates of the airport are amended to coincide with the FAAs aeronautical database.
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. 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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 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 6.6-mile radius of Fayetteville Municipal Airport and within 4 miles each side of the 014° bearing from airport, extending from the 6.6-mile radius to 10.1-miles north of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Laurel, MS, as the Tallahala non-directional radio beacon (NDB) has been decommissioned, requiring airspace reconfiguration at Hesler-Noble Field Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport.
Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, GA 30320; telephone (404) 305-6364.
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 amends Class E airspace extending upward from 700 feet above the surface within an 8.4-mile radius of Hesler-Noble Field Airport, Laurel, MS, in support of IFR operations at the airport.
The FAA published a notice of proposed rulemaking (NPRM) in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 8.4-mile (increased from a 7.5-mile) radius of Hesler-Noble Field Airport, Laurel, MS due to the decommissioning of the Tallahala NDB and cancellation of the NDB approach. The Tallahala NDB is removed from the legal description, thereby removing the 5-mile wide segment from the Tallahala NDB extending from the current 7.5-mile radius to 7 miles northwest of the NDB (excluding that airspace within the Hattiesburg, MS Class E airspace area). The geographic coordinates of the airport are amended to coincide with the FAAs aeronautical database. This action ensures the continued safety and management of IFR operations at the airport.
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. 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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 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 an 8.4-mile radius of Hesler-Noble Field Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace designated as an extension to a Class D or E surface area, Class E airspace extending upward from 700 feet above the surface, and removes Class E airspace upward from 1,200 feet above the surface at Rogue Valley International-Medford Airport, Medford, OR. This action is necessary due to the decommissioning of the PUMIE locator outer marker and removal of the Rogue Valley VHF Omnidirectional Range/Tactical Air Navigation (VORTAC) from the airspace description as the FAA transitions from ground-based navigation aids to satellite-based navigation. Also, this action updates the airport's geographic coordinates for the Class D and E airspace areas to reflect the FAA's current aeronautical database.
Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.
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 modifies Class E airspace at Rogue Valley International-Medford Airport, Medford, OR, in support of the transition from ground-based navigation aids to satellite-based navigation.
On April 13, 2017, the FAA published in the
Also, an editorial change is made to the Class D and Class E surface area airspace legal descriptions replacing Airport/Facility Directory with the term Chart Supplement.
Class D and E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016,
The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E airspace designated as an extension to a Class D or E surface area, modifying Class E airspace extending upward from 700 feet above the surface, removing Class E airspace upward from 1,200 feet above the surface at Rogue Valley International-Medford Airport, Medford, OR, and updating the geographic coordinates of the airport. This action is necessary due to the proposed decommissioning of the PUMIE locator outer marker and for the safety and management of aircraft within the national airspace system as the FAA transitions from ground-based navigation aids to satellite-based navigation.
Class E airspace designated as an extension to Class D or E surface area northeast of the airport is reduced to a 4-mile wide segment (from 5.5 miles wide) extending to 11 miles northwest (from 17.5 miles northwest) of the airport, and the segment to the southeast is reduced to a 5-mile wide segment (from 8 miles), extending to 9 miles (from 19.4 miles) southeast of the airport. This airspace redesign is due to the removal of the Rogue Valley VORTAC navigation aid.
Class E airspace extending upward from 700 feet above the surface is reduced northeast, southeast, and southwest of the airport to only that area necessary to contain IFR departures within 1,500 feet of the surface and IFR departures until reaching 1,200 feet above the surface. Additionally, the Class E airspace area extending upward from 1,200 feet above the surface designated for Rogue Valley International-Medford Airport is removed, as this airspace duplicates the Rogue Valley Class E en route airspace area.
Also, the geographic coordinates of the airport are updated to match the FAA's current aeronautical database. Additionally, this action replaces the outdated term Airport/Facility Directory with the term Chart Supplement in the associated Class D and E airspace legal descriptions.
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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 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 the surface to and including 3,800 feet MSL within a 4.1-mile radius of Rogue Valley International-Medford Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within a 4.1-mile radius of Rogue Valley International-Medford Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within 2.5 miles each side of the 159° bearing from the Rogue Valley International-Medford Airport, extending from the 4.1-mile radius of the airport to 9 miles southeast of the airport, and within 2 miles each side of the 339° bearing from the airport extending from the 4.1-mile radius of the airport to 11 miles northwest of the airport.
That airspace extending upward from 700 feet above the surface within a 9-mile radius of Rogue Valley International-Medford Airport, and within 4 miles each side of the 159° bearing from the airport extending from the 9-mile radius to 18.5 miles southeast of the airport, and within 9 miles west and 5.5 miles east of the 352° bearing from the airport extending from the 9-mile radius of the airport to 26 miles northwest of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace extending upward from 700 feet above the surface at Ashburn, GA, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Turner County Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.
Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
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 amends Class E airspace at Turner County Airport, Ashburn, GA, to support IFR operations under standard instrument approach procedures at the airport.
The FAA published a notice of proposed rulemaking (NPRM) in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This action amends 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 6.8-mile radius of Turner County Airport, Ashburn, GA. This action provides the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at Turner County Airport.
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. Therefore, this regulation: (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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the FAA amends 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 6.8-mile radius of Turner County Airport.
Coast Guard, DHS.
Notice of expired temporary rules issued.
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective, primarily between August 2014 and September 2015, and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this notice contact Yeoman First Class David Hager, Office of Regulations and Administrative Law, telephone (202) 372-3862.
Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations.
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between August 2014 and September 2015 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Final rule.
The Coast Guard is modifying the regulations that govern the drawbridges over the St. Louis River at Duluth-Superior Harbor. This waterway borders Minnesota and Wisconsin and is listed under Minnesota as St. Louis River (Duluth-Superior Harbor) and under Wisconsin as Duluth-Superior Harbor (St. Louis River) in the CFR. This rule affects both regulations. The owner of the Burlington Northern Grassy Point Railroad Bridge at mile 5.44 requested the regulation be updated to include permanent winter operating schedule. This rule also aligns river mile numbers with the United States Coast Pilot and deletes bridges from the regulations that were removed from the waterway and makes the regulation easier to read and less confusing to the mariner.
This rule is effective August 21, 2017.
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 Mr. Lee D. Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone 216-902-6085, email
On April 19, 2017, we published a notice of proposed rulemaking (NPRM) entitled, Drawbridge Operation Regulation; St. Louis River (Duluth-Superior Harbor), between the towns of Duluth, MN and Superior, WI, in the
The Coast Guard is issuing this rule under the authority of 33 U.S.C. 499. The current regulations for St. Louis River drawbridges (33 CFR 117.669 and 33 CFR 117.1083) includes the operating schedules for the Burlington Northern Grassy Point Railroad Bridge at mile 5.44, the Grassy Point Bridge at mile 8.0, the Arrow Head Bridge at mile 8.7, and the Duluth, Missabe & Iron Range combined Railroad and Highway Bridge, also known as the Oliver Bridge, at mile 13.91.
The Coast Guard provided a 30 day comment period in the
Title 33 of the Code of Regulations part 117 lists drawbridge regulations by state. The St. Louis River is the border between Minnesota (listed under 33 CFR 117.669) and Wisconsin (listed under 33 CFR 117.1083). The St. Louis River is listed by state separately under both sections of the CFR. This rule will revise 33 CFR 117.1083 (under Wisconsin) to direct readers to 33 CFR 117.669 (under Minnesota) to simplify the rule and make it easier to reference by mariners.
The Coast Guard is modifying the operating schedule of the The Burlington Northern Grassy Point Railroad Bridge at mile 5.44 to include authorized permanent winter hours. Mariners will still be able to request bridge openings with 12-hours advance notice during times of light traffic volume on the river due to ice formation that typically prevents most vessel navigation in the channel from December 15 through March 15 each year.
The bridges listed in the regulations as the Grassy Point Bridge at mile 8.0 and the Arrow Head Bridge at mile 8.7, respectively, have been removed from the waterway and will be removed from the regulations.
The Duluth, Missabe & Iron Range combined Railroad and Highway Bridge, also known as the Oliver Bridge, at mile 13.91, will be renamed the Canadian National Combined Railroad and Highway Bridge to reflect the current owner and use. The authorization to remain in the closed position will continue as before, but the drawbridge must return to operable condition when notified by the District Commander to do so.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protesters.
Executive Orders 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the ability that vessels can still transit the bridge given advanced notice during the winter when ice typically prevents vessels from transiting the waterway and vessel traffic is at its lowest. This rule will also align river mile numbers with the United States Coast Pilot and delete bridges from the regulations that have been removed from the waterway and make the regulation easier to read and less confusing to the mariner.
The Regulatory Flexibility Act of 1980 (RFA), 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
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 calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
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.
Also, this rule does not have tribal implications under Executive Order 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.
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 guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) The draw of the Burlington Northern Grassy Point railroad Bridge, mile 5.44, shall open on signal except that, from December 15 through March 15 the draw shall open if at least 12-hour notice is given.
(b) The draw of the Canadian National Combined Railroad and Highway Bridge, mile 13.91, need not be opened for the passage of vessels. The owner shall return the draw to operable condition within a reasonable time when notified by the District Commander to do so.
See § 117.669 St. Louis River (Duluth-Superior Harbor), listed under Minnesota.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a safety zone for the Upper Ohio Valley Italian Heritage Festival/Upper Ohio Valley Italian Heritage Festival Fireworks on the Ohio River mile 90.0 to 90.5. The safety zone is necessary to provide for the safety of life and to protect vessels from the hazards associated with the “Upper Ohio Valley
The regulations in 33 CFR 165.801, Table 1, line 14, will be enforced from 9 p.m. through 10:30 p.m., on July 22, 2017.
If you have questions about this notice of enforcement, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce the safety zone for the annual “Upper Ohio Valley Italian Heritage Festival/Upper Ohio Valley Italian Heritage Festival Fireworks” land based fireworks display, listed in the regulations in 33 CFR 165.801, Table 1, Sector Ohio Valley, line 14 from 9 p.m. through 10:30 p.m., on July 22, 2017. Our Sector Ohio Valley Annual and Recurring Safety Zones, § 165.801, specifies the location of the regulated area for the Ohio River, Mile 90.0 to 90.5. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or passage through the safety zone must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
United States Patent and Trademark Office, Commerce.
Final rule.
The United States Patent and Trademark Office (“USPTO”) published in the
This rule is effective on July 21, 2017.
Cheryl Butler, Trademark Trial and Appeal Board, by email at
The USPTO issues this final rule to clarify the latest time in an inter partes proceeding that certain motions may be filed. The USPTO's October 7, 2016 final rule revising the Trademark Trial and Appeal Board Rules of Practice (81 FR 69950) (published under RIN 0651-AC35), effective January 14, 2017, required that any motion to compel discovery, § 2.120(f)(1), motion to test the sufficiency of responses or objections to requests for admission, § 2.120(i)(1), or motion for summary judgment, § 2.127(e)(1), be filed prior to the deadline for pretrial disclosures for the first testimony period as set or as reset. The USPTO now amends the rules of practice to make clear that such motions must be filed before the day of the deadline for pretrial disclosures for the first testimony period as originally set or as reset.
The amendments promote clarity in the regulations and further the objectives of the January 14, 2017 final rule. They advance the goals of efficiency of inter partes proceedings by streamlining discovery and pretrial procedure, particularly by signaling that the trial phase of the proceedings commences with the deadline for the first pretrial disclosure, by which juncture all discovery disputes will have been resolved or at least brought to the attention of the Board and all parties.
The USPTO is amending the third sentence of § 2.120(f)(1) to indicate that a motion to compel discovery must be filed before the day of the deadline for pretrial disclosures for the first testimony period as originally set or as reset.
The USPTO is amending the first sentence of § 2.120(i)(1) to indicate that a motion to determine and test the sufficiency of an answer or objection to a request for admission must be filed before the day of the deadline for pretrial disclosures for the first testimony period as originally set or as reset.
The USPTO is amending the second sentence of § 2.127(e)(1) to indicate that a motion for summary judgment must be filed before the day of the deadline for pretrial disclosures for the first testimony period as originally set or as reset.
Accordingly, prior notice and opportunity for public comment for the rule changes are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law.
Similarly, the 30-day delay in effectiveness is not applicable because this rule is not a substantive rule. 5 U.S.C. 553(d). As discussed above, this rulemaking involves rules of agency practice and procedure, merely consisting of clarifications to the procedure and timing of filing certain motions in inter partes proceedings. These changes are procedural in nature and will have no impact on the substantive evaluation of a trademark application or registration.
This rulemaking involves changes to a rule of agency practice and procedure in matters before the Trademark Trial and Appeal Board. The changes provide greater clarity as to certain deadlines in Board proceedings. This rule does not alter any substantive criteria used to decide cases.
This rule will apply to all persons appearing before the Board. Applicants for a trademark and other parties to Board proceedings are not industry-specific and may consist of individuals, small businesses, non-profit organizations, and large corporations. The Office does not collect or maintain statistics in Board cases on small- versus large-entity parties, and this information would be required in order to determine the number of small entities that would be affected by this rule.
No additional burden is imposed by this rule change. This rule will benefit all the parties to proceedings by increasing certainty, efficiency and clarity in the process, and streamlining the procedures. Therefore, this action will not have a significant economic impact on a substantial number of small entities.
Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to, a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.
Administrative practice and procedure, Trademarks.
For the reasons given in the preamble and under the authority contained in 15 U.S.C. 1113, 15 U.S.C. 1123, and 35 U.S.C. 2, as amended, the Office is amending part 2 of title 37 as follows:
15 U.S.C. 1113, 15 U.S.C. 1123, 35 U.S.C. 2, Section 10(c) of Pub. L. 112-29, unless otherwise noted.
(f) * * *
(1) If a party fails to make required initial disclosures or expert testimony disclosure, or fails to designate a person pursuant to Rule 30(b)(6) or Rule 31(a) of the Federal Rules of Civil Procedure, or if a party, or such designated person, or an officer, director or managing agent of a party fails to attend a deposition or fails to answer any question propounded in a discovery deposition, or any interrogatory, or fails to produce and permit the inspection and copying of any document, electronically stored information, or tangible thing, the party entitled to disclosure or seeking discovery may file a motion to compel disclosure, a designation, or attendance at a deposition, or an answer, or production and an opportunity to inspect and copy. A motion to compel initial disclosures must be filed within thirty days after the deadline therefor and include a copy of the disclosure(s), if any, and a motion to compel an expert testimony disclosure must be filed prior to the close of the discovery period. A motion to compel discovery must be filed before the day of the deadline for pretrial disclosures for the first testimony period as originally set or as reset. A motion to compel discovery shall include a copy of the request for designation of a witness or of the relevant portion of the discovery deposition; or a copy of the interrogatory with any answer or objection that was made; or a copy of the request for production, any proffer of production or objection to production in response to the request, and a list and brief description of the documents, electronically stored information, or tangible things that were not produced for inspection and copying. A motion to compel initial disclosures, expert testimony disclosure, or discovery must be supported by a showing from the moving party that such party or the attorney therefor has made a good faith effort, by conference or correspondence, to resolve with the other party or the attorney therefor the issues presented in the motion but the parties were unable to resolve their differences. If issues raised in the motion are subsequently resolved by agreement of the parties, the moving party should inform the Board in writing of the issues in the motion which no longer require adjudication.
(i) * * *
(1) Any motion by a party to determine the sufficiency of an answer or objection, including testing the sufficiency of a general objection on the ground of excessive number, to a request made by that party for an admission must be filed before the day of the deadline for pretrial disclosures for the first testimony period, as originally set or as reset. The motion shall include a copy of the request for admission and any exhibits thereto and of the answer or objection. The motion must be supported by a written statement from the moving party showing that such party or the attorney therefor has made a good faith effort, by conference or correspondence, to resolve with the other party or the attorney therefor the issues presented in the motion and has been unable to reach agreement. If issues raised in the motion are subsequently resolved by agreement of the parties, the moving party should inform the Board in writing of the issues in the motion which no longer require adjudication.
(e)(1) A party may not file a motion for summary judgment until the party has made its initial disclosures, except for a motion asserting claim or issue preclusion or lack of jurisdiction by the Trademark Trial and Appeal Board. A motion for summary judgment must be filed before the day of the deadline for pretrial disclosures for the first testimony period, as originally set or as reset. A motion under Rule 56(d) of the Federal Rules of Civil Procedure, if filed in response to a motion for summary judgment, shall be filed within thirty days from the date of service of the summary judgment motion. The time for filing a motion under Rule 56(d) will not be extended or reopened. If no motion under Rule 56(d) is filed, a brief in response to the motion for summary judgment shall be filed within thirty days from the date of service of the motion unless the time is extended by stipulation of the parties approved by the Board, or upon motion granted by the Board, or upon order of the Board. If a motion for an extension is denied, the time for responding to the motion for summary judgment may remain as specified under this section. A reply brief, if filed, shall be filed within twenty days from the date of service of the brief in response to the motion. The time for filing a reply brief will not be extended or reopened. The Board will consider no further papers in support of or in opposition to a motion for summary judgment.
Postal Service.
Final rule.
The Postal Service is revising its rules concerning employee conduct to specify the circumstances under which a nonbargaining employee may consume intoxicating beverages at an Officer Approved Event or a Postmaster General Approved event. This revision is intended to ensure that the relevant rules conform to the Postal Service's existing practices regarding this matter.
David B. Ellis at (202) 268-2981, or
The Postal Service has determined that it is necessary to revise and update its regulations concerning employee conduct to reflect current practices concerning the possession and consumption of intoxicating beverages at officially-approved Postal Service events. The current rules, set forth at 39 CFR 447.21(e), are couched in general terms that fail to provide sufficient guidance to managers or employees.
As revised, the general prohibition against consuming intoxicating beverages on duty is replaced with a rule that intoxicating beverages may be consumed by non-bargaining employees while on duty only if consumption occurs at certain events known as
The Postal Service, however, wishes to restrict the consumption of intoxicating beverages by nonbargaining employees at Postal Service events to appropriate situations for which executive approval has been obtained, whether or not the employees are on duty. As a result, any event where intoxicating beverages are served to Postal Service nonbargaining employees, whether they are on duty or off duty, must meet the requirements for an Officer Approved Event or a Postmaster General Approved Event. Among other things, this means that the consumption of intoxicating beverages at the event would require the express approval of a Postal Service Officer or the Postmaster General.
The new regulations will not change the existing prohibitions against beginning work or returning to duty intoxicated. They will, however, impose a specific prohibition against becoming intoxicated at Officer Approved Events or Postmaster General Approved Events.
The new regulations also clarify the conditions under which intoxicating beverages may be possessed or consumed on Postal Service premises. First, beer and wine would be permitted on Postal Service premises if approved by a Postal Service Officer in connection with an Officer Approved Event. Under current regulations, only the Postmaster General may approve the consumption of intoxicating beverages on Postal Service Premises. Second, intoxicating beverages other than beer and wine would never be permitted on Postal Service premises, regardless of whether the event is an Officer Approved Event or a Postmaster General Approved Event. Under current regulations, the Postmaster General may approve the consumption of intoxicating beverages other than beer and wine on Postal Service premises.
Conflict of interests, Employee conduct, Government employees.
For the reasons stated in the preamble, the Postal Service amends 39 CFR part 447 as set forth below:
39 U.S.C. 401.
(e)(1) Except as provided in this paragraph, employees must not drink beer, wine, or other intoxicating beverages while on duty; begin work or return to duty intoxicated; or drink intoxicating beverages in a public place while in uniform. Employees found to be violating this policy may be subject to disciplinary action.
(2) A nonbargaining employee may consume beer or wine at an Officer Approved Event. An
(3) A nonbargaining employee may consume beer, wine, or other intoxicating beverages at a Postmaster General Approved Event. A
(4) No employee may become intoxicated while at an Officer Approved Event or a Postmaster General Approved Event. Except in connection with an Officer Approved Event or a Postmaster General Approved Event occurring at a Postal Service facility or premises, no employee shall have or bring any container of beer or wine into any Postal Service facility or premises, whether the container has been opened or not. Intoxicating beverages other than beer and wine may never be brought into any Postal Service facility or premises under any circumstances.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is approving a revision to the Florida State Implementation Plan submitted by the Florida Department of Environmental Protection (DEP) on February 20, 2013. The revision removes unnecessary and superseded rules from the Florida State Implementation Plan (SIP). Specifically, this revision removes non-regulatory introductory language, as well as a regulation that has been superseded by more stringent federal regulations. This action is being taken pursuant to the Clean Air Act (CAA or Act).
This direct final rule is effective September 19, 2017 without further notice, unless EPA receives adverse comment by August 21, 2017. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0656 at
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9043. Mr. Lakeman can also be reached via electronic mail at
In accordance with 40 CFR 51.103, DEP submitted for EPA to review and approve revisions to Florida's SIP under the CAA. The SIP revision removes four rules from the SIP that are unnecessary or have been superseded by federal regulations. The rules requested to be removed from the SIP are Rule 62-210.100, Florida Administrative Record (F.A.C.), “Purpose and Scope;” Rule 62-212.100, F.A.C., “Purpose and Scope;” Rule 62-296.407, F.A.C., “Portland Cement Plants;” and Rule 62-297.100, F.A.C., “Purpose and Scope.”
On February 20, 2013, the DEP submitted a SIP revision to EPA for review and approval. This SIP revision requests the removal of Rules 62-210.100, 62-212.100, and 62-297.100, F.A.C., each of which is titled “Purpose and Scope,” because they contain unnecessary, introductory language for the associated rule chapters. This introductory language serves no regulatory purpose and can be removed without being considered a relaxation of a regulation. The language merely introduces the regulatory chapter that follows and does not impose any regulatory requirements.
This SIP revision also removes Rule 62-296.407, F.A.C., “Portland Cement Plants,” from the current SIP. Particulate matter (PM) emissions from Portland cement kilns and clinker coolers are more stringently regulated under 40 CFR part 60, subpart F (Standards of Performance for Portland Cement Plants), and 40 CFR part 63, subpart LLL (National Emission Standards for Hazardous Air Pollutants From the Portland Cement Manufacturing Industry), than under Rule 62-296.407, F.A.C. The Florida DEP has been delegated the authority to implement and enforce both part 60, subpart F,
These changes are consistent with section 110 of the CAA and meet the regulatory requirements pertaining to SIPs. Pursuant to CAA section 110(l), the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in CAA section 171), or any other applicable requirement of the Act. The revision of Rules 62-210.100, 62-212.100, 62-296.407, and 62-297.100 and, F.A.C., are approvable under section 110(l) because they would not interfere with the attainment and maintenance of the NAAQS.
Pursuant to section 110 of the CAA, EPA is approving the revision to the Florida SIP removing unnecessary rules from the SIP. EPA has evaluated Florida's February 20, 2013, submittal and has determined that it meets the applicable requirements of the CAA and EPA regulations and is consistent with EPA policy.
EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this
If EPA receives such comments, then EPA will publish a document 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. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 19, 2017 and no further action will be taken on the proposed rule.
Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• 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 CAA; 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 SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 19, 2017. 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 proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Determination of acceptability.
This determination of acceptability expands the list of acceptable substitutes pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy (SNAP) program. This action lists as acceptable additional substitutes for use in the refrigeration and air conditioning sector and the cleaning solvents sector.
This determination is applicable on July 21, 2017.
EPA established a docket for this action under Docket ID No. EPA-HQ-OAR-2003-0118 (continuation of Air Docket A-91-42). All electronic documents in the docket are listed in the index at
Gerald Wozniak by telephone at (202) 343-9624, by email at
For more information on the Agency's process for administering the SNAP program or criteria for the evaluation of substitutes, refer to the initial SNAP rulemaking published in the
This action presents EPA's most recent decision to list as acceptable several substitutes in the refrigeration and air conditioning sector and the cleaning solvents sector. New substitutes are:
• Hydrofluorocarbon (HFC)-134a in residential and light commercial air conditioning and heat pumps (retrofit equipment);
• Hydrofluoroether (HFE)-7300 in non-mechanical heat transfer systems (new and retrofit equipment);
• R-407H in retail food refrigeration—remote condensing units (new and retrofit equipment);
• R-442A in retail food refrigeration—remote condensing units (new and retrofit equipment);
• R-448A in multiple refrigeration and air conditioning end-uses (new and retrofit equipment);
• R-449A in multiple refrigeration and air conditioning end-uses (new and retrofit equipment);
• R-449B in multiple refrigeration and air conditioning end-uses (new and retrofit equipment);
• R-452A in multiple refrigeration and air conditioning end-uses (new and retrofit equipment);
• R-452C in multiple refrigeration and air conditioning end-uses (new and retrofit equipment);
• R-453A in multiple refrigeration and air conditioning end-uses (new and retrofit equipment);
• R-458A in multiple refrigeration and air-conditioning end-uses (new and retrofit equipment);
• R-513A in residential dehumidifiers (new and retrofit equipment); and
• HFE-7300 in electronics cleaning, metals cleaning, and precision cleaning end-uses.
EPA's review of certain substitutes listed in this document is pending for other uses. Listing in the end-uses and applications in this document does not prejudge EPA's listings of these substitutes for other uses. For many of the substitutes being added through this document to the acceptable lists for specific end-uses, there are other listed substitutes for the end-use whose overall risk is comparable except that they have a lower risk in one SNAP criterion, for example toxicity or atmospheric effects. However, for the end-uses addressed in this action, those alternatives have not yet proven feasible in those specific end-uses. If alternatives that pose significantly less overall risk—either those currently listed or new alternatives added to the list—are demonstrated in the future as feasible for one or more of the relevant end-uses, EPA may evaluate whether to change the listing status of the substitutes addressed in this document.
For copies of the full list of acceptable substitutes for ozone depleting substances (ODS) in all industrial sectors, visit the SNAP portion of EPA's Ozone Layer Protection Web site at
The sections below discuss each substitute listing in detail. Appendix A contains tables summarizing today's listing decisions for these new substitutes. The statements in the “Further Information” column in the tables provide additional information but are not legally binding under section 612 of the Clean Air Act (CAA). In addition, the “Further Information” column may not include a comprehensive list of other legal obligations you may need to meet when using the substitute. Although you are not required to follow recommendations in the “Further Information” column of the table to use a substitute consistent with section 612 of the CAA, some of these statements may refer to obligations that are enforceable or binding under federal or state programs other than the SNAP program. In many instances, the information simply refers to standard operating practices in existing industry standards and/or building codes. When using these substitutes, EPA strongly encourages you to apply the information in this column. Many of these recommendations, if adopted, would not require significant changes to existing operating practices.
You can find submissions to EPA for the substitutes listed in this document, as well as other materials supporting the decisions in this action, in Docket EPA-HQ-OAR-2003-0118 at
HFC-134a is also known as R-134a, or 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2). EPA has previously listed HFC-134a as acceptable for use in residential and light commercial air conditioning and heat pumps in new equipment, as well as in a number of other end-uses and sectors.
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
The American Industrial Hygiene Association (AIHA) has established a workplace environmental exposure limit (WEEL) of 1,000 ppm as an eight-hour time-weighted average (8-hr TWA) for HFC-134a. EPA anticipates that users will be able to meet the AIHA WEEL and address potential health risks by following requirements and recommendations in the manufacturer's Safety Data Sheet (SDS), in the American Society for Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 15, and other safety precautions common to the refrigeration and air conditioning industry.
HFC-134a has a GWP of 1,430. All other substitutes listed as acceptable for residential and light commercial air conditioning and heat pumps in retrofit equipment have higher GWPs than HFC-134a, such as R-407C, R-438A, and R-507A with GWPs ranging from 1,770 to 3,990.
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds HFC-134a acceptable in the end-use listed above, because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.
HFE-7300 is also known as 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane (CAS Reg. No. 132182-92-4) and goes by the trade name of 3M
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
EPA anticipates that HFE-7300 will be used in a manner consistent with the recommendations specified in the SDS. The manufacturer recommends an acceptable exposure limit (AEL) of 100 ppm on an 8-hour TWA. EPA anticipates that users will be able to meet the manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS and in any other safety precautions common to the refrigeration and air conditioning industry.
For non-mechanical heat transfer systems, HFE-7300's GWP of 310 is lower than or comparable to that of acceptable substitutes, such as HFE-7100, HFC-245fa, and HFC-236fa with GWPs ranging from about 300 to 9,810. HFE-7300's GWP is higher than the GWPs of other acceptable substitutes in non-mechanical heat transfer systems, including C7 Fluoroketone, HFO-1234ze(E), and HFE-7200 with GWPs ranging from one to approximately 60.
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the manufacturer's AEL, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds HFE-7300 acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.
R-407H, marketed under the trade name D407, is a weighted blend of 52.5 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); 32.5 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); and 15 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
EPA anticipates that R-407H will be used in a manner consistent with the recommendations specified in the SDS. The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-134a, HFC-32, and HFC-125, the components of R-407H. The manufacturer recommends an AEL of 1,000 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet the manufacturer's AEL and the AIHA WEELs and to address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For retail food refrigeration—remote condensing units, R-407H's GWP of about 1,500 is lower than that of acceptable substitutes, such as R-407A, R-407C, R-407F, R-410B, and R-421A, with GWPs ranging from 1,770 to 2,630. R-407H's GWP is higher than the GWPs of other acceptable substitutes in retail food refrigeration—remote condensing units, including CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, manufacturer's AEL, ASHRAE 15, and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-407H acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.
R-442A, marketed under the trade name RS-50, is a weighted blend of 31 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 31 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 30 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); five percent HFC-227ea, which is also known as 1,1,1,2,3,3,3-heptafluoropropane (CAS Reg. No. 431-89-0); and three percent HFC-152a, which is also known as 1,1-difluoroethane (CAS Reg. No. 75-37-6).
EPA previously listed R-442A as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (May 17, 2013; 78 FR 29034).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, HFC-134a, HFC-227ea, and HFC-152a, the components of R-442A. The manufacturer of R-442A recommends an AEL of 1,000 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet the AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For retail food refrigeration—remote condensing units, R-442A's GWP of about 1,890 is lower than or comparable to that of acceptable substitutes, such as R-407A, R-407F, R-410B, and R-421A with GWPs ranging from 1,820 to 2,630. R-442A's GWP is higher than the GWPs of other acceptable substitutes in retail food refrigeration—remote condensing units, including CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15, and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-442A acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.
R-448A, marketed under the trade name Solstice® N-40, is a weighted blend of 26 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 26 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 21 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); 20 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No 754-12-1); and seven percent HFO-1234ze(E), which is also known as
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
EPA previously listed R-448A as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (
The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, and HFC-134a; 500 ppm for HFO-1234yf; and 800 ppm for HFO-1234ze(E), the components of R-448A. The manufacturer of R-448A recommends an AEL of 890 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet the AIHA WEELs and manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For cold storage warehouses, R-448A's GWP of 1,390 is lower than or comparable to that of acceptable substitutes, such as HFC-134a, R-407C, and R-407F, with GWPs ranging from 1,430 to 1,820. R-448A's GWP is higher than the GWPs of other acceptable substitutes for cold storage warehouses, including ammonia absorption, desiccant cooling, evaporative cooling, R-450A, and R-513A with GWPs ranging from zero to about 630.
For industrial process refrigeration, R-448A's GWP of 1,390 is lower than or comparable to that of acceptable substitutes, such as HFC-134a, R-404A, R-407C, and HFC-23 with GWPs ranging from 1,430 to 14,800. R-448A's GWP is higher than the GWPs of other acceptable substitutes for industrial process refrigeration, including ammonia absorption, ammonia vapor compression, Sterling cycle, CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-448A acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-449A, marketed under the trade name Opteon® XP 40, is a weighted blend of 24.3 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 24.7 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 25.7 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and 25.3 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 754-12-1).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
EPA previously listed R-449A as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (
The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, and HFC-134a and 500 ppm for HFO-1234yf, the components of R-449A. The manufacturer of R-449A recommends an AEL of 830 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the AIHA WEELs and the manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For cold storage warehouses, R-449A's GWP of 1,400 is lower than or comparable to that of acceptable substitutes, such as HFC-134a, R-407C, and R-407F with GWPs ranging from 1,430 to 1,820. R-449A's GWP is higher than the GWPs of other acceptable substitutes for cold storage warehouses, including ammonia absorption, desiccant cooling, evaporative cooling, R-450A, and R-513A with GWPs ranging from zero to about 630.
For industrial process refrigeration, R-449A's GWP of 1,400 is lower than or comparable to that of acceptable substitutes, such as HFC-134a, R-404A, R-407C, and HFC-23 with GWPs ranging from 1,430 to 14,800. R-449A's GWP is higher than the GWPs of other acceptable substitutes for industrial process refrigeration including ammonia absorption, ammonia vapor compression, Sterling cycle, CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-449A acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-449B, marketed under the trade name Forane® 449B, is a weighted blend of 25.2 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 24.3 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 27.3 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and 23.2 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 754-12-1).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
EPA previously listed R-449B as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (
The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, and HFC-134a and 500 ppm for HFO-1234yf, the components of R-449B. The manufacturer of R-449B recommends an AEL of 850 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the AIHA WEELs and the manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For cold storage warehouses, R-449B's GWP of 1,410 is lower than or
For industrial process refrigeration, many substitutes listed as acceptable have comparable or higher GWPs than R-449B's GWP of about 1,410, such as HFC-134a, R-404A, R-407C, and HFC-23 with GWPs ranging from 1,430 to 14,800; other substitutes listed as acceptable substitutes for industrial process refrigeration have a lower GWP including ammonia absorption, ammonia vapor compression, Sterling cycle, CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-449B acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-452A, marketed under the trade name Opteon® XP 44, is a weighted blend of 11 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 59 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); and 30 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoro-prop-1-ene (CAS Reg. No. 754-12-1).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
The AIHA has established WEELs for the components of R-452A of 1,000 ppm as an 8-hr TWA for HFC-32 and HFC-125, and of 500 ppm as an 8-hr TWA for HFO-1234yf. The manufacturer of R-452A recommends an AEL of 786 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For refrigerated transport—refrigerated trucks and trailers, R-452A's GWP of about 2,140 is lower than or comparable to that of acceptable substitutes, such as R-404A, R-507A, and a number of HFC refrigerant blends (with GWPs ranging from approximately 2,230 to 3,990). R-452A's GWP is higher than the GWPs of other acceptable substitutes for refrigerated transport, including CO
For retail food refrigeration—remote condensing units, R-452A's GWP of about 2,140 is lower than or comparable to that of acceptable substitutes, such as R-410B and R-421A, with GWPs ranging from 2,230 to 2,630. R-452A's GWP is higher than the GWPs of other acceptable substitutes in retail food refrigeration—remote condensing units, including CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-452A acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-452C, marketed under the trade name Forane® 452C, is a weighted blend of 12.5 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 61 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); and 26.5 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoro-prop-1-ene (CAS Reg. No. 754-12-1).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
The AIHA has established WEELs for the components of R-452C of 1,000 ppm as an 8-hr TWA for HFC-32 and HFC-125 and 500 ppm for HFO-1234yf. EPA anticipates that users will be able to meet each of the AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For refrigerated transport—refrigerated trucks and trailers, R-452C's GWP of about 2,220 is lower than or comparable to that of acceptable substitutes, such as R-404A, R-507A, and a number of HFC refrigerant blends (with GWPs ranging from approximately 2,230 to 3,990). R-452C's GWP is higher than the GWPs of other acceptable substitutes for refrigerated transport, including CO
For retail food refrigeration—remote condensing units, R-452C's GWP of about 2,220 is lower than or comparable to that of acceptable substitutes, such as R-410B and R-421A, with GWPs ranging from 2,230 to 2,630. R-452C's GWP is higher than the GWPs of other acceptable substitutes in retail food refrigeration—remote condensing units, including CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-452C acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-453A, marketed under the trade name RS-70, is a weighted blend of 20.0 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 20.0 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 53.8 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); five percent HFC-227ea, which is also known as 1,1,1,2,3,3,3-heptafluoropropane (CAS Reg. No. 439-89-0); 0.6 percent R-600, which is also known as butane (CAS Reg. No. 75-28-5); and 0.6 percent R-601a, which is also known as isopentane (CAS Reg. 78-78-4).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
For the components of R-453A, the AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, HFC-134a, and HFC-227ea, and the American Conference of Governmental Industrial Hygienists (ACGIH) has established a Threshold Limit Value (TLV) of 1,000 ppm for R-600 and a TLV of 600 ppm for R-601a, both as an 8-hr TWA. The manufacturer of R-453A recommends an AEL of 1,000 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the AIHA WEELs, the ACGIH's TLVs, and the manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For cold storage warehouses, R-453A's GWP of about 1,770 is lower than or comparable to that of acceptable substitutes, such as R-407C and R-407F, with GWPs ranging from 1,770 to 1,820. R-453A's GWP is higher than the GWPs of other acceptable substitutes for cold storage warehouses, including ammonia absorption, desiccant cooling, evaporative cooling, HFC-134a, R-450A, and R-513A with GWPs ranging from zero to 1,510.
For industrial process refrigeration, R-453A's GWP of about 1,770 is lower than or comparable to that of acceptable substitutes, such as R-404A, R-407C, and HFC-23 with GWPs ranging from 1,770 to 14,800. R-453A's GWP is higher than the GWPs of other acceptable substitutes for industrial process refrigeration, including ammonia absorption, ammonia vapor compression, Sterling cycle, CO
For retail food refrigeration—remote condensing units, R-453A's GWP of about 1,770 is lower than or comparable to that of acceptable substitutes, such as R-407A, R-407C, R-410B, and R-421A, with GWPs ranging from about 1,770 to 2,630. R-453A's GWP is higher than the GWPs of other acceptable substitutes in remote condensing units, including CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-453A acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-458A, marketed under the trade name Bluon TdX 20, is a weighted blend of 20.5 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 4.0 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 61.4 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); 13.5 percent HFC-227ea, which is also known as 1,1,1,2,3,3,3-heptafluoropropane (CAS Reg. No. 431-89-0); and 0.6 percent HFC-236fa, which is also known as 1,1,1,3,3,3-hexafluoropropane (CAS Reg. No. 690-39-1).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, HFC-134a, HFC-227ea, and HFC-236fa, the components of R-458A. EPA anticipates that users will be able to meet the AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15,
For industrial process refrigeration, R-458A's GWP of about 1,650 is lower than or comparable to that of acceptable substitutes, such as R-404A, R-407C, and HFC-23, with GWPs ranging from 1,770 to 14,800. R-458A's GWP is higher than the GWPs of other acceptable substitutes for industrial process refrigeration, including ammonia absorption, ammonia vapor compression, Sterling cycle, CO
For residential and light commercial air conditioning and heat pumps in retrofit equipment, R-458A's GWP of about 1,650 is lower than all other substitutes listed as acceptable, such as R-407C, R-438A, and R-507A, with GWPs ranging from 1,770 to 3,990.
For retail food refrigeration—remote condensing units, R-458A's GWP of about 1,650 is lower than that of acceptable substitutes, such as R-407A, R-407C, R-410B, and R-421A, with GWPs ranging from about 1,770 to 2,630. R-458A's GWP is higher than the GWPs of other acceptable substitutes in remote condensing units, including CO
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15, and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-458A acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
R-513A, marketed under the trade name Opteon® XP 10, is a weighted blend of 44 percent HFC-134a, which is also known as 1,1,1,2 tetrafluoroethane (CAS Reg. No. 811-97-2), and 56 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 754-12-1).
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
EPA previously listed R-513A as acceptable for use as a refrigerant in several refrigeration and air conditioning end-uses (May 23, 2016, 81 FR 32241; July 16, 2015, 80 FR 42053).
The AIHA has established WEELs of 1,000 ppm and 500 ppm as an 8-hour TWA for HFC-134a and HFO-1234yf, respectively, the components of R-513A. The manufacturer of R-513A recommends an AEL of 653 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the manufacturer's AEL and AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.
For residential dehumidifiers, R-513A's GWP of 630 is lower than that of other acceptable substitutes, such as HFC-134a, R-404A, R-407C, R-410A, and R-507A with GWPs ranging from 1,430 to 3,990.
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15, and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.
EPA finds R-513A acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.
HFE-7300 is also known as 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane (CAS Reg. No. 132182-92-4) and goes by the trade name of 3M
You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at
For both electronics cleaning and precision cleaning, HFE-7300's GWP of 310 is lower than or comparable to that of acceptable substitutes, such as HFE-7000, HFE-7100, HFC-365mfc, and HFC-43-10mee, with GWPs ranging from about 300 to 1,640. HFE-7300's GWP is higher than the GWPs of other acceptable substitutes for these end-uses, including acetone,
For metals cleaning, HFE-7300's GWP of 310 is lower than or comparable to that of acceptable substitutes, such as HFE-7100, HFC-365mfc and HFC-43-10mee, with GWPs ranging from about 300 to 1,640. HFE-7300's GWP is higher than the GWPs of other acceptable substitutes for this end-use including acetone,
Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the manufacturer's AEL, recommendations in the SDS, and other safety precautions common in the solvent cleaning industry.
EPA finds HFE-7300 acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.
Section 612 of the CAA requires EPA to develop a program for evaluating alternatives to ozone-depleting substances. EPA refers to this program as the Significant New Alternatives Policy (SNAP) program. The major provisions of section 612 are:
Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I substance (CFC, halon, carbon tetrachloride, methyl chloroform, methyl bromide, hydrobromofluorocarbon, and chlorobromomethane) or class II substance (HCFC) with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment, and (2) is currently or potentially available.
Section 612(c) requires EPA to publish a list of the substitutes unacceptable for specific uses and to publish a corresponding list of acceptable alternatives for specific uses. The list of “acceptable” substitutes is found at
Section 612(d) grants the right to any person to petition EPA to add a substance to, or delete a substance from, the lists published in accordance with section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.
Section 612(e) directs EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.
Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of such substances in key commercial applications.
Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.
On March 18, 1994, EPA published the initial SNAP rule (59 FR 13044) which established the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in the major industrial use sectors (subpart G of 40 CFR part 82). These sectors are the following: Refrigeration and air conditioning; foam blowing; solvents cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors comprise the principal industrial sectors that historically consumed the largest volumes of ODS.
Section 612 of the CAA requires EPA to list as acceptable those substitutes that do not present a significantly greater risk to human health and the environment as compared with other substitutes that are currently or potentially available.
Under the SNAP regulations, anyone who plans to market or produce a substitute to replace a class I substance or class II substance in one of the eight
The Agency has identified four possible decision categories for substitute submissions: Acceptable; acceptable subject to use conditions; acceptable subject to narrowed use limits; and unacceptable (40 CFR 82.180(b)).
After reviewing a substitute, the Agency may make a determination that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to minimize risks to human health and the environment. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of EPA's SNAP regulations (40 CFR 82.174(c)).
For some substitutes, the Agency may permit a narrowed range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. The Agency generally requires a user of a substitute subject to narrowed use limits to demonstrate that no other acceptable substitutes are available for their specific application.
The section 612 mandate for EPA to prohibit the use of a substitute that may present risk to human health or the environment where a lower risk alternative is available or potentially available”
As described in this document and elsewhere, including the initial SNAP rule published in the
In contrast, EPA publishes “notices of acceptability” or “determinations of acceptability,” to notify the public of substitutes that are deemed acceptable with no restrictions. As described in the
Many SNAP listings include “comments” or “further information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs (
For copies of the comprehensive SNAP lists of substitutes or additional information on SNAP, refer to EPA's Ozone Depletion Web site at:
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.
Federal Communications Commission.
Final rule.
In the document released June 6, 2017, the Media Bureau and the Wireless Telecommunications Bureau released instructions for filing applications in a filing window to be open from July 26, 2017, through August 2, 2017, in which certain AM station licensees and proposed assignees may seek new FM translator construction permits to retransmit the signals of the primary AM stations. In addition, the Media Bureau announced that it will not accept low-power FM and FM translator minor change construction permit applications and FM booster construction permit applications between July 19 and August 2, 2017. In the document released July 13, 2017, Commission staff announced that an online tutorial would be available for this auction, which is designated as Auction 99, and addressed a petition for clarification on an issue of applicant eligibility for this filing window opportunity.
From 12:01 a.m. Eastern Time (ET) on July 19, 2017, until midnight ET on August 2, 2017, there is a filing freeze for low-power FM and FM translator minor change construction permit applications and for FM booster construction permit applications. Starting at 12:01 a.m. ET on July 26, 2017, and prior to 6:00 p.m. on August 2, 2017, an eligible applicant may file its FCC Form 349. Starting at 9:00 a.m. ET on July 26, 2017, and prior to 6:00 p.m. ET on August 2, 2017, an eligible applicant may file its FCC Form 175.
About broadcast radio or FCC Form 349, James Bradshaw, Lisa Scanlan or Tom Nessinger in the Media Bureau's Audio Division at (202) 418-2700. About FCC Form 175 and competitive bidding rules, Lynne Milne in the Wireless Telecommunications Bureau's Auctions and Spectrum Access Division at (202) 418-0660. About general auction procedures, the Auctions Hotline at (717) 338-2868.
This is a summary of a public notice released on June 6, 2017, supplemented by a related public notice released on July 13, 2017. The complete texts of these documents are available for public inspection and copying from 8:00 a.m. to 4:30 p.m. ET Monday through Thursday or from 8:00 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th St. SW., Room CY-A257, Washington, DC 20554. The complete texts also are available on the Commission's Web site at
1. The Media Bureau will institute a freeze on the acceptance of FM booster construction permit applications, as well as minor change construction permit applications for FM translators or Low Power FM stations on all channels (channels 201-300) starting at 12:01 a.m. ET on July 19, 2017 until midnight ET on August 2, 2017. Any such applications filed during this freeze will be dismissed.
2. On June 6, 2017, the Media Bureau and the Wireless Telecommunications Bureau announced in a public notice (Filing Instructions Public Notice) details and filing instructions for certain AM broadcasters to apply for cross-service FM translator station construction permits in Auction 99. Eligibility for this filing opportunity is limited to any Class C or D AM station licensee or permittee, or the proposed assignee of such an AM station, wishing to file an application to establish a new cross-service FM translator to retransmit its AM station signal full time, provided that the AM primary station was not listed as the AM primary station in a FM translator modification application filed in either of the 2016 modification windows.
3. During this upcoming filing window, an applicant may propose only one cross-service FM translator for each Class C or D AM primary station to be rebroadcast. Any FM translator awarded through this filing window will only be authorized to rebroadcast the AM primary station identified in the applicant's FCC Form 349 Tech Box (or to originate nighttime programming during periods when a daytime-only AM primary station is not operating), on a permanent basis. The authorization for any FM translator station awarded through this filing window will be subject to a condition that it may not be assigned or transferred except in conjunction with the AM primary station that it rebroadcasts and with which it is commonly owned.
4. An eligible licensee or permittee, or proposed assignee if applicable, seeking a new cross-service FM translator for its AM station(s) must file electronically in the Media Bureau's Consolidated Database System (CDBS) prior to 6:00
5. Applicants must review carefully each Form 349 Tech Box submission for compliance with section 74.1201(g) and all other Commission technical rules relating to FM translator stations, as well as insuring that only one Form 349 is submitted for each qualified AM station. At the end of the initial filing window, if an applicant has filed more than one FM translator proposal (Form 349 Tech Box) designating the same AM primary station, only the first-filed FM translator engineering proposal (Form 349 Tech Box) will be considered. To avoid staff consideration of an unintended proposal, each applicant must carefully review its Forms 349 before submission, and delete each undesired engineering proposal that specifies the identical AM primary station. Any request to delete an undesired proposal must be emailed before the initial filing window closes to
6. After the August 2, 2017, application deadline, an Auction 99 applicant may only file a technical amendment during the settlement period to be specified in a future public notice. No amendment, technical or otherwise, to a cross-service FM translator Form 349 filed during this filing window will be accepted between the close of the application filing window on August 2, 2017, and the release of the public notice listing mutually exclusive (MX) FM translator engineering proposals (if the engineering proposal is MX) or the release of the public notice listing the non-mutually exclusive FM translator engineering proposals (if the engineering proposal is not MX). Additional instructions about the filing of a Form 349 in the upcoming filing window are provided in Attachment A of the Filing Instructions Public Notice.
7. Each eligible AM station licensee or permittee applicant, or proposed assignee if applicable, for a new FM translator station must file electronically via the FCC Auction System one FCC Form 175, an Application to Participate in an Auction, in compliance with the Commission's rules and the instructions provided in the Filing Instructions Public Notice. A Form 175 must be submitted and confirmed prior to 6:00 p.m. ET on August 2, 2017. The applicant name entered in the FCC Form 175 must be identical with the name of the licensee or permittee on the AM primary station license or construction permit, unless the applicant name is identical with the name of a pending or granted assignment application assignee, if applicable.
8. An individual or entity may not submit more than one FCC Form 175 during this filing window, regardless of the number of Forms 349 it files. As explained in the Filing Instructions Public Notice, the Bureaus waived for Auction 99 the prohibition of section 1.2105(a)(3) on the filing of more than one FCC Form 175 by entities with any of the same controlling interests, but will continue to apply the prohibition against the filing of more than one FCC Form 175 by the same individual or entity.
9. An applicant's one Form 175 must cover all proposed FM translator stations for which that applicant files a FCC Form 349 Tech Box. It is the applicant's responsibility to ensure that the CDBS-assigned file number(s) and facility identification (ID) number(s) from its Form(s) 349 are entered accurately in the View/Edit Engineering Proposals section of the applicant's Form 175. Any inaccuracy in data entry in the Form 175 of the CDBS-assigned file number(s) or facility ID number(s) could result in the Form 349 being excluded from auction processing. Also, any Form 349 submitted during the initial filing window that is not referenced on that applicant's Form 175 will be dismissed in CDBS.
10. Commission staff will not consider any proposal for which the required information is not on file by the close of the initial application filing window. No consideration will be given to the following: (a) Any application for which both a FCC Form 175 and a complete FCC Form 349 proposal are not on file by the close of the initial application filing window; (b) any proposal filed by an applicant that is not a licensee or permittee, or proposed assignee if applicable, of a Class C or D AM broadcast station (including but not limited to any proposal filed by the licensee or permittee of a Class A or B AM broadcast station); (c) any proposal designating an AM primary station that was designated as the primary station on any application filed in either of the 2016 modifications windows; or (d) any proposal that specifies a channel in the reserved FM broadcast band (Channels 200-220, 88.1-91.9 MHz).
11. Each prospective Auction 99 applicant must review carefully the instructions provided about completing and submitting a FCC Form 175 in the Filing Instructions Public Notice, including guidance in Attachments A and B to that document. This Filing Instructions Public Notice provided specific information about reporting authorized bidders, the disclosure of agreements relating to construction permits subject to Auction 99, disclosure requirements for applicant owners and controlling interests, and provisions regarding a current and former default or delinquency. For example, Commission rules prohibit an individual from serving as an authorized bidder for more than one auction applicant.
12. Further, the interests of the applicant, and of any individual or entity with an attributable interest in the applicant, in other media of mass communications are considered as of the initial Form 175 filing deadline when determining an applicant's eligibility for a new entrant bidding credit. Events occurring after this filing deadline, however, may cause diminishment or loss of bidding credit eligibility, and must be reported immediately.
13. The description in the Filing Instructions Public Notice of the noncommercial education (NCE) status election included a warning that if an FCC Form 175 identifies the application's proposed FM translator as noncommercial educational and that NCE engineering proposal is mutually exclusive with any engineering proposal for a commercial station, the NCE engineering proposal (Form 349) will be returned as unacceptable for filing. Each prospective applicant should consider carefully if it wishes to propose NCE operation for any FM translator acquired in this auction. This NCE election cannot be reversed after the initial application filing deadline on August 2, 2017.
14. After the initial application filing deadline, an applicant will be permitted to make only minor modifications to its FCC Form 175 and major modifications are not permitted. For example, a claim of eligibility for a higher percentage of bidding credit will not be permitted after the initial application filing
15. Each applicant has a continuing obligation to maintain the accuracy and completeness of information furnished in its pending FCC Form 175, including any change that may cause a loss of or reduction in the percentage of bidding credit requested previously. An auction applicant must file additional or corrected information within five days after a significant occurrence or amend its FCC Form 175 no later than five days after the applicant becomes aware of the need for amendment. An applicant's obligation to make modifications to a pending FCC Form 175 continues after these five days. An applicant is obligated to amend its pending application even if a reported change is considered to be a major modification that may result in the dismissal of its application.
16. Prospective applicants should study carefully the explanations in the Filing Instructions Public Notice concerning prohibited communication by an auction applicant contained in sections 1.2105(c) and 73.5002. For example, an applicant is defined in section 1.2105(c) for purposes of these prohibitions to include each officer and each director of the applicant, each controlling interest of the applicant, and each holder of an ownership interest in the applicant of 10 percent or more. The Filing Instructions Public Notice provided further details concerning an impermissible communication, including a reminder of the duty to report immediately a communication that appears to violate section 1.2105(c). If mutual exclusivity (MX) is determined to exist for any engineering proposals submitted during this filing window, the Bureaus will announce a subsequent period during which this prohibition will be suspended for the purpose of resolving MX conflicts. Until such time, however, these prohibited communication rules remain in effect for Auction 99 from 6:00 p.m. on August 2, 2017, until the down payment deadline which will be announced in a future public notice.
17. If any FM translator engineering proposals filed during this announced window are determined to be MX and such MX is not resolved through a future opportunity for settlement or technical amendment, the Commission will resolve MX engineering proposals for commercial stations through competitive bidding.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS announces that the 2017 summer flounder commercial quota allocated to the Commonwealth of Massachusetts has been harvested. Vessels issued a commercial Federal fisheries permit for the summer flounder fishery may not land summer flounder in Massachusetts for the remainder of calendar year 2017, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise Massachusetts that the quota has been harvested and to advise vessel permit holders and dealer permit holders that no Federal commercial quota is available for landing summer flounder in Massachusetts.
Effective 0001 hours, July 20, 2017 through December 31, 2017.
Cynthia Hanson, (978) 281-9180, or
Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102.
The initial commercial quota for summer flounder for the 2017 calendar year was set equal to 5,658,260 lb (2,566,544 kg) (81 FR 93842, December 22, 2016). The percent allocated to vessels landing summer flounder in Massachusetts is 6.82046 percent, resulting in a commercial quota of 385,988 lb (175,081 kg). Massachusetts has not received any quota transfers in 2017 that would cause the initial commercial quota to be adjusted.
The NMFS Administrator for the Greater Atlantic Region (Regional Administrator), monitors the state commercial landings and determines when a state's commercial quota has been harvested. NMFS is required to publish notification in the
Section 648.4(b) provides that Federal permit holders agree, as a condition of the permit, not to land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, July 20, 2017, landings of summer flounder in Massachusetts by vessels holding summer flounder commercial Federal fisheries permits are prohibited for the remainder of the 2017 calendar year, unless additional quota becomes available through a transfer and is announced in the
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest. This action closes the commercial summer flounder fishery for Massachusetts until January 1, 2018, under current regulations. The regulations at § 648.103(b) require such action to
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule invites comments on the establishment of reporting requirements under the Federal marketing order for pecans (order). The American Pecan Council (Council) locally administers the order and is comprised of growers and handlers of pecans operating within the production area and a public member. This action would require all pecan handlers to submit two forms to the Council: One for inter-handler transfers and another that includes year-end inventory and pecans handled throughout the year. The Council would use this information to facilitate assessment collection and provide valuable reports to the industry, including the annual marketing policy required by the order. This proposal also announces the Agricultural Marketing Service's (AMS) intention to request approval from the Office of Management and Budget (OMB) of a new information collection.
Comments must be received by September 19, 2017. Pursuant to the Paperwork Reduction Act, comments on the information collection burden must be received by September 19, 2017.
Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This proposal is issued under Marketing Agreement and Order No. 986, (7 CFR part 986), regulating the handling of pecans grown in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175.
This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) has exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled ‘Reducing Regulation and Controlling Regulatory Costs’ ” (February 2, 2017).
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This proposed rule would establish reporting requirements under the order. This action would require all pecan handlers to submit to the Council reports of inter-handler transfers of pecans, inventory, and a summary of pecans handled. This information would be used to facilitate assessment collection and provide valuable reports to the industry, including the annual marketing policy required by the order. This proposal was unanimously recommended by the Council at its April 17, 2017, meeting.
Section 986.61 of the order requires all handlers warehousing pecans as of August 31 be identified as the handler of those pecans and pay the assessment rate accordingly. Section 986.62 provides the Council, with the approval of the Secretary, authority to establish methods and procedures, including
At its November 16, 2016 meeting, the first meeting following the order's promulgation, the Council discussed its initial budget, assessment rates, and necessary reporting requirements in order to set up a program that is efficient and responsive to industry needs. During these discussions, the Council established a Statistics and Reporting Committee (Committee) to develop reporting requirements.
Members of the Committee discussed the reporting needs of the industry, reviewed examples of reporting forms from other marketing orders, and met and worked with the staff of another marketing order in developing the proposed reporting requirements. The Committee also worked with USDA to ensure the recommended information collection would provide the information necessary to facilitate the administration of the order.
At its February 23, 2017 meeting, the Council reviewed drafts of seven reporting forms as developed and recommended by the Committee. The Council expressed its interest in having as much electronic reporting as possible, but recognized that many handlers may prefer a paper submission. The Council also considered the timing of when forms would be due and submission dates that would work for all parts of the industry. After a thorough review and some modifications, seven forms were approved by the Council.
At a meeting on April 17, 2017, the Council revisited the recommended reporting requirements and the accompanying forms. Acknowledging the industry was more than halfway through the fiscal year at that time, the Council took action to move forward with the minimum reports necessary to facilitate the collection of assessments and to provide the other information needed for the 2016-17 fiscal year. Specifically, the Council voted to utilize two forms for the current fiscal year, one focusing on inter-handler transfers, and one containing information regarding year-end inventory and pecans handled throughout the fiscal year. The Council agreed it still wanted to move forward with all seven forms for the 2017-18 fiscal year, but considered year-end reporting on two forms as the most viable option for this fiscal year. The remaining five forms will be proposed in a subsequent rulemaking action.
This proposed rule would add two new reporting requirements and two new forms to the rules and regulations under the order by adding §§ 986.162 and 986.175. The pecan industry includes a subset of handlers, defined in the order as accumulators, who compile pecans for the purpose of resale or transfer to another handler. Additionally, small handlers may also sell or transfer pecans to other handlers. During the formal rulemaking hearing, the industry expressed concern that it may be difficult to track pecans moved through accumulators or transferred between handlers. Further, some handlers and accumulators that are small operations may find reporting, recordkeeping, and paying assessments burdensome.
The report of inter-handler transfers would include information on the month of transfer, type of pecans transferred, the volume transferred, the amount of assessments owed on the pecans transferred, identification information and signatures of the two handlers involved, and whether the transferring handler or receiving handler would be responsible for reporting and paying the assessments. This report would help ensure that transferred pecans are not counted twice for volume reporting purposes and would help facilitate the collection of assessments. It would also allow receiving handlers to assume the reporting burden from smaller entities and ensure payment of corresponding assessments.
The Council selected the tenth day of the month following the month of transfer as the due date for reports of inter-handler transfers. Should the tenth day of the month fall on a weekend or holiday, reports would be due by the first business day following the tenth day of the month. However, given that the current season began October 1, 2016, for the 2016-17 fiscal year, all inter-handler transfer forms would need to be submitted by Monday, September 11, 2017. For subsequent fiscal years, reports of inter-handler transfers would be due on a monthly basis as specified above.
In order to correctly collect assessments, provide industry data, and complete a marketing policy for the coming fiscal year, the Council requires accurate reports of what has been handled and what is in inventory going into the next fiscal year. Based on Council discussions, it is also important for the industry to know the variety and form of the pecan in inventory. This information would be vital to the industry as it enters the next harvest, as the amount and type of inventory impacts prices of the new crop. Collection of this data was one of the industry's goals in promulgating the order, as currently there is no source for this type of information across the 15-state production area. This information would be captured in the year-end inventory report.
The year-end inventory report would include information on the handler submitting the form, total pounds by type of pecans inshell and shelled in inventory, inventory committed but not shipped for both export and domestic, and any uncommitted inventory. It would also include information on pecans handled throughout the year, as well as data for total inventory including both shelled and inshell, with shelled volume converted to an inshell basis using the conversion specified in the order (volume shelled × 2). In addition, it would include information regarding total assessments owed, assessments paid to date, and remaining assessments due for that handler.
The order specifies that on August 31 of each year, every handler warehousing inshell pecans shall be identified as the first handler of those pecans and shall be required to pay the required assessment rate. The order also specifies that the marketing policy include an estimate of the handler inventory as of August 31. Consequently, the Council selected September 10 as the due date for the year-end inventory report, or the first business day following the tenth of September should the tenth fall on a weekend or a holiday. The Council believes this would give all handlers sufficient time to submit the information to the Council after August 31. Further, handlers would be required to pay to the Council all remaining unpaid assessments by the due date of the year-end inventory report.
This action would require all pecan handlers to provide the Council with reports of any inter-handler transfers, year-end inventory, and pecans handled throughout the year. This information would facilitate assessment collections, provide valuable reports to the industry,
The Council also recommended additional reporting requirements, which would be effective for the 2017-18 fiscal year. These requirements are being considered under a separate action.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to determine whether the regulatory action will have a significant economic impact on a substantial number of small entities and to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 2,500 growers of pecans in the production area and approximately 250 handlers subject to regulation under the marketing order. Small agricultural growers are defined by the Small Business Administration as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to information from the National Agricultural Statistics Service (NASS), the average grower price for pecans during the 2015-16 season was $2.20 per pound and 254 million pounds were utilized. The value for pecans that year totaled $558.8 million ($2.20 per pound multiplied by 254 million pounds). Taking the total value of production for pecans and dividing it by the total number of pecan growers provides an average return per grower of $223,520. Using the average price and utilization information, and assuming a normal bell-curve distribution of receipts among growers, the majority of growers receive less than $750,000 annually.
Evidence presented at the formal rulemaking hearing indicates an average handler margin of $0.58 per pound. Adding this margin to the average grower price of $2.20 per pound of inshell pecans results in an estimated handler price of $2.78 per pound. With a total 2015 production of 254 million pounds, ($2.78 per pound multiplied by 254 million pounds) the total value of production in 2015 was $706.12 million. Taking the total value of production for pecans and dividing it by the total number of pecan handlers provides an average return per handler of $2,824,480. Using this estimated price, the utilization volume, number of handlers, and assuming a normal bell-curve distribution of receipts among handlers, the majority of handlers have annual receipts of less than $7,500,000. Thus, the majority (a substantial number) of growers and handlers of pecans grown in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas may be classified as small entities.
This proposed rule would establish reporting requirements under the order. This action would require all pecan handlers to provide the Council with reports of any inter-handler transfers, year-end inventory, and pecans handled throughout the year. This information would facilitate the Council's collection of assessments and provide valuable reports to the industry. This rule would establish new §§ 986.162 and 986.175 under the rules and regulations of the order. The authority for this action is provided for in §§ 986.62, 986.75, 986.76, 986.77, and 986.78 of the order.
Requiring reports of transfers, handler inventory, and pecans handled throughout the year would impose an increase in the reporting burden on all pecan handlers. However, this data is already recorded and maintained by handlers as a part of their daily business. Handlers, regardless of size, should be able to readily access this information. Consequently, any additional costs associated with this change would be minimal (not significant) and apply equally to all handlers.
This action should also help the entire industry by providing comprehensive data on pecans handled and year-end inventory. Collection of this data was one of the industry's goals in promulgating the order as there is no other source for this type of data. This information would help with marketing and planning for the industry, as well as provide important information for the collection of assessments and in preparing the annual marketing policy required by the order. The benefits of this rule are expected to be equally available to all pecan growers and handlers, regardless of their size.
The Council discussed other alternatives to this action, including having additional reporting requirements, but determined that in order to efficiently carry out the objectives of the marketing order this first fiscal year, the information collected in these two reports would be sufficient. The Council also considered requiring the inter-handler transfer form to be submitted for each transfer. However, the Council determined that could be burdensome for some handlers and a monthly report would provide the necessary documentation. Therefore, the alternatives were rejected.
This proposal would establish two new reporting requirements and would require two new Council forms. Therefore, this proposed rule would impose an increase in the reporting burden for all handlers, which is discussed in the Paperwork Reduction Act section of this document.
As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
Further, the Council's meetings were widely publicized throughout the pecan industry and all interested persons were invited to attend the meetings and participate in Council deliberations on all issues. Additionally, the Council's Committee meetings held February 23, 2017, and April 17, 2017, were also public meetings and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 60-day comment period is provided to allow interested persons to respond to this proposal. All written comments
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), this notice announces AMS's intent to request approval from the Office of Management and Budget (OMB) for a new information collection under OMB No. 0581—NEW. It will be merged with the forms currently approved under OMB No. 0581-0291 “Federal Marketing Order for Pecans.”
On April 17, 2017, the Council unanimously recommended that all pecan handlers covered under the order provide the Council with a record of any inter-handler transfers by type and volume. This form, titled “Report of Inter-Handler Transfers of Pecans”, would be submitted directly to the Council by handlers by the tenth day of the month following the transfer(s).
This information collection would improve the accuracy of the Council's data collection by accounting for transferred pecans, and allow smaller handlers to transfer reporting and assessment obligations to another handler.
The Council also recommended that all handlers covered under the order submit an annual report of inventory held by type as well as a summary of pecans handled for the year. This form, titled “Year End Inventory Report”, would be submitted directly to the Council by handlers by September 10. This information collection will facilitate the Council's collection of assessments needed to administer the program and provide necessary data for the industry on volume handled. It would also provide the volume in inventory going into the next fiscal year, which would assist with market planning and provide information for the marketing policy required by the order.
The information collected would only be used by authorized representatives of the USDA, including the AMS Specialty Crops Program regional and headquarters staff, and authorized employees of the Council. Authorized Council employees would be the primary users of the information, and the AMS would be the secondary users. The Council's staff would compile the information and utilize it to account for assessments due, to calculate total pecans handled, and to prepare a marketing policy as required under the order. All proprietary information would be kept confidential in accordance with the Act and the order.
The proposed request for new information collection under the order is as follows:
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) 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) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments should reference OMB No. 0581-NEW and the Marketing Order for Pecans Grown in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas, and should be sent to the USDA in care of the Docket Clerk at the previously-mentioned address or at
All responses to this notice will be summarized and included in the request for OMB approval. All comments received will become a matter of public record and will be available for public inspection during regular business hours at the address of the Docket Clerk or at
If this proposed rule is finalized, this information collection will be merged with the forms currently approved under OMB No. 0581-0291 “Federal Marketing Order for Pecans.”
Marketing agreements, Nuts, Pecans, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 986 is proposed to be amended as follows:
7 U.S.C. 601-674.
(a) Inter-handler transfers of inshell pecans, pursuant to § 986.62, shall be reported to the Council on APC Form 4. Handlers shall file reports by the tenth day of the month following the month of transfer. Should the tenth day of the month fall on a weekend or holiday, reports are due by the first business day following the tenth day of the month; Provided, that for the 2016-17 fiscal year, all inter-handler transfer forms
(1) Month of transfer;
(2) The type and weight of pecans transferred;
(3) The amount of assessments owed on the pecans transferred;
(4) The names and signatures for both the transferring and receiving handlers;
(5) Handler assuming the reporting and assessment obligations on the pecans transferred.
(a) Handlers shall submit to the Council a year-end inventory report following August 31 each fiscal year. Handlers shall file such reports by September 10. Should September 10 fall on a weekend, reports are due by the first business day following September 10. Such reports shall be reported to the Council on APC Form 7 and include:
(1) The name and address of the handler;
(2) The total weight and type of inshell pecans in inventory, regardless of country of origin;
(3) The total weight and type of shelled pecans in inventory, regardless of country of origin;
(4) The total weight and type of inshell pecans committed, not shipped, for export and domestic shipments, and any uncommitted inventory, regardless of country of origin;
(5) The total weight and type of shelled pecans committed, not shipped, for export and domestic shipments, and any uncommitted inventory, regardless of country of origin;
(6) The combined total inventory for inshell and shelled pecans calculated on an inshell basis, and combined weight committed, not shipped, for exports and domestic shipments, and any uncommitted inventory;
(7) Total weight and type of domestic pecans handled for the fiscal year;
(8) Total assessments owed, assessments paid to date, and remaining assessments due to be paid by the due date of the year-end inventory report for the fiscal year.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class E airspace extending up to 700 feet above the surface at Seward Municipal Airport, Seward, NE., to accommodate new standard instrument approach procedures for instrument flight rules (IFR) operations at the airport. This action is necessary due to the decommissioning of the Seward non directional radio beacon (NDB), and cancellation of NDB approach, and would enhance the safety and management of IFR operations at the airport.
Comments must be received on or before September 5, 2017.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone (202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No. FAA-2017-0354 and Airspace Docket No. 17-ACE-8, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11A, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Walter Tweedy (prepare by Ron Laster), Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5802.
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 amend controlled airspace in Class E.
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-2017-0354/Airspace Docket No. 17-ACE-8.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A
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
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A 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 modifying Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Seward Municipal Airport. The segments within 4 miles each side of the 166° bearing from the Seward NDB extending from the 6.4-mile radius to 14 miles southeast of the NDB, and within 4 miles each side of the 359° bearing from the Seward NDB extending from the 6.4-mile radius to 13 miles north of the NDB, would be modified due to the decommissioning of the Seward NDB and cancellation of the NDB approach. This action would enhance the safety and management of the standard instrument approach procedures for IFR operations at the airport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, 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 proposed 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 proposed 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.
The airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Seward Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class E airspace extending upward from 700 feet above the surface at Schenck Field, Clarinda, IA. The FAA is proposing this action due to the decommissioning of the Clarinda non-directional radio beacon (NDB) and the cancellation of the associated instrument approach procedures. This action would enhance the safety and management of instrument flight rules (IFR) operations at this airport.
Comments must be received on or before September 5, 2017.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone (202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No. FAA-2017-0536; Airspace Docket No. 17-ACE-10 at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 amend Class E airspace extending upward from 700 feet above the surface at Schenck Field, Clarinda, IA, to support IFR operations at this airport.
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-2017-0536/Airspace Docket No. 17-ACE-10.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
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
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A 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 modifying the Class E airspace extending upward from 700 feet above the surface at Schenck Field, Clarinda, IA, by removing the Clarinda NDB from the legal description; removing the extension south of the airport; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.
Airspace reconfiguration is necessary due to the decommissioning of the Clarinda NDB, the cancellation of the associated instrument approach procedures, and to bring the airspace in compliance with FAA Order JO 7400.2L, Procedures for Handling Airspace Matters. Controlled airspace is necessary for the safety and management of standard instrument approach procedures for IFR operations at this airport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, 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 proposed 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 proposed 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
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 Schenck Field.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Augusta, AR. Controlled airspace is necessary to accommodate new special instrument approach procedures developed at Woodruff County Airport, for the safety and management of instrument flight rules (IFR) operations at the airport.
Comments must be received on or before September 5, 2017.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2016-9274; Airspace Docket No. 15-ASW-18, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Rebecca Shelby, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5857.
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 extending up to and including 700 feet above the surface at Woodruff County Airport, Augusta, AR, to support special instrument approach procedures for IFR operations at the airport.
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-2016-9274/Airspace Docket No. 15-ASW-18.” 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
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A 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 6.4-mile radius of Woodruff County Airport, Augusta, AR, to accommodate new special instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, 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 6.4-mile radius of Woodruff County Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to remove the Notice to Airmen (NOTAM) part-time status from the legal description of the Class E airspace area designated as an extension at Elizabeth City CGAS/Regional Airport, Elizabeth City, NC, and add NOTAM part-time language information to Class E surface area airspace. This proposal would bring the airspace descriptions in line with the airspace hours listed in the applicable Chart Supplement. This action also would update the geographic coordinates of the airport and the Woodville non-directional radio beacon (NDB) in the associated Class D and E airspace. Also, an editorial change would be made to the Class D and E surface area airspace legal descriptions replacing Airport/Facility Directory with the term Chart Supplement.
Comments must be received on or before September 5, 2017.
Send comments on this proposal to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg. Ground Floor Rm. W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or 202-366-9826. You must identify the Docket No. FAA-2016-0384; Airspace Docket No. 17-ASO-14, at the beginning of your comments. You may also submit and review received comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone 404 305-6364.
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 amend Class D and Class E airspace at Elizabeth City CGAS/Regional Airport, Elizabeth City, NC, to ensure the efficient use of airspace within the National Airspace System.
Interested persons are invited to comment on this rule 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. You may also submit comments through the Internet at
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-0384; Airspace Docket No. 17-ASO-14.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded from and comments submitted through
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by eliminating the NOTAM information that reads, “This Class D airspace is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.” from the regulatory text of Class E airspace designated as an extension to Class D, Elizabeth City CGAS/Regional Airport, Elizabeth City, NC.
This proposal also would add NOTAM part-time status information to the regulatory text in Class E surface area airspace. This would bring the airspace descriptions in Order 7400.11A in line with the airspace hours listed in the applicable Chart Supplement. Additionally, the geographic coordinates of the airport and Woodville NDB would be adjusted to coincide with the FAAs aeronautical database.
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. 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 proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal would 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).
In consideration of the foregoing, 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 the surface to and including 2,500 feet within a 4.1-mile radius of Elizabeth City CGAS/Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
Within a 4.1-mile radius of Elizabeth City CGAS/Regional Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within 1.6 miles each side of Elizabeth City VOR/DME 189° radial, extending from the 4.1-mile radius of Elizabeth City CGAS/Regional Airport to 9.5 miles south of the VOR/DME; within 3.3 miles each side of Elizabeth City VOR/DME 357° radial, extending from the 4.1-mile radius of Elizabeth City CGAS/Regional Airport to 7 miles north of the VOR/DME; within 1.2 miles each side of the 079° bearing from the Woodville NDB, extending from 4.1-mile radius of the airport to the NDB.
That airspace extending upward from 700 feet above the surface within a 7-mile radius of Elizabeth City CGAS/Regional Airport, and within 8 miles east and 4 miles west of Elizabeth City VOR/DME 189° radial, extending from the VOR/DME to 9.5 miles south of the VOR/DME.
Securities and Exchange Commission.
Proposed rule.
The Securities and Exchange Commission (“Commission”) proposes for comment an amendment to Rule 146 under Section 18 of the Securities Act of 1933 (“Securities Act”), as amended, to designate certain securities on Investors Exchange LLC (“IEX” or “Exchange”) as covered securities for purposes of Section 18(b) of the Securities Act. Covered securities under Section 18(b) of the Securities Act are exempt from state law registration requirements.
Comments should be received on or before August 21, 2017.
Comments may be submitted by any of the following methods:
Richard Holley III, Assistant Director; Edward Cho, Special Counsel; or Michael Ogershok, Attorney-Adviser, Office of Market Supervision, at (202) 551-5777, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-7010.
In 1996, Congress amended Section 18 of the Securities Act to exempt from state registration requirements securities listed, or authorized for listing, on the New York Stock Exchange LLC (“NYSE”), the American Stock Exchange LLC (“Amex”) (now known as NYSE American LLC),
In 1998, the Chicago Board Options Exchange, Incorporated (“CBOE”), the Pacific Exchange, Inc. (“PCX”) (now known as NYSE Arca, Inc.), the Philadelphia Stock Exchange, Inc. (“Phlx”) (now known as NASDAQ PHLX LLC),
Accordingly, Rule 146(b) lists those national securities exchanges, or segments or tiers thereof, that the Commission has determined to have listing standards that are “substantially similar” to those of the Named Markets and thus securities listed on such exchanges are deemed Covered Securities.
The Commission has since amended Rule 146(b) several times in response to petitions after having determined that the listing standards for securities listed, or authorized for listing, on the petitioning markets were substantially similar to those of the Named Markets and, accordingly, that such securities listed pursuant to such listing standards qualified as Covered Securities for purposes of Section 18(b) of the Securities Act.
In June 2016, the Commission granted the application of IEX to become a registered national securities exchange.
Subsequent to its exchange registration, IEX petitioned the Commission to amend Rule 146(b) and determine that the listing standards for securities listed on IEX are substantially similar to those of the Named Markets, such that IEX listed securities would be Covered Securities under Section 18(b) of the Securities Act.
For the reasons discussed below, the Commission preliminarily believes that IEX's listing standards are substantially similar to those of the Named Markets and, therefore, securities listed, or authorized for listing, on IEX would be eligible to be designated as Covered Securities under Rule 146(b)(1) under the Securities Act, which, as described above, are exempt from state law registration requirements. The
Under Section 18(b)(1)(B) of the Securities Act,
The Commission has reviewed the listing standards for securities to be listed and traded on IEX and, for the reasons discussed below, preliminarily believes that the standards are substantially similar to those of the Named Markets.
The Commission preliminarily believes that IEX's initial and continued quantitative listing standards for its securities are substantively identical to, and thus substantially similar to, the initial and continued quantitative listing standards for securities listed on Nasdaq/NGM.
The Commission requests comment on whether IEX's quantitative listing rules are “substantially similar” to Nasdaq/NGM's listing rules.
The Commission preliminarily believes that IEX's initial and continued qualitative listing standards for its securities are substantively identical to, and thus substantially similar to, the qualitative listing standards for securities listed on Nasdaq/NGM, with the exception of IEX Rule 14.201 (Confidential Pre-Application Review of Eligibility), discussed below, which is substantively similar to rules of NYSE and NYSE American, and IEX Rule 14.414 (Internal Audit Function), also discussed below, which is substantively similar to a rule of NYSE.
With respect to the standards relating to the listing and delisting of companies, including prerequisites for initial and continued listing on IEX, obligations of security issuers listed on IEX, as well as rules describing the application and qualification process,
The Commission also notes that IEX's corporate governance standards in connection with securities to be listed and traded on IEX are virtually identical to, and thus the Commission preliminarily believes they are substantially similar to, the current rules of Nasdaq/NGM and NYSE.
The Commission requests comment on whether IEX's qualitative listing standards are “substantially similar” to Nasdaq/NGM's and NYSE's listing standards.
IEX has listing standards for other types of securities and exchange-traded derivative securities products, including, for example, portfolio depository receipts; index fund shares; securities linked to the performance of indexes, commodities, and currencies; index-linked exchangeable notes; partnership units; trust units; and managed fund shares.
The Commission requests comment on whether IEX's listing standards relating to other securities are “substantially similar” to Nasdaq/NGM's listing standards.
Paragraphs (b)(1) and (b)(2) of Rule 146 use the term “NYSE Amex” to refer to the national securities exchange formerly known as the American Stock Exchange LLC. As noted above, in 2012, NYSE Amex changed its name from NYSE Amex LLC to NYSE MKT LLC, and, in 2017, NYSE MKT LLC intends to change its name to NYSE American LLC.
To date, the Commission has not received any comment letters on the IEX Petition.
The Commission seeks comment generally on amending Rule 146(b) to include securities listed, or authorized for listing, on IEX. As discussed above, based on its review of IEX's listing standards, the Commission preliminarily believes that the initial and continued listing standards for IEX are substantially similar to those of the Named Markets. In addition to the questions posed above, commenters are welcome to offer their views on any other matter raised by the proposed amendment to Rule 146(b).
The Paperwork Reduction Act of 1995 does not apply because the proposed amendment to Rule 146(b) does not impose recordkeeping or information collection requirements or other collection of information, which require the approval of the Office of Management and Budget under 44 U.S.C. 3501
The Commission is sensitive to the economic consequences of its rules, including the benefits, costs, and effects on efficiency, competition, and capital formation. As noted above, the Commission preliminarily believes that the overall listing standards for securities to be listed and traded on IEX are substantially similar to those of a Named Market. As such, the Commission proposes to amend Rule 146 under Section 18 of the Securities Act, as amended, to designate securities listed, or authorized for listing, on IEX as Covered Securities. The following analysis considers the economic effects that may result from the proposed amendment.
Where possible, the Commission has quantified the economic effects of the proposed amendment; however, as explained further below, the Commission is unable to quantify all of the economic effects because it lacks the information necessary to provide reasonable estimates. In some cases, quantification depends heavily on factors outside of the control of the Commission, particularly due to the flexibility that an issuer has when choosing if and where to list and the flexibility of a registered national securities exchange to tailor its policies and rules to the nature of its business and technology. These factors make it difficult to quantify the changes in market share of Named and Designated Markets that may result from the proposed amendment. In addition, the incumbent Named and Designated Markets and IEX each may react to the proposed amendments with respect to listing fees and services. These reactions are also difficult to quantify or predict, which further complicates quantification of changes to market share, and also makes quantification of the economic effects of the proposed amendment difficult. Therefore, some of the discussions below are qualitative in nature. The Commission encourages commenters to provide data and information to help quantify the costs, benefits, and the potential impacts on efficiency, competition, and capital formation of the proposed amendment.
We compare the economic effects of the proposed rule, including benefits, costs, and effects on efficiency, competition, and capital formation, to a baseline that consists of the existing regulatory framework and market structure.
The listing standards of Named and Designated Markets are quantitative and qualitative requirements that issuers must satisfy before they may list on these markets. Securities listed on a Named or Designated Market are Covered Securities, which are exempt from complying with state securities law registration and qualification requirements. As mentioned above,
Pursuant to unlisted trading privileges (“UTP”), a national securities exchange such as IEX currently can trade securities that are listed on other exchanges.
The Commission lacks comprehensive, independent data to precisely estimate the total time, registration and compliance costs associated with state registration and qualification. Moreover, those total costs may vary widely for issuers depending on how many states an issuer needs to register in. To provide some information about potential costs for state registration, we list examples of Blue Sky registration filing fees for several states below in Table 1.
The issuer of a non-Covered Security in multiple jurisdictions would have more compliance obligations than the issuer of a Covered Security, including the potential for considerable additional costs and legal fees associated with reviews of offering-related materials at the state level.
In addition, the Commission preliminarily believes that the state registration and qualification requirements applicable to non-Covered Securities also impose costs on broker-dealers. Specifically, broker-dealers may incur costs to ensure that they are
The proposed amendment, which would make IEX a Designated Market, would preempt the application of state securities law registration and qualification requirements for securities that are listed or authorized for listing on IEX, and would impact (1) issuers who currently list their securities on a Named or Designated Market; (2) issuers with securities not currently listed on any incumbent Named or Designated Market but who would consider listing on IEX, or on an incumbent Named or Designated Market, as a result of the competition from IEX if IEX enters the listing market; and (3) issuers with securities not currently listed on any incumbent Named or Designated Market and would eventually list on a Named or Designated Market, regardless of IEX's entry into the market. Given that issuers who meet the listing standards of IEX are likely to meet the listing standards of other Named or Designated Markets, the number of issuers that would list on a Named or Designated Market solely as a result of the proposed amendment (
Issuers of public securities make several considerations when deciding on which exchange to list their securities. These considerations include, among other things, the visibility and publicity provided by the exchange, the listing services and fees, and the exchange's listing standards. The Named and Designated Markets may provide issuers of Covered Securities with additional visibility over that of securities traded over the counter, which may, in turn, increase the pool of potential investors for an issuer and thereby improve an investor's access to capital. In addition, the Named and Designated Markets provide listing services for their listed issuers, which can include monitoring, communication, and regulatory compliance services. These services may help issuers by reducing the cost of raising capital and the costs associated with going or remaining public. However, many issuers that list for the first time do so as part of an initial public offering, which can include considerations not related to listing on an exchange, such as SEC reporting obligations, as well as legal, accounting, and other expenses (both for the initial offering and the ongoing requirements of remaining public), as well as the benefits of going public, such as increased access to capital and providing investors with a signal of an issuer's ability to meet obligations, such as reporting requirements, that apply to public companies. In this case, the decision of which exchange to list on is made along with the decision about whether or not to go public.
Issuers must pay listing fees and meet listing standards to list on a Named or Designated Market. Listing fees may include an initial application fee as well as an ongoing annual fee, and may vary by the number of shares in the initial offering or be a fixed fee. However, listing fees typically represent a small portion of the overall cost of an initial public offering or the ongoing costs of remaining public,
Because securities listed on the Named or Designated Markets are Covered Securities, being a Named Market or achieving status as a Designated Market permits exchanges to compete to provide listing services to issuers of Covered Securities.
Furthermore, as described below in SectionVI.A.3.b, evidence that the
Listing exchanges compete with each other on many dimensions for listing securities, including, but not limited to, listing fees, listing standards, and listing services. When issuers choose which listing exchange to list on, issuers compare the listing fees and the costs of compliance with listing standards against the quality of listing services across listing exchanges. Although issuers may incur costs to meet an exchange's listing standards, high listing standards may also yield benefits as they may serve as a positive signal to investors of an issuer's ability to satisfy high qualitative and quantitative listing requirements. Investors may interpret the reputation of listing exchanges and their listing standards as a credible signal of the quality of listed security, and the reputation of an exchange is one of the factors that issuers consider when choosing which listing exchange to list on.
Currently, there are three Named Markets under Section 18(b)(1)(A) of the Securities Act: NYSE, NYSE American, and Nasdaq/NGM. In addition, there are currently six Designated Markets: (1) Tier I of the NYSE Arca, Inc.; (2) Tier I of the NASDAQ OMX PHLX LLC; (3) CBOE; (4) options listed on ISE; (5) The Nasdaq Capital Market; and (6) Tier I and Tier II of BATS. As of June 2, 2017, NYSE listed 3,172, Nasdaq listed 3,183, NYSE Arca listed 1,529, NYSE American listed 359, and BATS listed 176.
While the number of equities listed on an exchange may be informative about the general size of exchanges, the market shares for recent equity issue listings may provide a better picture of the nature of competition between exchanges and the size of the new listings market. In Table 2, we show the number of new equity issue listings from 2008 to 2016.
As shown in Table 2, two listing exchanges—NYSE and Nasdaq—captured 71% of all new equity listings on Named and Designated Markets in 2016, which is evidence of a highly concentrated listing market.
A highly concentrated market may be the result of barriers to entry, which limit competition, and can include economies of scale, reputation, legal barriers to entry, and network externalities. Listing exchanges may exhibit economies of scale because an exchange with a large number of listings can spread the fixed costs of listing equities over a greater number of issuers. The larger these fixed costs are, the greater will be the scale economies of larger listing exchanges. Entrant exchanges can also face barriers to entry related to reputation. Exchanges that enter the market may not be able to quickly establish a strong reputation for high quality listings, which may adversely affect their ability to compete with incumbent exchanges. This lack of reputation may discourage both investors and issuers from transacting or listing on an entrant exchange, which may reinforce an entrant exchange's lack of reputation.
Legal barriers to entry could also apply because exchanges are self-regulatory organizations overseen by the Commission. The governing statute and regulations establish legal barriers of entry for an entity becoming an exchange as well as for an exchange becoming a Designated Market. As discussed, the fact that an exchange must be designated by the Commission to become a Designated Market, which enables such an exchange to effectively compete for the listing business of Covered Securities, imposes legal barriers to entry.
In addition, the market for listing exhibits positive network externalities: Issuers may prefer to be listed on exchanges where other similar issuers
Issuers also may face switching costs associated with moving their listing from one exchange to another. These switching costs would not only include the fixed costs associated with a listing on an new exchange such as the exchange's application fee, and the legal and accounting expenses associated with ensuring that the issuer satisfies the listing standards of the new exchange, but would also include the costs associated with communicating with investors, including about the move to the new exchange. Thus, an issuer that is considering moving from one exchange would compare the relatively lower annual listing fee of their current exchange with the relatively high costs of moving its listing to a new exchange, which places the new exchange at a disadvantage and creates a barrier to entry for a potential entrant. Even if an entrant exchange prices its listing fees and services competitively compared to the incumbent exchanges for new issuers, the switching costs for issuers that are already listed may prevent the entrant from gaining market share.
Table 3 shows estimates of the probability that an issuer would change its listing market in a given year, based on issuer switching behavior for equities over the period 2008 to 2016. As an example, during this period, if an equity security was listed on NYSE, there was a 99.33% chance that it would still be listed on NYSE the following year and a 0.04% chance it would be listed on AMEX the following year, a 0.34% chance it would be listed on Nasdaq the following year, and a 0.08% chance it would be listed on ARCA the following year. More generally, equities listed on NYSE and Nasdaq had a greater than 99% chance of remaining listed on that exchange the following year, which suggests that issuers were unlikely to switch their listings away from the two exchanges with the highest market shares.
Trading in Covered Securities is segmented from trading in securities that are not covered (“OTC trading”). In addition to trading on Named or Designated Markets, Covered Securities can also trade on 12 other registered national securities exchanges or off-exchange either on 35 alternative trading systems (“ATSs”) or by broker-dealers who internalize orders. The market to trade Covered Securities on Named and Designated Markets as well as other trading platforms is more liquid than OTC trading of securities that are not Covered Securities due to, among other things, the search costs associated with finding buyers and sellers in OTC markets.
Covered Securities can trade on exchanges and other markets that do not “list” the security. This flexibility allows trading platforms to compete with each other by offering better trading services or innovative trading mechanisms to attract order flow for securities, even if they do not list such securities. The order flow from these securities, through the application of transaction fees, can generate revenue for an exchange. Exchanges also receive revenue from the sale of SIP data, determined, in part, from an exchange's share of transaction volume.
Despite the historical advantages listing exchanges enjoy in the market for trading services, the success of listing exchanges when competing for equity issue listings by offering better trading services or innovative trading mechanisms has declined over the past decade.
The competition for trading services is not limited to exchanges. Over the past decade, greater trading volume has been executed on other venues, including ATSs. Since the third quarter of 2009, the number of ATSs that trade NMS stocks has increased from 32 to 34, while the share of trading volume of Covered Securities that trade on ATSs
Securities Act Section 2(b)
By listing on IEX, security issuers that otherwise would have not listed their securities on a Named or Designated Market would be able to avoid the duplicative costs of securities registration in multiple jurisdictions and thus reduce the impediments to listing on exchanges, which in turn can improve market efficiency. To the extent that the proposed amendment results in increased listing activity, then it may improve the allocative efficiency of securities markets by allowing investors to better diversify financial risks by investing in newly-listed securities.
However, these two impacts may be mitigated by the extent to which issuers' abilities to list on a Named or Designated Market are constrained by other factors, such as their ability to satisfy listing standards and the attendant costs from doing so. For example, issuers may face increased disclosure costs associated with becoming an SEC reporting company if they are not already an SEC reporting company because issuers must be an SEC reporting company to list on a national securities exchange.
As noted in Section VI.A, a reason issuers list on a Named or Designated Market is improved access to capital. Listing on a Named or Designated Market may improve access to capital, which can promote capital formation, in several ways. First, listing on a Named or Designated Market may credibly signal to investors that a firm is of higher quality because firms that list on these exchanges must meet certain minimum standards for governance and disclosure set by listing on these exchanges. Like listed issuers on the Named and Designated Markets, IEX's listed issuers might benefit from the signal of quality that comes from listing on a Named or Designated Market compared to issuers that do not list. The reputational benefits that come from listing on a Named or Designated Market may make investors more willing to invest in such issuers, which may improve the issuers' access to capital, and promote capital formation.
Second, listing on a Named or Designated Market may provide additional liquidity for equities relative to OTC trading, due in part to potential frictions to liquidity imposed by OTC search costs.
Whether IEX entering the listing market promotes capital formation depends on the extent to which issuers previously unable or unwilling to list on a Named or Designated Market subsequently do so. Some issuers may, as a result of improved services and/or decreased fees stemming from the increased competition between listing exchanges, be induced to list on an exchange where, in the absence of the proposed amendment, they would not have. If so, then the entrance of IEX could provide issuers with lower cost access to capital.
The proposed amendment to Rule 146(b) would likely increase competition among the Named and Designated Markets that compete to list securities. By determining that IEX has “substantially similar” listing standards to the Named and other Designated Markets, the proposed amendment permits IEX to compete with other Named and Designated Markets to list securities that are exempt from state registration requirements. This would reduce the costs associated with complying with state securities laws in multiple jurisdictions that are borne by broker-dealers and such a reduction would potentially be shared with customers. As mentioned earlier, the Named and Designated Markets compete with each other on many dimensions, including listing standards, listing fees, and listing services. Besides permitting IEX to compete to list securities as a Designated Market, IEX's entry as a listing market might also provide incumbent listing markets with incentives to change how they compete with each other.
Generally, there are two ways that increased competition can affect how listing markets compete with each other. The first involves how the Named or
The Named and Designated Markets also may compete to provide better services by increasing their level of specialization with respect to securities listings. As noted below, as in the case of BATS, some Named and Designated Markets may develop reputations for specializing in specific types of issues by catering to specific types of issuers. An increase in competitive pressures may cause the Named and Designated Markets to more closely cater to specific types of issuers. Specialization may reduce the cost of providing listing services or may promote innovation in the provision of listing services. To the extent that specialization improves the services provided to issuers or reduces the costs of these services, this competitive response may improve the efficiency of the market for listing services.
The second way that increased competition can affect how the Named and Designated Markets compete with each other is through their role as intermediaries. The Named and Designated Markets serve as information and reputation intermediaries partly through their listing standards. Because issuers cannot perfectly signal their quality, the reputation of a Named or Designated Market for strict listing standards may be informative to an investor and serve as a signal of the quality of an issuer.
Because the Named and Designated Markets serve as information and reputation intermediaries between issuers and investors, the impact of increased competition on listing standards is ambiguous. The Named and Designated Markets may respond to increased competition by increasing listing standards to provide additional signaling and attract investors. Alternatively, the Named and Designated Markets could instead respond to increased competition by decreasing listing standards to attract additional listings. The intermediaries' opposing incentives to cater to these two groups of market participants make predicting the impact of competition on listing standards difficult.
The Named and Designated Markets' ability to lower standards would be constrained by the fact that 1. any proposed listing standards or proposed changes to existing listing standards must be filed with the Commission pursuant to Section 19(b) of the Exchange Act and must meet statutory and rule requirements to become effective,
Despite the potential for increased competition, some of the features of the market for listings that inhibit competition, as discussed above, may also mitigate the effects of IEX's entry on competition. Specifically, some of the barriers to entry discussed in the baseline—economies of scale and network externalities—may make it difficult for IEX to effectively compete with incumbent exchanges for listings.
The latest example of an entrant into the market for listings is BATS BZX, which became a Designated Market in 2012.
Table 3 in Section VI.A.3.a shows that almost none of the new listings on BATS arrived as transfers from another exchange, but were instead the first listing for each issuer that listed on BATS. This evidence is consistent with the argument that switching costs may also have had an impact on BATS' ability to gain market share, and may be a factor that also shapes IEX's entry. Moreover, the vast majority of BATS-listed securities are exchange-traded products. This is consistent with the idea that despite barriers to entry, BATS was able to enter by competing for one segment of the market and specializing in listing exchange-traded products.
If the Commission amends Rule 146(b) to include IEX, then securities listed, or authorized for listing, on IEX would be eligible to be designated as Covered Securities under Rule 146(b)(1) under the Securities Act, which, as described above, are exempt from state law registration requirements.
As noted above, the Commission is unable to quantify all of the economic effects of the proposed amendment because it lacks the information necessary to provide reasonable estimates. The Commission seeks comment on any information on these factors or information that would help it directly quantify the economic effects of the rule.
The proposed amendment could provide benefits, flowing from the exemption from Blue Sky laws, to currently unlisted issuers that do not currently list on an existing Named or Designated Market but would choose to list on IEX.
More generally, by making IEX a Designated Market, the proposed amendment would benefit IEX by allowing it to compete in the listing market for Covered Securities on a more level playing field with similarly situated national securities exchanges.
Although the direct effect of the proposed amendment may reduce the costs associated with registering in multiple jurisdictions, the Commission notes that issuers already have other Named and Designated Markets as options to list, and are likely to be able to meet the listing standards of these other markets if they would be able to list on IEX. IEX's entry into the market for listings may have a larger impact on issuers by increasing the amount of competition between Named and Designated Markets, rather than through the direct provision of Covered Securities status provided to securities that list on IEX. An increased amount of competition between Named and Designated Markets may improve listing services, reduce listing fees, and issuer specialization, which may benefit issuers.
Last, issuers that choose to list on a Named or Designated Market because of IEX's entry may impact the trading of those issuers' securities on markets that are not Named or Designated Markets. As noted in the baseline, securities that list on a Named or Designated Market may also trade on exchanges that are not Named or Designated Markets, which may bring them additional revenue from trades.
The Commission notes that the overall magnitude of costs associated with the loss of state oversight depends on the number of unlisted issuers that choose to list as a result of the proposed amendment, and the Commission preliminarily believes this number is likely to be small, if any, for the reasons noted above.
The Commission preliminarily believes that any costs to investors from a loss of state oversight for such issuers would be mitigated by federal regulations and oversight of IEX and the other Named and Designated Markets and the requirement to meet their respective listing standards. Indeed, Congress, in Section 18, has already determined that federal regulation is sufficient for those issuers that meet the high listing standards of a Named/Designated Market. Furthermore, the Commission preliminarily believes that other regulatory protections (
Issuers who currently list on an existing Named or Designated Market that would switch to IEX would not experience potential costs from a loss of state oversight or compliance costs arising from new reporting obligations. However, any previously listed issuers that decide to change their listing from a Named or Designated Market to IEX
Some of the effects of the proposed amendments to IEX, incumbent Named and Designated Markets, and issuers involve transfers from one party to another. For example, the listing fees collected by IEX from previously-listed issuers may accompany a related loss of the listing fees collected by other Named or Designated Markets. Issuers that list on Named and Designated Markets may also enjoy savings from listing fee reductions as a result of increased listing exchange competition, which would also accompany a loss of listing fees collected by Named or Designated Markets.
Additionally, as a result of changes to competition in the market for listings, the volume of trade in trading venues may shift, to the advantage of some venues and to the detriment of others. Changes to the Named or Designated Markets' shares of the market for listings may affect the distribution of trading volumes across Named and Designated Markets, as well as other trading venues. Commission staff estimates that an exchange captures an average of about 20% higher share of volume in the securities listed by that exchange compared to the market share of other exchanges trading the same securities.
The Commission seeks comment and supporting information as to the costs and benefits associated with this rule amendment, including identification and assessments of any costs and benefits not discussed in this analysis, and the effects on efficiency, capital formation and competition. We solicit comments on the usefulness of the rule amendment to investors, reporting persons, registrants, and the marketplace at large. We encourage commentators to identify, discuss, analyze, and supply relevant data, information, or statistics regarding any such costs or benefits, as well as any costs and benefits not already defined. We also request qualitative feedback on the nature of the benefits and costs described above. Additionally, we request comment on the extent of any costs that may be attributable to any loss of protections that currently are afforded by the state registration process, such as any merit-based requirements imposed by states on issuers. In particular, the Commission seeks comment on the following:
1. Has the Commission accurately described the baseline for the economic analysis? What are the typical costs of registering securities in multiple states? In how many states do issuers that qualify or are close to qualifying to list register? What are the typical attorney fees and other costs for registering securities in multiple states?
2. Has the Commission accurately described the competitive landscape for the market for listing Covered Securities? Has the Commission accurately described the competitive landscape for the market for trading services?
3. Does the proposing release discuss all relevant markets and forms of competition? If not, which additional markets or forms of competition could the proposal impact and what is the current competitive landscape in those markets?
4. Has the Commission accurately identified all market participants that would be affected by the proposed amendments to Rule 146? Which market participants do commenters believe would be affected by the proposed amendments but have not been included in the analysis?
5. Has the Commission accurately identified the potential impacts on efficiency, competition, and capital formation?
6. Has the Commission accurately identified and explained the costs and benefits of the proposed amendments to Rule 146?
a. Has the Commission accurately described the benefits to issuers and investors that would choose to list on IEX should IEX become a Designated Market?
b. Has the Commission accurately described the benefits to investors, IEX and other Designated Markets as a result of IEX becoming a Designated Market?
c. Has the Commission accurately described the costs to investors in securities of issuers that will choose to list on IEX should IEX become a Designated Market?
d. Has the Commission accurately described the costs to issuers of securities that will choose to list on IEX should IEX become a Designated Market?
e. Has the Commission accurately described the costs to IEX and other Designated Markets as a result of IEX becoming a Designated Market?
7. Are there benefits or costs that could be quantified or otherwise monetized? The Commission encourages commenters to provide specific estimates or data.
8. In light of the relevant statutory language and in the context of this particular proposed rulemaking, are there reasonable alternatives to this proposal to designate securities listed on IEX as covered securities?
Section 603(a) of the Regulatory Flexibility Act
The Commission preliminarily believes that the proposal to amend Rule 146(b) would not affect a substantial number of small entities because IEX is not a small entity. Further, to list its securities on IEX, an issuer's aggregate market value of publicly held shares would be required to be at least $5 million. If an entity's market value of publicly held shares were at least $5 million, it is reasonable to believe that its assets generally would be worth more than $5 million. Therefore, an entity seeking to list securities on IEX pursuant to IEX's listing standards generally would have assets with a market value of more than $5 million and thus would not be a small entity.
Accordingly, the Commission hereby certifies, pursuant to Section 605(b) of the Regulatory Flexibility Act,
For purposes of the Small Business Enforcement Fairness Act of 1996, a rule is “major” if it results or is likely to result in:
1. An annual effect on the economy of $100 million or more;
2. a major increase in costs or prices for consumers or individual industries; or
3. significant adverse effects on competition, investment, or innovation.
The Commission requests comment regarding the potential impact of the proposed amendment on the economy on an annual basis. Commenters should provide empirical data to support their views to the extent possible.
The Commission is proposing an amendment to Rule 146 pursuant to the Securities Act of 1933,
Securities.
For the reasons set forth in the preamble, the Commission proposes to amend Title 17, Chapter II of the Code of Federal Regulations as follows:
15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78
(b) * * *
(1) For purposes of Section 18(b) of the Act (15 U.S.C. 77r), the Commission finds that the following national securities exchanges, or segments or tiers thereof, have listing standards that are substantially similar to those of the New York Stock Exchange (“NYSE”), the NYSE American LLC (“NYSE American”), or the National Market System of the Nasdaq Stock Market (“Nasdaq/NGM”), and that securities listed, or authorized for listing, on such exchanges shall be deemed covered securities:
(i) Tier I of the NYSE Arca, Inc.;
(ii) Tier I of the NASDAQ PHLX LLC;
(iii) The Chicago Board Options Exchange, Incorporated;
(iv) Options listed on Nasdaq ISE, LLC;
(v) The Nasdaq Capital Market;
(vi) Tier I and Tier II of Bats BZX Exchange, Inc.; and
(vii) Investors Exchange LLC.
(2) The designation of securities in paragraphs (b)(1)(i) through (vii) of this section as covered securities is conditioned on such exchanges' listing standards (or segments or tiers thereof) continuing to be substantially similar to those of the NYSE, NYSE American, or Nasdaq/NGM.
By the Commission.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Florida State Implementation Plan submitted by the Florida Department of Environmental Protection on February 20, 2013. The revision removes unnecessary and superseded rules from the Florida State Implementation Plan. Specifically, this revision removes non-regulatory introductory language, as well as a regulation that has been superseded by more stringent federal regulations. This action is being taken pursuant to the Clean Air Act.
Written comments must be received on or before August 21, 2017.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0656 at
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached via telephone at (404) 562-9043 or via electronic mail at
In the Final Rules Section of this
Committee for Purchase From People Who Are Blind or Severely Disabled.
Notice of proposed rulemaking.
The Committee for Purchase From People Who Are Blind or Severely Disabled (Committee) is proposing procedures to use in responding to subpoenas or other official demands for information and testimony served upon itself or its employees.
Comments must be received by September 19, 2017.
You may submit comments, identified by docket number and/or Regulatory Information Number (RIN) and title, to the Federal Rulemaking Portal at:
All submissions received must include the agency name and docket number or RIN for this document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing at
Timi Kenealy, (703) 603-2100, Email:
The Committee, operating as the U.S. AbilityOne Commission, administers the AbilityOne Program pursuant to the authority of 41 U.S.C. 8501. Through this program, employment opportunities are provided to people who are blind or severely disabled through the provisions of products and services to the Federal Government.
Pursuant to 5 U.S.C. 301, the head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. The part does not authorize withholding information from the public or limiting the availability of records to the public.
The United States Supreme Court held in
This proposed regulation will govern the Committee's procedures for authorizing or denying such demands. In addition to updating this section for the Touhy case, the Committee is taking this opportunity to make technical corrections to include changes to the mailing address and changing “JWOD” to “AbilityOne” the operating name of the agency since 2010. Changes to this section of the CFR were last made in 1994.
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, distribute 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 rule benefits the public and the United States Government by providing clear procedures for members of the public and Government employees to follow when official testimony or official documents, records, files or information are sought from the Committee or from Committee personnel in connection with legal proceedings. This rule has not been designated a significant regulatory action.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to 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 2016, that threshold is approximately $146 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.
The Committee certifies this proposed rule is not subject to the Regulatory Flexibility Act (5 U.S.C. Ch. 6) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule will provide clarity to U.S. Government personnel and outside counsel on the proper rules and procedures to serve process on U.S. Government officials in their official capacity and to obtain official U.S. Government testimony or documents for use in legal proceedings. Therefore, the Regulatory Flexibility Act, as amended, does not require the Committee to prepare a regulatory flexibility analysis.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule will not have a substantial effect on the States; the relationship between the National Government and the States; or the distribution of power and responsibilities among the various levels of Government.
It has been determined that this rule does not impose reporting or record keeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Administrative practices and procedures, Courts, Disclosure, Exemptions, Government employees, Subpoenas, Records, Testimony.
41 U.S.C. 85039d.
(a) This part sets forth policies and procedures of the Committee for Purchase From People Who Are Blind or Severely Disabled (Committee) regarding the testimony of current and former employees as witnesses and the production or disclosure of Committee documents or information:
(1) In all federal and state proceedings in which the United States is a party; and
(2) In all federal and state proceedings in which the United States is not a party, when a demand pursuant to a subpoena, order or request (collectively referred to in this part as a “demand”) of a court or other authority is issued for such material, testimony, or information.
(b) The Committee intends these provisions to:
(1) Promote economy and efficiency in its programs and operations;
(2) Minimize the possibility of involving the Committee in controversial issues not related to its functions;
(3) Prevent the misuse of the Committee's employees as involuntary expert witnesses for private interests or as inappropriate expert witnesses as to the state of the law;
(4) Maintain the Committee's impartiality among private litigants where neither the Committee nor any other Federal entity is a named party; and
(5) Protect sensitive, confidential information and the deliberative processes of the Committee.
(c) In providing for these requirements, the Committee does not waive the sovereign immunity of the United States.
(d) This part provides guidance for the internal operations of the Committee. The procedures specified in this part, or the failure of any Committee employee to follow the procedures specified in this part, are not intended to, do not, and may not be relied upon to create a right or benefit, substantive or procedural, enforceable at law by a party against the United States.
This part applies to demands and requests to employees of the Committee in legal proceedings, for factual or expert testimony relating to official information or for production of official records or information. However, it does not apply to:
(a) Demands for a current Committee employee to testify as to facts or events that are unrelated to his or her official duties or that are unrelated to the functions of the Committee;
(b) Demands for a former Committee employee to testify as to matters in which the former employee was not directly or materially involved while at the Committee;
(c) Requests for the release of non-exempt records under the Freedom of Information Act, 5 U.S.C. 552 (41 CFR part 51-8), or the Privacy Act, 5 U.S.C. 552(a) (41 CFR part 51-9); and
(d) Congressional or Government Accountability Office (GAO) demands and requests for testimony or records.
As used in this part:
(1) Any current or former officer or employee of the Committee;
(2) Any other individual hired through contractual agreement by or on behalf of the Committee or who has performed or is performing services under such an agreement for the Committee; and
(3) Any individual who served or is serving in any consulting or advisory capacity to the Committee, whether formal or informal.
(4) Provided, that this definition does not include persons who are no longer employed by the Committee and who are retained or hired as expert witnesses or who agree to testify about general matters available to the public, or matters with which they had no specific involvement or responsibility during their employment with the Committee.
(a) In any federal or state case or matter in which the United States is not a party, no employee or former employee of the Committee shall, in response to a demand, produce any record contained in the files of the Committee, or disclose any information relating to or based upon record contained in the files of the Department, or disclose any information or produce any record acquired as part of the performance of that person's official duties or because of that person's official status without prior written approval of the General Counsel in accordance with § 51-11.9.
(1) Whenever a demand is made upon an employee or former employee as described in paragraph (a) of this section, the employee shall immediately notify the General Counsel. The General Counsel shall follow procedures set forth in § 51-11.8.
(2) If oral testimony is sought by a demand in any case or matter in which the United States is not a party, an affidavit, or, if that is not feasible, a statement by the party seeking the testimony or by his attorney, setting forth a summary of the testimony sought and its relevance to the proceeding, must be furnished to the General Counsel. Any authorization for testimony by a present or former employee of the Committee shall be limited to the scope of the demand as summarized in such statement.
(3) When information other than oral testimony is sought by a demand, the General Counsel shall request a summary of the information sought and its relevance to the proceeding.
(b) In any federal or state case or matter in which the United States is a party, the General Counsel is authorized to reveal and furnish to any person, including an actual or prospective witness, a grand jury, counsel, or a court, either during or preparatory to a proceeding, such testimony, and relevant unclassified material, documents, or information secured by the employee or former employee of the Committee, as the General Counsel shall deem necessary or desirable to the discharge of the attorney's official duties:
(1) If oral testimony is sought by a demand in a case or matter in which the United States is a party, an affidavit, or, if that is not feasible, a statement by the party seeking the testimony or by the party's attorney setting forth a summary of the testimony sought must be furnished to the agency attorney handling the case or matter.
(2) [Reserved]
(c) In appropriate cases, the General Counsel shall notify the United States Department of Justice (DOJ) of the demand and coordinate with the DOJ to file any appropriate motions or other pleadings.
(a) Written demands directed to the Committee or requests for official records, information or testimony shall be served in accordance with the requirements of the Federal Rules of Civil or Criminal Procedure, or applicable State procedures, as appropriate. If the demand is served by U.S. mail, it should be addressed to the General Counsel, Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, VA 22202. The Committee's acceptance of service of a demand shall not constitute an admission or waiver of any objection with respect to the propriety of jurisdiction, service of process, venue or any other defense in law or equity available under applicable law.
(b) If any doubt exists, whether a demand relates to purely personal matters or arises out of the performance of official duties, copies of the demand may be delivered to the General Counsel for such determination.
Compliance with the following requirements is required when issuing demands or requests for official records, information or testimony.
(a) Requests must be in writing and must be submitted to the General Counsel. If a subpoena is served on the Committee or a Committee employee before submitting a written request and receiving a final determination, the Committee will object to the subpoena on grounds that it was not submitted in accordance with this part.
(b) Written requests must contain the following information:
(1) The caption of the legal proceeding, docket number, and name and address of the court or other authority involved;
(2) A copy of the complaint or equivalent document setting forth the assertions in the case and any other pleading or document necessary to show the relevance of the information sought;
(3) A detailed description of how the information sought is relevant to the issues in the legal proceeding, and a specific description of the substance of the testimony or records sought;
(4) A statement as to how the need for the information outweighs the need to maintain any confidentiality of the information and outweighs the burden on the Committee to produce the records or provide testimony;
(5) A statement indicating that the information sought is not available from another source, from other persons or entities, or from the testimony of someone other than a Committee employee, such as a retained expert;
(6) If testimony is requested, the intended use of the testimony, a general summary of the desired testimony, and a showing that no document could be provided and used in lieu of testimony;
(7) A description of all prior decisions, orders, or pending motions in the case that bear upon the relevance of the requested records or testimony;
(8) The name, address, and telephone number of counsel to each party in the case; and
(9) An estimate of the amount of time that the requester and other parties will require with each Committee employee for time spent by the employee to prepare for testimony, in travel, and for attendance at the legal proceeding.
(c) The Committee reserves the right to require additional information to complete any request where appropriate.
(d) Requests should be submitted at least 45 calendar days before the date that records or testimony is required. Requests submitted in less than 45 calendar days before records or testimony is required must be accompanied by a written explanation stating the reasons for the late request and the reasons for expedited processing.
(e) Failure to cooperate in good faith to enable the General Counsel to make an informed decision may serve as the basis for a determination not to comply with the request.
The General Counsel in his or her sole discretion, may grant an employee permission to testify on matters relating to official information, or produce
(a) The purposes of this part are met;
(b) Allowing such testimony or production of records would be necessary to prevent a miscarriage of justice;
(c) The Committee has an interest in the decision that may be rendered in the legal proceeding;
(d) Allowing such testimony or production of records would assist or hinder the Committee in performing its statutory duties or use the Committee resources in a way that will interfere with the ability of the Committee employees to do their regular work;
(e) Allowing such testimony or production of records would be in the best interest of the Committee or the United States;
(f) The records or testimony can be obtained from other sources;
(g) The demand or request is unduly burdensome or otherwise inappropriate under the applicable rules of discovery or the rules of procedure governing the case or matter in which the demand or request arose;
(h) Disclosure would violate a statute, Executive order or regulation;
(i) Disclosure would reveal confidential, sensitive, or privileged information, trade secrets or similar, confidential commercial or financial information, otherwise protected information, or would otherwise be inappropriate for release;
(j) Disclosure would impede or interfere with an ongoing law enforcement investigation or proceedings, or compromise constitutional rights;
(k) Disclosure would result in the Committee appearing to favor one private litigant over another private litigant;
(l) Disclosure relates to documents that originate from another agency;
(m) A substantial Government interest is implicated;
(n) The demand or request is within the authority of the party making it;
(o) The demand improperly seeks to compel a Committee employee to serve as an expert witness for a private interest;
(p) The demand improperly seeks to compel a Committee employee to testify as to a matter of law; and/or
(q) The demand or request is sufficiently specific to be answered.
(a) After service of a demand or request, the General Counsel will review the demand or request and, in accordance with the provisions of this part, determine whether, or under what conditions, to authorize an employee to testify on matters relating to Committee records and/or produce records.
(b) The Committee will process requests in the order in which they are received. Absent exigent or unusual circumstances, the Committee will respond within 45 calendar days from the date of receipt. The time for response will depend upon the scope of the request.
(c) The General Counsel may grant a waiver of any procedure described by this part where a waiver is considered necessary to promote a significant interest of the Committee or the United States or for other good cause.
The General Counsel makes the final determination on demands and requests for production of official records and information or testimony. All final determinations are within the sole discretion of the General Counsel. The General Counsel will notify the requester and the court or other authority of the final determination, the reasons for the grant or denial of the demand or request, and any conditions that the General Counsel may impose on the release of records or information, or on the testimony of a Committee employee.
(a) Conditions or restrictions may be imposed on the testimony of the Committee employees including, for example, limiting the areas of testimony or requiring the requester and other parties to the legal proceeding to agree that they will seek to file the transcript of the testimony under seal and that it will be used or made available only in the particular legal proceeding for which testimony was requested. The General Counsel may also require a copy of the transcript or testimony be provided to the Committee at the requester's expense.
(b) The Committee may offer the employee's written declaration in lieu of testimony.
(c) If authorized to testify pursuant to this part, an employee may testify as to facts within his or her personal knowledge, but, unless specifically authorized to do so by the General Counsel, the employee shall not:
(1) Disclose confidential or privileged information;
(2) Testify as to any information outside the scope of the General Counsel's authorization (
(3) For a current Committee employee, testify as an expert or opinion witness with regard to any matter arising out of the employee's official duties or the functions of the Committee unless testimony is being given on behalf of the United States whether or not the United States is a party.
(a) The General Counsel may impose conditions or restrictions on the release of official records and information, including the requirement that parties to the proceeding obtain a protective order or execute a confidentiality agreement to limit access and any further disclosure. The terms of the protective order or of a confidentiality agreement must be acceptable to the General Counsel. In cases where protective orders or confidentiality agreements have already been executed, the Committee may condition the release of official records and information on an amendment to the existing protective order or confidentiality agreement.
(b) If the General Counsel so determines, original Committee records may be presented for examination in response to a demand or request, but they are not to be presented as evidence or otherwise used in a manner by which they could lose their identity as official Committee records, and they are not to be marked or altered. In lieu of the original records, certified copies will be presented for evidentiary purposes.
If a response to a demand or request is required before the General Counsel can make the determination previously referred to, the General Counsel when necessary, will provide the court or other competent authority with a copy of this part, inform the court or other competent authority that the demand or request is being reviewed, and seek a stay of the demand or request pending a final determination.
If the court or other competent authority fails to stay the demand, the employee upon whom the demand or request is made, unless otherwise advised by the General Counsel, will appear at the stated time and place, produce a copy of this part, state that the employee has not been authorized to provide the requested testimony or produce documents, and respectfully
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a) An employee who discloses official records or information or gives testimony relating to official information, except as expressly authorized by the Committee, or as ordered by a Federal court after the Committee has had the opportunity to be heard, may face the penalties provided in 18 U.S.C. 641 and other applicable laws. Additionally, former Committee employees are subject to the restrictions and penalties of 18 U.S.C. 207 and 216.
(b) A current Committee employee who testifies or produces official records and information in violation of this part may be subject to disciplinary action.
Federal Communications Commission.
Petition for partial reconsideration or suspension.
A Petition for Partial Reconsideration, or in the Alternative Suspension of Compliance Deadline (Petition), has been filed in the Commission's rulemaking proceeding by Sorenson Communications, LLC.
Comments to the Petition must be filed on or before August 7, 2017. Reply Comments must be filed on or before July 31, 2017.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Eliot Greenwald, Consumer and Governmental Affairs Bureau, email:
This is a summary of the Commission's document DA 17-656, released July 7, 2017. The full text of the Petition is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554 or may be accessed online via the Commission's Electronic Comment Filing System at:
Federal Communications Commission.
Proposed rule.
In this document, the Commission proposes to amend its Caller ID rules to allow carriers to disclose blocked Caller ID information in the limited case of threatening calls as an aid to law enforcement investigations. Media and law enforcement reports indicate that the number of threatening calls targeting schools, religious organizations, and other entities appears to be increasing dramatically. In many cases, the perpetrators block the Caller ID information, making it difficult to trace the threatening calls. The Commission's current rules require that carriers not reveal blocked Caller ID information or use that information to allow the called party to contact the caller. Recognizing that threatening callers do not have a legitimate privacy interest in having
Comments are due on or before August 21, 2017, and reply comments are due on or before September 19, 2017.
You may submit comments identified by CC Docket No. 91-281 and/or FCC Number 17-76, by any of the following methods:
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Nellie Foosaner, Consumer Policy Division, Consumer and Governmental Affairs Bureau (CGB), at: (202) 418-2925, email:
This is a summary of the Commission's Notice of Proposed Rulemaking, document FCC 17-76, adopted on June 22, 2017, and released on June 22, 2017. The full text of document FCC 17-76 will be available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. A copy of document FCC 17-76 and any subsequently filed documents in this matter may also be found by searching ECFS at:
Pursuant to 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using ECFS.
• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th Street SW., Room TW-A325, Washington, DC 20554. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.
• Commercial Mail sent by overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
• U.S. Postal Service first-class, Express, and Priority mail should be addressed to 445 12th Street SW., Washington, DC 20554.
Pursuant to § 1.1200 of the Commission's rules, 47 CFR 1.1200, this matter shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to:
Document FCC 17-76 seeks comment on proposed rule amendments that may result in modified information collection requirements. If the Commission adopts any modified information collection requirements, the Commission will publish another notice in the
1. In the document FCC 17-76, the Commission proposes to amend its Caller ID rules to enable called parties and/or law enforcement to obtain blocked Caller ID information in connection with threatening calls. For purposes of document FCC 17-76, the Commission defines a “threatening call” as any call that includes a threat of serious and imminent unlawful action posing a substantial risk to property, life, safety, or health.
2. Based on reports of widespread and increasing numbers of threatening calls that have targeted schools, religious organizations and other entities, the Commission proposes amending § 64.1601 of its rules, which provides that “[n]o common carrier subscribing to or offering any service that delivers [the Calling Party Number (CPN)] may override the privacy indicator associate with an interstate call,” to ensure that all parties who receive threatening calls are not hindered by the Commission's rules in gaining timely access to CPN information that may allow them to identify threatening callers. Amending the Commission's Caller ID rules to permit threatened parties, law enforcement and security personnel of threatened entities to gain access to the CPN of threatening callers could promote public safety and provide administrative efficiencies over the current process, which necessitates addressing individual waiver requests on a case-by-case basis. Even when threatening calls prove to be a hoax, they can often result in substantial disruption and expenditure of public resources by law enforcement. The Commission therefore proposes to amend its rules to recognize an exemption from the privacy protections contained in § 64.1601(b) of its rules in the limited case of threatening calls. The Commission seeks additional comment on ways to facilitate the ability of law enforcement and security personnel to investigate and identify threatening callers while protecting the legitimate privacy interests of non-threatening callers. In that regard, the Commission seeks comment on how to define the term “security personnel” to ensure that
3. Section 64.1601(b) of the Commission's rules requires that carriers must act in accordance with the customer's privacy request that CPN not be passed on interstate calls. The Commission has recognized, however, certain exemptions to this requirement. The Commission has concluded, for example, that to the extent CPN-based services are used to deliver emergency services, privacy requirements should not apply to delivery of CPN to a public agency's emergency lines, a poison control line, or in conjunction with 911 emergency services. In these instances, the Commission concluded that Caller ID blocking mechanisms could jeopardize emergency services and therefore pose a serious threat to the safety of life and property. The Commission believes that threatening calls present equally compelling circumstances in which the need to ensure public safety, in accordance with the Commission's fundamental statutory mission, outweighs the threatening caller's interest in maintaining the privacy of his or her CPN.
4. Specifically, the Commission proposes amending § 64.1601 of its rules to recognize an exemption to § 64.1601(b)'s of its rules prohibition on overriding a privacy indicator associated with an interstate call when such call contains a threat of a serious nature. For purposes of this context, the Commission proposes defining a “threatening call” as any call that includes a threat of serious and imminent unlawful action posing a substantial risk to property, life, safety, or health. The Commission seeks comment on this definition and on any alternatives. Accordingly, the Commission proposes adding an exemption in § 64.1601(d) of its rules to exclude threatening calls from the privacy protections afforded by § 64.1601(b) of its rules.
5. In this context, the Commission seeks comment on how evaluations should be made to determine whether a threat meets the proposed definition of a threatening call, including who should make that evaluation. Should the Commission require, for example, that otherwise restricted CPN be made available only after a law enforcement agency confirms that it constitutes a threat of a serious and imminent unlawful action posing a substantial risk to property, life, safety, or health? Would this approach provide sufficient privacy safeguards to ensure that blocked CPN is released only in those limited situations? Conversely, to what extent would involving law enforcement in this process hinder the ability of threatened parties to gain timely access to the CPN of threatening callers?
6. The Commission seeks comment on this proposal and any additional options that might aid law enforcement and threatened parties in obtaining the information they need to identify threatening callers. In addition, the Commission seeks comment on how to facilitate the provision of CPN to threatened entities in a manner that minimizes administrative burdens on carriers while ensuring that such information is provided to the threatened party and law enforcement in a timely manner. How are carriers burdened today when law enforcement uses lawful processes to compel disclosure of call details? In particular, the Commission seeks comment on the potential burdens on small providers that may be asked to disclose information upon a report of a threatening call, including measures that could mitigate those burdens. The Commission recognizes that telecommunications systems utilized by threatened entities and relationships with their carriers may vary widely. The Commission therefore seeks the input of carriers on how best to facilitate the process of providing CPN information in a timely manner to parties that report a threatening call. Given the existing exemption for public agencies that deliver emergency services as noted above, the Commission also seeks comment on whether it should extend that exemption to non-public entities that provide emergency services such as private ambulance companies.
7.
8. Are there other means to ensure that legitimate privacy protections are not infringed should the Commissions exempt threatening calls from the privacy requirements of § 64.1601(b) of its rules? The Commission notes, for example, that CGB, in granting waivers of the Commission's rule, has imposed certain conditions and obligations on entities granted waivers of § 64.1601(b) of its rules in the past to ensure that restricted CPN information is disclosed only to authorized personnel for purposes of investigating threatening calls, and hence, any legitimate expectation of privacy by non-threatening callers is adequately protected. These conditions typically include: (1) The CPN on incoming restricted calls not be passed on to the line called; (2) any system used to record CPN be operated in a secure way, limiting access to designated telecommunications and security personnel; (3) telecommunications and security personnel may access restricted CPN data only when investigating phone calls of a threatening and serious nature, and shall document that access as part of the investigative report; (4) transmission of restricted CPN
9. The Commission seeks comment on whether circumstances have changed since the Commission originally adopted § 64.1601 of its rules. At the time, the Commission rejected arguments that parts of the rule would infringe on callers' expectations of privacy and anonymity. This was in part because the rule would allow callers to choose to block passage of CPN by choosing either per-call or per-line blocking. Would this logic hold true if the Commission were to allow call recipients to demand that CPN be revealed by asserting that the call contained a threat? In concluding that compelling the transmission of CPN would not violate any privacy rights under the Fourth Amendment, the Commission reasoned that callers have no reasonable expectation of privacy in their phone numbers because those numbers are voluntarily exposed to the telephone company's equipment. Does this hold true today, and would it be true if callers intending to block CPN delivery could have it unblocked by a called party's assertion that a call contained a threat?
10. Based on the large numbers of recent threats phoned in to the JCCs and the record compiled in this matter, the Commission confirms that good cause continues to exist to maintain the temporary waiver of § 64.1601(b) of its rules granted to JCCs and the carriers who serve them for disclosure of CPN associated with threatening calls to JCCs.
11. In the event the Commission amends its rules to recognize an exemption for threatening calls as proposed herein, this waiver, along with other similar prior waivers, will be encompassed within the protections afforded by that exemption. In the meantime, this temporary waiver ensures that JCCs are afforded certainty that they will continue to have the necessary protections from threatening calls.
12. As required by the Regulatory Flexibility Act (RFA), the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in document FCC 17-76. Written public comments are requested on the IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments specified in the
13. In recent years, media and law enforcement reports indicate that the number of threatening calls appears be increasing dramatically. In the past the Commission has addressed such situations on a case-by-case basis via a waiver process at the request of individual entities that report receiving threatening calls. In document FCC 17-76, the Commission takes steps to amend the Caller ID rules to ensure that law enforcement and threatened parties are not hindered in their ability to investigate and respond to threatening phone calls. The Commission recognizes the privacy interests of non-threatening callers that may have valid reasons to block their telephone numbers by limiting the proposal strictly to those situations that involve threatening calls of a serious and imminent nature while further limiting access to such restricted CPN information in the case of threatening calls only to those parties responsible for safety and security of the threatened party. The Commission proposes to amend the current process that necessitates addressing individual waiver requests on a case-by-case basis. The Commission proposes and seeks additional comment on ways to facilitate the ability of law enforcement and security personnel to investigate and identify callers while protecting the legitimate privacy interests of non-threatening callers.
14. Specifically, the Commission proposes to amend § 64.1601(d)(4)'s of its rules current list of exemptions by adding a new section (iv) to read: (4) CPN delivery—“(iv) Is made in connection with a threatening call. Upon report of such a threatening call, the carrier will provide any CPN of the calling party to the called party and/or law enforcement for the purpose of identifying the responsible party.” The Commission proposes defining a “threatening call” as any called that includes a threat of serious and imminent unlawful action posing a substantial risk to property, life, safety, or health. In addition, the Commission seeks comment on how to facilitate the provision of CPN to threatened entities in a manner that minimizes administrative burdens on carriers while ensuring that such information is provided to the threatened party and law enforcement in a timely manner.
15. For privacy purposes, the Commission seeks comment on whether it should require anyone reporting a threatening call for purpose of obtaining otherwise restricted CPN to do so in conjunction with a law enforcement agency to provide some assurance that the called party is not attempting to circumvent the privacy obligations of the rule by reporting a false threat. The Commission also inquiries into the possibility of excluding private individuals, who are not typically the target of mass phone threats, from this exemption in order to limit the potential for abuse. The Commission notes, for example, that CGB has imposed certain conditions and obligations on entities granted waivers of § 64.1601(b) of its rules in the past to ensure that restricted CPN information is disclosed only to authorized personnel for purposes of investigating threatening calls, and hence, any legitimate expectation of privacy by non-threatening callers is adequately protected. The Commission seeks comment on whether similar conditions should be imposed on any party that obtains restricted CPN pursuant to the proposed exemption.
16. The proposed and anticipated rules are authorized under sections 1-4 and 201 of the Act, as amended, 47 U.S.C. 151-154, and 201.
17. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that will be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern”
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22. The Commission has included small incumbent LECs in the RFA analysis. As noted above, a “small business” under the RFA is one that,
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31. As indicated above, document FCC 17-76 seeks comment on a proposed amendment to the rules to require carriers to make available, upon report of a threatening call from the called party, any CPN of the calling party to the called party and/or law enforcement for the purpose of identifying the responsible party. Until these requirements are defined in full, it is not possible to predict with certainty whether the costs of compliance will be proportionate between small and large providers. The Commission seeks to minimize the burden associated with reporting, recordkeeping, and other compliance requirements for the proposed rules, such as modifying software, developing procedures, and training staff.
32. Under the proposed rules, carriers will need to make the CPN of a calling party available to a threatened recipient of the call. They may need to work with law enforcement and the entity called to ensure there is a genuine threat in order to protect the privacy of the caller.
33. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
34. The Commission has proposed rules for carriers, upon report of a threatening call from the called party, to provide any CPN of the calling party to the called party and/or law enforcement for the purpose of identifying the responsible party. The Commission requested feedback from small businesses in document FCC 17-76, and seeks comment on ways to make the proposed rules less costly. The Commission asks how to facilitate the provision of CPN to threatened entities in a manner that minimizes the administrative burdens on carriers while ensuring that such information is provided to the threatened party and law enforcement in a timely manner. The Commission seeks the input of carriers on how to best facilitate the process of providing CPN information in a timely manner to parties that report a threatening call. To help carriers protect privacy interests, the Commission seeks comment on whether it should require anyone reporting a threatening call for purposes of obtaining otherwise restricted CPN to do so in conjunction with a law enforcement agency to provide some assurance that the called party is not attempting to circumvent the privacy obligations of the rule by reporting a false threat. The Commission also asks whether excluding private individuals would limit the potential for abuse. The Commission seeks comment on how to minimize the economic impact of its proposals, particularly to small businesses.
35. The Commission expects to consider the economic impact on small entities, as identified in comments filed in response to document FCC 17-76 and the IRFA, in reaching its final conclusions and taking action in this proceeding.
36. None.
Claims, Communications common carriers, Computer technology, Credit, Foreign relations, Individuals with disabilities, Political candidates, Radio, Reporting and recordkeeping requirements, Telecommunications, Telegraph, Telephone.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 64 as follows:
47 U.S.C. 154, 225, 254(k), 403(b)(2)(B), (c), 715, Pub. L. 104-104, 110 Stat. 56. Interpret or apply 47 U.S.C. 201, 218, 222, 225, 226, 227, 228, 254(k), 616, 620, and the Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112-96, unless otherwise noted.
(l)
(d) * * *
(4) * * *
(ii) Is used on a public agency's emergency telephone line or in conjunction with 911 emergency services, or on any entity's emergency assistance poison control telephone line;
(iii) Is provided in connection with legally authorized call tracing or trapping procedures specifically
(iv) Is made in connection with a threatening call. Upon report of such a threatening call, the carrier will provide any CPN of the calling party to the called party and/or law enforcement for the purpose of identifying the responsible party.
United States African Development Foundation.
Notice of meeting.
The US African Development Foundation (USADF) will hold its quarterly meeting of the Board of Directors to discuss the agency's programs and administration.
The meeting date is Monday, July 31, 10:00 a.m. to 1:00 p.m.
The meeting will take place via teleconference, with staff congregating at USADF, 1400 I St. Northwest, Suite # 1000 (Main Conference Room), Washington, DC 20005-2246.
Marie-Cecile Groelsema, 202-233-8883.
Public Law 96-533 (22 U.S.C. 290h).
Agricultural Marketing Service, USDA.
Notice of public meeting, via teleconference, of the National Organic Standards Board (NOSB).
In accordance with the Federal Advisory Committee Act, as amended, the Agricultural Marketing Service (AMS), U.S. Department of Agriculture (USDA), is announcing a meeting of the National Organic Standards Board (NOSB) to discuss the development of a proposal on aeroponics/bioponics/hydroponics.
August 14, 2017. 1:00 p.m. ET-3:00 p.m. ET.
Ms. Michelle Arsenault, Advisory Committee Specialist, National Organic Standards Board, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-S, Mail Stop 0268, Washington, DC 20250-0268; Phone: (202) 720-3252; Email:
The NOSB members will discuss the development of proposals on aeroponics/bioponics/hydroponics for a future NOSB meeting. The NOSB will not be voting on a recommendation during this conference call. The NOSB makes recommendations to the Department of Agriculture about whether substances should be allowed or prohibited in organic production and/or handling, assists in the development of standards for organic production, and advises the Secretary on other aspects of the implementation of the Organic Foods Production Act (7 U.S.C. 6501-6522).
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to 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.
Comments regarding this information collection received by August 21, 2017 will be considered. Written comments should be addressed to: Desk Officer for
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The Forest Service is preparing an environmental impact statement (EIS) on its proposed treatment of 150,000 acres of insect-infested areas of the Medicine Bow National Forest (MBNF). The Forest Service believes this treatment is necessary to ensure the future health of the MBNF.
Comments concerning the scope of the analysis must be received by August 21, 2017. The Draft Environmental Impact Statement is expected in November 2017 and the Final Environmental Impact Statement is due in March 2018.
Send written comments to: LaVA Project, Medicine Bow National Forest, 2468 Jackson Street, Laramie, WY 82070, or via facsimile to 307-745-2467, c/o LaVA Project. Written comments may also be hand-delivered to the above address between 8:00 a.m. and 4:30 p.m. Mountain Time, Monday through Friday except federal holidays. Comments may also be submitted electronically at
Melissa Martin, Project Manager, at 307-745-2371. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-811-8339 between 8:00 a.m. and 8:00 p.m., Eastern Time, Monday through Friday.
The Medicine Bow National Forest (MBNF) has experienced epidemic levels of mountain pine beetle and spruce bark beetle infestations since the mid to late 1990s. Although the epidemic has slowed in recent years, the infestation has left behind a changed landscape consisting primarily of regenerating forests that have an overstory of large, dead and dying trees. Action is needed to accelerate management response to this major forest health event to proactively and adaptively respond to changing forest vegetation conditions.
On March 22, 2017, Forest Service Chief Thomas L. Tidwell designated the majority of the MBNF as a landscape-scale insect and disease area under Section 602(d) of the Healthy Forests Restoration Action of 2003 (HFRA, 16 U.S.C. 6591
The LaVA analysis area encompasses the Snowy Range and Sierra Madre Mountain Ranges of the MBNF and includes roughly 850,000 acres of National Forest System (NFS) lands. Of the 850,000 acres, the Forest Service has identified roughly 575,000 acres wherein treatment activities could be proposed; these areas are termed `treatment opportunity areas' (TOAs). Actual treatments are proposed on a subset of the TOAs (150,000-350,000 acres), as described in the Proposed Action.
The purpose of the project is to respond to changed forest vegetation conditions presented by the bark beetle epidemics experienced on the MBNF. The approach is to actively manage forest vegetation using tree cutting and/or prescribed burning, consistent with the goals outlined in the Governor's Task Force on Forests (Final Report, 2015), the Western Bark Beetle Strategy (July 2011), and the Wyoming Statewide Forest Resource Strategy (2010). These goals include promoting recovery from the insect infestations, improving the resiliency of green stands to future disturbances, helping to protect forested areas on adjacent private and state land, and providing for human safety. These general goals will be adapted to local
• Increase age class, structural, and vegetative diversity across the landscape;
• Promote forest and rangeland conditions to improve forage and wildlife habitat; and
• Actively accelerate recovery and regeneration of forest ecosystems.
• Promote vegetation management to recover merchantable products; and
• Provide commercial forest products to local industries at a level commensurate with Forest Plan direction and goals.
• Treat hazard trees in areas not covered by the Forest-wide Hazard Tree Decision Notice (August 12, 2008);
• Treat hazard trees within and outside the wildland urban interface (WUI);
• Increase the extent of defensible space around resources at risk; and
• Create fuel breaks to slow or stop the progress of wildfires.
• Treat vegetation adjacent to infrastructure and non-federally owned lands;
• Treat vegetation to protect municipal water supplies and infrastructure; and
• Treat vegetation where fire is identified as a threat to the habitat of a threatened or endangered species.
• Treat hazardous fuels to minimize the potential for large, high intensity/high severity wildfires; and
• Treat hazardous fuels to reduce fire behavior and the possibility of fires spreading onto adjacent, non-federal lands.
The Forest Service proposes to conduct vegetation management activities on NFS lands, including inventoried roadless areas, within the Sierra Madre and Snowy Range Mountain Ranges of the MBNF. Vegetation management activities, including prescribed fire, mechanical, and hand treatment methods, could be applied to 150,000-350,000 acres to protect, restore and enhance forest ecosystem components; reduce wildfire risk to communities and municipal water supplies; supply forest products to local industries; and improve, protect, and restore wildlife habitat. Treatments would be authorized over a 10-year period beginning in 2018 and would be completed within approximately 15 years of the project decision.
Due to ever-changing conditions, the Proposed Action incorporates the principles of adaptive management in that it does not identify specific treatment units. Instead, it proposes a range of acres (150,000-350,000) that could be treated within the pre-established TOAs (575,000 acres). During project implementation, the Forest Service would cooperate with other agencies, local governments, interested stakeholders, and organizations to identify specific treatment units. Specific objectives of each treatment unit would be determined prior to any ground-disturbing activities using existing vegetation conditions and a series of project-developed field checklists. The sum of all treatments would not exceed 350,000 acres.
Specifically, the Proposed Action would allow each of the following activities to occur within the pre-established TOAs:
• Cutting trees or shrubs using a variety of treatment methods including, but not limited to, clearcutting/coppice; group and individual tree selection; salvage; mastication; sanitation; and thinning. Treatments would be designed to protect, restore, and enhance forest ecosystem components; supply forest products to local industries; provide for human safety; reduce wildfire risk to communities and municipal water supplies; and improve, protect, and restore wildlife habitat.
• Cutting trees that have encroached on grass and shrub lands to maintain desired species dominance and improve wildlife habitat.
• Prescribed burning areas using jackpot, pile burning, and broadcast burning. Maintenance burns on previously treated areas would occur to maintain desired fuels or habitat conditions.
• Prescribed burning or tree/shrub cutting on portions of inventoried roadless areas (IRAs). Treatment opportunity areas in IRAs were proposed by Cooperating Agencies and the Forest Service to protect communities at risk; threatened, endangered, and sensitive wildlife habitat; critical infrastructure; and municipal water supplies. No new permanent or temporary road construction would occur in IRAs.
• Utilizing and/or reconstructing existing open and closed NFS roads to access treatment units. Reconstruction may include road blading, culvert installation or replacement, and gravelling. Closed NFS roads would be for administrative access only (
• Constructing approximately 25 miles of new, permanent NFS roads, as necessary, to access treatment areas; the final assessment of road needs has not been determined and could be more or less. All newly constructed system roads would be physically closed to public motorized vehicle use following completion of treatment activities; however, their templates would be retained for future management entries.
• Constructing approximately 1,000 miles of temporary road, as necessary, to access treatment areas; the final assessment of road needs has not been determined and could be more or less. While open, the roads would be for administrative use only (
• Conducting regeneration surveys, noxious weed control, native grass seeding, and road maintenance.
• Using a combination of commercial timber sales, service contracts, stewardship contracts, cooperative authorities, partner capacity, and Forest Service crews to implement the project.
• Complete all required surveys for each individual treatment area; complete required layout and marking
• Perform monitoring during and following implementation of individual treatment activities to ensure treatments are implemented as planned and that project objectives are being attained.
• Establish an annual monitoring review with interested stakeholders, partners, and collaborative groups to ensure treatments are implemented as planned and that project objectives are being attained.
At a minimum, the environmental impact statement will disclose the effects of the Proposed Action and a No Action alternative. The No Action alternative represents no change from current conditions and serves as the baseline for the comparison among alternatives. An alternative to the Proposed Action may be developed in response to public comments.
The Forest Supervisor of the MBNF is the deciding official for the LaVA Project. Once the NEPA analysis is completed, he will decide: Whether or not to implement, in part or full, the proposed actions or other alternatives; rationale for the decision; and design criteria, mitigation and monitoring requirements necessary for project implementation.
This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. It is important that reviewers provide comments at such times and in such a 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 contentions. A more detailed scoping document may be accessed at
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, they will not become part of the public record.
The Forest Service is operating under Part 218—Project-level Pre-decisional Administrative Review Process (hereinafter referred to as `objection'), 36 CFR. 218 Subparts A and C, for this analysis. Per these regulations, individuals and entities who submit timely, specific written comments regarding a proposed project or activity during any designated opportunity for public comment will have standing to file an objection. This includes requests for comments during this initial scoping period as well as comments submitted during the 45-day comment period for the draft environmental impact statement.
It is the responsibility of persons providing comments to submit them by the close of established comment periods. Only those who submit timely and specific written comments will have eligibility (36 CFR 218.5) to file an objection under 36 CFR 218.8. For objection eligibility, each individual or representative from each entity submitting timely and specific written comments must either sign the comment or verify identity upon request. Individuals and organizations wishing to be eligible to object must meet the information requirements in § 218.25(a)(3). Names and contact information submitted with comments will become part of the public record and may be released under the Freedom of Information Act.
Rural Housing Service, USDA.
Proposed collection; comments requested.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Housing Service's (RHS) intent to reinstate a previously approved information collection in support of the Single Family Housing Guaranteed Loan Program.
Comments on this notice must be received by [60 days] to be assured of consideration.
Kate Jensen, Finance and Loan Analyst, Single Family Housing Guaranteed Loan Division, Stop 0784, Room 2250, USDA Rural Development, South Agriculture Building, 1400 Independence Avenue SW., Washington, DC 20250-0784, telephone (503) 894-2382, Email
Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, at (202) 692-0040.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Texas Advisory Committee (Committee) to the Commission will be held at 2:00 p.m. (Central Time) August 21, 2017. The purpose of the meeting is for the Committee to discuss project topics of study.
The meeting will be held on Monday, August 21, 2017, at 2:00 p.m. CDT.
Ana Victoria Fortes (DFO) at
This meeting is available to the public through the following toll-free call-in number: 888-471-3820, conference ID number: 2807375. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Commission on Civil Rights.
Announcement of planning meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Maryland Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EDT) on Thursday, August 10, 2017. The purpose of the planning meeting is to review the Advisory Memorandum for its Bail Reform and Fines and Fees project and vote to submit the memorandum for Commission review.
Thursday, August 10, 2017 at 12 p.m. (EDT).
Public call-in information: Conference call-in number: 1-877-440-5787 and conference call ID: 1233406.
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-440-5787 and conference call ID: 1233406. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-877-440-5787 and conference call ID: 1233406.
Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held at 2:00 p.m. (Alaska Time) Thursday, July 20, 2017. The purpose of the meeting is for the Committee to discuss potential panelists to speak at the Alaska Native voting rights briefing.
The meeting will be held on Thursday, July 20, 2017, at 2:00 p.m. AKDT.
Ana Victoria Fortes (DFO) at
This meeting is available to the public through the following toll-free call-in number: 877-719-9788, conference ID number: 2981918. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the California State Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Pacific Time) Wednesday, August 16, 2017. The purpose of the meeting is for the Committee to discuss project topics of study.
The meeting will be held on Wednesday, August 16, 2017, at 12:00 p.m. PDT.
Ana Victoria Fortes at
This meeting is available to the public through the following toll-free call-in number: 888-516-2447, conference ID number: 9545369. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
First Responder Network Authority, National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of availability of a final programmatic environmental impact statement.
The First Responder Network Authority (“FirstNet”) announces the availability of the Final Programmatic Environmental Impact Statement for the West Region (“Final PEIS”). The Final PEIS evaluates the potential environmental impacts of the proposed nationwide public safety broadband network in the West Region (Arizona, California, Idaho, Nevada, Oregon, and Washington).
The Final PEIS is available for download from
For more information on the Final PEIS, contact Amanda Goebel Pereira, NEPA Coordinator, First Responder Network Authority, National Telecommunications and Information Administration, U.S. Department of Commerce, 12201 Sunrise Valley Drive, M/S 243, Reston, VA 20192.
The Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96, Title VI, 126 Stat. 256 (codified at 47 U.S.C. 1401
The National Environmental Policy Act of 1969 (42 U.S.C. 4321-4347) (“NEPA”) requires federal agencies to undertake an assessment of environmental effects of their proposed actions prior to making a final decision and implementing the action. NEPA requirements apply to any federal project, decision, or action that may have a significant impact on the quality of the human environment. NEPA also establishes the Council on Environmental Quality (“CEQ”), which issued regulations implementing the procedural provisions of NEPA (see 40 CFR parts 1500-1508). Among other considerations, CEQ regulations at 40 CFR 1508.28 recommend the use of
Due to the geographic scope of FirstNet (all 50 states, the District of Columbia, and five territories) and the diversity of ecosystems potentially traversed by the project, FirstNet has elected to prepare five regional PEISs. The five PEISs are divided into the East, Central, West, South, and Non-Contiguous Regions. The West Region consists of Arizona, California, Idaho, Nevada, Oregon, and Washington. The Final PEIS analyzes potential impacts of the deployment and operation of the NPSBN on the natural and human environment in the West Region, in accordance with FirstNet's responsibilities under NEPA.
Now that this PEIS has been completed and once a Record of Decision (ROD) has been signed, the proposed FirstNet projects can begin to submit the site-specific environmental documentation to determine if the proposed project has been adequately evaluated in the PEIS or whether it instead warrants a Categorical Exclusion, an Environmental Assessment, or an Environmental Impact Statement.
National Institute of Standards and Technology, Commerce.
Notice of open meeting.
The National Institute of Standards and Technology (NIST) announces that the Manufacturing Extension Partnership (MEP) Advisory Board will hold an open meeting on September 27, 2017.
The meeting will be held Wednesday, September 27, 2017, from 8:00 a.m. to 12:00 p.m. Eastern Time.
The meeting will be held in Building 215, Room C103, at NIST, 100 Bureau Drive, Gaithersburg, MD 20899. Please note admittance instructions in the
Cheryl L. Gendron, Manufacturing Extension Partnership, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 4800, Gaithersburg, Maryland 20899-4800, telephone number (301) 975-2785, email:
The MEP Advisory Board is authorized under
Background information on the MEP Advisory Board is available at
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the MEP Advisory Board will hold an open meeting on Wednesday, September 27, 2017, from 8:00 a.m. to 12:00 p.m. Eastern Time. The meeting agenda will include an update on Hollings MEP programmatic operations, as well as provide guidance and advice to NIST on the development of the 2017-2022 Hollings MEP Strategic Plan. The MEP Advisory Board will also provide input to NIST on developing protocols that will connect user facilities, research, and technologies at NIST and other federal laboratories with the help of the Hollings MEP national network to support small and mid-size manufacturers, and make recommendations on how the Hollings MEP operates as a Learning Organization. This encompasses an effort to strengthen connections by sharing best practices and building Working Groups and Communities of Practice in furtherance of the Hollings MEP Program's mission. The final agenda will be posted on the MEP Advisory Board Web site at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the MEP Advisory Board's business are invited to request a place on the agenda. Approximately 15 minutes will be reserved for public comments at the end of the meeting. Speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received but is likely to be no more than three to five minutes each. Requests must be received in writing before September 15, 2017, to be considered. The exact time for public comments will be included in the final agenda that will be posted on the MEP Advisory Board Web site at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; availability of permits.
NMFS announces that 12 American Samoa pelagic longline limited entry permits in three vessel size classes are available for 2017. NMFS is accepting applications for these available permits.
NMFS must receive completed permit applications and payment by November 20, 2017.
Request a blank application from the NMFS Pacific Islands Regional Office (PIR), 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818, or the PIR Web site
Walter Ikehara, Sustainable Fisheries, NMFS PIR, tel 808-725-5175, fax 808-725-5215, or email
Federal regulations at 50 CFR 665.816 allow NMFS to issue new permits for the American Samoa pelagic longline limited entry program if the number of permits in a size class falls below the maximum allowed. At least 12 permits are available for issuance, as follows:
• Ten in Class A (vessels less than or equal to 40 ft in overall length);
• One in Class B (over 40 ft to 50 ft); and
• One in Class C (over 50 to 70 ft).
NMFS will only consider complete applications, which must include the completed and signed application form, evidence of documented participation in the fishery, and non-refundable payment for the application-processing fee.
If NMFS receives more completed applications than the number of available permits for a given permit class, NMFS will prioritize applicants using the information in the
Applicants with the earliest documented participation in the fishery on a Class A sized vessel will receive the highest priorities for obtaining permits in any size class, followed by applicants with the earliest documented participation in Classes B, C, and D, in that order. In the event of a tie in the priority ranking between two or more applicants, NMFS will rank higher the applicant whose second documented participation is earlier. Detailed criteria for prioritization of eligible applicants are in the regulations at 50 CFR 665.816(g).
NMFS must receive applications by November 20, 2017 to be considered for a permit (see
16 U.S.C. 1801
Committee for Purchase from People Who are Blind or Severely Disabled.
Proposed deletions from the Procurement List.
The Committee is proposing to delete products and services from the Procurement List that were previously by nonprofit agencies employing persons who are blind or have other severe disabilities.
Comments must be received on or before: August 20, 2017.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
The following products and services are proposed for deletion from the Procurement List:
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995, the Consumer Product Safety Commission (CPSC or Commission) announces that the CPSC has submitted to the Office of Management and Budget (OMB), a request for extension of approval of a collection of information from persons who may voluntarily participate in consumer focus groups. In the
Written comments on this request for extension of approval of information collection requirements should be submitted by August 21, 2017.
Submit comments about this request by email:
Charu S. Krishnan, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7221, or by email to:
CPSC seeks to renew the following currently approved collection of information:
To help identify and evaluate product-related incidents, Commission staff invites and obtains direct feedback from consumers on issues related to product safety, such as recall effectiveness, product use, and perceptions regarding safety issues. The information that the CPSC collects from future focus groups will help inform the Commission's identification and evaluation of consumer products and product use, by providing insight and information into consumer perceptions and usage patterns. In some cases, one-on-one interviews may be conducted as a more in-depth extension of a focus group or in place of a traditional focus group. This information may also assist the Commission in its efforts to support voluntary standards activities and help CPSC identify consumer safety issues requiring additional research. In addition, based on the information obtained, CPSC may be able to provide safety information to the public that is easier to read and understood by a wider range of consumers.
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995, the Consumer Product Safety Commission (CPSC or Commission) announces that the CPSC has submitted to the Office of Management and Budget (OMB) a request for extension of approval of a collection of information relating to the procedures for the export of noncomplying products (OMB No. 3041-0003). In the
Written comments on this request for extension of approval of information collection requirements should be submitted by August 21, 2017.
Submit comments about this request by email:
Charu S. Krishnan, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7221, or by email to:
CPSC seeks to renew the following currently approved collection of information:
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995, the Consumer Product Safety Commission (CPSC or Commission) announces that the CPSC has submitted to the Office of Management and Budget (OMB) a request for extension of approval of a collection of information relating to the generic clearance for the collection of qualitative feedback on agency service delivery (OMB No. 3041-0148). In the
Written comments on this request for extension of approval of information collection requirements should be submitted by August 21, 2017.
Submit comments about this request by email:
Charu S. Krishnan, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; (301) 504-7221, or by email to:
Consumer Product Safety Commission.
Notice.
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995, the Consumer Product Safety Commission (Commission or CPSC) invites comments on a proposed request for extension of approval of a collection of information relating to the Safety Standard for Bicycle Helmets (OMB No. 3041-0127). The Commission will consider all comments received in response to this notice before requesting an extension of approval of this collection of information from the Office of Management and Budget (OMB).
The Office of the Secretary must receive comments not later than September 19, 2017.
You may submit comments, identified by Docket No. CPSC-2010-0056, by any of the following methods:
For further information contact: Charu Krishnan, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7221, or by email to:
CPSC seeks to renew the following collection of information:
The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:
• Whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;
• Whether the estimated burden of the proposed collection of information is accurate;
• Whether the quality, utility, and clarity of the information to be collected could be enhanced; and
• Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995, the Consumer Product Safety Commission (CPSC or Commission) announces that the CPSC has submitted to the Office of Management and Budget (OMB) a request for extension of approval of a collection of information associated with the Safety Standard for Multi-Purpose Lighters (OMB No. 3041-0130). In the
Written comments on this request for extension of approval of information collection requirements should be submitted by August 21, 2017.
Submit comments about this request by email:
Charu S. Krishnan, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; (301) 504-7221, or by email to:
CPSC seeks to renew the following currently approved collection of information:
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by August 21, 2017.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Mr. Vlad Dorjets, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
Pamela Young, (703) 697-9107 or Kathy Valadez, (703) 697-9217; DSCA/DSA-RAN.
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-77 with attached Policy Justification.
(i)
(ii)
(iii)
Continuation of a blanket order training program inside and outside of the Kingdom of Saudi Arabia that includes, but is not limited to, flight training, technical training, professional military education, specialized training, mobile training teams (MTTs), and English language training. These blanket order training cases will cover all relevant types of training offered by or contracted through the U.S. Air Force or Department of Defense Agencies (DOD), to include participation in CONUS DOD-sponsored education, as well as MTTs that will travel to Saudi Arabia. This training for the Royal Saudi Air Force (RSAF) and other Saudi forces will include such subjects as civilian
(iv)
(v)
(vi)
(vii)
(viii)
*As defined in Section 47(6) of the Arms Export Control Act.
The Government of Saudi Arabia requested a possible sale of continued blanket order training program inside and outside of the Kingdom of Saudi Arabia that includes, but is not limited to, flight training, technical training, professional military education, specialized training, mobile training teams (MTTs), and English language training. These blanket order training cases cover all relevant types of training offered by or contracted through the U.S. Air Force or Department of Defense (DoD) Agencies, to include participation in CONUS DOD-sponsored education, as well as MTTs that will travel to Saudi Arabia. This training for the Royal Saudi Air Force (RSAF) and other Saudi forces will include such subjects as civilian casualty avoidance, the law of armed conflict, human rights command and control, and targeting via MTTs and/or broader Programs of Instruction (POIs). Program management, trainers, simulators, travel, billeting, and medical support may also be included. The estimated program cost is $750 million.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of an important partner which has been and continues to be a leading contributor of political stability and economic progress in the Middle East.
This training would support the United States' continued commitment to Saudi Arabia's security and strengthen the U.S.-Saudi Arabia strategic partnership. Assisting the RSAF supports Saudi Arabia in deterring hostile actions and increases U.S.-Saudi Arabia military interoperability. It also helps their ability to work with coalition partners during training, exercises, and operations. Saudi Arabia will have no difficulty absorbing this training and support.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Saudi Arabia.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale. All defense articles/services have been approved for release.
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before August 21, 2017.
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 Todd Stephenson, 202-205-1645.
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 Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before September 19, 2017.
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 Samuel Pierre, 202-245-6488.
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 for Civil Rights (OCR), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before August 21, 2017.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to the collection activities, please contact Rosa Olmeda, 202-453-5968.
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
Office of Innovation and Improvement, Department of Education.
Notice.
The Department of Education is issuing a notice inviting applications for new awards for fiscal year (FY) 2017 for the Promise Neighborhoods Program—Grant Competition, Catalog of Federal Domestic Assistance (CFDA) number 84.215N.
Applications Available: July 21, 2017.
Adrienne Hawkins, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W256, Washington, DC 20202. Telephone: (202) 453-5638 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
The Promise Neighborhoods program is newly authorized under the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the Every Student Succeeds Act (ESSA). The purpose of the Promise Neighborhoods program is to significantly improve the academic and developmental outcomes of children living in the most distressed communities of the United States, including ensuring school readiness, high school graduation, and access to a community-based continuum of high-quality services. The program serves neighborhoods with high concentrations of low-income individuals; multiple signs of distress, which may include high rates of poverty, childhood obesity, academic failure, and juvenile delinquency, adjudication, or incarceration; and schools implementing comprehensive support and improvement activities or targeted support and improvement activities under section 1111(d) of the ESEA. All strategies in the continuum of solutions must be accessible to children with disabilities and English learners.
The vision of the Promise Neighborhoods program is that all children and youth living in our most distressed communities have access to great schools and strong systems of family and community support that will prepare them to attain an excellent education and successfully transition to postsecondary education and a career.
A Promise Neighborhood is both a place and a strategy. A place eligible to become a Promise Neighborhood is a geographic area
A Promise Neighborhood strategy addresses the complex, interconnected issues in the distressed community it serves. Promise Neighborhoods are led by organizations, such as nonprofit organizations, institutions of higher education, offices of chief elected officials of local governments, or Indian Tribes or Tribal organizations, that work to ensure that all children and youth in the target geographic area have access to services that lead to improved educational and developmental outcomes from cradle-to-career. The organizations ensure that services are based on the best available evidence and employ robust data collection and management systems to learn about the impact of approaches for which there is less evidence; that services are linked and integrated seamlessly; and that services include education programs as well as programs that provide family and community supports. Promise Neighborhoods enable children and youth within targeted distressed communities to participate in the full range of cradle-to-career supports that are necessary for them to realize their potential. The Department of Education's expectation is that over time, a greater proportion of the neighborhood residents receive these supports and that neighborhood indicators (see Table 1) show significant progress. For this reason, each Promise Neighborhood applicant must demonstrate several core features: (1) Significant need in the neighborhood; (2) a strategy to build pipeline services (as defined in this notice) with strong schools at the center; and (3) the organizational and relational capacity to achieve results.
This year's Promise Neighborhoods competition is different from previous years' competitions in several ways. The Promise Neighborhoods program, under the ESEA as amended by ESSA, requires applicants to propose the use of not less than 50 percent of grant funds in year one, and not less than 25 percent in year two, to support planning activities for the development and implementation of pipeline services. Because applicants must now propose to use grant funds for limited planning activities, the Department will no longer award separate Promise Neighborhoods planning and implementation grants. The priorities and some program requirements for this year's competition have also changed from previous competitions. In this year's competition, we introduce new data and performance management requirements while continuing to prioritize evidence-based (see section 8101(21) of the ESEA) activities and programs. Previously funded Promise Neighborhoods grantees have struggled to conduct meaningful data collection and evaluation activities, which include collecting the full range of data necessary to effectively employ comprehensive case and longitudinal data management systems. Such data systems are critical to effectively coordinate a range of services for high-need students and their families within a Promise Neighborhood. In response to this challenge, we now require applicants to address specific data collection and performance management requirements.
In addressing these requirements, we strongly encourage applicants to review a publication released by the Department in 2013 entitled, “Measuring Performance: A Guidance Document for Promise Neighborhoods on Collecting Data and Reporting Results.”
Each of the three absolute priorities constitutes its own funding category. Assuming that applications in each funding category are of sufficient quality, the Secretary intends to award grants under each absolute priority.
Under 34 CFR 75.105(c)(3) we consider only applications that meet one or more of these priorities.
These priorities are:
To meet this priority, an applicant must propose to implement a Promise Neighborhood strategy that serves one or more non-rural or non-Tribal communities.
To meet this priority, an applicant must propose to implement a Promise Neighborhood strategy that serves one or more rural communities (as defined in this notice) only.
Under section 4623 of the ESEA, the Department will use at least 15 percent of the funds available for the Promise Neighborhoods program to award grants to eligible entities (as defined in this notice) that propose to carry out the Promise Neighborhoods activities in rural areas. The Department will reduce the funds reserved for rural areas if we do not receive enough applications of sufficient quality.
To meet this priority, an applicant must propose to implement a Promise Neighborhood strategy that serves one or more Indian Tribes (as defined in this notice).
For FY 2017 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i), we award an additional three points to an application that meets Competitive Preference
Applicants may address all of the competitive preference priorities. Also, applicants should identify on the abstract form and in the project narrative section of their application which competitive preference priority or priorities the applicants address. We will not award competitive preference priority points to an application that fails to clearly identify the competitive preference priority or priorities it wishes the Department to consider for purposes of earning the competitive preference priority points.
These priorities are:
To meet this priority, an applicant must propose to serve geographic areas that were the subject of a targeted strategy addressing crime in a specific community pursuant to a BCJI grant awarded by the U.S. Department of Justice during FY 2012 or later years. To be eligible under this priority, the applicant must either: (1) Be able to demonstrate that it has received a BCJI grant; or (2) provide, in its application, a memorandum of understanding between it and a partner that is a recipient of a BCJI grant. The memorandum of understanding must indicate a commitment on the part of the applicant and partner to coordinate implementation and align resources to the greatest extent practicable.
To receive points under this priority, the applicant must either: (1) Demonstrate that it has received a DFC grant to prevent opioid abuse (as one of its areas of focus); or (2) provide, in its application, a memorandum of understanding between it and a partner that is a recipient of a DFC grant to address opioid abuse prevention as one of its areas of focus.
To meet this priority, an applicant must propose to carry out evidence-based activities, strategies, or interventions that, based on information included in their application, are supported by promising evidence (as defined in this notice).
This priority is for projects that are designed to serve and coordinate with a federally designated Promise Zone.
To meet this priority, an applicant must include a Certification of Consistency with Promise Zone Goals and Implementation (HUD Form 50153) signed by an authorized representative of the lead organization of a Promise Zone designated by the Department of Housing and Urban Development (HUD) or the United States Department of Agriculture. An application for Promise Neighborhoods grant funds that is not accompanied by a signed certification (HUD Form 50153) will receive zero points for this priority. The certification form is available at
The definition of “strong theory” is from 34 CFR 77.1. The remaining definitions are established in accordance with section 437(d)(1) of GEPA, 20 U.S.C. 1232(d)(1).
The following definitions apply to this program:
(1) Is representative of the geographic area (as defined in this notice) proposed to be served;
(2) Operates or proposes to work with and involve in carrying out its proposed project, in coordination with the school's local educational agency (LEA), at least one public elementary or secondary school that is located within the identified geographic area that the grant will serve;
(3) Is one of the following:
(a) An institution of higher education, as defined in section 102 of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1002);
(b) An Indian Tribe or Tribal organization, as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); or
(c) One or more nonprofit entities working in formal partnership with not less than one of the following entities:
i. A high-need LEA.
ii. An institution of higher education, as defined in section 102 of the HEA (20 U.S.C. 1002).
iii. The office of a chief elected official of a unit of local government.
iv. An Indian Tribe or Tribal organization, as defined under section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); and
(4) Currently provides at least one of the solutions from the applicant's proposed pipeline services in the geographic area proposed to be served.
This definition is not meant to prevent a grantee from also collecting information about the reasons why students do not graduate from the target high school,
(1) Education need, which means—
(a) All or a portion of the neighborhood includes or is within the attendance zone of a low-performing school that is a high school, especially one in which the graduation rate (as defined in this notice) is less than 60 percent or a school that can be characterized as low-performing based on another proxy indicator, such as students' on-time progression from grade to grade; and
(b) Other indicators, such as significant achievement gaps between subgroups of students (as identified in section 1111(b)(2)(B)(xi) of the ESEA) within a school or LEA, high teacher and principal turnover, or high student absenteeism; and
(2) Family and community support need, which means—
(a) Percentages of children with preventable chronic health conditions (
(b) Immunization rates;
(c) Rates of crime, including violent crime;
(d) Student mobility rates;
(e) Teenage birth rates;
(f) Percentage of children in single-parent or no-parent families;
(g) Rates of vacant or substandard homes, including distressed public and assisted housing; or
(h) Percentage of the residents living at or below the Federal poverty threshold.
(a) High-quality early childhood education programs.
(b) High-quality school and out-of-school-time programs and strategies.
(c) Support for a child's transition to elementary school, from elementary school to middle school, from middle school to high school, and from high school into and through postsecondary education and into the workforce, including any comprehensive readiness assessment determined necessary.
(d) Family and community engagement and supports, which may include engaging or supporting families at school or at home.
(e) Activities that support postsecondary and work-force readiness, which may include job training, internship opportunities, and career counseling.
(f) Community-based support for students who have attended the schools in the area served by the pipeline, or students who are members of the community, facilitating their continued connection to the community and success in postsecondary education and the workforce.
(g) Social, health, nutrition, and mental health services and supports.
(h) Juvenile crime prevention and rehabilitation programs.
(a) There is at least one study that is a correlational study with statistical controls for selection bias with a relevant finding (quasi-experimental design studies or experimental studies may also qualify); and
(b) The relevant finding in the study described in paragraph (a) is of a statistically significant and positive (
(1) Residents who live in the geographic area proposed to be served, which may include residents who are representative of the ethnic and racial composition of the neighborhood's residents and the languages they speak;
(2) Residents of the city or county in which the neighborhood is located but who live outside the geographic area proposed to be served, and who are low-income (which means earning less than 80 percent of the area's median income as published by HUD);
(3) Public officials (as defined in this notice) who serve the geographic area proposed to be served (although not more than one-half of the governing board or advisory board may be made up of public officials); or
(4) Some combination of individuals from the three groups listed in paragraphs (1), (2), and (3) of this definition.
(1) Is served by an LEA that is currently eligible under the Small Rural School Achievement (SRSA) program or the Rural and Low-Income School (RLIS) program authorized under Title VI, Part B of the ESEA. Applicants may determine whether a particular LEA is eligible for these programs by referring to information on the following Department Web sites. For the SRSA program:
(2) Includes only schools designated with a school locale code of 41, 42, or 43. Applicants may determine school locale codes by referring to the following Department Web site:
(1) For tested grades and subjects:
(a) A student's score on the State's assessments under the ESEA; and, as appropriate,
(b) Other measures of student learning, such as those described in paragraph (2) of this definition, provided they are rigorous and comparable across classrooms and programs.
(2) For non-tested grades and subjects: Alternative measures of student learning and performance, such as student scores on pre-tests and end-of-course tests; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across classrooms.
This definition is not meant to limit a grantee from also collecting information about why students enter or withdraw from the school,
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
The maximum award amount is $6,000,000 per 12-month budget period. We will not fund an annual budget exceeding $6,000,000 per 12-month budget period.
The Department is not bound by any estimates in this notice.
Under section 4623 of the ESEA, a grant awarded under this competition will be for a period of not more than five years, and may be extended for an additional period of not more than two
1.
(1) Be representative of the geographic area proposed to be served;
(2) Operate or propose to work with and involve in carrying out its proposed project, in coordination with the school's LEA, at least one public elementary or secondary school that is located within the identified geographic area that the grant will serve;
(3) Be one of the following:
(a) An institution of higher education, as defined in section 102 of the HEA (20 U.S.C. 1002);
(b) An Indian Tribe or Tribal organization, as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); or
(c) One or more nonprofit entities working in formal partnership with not less than one of the following entities:
i. A high-need LEA.
ii. An institution of higher education, as defined in section 102 of the HEA (20 U.S.C. 1002).
iii. The office of a chief elected official of a unit of local government.
iv. An Indian Tribe or Tribal organization, as defined under section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); and
(4) Currently provide at least one of the solutions from the applicant's proposed pipeline services in the geographic area proposed to be served.
2.
Eligible sources of matching funds include sources of funds used to pay for solutions within the pipeline services, initiatives supported by the LEA, or public health services for children in the neighborhood. At least 10 percent of an applicant's total match must be cash or in-kind contributions from the private sector, which may include philanthropic organizations, private businesses, or individuals.
Applicants must demonstrate a commitment of matching funds in the application. Applicants must specify the source of the funds or contributions and in the case of a third-party in-kind contribution, a description of how the value was determined for the donated or contributed goods or service. Applicants must demonstrate the match commitment by including letters in their applications explaining the type and quantity of the match commitment with original signatures from the executives of organizations or agencies providing the match.
The Secretary may consider decreasing the matching requirement in the most exceptional circumstances, on a case-by-case basis. An applicant that is unable to meet the matching requirement must include in its application a request to the Secretary to reduce the matching requirement, including the amount of the requested reduction, the total remaining match contribution, and a statement of the basis for the request. The Secretary will grant this request only if an applicant demonstrates a significant financial hardship. An applicant should review the Department's cost-sharing and cost-matching regulations, which include specific limitations, in 2 CFR 200.306 and the cost principles regarding donations, capital assets, depreciations and allowable costs, set out in subpart E of 2 CFR part 200.
3.
Under section 4624 of the ESEA, as amended by the ESSA, applicants must submit and address the following:
(1) A plan to significantly improve the academic outcomes of children living in the geographically defined area (neighborhood) that is served by the eligible entity by providing pipeline services that address the needs of children in the neighborhood, as identified by the needs analysis; and that is supported by effective practices.
(2) A description of the neighborhood the eligible entity will serve. Applicants may propose to serve multiple, non-contiguous geographically defined areas. In cases where target areas are non-contiguous, the applicant must explain its rationale for including non-contiguous areas.
(3) An analysis of the needs and assets of the neighborhood, including:
(a) The size and scope of the population affected;
(b) A description of the process through which the needs analysis was produced, including a description of how parents, families, and community members were engaged in such analysis;
(c) An analysis of community assets and collaborative efforts (including programs already provided from Federal and non-Federal sources) within, or accessible to, the neighborhood, including, at a minimum, early learning opportunities, family and student supports, local businesses, local educational agencies, and institutions of higher education;
(d) The steps that the eligible entity is taking at the time of the application to address the needs identified in the needs analysis; and
(e) Any barriers the eligible entity, public agencies, and other community-based organizations have faced in meeting such needs.
(4) A description of all information the entity used to identify the pipeline services to be provided, which shall not include information that is more than 3 years old. This description should address how the eligible entity plans to collect data on children served by each pipeline service; and increase the percentage of children served over time.
(5) A description of the process used to develop the Promise Neighborhoods application, including the involvement of family and community members.
(6) A description of how the pipeline services will facilitate the coordination of the following activities:
(a) Providing early learning opportunities for children, including by:
(i) Providing opportunities for families to acquire the skills to promote early learning and child development; and
(ii) Ensuring appropriate diagnostic assessments and referrals for children with disabilities and children aged 3
(b) Supporting, enhancing, operating, or expanding rigorous, comprehensive, effective educational improvements, which may include high-quality academic programs, expanded learning time, and programs and activities to prepare students for postsecondary education admissions and success.
(c) Supporting partnerships between schools and other community resources with an integrated focus on academics and other social, health, and familial supports.
(d) Providing social, health, nutrition, and mental health services and supports, for children, family members, and community members, which may include services provided within the school building.
(e) Supporting evidence-based programs (see section 8101(21) of the ESEA) that assist students through school transitions, which may include expanding access to postsecondary education courses and postsecondary education enrollment aid or guidance, and other supports for at-risk youth.
(7) A description of the strategies that will be used to provide pipeline services (including a description of which programs and services will be provided to children, family members, community members, and children within the neighborhood) to support the purpose of the Promise Neighborhoods program.
(8) An explanation of the process the eligible entity will use to establish and maintain family and community engagement, including:
(a) Involving representative participation by the members of such neighborhood in the planning and implementation of the activities of each grant awarded;
(b) The provision of strategies and practices to assist family and community members in actively supporting student achievement and child development;
(c) Providing services for students, families, and communities within the school building; and
(d) Collaboration with institutions of higher education, workforce development centers, and employers to align expectations and programming with postsecondary education and workforce readiness.
(9) An explanation of how the eligible entity will continuously evaluate and improve the continuum of high-quality pipeline services to provide for continuous program improvement and potential expansion.
(10) A commitment to collecting the required Promise Neighborhoods performance indicators' data; establishing the conditions for effective case and data management; and using data to improve program outcomes. In understanding the conditions necessary to collect, manage, and utilize data for Promise Neighborhoods, an applicant is required to:
(a) Hire dedicated staff to ensure its project has sufficient personnel and/or contractors to effectively manage its data collection activities, case management, and data systems;
(b) Submit a detailed data collection and reporting plan that includes a description of how it will conduct a bi-annual neighborhood survey of children and adults in the Promise Neighborhood; collect, at least annually, data on the performance indicators in Table 1; establish clear, annual targets and goals for growth on the performance indicators; and report those data to the Department annually;
The indicators in Table 1 are not intended to limit an applicant from collecting and using data from additional Family and Community Support indicators proposed to the Department. Applicants are strongly encouraged, but not required, to propose additional performance indicators aligned to the specific pipeline services proposed in their application.
(c) Describe how it will develop a case management system to track key information and progress toward outcomes for individual children and adults participating in its Promise Neighborhoods programs and to facilitate communication and the coordination of services on behalf of these individuals; and
(d) Describe how it will develop and maintain a longitudinal data system to track outcome measures and other performance indicators over time (
The established performance indicators for the Promise Neighborhoods program serve as indicators of improved academic and developmental outcomes for children, including indicators of school readiness, high school graduation, postsecondary education and career readiness, and other academic and developmental outcomes. Each grantee is required to collect and report data on the performance indicators annually. Subsequently, the Department will make a determination for continuation funding and grant extensions based on performance indicator outcomes and available funding.
(11) A commitment to work with the Department, and with a national evaluator for Promise Neighborhoods or another entity designated by the Department, to ensure that data collection and program design are consistent with plans to conduct a rigorous national evaluation of the Promise Neighborhoods program and of specific solutions and strategies pursued by individual grantees. This commitment must include, but need not be limited to—
(a) Ensuring that, through memoranda of understanding with appropriate entities, the national evaluator and the Department have—consistent with applicable privacy requirements—access to relevant program and project data sources (
(b) Developing, in consultation with the national evaluator, an evaluation strategy, including identifying a credible comparison group; and
(c) Developing, in consultation with the national evaluator, a plan for identifying and collecting reliable and valid baseline data for both program participants and a designated comparison group of non-participants.
(12) Each applicant must submit, as part of its application, a preliminary memorandum of understanding, signed by each organization or agency with which it would partner in implementing the proposed Promise Neighborhood. Within the preliminary memorandum of understanding, all applicants must detail each partner's financial, programmatic, and long-term commitment with respect to the strategies described in the application.
Under section 4624(c) of the ESEA, applicants that are non-profit entities must submit a preliminary memorandum of understanding signed by each partner entity or agency, which must include at least one of the following: A high-need LEA; an institution of higher education, as defined in section 102 of the HEA (20 U.S.C. 1002); the office of a chief elected official of a unit of local government; or an Indian Tribe or Tribal organization as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).
Each eligible entity that receives a grant under this program is required to prepare and submit an annual report to the Secretary that must include the following: (1) Information about the number and percentage of children in the neighborhood who are served by the grant program, including a description of the number and percentage of children accessing each support service offered as part of the pipeline of services; and (2) information relating to the metrics established under the Promise Neighborhood Performance Indicators.
In addition, grantees are required to make these data publicly available, including through electronic means. To the extent practicable, and as required by law, such information must be provided in a form and language accessible to parents and families in the neighborhood served under the Promise Neighborhoods grant. In addition, data on academic indicators pertinent to the Promise Neighborhoods program will, in most cases, already be part of statewide longitudinal data systems.
1.
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA number 84.215N.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2. a.
The Department will be able to develop a more efficient process for reviewing grant applications if it has a better understanding of the number of entities that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify the Department of the applicant's intent to submit an application for funding by completing a web-based form. When completing this form, applicants will provide (1) the applicant organization's name and address, and (2) information on the competitive preference priority or priorities under which the applicant intends to apply. Applicants may access this form online at
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the recommended page limit does apply to all of the application narrative.
2. b.
Because we plan to make successful applications available to the public, you may wish to request confidentiality of business information.
Consistent with Executive Order 12600, please designate in your application any information that you feel is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).
3.
Applications for grants under this competition must be submitted electronically using the
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
Applicants that operate a school in a neighborhood served by a grant program must provide such school with the operational flexibility, including autonomy over staff, time, and budget, needed to effectively carry out the activities described in this Notice.
Grantees cannot, in carrying out activities to improve early childhood education programs, use Promise Neighborhoods funds to carry out the following activities:
(1) Assessments that provide rewards or sanctions for individual children or teachers.
(2) A single assessment that is used as the primary or sole method for assessing program effectiveness.
(3) Evaluation of children, other than for the purposes of improving instruction, classroom environment, professional development, or parent and family engagement, or program improvement.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program
Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through,
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via
7.
a.
Applications for grants under Promise Neighborhoods, CFDA number 84.215N, must be submitted electronically using the Governmentwide
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the Promise Neighborhoods program at
Please note the following:
• When you enter the
• Applications received by
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through
• You should review and follow the Education Submission Procedures for submitting an application through
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, flattened Portable Document Format (PDF), meaning any fillable PDF documents must be saved as flattened non-fillable files. Therefore, do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, flattened PDF (
• Your electronic application must comply with any page limit requirements described in this notice.
• After you electronically submit your application, you will receive from
Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Adrienne Hawkins, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W256, Washington, DC 20202-5970. FAX: (202) 205-5630.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.215N), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
We will not consider applications postmarked after the application deadline date.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.215N), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
Points awarded under these selection criteria are in addition to any points an applicant earns under the competitive preference priorities in this notice. The maximum score that an application may receive under the competitive preference priorities and the selection criteria is 108 points.
(a)
The Secretary considers the need for the proposed project. In determining the need for the proposed project, the Secretary considers:
(1) The magnitude or severity of the problems to be addressed by the proposed project as described by indicators of need (as defined in this notice) and other relevant indicators identified in part by the needs assessment and segmentation analysis (as defined in this notice);
(2) The extent to which the geographically defined area has been described; and
(3) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses. (34 CFR 75.210)
(b)
The Secretary reviews each application to determine the quality of the project design. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(1) The extent to which the applicant describes a plan to create a complete pipeline of services, including early learning through grade 12, college- and career-readiness, and family and community supports, without time and resource gaps, that will prepare all children in the neighborhood to attain an excellent education and successfully transition to college and a career, and that will significantly increase the proportion of students in the neighborhood that are served by the complete continuum to reach scale over time;
(2) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible (34 CFR 75.210); and
(3) The extent to which the proposed project is supported by strong theory (as defined in this notice) (34 CFR 75.210).
(c)
The Secretary considers the quality of the services to be provided by the proposed project. In determining the quality of the project services, the Secretary considers:
(1) The quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability (34 CFR 75.210);
(2) The likelihood that the services to be provided by the proposed project will lead to improvement in the achievement of students as measured against rigorous academic standards (34 CFR 75.210); and
(3) The quality of the applicant's plan to establish formal and informal partnerships, including the alignment of the visions, theories of action, and theories of change described in its memorandum of understanding, and to create a system for holding partners accountable for performance in accordance with the memorandum of understanding.
(d)
The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks (34 CFR 75.210); and
(2) The adequacy of the management plan's provisions on collecting, analyzing, and using data for decision-making, learning, continuous improvement, and accountability, including whether the applicant has a plan to build, adapt, or expand a longitudinal data system that integrates student-level data from multiple sources in order to measure progress while abiding by privacy laws and requirements, and ensuring that any systems built, adapted, or expanded upon includes essential security controls.
(e)
The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers:
(1) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits (34 CFR 75.210);
(2) The extent to which the applicant demonstrates that it has the resources to operate the project beyond the length of the grant, including a multi-year financial and operating model and accompanying plan; the demonstrated commitment of any partners; evidence of broad support from stakeholders (
(3) The extent to which the applicant identifies existing neighborhood assets and programs supported by Federal, State, local, and private funds that will be used to implement pipeline services.
2.
The Department will use independent reviewers from various backgrounds and professions including: Pre-kindergarten through grade 12, teachers and principals, college and university educators, researchers and evaluators, social entrepreneurs, strategy consultants, grant makers and managers, and others with community development and education expertise. The Department will thoroughly screen all reviewers for conflicts of interest to ensure a fair and competitive review process.
Reviewers will read, prepare a written evaluation of, and score the applications assigned to their panel, using the selection criteria provided in this notice.
The Secretary prepares a rank order of applications for each absolute priority based solely on the evaluation of their quality according to the selection criteria and competitive preference priority points. The Department may use more than one tier of reviews in determining grantees, including possible site visits for applicants. Additional information about the review process will be posted on the Department's Web site.
We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
5.
5.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
Office of Elementary and Secondary Education, Department of Education.
Notice.
The Department of Education is issuing a notice inviting applications for fiscal year (FY) 2017 for the Impact Aid Discretionary Construction Grant Program, Catalog of Federal Domestic Assistance (CFDA) number 84.041C.
Amanda Ognibene, Impact Aid Program, U.S. Department of Education, 400 Maryland Avenue SW., Room 3C129, Washington, DC 20202-6244. Telephone: 202-260-3858 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
This priority is:
An LEA is eligible to apply for and receive an emergency grant under this priority if it—
(a) Is eligible to receive formula construction funds for the fiscal year under section 7007(a) of the Act (20 U.S.C. 7707(a));
(b)(1) Has no practical capacity to issue bonds;
(2) Has minimal capacity to issue bonds and has used at least 75 percent of its bond limit; or
(3) Is eligible to receive funds for the fiscal year for heavily impacted districts under section 7003(b)(2) of the Act (20 U.S.C. 7707(b)(2)); and
(c) Has a school facility emergency that the Secretary has determined, consistent with 34 CFR 222.172(a) and 222.173, poses a health or safety hazard to students and school personnel.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2018 from the list of unfunded applications from this competition.
The Department is not bound by any estimates in this notice.
1.
(a) Is eligible to receive formula construction funds for the fiscal year under section 7007(a) of the Act (20 U.S.C. 7707(a)) because it enrolls a high percentage (at least 50 percent) of federally connected children in average daily attendance (ADA) who either reside on Indian lands or who have a parent on active duty in the U.S. uniformed services.
(b)(1) Has no practical capacity to issue bonds (as defined in 34 CFR 222.176);
(2) Has minimal capacity to issue bonds (as defined in 34 CFR 222.176) and has used at least 75 percent of its bond limit; or
(3) Is eligible to receive funds for the fiscal year for heavily impacted districts under section 7003(b)(2) of the Act (20 U.S.C. 7703(b)(2)); and
(c) Has a school facility emergency that the Secretary has determined, consistent with 34 CFR 222.172(a) and 222.173, poses a health or safety hazard to students and school personnel.
2.a.
b.
1.
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
3.
Applications for grants under this competition must be submitted electronically using G5, the Department's grant management system, accessible through the Department's G5 site. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
We reference additional regulations outlining funding restrictions in the
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through,
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
7.
a.
Applications for grants under the Impact Aid Discretionary Construction Grant Program, CFDA number 84.041C, must be submitted electronically using the G5 system, accessible through the Department's G5 site at:
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
Please note the following:
• You must complete the electronic submission of your grant application by midnight, Washington, DC time, on the application deadline date. G5 will not accept an application for this competition after 11:59:59 p.m., Washington, DC time, on the application deadline date. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the application process.
• The hours of operation of the G5 Web site are 6:00 a.m. Monday until 9:00 p.m. Wednesday; and 6:00 a.m. Thursday until 3:00 p.m. Sunday, Washington, DC time. Please note that, because of maintenance, the system is unavailable between 3:00 p.m. on Sundays and 6:00 a.m. on Mondays, and between 9:00 p.m. on Wednesdays and 6:00 a.m. on Thursdays, Washington, DC time. Any modifications to these hours are posted on the G5 Web site.
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Discretionary Construction Program under Section 7007(b) and all necessary signature pages.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, flattened Portable Document Format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, flattened PDF (
• Prior to submitting your electronic application, you may wish to print a copy of it for your records.
• After you electronically submit your application, you will receive an automatic acknowledgment that will include a unique PR/Award number for your application.
• By the application deadline date, you must fax or email to the Impact Aid Program a signed copy of the cover page and the independent emergency certification form for the Application for Discretionary Construction Program under Section 7007(b) after following these steps:
(1) Print a copy of the application from G5 for your records.
(2) The applicant's Authorizing Representative must sign and date the cover page. The local certifying official must sign the certification for an emergency application. These forms must be submitted by the application deadline in order to be considered for funding under this program.
(3) Place the PR/Award number in the upper, right-hand corner of the hard-copy signed cover page of the application.
(4) Fax or email the signed cover page and independent emergency certification to the Impact Aid Program at 1-866-799-1273 or by email to
• We may request that you provide us original signatures on other forms at a later date.
(1) You are a registered user of the G5 system and you have initiated an electronic application for this competition; and
(2) (a) G5 is unavailable for 60 minutes or more between the hours of 8:30 a.m. and 11:00 p.m., Washington, DC time, on the application deadline date; or
(b) G5 is unavailable for any period of time between 11:00 p.m. and midnight, Washington, DC time, on the application deadline date.
We must acknowledge and confirm these periods of unavailability before granting you an extension. To request this extension or to confirm our acknowledgment of any system unavailability, you may contact either (1) the person listed under
• You do not have access to the internet; or
• You do not have the capacity to upload large documents to G5;
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the internet to submit your application. If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Amanda Ognibene, Impact Aid Program, U.S. Department of Education, 400 Maryland Avenue SW., Room 3C129, Washington, DC 20202-6244. Telephone: 202-260-3858. FAX: 1-866-799-1273.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Impact Aid Program, Attention: (CFDA Number 84.041C), Room 3C129, 400 Maryland
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
We will not consider applications postmarked after the application deadline date.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application, by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Impact Aid Program, Attention: (CFDA Number 84.041C), Room 3C129, 400 Maryland Avenue SW., Washington, DC 20202-6244.
The Impact Aid Program accepts hand deliveries daily between 8:00 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope—if not provided by the Department—the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Impact Aid Program will mail to you a notification of receipt of your grant application. If you do not receive this grant notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Impact Aid Program at (202) 260-3858.
1.
(a) Severity of the school facility problem to be addressed by the proposed project (34 CFR 222.189(a)(1)) (Maximum 30 points).
(i) Justification that the proposed emergency project will address a deficiency that poses a health or safety hazard to occupants of the facility, and consistency of the emergency description and the proposed project with the certifying local official's statement (34 CFR 222.185(a) and (c)) (15 points).
(ii) Impact of the emergency condition on the health and safety of the building occupants and how free public education program delivery in the instructional school facility is adversely affected (34 CFR 222.172, 222.173, 222.176, and 222.185(b)). Applicants should describe: The systems or areas of the facility involved (
(b) Project urgency (Maximum 28 points).
(i) Risk to occupants if the facility condition is not addressed (34 CFR 222.176, definition of “emergency”). Applicants should describe: Projected increased future costs; the anticipated effect of the proposed project on the useful life of the facility or the need for major construction; and the age and condition of the facility and date of last renovation of affected areas.
(ii) The justification for rebuilding, if proposed (34 CFR 222.172(c)).
(c) Effects of Federal presence (section 7007(b)(4)(B) and (C) and 34 CFR 222.184(b)) (Maximum 30 points).
(i) Amount of non-taxable Federal property in the applicant LEA (percentage of Federal property divided by 10) (10 points).
(ii) The number of federally connected children identified in section 7003(a)(1)(A), (B), (C), and (D) of the Act in the LEA (percentage of identified children in LEA divided by 10) (10 points).
(iii) The number of federally connected children identified in section 7003(a)(1)(A), (B), (C), and (D) of the Act in the school facility (percentage of identified children in school facility divided by 10) (10 points).
(d) Ability to respond or pay (section 7007(b)(4)(A)) (Maximum 12 points).
(i) The percentage of its bonding capacity used by the LEA. Four points will be distributed based on this percentage such that: Four points will be given to an LEA that has used 75 percent or more of its bonding capacity; three points will be given to an LEA that has used 50 percent to 74 percent of its bonding capacity; two points will be given to an LEA that has used 25 percent to 49 percent of its bonding capacity; and one point will be given to an LEA that has used less than 25 percent of its bond limit. LEAs that do not have limits on bonded indebtedness established by their States will be evaluated by assuming that their bond limit is 10 percent of the assessed value of real property in the LEA. LEAs deemed to have no practical capacity to issue bonds will receive all four points (4 points).
(ii) Assessed value of real property per student (applicant LEA's total assessed valuation of real property per pupil as a percentile ranking of all LEAs in the State). Points will be distributed by providing all four points to LEAs in the State's poorest quartile and only one point to LEAs in the State's wealthiest quartile (4 points).
(iii) Total tax rate for capital or school purposes (applicant LEA's tax rate for capital or school purposes as a percentile ranking of all LEAs in the State). If the State authorizes a tax rate for capital expenditures, then these data must be used; otherwise, data on the total tax rate for school purposes are used. Points will be distributed by providing all four points to LEAs in the State's highest-taxing quartile and only one point to LEAs in the State's lowest-taxing quartile (4 points).
2.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial
(b) Upon receipt, Impact Aid program staff will screen all applications to eliminate any applications that do not meet the eligibility standards, are incomplete, or are late. Applications that do not include a signed cover page and a signed independent emergency certification submitted by fax or email before midnight, Washington, DC time on the application deadline are considered incomplete and will not be considered for funding. Program staff will also calculate the scores for each application under criteria (c) and (d). Panel reviewers will assess the applications under criteria (a) and (b).
(c) Applications are ranked based on the total number of points received during the review process. Those with the highest scores will be at the top of the funding slate.
(d) Applicants may submit only one application for one educational facility. If an applicant submits multiple applications, the Department will only consider the first sequentially submitted application, as provided under 34 CFR 222.183.
3.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
4.
5.
You may also access documents of the Department published in the
This is a supplemental notice in the above-referenced proceeding of Hog Creek Wind Project, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 3, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on July 14, 2017, AEP Texas Central Company and AEP Texas North Company filed a request for waiver of requirement to file FERC Form No. 3-Q, as required by 18 CFR 141.400.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff may attend the meetings of the Southwest Power Pool, Inc. Regional State Committee (RSC), Regional Entity Trustee (RET), Members' Committee and Board of Directors as noted below. Their attendance is part of the Commission's ongoing outreach efforts.
The meetings will be held at the Hyatt Regency Denver, 650 15th Street, Denver, Colorado 80202. The phone number is (888) 421-1442. All meetings are Mountain Time.
The discussions may address matters at issue in the following proceedings:
These meetings are open to the public.
For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on July 6, 2017, Pike County Light and Power Company filed a request for waiver of requirement for its Certified Public Accountant (CPA) to file a statement certifying data in its FERC Form 1-F for a calendar year and in lieu thereof to file a CPA certification based on a fiscal year, which runs from September to September.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
This is a supplemental notice in the above-referenced proceeding of Apple Blossom Wind, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 3, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice of availability and public comment period.
The Environmental Protection Agency (EPA) is providing notice that two chapters of the current EPA Air Pollution Control Cost Manual (Control Cost Manual) have been updated. The EPA is requesting comment on: Chapter 1, Section 3 and Section 3.1, “Carbon Adsorbers,” and Chapter 1, Section 3 and Section 3.2, “Flares.” These two Control Cost Manual chapters cover control measures for volatile organic compound (VOC) emissions.
Comments must be received on or before October 19, 2017. Please refer to
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-0341, to the
Larry Sorrels, Health and Environmental Impacts Division, Environmental Protection Agency, C439-02, 109 T.W. Alexander Drive, Research Triangle Park, NC 27709; telephone number: (919) 541-5041; fax number: (919) 541-0839; email address:
The EPA is requesting comment on the specific Control Cost Manual chapters included in this notice.
1.
2.
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.
• Explain why you agree or disagree; suggest alternatives and substitute language/data for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
The EPA is requesting comment on two updated chapters of the EPA Air Pollution Control Cost Manual. The Control Cost Manual contains individual chapters on control measures, including data and equations to aid users in estimating capital costs for installation and annual costs for operation and maintenance of these measures. The Control Cost Manual is used by the EPA for estimating the impacts of rulemakings, and serves as a basis for sources to estimate costs of controls that are Best Available Control Technology under the New Source Review Program, and Best Available Retrofit Technology under the Regional Haze Program and for other programs.
The two updated Control Cost Manual chapters are: Chapter 1, Section 3 and Section 3.1, Carbon Adsorbers; Chapter 1, Section 3 and Section 3.2, Flares. These two revised Control Cost Manual chapters can be found in the docket for the Control Cost Manual update (Docket ID No. EPA-HQ-OAR-2015-0341). The current Control Cost Manual version (sixth edition) is available at
To help focus review of the Carbon Adsorbers (Chapter 1, Section 3, and Section 3.1) and Flares (Chapter 1, Section 3 and Section 3.2) chapters, we offer the following list of questions that the EPA is particularly interested in addressing in the updated chapters. Commenters are welcome to address any aspects of these chapters. Please
(1) What is a reasonable estimate of equipment life (defined as design or operational life) for this control measure?
(2) Is the description of carbon adsorbers complete, up to date, and accurate, particularly with regard to control of VOC?
(3) Are the cost correlations, factors, and equations for carbon adsorbers accurate? If not, how should they be revised? Please provide data, if possible, to address inaccuracies.
(4) Are the estimates of VOC removal or control efficiency for carbon adsorbers accurate? If not, what are more accurate estimates? Please provide data, if possible, to address inaccuracies.
(1) What is a reasonable estimate of equipment life (defined as design or operational life) for this control measure?
(2) Is the description of flares technology complete, up to date, and accurate?
(3) Are the cost correlations, factors, and equations for flares accurate? If not, how should they be revised? Please provide data, if possible, to address inaccuracies.
(4) Are the estimates of flares VOC destruction efficiency accurate? If not, what are more accurate estimates? Please provide data, if possible, to address inaccuracies.
Environmental Protection Agency (EPA).
Notice.
On June 23, 2017, the Environmental Protection Agency (EPA) received a written request from the U.S. Energy Information Administration (EIA) for historical model year sales data for year 2015 by manufacturer and nameplate. This requested data may contain confidential business information (CBI). The EPA may disclose business information to other Federal agencies that otherwise is not available to the public if certain requirements are met. The EPA intends to share certain information, detailed below, with EIA ten (10) days after publication of this notice. The information requested has been used to model and project energy demand in the light-duty vehicle sector and is critical to EIA's efforts to project energy demand, fuel efficiency, fuel consumption, and greenhouse gas emissions for the transportation sector. EIA has agreed to keep the data confidential and not disclose it further.
The sales data will be disclosed to EIA on or after July 31, 2017.
Sara Zaremski, Office of Transportation and Air Quality, Compliance Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4362; fax number: 734-214- 4053; email address:
Entities potentially affected by this action are those involved with the production and sale of motor vehicles. Regulated categories include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by the disclosure.
In their June 23, 2017 request letter to EPA, EIA requested that EPA provide to EIA historical model year sales data for year 2015 by manufacturer and nameplate. As noted earlier in this document, EIA uses this information to model and project energy demand in the light-duty vehicle sector. Additionally, EIA noted that these data are critical to EIA's continued efforts to project energy demand, fuel efficiency, fuel consumption, and greenhouse gas emissions for the transportation sector. Previously, EIA had been unable to obtain official model year sales data for 2015 due to the fact that it contained CBI. The specific data they requested includes all the data fields currently available in the Excel files provided on the
Additionally, EIA requested the following data fields: model year sales, tank size, track width, wheelbase, curb weight, horsepower, interior volume, fleet (DP, IP, LT), and test weight. EIA indicated that they are aware that this information is subject to claims of confidential business information. EIA's letter states “We will take the necessary steps to ensure the data are secure and kept confidential. EIA routinely works with sensitive data and has strong data handling safeguards in place.”
Pursuant to 40 CFR 2.209(c), EPA may disclose business information to another Federal agency if: (1) EPA receives a written request for disclosure of the information from a duly authorized officer or employee of the other agency; (2) the request sets forth the official purpose for which the information is needed; (3) when the information has been claimed as confidential or has been determined to be confidential, the responsible EPA office provides notice to each affected business of the type of information to be disclosed and to whom it is to be disclosed, and such notice may be given by notice published in the
In the case at hand, all of the required elements of 40 CFR 2.209(c) have been met upon publication of this notice.
Given that EIA is aware that the shared information is CBI or has been claimed as CBI, and intends to take the necessary steps to ensure that the data provided is kept secure and confidential, there is no impact on vehicle manufacturers to the release of this data.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has entered into a Consent Agreement with JPMorgan Chase Bank, N.A. (JPMC or Respondent) to resolve violations of the Clean Water Act (CWA), the Clean Air Act (CAA), the Resource Conservation and Recovery Act (RCRA) and the Emergency Planning and Community Right-to-Know Act (EPCRA) and their implementing regulations.
The Administrator is hereby providing public notice of this Consent Agreement and proposed Final Order (CAFO), and providing an opportunity for interested persons to comment on the CAFO. Upon closure of the public comment period, the CAFO and any public comments will be forwarded to the Agency's Environmental Appeals Board (EAB).
Comments are due on or before August 21, 2017.
Submit your comments, identified by Docket ID No. EPA-HQ-OECA-2017-0206, to the
Philip Milton, Waste and Chemical Enforcement Division (2249-A), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: (202) 564-5029; fax: (202) 564-0010; email:
This proposed settlement agreement is the result of voluntary disclosures of CWA, CAA, RCRA and EPCRA violations by JPMC to the EPA. JPMC and affiliated entities comprise one of the largest financial services firms in the United States, offering investment banking, financial services for consumers and small businesses, commercial banking, financial transaction processing and asset management, both domestically and internationally. JPMorgan Chase Bank, N.A. is a national banking association with its main office located at 1111 Polaris Parkway, Columbus, Ohio 43240.
On August 6, 2014, EPA accepted JPMC's June 19, 2014 proposal to enter into an audit agreement to audit 133 facilities owned and/or operated by JPMC or affiliated entities for compliance with the CAA, CWA, EPCRA, and RCRA under EPA's
In follow-up to its 2014 Audit and JPMC's commitment to prevent recurrence of noncompliance in the future, JPMC developed and implemented a compliance management system (CMS) that incudes annual auditing. JPMC approached the design of this annual audit program with the same integrity and objectivity as used in the original 2014 Audit program. With the benefit of this expertise, JPMC conducted annual internal audits in 2015 (at 42 sites) and 2016 (at 39 sites) and disclosed additional potential noncompliance discovered through its 2015 and 2016 internal audits on November 20, 2015 and December 2, 2016, respectively.
All violations discovered and disclosed by the Respondent are listed in Attachments A and B to the CAFO.
The EPA determined that Respondent satisfactorily completed its audit and has met all conditions set forth in the Audit Policy for the violations identified in Attachment A of the CAFO. Therefore, 100 percent of the gravity-based penalty calculated for the violations identified in Attachment A of the CAFO is being waived.
Attachment B of the CAFO identifies certain violations that did not meet all the conditions of the Audit Policy. For these violations, a gravity-based penalty of $52,977 is assessed.
For all violations listed in Attachments A and B, EPA calculated an economic benefit of noncompliance of $177,415. This number was calculated using specific cost information provided by Respondent and use of the Economic Benefit (BEN) computer model.
JPMC has agreed to pay a total civil penalty of $230,392 for all the violations identified in Attachments A and B of the CAFO. Of this amount, $177,415 is the economic benefit of noncompliance and $52,977 is the gravity-based penalty for the violations listed in Attachment B of the CAFO.
Of this total amount, $16,731 is attributable to the CAA violations, $88,538 is attributable to the CWA SPCC violations, $27,649 is attributable to the RCRA violations, and $97,474 is attributable to the EPCRA violations.
The EPA and Respondent negotiated the Consent Agreement in accordance with the Consolidated Rules of Practice, 40 CFR part 22, specifically 40 CFR 22.13(b) and 22.18(b) (
Respondent disclosed that it failed to prepare and/or implement a Spill Prevention, Control, and Countermeasure (SPCC) Plan in violation of CWA Section 311(j), 33 U.S.C. 1321(j), and the implementing regulations found at 40 CFR part 112, at the following forty-four (44) facilities located in Arizona, California, Delaware, Florida, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Ohio, and Texas, identified in Attachments A and B of the CAFO.
Under CWA Section 311(b)(6)(A), 33 U.S.C. 1321(b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of CWA Section 311(b)(3), 33 U.S.C. 1321(b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA Section 311(j), 33 U.S.C. 1321(j), may be assessed an administrative civil penalty of up to $226,338 by the EPA. Class II proceedings under CWA Section 311(b)(6), 33 U.S.C. 1321(b)(6), are conducted in accordance with 40 CFR part 22. As authorized by CWA Section 311(b)(6), 33 U.S.C. 1321(b)(6), the EPA has assessed a civil penalty for these violations.
Pursuant to CWA Section 311(b)(6)(C), 33 U.S.C. 1321(b)(6)(C), the EPA will not issue an order in this proceeding prior to the close of the public comment period.
Respondent disclosed that it violated EPCRA Section 311(a), 42 U.S.C. 11021(a), and the implementing regulations found at 40 CFR part 370, at seventy-four (74) facilities listed in Attachments A and B of the CAFO when it failed to submit a Material Safety Data Sheet (MSDS) for a hazardous chemical(s) and/or extremely hazardous substance(s) or, in the alternative, a list of such chemicals, to the LEPCs, SERCs, and the fire departments with jurisdiction over these facilities. These seventy-four (74) facilities are located in the following states: Arizona, California, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Missouri, New Hampshire, New Jersey, New York, Ohio, and Texas.
Respondent disclosed that it violated EPCRA Section 312(a), 42 U.S.C. 11022(a), and the implementing regulations found at 40 CFR part 370, at seventy-three (73) facilities listed in Attachments A and B of the CAFO when it failed to prepare and submit emergency and chemical inventory forms to the LEPCs, SERCs, and the fire departments with jurisdiction over these facilities. These seventy-one facilities are located in the following states: Arizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Missouri, New Hampshire, New Jersey, New York, Ohio, and Texas.
Under EPCRA Section 325, 42 U.S.C. 11045, the Administrator may issue an administrative order assessing a civil penalty against any person who has violated applicable emergency planning or right-to-know requirements, or any other requirement of EPCRA. Proceedings under EPCRA Section 325, 42 U.S.C. 11045, are conducted in accordance with 40 CFR part 22. The EPA, as authorized by EPCRA Section 325, 42 U.S.C. 11045, has assessed a civil penalty for these violations.
Respondent disclosed that it violated CAA Sections 608(a)(1) and (2), 42 U.S.C. 7671g(a)(l) and (2), and the implementing regulations found 40 CFR part 82, at thirty-four (34) facilities listed in Attachments A and B of the CAFO when it failed to maintain records required by 40 CFR 82.166 for its appliances. These thirty-four (34) facilities are located in the following states: Arizona, California, Illinois, Louisiana, Michigan, Missouri, New York, Ohio, Oklahoma, Oregon, Texas, and Wisconsin.
Respondent disclosed that it failed to comply with CAA Section 111, 42 U.S.C. 7411, and 40 CFR part 60, subpart IIII when it failed to maintain a 12-month rolling total log of the hours of operation for four (4) compression ignition internal combustion engines (emergency generators) at one (1) facility in Michigan.
Under CAA Section 113(d), 42 U.S.C. 7413(d), the Administrator may issue an administrative penalty order to any person who has violated or is in violation of any applicable requirement or prohibition of the CAA, including any rule, order, waiver, permit, or plan. Proceedings under CAA Section 113(d), 42 U.S.C. 7413(d), are conducted in accordance with 40 CFR part 22. The EPA, as authorized by the CAA, has assessed a civil penalty for these violations.
Respondent disclosed that it failed to comply with RCRA Section 3002 of RCRA, 42 U.S.C. 6922, and the regulations found at 40 CFR part 273, at seventy-eight (78) facilities listed in Attachments A and B of the CAFO when it failed to maintain proper universal waste disposal and handling by failing to properly store, label, or inventory spent fluorescent lamps and tubes, used lead-acid batteries, and by failing to train employees in proper identification. These seventy-eight (78) facilities are located in the following states: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Texas, Washington, and Wisconsin.
Under RCRA Section 3008, 42 U.S.C. 6928, the Administrator may issue an order assessing a civil penalty for any past or current violation the RCRA. Proceedings under RCRA Section 3008, 42 U.S.C. 6928, are conducted in accordance with 40 CFR part 22. The EPA, as authorized by the RCRA, has assessed a civil penalty for these violations.
Environmental protection.
Environmental Protection Agency (EPA).
Notice of proposed settlement; request for public comments.
Notice is hereby given of a proposed administrative cost settlement for recovery of response costs concerning the Parker Street Waste Site, located in New Bedford, Bristol County, Massachusetts with the Settling Party the City of New Bedford. The proposed settlement requires the Settling Party pay EPA $1,600,000 to settle EPA's past response costs, which currently amount to $18,408,619. In exchange, EPA will provide the Settling Party with a covenant not to sue for past costs. The settlement has been approved by the Environmental and Natural Resources Division of the United States Department of Justice. For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the settlement for recovery of response costs. The Agency will consider all comments received and may modify or withdraw its consent to this cost recovery settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the New Bedford Free Public Library, 613 Pleasant Street, New Bedford 02740 and at the Environmental Protection Agency—Region I, 5 Post Office Square, Suite 100, Boston, MA 02109-3912.
Comments must be submitted by August 21, 2017.
Comments should be addressed to John Kilborn, Senior Enforcement Counsel, U.S. Environmental Protection Agency, 5 Post Office Square, Suite 100 (OES04-3), Boston, MA 02109-3912 (Telephone No. 617-918-1893) and should reference the Parker Street Waste Site, U.S. EPA Docket No: CERCLA 01-2012-0040.
A copy of the proposed settlement may be obtained from Stacy Greendlinger, Office of Site Remediation and Restoration, U.S. Environmental Protection Agency, Region I, 5 Post Office Square, Suite 100 (OSRR02-2),
This proposed administrative settlement for recovery of past response costs concerning the Parker Street Waste Site, located in New Bedford, Bristol County, Massachusetts is made in accordance with Section 122(h)(l) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA covenants not to sue or take administrative action against the Settling Party, the City of New Bedford, pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a), for Past Response Costs. In exchange, the Settling Party agrees to pay EPA $1,600,000. Payment of such amount shall be due within 30 days after the Effective Date and, if timely paid, shall include no interest. If payment is not paid as stipulated, interest shall accrue beginning as of the Effective Date and shall continue to accrue on any unpaid amount until the total amount due has been received. For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the settlement for recovery of response costs. The Effective Date of the Agreement is the date upon which EPA notifies the City that the public comment period has closed and that such comments, if any, do not require that EPA modify or withdraw from the Agreement.
Environmental Protection Agency (EPA).
Notice of a final decision on a UIC no migration petition reissuance.
Notice is hereby given that a reissuance of an exemption to the Land Disposal Restrictions, under the 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act, has been granted to Vopak for one Class I hazardous waste injection well located at their Deer Park, Texas facility. The company has adequately demonstrated to the satisfaction of the Environmental Protection Agency by the petition reissuance application and supporting documentation that, to a reasonable degree of certainty, there will be no migration of hazardous constituents from the injection zone for as long as the waste remains hazardous. This final decision allows the underground injection by Vopak of the specific restricted hazardous wastes identified in this exemption reissuance, into Class I hazardous waste injection Well WDW-157 until December 31, 2030, unless EPA moves to terminate this exemption or other petition condition limitations are reached. Additional conditions included in this final decision may be reviewed by contacting the Region 6 Ground Water/UIC Section. A public notice was issued May 3, 2017, and the public comment period closed on June 19, 2017, and no comments were received. This decision constitutes final Agency action and there is no Administrative appeal. This decision may be reviewed/appealed in compliance with the Administrative Procedure Act.
This action is effective as of June 23, 2017.
Copies of the petition reissuance and all pertinent information relating thereto are on file at the following location: Environmental Protection Agency, Region 6, Water Division, Safe Drinking Water Branch (6WQ-S), 1445 Ross Avenue, Dallas, Texas 75202-2733.
Philip Dellinger, Chief Ground Water/UIC Section, EPA—Region 6, telephone (214) 665-8324.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency is planning to submit an information collection request (ICR), “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through November 30, 2017. 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.
Comments must be submitted on or before September 19, 2017.
Submit your comments, referencing Docket ID No. EPA-HQ-OEI-2017-0380 online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Courtney Kerwin, Office of Environmental Information, Regulatory Support Division, Environmental Protection Agency, Mail Code 2822T 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-566-1669 and email address
The supporting documents for this ICR (Generic Clearance for the Collection of Qualitative Feedback on Agency Service
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable.
The Agency will only submit a collection for approval under this generic clearance if: The collections are voluntary; the collections are low-burden for respondents and are low-cost for both the respondents and the Federal Government; the collections are noncontroversial and do not raise issues of concern to other Federal agencies; the collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; personally identifiable information (PII) is collected only to the extent necessary and is not retained; information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency; information gathered will not be used for the purpose of substantially informing influential policy decisions; information gathered will yield qualitative information.
Environmental Protection Agency (EPA).
Notice of final action.
Pursuant to the Clean Air Act (CAA), the EPA Administrator signed an Order, dated June 7, 2017, denying a petition asking EPA to object to the operating permit issued by the Louisiana Department of Environmental Quality (LDEQ) to Bunge North America, Inc. (Bunge) for its Destrehan Grain Elevator. Title V operating permit number 2520-00048-V5 was issued on December 18, 2015 by the LDEQ to Bunge for modifications to the Destrehan Grain Elevator located in St. Charles Parish, Louisiana. EPA's June 7, 2017 Order responds to a petition submitted on January 24, 2016 by the Tulane Environmental Law Clinic on behalf of Petitioners Ms. Cynthia Portera and Ms. Toni Offerman. Sections 307(b) and 505(b)(2) of the Act provide that a petitioner may ask for judicial review of those portions of the Orders that deny objections raised in the petitions in the appropriate United States Court of Appeals. Any petition for review shall be filed within 60 days from the date this notice appears in the
You may review copies of the final Order, the petition, and other supporting information at EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733.
EPA requests that if at all possible, you contact the individual listed in the
Brad Toups at (214) 665-7258, email address:
The CAA affords EPA a 45-day period to review, and object, as appropriate, to a title V operating permit proposed by a state permitting authority. Section 505(b)(2) of the CAA and 40 CFR 70.8(d) authorizes any person to petition the EPA Administrator, within 60 days after the expiration of this review period, to object to a title V operating permit if EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or unless the grounds for the issue arose after this period.
EPA received the petition from the Petitioners on January 24, 2016 for the operating permit issued on December 18, 2015 to Bunge North America, Inc. Destrehan Grain Elevator, Destrehan, St. Charles Parish, Louisiana.
The Petitioner requests that the Administrator object to the proposed operating permit issued by the LDEQ to Bunge based on two claims. The claims are described in detail in Section IV of the Order. In summary, the issues raised are that: (1) The permit fails to comply with the Act's requirements for inclusion of a compliance plan and schedule in an issued permit; and, (2) the permit should have addressed the state `Environmental Assessment' as mandated under Louisiana Revised Statute R.S. 30:2018(C) for any source undergoing a `substantial modification.' The Order issued on June 7, 2017 responds to the Petition and explains the basis for EPA's decision.
Environmental Protection Agency (EPA).
Notice of request for nominations.
EPA's Local Government Advisory Committee (LGAC) is a federal advisory committee chartered in 1992 under the Federal Advisory Committee Act (FACA) to advise the EPA Administrator “from the field” on a broad range of environmental issues impacting local governments. Current LGAC committee members, and future qualified nominees, hold either elected or non-elected/appointed positions and possess leadership experience—whether managerial or technical/programmatic—in the following contexts: Small community or township government (under 10,000 population); moderate-size or large city government; county government; state government; and, tribal government.
This notice solicits nominations to fill 10-15 vacancies on EPA's LGAC—currently comprised of 35 individuals—beginning in July, 2017. Vacancies are anticipated to be filled by September, 2017.
Nominations are reviewed on an ongoing basis. However, to be considered for September 2017 appointments, nominations should be submitted by August 10, 2017.
Submit nominations electronically to
M. Frances Eargle, Designated Federal Officer for the LGAC, U.S. EPA; telephone (202)564-3115; email:
LGAC members are appointed for 1-2 year terms and are eligible for reappointment. The Committee meets several times a year, and the Administrator may ask members to serve on Subcommittees and Workgroups to develop reports and recommendations to address specific policy issues. The average workload for members is approximately 5 to 8 hours per month. While EPA is unable to provide compensation for services, official Committee travel and related expenses (lodging, etc.) will be fully reimbursed.
Nominations can be submitted in electronic format (preferred) or in hard copy format (see
• Current contact information for the applicant/nominee, including name, organization (and position within that organization), current business address, email address, and daytime telephone number;
• Brief statement describing the nominee's interest in serving on the LGAC;
• Resume and short biography (no more than 2 paragraphs) describing professional, educational and other pertinent qualifications of the nominee, including a list of relevant activities as well as any current or previous service on advisory committees; and,
• Letter(s) of recommendation from a third party (or parties) supporting the nomination. Letter(s) should describe how the nominee's experience and knowledge will bring value to the work of the LGAC.
Other sources, in addition to this
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 16, 2017.
1.
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for public comments regarding an extension to an existing 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 an extension of a previously approved information collection requirement regarding Information Specific to a Contract or Contracting Action (not required by regulation).
Submit comments on or before: September 19, 2017.
Submit comments identified by Information Collection 3090-0163, Information Specific to a Contract or Contracting Action (Not Required by Regulation), by any of the following methods:
•
•
Ms. Jennifer Calik, Procurement Analyst, GSA Acquisition Policy Division, at
GSA has various mission responsibilities related to the acquisition and provision of supplies, transportation, information technology, telecommunications, real property management, and disposal of real and personal property. These mission responsibilities generate requirements that are realized through the solicitation and award of public contracts. In Fiscal Year 2016, these contracts had values ranging from under $100 to over $777,000,000, including the base and all options.
Most GSA procurement-related information collections are required by the Federal Acquisition Regulation (FAR) or General Services Administration Acquisition Regulation (GSAR); each clause requiring such a collection must be individually approved by OMB. However, some solicitations require contractors to submit information specific to that contracting action, such as information needed to evaluate offers (
This information collection is currently associated with GSA's information collection requirements contained in solicitations issued in accordance with the Uniform Contract Format under FAR Part 14, Sealed Bidding (see GSAR 514.201-1); FAR Part 15, Contracting by Negotiation (see GSAR 515.204-1); and solicitations under FAR Part 12, Acquisition of Commercial Items, when issued in accordance with the policy and procedures of FAR Part 14 and FAR Part 15 (see GSAR 512.301). This includes information collection requirements found in GSA Federal Supply Schedule (FSS) solicitations.
Public comments are particularly invited on: Whether this collection of information is necessary and whether it 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; and ways to enhance the quality, utility, and clarity of the information to be collected.
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 announces the intent to extend the fund to Special Olympics Inc. To improve knowledge and awareness about the usefulness and effectiveness of health promotion programs and policy, systems and environmental improvements for people with intellectual disabilities.
Funding is extended from September 30, 2017 to March 31, 2018.
L.C. Browning, Office of Grants Services (OGS), Technical Information Management Section (TIMS),
This notice announces the Centers for Disease Control and Prevention's (CDC) intent to extend the fund to Special Olympics Inc.
Reports and Proposals must be submitted by August 11, 2017 for the supplemental period (9/30/2017 through 3/31/2018). Late or incomplete reports could result in an enforcement action such as a delay in the award. CDC will accept requests for a deadline extension on rare occasions and after adequate justification has been provided.
General Application Packet Tips:
1. CDC requires the use of PDF format for ALL attachments.
2. Use of file formats other than PDF may result in the file being unreadable by CDC staff.
Checklist of Required Contents of Application Packet:
A. In addition to inserting the legal name of your organization in Block #5a, insert the CDC Award Number provided in the CDC Notice of Award. Failure to provide your award number could cause delay in processing your application.
B. Please insert your organization's Business Official information in Block #8.
A. Complete all applicable sections.
B. Analysis of Remaining Time and Funds.
1. Based on the current rate of obligation, if it appears there will be un-obligated funds at the end of the current budget period, provide detailed actions that will be taken to obligate this amount.
2. If it appears there will be insufficient funds, provide a detailed justification of the shortfall and list the actions taken to bring the obligations in line with the authorized funding level.
C. The proposed budget should be based on the federal funding level stated in the letter from CDC.
D. The budget justification must be prepared in the general form, format, and to the level of detail as described in the CDC Budget Guidance. The sample budget guidance is provided on CDC's internet at:
E. For any new proposed subcontracts provide the information specified in the Budget Guidance.
F. When non-federal matching is required, provide a line-item list of non-federal contributions including source, amount, and/or value of third party contributions proposed to meet a matching requirement.
G. Applicants should send their application via email attachment(s) to Barbara Strother at
Requirements for development and submission of indirect (F&A) cost rate proposals and cost allocation plans for all grantees are contained in 45 CFR part 75, Appendices III through VII.
Provide a detailed description of proposed activities, objectives, and performance measures for the new budget period as described below.
A. List the proposed objectives for the upcoming budget period. These objectives must support the intent of the original Funding Opportunity Announcement (FOA) or Program Announcement (PA).
B. Each objective and activity must contain a performance or outcome measure that assesses the effectiveness of the project.
C. Provide an updated work plan that cross walks to the objectives and associated performance measures, program strategies and activities, target dates for completion, and person(s) responsible for the activities. Awardees are strongly encouraged to use the sample Excel-based work plan provided by the Disability and Health Branch. The work plan must be uploaded as a PDF file and included in the appendix.
Any proposed changes in programmatic priorities must be within the scope of the approved funding opportunity announcement and Notice of Award. CDC will work with each awardee to refine and consolidate work plans within 30 days of award as needed.
A merit review will be conducted by the CDC Program Office. The merit review will cover technical and cost matters. The initial application received an objective review to ensure recipient complies with all the activities required. The recipient was selected thru a competitive process during the initial FOA award.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
This notice announces a public meeting to discuss ideas for a potential behavioral health payment model to improve health care quality and access, while lowering the cost of care for Medicare, Medicaid, or Children's Health Insurance Program (CHIP) beneficiaries with behavioral health conditions.
The Center for Medicare and Medicaid Innovation (the Innovation Center) within the Centers for Medicare & Medicaid Services (CMS) was established by section 1115A of the Social Security Act (the Act). The Congress created the Innovation Center for the purpose of testing “innovative payment and service delivery models to reduce program expenditures . . . while preserving or enhancing the quality of care” for those individuals who receive Medicare, Medicaid, or Children's Health Insurance Program (CHIP) benefits. New payment and service delivery model tests are designed by the Innovation Center in accordance with the requirements of section 1115A of the Act. During the design of a model test, the Innovation Center builds on the ideas received from stakeholders and consults with clinical and analytical experts with expertise in medicine and health care management, as well as with representatives of relevant Federal agencies, beneficiaries and caregivers, health care providers, advocacy groups, and other experts in the field.
The Innovation Center is interested in designing a potential payment or service delivery model to improve health care quality and access, while lowering the cost of care for Medicare, Medicaid, or CHIP beneficiaries with behavioral health conditions. The model may include participation by other payers, qualify as an Advanced Alternative Payment Model (APM), improve health care provider participation in telehealth services, and address the needs of beneficiaries with deficits in care in the following potential areas leading to poor clinical outcomes or potentially avoidable expenditures: (1) Substance use disorders; (2) mental disorders in the presence of co-occuring conditions; (3) Alzheimer's disease and related dementias; and/or (4) behavioral health workforce challenges.
The Innovation Center solicits and selects organizations to participate in voluntary model tests through open, competitive processes. The process follows established protocols to ensure that it is fair and transparent, provides opportunities for potential participants to ask questions regarding the Innovation Center's expectations, and relies on multi-stakeholder input to inform selection of the most qualified participants. Many factors are used in the design and selection of models to be tested. The Innovation Center does not test unsolicited proposals, but does use such ideas to inform model design.
The meeting will include four panel sessions of behavioral health experts of varied backgrounds who will discuss substance use disorders, mental health in the presence of co-occuring conditions, Alzheimer's disease and related dementias, and behavioral health workforce development.
All stakeholders, including community health organizations, medical societies, health care providers, State Medicaid agencies, advocacy groups, non-profit organizations, and other interested parties are invited to participate in this meeting by: (1) Listening to panelists discuss payment for and delivery of behavioral health services and share experiences of furnishing behavioral health services; (2) asking questions to panelists; and (3) making brief individual statements. We note that the time for participants to make statements will be limited to 2 minutes per panel.
The recommendations provided during this meeting will assist us, as we explore the possibility of designing a model test to address behavioral health payment and service delivery.
Participants must register at
The meeting is open to the public, but attendance will be limited based on meeting room capacity. Seating capacity is limited to approximately 400 registrants. Persons wishing to attend this meeting must register by the dates specified in the
This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. The on-site check-in for visitors will be held from 9:00 a.m. to 10:00 a.m. We recommend that confirmed registrants arrive reasonably early, to allow additional time to clear security. We recommend arrival no later than 9:30 a.m. to complete the security checkpoints and be escorted for the start of the meeting at 10:00 a.m. Security measures include the following:
• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. As of October 10, 2015, visitors seeking access to federal agency facilities using their state-issued driver's license or identification cards must present proper identification issued by a state that is compliant with the REAL ID Act of 2005 (Pub. L. 109-13, 119 Statute 302, enacted on May 11, 2005) or a state that has received an extension. What constitutes proper identification and whether a driver's license is acceptable identification for accessing a federal facility may vary, based on which state issued the driver's license. For detailed information, please refer to the Department of Homeland Security (DHS) Web site at:
• Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. Participants not in possession of a valid identification or who are in possession of prohibited items will be denied access to the complex. Prohibited items on federal property include but are not limited to, alcoholic beverages, illegal narcotics, explosives, firearms or other dangerous weapons (including pocketknives), dogs or other animals except service animals.
• Inspection, via metal detector or other applicable means of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation.
Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the start of check-in of the meeting (8:15 a.m.).
All visitors must be escorted in areas other than the lower and first floor levels in the CMS Central Office.
Individuals requiring special accommodations must include the request for these services when registering for the meeting.
This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice sets forth the states' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the federal fiscal year (FY) 2014 and the preliminary QI allotments for federal FY 2015 which is extended through calendar year (CY) 2015 (December 2015) by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation.
The final QI allotments for payment of Medicare Part B premiums for FY 2014 are effective October 1, 2013. The preliminary QI allotments for FY 2015, extended through CY 2015 are effective October 1, 2014.
Jennifer Gibson, (410) 786-5404 or Toni Cincibus at (410) 786-2997.
As amended by section 621 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240, enacted on January 2, 2013), section 1933(g)(2) of the Social Security Act (the Act) provided $300 million in funding for the period October 1, 2013 through December 31, 2013, the first quarter of fiscal year (FY) 2014. Section 1201 of Division B of the legislation “Pathway for SGR Reform Act of 2013” (Pub. L. 113-67 enacted on December 26, 2013) provided an additional $200 million and authority for the Qualifying Individual (QI) program for the period January 1, 2014 through March 31, 2014 (second quarter of FY 2014). In addition, section 201 of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93 enacted on April 1, 2014) revised the $200 to $485 million and extended the period for which such funds were available to the end of September 2014. Therefore, the total funding available for the QI program for FY 2014 is $785 million ($300 million for the first quarter of FY 2014, and $485 million for the second through fourth quarters of FY 2014).
Section 201 of PAMA extended the authority and funding for the QI program for FY 2015 as follows: $300 million for the period October 1, 2014 through December 31, 2014 (first quarter of FY 2015); and, $250 million for the period January 1, 2015 through March 31, 2015 (second quarter FY 2015). Section 211 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted on April 16, 2015) further extended the authority and funding for the QI program for FY 2015 as follows: $535 million for the period April 1, 2015 through December 31, 2015, effectively changing QI to a calendar year basis from a fiscal year basis. Therefore, a total of $1.085 billion is available for the QI program for FY/CY 2015.
Section 211 of MACRA also permanently extended the QI program while allocating $980 million for CY 2016.
The amounts of the states' final FY 2014 and preliminary FY/CY 2015 QI allotments, contained in this notice, were determined in accordance with the methodology set forth in existing regulations at 42 CFR 433.10(c)(5) and reflect funding for the QI program made available under the legislation discussed above.
The final QI allotments for FY 2014 and the preliminary QI allotments for FY/CY 2015 are shown by state in Table 1 and Table 2, respectively:
Table 1—Final Qualifying Individuals Allotments for October 1, 2013 through September 30, 2014.
Table 2—Preliminary Qualifying Individuals Allotments for October 1, 2014 through December 31, 2015.
The following describes the information contained in the columns of Table 1 and Table 2:
Column A—
Column B—
Column C—
Column D—
Columns E through L show the determination of the States' Final QI Allotments for FY 2014 (Table 1) or Preliminary QI Allotments for FY/CY 2015 (Table 2).
Column E—
Column F—
Column G—
Column H—
Column I—
Column J—
Column K—
Column L—
This notice does not impose any information collection or recordkeeping requirements. Consequently, it does not need Office of Management and Budget review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
In response to an earlier
One respondent was concerned with the Tribal and State governments using the same OCSE-34 Form, which was perceived to lead to an added burden and confusion about the submission of specific data elements. Our sense is that the form is developed in a sufficiently clear manner to inform respondents on the data elements required by each type of grantee. Furthermore, we consistently provide outreach and technical assistance to all grantees to ensure that reporting burdens are clear and minimized.
A few respondents provided technical and clerical edits to the OCSE-396 Form to increase accuracy and clarity. We have incorporated many of the requested edits and appreciate the detailed and thoughtful comments.
One respondent was concerned that the instructions to the OCSE-396 may be creating an additional burden by maintaining a 5 percent variance threshold (an increase or decease in any data element of Part 1 compared to that same data element for the previous quarter). While we are understanding of this concern our position is that the form will be used nationally and raising the variance threshold above 5 percent is not justified at this time.
Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address:
OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the
Health Resources and Services Administration, HHS.
Notice of non-competitive, HRSA-initiated supplemental funding award.
To prevent a lapse in comprehensive HIV primary care services for persons living with HIV, HRSA will provide a one-time non-competitive, HRSA-initiated supplemental award to Cape Cod Hospital. The purpose of the Fiscal Year 2017 RWHAP Part C Early Intervention
Sections 2651-2667 of the Public Health Service Act, (42 U.S.C. 300ff-51 through 67) and section 2693 of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Act of 2009 (P.L. 111-87).
CAPT Mahyar Mofidi, DMD, Ph.D., Director, Division of Community HIV/AIDS Programs, HIV/AIDS Bureau, Health Resources and Services Administration, 5600 Fishers Lane, 09N09, Rockville, Maryland 20857, phone: (301) 443-2075, email:
Pursuant to Public Law 92-463, notice is hereby given that the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS) National Advisory Council (NAC) will meet on August 10, 2017, from 9:00 a.m. to 5:15 p.m. and on August 11, 2017, from 8:30 a.m. to 12:00 p.m. EDT. The NAC will convene in both open and closed sessions on August 10, 2017, and will convene in open session on August 11, 2017.
The closed portion of the meeting will include discussion and evaluation of grant applications reviewed by SAMHSA's Initial Review Groups, and involve an examination of confidential financial and business information as well as personal information concerning the applicants. Therefore, the meeting will be closed to the public from 9:00 a.m. to 10:30 a.m. as determined by the Acting Deputy Assistant Secretary for Mental Health and Substance Use, SAMHSA in accordance with Title 5 U.S.C. 552b(c)(4) and (6) and Title 5 U.S.C. App. 2, 10(d). The remainder of this meeting will be open to the public from 10:45 a.m. to 5:15 p.m. and will continue on Friday, August 11, 2017, from 8:30 a.m. to 12:00 p.m. EDT to include discussion of the Center's policy issues, presentations on SAMHSA's Learning Agenda, Treatment Innovations, Cognitive Behavioral Therapy for Serious Mental Illness, Co-occurring Mental Illness and Opioid Addiction, Continuum of Care for Adults with Serious Mental Illness, Prodromal Care Approaches in Children's Mental Health, Faith-based Approaches, and a conversation with the Acting Deputy Assistant Secretary for Mental Health and Substance Use.
Attendance by the public will be limited to available space. Interested persons may present data, information, or views, orally or in writing, on issues pending before the council. Written submissions should be forwarded to the contact person (below) on or before July 27, 2017. Oral presentations from the public will be scheduled at the conclusion of the meeting on Friday, August 11, 2017. Five minutes will be allotted for each presentation. Meeting information and a roster of Council members may be obtained either by accessing the SAMHSA Council Web site at
The meeting can be accessed via telephone. To obtain the conference call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register at the SAMHSA's Advisory Council Web site at
Information Sharing and Services Organization (IS
Committee management; notice of Federal Advisory Committee meeting.
The Homeland Security Information Network Advisory Committee (HSINAC) will meet on Wednesday, September 6, 2017, to
The HSINAC will meet on Wednesday, September 6, 2017, from 1:00 p.m. to 2:00 p.m. Eastern Standard Time (EST). Please note that the meeting may close early if the committee has completed its business.
The meeting will be held virtually via HSIN Connect, an online web-conferencing tool at
The HSIN Program Office is inviting public comment on the issues to be considered by the HSINAC in order to facilitate public participation in the meeting. Comments must be identified by Docket Number DHS-2017-0041 and may be submitted by
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A public comment period is scheduled during the meeting on Wednesday, September 6, 2017, from 1:40 p.m. to 1:55 p.m. EST. Speakers who wish to participate in the public comment period must register in advance and can do so by emailing
Ms. Maria Petrakis, HSINAC Designated Federal Officer and HSIN Policy Manager, Department of Homeland Security, (202) 343-4280 (office),
Notice of this meeting is given under the
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, marine mammals, or both. With some exceptions, the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA) prohibit activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before August 21, 2017.
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When submitting comments, please indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Joyce Russell, Government Information Specialist, Division of Management Authority, U.S. Fish and Wildlife Service Headquarters, MS: IA; 5275 Leesburg Pike, Falls Church, VA 22041-
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 in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
We invite the public to comment on applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (16 U.S.C. 1531
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for radiated tortoise (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for radiated tortoise (
The applicant requests a renewal of a captive-bred wildlife registration under 50 CFR 17.21(g) to enhance the propagation or survival of the following species: Ring-tailed lemur (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) to enhance species propagation or survival of the species for the golden parakeet (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for red siskin (
If the Service decides to issue permits to any of the applicants listed in this notice, we will publish a notice in the
You may submit your comments and materials concerning this notice by one of the methods listed in
If you submit a comment via
We will post all hardcopy comments on
Endangered Species Act of 1973, (16 U.S.C. 1531
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the
On May 31, 2017, DAK Americas LLC, Charlotte, NC; Nan Ya Plastics Corporation, America, Lake City, SC; and Auriga Polymers Inc., Charlotte, NC filed a petition with the Commission and Commerce, alleging that an industry in the United States is materially injured or threatened with material injury by reason of subsidized imports of fine denier polyester staple fiber from China and India and LTFV imports of fine denier polyester staple fiber from China, India, Korea, Taiwan, and Vietnam. Accordingly, effective May 31, 2017, the Commission, pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)), instituted countervailing duty investigation Nos. 701-TA-579-580 and antidumping duty investigation Nos. 731-TA-1369-1373 (Preliminary). On July 13, 2017, the Department of Commerce terminated its antidumping duty investigation of imports of fine denier polyester staple fiber from Vietnam, following a request for withdrawal of the petition. Accordingly, the Commission has also terminated its antidumping duty investigation concerning fine denier polyester staple fiber from Vietnam (Investigation No. 731-TA-1373).
Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on July 17, 2017. The views of the Commission are contained in USITC Publication 4709 (July 2017), entitled
By order of the Commission.
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the
On June 2, 2017, Archer Daniels Midland Company (Decatur, Illinois), Cargill, Inc. (Minneapolis, Minnesota), and Tate & Lyle Ingredients Americas LLC (Hoffman Estates, Illinois) filed a petition with the Commission and Commerce, alleging that an industry in the United States is materially injured or threatened with material injury by reason of subsidized imports of citric acid and certain citrate salts from Thailand and LTFV imports of citric acid and certain citrate salts from Belgium, Colombia, and Thailand. Accordingly, effective June 2, 2017, the Commission, pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)), instituted countervailing duty investigation No. 701-TA-581 and antidumping duty investigation Nos. 731-TA-1374-1376 (Preliminary).
Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on July 17, 2017. The views of the Commission are contained in USITC Publication 4710 (July 2017), entitled
By order of the Commission.
United States International Trade Commission.
Notice of termination of investigation.
On July 13, 2017, the Department of Commerce terminated its antidumping duty investigation of imports of fine denier polyester staple fiber from Vietnam, following a request for withdrawal of the petition. Accordingly, the Commission is terminating its antidumping duty investigation concerning fine denier polyester staple fiber from Vietnam (Investigation No. 731-TA-1373 (Preliminary)).
July 13, 2017.
Calvin Chang (202-205-3062), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
This investigation is being terminated under authority of title VII of the Tariff Act of 1930 and pursuant to section 207.40(a) of the Commission's Rules of Practice and Procedure (19 CFR 207.40(a)). This notice is published pursuant to section 201.10 of the Commission's rules (19 CFR 201.10).
By order of the Commission.
United States International Trade Commission.
Notice; amendment.
The Commission published a notice in the
Michael Szustakowski (202-205-3169), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
No posthearing brief, either in the injury phase or any remedy phase, shall exceed fifteen (15) pages of textual
By order of the Commission.
United States International Trade Commission.
Notice; amendment.
The Commission published a notice in the
Mary Messer (202-205-3193), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
No posthearing brief, either in the injury phase or any remedy phase, shall exceed fifteen (15) pages of textual material, double-spaced and single-sided, when printed out on pages measuring 8.5 x 11 inches. In addition, the presiding official may permit persons to file answers to questions or requests made by the Commission at the hearing for the injury phase, and at any hearing for the remedy phase, within a specified time.
By order of the Commission.
Office of Disability Employment Policy, Department of Labor.
60-Day notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents is properly assessed. Currently, the Department of Labor is soliciting comments concerning the extension of data collection for the Evaluation of the EFSLMP. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed in the addressee section of this notice.
Written comments must be submitted to the office listed in the addressee's section below on or before September 19, 2017.
You may submit comments by either one of the following methods: Email:
Cherise Hunter by email at
The proposed information collection extension described in this notice will provide ongoing data for an evaluation of the EFSLMP. EFSLMP, a cross-disability and cross-systems change initiative, provides a platform for multi-disciplinary state teams to focus on implementing an employment first (EF) approach when supporting individuals with disabilities. EFSLMP helps the state teams align policies, coordinate resources, and update service delivery models, to facilitate increased competitive integrated employment options for people with the most significant disabilities.
The purpose of this information collection is to gauge, via a Web-based survey, the effectiveness of ODEP's EFSLMP efforts to promote the implementation of EF policies and practices for persons with disabilities and to determine how well remote training and online forums facilitate the implementation of EF activities in each of the 14 participating states. This
Currently, DOL is soliciting comments concerning the extension of data collection for the evaluation of the EFSLMP. DOL is particularly interested in comments that do the following:
• Evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's burden estimate of the proposed information collection, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• 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 (for example, permitting electronic submissions of responses).
At this time, the Department of Labor is requesting clearance for the extension of data collection to evaluate the EFSLMP via a community of practice pre/post survey.
Comments submitted will be summarized and/or included in the request for Office of Management and Budget approval of the information collection; they will also become a matter of public record.
Bureau of Labor Statistics, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed revision of the Annual Refiling Survey (ARS). A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the
Send comments to Carol Rowan, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by fax to 202-691-5111 (this is not a toll free number).
Carol Rowan, BLS Clearance Officer, 202-691-7628 (this is not a toll free number). (See
The Quarterly Census of Employment and Wages (QCEW) program is a Federal/State cooperative effort which compiles monthly employment data, quarterly wages data, and business identification information from employers subject to State Unemployment Insurance (UI) laws. These data are collected from State Quarterly Contribution Reports (QCRs) submitted to State Workforce Agencies (SWAs). The States send micro-level employment and wages data, supplemented with the names, addresses, and business identification information of these employers, to the BLS. The State data are used to create the BLS sampling frame, known as the longitudinal QCEW data.
To ensure the continued accuracy of these data, the information supplied by employers must be periodically verified and updated. For this purpose, the ARS is used in conjunction with the UI tax reporting system in each State. The information collected by the ARS is used to review the existing industry code assigned to each establishment as well as the physical location of the business establishment. As a result, changes in the industrial and geographical compositions of our economy are captured in a timely manner and reflected in the BLS statistical programs.
The ARS also asks employers to identify new locations in the State. If these employers meet QCEW program reporting criteria, then a Multiple
Office of Management and Budget clearance is being sought for a revision of the ARS. While the primary purpose of the ARS is to verify or to correct the North American Industry Classification System (NAICS) code assigned to establishments, there are other important purposes of the ARS. For example, the BLS and the Census Bureau enhance the quality of their data and reduce costs and respondent burden through increased data sharing. Such sharing improves the quality and the reliability of information for multi-location businesses by developing consistent industrial and geographical classifications for these businesses. The ARS seeks accurate mailing and physical location addresses of establishments as well as geographical codes such as county and township (independent city, parish, or island in some States).
Once every three years, the SWAs survey employers that are covered by the State's UI laws to ensure that State records correctly reflect the business activities and locations of those employers. States survey approximately one-third of their businesses each year and largely take care of the entire universe of covered businesses over a three-year cycle. The selection criterion for surveying establishments is based on the nine-digit Federal Employer Identification Number of the respondent.
BLS constantly pursues a growing number of automated reporting options to reduce employer burden and costs and to take advantage of more efficient methods and procedures. Even given such actions, mailing remains an important part of the survey. The BLS developed a one-page letter rather than mailing forms for ARS solicitation. This letter explains the purpose of the ARS and provides respondents with a unique Web ID and password. Respondents are directed to the BLS online web collection system to verify or to update their geographic and industry information.
Additionally, BLS staff review selected, large multi-worksite national employers rather than surveying these employers with traditional ARS forms. This central review reduces postage costs incurred in sending letters or forms. It also reduces respondent burden, as the selected employers do not have to return forms either.
Finally, BLS continues to use a private contractor to handle various administrative aspects of the survey to reduce the costs associated with the ARS. This initiative is called the Centralized Annual Refiling Survey (CARS). Under CARS, BLS effectively utilizes the commercial advantages related to printing and mailing large volumes of survey letters.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• 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.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological 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 approval of the information collection request; they also will become a matter of public record.
National Science Foundation.
Submission for OMB review; comment request.
Under the Paperwork Reduction Act of 1995, and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public and other Federal agencies to comment on this proposed reinstated information collection. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at
Written comments on this notice must be received by August 21, 2017, to be assured consideration. Comments received after that date will be considered to the extent practicable. Send comments to address below.
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation,
This is the second notice for public comment; the first was published in the
The Early Career Doctorates Project was established to gather in-depth information about early career doctorates (ECD), including postdoctoral researchers (postdocs). Early career doctorates are critical to the success of the U.S. scientific enterprise and will influence U.S. and global scientific markets for years to come. Despite their importance, current surveys of this population are limited, and extant workforce studies are insufficient for covering all doctorates who contribute to the U.S. economy. The NSF's Survey of Earned Doctorates and the Survey of Doctorate Recipients are limited to individuals who received research doctorates from U.S. academic institutions, thereby excluding individuals who earned professional doctorates and those who earned doctorates from institutions outside the United States but are currently employed in the United States. The NSF's Survey of Graduate Students and Postdoctorates in Science and Engineering (GSS) provides aggregate level data for all postdocs and nonfaculty researchers regardless of where they earned the degree. However, the GSS is limited to science, engineering, and selected health (SEH) fields in U.S. academic institutions and their related research facilities and is collected at the program rather than the individual level.
Through its multi-year Postdoc Data Project, NCSES determined the need for and the feasibility of gathering information about postdocs working in the United States. However, efforts to reliably identify and gather information about postdocs proved difficult due to substantial variation in how institutions characterize postdoc appointments. As a result, NCSES expanded the target population to include all individuals who earned their first doctorate within the past 10-years. Expanding the population to doctoral degree holders ensures a larger, more consistent and reliable target population. Unique in scope, the key goals of the ECD Project are:
• To broaden the scope and depth of national statistics on the ECD population both U.S. degreed and non-U.S. degreed, across employment sectors and fields of discipline
• To collect nationally representative data from ECD that can be used by funding agencies, policy makers, and other researchers to better understand the labor market and work experiences of recent doctorate recipients
• To gather the diverse definitions for ECD to allow for analysis within and across employment sectors
The current focus of the ECD Project is to conduct a survey of ECD working in three areas of employment: U.S. academic institutions in the GSS, Federally Funded Research and Development Centers, and the National Institutes of Health Intramural Research Programs. NCSES, under full clearance (OMB #3145-0235), has conducted a pilot survey with data collection period spanning July 2014 to March 2015. The Pilot ECDS data was released in January 2017.
Beginning in August 2017, NSF will request lists of ECD from approximately 350 institutions nationwide, and sample 22,855 individuals from these lists. Sample members will be invited to participate in a 32-minute web-based questionnaire. The survey topics cover: educational achievement, professional activities, employer demographics, professional and personal life balance, mentoring, training and research opportunities, and career paths and plans. Participation in the survey is voluntary.
The survey will be collected in conformance with the Privacy Act of 1974, the Confidential Information Protection and Statistical Efficiency Act (CIPSEA) of 2002, and the Federal Cybersecurity Enhancement Act of 2015. The NSF will ensure that all individually identifiable information collected will be kept strictly confidential and will be used for research or statistical purposes.
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collections are entitled, “DOE/NRC Form 740M, Concise Note; DOE/NRC Form 741, Nuclear Material Transaction Report; DOE/NRC Form 742, Material Balance Report and, DOE/NRC Form 742C, Physical Inventory Listing.”
Submit comments by August 21, 2017.
Submit comments directly to the OMB reviewer at: Aaron Szabo, Desk Officer, Office of Information and Regulatory Affairs (3150-0057, 3150-0003, 3150-0004, 3150-0058), NEOB-10202, Office of Management and Budget, Washington, DC 20503; telephone: 202-395-3621, email:
David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
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The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the OMB, 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 comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted an extension of four collections of information to OMB for review entitled, “DOE/NRC Form 740M, Concise Note; DOE/NRC Form 741, Nuclear Material Transaction Report; DOE/NRC Form 742, Material Balance Report; DOE/NRC Form 742C, Physical Inventory Listing.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The NRC published a
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Any licensee who had possessed in the previous reporting period, at any one time and location, nuclear material in a quantity totaling one gram or more shall complete DOE/NRC Form 742. In addition, each licensee, Federal or State, who is authorized to possess, at any one time or location, one kilogram of foreign obligated source material, is required to file with the NRC an annual statement of source material inventory which is foreign obligated.
Any licensee, who had possessed in the previous reporting period, at any one time and location, special nuclear material in a quantity totaling one gram or more shall complete DOE/NRC Form 742C.
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For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Regulatory guide; withdrawal.
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 5.22, “Assessment of the Assumption of Normality (Employing Individual Observed Values).” This RG is being withdrawn because the guidance for licensees to develop written procedures describing statistical analyses of nuclear material accounting data, specifically when assessing the assumption of normality in a data set, is no longer needed.
The effective date of the withdrawal of RG 5.22 is July 21, 2017.
Please refer to Docket ID NRC-2017-0161 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document, using the following methods:
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Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Glenn Tuttle, Office of Nuclear Materials Safety and Safeguards, telephone: 301-415-7230; email:
Regulatory Guide 5.22 was published in April 1974 to provide guidance on meeting the requirements related to material control and accounting (MC&A) statistical control procedures in § 70.22(b) of title 10 of the
Regulatory Guide 5.22 endorsed the American National Standards Institute (ANSI) Standard N15.15-1973, “Assessment of the Assumption of Normality (Employing Individual Observed Values),” with qualifications. The ANSI Standard N15.15-1973 provided a common method used in assessing the assumption of normality in a data set. However, the NRC is not aware that any licensee ever used this particular RG or the ANSI standard it endorsed since the method is not required by NRC regulations. Instructions on performing such an analysis, if a licensee chose to test their MC&A data for the assumption of normality, can be found in NUREG/CR-4604 (PNL-5849), “Statistical Methods for Nuclear Material Management” (ADAMS Accession No. ML103430339). NUREG/CR-4604 was developed to be a comprehensive guidance document on statistical methods that licensees may use in evaluating MC&A data.
Withdrawal of a RG means that the guide no longer provides useful information or has been superseded by other guidance, technological innovations, congressional actions, or other events. The NRC is withdrawing RG 5.22 because it is no longer needed. The withdrawal of RG 5.22 does not alter any prior or existing NRC licensing approvals or the acceptability of licensee commitments to RG 5.22. Although RG 5.22 is withdrawn, current licensees may continue to use it, and withdrawal does not affect any existing licenses or agreements. However, by withdrawing RG 5.22, the NRC will no longer approve its use in future requests or applications for NRC licensing actions.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Form 4, Cumulative Occupational Exposure History”.
Submit comments by August 21, 2017.
Submit comments directly to the OMB reviewer at: Aaron Szabo, Desk Officer, Office of Information and Regulatory Affairs (3150-0005), NEOB-10202, Office of Management and
David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2017-0066 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:
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The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the OMB, 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 comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “NRC Form 4, Cumulative Occupational Exposure History.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The NRC published a
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For the Nuclear Regulatory Commission.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Information collected and information prepared pursuant to Regulation S-X focus on the form and content of, and requirements for, financial statements filed with periodic reports and in connection with the offer and sale of securities. Investors need reasonably current financial statements to make informed investment and voting decisions.
The potential respondents include all entities that file registration statements or reports pursuant to the Securities Act of 1933 (15 U.S.C. 77a,
Regulation S-X specifies the form and content of financial statements when those financial statements are required to be filed by other rules and forms under the federal securities laws. Compliance burdens associated with the financial statements are assigned to the rule or form that directly requires the financial statements to be filed, not to Regulation S-X. Instead, an estimated
Written 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 will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information 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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549. or send an email to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 30b1-5 (17 CFR 270.30b1-5) under the Investment Company Act of 1940 (15 U.S.C. 80a-1
The Commission estimates that there are 2,380 management investment companies, with a total of approximately 11,757 portfolios, that are governed by the rule. For purposes of this analysis, the burden associated with the requirements of rule 30b1-5 has been included in the collection of information requirements of Form N-Q, rather than the rule.
The collection of information under rule 30b1-5 is mandatory. The information provided under rule 30b1-5 is not kept confidential. 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.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17g-2, “Records to be made and retained by nationally recognized statistical rating organizations,” implements the Commission's recordkeeping rulemaking authority under Section 17(a) of the Exchange Act.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Background documentation for this information collection may be viewed at the following Web site:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17Ab2-1 and Form CA-1 require clearing agencies to register with the Commission and to meet certain requirements with regard to, among other things, the clearing agency's organization, capacities, and rules. The information is collected from the clearing agency upon the initial application for registration on Form CA-1. Thereafter, information is collected by amendment to the initial Form CA-1 when changes in circumstances that render certain information on Form CA-1 inaccurate, misleading, or incomplete necessitate modification of the information previously provided to the Commission.
The Commission uses the information disclosed on Form CA-1 to (i) determine whether an applicant meets the standards for registration set forth in Section 17A of the Exchange Act, (ii) enforce compliance with the Exchange Act's registration requirement, and (iii) provide information about specific registered clearing agencies for compliance and investigatory purposes. Without Rule 17Ab2-1, the Commission could not perform these duties as statutorily required.
The Commission staff estimates that the average Form CA-1 requires approximately 130 hours to complete and submit for approval. This burden is composed primarily of a one-time reporting burden that reflects the applicant's staff time (
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend the Fee Schedule. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public
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 Exchange proposes to amend the Fee Schedule for trading on BOX to adopt transactions fees for Qualified Contingent Cross (“QCC”) transactions. A QCC Order is an originating order (Agency Order) to buy or sell at least 1,000 standard option contracts, or 10,000 mini-option contracts, that is identified as being part of a qualified contingent trade, coupled with a contra side order to buy or sell an equal number of contracts. The Exchange is proposing to establish fees for QCC Orders to coincide with the launch of QCC Orders on the Exchange beginning July 10, 2017.
The Exchange proposes to establish a transaction fee for all Public Customer QCC Orders of $0.00 per contract side. Further, the Exchange proposes to establish a transaction fee for all non-Public Customer (Professional Customers, Broker Dealers and Market Makers) QCC Orders of $0.20 per contract side.
Additionally, the Exchange proposes to state explicitly in the Fee Schedule that a QCC transaction must be comprised of an originating order to buy or sell at least 1,000 contracts or 10,000 mini-option contracts,
Lastly, the Exchange proposes to specify that QCC Orders will be exempt from the Liquidity Fees and Credits outlined in Section II of the BOX Fee Schedule.
The purpose of these changes is to incentivize the sending of QCC Orders to the Exchange. The Exchange notes that other competing exchanges similarly provide fees and rebates on QCC Orders.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act, in general, and Section 6(b)(4) and 6(b)(5)of the Act,
The Exchange believes the proposed transaction fees for QCC Orders are reasonable and in line with the amount assessed at other Exchanges for similar transactions.
The Exchange believes the proposed rebate for the originating side of a QCC transaction is reasonable, as other competing exchanges also provide a rebate on the originating side of a QCC order. Additionally, the proposed rebate amount is in line with the rebates offered at other competing exchanges.
The Exchange believes that exempting QCC Orders from Section II (Liquidity Fees and Credits) is reasonable, equitable and not unfairly discriminatory. The Exchange's Liquidity Fees and Credits are intended to attract order flow to the Exchange by offering incentives to all market participants to submit orders to the Exchange and the Exchange believes that the proposed QCC fee structure will provide appropriate incentives to encourage Participants to submit QCC Orders to the Exchange. The Exchange believes that exempting QCC Orders from liquidity fees and credits is reasonable compared to similar fees and credits offered by another exchange.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes this proposal will not cause unnecessary burden on intermarket competition because the proposed changes will actually enhance the competiveness of the Exchange relative to other exchanges which offer comparable fees and rebates for QCC transactions. To the extent that the proposed changes make the Exchange a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become market participants on the Exchange.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Exchange Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further 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.
On December 30, 2016, NYSE Arca, Inc. filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On February 23, 2017, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider this proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of MISSOURI (FEMA-4317-DR), dated 06/02/2017.
Applicable 07/13/2017.
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, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the Presidential disaster declaration for the State of MISSOURI, dated 06/02/2017 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of MISSOURI (FEMA-4317-DR), dated 06/02/2017.
Applicable 07/13/2017.
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, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of MISSOURI, dated 06/02/2017, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
The Defense Trade Advisory Group (DTAG) will meet in open session from 1:00 p.m. until 5:00 p.m. on Friday, September 8, 2017 at 1777 F Street NW., Washington DC 20006. Entry and registration will begin at 12:30 p.m. The membership of this advisory committee consists of private sector defense trade representatives, appointed by the Assistant Secretary of State for Political-Military Affairs, who advise the Department on policies, regulations, and technical issues affecting defense trade. The purpose of the meeting will be to discuss current defense trade issues and topics for further study.
The following agenda topics will be discussed: (1) One-Form electronic filing, review and discuss recommendations for making electronic filing more cost-effective and efficient for industry; (2) Identify key areas of concern with the proposed definition for defense services in 80 FR 31525 (June 3, 2015); (3) Review and provide feedback to accurately and effectively define “manufacturing” and distinguish it from other related activities like assembly, integration, installment and various services; (4) Examine and discuss the current rules regarding the release of technical data to foreign dual-nationals and identify alternative options which sufficiently facilitates risk assessment and risk mitigation and (5) Discuss and provide assessment, including a cost-benefit analysis, of
Members of the public may attend this open session and will be permitted to participate in the discussion in accordance with the Chair's instructions. Members of the public may, if they wish, submit a brief statement to the committee in writing.
As seating is limited to 125 persons, each member of the public or DTAG member that wishes to attend this plenary session should provide: His/her name and contact information such as email address and/or phone number and any request for reasonable accommodation to the DTAG Alternate Designated Federal Officer (DFO), Anthony Dearth, via email at
Chicago Rail & Port, LLC (CRP), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to acquire by lease from South Chicago Property Development, LLC (SCPD) and to operate,
According to CRP, there are no mileposts associated with the Chicago Transload Facility trackage. CRP states that the trackage is used to transload gravel and other stone products (including railroad stone ballast), and aggregate materials from water to rail. The trackage is used in conjunction with interchanging to and from the Indiana Harbor Belt Railroad Company.
CRP asserts that because the trackage in question will constitute the entire line of railroad of CRP, this trackage is a line of railroad under 49 U.S.C. 10901, rather than spur, switching or side tracks excepted from Board acquisition and operation authority by virtue of 49 U.S.C. 10906.
Although CRP states in its verified notice that the operations were proposed to be consummated on or about June 1, 2017, this transaction may not be consummated until August 5, 2017 (30 days after the verified notice was officially filed).
CRP certifies that its projected annual revenues as a result of this transaction do not exceed those that would qualify it as a Class III rail carrier and will not exceed $5 million. CRP also certifies that there are no provisions or agreements that may limit future interchange commitments.
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed no later than July 28, 2017 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36126, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on CRP's representative, David C. Dillon, Dillon & Nash, Ltd., 3100 Dundee Road, Suite 508, Northbrook, IL 60062.
According to CRP, this action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 10, 2017.
Send comments identified by docket number FAA-2017-0423 using any of the following methods:
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Brittany Newton (202) 267-6691, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 10, 2017.
Send comments identified by docket number FAA-2016-2215 using any of the following methods:
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Jake Troutman (202) 683-7788, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 10, 2017.
Send comments identified by docket number FAA-2014-0692 using any of the following methods:
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Jake Troutman (202) 683-7788, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Highway Administration (FHWA), DOT.
Notice of Limitation on Claims for Judicial Review of Actions by FHWA, the U.S. Army Corps of Engineers, and the U.S. Fish and Wildlife Service.
The FHWA is issuing this notice to announce actions taken by FHWA, the U.S. Army Corps of Engineers, and the U.S. Fish and Wildlife Service that are final within the meaning of applicable law. The FHWA is issuing this notice to announce to the public that FHWA, as NEPA lead agency, has prepared and approved (May 26, 2017) a Final Environmental Assessment (EA) with a Finding of No Significant Impact (FONSI) and Section 4(f) Evaluation. The actions relate to a proposed highway project: Widen approximately 12.6 miles of U.S. Highway 395 from two lanes to four lanes from the existing four-lane highway segment just south of the Los Angeles Aqueduct Bridge No. 48-10 at post mile 29.2 north to the four-lane segment at the Ash Creek Bridge No. 48-068R, post mile 41.8, in the County of Inyo, State of California. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA, is advising the public of final agency actions subject to 23 U.S.C. 139(
The Final EA/EIR is a joint project by the California Department of Transportation (Caltrans) and the Federal Highway Administration (FHWA) and is subject to state and federal environmental review requirements. FHWA and Caltrans jointly prepared the Final EA/EIR pursuant to the requirements of the National Environmental Policy Act and the California Environmental Quality Act. Caltrans is the lead agency under the CEQA. The Federal Highway Administration is the lead agency under the NEPA.
The project proposes to widen approximately 12.6 miles of U.S. Highway 395 from two lanes to four lanes from the existing four-lane highway segment just south of the Los Angeles Aqueduct Bridge No. 48-10 at post mile 29.2 north to the four-lane segment at the Ash Creek Bridge No.
The U.S. Army Corps of Engineers decision and permit SPL-2009-00965-TS, and the U.S. Fish and Wildlife biological opinion FWS-INY-13B0156-14F0013 are available by contacting FHWA, at the address provided above. This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. Council on Environmental Quality regulations (40 CFR 1500
2. National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4351
3. Clean Air Act of 1963, as amended (42 U.S.C. 7401
4. Noise Control Act of 1979 (42 U.S.C. 4901
5. FHWA Noise Standards, Policies, and Procedures (23 CFR 772);
6. Department of Transportation Act of 1966, Section 4(f) (49 U.S.C. 303);
7. Clean Water Act of 1977 (33 U.S.C. 1344);
8. Endangered Species Act of 1973 (16 U.S.C. 1531-1543);
9. Migratory Bird Treaty Act (16 U.S.C. 703-712);
10. National Historic Preservation Act of 1966, as amended (54 U.S.C. 306108
11. Executive Order 11990, Protection of Wetlands;
12. Executive Order 11988, Floodplain Management;
13. Executive Order 13112, Invasive Species;
14. Executive Order 12898, Federal Actions to Address Environmental Justice and Low-Income Populations;
15. Title VI of Civil Rights Act 1964 (42 U.S.C. 2000d
23 U.S.C.139(
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated National and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's Web site (
On July 18, 2017, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. LIU, Emily (a.k.a. BAOXIA, Liu; a.k.a. LAU, Emily), China; DOB 10 Sep 1981; POB Shandong, China; nationality China; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Female; Passport G28882492 (China) expires 04 May 2018 (individual) [NPWMD] [IFSR] (Linked To: SHIRAZ ELECTRONICS INDUSTRIES).
Designated pursuant to section 1(a)(iii) of Executive Order 13382 of June 28, 2005, “Blocking Property of Weapons of Mass Destruction Proliferators and Their Supporters” (“E.O. 13382”) for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, SHIRAZ ELECTRONICS INDUSTRIES, a person whose property and interests in property are blocked pursuant to E.O. 13382.
2. GHASEMI, Seyyed Reza (a.k.a. QASEMI, Seyed Reza); Additional Sanctions Information—Subject to Secondary Sanctions; National ID No. 004-3-94558-9 (Iran); Chief Executive Officer, Rayan Roshd Afzar Company; Managing Director, Rayan Roshd Afzar Company (individual) [NPWMD] [IFSR] (Linked To: RAYAN ROSHD AFZAR COMPANY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, RAYAN ROSHD AFZAR COMPANY, a person whose property or interests in property are blocked pursuant to E.O. 13382.
3. HAKEMZADEH, Farshad; Additional Sanctions Information—Subject to Secondary Sanctions; National ID No. 005-1-61706-4 (Iran) (individual) [NPWMD] [IFSR] (Linked To: RAYAN ROSHD AFZAR COMPANY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, RAYAN ROSHD AFZAR COMPANY, a person whose property or interests in property are blocked pursuant to E.O. 13382.
4. PARSAJAM, Mohsen (a.k.a. HODJATABADI, Mohsen Kargar; a.k.a. HODJAT ABADI, Mohsen Kargar; a.k.a. “KARGAR, Mohsen”); DOB 23 Aug 1964; POB Qom, Iran; nationality Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male; Passport N95873956 (Iran) expires 05 May 2020; National ID No. 038-1-57690-6 (Iran); Chairman of the Board, Rayan Roshd Afzar Company (individual) [NPWMD] [IFSR] (Linked To: RAYAN ROSHD AFZAR COMPANY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, RAYAN ROSHD AFZAR COMPANY, a person whose property or interests in property are blocked pursuant to E.O. 13382.
5. TAVAN, Resit (a.k.a. TAVAN, Reshit); DOB 01 Jan 1977; nationality Turkey; Additional Sanctions Information—Subject to Secondary Sanctions; Passport U06314813 (Turkey) (individual) [NPWMD] [IFSR] (Linked To: QESHM MADKANDALOO SHIPBUILDING COOPERATIVE CO).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, QESHM MADKANDALOO SHIPBUILDING COOPERATIVE CO, a person whose property and interests in property are blocked pursuant to E.O. 13382.
6. AJILY, Mohammed Saeed (a.k.a. AJILI, Sa'id); DOB 03 Sep 1982; nationality Iran (individual) [TCO] (Linked To: AJILY SOFTWARE PROCUREMENT GROUP).
Designated pursuant to sections 1(a)(ii)(C) of E.O. 13581, “Blocking Property of Transnational Criminal Organizations” (“E.O. 13581”) for having acted or purported to act for or on behalf of, directly or indirectly, the AJILY SOFTWARE PROCUREMENT GROUP, a person whose property and interests in property are blocked pursuant to E.O. 13581.
7. REZAKHAH, Mohammed Reza (a.k.a. REZAKHAH, Mohammad Reza); DOB 04 Aug 1978; nationality Iran (individual) [TCO] (Linked To: AJILY SOFTWARE PROCUREMENT GROUP).
Designated pursuant to sections 1(a)(ii)(C) of E.O. 13581 for having acted or purported to act for or on behalf of, directly or indirectly, the AJILY SOFTWARE PROCUREMENT GROUP, a person whose property and interests in property are blocked pursuant to E.O. 13581.
1. ABASCIENCE TECH CO. LTD., Room 1724, Si Fang Building No. 5, Xiao Ying Road, ChaoYang District, Beijing 100101, China; 14C, Hung Shui Kiu Main Street, Yuen Long, N.T., Hong Kong; Additional Sanctions Information—Subject to Secondary Sanctions [NPWMD] [IFSR] (Linked To: SHIRAZ ELECTRONICS INDUSTRIES; Linked To: LIU, Emily).
Designated pursuant to sections 1(a)(iii) and 1(a)(iv) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, SHIRAZ ELECTRONICS INDUSTRIES, a person whose property and interests in property are blocked pursuant to E.O. 13382, and for being owned or controlled by EMILY LIU, a person whose property and interests in property are blocked pursuant to E.O. 13382.
2. RAYBEAM OPTRONICS CO. LTD., 10-D, Blessgo Industrial Park, Yanjiao High and New Tech Zone, Beijing 101601, China; 10-D Blessgo Industrial Park, Yanjiao Economic Development Zone, Sanhe, Hebei Province, China; Additional Sanctions Information—Subject to Secondary Sanctions [NPWMD] [IFSR] (Linked To: LIU, Emily).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for being owned or controlled by EMILY LIU, a person whose property and interests in property are blocked pursuant to E.O. 13382.
3. RAYTRONIC CORPORATION, LIMITED, No. 901, Jing Shu Dong Li, Haidian Dist, Beijing 100083, China; Additional Sanctions Information—Subject to Secondary Sanctions [NPWMD] [IFSR] (Linked To: LIU, Emily).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, EMILY LIU, a person whose property and interests in property are blocked pursuant to E.O. 13382.
4. SUNWAY TECH CO., LTD, No. 1724, Xiao Ying Rd, Si Fang Building, Chao Yang District, Beijing, China; Additional Sanctions Information—Subject to Secondary Sanctions [NPWMD] [IFSR] (Linked To: SHIRAZ ELECTRONICS INDUSTRIES; Linked To: LIU, Emily).
Designated pursuant to sections 1(a)(iii) and 1(a)(iv) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, SHIRAZ ELECTRONICS INDUSTRIES, a person whose property and interests in property are blocked pursuant to E.O. 13382, and for being owned or controlled by EMILY LIU, a person whose property and interests in property are blocked pursuant to E.O. 13382.
5. RAYAN ROSHD AFZAR COMPANY (a.k.a. RAYAN ROSHD COMPANY; a.k.a. “RAYAN ROSHD”), No. 16, Barazandeh St., North Sohrevardi St., Seyed Khandan, Tehran, Iran; Number 24 Barzandeh St., North Sohrevardi Ave., Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [NPWMD] [IFSR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, the ISLAMIC REVOLUTIONARY GUARD CORPS, a person whose property and interests in property are blocked pursuant to E.O. 13382.
6. QESHM MADKANDALOO SHIPBUILDING COOPERATIVE CO (a.k.a. MAD KANDALU COMPANY; a.k.a. MAD KANDALU SHIPBUILDING COOPERATIVE; a.k.a. MAD KANDALU SHIPBUILDING COOPERATIVE QESHM; a.k.a. MADKANDALOU COMPANY), Qeshm Island, Iran; Web site
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological, or other support for, or goods or services in support of, the ISLAMIC REVOLUTIONARY GUARD CORPS, a person whose property and interests in property are blocked pursuant to E.O. 13382.
7. RAMOR GROUP (a.k.a. RAMOR DIS TICARET VE INSAAT YATIRIM ANONIM SIRKETI), Ataturk mah. 42 Ada Gardenya 7/1 Kat. 12 D.77 Atasehir, Istanbul, Turkey; 42A ADA Kat: 12, Daire: 77, No: 7/1, Gardenya Plaza, Atasehir, Istanbul 34758, Turkey; Web site
Designated pursuant to section 1(a)(iv) of E.O. 13382 for being owned or controlled by RESIT TAVAN, a person whose property and interests in property are blocked pursuant to E.O. 13382.
8. AJILY SOFTWARE PROCUREMENT GROUP, Iran [TCO].
Designated pursuant to sections 1(a)(ii)(A) of E.O. 13581 for being a foreign person that constitutes a significant transnational criminal organization.
9. ANDISHEH VESAL MIDDLE EAST COMPANY, No. 3, Unit 6, Daroos Building, Qanat Crossroad, Dolat St, Pasdaran Ave., Tehran, Iran [TCO] (Linked To: AJILY SOFTWARE PROCUREMENT GROUP).
Designated pursuant to sections 1(a)(ii)(C) of E.O. 13581 for having acted or purported to act for or on behalf of, directly or indirectly, the AJILY SOFTWARE PROCUREMENT GROUP, a person whose property and interests in
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments should be received on or before September 19, 2017 to be assured of consideration.
Direct all written comments to L. Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or at
Please send separate comments for each specific information collection listed below. You must reference the information collection's title, form number, reporting or record-keeping requirement number, and OMB number (if any) in your comment. Requests for additional information, or copies of the information collection and instructions, or copies of any comments received, contact Elaine Christophe, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet, at
The Internal Revenue Service, as part of their continuing effort to reduce paperwork and respondent burden, invite the general public and other Federal agencies to take this opportunity to comment on these continuing information collections listed below in this notice, as required by the Paperwork Reduction Act of 1995.
1.
2.
3.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 945 Annual Return of Withheld Federal Income Tax, Form 945-A Annual Record of Federal Tax Liability, and Form 945-X Adjusted Annual Return of Withheld Federal Income Tax or Claim for Refund.
Written comments should be received on or before September 19, 2017 to be assured of consideration.
Direct all written comments to L. Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224. Requests for additional information or copies of the forms and instructions should be directed to Sara Covington, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Notice, amended.
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for appointment to the VA Prevention of Fraud, Waste, and Abuse Advisor Committee (herein-after in this section referred to as “the Committee”).
Nominations for membership on the Committee must be received no later than 5:00 p.m. EST on July 24, 2017.
All nominations should be sent electronically to the Advisory Committee Management Office mailbox at
Gregory Woskow, Designated Federal Officer, Office of Finance, Department of Veterans Affairs, 810 Vermont Avenue NW., (047), Washington, DC 20420, telephone (720) 471-1235.
In carrying out the duties set forth, the activities of the Committee include, but are not limited to:
(1) Identifying best practices and lessons learned from private industry and other Federal agencies that VA can leverage to maximize the effectiveness and efficiency of Department-wide activities to detect and prevent fraud, waste, and abuse in VA programs at significant risk;
(2) Providing advice on leveraging cutting-edge fraud detection and prevention tools and technologies used by other Federal agencies and private industry, including the identification of ways to utilize such tools in the short-term, as well as in the future, given VA's current Financial Management Business Transformation break-thru initiative; and
(3) Providing advice on leveraging partnerships and experience to assist in maximizing the efficiency and effectiveness of VA's “Seek to Prevent Fraud, Waste, and Abuse (STOP FWA)” initiative, which is designed to increase activities that prevent fraud, waste, and abuse and to reduce improper payments.
The Committee is being established by the directive of the Secretary of VA, in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2. The Committee will provide the Secretary of Veterans Affairs with advice related to improving and enhancing VA's efforts to identify, prevent, and mitigate fraud, waste, and abuse across VA in order to improve the integrity of VA's payments and the efficiency of VA's programs and activities.
The members of the Committee are appointed by the Secretary of Veteran Affairs from the general public, from various sectors and organizations, including but not limited to:
a. Veteran-focused organizations;
b. Academic communities;
c. Health care providers;
d. Other Federal agencies;
e. Insurance;
f. Former Inspectors General;
g. Veteran Service Organizations;
h. Military service organizations;
i. Academic communities; and
j. Leaders of key stakeholder associations and organizations.
In accordance with the Committee Charter, the Secretary shall determine the number, terms of service, and pay and allowances of Committee members, except that a term of service of any such member may not exceed two years. The Secretary may reappoint any Committee member for additional terms of service.
To the extent possible, the Secretary seeks members who have diverse professional and personal qualifications including but not limited to subject matter experts in the areas described above. We ask that nominations include any relevant experience information so that VA can ensure diverse Committee membership.
Nominations should be typed (one nomination per nominator). Nomination package should include:
(1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (
(2) The nominee's contact information, including name, mailing address, telephone numbers, and email address;
(3) The nominee's curriculum vitae; and
(4) A summary of the nominee's experience and qualifications relative to the membership considerations described above.
Individuals selected for appointment to the Committee shall be invited to serve a two-year term. Committee members will receive a stipend for attending Committee meetings, including per diem and reimbursement for eligible travel expenses incurred.
The Department makes every effort to ensure that the membership of VA Federal advisory committees is diverse in terms of points of view represented and the committee's capabilities. Appointments to this Committee shall be made without discrimination because of a person's race, color, religion, sex, sexual orientation, gender identify, national origin, age, disability, or genetic information. Nominations must state that the nominee is willing to serve as a member of the Committee and appears to have no conflict of interest that would preclude membership. An ethics review is conducted for each selected nominee.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 11, 2017. (See the
In commenting, please refer to file code CMS-1676-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
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2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
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4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
Jamie Hermansen, (410) 786-2064, for issues related to the valuation of anesthesia services and any physician payment issues not identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, for issues related to telehealth services and primary care.
Roberta Epps, (410) 786-4503, for issues related to PAMA section 218(a) policy and transition from traditional X-ray imaging to digital radiography.
Isadora Gil, (410) 786-4532, for issues related to the valuation of cardiovascular services, bone marrow services, surgical respiratory services, dermatological procedures, and payment rates for nonexcepted items and services furnished by nonexcepted off-campus provider-based departments of a hospital.
Donta Henson, (410) 786-1947, for issues related to ophthalmology services.
Tourette Jackson, (410) 786-4735, for issues related to the valuation of musculoskeletal services, allergy and clinical immunology services, endocrinology services, genital surgical services, nervous system services, INR monitoring services, injections and infusions, and chemotherapy services.
Ann Marshall, (410) 786-3059, for issues related to primary care, chronic care management (CCM), and evaluation and management (E/M) services.
Geri Mondowney, (410) 786-4584, for issues related to malpractice RVUs.
Patrick Sartini, (410) 786-9252, for issues related to the valuation of imaging services and malpractice RVUs.
Michael Soracoe, (410) 786-6312, for issues related to the practice expense methodology, impacts, conversion factor, and valuation of pathology and surgical procedures.
Pamela West, (410) 786-2302, for issues related to therapy services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health clinics or federally qualified health centers.
Felicia Eggleston, (410) 786-9287, for issues related to DME infusion drugs.
Rasheeda Johnson, (410) 786-3434, for issues related to initial data collection and reporting periods for the clinical laboratory fee schedule.
Edmund Kasaitis, (410) 786-0477, for issues related to biosimilars.
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, for issues related to appropriate use criteria for advanced diagnostic imaging services.
Alesia Hovatter, (410) 786-6861, for issues related to PQRS.
Alexandra Mugge, (410) 786-4457, or Elizabeth Holland, (410) 786-1309, for issues related to the EHR incentive program.
Rabia Khan or Terri Postma, (410) 786-8084 or
Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-7224, for issues related to Value-based Payment Modifier and Physician Feedback Program.
Wilbert Agbenyikey, (410) 786-4399, for issues related to MACRA patient relationship categories and codes.
Carlye Burd, (410) 786-1972, or Albert Wesley, (410) 786-4204, for issues related to diabetes prevention program.
In addition, because of the many organizations and terms to which we refer by acronym in this final rule, we are listing these acronyms and their corresponding terms in alphabetical order below:
The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available on the CMS Web site at
Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2016 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
This major proposed rule proposes to revise payment polices under the Medicare PFS and make other policy changes related to Medicare Part B payment, applicable to services furnished in CY 2018. In addition, this proposed rule includes proposals related to payment policy changes that are addressed in section III. of this proposed rule.
The statute requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work, practice expense (PE); and malpractice (MP) expense; and, that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major proposed rule, we are proposing to establish RVUs for CY 2018 for the PFS, and other Medicare Part B payment policies, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this proposed rule includes discussions and proposals regarding:
• Potentially Misvalued Codes.
• Telehealth Services.
• Establishing Values for New, Revised, and Misvalued Codes.
• Establishing Payment Rates under the PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital.
• Evaluation & Management (E/M) Guidelines and Care Management Services.
• Care Coordination Services and Payment for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
• Payment for DME Infusion Drugs.
• Solicitation of Public Comments on Initial Data Collection and Reporting Periods for Clinical Laboratory Fee Schedule.
• Solicitation of Public Comments on Payment for Biosimilar Biological Products under Section 1847A of the Act.
• Appropriate Use Criteria for Advanced Diagnostic Imaging Services.
• PQRS Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment.
• Medicare EHR Incentive Program.
• Medicare Shared Savings Program.
• Value-Based Payment Modifier and the Physician Feedback Program.
• MACRA Patient Relationship Categories and Codes.
• Medicare Diabetes Prevention Program.
We have determined that this major proposed rule is economically significant. For a detailed discussion of the economic impacts, see section VI. of this proposed rule.
Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The PFS relies on national relative values that are established for work, PE, and MP, which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.
We note that throughout this major proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for services furnished to Medicare beneficiaries.
The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations
Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.
Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians' service in a final rule, published on November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. These data sources are described in greater detail in the CY 2012 final rule with comment period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the hospital outpatient department (HOPD)) would reflect costs typically incurred by the facility. Thus, payment associated with those facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the
In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.
Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' malpractice insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.C. of this proposed rule.
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed five-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.
Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and the RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, that require the agency to periodically identify, review and adjust values for potentially misvalued codes.
As described in section VI.C. of this proposed rule, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.
To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services.
RVUs are converted to dollar amounts through the application of a conversion factor (CF), which is calculated based on a statutory formula by CMS's Office of the Actuary (OACT). The formula for calculating the Medicare PFS payment amount for a given service and fee schedule area can be expressed as:
Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia conversion factor, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate conversion factor for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.
Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.
We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5 Year Review of Work Relative Value Units under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
We use survey data on indirect PEs incurred per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.
Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and
To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.
We allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion (see section II.B.2.b of this proposed rule). The general approach to developing the indirect portion of the PE RVUs is as follows:
• For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
• Next, we incorporated the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.
For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: Facility, and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.
Diagnostic services are generally comprised of two components: A professional component (PC) and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)
For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct interested readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our Web site under downloads for the CY 2018 PFS proposed rule at
First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.
Sum the costs of each direct input.
Create indirect allocators.
We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Prior to implementing that policy, we used the most recent year of available claims data to determine the specialty mix assigned to each code.
Under either of these approaches, codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. Prior to adopting the 3-year average of data, for low-volume services (fewer than 100 Medicare allowed services), we assigned the values associated with the specialty that most frequently reported the service in the most recent claims data (dominant specialty). For some time, stakeholders, including the RUC, have requested that we use a recommended “expected” specialty for all low volume services instead of the information contained in the claims data. Currently, in the development of PE RVUs we use “expected specialty” overrides for only several dozen services based on several code-specific policies we established in prior rulemaking. As we stated in the CY 2016 final rule with comment period (80 FR 70894), we hoped that the 3-year average would mitigate the need to use dominant or expected specialty instead of the specialty identified using claims data. Because we incorporated CY 2015 claims data for use in the CY 2017 proposed rates, we believe that the finalized PE RVUs associated with the CY 2017 PFS final rule provided a first opportunity to determine whether service-level overrides of claims data are necessary.
Although we believe that the use of the 3-year average of claims data to determine specialty mix has led to an improvement in the stability of PE and MP RVUs from year to year, after reviewing the RVUs for low volume services, we continue to see possible distortions and wide variability from year to year in PE and MP RVUs for low volume services. Several stakeholders have suggested that CMS implement service-level overrides based on the expected specialty in order to determine the specialty mix for these low volume procedures. The RUC previously supplied us with a list of nearly 2,000 lower volume codes and their suggested specialty overrides. After reviewing the finalized PE RVUs for the CY 2017 PFS final rule, we agree that the use of service-level overrides for low volume services would help mitigate annual fluctuations and provide greater stability in the valuation of these services. While the use of the 3-year average of claims data to determine specialty mix has helped to mitigate some of the year-to-year variability for low volume services, it has not fully mitigated what appear to be anomalies for many of these lower volume codes.
We are, therefore, proposing to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we are proposing to instead use the expected specialty that we identify on a list. For CY 2018, we are proposing to use a list that was developed based on our medical review of the list most recently recommended by the RUC, in addition to our own proposed expected specialty for certain other low-volume codes for which we have historically used expected specialty assignments. We would display this list as part of the annual set of data files we make available as part of notice and comment rulemaking. We propose to consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis.
We are also proposing to apply these service-level overrides for both PE and MP, rather than one or the other category. We believe that this would simplify the implementation of service-level overrides for PE and MP, and would also address stakeholder concerns about the year-to-year variability for low volume services. We are soliciting public comment on the proposal to use service-level overrides to determine the specialty mix for low volume procedures, as well as on the proposed list of expected specialty overrides itself, which is largely based on the recommendations submitted by the RUC last year. The proposed list of expected specialty assignments for individual low volume services is available on our Web site under downloads for the CY 2018 PFS proposed rule at
For most services the indirect allocator is: indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.
• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.
(
For presentation purposes, in the examples in the download file called “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service.
• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
• The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).
Apply a scaling adjustment to the indirect allocators.
Calculate the indirect practice cost index.
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We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.
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The equipment cost per minute is calculated as:
Stakeholders have often suggested that particular equipment items are used less frequently than 50 percent of the time in the typical setting and that CMS should reduce the equipment utilization rate based on these recommendations. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items. However, we believe that absent robust, objective, auditable data regarding the use of particular items, the 50 percent assumption is the most appropriate within the relative value system. We welcome the submission of data that illustrates an alternative rate.
This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2018 direct PE input database, which is available on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
In the CY 2017 PFS final rule (81 FR 80179 through 80184), we finalized our proposal to add a professional PACS workstation (ED053) used for interpretation of digital images to a series of CPT codes and to address costs related to the use of film that had previously been incorporated as direct PE inputs for these services. We finalized the following criteria for the inclusion of a professional PACS workstation:
• We did not add the professional PACS workstation to any code that currently lacks a technical PACS workstation (ED050) or lacks a work RVU. We continue to believe that procedures that do not include a technical workstation, or do not have physician work, would not require a professional workstation.
• We did not add the professional PACS workstation to add-on codes. Because the base codes include equipment minutes for the professional PACS workstation, we continue to believe it would be duplicative to add additional equipment time for the professional PACS workstation in the add-on code.
• We also did not add the professional PACS workstation to image guidance codes where the dominant provider is not a radiologist according to the most recent year of claims data, because we believe a single technical PACS workstation would be more typical in those cases.
• We agreed with commenters that because the clinical utility of the PACS workstation is not necessarily limited to diagnostic services, there may be therapeutic codes where it would be reasonable to assume its use to be typical. Based on information provided by commenters and our own medical review, we stated that we believe that the use of the professional PACS workstation is typical for many of the specific codes that were identified. We added the workstation to many of the therapeutic codes requested by commenters, specifically CPT codes listed outside the 70000 series, where we agreed that use of the professional PACS workstation was typical.
• For CPT codes in the 80000 and 90000 series, we expressed our concerns about whether it is appropriate to include the technical PACS workstation in many of these services. PACS workstations were created for imaging purposes, but many of these services that include a technical PACS workstation do not appear to make use of imaging. Although we did not remove the technical PACS workstation from these codes at that time, we did not believe that a professional PACS workstation should be added to these procedures.
Prior to the publication of this CY 2018 PFS proposed rule, a stakeholder expressed concern about our decision not to include the professional PACS workstation in a series of vascular ultrasound codes that use technical PACS workstations. The stakeholder indicated that the vascular ultrasound codes in question do make use of a professional PACS workstation, and that the dominant specialty provider requirement (that is, that the code's dominant specialty provider being diagnostic radiology) would exclude codes for which the professional PACS workstation is typical based on a mistaken assumption. The stakeholder stated that to furnish vascular ultrasound services following the transition from film to digital imaging, both a technical and a professional PACS workstation are required, regardless of whether the practitioner furnishing the service is a radiologist, cardiologist, neurologist, or vascular surgeon.
We appreciate the submission of this additional information regarding the use of the professional PACS workstation in vascular ultrasound codes. Therefore, we seek comments regarding whether or not the use of the professional PACS workstation would be typical in the following list of CPT and HCPCS codes. The codes brought to our attention by the stakeholder are CPT codes 93880, 93882, 93886, 93888, 93890, 93892, 93893, 93922, 93923, 93924, 93925, 93926, 93930, 93931, 93965, 93970, 93971, 93975, 93976, 93978, 93979, 93980, 93981, 93990, and 76706, and HCPCS code G0365. We will consider information submitted in comments to determine whether the professional
As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this improvement would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.
In the following paragraphs, we address a series of issues related to clinical labor tasks, particularly relevant to services currently being reviewed under the misvalued code initiative.
Several years ago, the RUC's PE Subcommittee reviewed the preservice clinical labor times for CPT codes with 0-day and 10-day global periods. The RUC concluded that these codes are assumed to have no preservice clinical staff time (standard time of 0 minutes) unless the specialty can provide evidence that the preservice time is appropriate. In other words, for minor procedures, it is assumed that there is no clinical staff time typically spent preparing for the specific procedure prior to the patient's arrival. However, we note that for CY 2018, 41 of the 53 reviewed codes with 0-day or 10-day global periods include preservice clinical labor of some kind, suggesting that it is typical for clinical staff to prepare for the procedure prior to the patient's arrival. As we review misvalued codes, we believe that the general adherence to values that we have established as standards supports relativity within the PFS. Because 77 percent of the reviewed codes for the current calendar year deviate from the “standard,” we are seeking comment on the value and appropriate application of the standard in our review of RUC recommendations in future rulemaking. In reviewing the inputs included in the direct PE inputs database, we found that for the 1,142 total 0-day global codes, 741 of them had preservice clinical labor of some kind (65 percent). We also noticed a general correlation between preservice clinical labor time and the recent review. We are seeking comment specifically on whether the standard preservice clinical labor time of 0 minutes should be consistently applied for 0-day and 10-day global codes in future rulemaking.
The direct PE inputs for each CPT code paid under the PFS include minutes assigned to a series of standard clinical labor tasks assumed to be typical for the service in question. The minutes assigned to each of these tasks for each CPT code have been developed over several decades, and what was previously considered to be a standard value in the review of the codes has changed over time. Because each year we perform a detailed review of all of the inputs for only several hundred of the over 7,000 CPT codes paid under the PFS, valuation for individual services can be influenced by shifts in review standards over time rather than purely based on changes in practice.
For example, we traditionally assigned a clinical labor time of 3 minutes for the “Obtain vital signs” clinical labor activity, based on the amount of time typically required to check a patient's vitals. Over time, that number of minutes has increased as codes are reviewed. For example, many of the reviewed codes for the current CY 2018 rulemaking cycle have a recommended clinical labor time of 5 minutes for “Obtain vital signs,” based on the understanding that these services are measuring two additional vital signs: The patient's height and weight. We do not have any reason to believe that measuring a patient's height and weight is only typical for services described by recently reviewed codes. Instead, we believe that the review standards have changed, perhaps in conjunction with changes in medical practice, and that the change in the minutes assigned for the “Obtain vital signs” task for newer-reviewed services is detrimental to relativity among PFS services.
Therefore, to preserve relativity among the PFS codes, we are proposing to assign 5 minutes of clinical labor time for all codes that include the “Obtain vital signs” task, regardless of the date of last review. We are proposing to assign this 5 minutes of clinical labor time for all codes that include at least 1 minute previously assigned to this task. We are also proposing to update the equipment times of the codes with this clinical labor task accordingly to match the changes in clinical labor time. For codes that were not recently reviewed and for which we lacked a breakdown of how the equipment time was derived from the clinical labor tasks, we could not determine if the equipment time included time assigned for the “Obtain vital signs” task. In these cases, we are proposing to adjust the equipment time of any equipment item that matched the clinical labor time of the full service period to match the change in the “Obtain vital signs” clinical labor time. The proposed list of all codes affected by these proposed vital signs changes to direct PE inputs is available on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning for the CY 2019 PFS rulemaking cycle, we understand that the RUC intends to mandate the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations to us would, in turn, help us to simplify and standardize the hundreds of different clinical labor tasks
To help facilitate this transition to the new clinical labor activity codes, we have developed a crosswalk to link the old clinical labor tasks to the new clinical labor activity codes. Our crosswalk is for informational purposes only, and would not change either the direct PE input values or the PE RVUs for codes. Instead, we hope that the crosswalk would help us to translate the sprawling, existing data set into a condensed version that would significantly improve the standardization of clinical labor recommendations and improve the ability of commenters to identify concerns with our proposed valuation. For CY 2018 rulemaking, we are displaying two versions of the Labor Task Detail public use file: One version with the old listing of clinical labor tasks, and one with the same tasks as described by the new listing of clinical labor activity codes. These lists are available on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.
To promote appropriate relativity among the services and facilitate the transparency of our review process, during review of recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope and the associated video system as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems that are used with scopes. We proposed to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. We understand that there may be other accessories associated with the use of scopes; we proposed to separately price any scope accessories, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.
We also proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. But, we did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we could consider proposing to apply to other codes in future rulemaking. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule. We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. We also finalized a price of $16,843.87 for the stroboscopy system scope accessory (ES065). We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY 2017 in order to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believe there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. We are making further proposals to continue clarifying scope equipment inputs, and seek comments regarding the new set of scope proposals. We welcome feedback from all stakeholders, including practitioners with direct experience in the use of scope equipment.
We are seeking comment on several potential categories of scope system PE inputs. We are considering creating a single scope equipment code for each of the five categories detailed in this proposed rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We believe that the variation between these scopes is not significant enough to warrant maintaining these distinctions, and we believe that creating and pricing a single scope equipment code for each category would help provide additional clarity. We are seeking public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.
For CY 2018, we are proposing two minor changes to PE inputs related to scopes. We are proposing to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. If this proposal were to be finalized, we would remove the equipment time for the separate light source from CPT codes that include the scope video system. We are also proposing an increase to the price of the scope video system of $1,000.00 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.) We seek comments on the inclusion of the LED light in the scope video system, and the appropriate pricing of the system with the inclusion of these additional equipment items.
We anticipate adopting detailed changes to scope systems at the code level through rulemaking for CY 2019, because we believe that additional feedback from expert stakeholders will improve the details of the proposed changes. We are not proposing any additional pricing changes to scope equipment for CY 2018 due to the proposed reorganization into a single type of scope equipment for each of the five scope categories. However, we would consider updating prices for these equipment items through the public request process for price updates, or based on information submitted as part of RUC recommendations.
In the CY 2017 PFS final rule, we finalized work RVUs and direct PE inputs for two new codes related to mechanochemical vein ablation, CPT codes 36473 and 36474. Following the publication of the final rule, stakeholders contacted CMS and requested that a Clarivein kit supply item (SA122) be added to the direct PE inputs for CPT code 36474, the add-on code for ablation of subsequent veins. They stated that the Clarivein kit was accidentally omitted from the RUC recommendations, and that an additional kit is necessary to perform the service described by the add-on procedure. We are soliciting comment regarding the use of multiple kits during procedures described by the base and add-on codes to determine whether or not this supply should be included as a direct PE input for CPT code 36474 for CY 2018.
After finalizing the creation of separately billable codes for moderate sedation during the CY 2017 PFS final rule, we received additional recommendations to remove the oxygen gas supply item (SD084) from a series of CPT codes that were previously valued with moderate sedation as an inherent part of the procedure. Because oxygen gas is included in the moderate sedation pack contained within the separately billed moderate sedation codes, we believe that the continued inclusion of the oxygen gas in these codes is a duplicative supply. We are therefore proposing to remove the oxygen gas from the following codes (see Table 4):
Subsequent to the publication of the CY 2017 PFS final rule, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We are proposing to correct these inconsistencies as described in this proposed rule and reflected in the CY 2018 proposed direct PE input database displayed on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
For CY 2018, we are proposing to address the following inconsistencies:
• For CY 2018, we are proposing to make direct PE changes for CPT code 96416 (Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump) to improve payment accuracy, in response to a stakeholder inquiry regarding the use of the ambulatory IV pump equipment for this service. We are proposing to add 6 additional minutes of RN/OCN clinical labor (L056A), 4 minutes for the “Review charts by chemo nurse regarding course of treatment & obtain chemotherapy-related medical hx” task, and 2 minutes for the “Greet patient and provide gowning” task. We are proposing to add 1 quantity of the IV infusion set supply (SC018) and proposing to lower the quantity from 2 to 1 of the 20 ml syringe supply (SC053). We are proposing to add 1800 minutes for the new ambulatory IV pump equipment, and we are proposing to increase the equipment time of the medical recliner chair (EF009) from 83 minutes to 89 minutes to match the increase in RN/OCN clinical labor. For CY 2018, these
• We propose to correct an anomaly in the postservice work time for CPT code 91200 (Liver elastography, mechanically induced shear wave (
• In the process of making updates to our direct PE database, we discovered a series of discrepancies between the finalized direct PE inputs and the values entered into the database from previous calendar years. To reconcile these discrepancies, we are proposing the following direct PE refinements:
The proposed PE RVUs displayed in Addendum B on our Web site were calculated with the inputs displayed in the CY 2018 proposed direct PE input database.
In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2018, we are proposing the following price updates for existing direct PE inputs.
We are proposing to update the price of thirteen supplies and one equipment item in response to the public submission of invoices. For the details of these proposed price updates, please refer to section II.H, of this proposed rule, Table 14: Invoices Received for Existing Direct PE Inputs.
We are not proposing to update the price of the blood warmer (EQ072), the cell separator system (EQ084), or the photopheresor system (EQ206) equipment items. The only pricing information that we received for these three equipment items was an invoice that included a hand-written price over redacted information. We were unable to verify the accuracy of this invoice. We are also not proposing to update the price of the DNA image analyzer (ACIS) (EP001) equipment item, due to the
We are also proposing to change the name of the ED050 equipment from the “PACS Workstation Proxy” to the “Technologist PACS workstation.” In the CY 2017 final rule (81 FR 80180-80182), we finalized a policy to add a professional PACS workstation (ED053) to the list of approved equipment items, and we believe that renaming ED050 to the technologist PACS workstation would help to alleviate potential confusion between the two PACS workstations.
We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. For CY 2018, we note that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February 10th deadline established for code valuation recommendations. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline. However, we would consider invoices submitted as public comments during the comment period following the publication of the proposed rule, and would consider any invoices received after February or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.
As we explain in section II.B.2.c.(2) of this proposed rule, we allocate indirect costs for each code on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. Indirect expenses include administrative labor, office expense, and all other expenses. For PFS services priced in both the facility and non-facility settings, the difference in indirect PE RVUs between the settings is driven by differences in direct PE inputs for those settings since the other allocator of indirect PE, the work RVU, does not differ between settings. For most services, the direct PE input costs are higher in the nonfacility setting than in the facility setting. As a result, indirect PE RVUs allocated to these services are higher in the nonfacility setting than in the facility setting. When direct PE inputs for a service are very low, however, the allocation of indirect PE RVUs is almost exclusively based on work RVUs, which results in a very small (or no) site of service differential between the total PE RVUs in the facility and nonfacility setting.
Some stakeholders have suggested that for codes in which direct PE inputs for a service are very low, this allocation methodology does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. Among the services most affected by this anomaly are the primary therapy and counseling services available to Medicare beneficiaries for treatment of behavioral health conditions, including substance use disorders. For example, for the most commonly reported psychotherapy service (CPT code 90834), the difference between the nonfacility and facility PE RVUs is only 0.02 RVUs, which seems unlikely to represent the difference in relative resource costs in terms of administrative labor, office expense, and all other expenses incurred by the billing practitioner for 45 minutes of psychotherapy services when furnished in the office setting versus the facility setting.
We agree with these stakeholders that the site of service differential for these services that is produced by our PE methodology seems unlikely to reflect the relative resource costs for the practitioners furnishing these services in nonfacility settings. For example, we believe the 0.02 RVUs, which translates to approximately $0.72, would be unlikely to reflect the relative administrative labor, office rent, and other overhead involved in furnishing the 45 minute psychotherapy service in a nonfacility setting. Consequently, we believe it would be appropriate to modify the existing methodology for allocating indirect PE RVUs in order to better reflect the relative indirect PE resources involved in furnishing these kinds of services in the nonfacility setting.
In examining the range of services furnished in the nonfacility setting that are most affected by this circumstance, we identified HCPCS codes that describe face-to-face services, have work RVUs greater than zero, and are priced in both the facility and nonfacility setting. From among these codes, we further selected those with the lowest ratio between nonfacility PE RVUs and work RVUs. We selected 0.4 as an appropriate threshold based on several factors, including the range of nonfacility PE RVU to work RVU ratios among the codes identified. Based on these criteria, there were fewer than 50 codes that we identified with a ratio of less than 0.4 nonfacility PE RVUs for each work RVU, most of which are primarily furnished by behavioral health professionals, for a potential modification to our indirect PE allocation methodology.
In considering how to address the anomaly and ensure that an appropriate number of indirect PE RVUs are allocated to these services in the nonfacility setting, we looked at the indirect, nonfacility PE RVU for the most commonly billed physician office visit, CPT code 99213, which is billed by a wide range of physicians and non-physician practitioners under the PFS. We believe that the indirect PE costs allocated to services reported with CPT code 99213, including administrative labor and office rent, would be common for a broad range of physicians and non-physician practitioners across the PFS. We recognize that the services we seek to address are primarily furnished by behavioral health professionals who may be unlikely to incur some of the costs incurred by other practitioners furnishing a broader range of medical services. For instance, a practitioner furnishing a broader range of primary care services likely requires separate office and examination room space, and storage for disposable medical supplies and equipment. Some costs, however, such as those for office staff and records maintenance, would be analogous.
We looked at the relationship between indirect PE and work RVUs for CPT code 99213 as a marker because that is the most commonly and broadly reported PFS code that describes face-to-face office-based services. We compared the relationship between indirect PE and work RVUs for the set of HCPCS codes that we identified using the criteria discussed above and found that for the significant majority of codes, that ratio was at least 0.4 nonfacility PE RVUs for each work RVU. We believe the 0.4 nonfacility PE RVUs can serve as an appropriate marker that appropriately reflects the relative resources involved in furnishing these services.
For the fewer than 50 outlier codes identified using the criteria above, we believe it would be appropriate to establish a minimum nonfacility indirect PE RVU that would be a better reflection the resources involved in furnishing these services. We propose to set the nonfacility indirect PE RVUs for these codes using the indirect PE RVU to work RVU ratio for the most commonly furnished office-based, face-to-face service (CPT 99213) as a marker. Specifically, for each of these outlier codes, we propose to compare the ratio between indirect PE RVUs and work RVUs that result from the preliminary application of the standard methodology to the ratio for the marker code, CPT code 99213. Our proposed change in the methodology would then increase the allocation of indirect PE RVUs to the outlier codes to at least one quarter of the difference between the two ratios. We believe this approach reflects a reasonable minimum allocation of indirect PE RVUs, but we do not currently have empirical data that would be useful in establishing a more precise number.
In developing the proposed PE RVUs for CY 2018, we propose to implement only one quarter of this proposed minimum value for nonfacility indirect PE for the outlier codes. We recognize that this change in the PE methodology could have a significant impact on the allocation of indirect PE RVUs across all PFS services. In making significant changes to the PE methodology in previous years, we have implemented such changes using 4 year transitions, based largely on concerns that some specialties experience significant payment reductions with changes in PE relativity, and a transition period allows for a more gradual adjustment for affected practitioners. Under the approach we are proposing, we estimate that approximately $40 million, or approximately 0.04 percent of total PFS allowed charges, would shift within the PE methodology for each year of the proposed 4-year transition, including for CY 2018. We also note that we are proposing to exclude the codes directly subject to this proposed change from the misvalued code target calculation because the proposed change is a methodological change to address an anomaly produced by our indirect PE allocation process as opposed to a change to address misvalued codes. The PE RVUs displayed in Addendum B on our Web site were calculated with the one quarter of the indirect PE adjustment factor implemented.
Section 1848(c) of the Act requires that each service paid under the PFS be composed of three components: work, PE, and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource based. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a comprehensive discussion of the third review and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP methodology is composed of three factors: (1) Specialty-level risk factors derived from data on specialty-specific MP premiums incurred by practitioners, (2) service level risk factors derived from Medicare claims data of the weighted average risk factors of the specialties that furnish each service, and (3) an intensity/complexity of service adjustment to the service level risk factor based on either the higher of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.
As explained in the CY 2011 PFS final rule with comment period (75 FR 73208), MP RVUs for new and revised codes effective before the next 5-year review of MP RVUs were determined either by a direct crosswalk from a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjusted (or scaled) the MP RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work RVU (or, if greater, the difference in the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code were 10 percent higher than the work RVU for its source code, the MP RVU for the revised code would be increased by 10 percent over the source code MP RVU. Under this approach, the same risk factor was applied for the new/revised code and source code, but the work RVU for the new/revised code was used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906 through 70910), we finalized a policy to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services (using Medicare claims data), and to adjust MP RVUs for risk, intensity and complexity (using the work RVU or clinical labor RVU). We also finalized a policy to modify the specialty mix assignment methodology (for both MP and PE RVU calculations) to use an average of the 3 most recent years of data instead of a single year of data. Under this approach, for new and revised codes, we generally assign a specialty risk factor to individual codes based on the same utilization assumptions we make regarding specialty mix we use for calculating PE RVUs and for PFS budget neutrality. We continue to use the work RVU or clinical labor RVU to adjust the MP RVU for each code for intensity and complexity. In finalizing this policy, we stated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews.
In CY 2017, we finalized the eighth GPCI update, which reflected updated MP premium data. We did not propose to use the updated MP premium data to propose updates for CY 2017 to the specialty risk factors used in the calculation of MP RVUs because it was inconsistent with the policy we previously finalized in the CY 2016 PFS final rule with comment period, whereby we indicated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews. However, we solicited comment on whether we should consider doing so, perhaps as early as for CY 2018, prior to the fourth review and update of MP RVUs that must occur no later than CY 2020. After consideration of the comments received, we stated that we would consider the possibility of using the updated MP data to update the specialty risk factors used in the calculation of the MP RVUs prior to the next 5-year update in future rulemaking (81 FR 80191 through 80192). Since MP premium data are used to update both the MP GPCIs and the MP RVUs, going forward we believe it would be logical to align the update of MP premium data used to determine the MP RVUs with the update of the MP GPCI. Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the
We propose to use the most recent data for the proposed MP RVUs for CY 2018 and to align the update of MP premium data and MP GPCIs to once every 3 years. We are seeking comment on these proposals, and we are also seeking comment on methodologies and sources that we might use to improve the next update of MP premium data.
The proposed MP RVUs were calculated based on updated malpractice premium data obtained from state insurance rate filings by a CMS contractor. The methodology used in calculating the proposed CY 2018 review and update of resource based MP RVUs largely parallels the process used in the CY 2015 update. The calculation requires using information on specialty-specific malpractice premiums linked to specific services based upon the relative risk factors of the various specialties that furnish a particular service. Because malpractice premiums vary by state and specialty, the malpractice premium information must be weighted geographically and by specialty. Accordingly, the proposed MP RVUs are based upon four data sources: CY 2014 and CY 2015 malpractice premium data; CY 2016 and 2017 Medicare payment and utilization data; CY 2017 geographic practice cost indices (GPCIs), and CY 2018 proposed work and clinical labor RVUs.
Similar to the previous update, we calculated the proposed MP RVUs using specialty-specific malpractice premium data because they represent the actual expense incurred by practitioners to obtain malpractice insurance. We obtained malpractice premium data exclusively from the most recently available data published in the 2014 and 2015 Market Share Reports accessed from the National Association of Insurance Commissioners (NAIC) Web site. We used information obtained from malpractice insurance rate filings with effective dates in 2014 and 2015. These were the most current data available during our data collection process. We collected malpractice insurance premium data from all 50 States, and the District of Columbia, and Puerto Rico. Rate filings were not available in American Samoa, Guam or the Virgin Islands. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than those covering services furnished, during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. We made adjustments to the premium data to reflect mandatory surcharges for patient compensation funds (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in states where participation in such funds is mandatory.
We included premium information for all physician and NPP specialties, and all risk classifications available in the collected rate filings. Although we collected premium data from all states, the District of Columbia, and Puerto Rico, not all specialties had distinct premium data in the rate filings from all states. Additionally, for some specialties, MP premiums were not available from the rate filings in any state. Therefore, for specialties for which there were not premium data for at least 35 states, and specialties for which there were not distinct premium data in the rate filings, we crosswalked the specialty to a similar specialty, either conceptually or by available premium data, for which we did have sufficient and reliable data. These specialties and the specialty data that we propose to use are shown in Table 6.
For example, for radiation oncology, data were only available from 23 states, and therefore this specialty does not meet our 35-state threshold, which determines whether or not a specialty is deemed to have premium data sufficient to construct a unique risk factor. However, based on the 23 states' worth of rate filings for radiation oncology, the resource costs for the premiums suggests a similar, though slightly lesser average than that of the premiums for diagnostic radiology. We developed the proposed MP RVUs for radiation oncology by crosswalking the risk factor for diagnostic radiology as a similar specialty with similar premium data. We are seeking comment as to the appropriateness of this and the other crosswalks used in developing MP RVUs.
For the proposed CY 2018 MP RVU update, sufficient and reliable premium data were available for 43 specialty types, representing over 76 percent of allowed Medicare PFS services, which we used to develop specialty specific malpractice risk factors. (See Table 8 for a list of these specialties.)
Calculation of the proposed MP RVUs conceptually follows the specialty-weighted approach used in the CY 2015 final rule with comment period (79 FR 67591). The specialty-weighted approach bases the MP RVUs for a given service upon a weighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given service are accounted for in the calculation of the MP RVUs. The steps for calculating the proposed MP RVUs are described below.
Insurance rating area malpractice premiums for each specialty are mapped to the county level. The specialty premium for each county is then multiplied by its share of the total U.S. population (from the U.S. Census Bureau's 2014 American Community (ACS) estimates). This is in contrast to the method used for creating national average premiums for each specialty in the 2015 update; in that update, specialty premiums were weighted by the total RVU per county, rather than by the county share of the total U.S. population. We refer readers to the PFS 2016 Final Rule with comment period (80 FR 70909) for a discussion of why we have adopted a weighting method based on share of total U.S. population. This calculation is then divided by the average MP GPCI across all counties for each specialty to yield a normalized national average premium for each specialty. The specialty premiums are normalized for geographic variation so that the locality cost differences (as reflected by the GPCIs) would not be counted twice. Without the geographic variation adjustment, the cost differences among fee schedule areas would be reflected once under the methodology used to calculate the MP RVUs and again when computing the service specific payment amount for a given fee schedule area.
Some specialties had premium rates that differed for surgery, surgery with obstetrics, and non-surgery. These premium classes are designed to reflect differences in risk of professional liability and the cost of malpractice claims if they occur. To account for the presence of different classes in the malpractice premium data and the task of mapping these premiums to procedures, we calculated distinct risk factors for surgical, surgical with obstetrics, and nonsurgical procedures. However, the availability of data by surgery and non-surgery varied across specialties. Consistent with the CY 2015 MP RVU update, because no single approach accurately addressed the variability in premium class among specialties, we employed several methods for calculating average premiums by specialty. These methods are discussed below.
(a)
(b)
(c)
The three methods for calculating premiums by specialty type are summarized in Table 7. (See Table 8: “Proposed Risk Factors by Specialty Type” for the specialty names associated with the specialty codes listed in Table 7.)
The relative differences in national average premiums between specialties are expressed in our methodology as a specialty risk factor. These risk factors are an index calculated by dividing the national average premium for each specialty by the national average premium for the specialty with the lowest premiums for which we had sufficient and reliable data, allergy and immunology. For specialties with sufficient surgical and non-surgical premium data, we calculated both a surgical and non-surgical risk factor. For specialties with rate filings that distinguished surgical premiums with obstetrics, we calculated a separate surgical with obstetrics risk factor. For all other specialties we calculated a single risk factor and applied the specialty risk factor to both surgery and non-surgery services.
We note that for determining the risk factor for suppliers of TC-only services in the CY 2015 update, we updated the premium data for independent diagnostic testing facilities (IDTFs) that we used in the CY 2010 update. These data were obtained from a survey conducted by the Radiology Business Management Association (RBMA) in 2009; we ultimately used these data to calculate an updated TC specialty risk factor. We applied the updated TC specialty risk factor to suppliers of TC-only services. In the CY 2015 final rule with comment period (79 FR 67595), RBMA voluntarily submitted updated MP premium information collected from independent diagnostic testing facilities (IDTFs) in 2014, and requested that we use the data for calculating the CY 2015 MP RVUs for TC services. We declined to utilize the data and stated that we believe further study is necessary and we would consider this matter and propose any changes through future rulemaking. We believe that data for a broader set of technical component services are needed, and seek comment on appropriate, comparable data sources for such information. We also seek comment on whether the data for IDTFs are comparable and appropriate as a proxy for the broader set of TC services. We endeavor to, in the next update of specialty risk factors, collect more data across a broader set of the technical component services, not just for radiology (as is currently reflected in the RBMA data), but data for services performed by other non-physician practitioners including cytotechnologists, and cardiovascular technologists. In the interim, for CY 2018, we propose to assign a TC risk factor of 1.0, which corresponds to the lowest physician specialty risk factor.
We assigned the risk factor of 1.0 to the TC services because we do not have comparable professional liability premium data for the full range of clinicians that furnish these services. In lieu of comprehensive, comparable data, we used 1.0 as the default minimum risk factor, though we seek information on the best available data sources for use in the next update, as well as empirical information that would support assignment of an alternative risk factor for these services. Table 8 shows the proposed risk factors by specialty type.
Resource-based MP RVUs were calculated for each HCPCS code that has work or PE RVUs. The first step was to identify the percentage of services furnished by each specialty for each respective HCPCS code. This percentage was then multiplied by each respective specialty's risk factor as calculated in Step 3. The products for all specialties for the HCPCS code were then added together, yielding a specialty-weighted service specific risk factor reflecting the weighted malpractice costs across all specialties furnishing that procedure. The service specific risk factor was multiplied by the greater of the work RVU or PE clinical labor index for that service to reflect differences in the complexity and risk-of-service between services.
Given that we now annually recalibrate MP RVUs based on claims data, and in light of our proposed introduction of the service-level specialty override for low volume services, we believe that there would no longer be a need to apply service-level MP crosswalks in order to assign a specialty-mix risk factor. Contingent on finalizing this proposal, we are also proposing to eliminate general use of an MP-specific specialty-mix crosswalk for new and revised codes. However, we would continue to consider, in conjunction with annual recommendations, specific recommendations from the public and the RUC regarding specialty mix assignments for new and revised codes, particularly in cases where coding changes are expected to result in differential reporting of services by specialty, or where the new or revised code is expected to be low-volume. Absent such information, we would derive the specialty mix assumption for the first year for a new or revised code from the specialty mix used for purposes of ratesetting. In subsequent years when claims data are available, we would assign the specialty based on claims data unless the service does not exceed the low volume threshold (99 or fewer allowed services). If the service is low volume, we would assign the expected specialty, establishing a new expected specialty through rulemaking as needed, which is consistent with our approach for developing PE RVUs.
The statute requires that changes to fee schedule RVUs must be budget neutral. Thus, the last step is to adjust for relativity by rescaling the proposed MP RVUs so that the total proposed resource based MP RVUs are equal to the total current resource based MP RVUs scaled by the ratio of current aggregate MP and work RVUs. This scaling is necessary in order to maintain the work RVUs for individual services from year to year while also maintaining the overall relationship among work, PE, and MP RVUs.
The proposed resource based MP RVUs are shown in Addendum B, which is available on the CMS Web site under the downloads section of the CY 2018 PFS proposed rule at
Because a different share of the resources involved in furnishing PFS services is reflected in each of the three fee schedule components, implementation of the resource based MP RVU update will have much smaller payment effects than implementing updates of resource based work RVUs and resource based PE RVUs. On average, work represents about 50.9 percent of payment for a service under the fee schedule, PE about 44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change in PE RVUs or work RVUs for a service would result in a change in payment of about 11 to 13 percent. In contrast, a corresponding 25 percent change in MP values for a service would yield a change in payment of only about one percent. Estimates of the effects on payment by specialty type can be found in section VI. of this proposed rule.
Additional information on our proposed methodology for updating the MP RVUs may be found in our contractor's report, “
We are seeking comments on these proposals for calculating the MP RVUs for CY 2018.
Several conditions must be met for Medicare to make payments for telehealth services under the PFS. The service must be on the list of Medicare telehealth services and meet all of the following additional requirements:
• The service must be furnished via an interactive telecommunications system.
• The service must be furnished by a physician or other authorized practitioner.
• The service must be furnished to an eligible telehealth individual.
• The individual receiving the service must be located in a telehealth originating site.
When all of these conditions are met, Medicare pays a facility fee to the originating site and makes a separate payment to the distant site practitioner furnishing 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. We first implemented this statutory provision, which was effective October 1, 2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). We established a process for annual updates to the list of Medicare telehealth services as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS final rule with comment period (67 FR 79988).
As specified at § 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under § 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.
Telephones, facsimile machines, and stand-alone electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act allows the use of asynchronous “store-and-forward” technology when the originating site is part of a federal telemedicine demonstration program in Alaska or Hawaii. As specified in § 410.78(a)(1), asynchronous store-and-forward is the transmission of medical information from an originating site for review by the distant site physician or practitioner at a later time.
Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual is an individual enrolled under Part B who receives a telehealth service furnished at a telehealth originating site.
Practitioners furnishing Medicare telehealth services are reminded that these services are subject to the same non-discrimination laws as other services, including the effective communication requirements for persons with disabilities of section 504 of the Rehabilitation Act and language access for persons with limited English proficiency, as required under Title VI of the Civil Rights Act of 1964. For more information, see
Practitioners furnishing Medicare telehealth services submit claims for
Originating sites, which can be one of several types of sites specified in the statute where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system, are paid a facility fee under the PFS for each Medicare telehealth service. The statute specifies both the types of entities that can serve as originating sites and the geographic qualifications for originating sites. For geographic qualifications, our regulation at § 410.78(b)(4) limits originating sites to those located in rural health professional shortage areas (HPSAs) or in a county that is not included in a metropolitan statistical area (MSA).
Historically, we have defined rural HPSAs to be those located outside of MSAs. Effective January 1, 2014, we modified the regulations regarding originating sites to define rural HPSAs as those located in rural census tracts as determined by the Federal Office of Rural Health Policy of the Health Resources and Services Administration (HRSA) (78 FR 74811). Defining “rural” to include geographic areas located in rural census tracts within MSAs allows for broader inclusion of sites within HPSAs as telehealth originating sites. Adopting the more precise definition of “rural” for this purpose expands access to health care services for Medicare beneficiaries located in rural areas. HRSA has developed a Web site tool to provide assistance to potential originating sites to determine their geographic status. To access this tool, see our Web site at
An entity participating in a federal telemedicine demonstration project that has been approved by, or received funding from, the Secretary as of December 31, 2000 is eligible to be an originating site regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that geographic status for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic status for Medicare telehealth originating sites for each calendar year is now based upon the status of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR 74399.
As noted previously, in the CY 2003 PFS final rule with comment period (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opportunity to submit requests for adding services. Under this process, we assign any qualifying request to make additions to the list of telehealth services to one of two categories. Revisions to criteria that we use to review requests in the second category were finalized in the CY 2012 PFS final rule with comment period (76 FR 73102). The two categories are:
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Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
The list of telehealth services, including the proposed additions described below, is included in the Downloads section to this proposed rule at
Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, qualifying requests submitted before the end of CY 2017 will be considered for the CY 2019 proposed rule. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requesters should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, see our Web site at
Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list for the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY
We received several requests in CY 2016 to add various services as Medicare telehealth services effective for CY 2018. The following presents a discussion of these requests, and our proposals for additions to the CY 2018 telehealth list. Of the requests received, we found that three services were sufficiently similar to services currently on the telehealth list to qualify on a category 1 basis. Therefore, we are proposing to add the following services to the telehealth list on a category 1 basis for CY 2018:
• HCPCS code G0296 (Counseling visit to discuss need for lung cancer screening using low dose ct scan (ldct) (service is for eligibility determination and shared decision making))
We found that the service described by HCPCS code G0296 is sufficiently similar to office visits currently on the telehealth list. We believe that all the components of this service, which include assessment of the patient's risk for lung cancer, shared decision making, and counseling on the risks and benefits of LDCT, can be furnished via interactive telecommunications technology.
• CPT codes 90839 and 90840 (Psychotherapy for crisis; first 60 minutes) and (Psychotherapy for crisis; each additional 30 minutes (List separately in addition to code for primary service))
We are proposing to add CPT codes 90839 and 90840 on a Category 1 basis. We found that these services are sufficiently similar to the psychotherapy services currently on the telehealth list, even though these codes describe patients requiring more urgent care and psychotherapeutic interventions to minimize the potential for psychological trauma. However, we did identify one specific element of the services as described in the CPT prefatory language that we concluded may or may not be able to be furnished via telehealth, depending on the circumstances of the particular service. The CPT prefatory language specifies that the treatment described by these codes requires, “mobilization of resources to defuse the crisis and restore safety.” In many cases, we believe that a distant site practitioner would have access (via telecommunication technology, presumably) to the resources at the originating site that would allow for the kind of mobilization required to restore safety. However, we also believe that it would be possible that a distant site practitioner would not have access to such resources. Therefore we are proposing to add the codes to the telehealth list with the explicit condition of payment that the distant site practitioner be able to mobilize resources at the originating site to defuse the crisis and restore safety, when applicable, when the codes are furnished via telehealth. “Mobilization of resources” is a description used in the CPT prefatory language. We believe the critical element of “mobilizing resources” is the ability to communicate with and inform staff at the originating site to the extent necessary to restore safety. We solicit comment on whether our assumption that the remote practitioner is able to mobilize resources at the originating site to defuse the crisis and restore safety is valid.
Although we did not receive specific requests, we are also proposing to add four additional services to the telehealth list based on our review of services. All four of these codes are add-on codes that describe additional elements of services currently on the telehealth list and would only be considered telehealth services when billed as an add-on to codes already on the telehealth list. The four codes are:
• CPT code 90785 (Interactive complexity (List separately in addition to the code for primary procedure))
• CPT codes 96160 and 96161 (Administration of patient-focused health risk assessment instrument (
• HCPCS code G0506 (Comprehensive assessment of and care planning for patients requiring chronic care management services (list separately in addition to primary monthly care management service))
In the case of CPT codes 96160 and 96161, and HCPCS code G0506, we recognize that these services may not necessarily be ordinarily furnished in-person with a physician or billing practitioner. Ordinarily, services that are typically not considered to be face-to-face services do not need to be on the list of Medicare telehealth services; however, these services would only be considered Medicare telehealth services when billed with a base code that is also on the telehealth list and would not be considered Medicare telehealth services when billed with codes not on the Medicare telehealth list. We believe that by adding these services to the telehealth list it will be administratively easier for practitioners who report these services in association with a visit code that is furnished via telehealth as both the base code and the add-on code would be reported with the telehealth place of service.
We also received requests to add services to the telehealth list that do not meet our criteria for Medicare telehealth services. We are not proposing to add the following procedures for physical, occupational, and speech therapy, initial hospital care, and online E/M by physician/qualified healthcare professional to the telehealth list, or changing the requirements for ESRD procedure codes furnished via telehealth, for the reasons noted in the paragraphs that follow.
• CPT code 97001: Now deleted and reported as CPT code 97161 (Physical therapy evaluation: low complexity, requiring these components: A history with no personal factors and/or comorbidities that impact the plan of care; An examination of body system(s) using standardized tests and measures addressing 1-2 elements from any of the following: Body structures and functions, activity limitations, and/or participation restrictions; A clinical presentation with stable and/or uncomplicated characteristics; and Clinical decision making of low complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome.)
• CPT code 97002: Now deleted and reported as CPT code 97162 (Physical therapy evaluation: moderate complexity, requiring these components: A history of present problem with 1-2 personal factors and/or comorbidities that impact the plan of care; An examination of body systems using standardized tests and measures in addressing a total of 3 or more elements from any of the following: Body structures and functions, activity limitations, and/or participation restrictions; An evolving clinical presentation with changing characteristics; and Clinical decision making of moderate complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome)
• CPT code 97003: Now deleted and reported as CPT code 97165 (Occupational therapy evaluation, low
• CPT code 97004: Now deleted and reported as CPT code 97166 (Occupational therapy evaluation, moderate complexity, requiring these components: An occupational profile and medical and therapy history, which includes an expanded review of medical and/or therapy records and additional review of physical, cognitive, or psychosocial history related to current functional performance; An assessment(s) that identifies 3-5 performance deficits (
• CPT code 97110 (Therapeutic procedure, 1 or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility)
• CPT code 97112 (Therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities)
• CPT code 97116 (Therapeutic procedure, 1 or more areas, each 15 minutes; gait training (includes stair climbing))
• CPT code 97535 (Self-care/home management training (
• CPT code 97750 (Physical performance test or measurement (
• CPT code 97755 (Assistive technology assessment (
• CPT code 97760 (Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(s), lower extremity(s) and/or trunk, each 15 minutes).
• CPT code 97761 (Prosthetic training, upper and/or lower extremity(s), each 15 minutes).
• CPT code 97762 (Checkout for orthotic/prosthetic use, established patient, each 15 minutes).
In section 1834(m)(4)(E) of the Act, the statute specifies the types of practitioners who may furnish and bill for Medicare telehealth services as those practioners under section 1842(b)(18)(C) of the Act. Physical therapists, occupational therapists and speech-language pathologists are not among the practitioners identified in section 1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81 FR 80198) that because these services are predominantly furnished by physical therapists, occupational therapists and speech-language pathologists, we did not believe it would be appropriate to add them to the list of telehealth services at this time. In an ensuing submission for 2018, the original requester suggested that we might propose these services to be added to the list so that they can be furnished via telehealth when furnished by eligible distant site practitioners. We considered that possibility; however, since the majority of the codes are furnished by therapy professionals over 90 percent of the time, we believe that adding therapy services to the telehealth list that explicitly describe the services of the kinds of professionals not included on the statutory list of distant site practitioners could result in confusion about who is authorized to furnish and bill for these services when furnished via telehealth. We also note that several of these services, such as CPT code 97761, require directly physically manipulating the beneficiary, which is not possible to do through telecommunications technology. Therefore, we are not proposing to add these codes to the list of Medicare telehealth services.
• CPT code 99221 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or 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 and/or family's needs. Usually, the problem(s) requiring admission are of low severity.)
• CPT code 99222 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of moderate complexity. Counseling and/or 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 and/or family's needs. Usually, the problem(s) requiring admission are of moderate severity.)
• CPT code 99223 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of high complexity. Counseling and/or 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 and/or family's needs. Usually, the problem(s) requiring admission are of high severity.)
We previously considered a request to add these codes to the telehealth list. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73315), while initial inpatient consultation services are currently on the list of approved telehealth services, there are no services on the current list of telehealth services that resemble initial hospital care for an acutely ill patient by the admitting practitioner who has ongoing responsibility for the patient's
The initial hospital care codes describe the first visit of the hospitalized patient by the admitting practitioner who may or may not have seen the patient in the decision-making phase regarding hospitalization. Based on the description of the services for these codes, we believe it is critical that the initial hospital visit by the admitting practitioner be conducted in person to ensure that the practitioner with ongoing treatment responsibility comprehensively assesses the patient's condition upon admission to the hospital through a thorough in-person examination. Additionally, the requester submitted no additional research or evidence that the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient; therefore, we also are not proposing to add initial hospital care services to the Medicare telehealth services list on a category 2 basis.
We note that Medicare beneficiaries who are being treated in the hospital setting can receive reasonable and necessary E/M services using other HCPCS codes that are currently on the Medicare telehealth list including those for subsequent hospital care, initial and followup telehealth inpatient and emergency department consultations, as well as initial and followup critical care telehealth consultations.
Therefore, we do not propose to add the initial hospital care services to the list of Medicare telehealth services for CY 2018.
• CPT code 99444 (Online evaluation and management service provided by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient or guardian, not originating from a related E/M service provided within the previous 7 days, using the Internet or similar electronic communications network)
As we indicated in the CY 2016 final rule with comment period (80 FR 71061), CPT code 99444 is assigned a status indicator of “N” (Non-covered service). Under section 1834(m)(2)(A) of the Act, Medicare pays the physician or practitioner furnishing a telehealth service an amount equal to the amount that would have been paid if the service was furnished without the use of a telecommunications system. Because CPT code 99444 is currently non-covered, there would be no Medicare payment if this service were furnished without the use of a telecommunications system. Because this code is a non-covered service for which no Medicare payment may be made under the PFS, we do not propose to add online E/M services to the list of Medicare telehealth services for CY 2018.
• CPT codes 90963 (End-stage renal disease (ESRD) related services for home dialysis per full month, for patients younger than 2 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents); 90964 (End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 2- 11 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents); 90965 (End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 12-19 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents); and 90966 (End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 20 years of age and older)
• 90967 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients younger than 2 years of age); 90968 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 2-11 years of age); and 90969 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 12-19 years of age); and 90970 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 20 years of age and older).
In the CY 2004 PFS final rule (68 FR 63216), we established G-codes for ESRD monthly capitation payments (MCPs), which were replaced by CPT codes in CY 2009 (73 FR 69898). The services described by CPT codes 90963 through 90966 were added to the Medicare telehealth list in CY 2005 (69 FR 66276) and CPT codes 90967 through 90970 were added to the Medicare telehealth list in the CY 2017 PFS final rule (81 FR 80194); however, we specified that the required clinical examination of the vascular access site must be furnished face-to-face “hands on” (without the use of an interactive telecommunications system) by a physician, clinical nurse specialist (CNS), nurse practitioner (NP), or physician assistant (PA). The American Telemedicine Association (ATA) submitted a new request for CY 2018 requesting that we allow telehealth coverage of ESRD procedure codes without in-person exam of the catheter access site monthly. Our current policy reflects our understanding that evaluation of the integrity and functionality of the access site is a critical element of the services described by the codes and that this element cannot be performed via telecommunications technology. The requester did not submit evidence to support the assertation that effective examination of the access site can be executed via telecommunications technology. Therefore, for CY 2018, we are not proposing any changes to the policy requiring that the MCP practitioner must furnish at least one face-to-face encounter with the home dialysis patient per month for clinical examination of the catheter access site. However, we are interested in more information about current clinically accepted care practices and to what extent telecommunications technology can be used to examine the access site. We are also interested in information about the clinical standards of care regarding the frequency of the evaluation of the access site.
In summary, we are proposing to add the following codes to the list of Medicare telehealth services beginning in CY 2018 on a category 1 basis:
• HCPCS code G0296 (Counseling visit to discuss need for lung cancer screening using low dose CT scan (ldct) (service is for eligibility determination and shared decision making)).
• HCPCS code G0506 (Comprehensive assessment of and care planning for patients requiring chronic care management services (list separately in addition to primary monthly care management service)).
• CPT code 90785 (Interactive complexity (List separately in addision to the code for primary procedure)).
• CPT codes 90839 and 90840 (Psychotherapy for crisis; first 60 minutes) and (Psychotherapy for crisis; each additional 30 minutes (List separately in addition to code for primary procedure)).
• CPT codes 96160 and 96161 (Administration of patient-focused health risk assessment instrument (
Medicare has required distant site practitioners to report one of two longstanding HCPCS modifiers when reporting telehealth services. Current guidance instructs practitioners to submit claims for telehealth services using the appropriate CPT or HCPCS code for the professional service along with the telehealth modifier GT (via interactive audio and video telecommunications systems). For federal telemedicine demonstration programs in Alaska or Hawaii, practitioners are instructed to submit claims using the appropriate CPT or HCPCS code for the professional service along with the telehealth modifier GQ if telehealth services are performed “via an asynchronous telecommunications system.” By coding and billing these modifiers with a service code, practitioners are certifying that both the broad and code-specific telehealth requirements have been met.
In the CY 2017 PFS final rule (81 FR 80201), we finalized payment policies regarding Medicare's use of a new Place of Service (POS) Code describing services furnished via telehealth. The new POS code became effective January 1, 2017, and we believe its use is redundant with the requirements to apply the GT modifier for telehealth services. We did not propose to implement a change to the modifier requirements during CY 2017 rulemaking because at the time of the CY 2017 PFS proposed rule, we did not know whether the telehealth POS code would be made effective for January 1, 2017. However, we noted in the CY 2017 PFS final rule that, like the modifiers, use of the telehealth POS code certifies that the service meets the telehealth requirements.
Because a valid POS code is required on professional claims for all services, and the appropriate reporting of the telehealth POS code serves to indicate both the provision of the service via telehealth and certification that the requirements have been met, we believe that it is unnecessary to also require the distant site practitioner report the GT modifier on the claim. Therefore, we are proposing to eliminate the required use of the GT modifier on professional claims. Because institutional claims do not use a POS code, we propose for distant site practitioners billing under CAH Method II to continue to use the GT modifier on institutional claims. For purposes of the federal telemedicine demonstration programs in Alaska or Hawaii, we propose to retain the GQ modifier to maintain the distinction between synchronous and asynchronous telehealth services, as reflected in statute.
We have received numerous requests from stakeholders to expand access to telehealth services. As noted above, Medicare payment for telehealth services is restricted by statute, which establishes the services initially eligible for Medicare telehealth and limits the use of telehealth by defining both eligible originating sites (the location of the beneficiary) and the distant site practitioners who may furnish and bill for telehealth services. Originating sites are limited both by geography and provider setting. We have the authority to add to the list of eligible services based on our annual process, but cannot change the limitations relating to geography, patient setting, or type of furnishing practitioner because these requirements are specified in statute. For CY 2018, we are seeking information regarding ways that we might further expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies.
In addition to the broad comment solicitation regarding Medicare telehealth services, we are also specifically seeking comment on whether to make separate payment for CPT codes that describe remote patient monitoring. We note that remote patient monitoring services would generally not be considered Medicare telehealth services as defined under section 1834(m) of the Act. Rather, like the interpretation by a physician of an actual electrocardiogram or electroencephalogram tracing that has been transmitted electronically, these services involve the interpretation of medical information without a direct interaction between the practitioner and beneficiary. As such, they are paid under the same conditions as in-person physicians' services with no additional requirements regarding permissible originating sites or use of the telehealth place of service code.
We are particularly interested in comments regarding CPT code 99091 (Collection and interpretation of physiologic data (
We are also seeking comment on other existing codes that describe extensive use of communications technology for
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) to the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.
As discussed in section II.H. of this proposed rule, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Medicare Payment Advisory Commission (MedPAC), and others. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting System (PQRS) databases. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (
As MedPAC noted in its March 2009 Report to Congress (
• Codes that have experienced the fastest growth.
• Codes that have experienced substantial changes in practice expenses.
• Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
• Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes that have not been subject to review since implementation of the fee schedule.
• Codes that account for the majority of spending under the physician fee schedule.
• Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
• Codes for which there may be a change in the typical site of service since the code was last valued.
• Codes for which there is a significant difference in payment for the same service between different sites of service.
• Codes for which there may be anomalies in relative values within a family of codes.
• Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
• Codes with high intra-service work per unit of time.
• Codes with high practice expense relative value units.
• Codes with high cost supplies.
• Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions
To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.
Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed approximately 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the CY 2012 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In CY 2009 (73 FR 38589), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for review a list of potentially misvalued services, which included eight codes in the neurostimulators analysis-programming family (CPT 95970-95982). We also finalized as potentially misvalued 103 codes identified through our screen of high expenditure services across specialties.
In the CY 2017 PFS final rule, we finalized for review a list of potentially misvalued services, which included eight codes in the end-stage renal disease home dialysis family (CPT codes 90963-90970). We also finalized as potentially misvalued 19 codes identified through our screen for 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.
In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. The public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10 of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:
• Documentation in peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.
• An anomalous relationship between the code being proposed for review and other codes.
• Evidence that technology has changed physician work.
• Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
• Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
• Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
• Analyses of work time, work RVU, or direct PE inputs using other data sources (for example: Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS) National Database, and the Physician Quality Reporting System (PQRS) databases).
• National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.
We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate whether we are proposing each nominated code as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.
After we issued the CY 2017 PFS final rule, we received a nomination and supporting documentation for one code to be considered as potentially misvalued. We evaluated the supporting documentation for this nominated code to ascertain whether the submitted information demonstrated that the code should be proposed as potentially misvalued.
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device) was nominated for review as a potentially misvalued code because the current work RVU is potentially undervalued and stakeholders recommend that it should be increased to 14.23. We are proposing this code as a potentially misvalued code. In the CY 2017 PFS final rule, we noted that some assertions regarding appropriate values for the dialysis vascular access codes newly created in CY 2017 (CPT codes 36901 through 36909) did not include data that would warrant increases to the work RVUs. However, we urged interested stakeholders to consider
We have received information suggesting that the work RVUs for emergency department visits may not appropriately reflect the full resources involved in furnishing these services. Specifically, stakeholders have expressed concerns that the work RVUs for these services have been undervalued given the increased acuity of the patient population and the heterogeneity of the sites, such as freestanding and off-campus emergency departments, where emergency department visits are furnished. We are, therefore, seeking comment on whether CPT codes 99281-99385 (Emergency department visits for the evaluation and management of a patient) should be reviewed under the misvalued code initiative.
For over a decade, CMS has collaborated with the RUC to regularly prioritize codes for review by using the categories specified in the statute or as determined appropriate. We generally have referred to these categories as “misvalued code screens.” To supplement ongoing RUC identification of potentially misvalued codes through established screens, CMS regularly uses PFS rulemaking to identify other screens for use in identifying potentially misvalued codes. For example, in recent years, CMS has prioritized the following screens:
• Codes with low work RVUs commonly billed in multiple units per single encounter.
• Codes with high volume and low work RVUs.
• Codes with site-of-service-anomalies.
• E/M codes.
• PFS high expenditure services.
• Services with standalone PE procedure time.
• Services with anomalous time.
• Contractor Medical Director identified potentially misvalued codes.
• Codes with higher total Medicare payments in office than in hospital or ASC.
• Publicly nominated potentially misvalued codes.
• 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.
Although we are not proposing a new screen for CY 2018, we continue to believe that it is important to prioritize codes for review under the misvalued code initiative. As a result, we are seeking public comment on the best approach for developing screens, as well as what particular new screens we might consider. We will consider these comments for future rulemaking.
Section 502(a)(1) of Division O, Title V of the Consolidated Appropriations Act of 2016 (Pub. L. 114-113) amended section 1848(b) of the Act by establishing a new paragraph (9) of subsection (b). Section 1848(b)(9)(B) of the Act provides for a 7 percent reduction in payments for the technical component (TC) for imaging services made under the PFS that are X-rays (including the technical component portion of a global service) taken using computed radiography technology furnished during CYs 2018, 2019, 2020, 2021, or 2022, and for a 10 percent reduction for the technical component of such imaging services furnished during CY 2023 or a subsequent year. Computed radiography technology is defined for purposes of this paragraph as cassette-based imaging that utilizes an imaging plate to create the image involved. Section 1848(b)(9) of the Act also requires implementation of the reduction in payments through appropriate mechanisms, which can include the use of modifiers. In accordance with section 1848(c)(2)(B)(v)(X) of the Act, the adjustments under section 1848(b)(9)(A) of the Act are exempt from the budget neutrality requirement.
We stated in the CY 2017 PFS proposed rule that because the required reductions in PFS payment for the TC of imaging services (including the TC portion of a global service) that are X-rays taken using computed radiography technology did not apply for CY 2017, we would address implementation of section 1848(b)(9)(B) of the Act in future rulemaking. Therefore, to implement the provisions of section 1848(b)(9)(B) of the Act relating to the payment reduction for the TC (including the TC portion of a global service) of X-rays taken using computed radiography technology during CY 2018 or subsequent years, we are proposing to establish a new modifier to be used on claims for these services.
We are proposing that beginning January 1, 2018, this modifier would be required to be used when reporting imaging services for which payment is made under the PFS that are X-rays (including the X-ray component of a packaged service) taken using computed radiography technology. The modifier would be required on claims for the technical component of the X-ray service, including when the service is billed globally because the PFS payment adjustment is made to the technical component regardless of whether it is billed globally, or billed separately using the TC modifier. The modifier must be used to report the specific services that are subject to the payment reduction and accurate use is subject to audit. The use of this proposed modifier to indicate an X-ray taken using computed radiography would result in a 7 percent reduction for CYs 2018 through 2022 and a 10 percent reduction for CY 2023 or a subsequent calendar year to the payments for the TC for such imaging services furnished as specified under section 1848(b)(9)(B) of the Act.
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that certain items and services furnished by certain off-campus
As part of that discussion, we indicated that, in response to public comments received on the proposed payment policies for nonexcepted items and services, we would issue an interim final rule with comment period (the CY 2017 interim final rule, 81 FR 79720 through 79729) to establish payment policies under the PFS for nonexcepted items and services furnished on or after January 1, 2017. In the following paragraphs, we propose the payment policies under the PFS for nonexcepted items and services furnished during CY 2018. The CY 2017 interim final rule can be found on the Internet at
Coding and payment policies under the PFS have long recognized the differences between the portions of services for which direct costs generally are incurred by practitioners and the portions of services for which direct costs generally are incurred by facilities. At present, the coding and RVUs established for particular groups of services under the PFS generally reflect such direct cost differences. As described in section II.B of this proposed rule, we establish separate nonfacility and facility RVUs for many HCPCS codes describing particular services paid under the PFS. For many other services, we establish separate RVUs for the professional component and the technical component of the service described by the same HCPCS code. For other services, we establish RVUs for the different HCPCS codes that segregate and describe the discrete professional and technical aspects of particular services.
Because hospitals with nonexcepted off-campus PBDs that furnish nonexcepted items and services are likely to furnish a broader range of services than other provider or supplier types for which there is a separately valued technical component under the PFS, for CY 2017, we established a new set of payment rates under the PFS that reflected the relative resource costs of furnishing the technical component of a broad range of services to be paid under the PFS specific to the off-campus PBD of a hospital with packaging (bundling) rules that are unique to the hospital outpatient setting under the OPPS.
In principle, the coding and billing mechanisms required to make appropriate payment to hospitals for nonexcepted items and services furnished by nonexcepted off-campus PBDs are parallel to those used to make payment for the technical component services for a range of supplier types paid under the PFS. That is, payments to hospitals are made for the technical aspect of services, while physicians and other practitioners report the professional aspect of these same services. In some cases, the entities reporting the technical aspect of services use the same coding that is used by the individuals reporting the professional services. In other cases, different coding applies. We are proposing to maintain this mechanism for CY 2018.
Using the relativity among OPPS payments to establish rates for the nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals under the PFS was only one aspect of establishing the necessary relativity of these services under the PFS more broadly. It was necessary to estimate the relativity of these services compared to PFS services furnished in other settings. For CY 2017, we used our best estimate of the more general relativity between the technical component of PFS services furnished in nonexcepted off-campus PBDs and all other PFS services furnished in other settings using the limited information available to us at that time. As described in the CY 2017 interim final rule (81 FR 79722 through 79726), we estimated that for CY 2017, scaling the OPPS payment rates by 50 percent would strike an appropriate balance that avoided potentially underestimating the relative resources involved in furnishing services in nonexcepted off-campus PBDs as compared to the services furnished in other settings for which payment was made under the PFS. Specifically, we established site-specific rates under the PFS for the technical component of the broad range of nonexcepted items and services furnished by nonexcepted off-campus PBDs to be paid under the PFS that was based on the OPPS payment amount for the same items and services, scaled downward by 50 percent. We called this adjustment the “PFS Relativity Adjuster.” The PFS Relativity Adjuster refers to the percentage of the OPPS payment amount paid under the PFS for a nonexcepted item or service to the non-excepted off-campus PBD under this policy.
In developing the CY 2017 interim final rule, we began by analyzing hospital outpatient claims data from January 1 through August 26, 2016, that contained the “PO” modifier signifying that they were billed by an off-campus department of a hospital paid under the OPPS other than a remote location, a satellite facility, or a dedicated emergency department (ED). We noted that the use of the “PO” modifier was a new mandatory reporting requirement for CY 2016. We limited our analysis to those claims billed on the 13X Type of Bill because those claims were used for Medicare Part B billing under the OPPS. We then identified the top (most frequently billed) 25 major codes that were billed by claim line; that is, items and services that were separately payable or conditionally packaged. Specifically, we restricted our analysis to codes with OPPS status indicators “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”. We did not include separately payable drugs or biologicals in this analysis because those drugs or biologicals were not paid under the PFS under the CY 2017 interim final rule. As such, under the CY 2017 interim final rule, the PFS Relativity Adjuster did not apply to separately payable drugs and biologicals furnished by a nonexcepted PBD. Similarly, we excluded codes assigned an OPPS status indicator “A” because the services described by those codes were already paid at a rate under a fee schedule other than the OPPS and payment for those nonexcepted items and services was not changed by the rates established under the CY 2017 interim final rule. Next, for the same major codes (or analogous codes in the rare instance that different coding applies under the OPPS than the PFS), we compared the CY 2016 payment rate under the OPPS to a CY 2016 payment rate under the PFS attributable to the nonprofessional relative resource costs involved in furnishing the services.
The most frequently billed service with the “PO” modifier was described by HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient), which is paid under APC 5012; the total number
We then assessed the next 24 major codes most frequently billed on the 13X claim form by hospitals. We removed HCPCS code 36591 (Collection of blood specimen from a completely implantable venous access device) because, under current PFS policies, the code is used only to pay separately under the PFS when no other service was on the claim. We also removed HCPCS code G0009 (Administration of Pneumococcal Vaccine) because there was no payment for the code under the PFS. For the remaining 22 major codes most frequently billed, we estimated the amount that would have been paid to the physician in the office setting under the PFS for practice expenses not associated with the professional component of the service. As indicated in Table 9, this amount reflected (1) the difference between the PFS nonfacility payment rate and the PFS facility rate, (2) the technical component, or (3) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. This estimate ranged from zero percent to 137.8 percent of the OPPS payment rate for a code. Overall, the average (weighted by claim line volume times rate) of the nonfacility payment rate estimate for the PFS compared to the estimate for the OPPS for the 22 remaining major codes was 45 percent.
As noted with the clinic visits, we recognized that there were limitations to our data analysis, including that OPPS payment rates include the costs of packaged items or services billed with the separately payable code, and therefore the comparison to rates under the PFS was not a one-to-one comparison. Also, we included only a limited number of services, and noted that additional services may have different patterns than the services described. After considering the payment differentials for major codes billed by off-campus departments of hospitals with the “PO” modifier and based on the data limitations of our analysis, we adopted, with some exceptions noted below, a set of PFS payment rates that were based on a 50-percent PFS Relativity Adjuster to the OPPS payment rates (inclusive of packaging) for nonexcepted items and services furnished by nonexcepted off-campus PBDs in the CY 2017 interim final rule. Generally speaking, we arrived at the 50 percent PFS Relativity Adjuster by examining the 45-percent comparison noted above, the ASC payment rate—which was roughly 55 percent of the OPPS payment rate on average—and the payment rate differential for the large number of OPPS and PFS evaluation and management services, as described above. We recognized that the equivalent PFS nonfacility rates may be higher or lower on a code-specific basis than the rates that result from applying the overall PFS Relativity Adjuster to the OPPS payment rates on a code specific basis. However, we believed that, on the whole, the percentage reduction did not underestimate the overall relativity between the OPPS and the PFS based on the limited data that was available. We were concerned, however, that the 50 percent PFS Relativity Adjuster might overestimate PFS nonfacility payments relative to OPPS payments. For example, if we were able at the time to sufficiently estimate the effect of the packaging differences between the OPPS and PFS, we suspected that the equivalent portion of PFS payments for evaluation and management codes, and for PFS services on average, would likely have been less than 50 percent for the same services. We considered the 50 percent PFS Relativity Adjuster for CY 2017 to be a transitional policy until such time that we had more precise data to better
We established several significant exceptions to the application of the 50 percent PFS Relativity Adjuster. For example, we did not apply the 50 percent PFS Relativity Adjuster to services that are currently paid under the OPPS based on payment rates from other Medicare fee schedules (including the PFS) on an institutional claim. The items and services that are assigned status indicator “A” in Addendum B to the CY 2017 OPPS/ASC final rule with comment period (available on the CMS Web site at
All nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by a hospital on an institutional claim with modifier “PN” (Nonexcepted service provided at an off-campus, outpatient, provider-based department of a hospital) are currently paid under the PFS at the rate established in the CY 2017 interim final rule. Specifically, nonexcepted off campus PBDs must report modifier “PN” on each UB-04 claim line to indicate a nonexcepted item or service, and otherwise continue to bill as they currently do. Further billing instructions on the PN modifier can be found in the January 2017 OPPS Quarterly Update (transmittal 3685, Change Request 9930) released December 22, 2016, available on the CMS Web site at
As noted in the CY 2017 interim final rule, we considered the CY 2017 50 percent PFS Relativity Adjuster to be a transitional policy until such time that we had more precise data to better identify and value nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals. At present, we do not have more precise data than were available when we established the PFS Relativity Adjuster in the CY 2017 interim final rule, and we do not anticipate having such data until after the end of CY 2017, at the earliest. However, in developing a proposed policy for CY 2018, we have continued to explore options for modifying the calculation of the CY 2018 PFS Relativity Adjuster.
There is no consensus among stakeholders regarding the appropriate PFS Relativity Adjuster. Many stakeholders have suggested that making separate facility fee payments to hospitals under the PFS for all services that are separately paid under the OPPS itself undermines site-neutral payment because practitioners are only paid a single combined fee for many services when furnished in an office setting, while there are two separate fees (professional and facility) paid when the service is furnished in the hospital setting. We acknowledge that there are many cases where single fees are paid to practitioners for services furnished in an office setting while fees for comparable services when furnished in the hospital setting are paid to both the professional and facility entities. However, we do not agree that this necessarily means that overall payment cannot be site neutral. We point out that the sum of the professional and the facility portions of payment for a service furnished in a nonexcepted off-campus PBD or in a different institutional setting could be equivalent to a single fee paid to the professional in the office setting. In the case of some services, in fact, the single payment made under the PFS at the nonfacility rate exceeds the sum of the separate payments Medicare makes to the professional at the facility rate under the PFS and to the facility under the OPPS. We also note that there are many separately reportable services under the PFS (for example, the vast majority of services described by add-on codes) for which separate payment is made to physician offices but no separate payment is made under either the OPPS or under the site-specific PFS payments made to hospitals billing for nonexcepted items and services furnished by nonexcepted off-campus PBDs. For these reasons, we believe that the overall total payment made for services is more relevant to the goal of site neutrality than the quantity of individual payments made. Nonetheless, we continue to recognize and share stakeholders' concerns regarding the importance of equivalent overall payment for services, regardless of setting.
In considering the appropriate PFS Relativity Adjuster for CY 2018, we continue to believe that claims data from CY 2017, which are not yet available, are needed to guide potential changes to our general approach. In the absence of such data, however, we have continued to consider the appropriate PFS Relativity Adjuster based on the information that is available. In the analysis we used to establish the PFS Relativity Adjuster for CY 2017, we attempted to identify the appropriate value by comparing OPPS and PFS payment rates for services frequently reported in PBDs and described by the same codes under the two payment systems. As we acknowledged in the CY 2017 interim final rule, that data analysis did not include the most frequently billed service furnished in nonexcepted off-campus hospital PBDs, outpatient visits. Outpatient visits are reported using a single code under the OPPS and by one of ten different codes under the PFS.
Consistent with our previously stated concern that the PFS Relativity Adjuster for CY 2017 might be too small, generally resulting in greater overall payments to hospitals for services furnished by nonexcepted off-campus PBDs than would otherwise be paid under the PFS in the non-facility setting, we believe it is appropriate to propose changing the PFS Relativity Adjuster in order to ensure that payment made to these nonexcepted PBDs better aligns with these services that are the most frequently furnished in this setting.
For CY 2018, we propose to revise the PFS Relativity Adjuster for nonexcepted items and services furnished by nonexcepted off-campus PBDs to be 25 percent of the OPPS payment rate. We arrived at this proposed PFS Relativity Adjuster by making a code-level comparison for the service most
This proposed 25 percent PFS Relativity Adjuster is based solely on the comparison for the visit services that reflect greater than 50 percent of services billed in off-campus PBDs. We continue to recognize that the comparison between the OPPS and PFS rates for other services varies greatly, and that there are other factors, including the specific mix of services furnished by non-excepted PBDs, policies related to packaging of codes under OPPS, and payment adjustments like MPPRs and bundling under the PFS that rely on empirical information about whether or not codes are billed on the same day, that contribute to the differences in aggregate payment amounts for a broader range of services. However, for CY 2018, as for CY 2017, we must set the PFS Relativity Adjuster prior to studying the CY 2017 claims data that might allow us to consider and incorporate many more factors, including the ones stated above. When we established the 50 percent PFS Relativity Adjuster for CY 2017, we stated that we did so with the goal of ensuring adequate payment but remained concerned that the resulting reduction was too small. For CY 2018, we are focused on ensuring that we do not overestimate the appropriate overall payments for these services. Until we are able to study claims data, we believe that the comparison between PFS and OPPS payment for the most common services furnished in off-campus PBDs, outpatient visits, is a better proxy than our previous approach.
We welcome stakeholder input with regard to this analysis and the resulting rate. We also request comment on whether we should adopt a different PFS Relativity Adjuster, such as 40 percent, that represents a relative middle ground between the CY 2017 PFS Relativity Adjuster, selected to ensure adequate payment to hospitals and our proposed CY 2018 PFS Relativity Adjuster, selected to ensure that hospitals are not paid more than others would be paid through the PFS nonfacility rate. We intend to continue to study this issue and welcome comments regarding potential future refinements to payment rates for non-excepted items and services furnished by non-excepted off-campus PBDs as we gain more experience with these new site-of-service PFS rates.
Finally, we note that for CY 2018, as in recent years, the proposed annual update to OPPS payments exceeds the proposed annual update to PFS payments. Because we are proposing to make a single, across-the-board and, by necessity, imprecise adjustment to OPPS payment rates to establish PFS payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs, we expect that the actual difference between OPPS and PFS payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs falls in a range which includes our proposed PFS Relativity Adjuster (that is, the actual differential may differ from our proposed PFS Relativity Adjuster). As such, taking into account the differential between the OPPS and PFS annual updates by making an adjustment to the PFS Relativity Adjuster our proposal for CY 2018 would presume a level of precision in our estimates that is simply not present in our analysis. Therefore, we will not adjust our proposal to reflect the relative updates to PFS and OPPS between CY 2017 and CY 2018, and instead note that the differential between the OPPS and PFS payment update for CY 2018 is a factor that suggests that the proposed PFS Relativity Adjuster may overestimate PFS nonfacility payment relative to OPPS payments; in future years, we intend to more precisely account for any differential between these two update factors.
For CY 2017, we established class-specific geographic practice cost indices (GPCIs) under the PFS exclusively used to adjust these site-specific, technical component rates for nonexcepted items and services furnished in nonexcepted off-campus PBDs. These class-specific GPCIs are parallel to the geographic adjustments made under the OPPS based on the hospital wage index. We believed it was appropriate to adopt the hospital wage index areas for purposes of geographic adjustment because non-excepted off-campus PBDs are still considered to be part of a hospital, and the PFS payments to these entities will be limited to the subset of PFS services furnished by hospitals. We also believed it was appropriate, as an initial matter for CY 2017, to adopt the actual wage index values for these hospitals in addition to the wage index areas. The PFS GPCIs that would otherwise currently apply are not based on the hospital wage index areas. For CY 2018, we are proposing to continue using the authority under section 1848(e)(1)(B) of the Act to maintain a class-specific set of GPCIs for these site-specific technical component rates that are based both on the hospital wage index areas and the hospital wage index value themselves. For purposes of payment to hospitals, this means that the geographic adjustments used under the OPPS continue to apply.
For most services, the same HCPCS codes are used to describe services paid under both the PFS and the OPPS. There are two notable exceptions that describe high-volume services. The first is the set of codes that describe evaluation and management (E/M) services which are reported under the PFS using the 5 levels of CPT codes describing new or established patient visits (for a total of 10 codes). However, since CY 2014, these visits have been reported under the OPPS using the single HCPCS code G0463 (Hospital Outpatient Clinic Visit) (see 78 FR 75042). We are proposing to maintain the current PFS payment rate for HCPCS code G0463 based on the OPPS payment rate modified by the PFS Relativity Adjuster.
The second is a set of radiation treatment delivery and imaging guidance services that are reported using different codes under the PFS and the OPPS. CMS established HCPCS Level II G codes to describe radiation treatment delivery services when furnished in the physician office setting (see 79 FR 67666 through 67667). However, these HCPCS G codes are not recognized under the OPPS; rather, CPT codes are used to describe these services when furnished in the HOPD. Both sets of codes were implemented for CY 2015 and were maintained for CY 2016. Under the PFS, there is a particular statutory provision under section 1848(c)(2)(K) of the Act that required maintenance of the CY 2016 coding and payment inputs for these services for CY 2017 and also for CY 2018. Accordingly, the proposed CY 2018 PFS rates for these services are calculated based on the maintenance of the CY 2016 coding and payment inputs. Because non-excepted items and services furnished by a nonexcepted off-campus PBD are paid under the PFS, and we are required to maintain the CY 2016 coding and payment inputs for these services under
In the CY 2017 interim final rule, we adopted the packaging payment rates and multiple procedure payment reduction (MPPR) percentage that applied under the OPPS to establish the PFS payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals. That is, the claims processing logic that was used for payments under the OPPS for comprehensive APCs (C-APCs), conditionally and unconditionally packaged items and services, and major procedures, was incorporated into the newly established PFS rates. We continue to believe it is necessary to incorporate the OPPS payment policies for C-APCs, packaged items and services, and the MPPR in order to maintain the integrity of the PFS Relativity Adjuster because the adjuster is intended in part to account for the methodological differences between the OPPS and the PFS rates that would otherwise apply. We also direct interested stakeholders to related proposed policies under the OPPS, since prospective changes in the applicable adjustments and policies would generally apply to non-excepted items and services furnished by nonexcepted off-campus PBDs for CY 2018. We are interested in comments regarding the applicability of particular prospective OPPS adjustments to non-excepted items and services.
In order to apply these OPPS payment policies and adjustments to non-excepted items and services, we propose that hospitals continue to bill on an institutional claim form that will pass through the Outpatient Code Editor and into the OPPS PRICER for calculation of payment. This approach will yield data based on claims for non-excepted items and services furnished by nonexcepted off-campus PBDs, which can be used to refine PFS payment rates for these services in future years.
There were several OPPS payment adjustments that we did not adopt in the CY 2017 interim final rule, including, but not limited to, outlier payments, the rural sole community hospital (SCH) adjustment, the cancer hospital adjustments, transitional outpatient payments, the hospital outpatient quality reporting payment adjustment, and the inpatient hospital deductible cap to the cost-sharing liability for a single hospital outpatient service. We believed these payment adjustments were expressly authorized for, and should be limited to, hospitals that are paid under the OPPS for covered OPD services in accordance with section 1833(t) of the Act. We continue to believe that these policies should not apply to non-excepted items and services furnished by nonexcepted off-campus PBDs, and are not proposing that they apply for CY 2018.
With respect to partial hospitalization programs (PHP) (intensive outpatient psychiatric day treatment programs furnished to patients as an alternative to inpatient psychiatric hospitalization or as a stepdown to shorten an inpatient stay and transition a patient to a less intensive level of care), section 1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished by a hospital, to its outpatients, or by a CMHC. In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in the discussion of the proposed implementation of section 603 of Public Law 114-74, we noted that because CMHCs also furnish PHP services and are ineligible to be provider-based to a hospital, a nonexcepted off-campus PBD would be eligible for PHP payment if the entity enrolls and bills as a CMHC for payment under the OPPS. We further noted that a hospital may choose to enroll a nonexcepted off-campus PBD as a CMHC, provided it meets all Medicare requirements and conditions of participation.
Commenters expressed concern that without a clear payment mechanism for PHP services furnished by nonexcepted off-campus PBDs, access to partial hospitalization services would be limited, and pointed out the critical role PHPs play in the continuum of mental health care. Many commenters believed that Congress did not intend for partial hospitalization services to no longer be paid for by Medicare when such services are furnished by nonexcepted off-campus PBDs. Several commenters disagreed with the notion of enrolling as a CMHC in order to receive payment for PHP services. These commenters stated that hospital-based PHPs and CMHCs are inherently different in structure, operation, and payment, and noted that the conditions of participation for hospital departments and CMHCs are different. Several commenters requested that CMS find a mechanism to pay hospital-based PHPs in nonexcepted off-campus PBDs.
Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC final rule with comment period and the CY 2017 interim final rule (81 FR 79727), we adopted payment for partial hospitalization items and services furnished by nonexcepted off-campus hospital-based PBDs under the PFS. When billed in accordance with the CY 2017 interim final rule, these partial hospitalization services are paid at the CMHC per diem rate for APC 5853, for providing three or more partial hospitalization services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017 OPPS/ASC final rule with comment period, and the CY 2017 interim final rule (81 FR 79727), we noted that when a beneficiary receives outpatient services in an off-campus department of a hospital, the total Medicare payment for those services is generally higher than when those same services are provided in a physician's office. Similarly, when partial hospitalization services are provided in a hospital-based PHP, Medicare pays more than when those same services are provided by a CMHC. Our rationale for adopting the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing PHP services is because CMHCs are freestanding entities that are not part of a hospital, but they provide the same PHP services as hospital-based PHPs (81 FR 79727). This is similar to the differences between freestanding entities paid under the PFS that furnish other services also provided by hospital-based entities. Similar to other entities currently paid for their technical component services under the PFS, we believe CMHCs would typically have lower cost structures than hospital-based PHPs, largely due to lower overhead costs and other indirect costs such as administration, personnel, and security. We believe that paying for nonexcepted hospital-based partial hospitalization services at the lower CMHC per diem rate aligns with section 603 of Pubic Law 114-74, while also preserving access to PHP services. In addition, nonexcepted off-campus PBDs will not be required to enroll as CMHCs
The supervision rules that apply for hospitals continue to apply for nonexcepted off-campus PBDs that furnish nonexcepted items and services. The amendments made by section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2, 2015) did not change the status of these PBDs, only the status of, and payment mechanism for, the services they furnish. These supervision requirements are specified in § 410.27.
Under the PFS, the beneficiary copayment is generally 20 percent of the fee schedule amount, unless there is an applicable exception in accordance with the statute. All cost-sharing rules that apply under the PFS in accordance with section 1848(g) of the Act and section 1866(a)(2)(A) of the Act continue to apply for all nonexcepted items and services furnished by nonexcepted off-campus PBDs, regardless of the cost-sharing obligation under the OPPS.
We continue to believe the amendments made to the statute by section 603 of the Bipartisan Budget Act of 2015 intended to eliminate the Medicare payment incentive for hospitals to purchase physician offices, convert them to off-campus PBDs, and bill under the OPPS for items and services they furnish there. Therefore, we continue to believe the payment policy under this provision should ultimately equalize payment rates between nonexcepted off-campus PBDs and physician offices to the greatest extent possible, while allowing nonexcepted off-campus PBDs to bill in a straight-forward way for services they furnish.
We note that a full year of claims data regarding the mix of services reported using the “PN” modifier (from CY 2017) will first be available for use in PFS ratesetting for CY 2019. Under the current methodology, we would expect to use that data in order to ensure that Medicare payment to hospitals billing for non-excepted items and services furnished by nonexcepted off-campus PBDs under the PFS would reflect the relative resources involved in furnishing the items and services relative to other PFS services. We recognize that under our current approach, the payment rates would not be equal on a procedure-by-procedure basis, application of the PFS Relativity Adjuster would move toward equalizing payment rates in the aggregate between physician offices and nonexcepted off-campus PBDs to the extent appropriate. Therefore, for certain specialties, service lines, and nonexcepted off-campus PBD types, total Medicare payments for the same services might be either higher or lower when furnished by a nonexcepted off-campus PBD rather than in a physician office.
Depending on the mix of services for particular off-campus PBDs, we remain concerned that such specialty-specific patterns in payment differentials could result in continued incentives for hospitals to buy certain types of physician offices and convert them to nonexcepted off-campus PBDs; these are the incentives we believe Congress intended to avoid. However, continuing a policy similar to the one we are proposing in this proposed rule would allow hospitals to continue billing through a facility claim form and would allow for continuation of the packaging rules and cost report-based relative payment rate determinations under OPPS, which we believe are preferable to using the current valuation methodologies under the PFS that are not well-suited for nonexcepted items and services furnished by nonexcepted off-campus PBDs. Therefore, for CY 2019 and for future years, we intend to examine the claims data in order to determine not only the appropriate PFS Relativity Adjuster(s), but also to determine whether additional adjustments to the methodology are appropriate—especially with the goal of attaining site neutral payments to promote a level playing field under Medicare between physician office settings and nonexcepted off-campus PBD settings, without regard to the kinds of services furnished by particular off-campus PBDs. We solicit comments on potential changes to our methodology that would better account for these specialty-specific patterns.
Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC have identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.E.4 of this proposed rule. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule for a year. Then, during the 60-day period following the publication of the final rule, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period, we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule, the new process was applicable to all codes, except for new codes that describe truly new services.
We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values. For CY 2017, we were not aware of any new codes that described such wholly new services. Therefore, we did not establish any code values on an interim final basis.
We conduct a review of each code identified in this section and review the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs have generally included, but have not been limited to, a review of information provided by the RUC, the Health Care Professionals Advisory Committee (HCPAC), and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We have also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process. We have used the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code.
Components that we have used in the building block approach may have included preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could be the CPT codes that make up the bundled code and the inputs associated with those codes. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. The statute specifically defines the work component as the resources in time and intensity required in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we have refined the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.
Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently there are preservice time packages for services typically furnished in the facility setting (for example: Preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an E/M service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we have believed that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we have adjusted the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.
Therefore, in many cases when we have removed 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we have also removed a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we have not believed the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.
We note that many commenters and stakeholders have expressed concerns with our ongoing adjustment of work RVUs based on changes in the best information we have had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we have used to make the adjustments is derived from their survey process. We are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.
We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we have recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have begun by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs have not appeared to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we have sometimes used the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.
In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe had not otherwise been reflected in the RUC-recommended value. When we have believed that such changes in time have already been accounted for in the RUC recommendation, then we have not made such adjustments. Likewise, we have not arbitrarily applied time ratios to current work RVUs to calculate proposed work RVUs. We have used the ratios to identify potential work RVUs and considered these work RVUs as potential options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we have believed that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC recommendation had appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned referenced methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.
Several stakeholders, including the RUC, in general have objected to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed concerns with CMS refinements to RUC recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277) we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule, we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives as requested.
In developing proposed values for new, revised, and potentially misvalued codes for CY 2018, we considered the lack of alternative approaches to making the adjustments, especially since many stakeholders have routinely urged us to propose and finalize the RUC recommended values. We also considered the RUC's consistent reassurance that these kinds of concerns (regarding changes in time, for example) had already been considered, and either incorporated or dismissed, as part of the development of their recommended values. These have led us to shift our approach to reviewing RUC recommendations, especially as we believe that the majority of practitioners paid under the PFS, though not necessarily those in any particular specialty, would prefer CMS rely more heavily on RUC recommended values in establishing payment rates under the PFS.
For CY 2018, we have generally proposed RUC-recommended work RVUs for new, revised, and potentially misvalued codes. We are proposing these values based on our understanding that the RUC generally considers the kinds of concerns we have historically raised regarding appropriate valuation of work RVUs. During our review of these recommended values, however, we identified some concerns similar to those we have recognized in prior years. Given the relative nature of the PFS and our obligation to ensure that the RVUs reflect relative resource use, we have included descriptions of potential approaches we might have taken in developing work RVUs that differ from the RUC recommended values. We are seeking comment on both the RUC-recommended values as well as the alternatives considered.
Table 10 contains a list of codes for which we proposed work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2017. The proposed work RVUs, work time and other payment information for all proposed CY 2018 payable codes are available on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs includes many refinements that are common
We also note that the proposed direct PE inputs for CY 2018 are displayed in the CY 2018 direct PE input database, available on the CMS Web site under the downloads for the CY 2018 PFS proposed rule at
Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.
Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We continue to appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We have clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up post-operative visits included in the global period for a service, the equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).
In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.
We refer readers to section II.B. of this proposed rule for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.
In some cases, the PE worksheets included with the RUC recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We have addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.
The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. Some recommendations, however, include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2018, we received invoices for several new supply and equipment items. Tables 13 and 14 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this proposed rule, we encourage stakeholders to review the prices associated with these new and existing
We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 13 and 14 also include the number of invoices received, as well as the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we have included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the proposed PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.
Generally speaking, our proposed inputs did not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address proposed code-specific refinements to clinical labor in the individual code sections.
We note that the public use files for the PFS proposed and final rules for each year display both the services subject to the MPPR lists on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services and therapy services and the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap for the upcoming calendar year. The public use files for CY 2018 are available on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
In the CY 2016 PFS proposed rule (80 FR 41686), we discussed that in reviewing Medicare claims data, a separate anesthesia service is typically reported more than 50 percent of the time that various colonoscopy procedures are reported. We discussed that given the significant change in relative frequency with which anesthesia codes are reported with colonoscopy services, we believed the relative values of the anesthesia services should be reexamined and proposed to identify CPT codes 00740 (Anesth upper gi visualize) and 00810 (Anesth low intestine scope) as potentially misvalued. For CY 2018, the CPT Editorial Panel is deleting CPT codes 00740 and 00810 and creating new codes for anesthesia services furnished in conjunction with and in support of gastrointestinal endoscopic procedures: Two codes for upper GI procedures (007X1 and 007X2), two codes for lower GI procedures (008X1 and 008X2), and one code for upper and lower GI procedures (008X3).
For CY 2018, we are proposing the RUC-recommended base units without refinement for CPT codes 007X1 (5.00 base units), 007X2 (6.00 base units), 008X1 (4.00 base units), 008X2 (4.00 base units) and 008X3 (5.00 base units). We considered 3.00 base units (the 25th percentile survey result) for CPT code 008X2 (Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum; screening colonoscopy), based on our comparison of the surveyed post-induction anesthesia-intensity allocation for CPT code 008X2 to codes with similar allocations (CPT code 01382 (Anesth dx knee arthroscopy)). We found that CPT code 01382, which was also valued with 3.00 base units, had similar allocations compared to the survey results for CPT code 008X2. We are seeking comment on our proposed and alternative value for CPT code 008X2.
CPT code 10040 was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014. We are proposing the RUC-recommended work RVU of 0.91 for CPT code 10040 and the RUC-recommended work time values. We considered using the current number of 0.5 post-procedure office visits of CPT code 99212 (Office/outpatient visit est) rather than the RUC-recommended number of 1.0 post-procedure office visits. For CPT code 10040, the RUC states that it is a low intensity service that can be performed by a nurse under a physician's supervision, and that the average number of office visits in the follow-up period of acne surgery is 0.4. We are seeking public comments regarding the typical number of postoperative visits for this code, considering there have been no changes made to the code descriptor and we have not found evidence of changes to the typical patient population.
We are proposing the RUC-recommended direct PE inputs for CPT code 10040 without refinement. We considered refinements to the clinical
For CY 2018, we are proposing the RUC-recommended work RVUs and direct PE inputs for CPT code 10040 and are seeking comment on our proposed and alternative values.
CPT codes 15732 and 15736 were identified via a screen of high level E/M visits included in their global periods. This screen identified that a CPT code 99214 office visit was included for CPT codes 15732 and 15736 but not included in the other codes in this family. During the review process for this family of codes, CPT code 15732 was deleted and replaced with two new codes, CPT codes 157X1 and 157X2, to better differentiate and describe the work of large muscle flaps performed on patients with head and neck cancer depending on the site where the service was performed.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 15734 (a work RVU of 23.00), 15736 (a work RVU of 17.04), 15738 (a work RVU of 19.04), 157X1 (a work RVU of 13.50), and 157X2 (a work RVU of 15.68). For CPT code 157X1, we considered a work RVU of 12.03, crosswalking to CPT code 36830 (Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); nonautogenous graft (eg, biological collagen, thermoplastic graft)). We have concerns because the RUC-recommended work RVU of 13.50 would represent nearly double the intensity of CPT codes 15734 through 15738, as well as nearly double the intensity of deleted CPT code 15732. The RUC-recommended work RVU for CPT code 157X1 is also based on a direct crosswalk to CPT code 36832 (Revision, open, arteriovenous fistula; without thrombectomy, autogenous or nonautogenous dialysis graft (separate procedure)), which has the same intraservice time, but with 20 additional minutes of total time. We considered a potential crosswalk to another code in the same family, CPT code 36830, which also shares the same intraservice time with CPT code 157X1 but differs by only 8 minutes of total time. However, we seek comment on whether the RUC recommendation is appropriate given the significant variation in intensity among these services.
We considered a work RVU of 14.63 for CPT code 157X2 (survey 25th percentile), crosswalking to CPT code 36833 (Revision, open, arteriovenous fistula; with thrombectomy, autogenous or nonautogenous dialysis graft (separate procedure)), which has the same intraservice time, 1 minute of additional total time, and a work RVU of 14.50. We are seeking comment on the effect that an alternative work RVU of 14.50 would have on relativity among the codes in this family.
We considered refining the clinical labor time for “Check dressings & wound/home care instructions” for CPT code 157X1 from 10 minutes to 5 minutes. We are seeking comment on the typical time input for checking dressings, and whether removing and replacing dressings, would typically take place during the intraservice or postservice period.
We are also seeking comments regarding the use of the new “plate, surgical, mini-compression, 4 hole” (SD189) supply included in CPT code 157X1, including whether use of this supply would be typical, and if so, whether it should be included in the work description. We note that SD189 is mentioned in the direct PE recommendations, but the supply does not appear in the work description. In the work description, the fixation screws are applied to the orbital rim and lateral nasal wall, not the surgical plate.
CPT code 29445 appeared on a high growth screen of all services with total Medicare utilization of 10,000 or more that increased by at least 100 percent from 2008 through 2013. This screen also indicated that the code was last surveyed more than 10 years previously, and that the dominant specialty had changed during that time.
For CY 2018, we are proposing the RUC-recommended work RVU of 1.78 for CPT code 29445. For the direct PE inputs, we are proposing to refine the clinical labor time for “Check dressings & wound/home care instructions” from 5 minutes to 3 minutes. We believe that the additional 2 minutes of clinical labor time that we are proposing to remove would take place during the monitoring time following the procedure and be accounted for in that clinical labor time.
We also considered refining the clinical labor time for “Remove cast” from 22 minutes to 11 minutes: 1 minute for room prep, 10 minutes for assisting the physician, and 0 minutes for the additional activities described in the RUC recommendations, which would have only taken place during the initial casting. We have concerns that the RUC-recommended clinical labor regarding the “remove cast” task is based only on an initial visit where a new cast would be applied and 22 minutes may be an appropriate length of time. However, the RUC recommendations suggest that four to twelve cast changes are common for patients, and we are seeking comment on whether the initial application of a new cast would be typical for CPT code 29445. We reviewed the Medicare claims data for CPT code 29445 and found that three or more castings took place for 52 percent of beneficiaries, which suggests that three or more castings may be the typical case. A single casting only took place for 30 percent of services reported with CPT code 29445.
The RUC reviewed CPT code 29580 since it appeared on the screen for high expenditure services and reviewed CPT code 29581 as part of this family of codes. For CY 2018, the CPT Editorial Panel is deleting two additional codes in the family: CPT codes 29582 (Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed) and 29583 (Application of multi-layer compression system; upper arm and forearm).
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT code 29580 (a work RVU of 0.55) and CPT code 29581 (a work RVU of 0.60).
However, we are concerned about the changes in preservice time reflected in the specialty surveys compared to the RUC-recommended work RVUs. For instance, for CPT code 29580, we considered a work RVU of 0.46, crosswalking to CPT code 98925 (Osteopathic manipulative treatment (OMT); 1-2 body regions involved)), which has a work RVU of 0.46 and shares a similar intraservice time. Compared to the specialty survey times, the RUC recommended a slight decrease (9 minutes) in preservice time for CPT code 29580, with the intraservice and immediate postservice times remaining unchanged.
For CPT code 29581, we considered a work RVU of 0.5 by using the RUC-recommended work RVU increment between CPT codes 29580 and 29581 (+0.05), added to the work RVU we considered for CPT code 29580 (0.46), and crosswalking to CPT code 97597 (Debridement (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm), including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session, total wound(s) surface area; first 20 sq cm or less)), which has similar intraservice and total times to the RUC-recommended services times for CPT code 29581. We are seeking comment on whether a work RVU of 0.51 would improve relativity among the codes in this family.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 29580 and 29581 and are seeking comment on whether the alternative values we considered would be more appropriate.
CPT code 30140 was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014. During the review process, the RUC re-surveyed the code as a 0-day global period, based on the presence of a negative intensity value in the initial survey and highly variable postoperative office visits.
For CY 2018, we are proposing the RUC-recommended work RVU of 3.00 for CPT code 30140 as a 0-day global code. We also considered a work RVU of 2.68 for CPT code 30140 and are seeking comment on changes in practice patterns since the code was previously reviewed, service times of comparable services, and whether a work RVU of 2.68 would better maintain relativity among similar codes. We note that the RUC-recommended work RVU of 3.0 nearly doubles the derived intensity of the code as currently valued. We note that the RUC recommendations referenced services that had similar service times to CPT code 30140 (CPT code 31240 (Nasal/sinus endoscopy, surgical; with concha bullosa resection), with a work RVU of 2.61; and CPT code 31295 (Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (eg, balloon dilation), transnasal or via canine fossa), with a work RVU of 2.70).
We note that the initial survey for CPT code 30140 as a 90-day global resulted in a RUC-recommended work RVU of 3.57, while the second survey for the code as a 0-day global resulted in a RUC-recommended work RVU of 3.00, despite the removal of two postoperative office visits of CPT code 99212 and a half discharge visit of CPT code 99238. These removed postoperative visits have a total work RVU of 2.58, which is notably higher than the difference in the RUC-recommended work RVU between the two surveys.
We are also proposing to create equipment codes for three new equipment items based on invoices submitted with the RUC recommendations for CPT code 30140. We are proposing to create three new equipment codes based on the invoices submitted for this code family: the 2mm reusable shaver blade (EQ383) at a price of $790, the microdebrider handpiece (EQ384) at a price of $4,760, and the microdebrider console (EQ385) at a price of $9,034.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 30901 (a work RVU of 1.10), 30903 (a work RVU of 1.54), 30905 (a work RVU of 1.97), and 30906 (a work RVU of 2.45). We are also proposing to use the RUC-recommended direct PE inputs for CPT codes 30901, 30903, 30905, and 30906, with standard refinements to the equipment times to account for patient monitoring times. We noted that as part of its recommendation, the RUC informed us that the specialty societies presented evidence stating that the 1995 valuations for these services factored in excessive times, specifically to account for infection control procedures that were necessary at that time due to the prevalence of HIV/AIDS. The specialty societies also noted that increased availability and use of blood thinner medications compared to those available in 1995, has increased the difficulty and intensity of these procedures. We are seeking additional information regarding the presumption that the relative resource intensity of these services, specifically, would be affected by the commercial availability of additional blood thinner medications. We believe that blood thinner medications were widely available before 1995 when these codes were last valued. Additionally, we seek comments on the prevalence of HIV/AIDS and whether the work related to infection control procedures would be relative across many PFS services or specifically related to nasal hemorrhage control procedures.
For CPT code 30901 (Control nasal hemorrhage, anterior, simple (limited cautery and/or packing) any method), we considered a work RVU of 1.00 (the 25th percentile survey result), crosswalking to CPT code 20606 (Drain/inj joint/bursa w/us), which has similar service times. The median survey total time (24 minutes) dropped by 2 minutes (from preservice time), to 24 minutes compared to the existing total time. The difference in total time reflected a small decrease in preservice time, with no change in intraservice time (10 minutes). Among codes with similar service times, we found only three codes that had a higher work RVU than the RUC-recommended value.
For CPT code 30903 (Control nasal hemorrhage, anterior, complex (extensive cautery and/or packing) any method), we considered a work RVU of 1.30 (the 25th percentile survey result), which would have been further supported by CPT codes 36584 and 51710 which have similar service times to the median survey results. The RUC recommended a decreased total time of 39 minutes compared to the existing total time (70 minutes), with intraservice time dropping from 30 to 15 minutes.
For CPT code 30905 (Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; initial), we considered a work RVU of 1.73, using the RUC-recommended work RVU increment between CPT code 30903 and CPT code 30905 (0.43), added to the work RVU we considered for CPT code 30903 (1.30), and crosswalking to CPT code 45321 (Proctosigmoidoscopy volvul), which has similar service times. The surveyed intraservice time dropped from 48 minutes to 20 minutes. The RUC recommendations indicated that surveyed service times for CPT code 30905 are longer than for CPT code 30903 since the service is performed to control an arterial posterior bleed. According to the specialty society, arterial posterior bleeds are more difficult to treat and require a more extensive procedure in comparison to services reported with CPT code 30903. We considered using the RUC-recommended work RVU increment between CPT code 30903 and CPT code 30905 (0.43), added to the work RVU we considered for CPT code 30903 (1.30), resulting in a work RVU of 1.73. We are seeking comment on whether a work RVU of 1.73 would potentially affect relativity among the codes in this family.
For CPT code 30906 (Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; subsequent), we considered a work RVU of 2.21, using the RUC-recommended work RVU increment between CPT codes 30905 and 30906 (0.48), added to the work RVU we considered for CPT code 30905 (1.73), and crosswalking to services with similar service times (CPT codes 19281 (Perq device breast 1st imag), 51727 (Cystometrogram w/up), 49185 (Sclerotx fluid collection), and 62305 (Myelography lumbar injection)). The surveyed median intraservice time dropped from 60 minutes to 30 minutes. We are seeking comment on whether a work RVU of 2.21 would potentially improve relativity among the codes in this family.
Given the RUC's consensus for CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family and seeking comment on whether our alternative values would be more appropriate.
In October 2016, the CPT Editorial Panel created five new codes (CPT codes 31XX1, 31XX2, 31XX3, 31XX4 and 31XX5) and revised CPT codes 31238, 31254, 31255, 31276, 31287, 31288, 31296, and 31297. CPT codes 31XX2—31XX5 are newly bundled services representing services that are frequently reported together. CPT code 31XX1 represents a new service. The RUC reviewed this family of codes at their January 2017 meeting. For CY 2018, we are proposing the RUC-recommended work RVUs for all 15 CPT codes in this family as follows: 4.27 for CPT code 31254, 5.75 for CPT code 31255, 3.11 for CPT code 31256, 4.68 for CPT code 31267, 6.75 for CPT code 31276, 3.50 for CPT code 31287, 4.10 for CPT code 31288, 2.70 for CPT code 31295, 3.10 for CPT code 31296, 2.44 for CPT code 31297, 8.00 for CPT code 31XX1, 9.00 for CPT code 31XX2, 8.00 for CPT code 31XX3, 8.48 for CPT code 31XX4, and 4.50 for CPT code 31XX5.
For CPT code 31296, we considered a work RVU of 2.82, supported by a crosswalk to CPT code 36901 (Intro cath dialysis circuit) with an intraservice time of 25 minutes and total time of 66 minutes, similar to the service times for CPT code 31296. We are concerned about the decrease in service time compared to the work RVU and we seek comment on whether or not a work RVU of 2.82 might improve relativity with other PFS services.
For CPT code 31256, we considered a work RVU of 2.80, supported by a crosswalk to CPT code 43231 (Esophagoscopy, flexible, transoral; with endoscopic ultrasound examination), which has 30 minutes of intraservice time and 81 minutes of total time, similar to the RUC-recommended service times. We are concerned about the difference in total time between CPT code 31256 and the RUC-recommended crosswalk to CPT code 43247. CPT code 43247 has 30 minutes intraservice time and 58 minutes total time), and CPT code 31256 (30 minutes intraservice time and 83 minutes total time).
For CPT code 31254, we note the RUC's explanation that this service is more intense than the functional endoscopic sinus surgery on the maxillary or sphenoid sinuses due to the risk of major complications such as injury to the eye muscles, bleeding into the eye or brain fluid leak and, consequently, that the RUC concluded that it should be valued higher than either CPT code 31256 or CPT code 31287. Since CPT code 31256 has the same total time (30 minutes) and intraservice time (30 minutes) as CPT code 31254, we considered whether the incremental difference recommended by the RUC between these two codes (work RVU of 1.16) would reflect the intensity of the service. We considered a work RVU of 2.80 for CPT code 31256, and also considered an alternative work RVU of 3.97 for CPT code 31254.
For CPT code 31287, we considered a work RVU of 3.19 based on the difference between the RUC-recommended work RVU for the maxillary sinus surgery (CPT code 31256) and the sphenoid sinus surgery (CPT code 31287) (difference = 0.28) added to the work RVU that we considered for the base code (CPT code 31256, a work RVU of 2.80). We note that the magnitude of decreases in service times are greater than those for the work RVU, which potentially could affect relativity among PFS services.
For CPT code 31255, we considered a work RVU of 5.30, based on a crosswalk to CPT codes 36475 (Endovenous rf 1st vein) and 36478 (Endovenous laser 1st vein) since both of these services have the same intraservice times, total times, and work RVUs). We note that there are several CPT codes with similar total and intraservice times that have lower work RVUs than the crosswalk to CPT code 36246 (Ins cath abd/l-ext art 2nd) noted by the RUC, which has 45 minutes intraservice and 96 minutes total time, has work RVU of 5.02; CPT code 36475 (Endovenous rf 1st vein) has 94 minutes intraservice and 94 minutes total time and has work RVU of 5.30).
For CPT code 31276 (Nasal/sinus endoscopy, surgical; with frontal sinus exploration, including removal of tissue from frontal sinus, when performed), we considered a work RVU of 6.30, which is similar to other functional endoscopic surgeries. We note that the services reported with CPT code 31276 are the most intense and complex of the functional endoscopic surgeries due to the risks of working in the narrow confines in the frontal recess. However, we have concerns that a crosswalk to CPT code 52352 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with removal or manipulation of calculus (ureteral catheterization is included)), and we seek comment on whether the RUC-recommended decrease in service times is appropriate since CPT code 52352 has 20 minutes more total time than CPT code 31276.
For CPT 31XX1 (nasal/sinus endoscopy, surgical; with ligation of Sphenopalatine artery), we have concerns and seek comment regarding the accuracy and applicability of the surveys as the RUC indicated that the specialty society did not use the survey instrument that contains questions about the number and types of visits and that this service requires a half day discharge day management as the patients typically stay overnight to be monitored for further bleeding. We seek comment on whether inclusion of a half day discharge day visit is typical for this service since services assigned 0-day global periods do not typically include discharge visits. We considered reducing the total time from 142 minutes to 123 minutes by removing the half day discharge. Using the alternative total time of 123 minutes, we found services with similar total and intraservice time (60 minutes) and total time (123 minutes).
We considered a work RVU of 7.30 for CPT code 31XX1, supported by a direct crosswalk to CPT code 36253 (Superselective catheter placement (one or more second order or higher renal artery branches) renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture, catheterization, fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral), since CPT code 36253 has a similar total time compared to our alternative total time.
For CPT code 31XX3, we considered a work RVU of 7.30, based on a crosswalk to CPT code 36253 (Superselective catheter placement (one
CPT code 31XX4 is a new code representing a combination of the services previously described by CPT codes 31255 and 31288. We note the changes in overall service times compared to other codes in this family and other PFS services. We considered a work RVU of 7.85 for CPT code 31XX4, crosswalking to CPT code 93461 (R&l hrt art/ventricle angio), which has identical intraservice times. We are seeking comment on the effect that this alternative work RVU might have on consistency and rank order compared to the other bundled codes in this family.
CPT code 31XX5 represents a combination of CPT codes 31296 and 31297. We have concerns about the use of CPT codes 47532 and 58558, which were used by the RUC as comparison codes, due to differences in both intraservice and total time compared to the service times for CPT code 31XX5. We considered a work RVU of 4.10 for CPT code 31XX5, crosswalking to CPT code 44406 (Colonoscopy w/ultrasound), which has similar service times.
For CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family and are seeking comment on our alternative values.
Regarding the recommended direct PE inputs, we are concerned about one of the supply items used in furnishing services for several CPT codes in this family:, “sinus surgery balloon (maxillary, frontal, or sphenoid) kit” (SA106). In the current recommendations, half of one kit (each kit has sufficient supply for two sinuses) is included in the practice expense inputs for CPT codes 31295, 31296, and 31297. The new CPT code 31XX5 has one full kit, reflecting a service consisting of two sinuses, according to the RUC's explanation. The price of the full kit (two sinuses) of this disposable supply is $2599.06. Our analysis of 2016 Medicare claims data indicates that 48 percent of the time one of the three CPT codes (31295, 31296, and 31297) is billed, it is reported on a claim with either one or both of the other codes. Ten percent of the time one of the three CPT codes is billed, it is reported on a claim with both of the other two codes. Effectively, 10 percent of claims reporting these CPT codes are being paid for three sinuses.
We are seeking comments on the number of units of this supply item that are used for each service. We welcome suggestions about improved methodologies for identifying the quantity of this disposable supply used during these procedures and will continue to monitor utilization and reporting of these services.
In reviewing the RUC recommendations for this family of CPT codes, we note that CPT codes in this family are subject to the standard payment adjustment for multiple surgeries. In our analysis of the claims data, we noted that the average number of HCPCS codes in this family reported together on a claim line is approximately 2.89. In addition, about 15 percent of claims have two of the newly bundled CPT codes reported together on a claim line. We are concerned about the frequency with which the nasal sinus endoscopy CPT codes in this family are billed together. We are seeking comments on whether we should consider the endobase code adjustments as a better approach to adjusting payment for these services instead of the current multiple procedure reduction. For additional information about the payment adjustment under the special rule for multiple endoscopic services, we refer readers to the Medicare Claims Processing Manual, Chapter 23 (available on the CMS Web site at
We note that in developing the utilization crosswalk we use for purposes of PFS ratesetting, for this complex set of newly bundled codes, we adopted ratios that differ significantly from the ratios accompanying the RUC recommendations to better account for the reductions in overall reporting frequency. We direct readers to the file called “CY 2017 Analytic Crosswalk to CY 2018” on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
CPT code 31600 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. CPT codes 31601, 31603, 31605, and 31610 were added and reviewed as part of the code family.
We are proposing the RUC-recommended work RVUs for all five codes in this family. We are proposing a work RVU of 5.56 for CPT code 31600, a work RVU of 8.00 for CPT code 31601, a work RVU of 6.00 for CPT code 31603, a work RVU of 6.45 for CPT code 31605, and a work RVU of 12.00 for CPT code 31610.
We considered a work RVU of 6.50 for CPT code 31601. We seek comment on the effect that this alternative value would have on relativity compared to other PFS services, especially since the survey data does not suggest an increase in the time required to perform the procedure.
We considered a work RVU of 4.77 for CPT code 31605, based on the survey 25th percentile from the combined survey total. We also considered an intraservice work time of 15 minutes, based on the median intraservice work time from the combined survey total for CPT code 31605. We are seeking comments on the methodology used to determine the RUC-recommended work RVU and intraservice work time. We are concerned that the number of respondents (20) is below the threshold typically required for submission of a survey, and the effect of using survey results only from physicians who had personal experience performing the procedure (20 respondents). CPT code 31605 has a lower intraservice and total time, but a higher work RVU than comparable codes under the PFS. We note that the next highest 0-day global code with 20 minutes of intraservice time is CPT code 16035 (Escharotomy; initial incision) at a work RVU of 3.74. All other 0-day global codes with a work RVU of 6.45 or greater have at least 40 minutes of intraservice time. We are seeking comment on the effect that an alternative work RVU of 4.77 would have on the relativity of this service compared to other services in this family of codes and compared to other PFS services, taking into account that CPT code 31605 describes a difficult and dangerous life-threatening emergency procedure.
We considered a work RVU of 6.50 for CPT code 31610 based on a direct crosswalk to CPT code 31601 (Incision of windpipe). We understand that the RUC considered the possibility of
We are proposing the RUC-recommended direct PE inputs for all five CPT codes in this family without refinements. As discussed earlier, we considered a 0-day global period for CPT code 31610, which would also have resulted in removal of the clinical labor associated with the postoperative E/M visits, along with the supplies and equipment utilized during those visits.
While we remain concerned about the global period assigned to CPT code 31610 and the changes in service times reflected in the specialty surveys compared to the RUC-recommended work RVUs, for CY 2018, we are proposing the RUC-recommended work RVUs and direct PE inputs for each code in this family and are seeking comment on our proposed and alternative values.
CPT code 31645 was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014. CPT code 31646 was added for review as part of the family of codes, and both were revised to reflect recent changes in how the services are typically performed. For CY 2018, we are proposing the RUC-recommended work RVU of 2.88 for CPT code 31645 and the RUC-recommended work RVU of 2.78 for CPT code 31646.
We considered a work RVU of 2.72 for CPT code 31645, crosswalking to CPT code 45347 (Sigmoidoscopy, flexible; with placement of endoscopic stent). We have concerns regarding the decrease in intraservice and total time compared to the current values (we also believe that it is important to note how these related codes have been affected by the creation of separately billable codes for moderate sedation (see CY 2017 PFS final rule (81 FR 80339)). The RUC-recommended values CPT code 31645 higher than CPT code 31622 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; diagnostic, with cell washing, when performed), which is the base procedure for this wider group of codes. We agree that CPT code 31645 should be valued at a higher work RVU than CPT code 31622, however, we are seeking comment on whether the work of moderate sedation was inadvertently included in the development of the recommended work RVU. We note that as part of the CY 2017 PFS final rule (81 FR 80339), we finalized separate payment for moderate sedation.
Following the creation of separately billable codes for moderate sedation, CPT code 31622 is currently valued at a work RVU of 2.53, not 2.78 as it was previously valued, and we do not believe it would be appropriate to continue to value CPT code 31645 as though moderate sedation was still an inherent part of the work of this service. As a result, we considered a direct crosswalk to CPT code 45347, which has the same intraservice time and 8 additional minutes of total time, at a work RVU of 2.72.
We considered a work RVU of 2.53 for CPT code 31646, crosswalking to CPT code 31622 (Dx bronchoscope/wash). The RUC recommendation for CPT code 31646 indicated that the code was comparable to CPT code 31622, since they share the same intraservice time and similar total time, and that the recommended work RVU of 2.78 for CPT code 31646 was equal to the work RVU of CPT code 31622 before the CY 2017 changes to reporting of moderate sedation. We agree with the survey participants that these two codes are comparable to one another, but have concerns about valuation of CPT code 31646 using a cross reference to a code that included moderate sedation. We considered crosswalking CPT code 31646 (Bronchoscopy reclear airway) using the current CY 2017 valuation for CPT code 31622 (a work RVU of 2.53).
For the direct PE inputs, we are proposing to remove the oxygen gas (SD084) from CPT code 31645. This supply is included in the separately billable moderate sedation codes, and we are proposing to remove the oxygen gas as recommended by the RUC's PE Subcommittee as part of the removal of oxygen from non-moderate sedation post-procedure monitoring codes. We are proposing to remove the equipment time for the IV infusion pump (EQ032) from CPT code 31645. We do not agree that there would typically be a need for a separate infusion pump in CPT code 31645, as the infusion pump is contained in the separately reportable moderate sedation codes. We are also proposing to remove the equipment time for the CO
We are proposing to increase the equipment time for the flexible bronchoscopy fiberscope (ES017) for CPT code 31645 consistent with standard equipment times for scopes. We are also proposing to increase the equipment time for the Gomco suction machine (EQ235) and the power table (EF031) consistent with standard equipment times for non-highly technical equipment.
For CY 2018, we are proposing the RUC-recommended work RVUs for both codes in this family and are seeking comment on whether we should finalize refined values consistent with the implementation of separately billable codes for moderate sedation.
For CY 2018, the CPT Editorial Panel modified the descriptor for CPT code 32998 (Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; radiofrequency) to include imaging guidance. In addition, the panel deleted Category III CPT Code 0304T and replaced it with a new CPT code 32X99, to describe ablation therapy for reduction of pulmonary tumor using cryoablation with imaging guidance. For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 32998 (a work RVU of 9.03) and 32X99 (a work RVU of 9.03).
However, we have concerns about the descriptions of the codes and the recommended valuations assuming that imaging guidance is inherent to the
For CPT codes 32998 and 32X99, we are proposing to use the RUC-recommended direct PE inputs with standard refinements.
For CY 2018, we are proposing the RUC-recommended work RVUs and direct PE inputs for both codes and are seeking comment on our proposed and alternative values.
For CY 2018, the CPT Editorial Panel deleted Category III CPT Codes 0051T through 0053T and created CPT codes 339X1, 339X2, and 339X3 to report artificial heart system procedures. We are proposing the RUC-recommended work RVU of 49.00 for CPT code 339X1, and proposing to assign contractor-priced status to CPT codes 339X2 and 339X3 as recommended by the RUC.
We considered assigning contractor-priced status for CPT code 339X1. We have concerns regarding the accuracy of the RUC-recommended work valuation for CPT code 339X1, due to its low utilization and the resulting difficulties in finding enough practitioners with direct experience of the procedure for the specialty societies to survey. We seek comment on the sufficiency of the survey data, especially since new technologies and those with lower utilization are typically contractor-priced. For CY 2018, we are proposing the RUC-recommended work RVUs for CPT code 339X1. We are seeking comment on alternative pricing for this CPT code 339X1.
We are not proposing any direct PE inputs, as we did not receive RUC-recommended PE information for CPT codes 339X1, 339X2, and 339X3. These three codes will be placed on the RUC's new technology list and will be re-reviewed by the RUC in 3 years.
The CPT/RUC joint workgroup on codes recommended in October 2015 to bundle endovascular abdominal aortic aneurysm repair (EVAR) codes together with radiologic supervision and interpretation codes, since these codes were typically reported together at least 50 percent of the time. The CPT Editorial Panel bundled these services together in September 2016, creating 16 new codes, revising four existing codes, and deleting 14 other codes related to endovascular repair procedures.
We are proposing the RUC-recommended work RVUs for all 20 codes in this family. We are proposing a work RVU of 23.71 for CPT code 34X01, a work RVU of 36.00 for CPT code 34X02, a work RVU of 26.52 for CPT code 34X03, a work RVU of 45.00 for CPT code 34X04, a work RVU of 29.58 for CPT code 34X05, a work RVU of 45.00 for CPT code 34X06, a work RVU of 22.28 for CPT code 34X07, a work RVU of 36.50 for CPT code 34X08, a work RVU of 6.50 for CPT code 34X09, a work RVU of 15.00 for CPT code 34X10, a work RVU of 6.00 for CPT code 34X11, a work RVU of 12.00 for CPT code 34X12, a work RVU of 2.50 for CPT code 34X13, a work RVU of 4.13 for CPT code 34812, a work RVU of 5.25 for CPT code 34X15, a work RVU of 7.00 for CPT code 34820, a work RVU of 8.16 for CPT code 34833, a work RVU of 2.65 for CPT code 34834, a work RVU of 6.00 for CPT code 34X19, and a work RVU of 7.19 for CPT code 34X20.
We are also proposing the RUC-recommended direct PE inputs without refinement for all 20 codes in the family.
We considered a work RVU of 32.00 for CPT code 34X02 based on the survey 25th percentile, and further supported with a crosswalk to CPT code 48000 (Placement of drains, peripancreatic, for acute pancreatitis), which has the same intraservice time of 120 minutes and a work RVU of 31.95. When we compared the RUC-recommended work RVU to similar codes valued under the PFS, we were unable to find any 90-day global services with 120 minutes of intraservice time and approximately 677 minutes of total time that had a work RVU greater than 36.00.
We considered a work RVU of 40.00 for CPT code 34X04 based on the survey 25th percentile, crosswalking to CPT code 33534 (Coronary artery bypass, using arterial graft(s); 2 coronary arterial grafts) which has a work RVU of 39.88. CPT code 33534 has 193 minutes of intraservice time, but a lower total time of 717 minutes. When we compared the RUC-recommended work RVU for CPT code 34X04 to similar codes paid under the PFS, we were unable to find any 90-day global services with 180 minutes of intraservice time and approximately 737 minutes of total time that had a work RVU greater than 45.00.
We considered a work RVU of 40.00 for CPT code 34X06 based on the survey 25th percentile. CPT code 34X06 has nearly identical time values to CPT code 34X04, with 2 fewer minutes of intraservice time and total time, and the RUC-recommended work RVU was the same for both of these codes. The survey respondents also believe that these two codes had a comparable amount of work, as the survey 25th percentile work RVU is 40.00 for both codes.
We considered a work RVU of 30.00 for CPT code 34X08 based on the survey 25th percentile and seek comment on whether a work RVU of 30.00 would improve relativity among the codes in this family. CPT code 34X08 has identical intraservice and total times as CPT code 34X02. However, we note that the RUC-recommended work RVU of 36.50 for CPT code 34X08 is higher than the RUC-recommended work RVU of 36.00 for CPT code 34X02. This is the inverse of the relationship between CPT codes 34X07 and 34X01, which describe the same procedures in a non-emergent state when a rupture does not take place. CPT code 34X07 has a RUC-recommended work RVU of 22.28 while CPT code 34X01 has a RUC-recommended work RVU of 23.71. We seek comment on whether the RUC-recommended work RVUs would create a rank order anomaly within the family by reversing the relationship between these paired codes when performed in an emergent state. We note that if CPT codes 34X08 and 34X02 were valued at the survey 25th percentile, this potential rank order anomaly disappears; in this scenario, we considered valuing CPT code 34X08 at a work RVU of 30.00 and CPT code 34X02 at a work RVU of 32.00. We seek comment on whether these alternative work values would improve relativity with the RUC-recommended work RVUs for CPT code 34X07 (22.28) and CPT code 34X01 (23.71), with an increment of
For the eight remaining codes that describe endovascular access procedures, we considered assignment of a 0-day global period, instead of the RUC-recommended add-on (ZZZ) global period and subsequently adding back the preservice and immediate postservice work time, and increasing the work RVU of each code accordingly using a building block methodology. We note that as add-on procedures, these eight codes would not be subject to the multiple procedure payment discount. We are concerned that the total payment for these services will be increasing in the aggregate based on changes in coding that alter MPPR adjustments, despite the information in the surveys that reflects a decrease in the intraservice time required to perform the procedures, and a decrease in their overall intensity as compared to the current values.
We considered a work RVU of 3.95 for CPT code 34X13, based on the RUC-recommended work RVU of 2.50 plus an additional 1.45 work RVUs. This additional work results from the addition of 38 total minutes of preservice work time and 30 minutes of postservice work time based on a crosswalk to CPT code 37224 (Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal angioplasty) as valued by using the building block methodology. Using the same method, we considered a work RVU of:
• 6.48 for CPT code 34812 based on maintaining the current 75 minutes of preservice work time and the current 30 minutes of postservice work time, with a total work RVU of 2.35, added to the RUC-recommended work RVU of 4.13;
• 7.53 for CPT code 34X15 with the addition of 75 minutes of preservice work time and 27 minutes of postservice work time to match CPT code 34833;
• 9.46 for CPT code 34820 based on maintaining the current 80 minutes of preservice work time and the current 30 minutes of postservice work time;
• 10.44 for CPT code 34833 based on maintaining the current 75 minutes of preservice work time and the current 27 minutes of postservice work time;
• 5.00 for CPT code 34834 based on maintaining the current 70 minutes of preservice work time and the current 35 minutes of postservice work time;
• 8.35 for CPT code 34X19 with the addition of 70 minutes of preservice work time and 35 minutes of postservice work time to match CPT code 34834; and
• 9.47 for CPT code 34X20 with the addition of 75 minutes of preservice work time and 27 minutes of postservice work time to match CPT code 34833.
CPT code 36215 was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014, as well as on a screen of high expenditure services across specialties with Medicare allowed charges of over $10 million. CPT codes 36216, 36217, and 36218 were added to the family to be reviewed together with CPT code 36215.
We are proposing the RUC-recommended work RVUs for each code in this family as follows: A work RVU of 4.17 for CPT code 36215, a work RVU of 5.27 for CPT code 36216, a work RVU of 6.29 for CPT code 36217, and a work RVU of 1.01 for CPT code 36218.
We also considered refinements to the intraservice work time for CPT code 36217 from 60 minutes to 50 minutes, consistent with the RUC's usual use of the survey median intraservice work time. We have concerns that the use of the recommended survey 75th percentile intraservice work time will not be clinically appropriate for this code, as the 75th percentile time was identical for both CPT code 36216 and 36217, and therefore, the use of this value would not preserve the incremental, linear consistency between the work RVU and the intraservice time within the family.
For the direct PE inputs, we are proposing to refine the clinical labor time for the “Post-procedure doppler evaluation (extremity)” activity from 3 minutes to 1 minute for CPT codes 36215, 36216, and 36217. We believe that 1 minute would be more typical for this task, as the practitioner would be able to quickly evaluate if there was an issue with the extremity because there would be visual signs of arterial insufficiency resulting from the procedure.
We are proposing to remove the equipment time for the mobile instrument table (EF027) from CPT codes 36215, 36216, and 36217. We believe that the mobile instrument table would be used for moderate sedation, which was removed from these procedures in CY 2017 (see CY 2017 PFS final rule (81 FR 80339)). While we recognize that 180 minutes of post-procedure monitoring time remains in these codes during which the stretcher (EF018), IV infusion pump (EQ032), and 3-channel ECG (EQ011) would remain in use, we do not agree that the mobile instrument table would typically be in use during this period of monitoring. As a result, we are proposing to remove this equipment time from these three codes.
While we remain concerned about the use of the survey 75th percentile intraservice work time for CPT code 36217, for CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family and seek comment on whether our alternative values would be more appropriate.
In September 2016, the CPT Editorial Panel created four new codes to describe the treatment of incompetent veins, and revised existing CPT codes 36470 and 36471. These six codes were reviewed together as part of the same family of procedures. For CY 2018, we are proposing the RUC-recommended work RVU for all six codes as follows: A work RVU of 0.75 for CPT code 36470, a work RVU of 1.50 for CPT code 36471, a work RVU of 3.50 for CPT code 364X3, and a work RVU of 1.75 for CPT code 364X4, a work RVU of 2.35 for CPT code 364X5, and a work RVU of 3.00 for CPT code 364X6.
We considered a work RVU of 4.38 for CPT code 364X3, which would have been based on the RUC-recommended work RVU of 3.50 plus half of the RUC-recommended work RVU of CPT code 364X4. We also considered assigning CPT code 364X4 a status indicator of “bundled.” The services that would be reported using CPT codes 364X3 and 364X4 in CY 2018, are currently reported with unlisted CPT code 37799 (Unlisted procedure, vascular surgery). We have concerns about the frequency that the current services include treatment of an initial vein (CPT code 364X3) as compared to the treatment of initial and subsequent veins (CPT codes 364X3 and 364X4 together). It may be more accurate to describe these services through the use of a single code, as in the rest of this code family, instead of a base code and add-on code pair. Under this potential scenario, we looked at the RUC-recommended crosswalk and noted that the add-on CPT code 364X4 was estimated to be billed 50 percent of the time together with CPT code 364X3. We therefore considered adding half of the RUC-recommended work RVU of CPT code 364X4 (0.88) to the RUC-recommended work RVU of CPT code 364X3 (3.50), resulting in a work RVU of 4.38.
We are proposing to remove the 2 minutes of clinical labor for the “Setup scope” (CA015) activity and add the same 2 minutes of clinical labor for the “Prepare room, equipment and
We are proposing to remove the six individual 4x4 sterile gauze (SG055) supplies and replace them with a 4x4 sterile gauze pack of 10 (SG056) for CPT codes 36470, 36471, 364X3, 364X5, and 364X6. The pack of 10 sterile gauze is cheaper than six individual pieces of sterile gauze, and we do not agree that it would be typical to pay a higher cost for fewer supplies. We are also proposing to create three new supply codes in response to the invoices submitted for this family of codes. We are proposing to establish a price of $1495 for the Venaseal glue (SD323) supply, a price of $3195 for the Varithena foam (SD324) supply, and a price of $40 for the Varithena admin pack (SA125) supply.
We are proposing to adjust the equipment times for the surgical light (EF014), the power table (EF031), and the portable ultrasound unit (EQ250) for CPT codes 364X3, 364X5, and 364X6 consistent with the standards for non-highly technical equipment and to reflect the changes in the clinical labor described in this section of the proposed rule.
While we remain concerned about the creation of a base code and add-on code pairing (CPT codes 364X3 and 364X4) out of services that are currently reported using an unlisted code, for CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family and are seeking comment on whether our alternative values would be more appropriate.
CPT code 36516 was nominated as potentially misvalued in the CY 2016 PFS proposed rule. The CPT Editorial Panel deleted CPT code 36515 and made revisions to CPT code 36516 to include immunoabsorption. CPT codes 36511, 36512, 36513, 36514, and 36522 were added to CPT code 36516 to be reviewed together as part of the therapeutic apheresis family.
For CY 2018, we are proposing the RUC-recommended work RVU for all six codes in the family as follows: A work RVU of 2.00 for CPT code 36511, a work RVU of 2.00 for CPT 36512, a work RVU of 2.00 for CPT code 36513, a work RVU of 1.81 for CPT code 36514, a work RVU of 1.56 for CPT code 36516, and a work RVU of 1.75 for CPT code 36522.
We are proposing to use the RUC-recommended direct PE inputs for these codes without refinement. We considered refining the clinical labor time for the “Prepare room, equipment, supplies” activity from 20 minutes to 10 minutes for CPT codes 36514 and 36522, and from 30 minutes to 10 minutes for CPT code 36516. We also considered refining the clinical labor for the “Prepare and position patient/monitor patient/set up IV” activity from 15 minutes to 10 minutes for these same three codes. In both cases, we considered maintaining the current clinical labor time for CPT codes 36514 and 36516, and adjusting the clinical labor time for CPT code 36522 to match the other two codes in the family. We have concerns about the lack of a rationale provided for these changes in clinical labor time, and whether these clinical labor tasks would typically require this additional time.
We are proposing the RUC-recommended work RVUs and to use the RUC-recommended direct PE inputs for each code in this family and seeking comment on whether our alternative values would be more appropriate. We are also seeking comment on whether these procedures are creating a new point of venous access or utilizing a previously placed access.
CPT code 36556 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. CPT codes 36555, 36620, and 93503 were added for review as part of the code family. We are proposing the RUC-recommended work RVUs for each code in this family as follows: A work RVU of 1.93 for CPT code 36555, a work RVU of 1.75 for CPT code 36556, a work RVU of 1.00 for CPT code 36620, and a work RVU of 2.00 for CPT code 93503.
We are proposing to remove the clinical labor time for the “Monitor pt. following procedure” activity and the equipment time for the 3-channel ECG (EQ011) for CPT code 36555. CPT code 36555 no longer includes moderate sedation as part of the procedure (see CY 2017 PFS final rule (81 FR 80339). We are proposing to remove the direct PE inputs related to moderate sedation from CPT code 36555 as they would now be included in the separately reported moderate sedation services. We are also proposing to refine the equipment times for the exam table (EF023) and the exam light (EQ168) to reflect changes in the clinical labor time.
CPT code 36569 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. For CY 2018, we are proposing the RUC-recommended work RVU of 1.70 for CPT code 36569.
We are proposing to remove the equipment time for the exam table (EF023), as this equipment item is a component part of the radiographic-fluoroscopic room (EL014) included in CPT code 77001 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal). Because CPT code 36569 is typically billed together with CPT code 77001, we believe that the additional equipment time for the exam table would be duplicative.
CPT code 38221 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. The descriptors for CPT codes 38220 and 38221 were revised to reflect changes in practice patterns, and two new CPT codes (382X3 and 2093X) were created to more accurately describe new services that are now available. For CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family as follows: A work RVU of 1.20 for CPT code 38220, a work RVU of 1.28 for CPT code 38221, a work RVU of 1.44 for CPT code 382X3, and a work RVU of 1.16 for CPT code 2093X.
We also received a recommendation from the RUC to change the global period for CPT codes 38220, 38221, and 382X3 from XXX global periods to 0-day global periods, even though these codes were surveyed under the XXX global period. We agree with the recommendation that for these three particular codes, their services are more accurately described when assigned 0-day global periods as opposed to the XXX global status. Therefore, we propose to assign a 0-day global period
We are also proposing to refine the clinical labor for “Lab Tech activities” from 12 minutes to 9 minutes for CPT code 38220, from 7.5 minutes to 7 minutes for CPT code 38221, and from 12.5 minutes to 10 minutes for CPT code 382X3. We are maintaining the current time value for the two existing codes, as we have no reason to believe that the typical duration has increased for these lab activities. We are assigning 10 minutes for CPT code 382X3 based on the statement in the RUC-recommended materials for the direct PE inputs that this activity takes 0.5 minutes longer than it does in the current version of CPT code 38220. We are also proposing to remove the breakout lines for the lab activities. We believe that the breakout of activities into numerous subactivities generally tends to inflate the total time assigned to clinical labor activities and results in values that are not consistent with the analogous times for other PFS services.
We considered refining the clinical labor for “Provide preservice education/obtain consent” for CPT codes 38220, 38221, and 382X3 from 12 minutes to 6 minutes. We have concerns regarding whether 12 minutes would be typical for education and consent prior to these procedures, as much of the patient education takes place following the procedure, in the clinical labor activity described under the “Check dressings & wound/home care instructions” heading.
We are proposing the RUC-recommended work RVUs for each code in this family and are seeking comment on whether our alternative values would be more appropriate.
CPT codes 432X5, 432X6, and 432X7 were created by the CPT Editorial Panel to report esophagectomy via laparoscopic and thoracoscopic approaches. CPT codes 43107, 43112, and 43117 were also reviewed as part of the family with the three new codes. CPT code 43112 was revised to clarify the nature of the service being performed. We are proposing the RUC-recommended work RVUs and work times for all six codes in the family as follows: A work RVU of 52.05 for CPT code 43107, a work RVU of 62.00 for CPT code 43112, a work RVU of 57.50 for CPT code 43117, a work RVU of 55.00 for CPT code 432X5, a work RVU of 63.00 for CPT code 432X6, and a work RVU of 66.42 for CPT code 432X7.
We are also proposing the RUC-recommended work times for all six codes in this family. We considered removing 20 minutes from the preservice evaluation work time from all six of the codes in this family. We have concerns as to whether this additional evaluation time should be included for surgical procedures, due to the lack of evidence indicating that it takes longer to review outside imaging and lab reports for surgical services than for non-surgical services. We also considered refining the preservice positioning work time and the immediate postservice work time for all six of the codes in this family consistent with standard preservice and postservice work times allocated to other PFS services.
We have concerns about the presence of two separate surveys conducted for the three new codes. We note that CPT codes 432X5, 432X6, and 432X7 were surveyed initially in January 2016, and then were surveyed again in October 2016 together with CPT codes 43107, 43112, and 43117 due to concerns about the description of the typical patient in the original vignette and a change in the codes on the reference service list (RSL). We note that CPT codes 432X5 and 432X6 had the same median intraservice time on both surveys, while CPT code 432X7 had a median intraservice time that was an hour longer on its second survey (420 minutes) as compared to its first survey (360 minutes). We also note that the total survey time for CPT code 432X5 decreased from 1058 minutes in the first survey to 972 minutes in the second survey, while the median work RVU increased from 50.00 to 65.00. We do not understand how the survey median intraservice time could increase so significantly from the first survey to the second survey for CPT code 432X7, or how the surveyed times for CPT code 432X5 could be decreasing while the work RVU was simultaneously increasing by 15.00 work RVUs.
Based on our analysis, it appears that the accompanying RSL is the main difference between the two surveys; the codes on the initial RSL had a median work RVU of 44.18, while the codes on the second RSL had a median work RVU of 59.64. This increase of 15.00 work RVUs between the two RSLs that accompanied the surveys appears to account for the increase in the work RVUs for the three new codes. We are concerned that the second survey may have overestimated the work required to perform these procedures, as the 25th percentile work RVU of the second survey is higher than the median work RVU of the initial survey for all three codes, despite no change in the median intraservice work time for CPT codes 432X5 and 432X6.
Given these concerns, we considered a work RVU of 50.00 for CPT code 432X5, a work RVU of 60.00 for CPT code 432X6, and a work RVU of 61.00 for CPT code 432X7, by using the survey median work RVU from the first survey for the three new codes. For CPT codes 43107 and 43117, we considered employing the intraservice time ratio between the laparoscopic version of the procedure represented by the new code and the open version of the same procedure represented by the existing code.
We considered a work RVU of 45.00 for CPT code 43107 based on the intraservice time ratio with CPT code 432X5 and a work RVU of 55.00 for CPT code 43117 based on the intraservice time ratio with CPT code 432X6. CPT code 43107 has 270 minutes of intraservice time as compared with 300 minutes of intraservice time for CPT code 432X5, which produces a ratio of 0.9, and when multiplied by a work RVU of 50.00 (CPT code 432X5), results in the proposed work RVU of 45.00. We considered using the same methodology for CPT codes 43117 and 432X6.
Finally, we considered a work RVU of 58.94 for CPT code 43112 based on a direct crosswalk to CPT code 46744 (Repair of cloacal anomaly by anorectovaginoplasty and urethroplasty, sacroperineal approach). We note that the intraservice time ratio when applied to CPT codes 43112 and 432X7, the paired McKeown esophagectomy procedures, would have produced a potential work RVU of 52.29, creating a rank order anomaly within the family by establishing a higher work RVU for CPT code 43117 than CPT code 43112, and are concerned with whether this is an appropriate valuation for the code. We are seeking comment on whether the alternative work RVUs that we considered may reflect the relative difference in work more accurately between the six codes in the family. We note, for example, that these valuations correct the rank order anomaly between CPT codes 43112 and 43121 as noted in the RUC recommendations.
We are proposing the RUC-recommended direct PE inputs for all six codes in the family without refinement. We considered changing the preservice clinical labor type for all six codes from an RN (L051) to an RN/LPN/MTA blend (L037D). We have concerns about whether the use of RN clinical labor would be typical for filling out referral forms or for scheduling space and equipment in the facility. We also considered removing the additional clinical labor time for the “Additional coordination between multiple specialties for complex procedures (eg, tests, meds, scheduling)” activity, consistent with preservice standards for codes with 90-day global periods. We are concerned that this time would not typically be included in non-surgical procedures performed by other specialties even when additional coordination is required.
We are seeking comment regarding the changes in the valuation between the two surveys, the preservice and immediate postservice work times, and the RN staffing type employed for routine preservice clinical labor.
CPT code 52601 appeared on a screen of potentially misvalued codes which indicated that it was performed less than 50 percent of the time in the inpatient setting, yet included inpatient hospital E/M services within the global period. For CY 2018, we are proposing the RUC-recommended work RVU of 13.16 for CPT code 52601 and proposing to use the RUC-recommended direct PE inputs without refinements.
We considered a work RVU of 12.29 for CPT code 52601 based on a direct crosswalk to CPT code 58541 (Laparoscopy, surgical, supracervical hysterectomy, for uterus 250 g or less), which is one of the reference codes. CPT code 58541 may potentially be a more accurate crosswalk for CPT code 52601 than the RUC-recommended direct crosswalk to CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis). Although all three of these codes share the same intraservice time of 75 minutes, CPT code 58541 is a closer match in terms of the total time at only 10 minutes difference. CPT code 58541 also shares the same postoperative office visits as CPT code 52601, a pair of CPT code 99213 office visits, while CPT code 29828 also contains two CPT code 99212 office visits that are not present in the reviewed code.
We note that if we were to use a reverse building block methodology for CPT code 52601 and subtract out the value of the E/M visits being removed, the proposed work RVU would be 11.21. We are not proposing this work RVU, however, because as we noted in the CY 2017 PFS final rule (81 FR 80274), we agree that the per-minute intensity of work is not necessarily static over time or even necessarily during the course of a procedure. Instead, we utilize time ratios and building block methodologies to identify potential values that account for changes in time and compare these values to other PFS services for estimates of overall work. When the values we develop reflect a similar derived intensity, we agree that our values are the result of our assessment that the relative intensity of a given service has remained similar. For CPT code 52601, we are concerned as to how the RUC-recommended derived intensity of the procedure could be increasing by 30 percent over the current derived intensity, while at the same time the typical site of service is changing from inpatient to outpatient status. In other words, if it is now typical for CPT code 52601 to be performed on an outpatient basis, then we would generally expect the intensity of the procedure to be decreasing, not increasing. We considered a work RVU of 12.29 for CPT code 52601 based on a direct crosswalk to CPT code 58541 (Lsh uterus 250 g or less), and seek comment on whether this alternative value might better reflect relativity.
In October 2016, the CPT Editorial Panel deleted CPT Category III code 0438T and created a new CPT code 55X87 (Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed). For CY 2018, we are proposing the RUC-recommended work RVU of 3.03 for CPT code 55X87.
In reviewing the RUC recommendations, we noted a decrease in preservice time (30 minutes) compared to the current value. In order to account for this change in time, we considered calculating the intraservice time ratio between the key reference code (CPT code 49411), which has an intraservice time of 40 minutes, and the RUC-recommended intraservice time (30 minutes) and multiplying that against the work RVU for CPT code 49411 (3.57), which would have resulted in a work RVU of 2.68. A work RVU of 2.68 would have been further supported by a bracket of two crosswalk codes, CPT code 65779 (Placement of amniotic membrane on the ocular surface; single layer, sutured) which has a work RVU of 2.50 and CPT code 43252 (Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy), which has a work RVU of 2.96. Compared with CPT code 55X87, these codes have identical intraservice and similar total times. We are seeking comment on whether these alternative values should be considered, especially given the changes in time reflected in the survey data.
We received invoices with pricing information regarding two new supply items: “endocavity balloon” and “biodegradeable material kit—periprostatic”. The invoice for endocavity balloon was $399.00 and the input price on the PE spreadsheet for this supply item was noted as such. We believe the input price noted on the PE spreadsheet was an error, given that the invoice noted that the price of $399.00 was for a box of ten and the specialty society requested a single unit of this supply item. Therefore, we are proposing to use this information to propose for supply item “endocavity balloon” a price of $39.90. The invoice
In October 2015, CPT code 57240 was identified by analysis of the Medicare data from 2011-2013 that indicated that services reported with CPT code 57240 were performed less than 50 percent of the time in the inpatient setting, yet include inpatient hospital E/M services within the global period. The RUC recommended that CPT codes 57240 (Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele), 57250 (Posterior colporrhaphy, repair of rectocele with or without perineorrhaphy), 57260 (Combined anteroposterior colporrhaphy), and 57265 (Combined anteroposterior colporrhaphy; with enterocele repair) be referred to the CPT Editorial Panel. In September 2016, the CPT Editorial Panel revised 57240, 57260 and 57265 to preclude separate reporting of follow up cystourethroscopy after colporrhaphy (CPT code 52000).
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT code 57240 (a work RVU of 10.08), CPT code 57250 (a work RVU of 10.08), CPT code 57260 (a work RVU of 13.25), and CPT code 57265 (a work RVU of 15.00).
We note that there were changes in service times reflected in the specialty surveys compared to the RUC-recommended work RVUs for CPT code 57240. Specifically, we note that the RUC recommended a 48 minute decrease in total time, compared to the specialty survey total time of 259 minutes. The difference in total time reflected a decrease in preservice time (29 minutes) and inpatient visits (0.5 visits = 19 minutes). We considered a work RVU of 9.77 for CPT code 57240, crosswalking to CPT code 50590 (Lithotripsy, extracorporeal shock wave), which has similar service times. We are seeking comment on whether CPT code 57250 would be a relevant comparator for CPT code 57240, based on the described elements of each service and existing or surveyed service times, compared to CPT code 57240.
We considered a work RVU of 11.47 for CPT code 57265, crosswalking to CPT code 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography) with similar service times. We seek comment on how an alternative work RVU of 11.47 for CPT code 57265 would affect relativity among PFS services, and on whether CPT code 57260 is a relevant comparator for CPT code 57265, considering differences in the described procedures and service times.
We are proposing the RUC-recommended direct PE inputs for CPT codes 57240, 57250, 57260 and 57265 without refinements.
The CPT Editorial Panel created two new CPT Category I codes (64X91 and 64X92) to report the repair of a nerve using a nerve allograft. CPT codes 64910 and 64911 were also reviewed as part of this code family. CPT codes 64X91 and 64X92 will be placed on the new technology list to be re-reviewed by the RUC in 3 years to ensure correct valuation and utilization assumptions.
For CY 2018, we are proposing the RUC-recommended work RVUs for the following codes: A work RVU of 10.52 for CPT code 64910, a work RVU of 14.00 for CPT code 64911, a work RVU of 12.00 for CPT code 64X91, and a work RVU of 3.00 for CPT code 64X92.
We noted a decrease in preservice time (7 minutes) for CPT code 64910 and considered an alternate work RVU of 10.15, crosswalking to CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100 sq cm or less, or 1 percent of body area of infants and children (except 15050)), which has similar service times. We seek comments on whether an alternative work RVU of 10.15 for CPT code 64910 would better reflect relativity among PFS services with similar service times.
For CPT code 64911 (Nerve repair; with autogenous vein graft (includes harvest of vein graft), each nerve)), we considered a work RVU of 13.50, crosswalking to CPT code 31591 (Laryngoplasty, medicalization, unilateral), which has similar service times. We seek comments on whether a work RVU of 13.50 for CPT code 64911 would better reflect relativity among other PFS services with similar service times.
The new coding structure for these services increases granularity by including add-on codes that describe each strand of nerve repair. While we recognize that additional granularity may be important and useful for purposes of data collection, the advantages to Medicare for such granularity for purposes of payment are unclear, especially since we are unaware of a payment-related reason for such coding complexity. We considered proposing a bundled status to the new add-on codes and incorporating the relative resources in furnishing the add-on code (CPT code 64X92) into the base code (CPT code 64X91) based on the utilization assumptions that accompanied the RUC recommendations. The RUC estimated that CPT code 64X91 would have 750 Medicare allowed services in CY 2018, and that the corresponding add-on CPT code 64X92 would have 150 Medicare allowed services in CY 2018. Therefore, the RUC estimates that CPT code 64X91 will be billed without add-on CPT code 64X92 for 80 percent (750/900) of the Medicare allowed services, and that CPT code 64X91 will be billed with add-on CPT code time 64X92 for 20 percent (150/900) of the Medicare allowed services in CY 2018. To account for the additional work involved in 20 percent of the allowed services, we added a work RVU of 0.60 (20 percent of a work RVU of 3.00 for CPT code 64X92) to the work RVU of 12.00 for CPT code 64X91, to get to an alternate work RVU of 12.60 for CPT code 64X91 and increased the intraservice time by 6 minutes to account for the bundling of services from CPT code 64X92. The alternative work RVU of 12.60 would have been further supported by a crosswalk to CPT code 14301 (Adjacent tissue transfer or rearrangement, any area; defect 30.1 sq cm to 60.0 sq cm), which has similar intraservice and total times.
We are proposing the RUC-recommended direct PE inputs for CPT codes 64910, 64911, 64X91 and 64X92 without refinements.
CPT codes 70490 and 70492 were identified through the high expenditure services across specialties with Medicare allowed charges of $10 million or more screen. CPT code 70491 was also included for review as part of this code family. For CY 2018, we are proposing the RUC-recommended work RVUs of 1.28 for CPT code 70490, 1.38
For CPT code 70490, we considered a work RVU of 1.07 based on a crosswalk to CPT code 72125 (Computed tomography, cervical spine; without contrast material). CPT code 72125 is a non-contrast CT service on a similar anatomical area and has identical intraservice and total times to those recommended by the RUC for CPT code 70490. We also considered work RVUs of 1.17 for CPT code 70491 and 1.41 for CPT code 70492. We are seeking comment on how relativity among other CT services paid under the PFS would be affected by applying the alternative work RVUs described above for CPT codes in this family.
CPT code 70544 was identified by a screen of services across specialties with Medicare allowed charges of $10 million or more. Subsequently, CPT codes 70545 and 70546 were also reviewed as part of this code family. We are proposing the RUC-recommended work RVUs of 1.20 for CPT code 70544, 1.20 for CPT code 70545, and 1.48 for CPT code 70546.
We are also proposing the following refinements to the RUC-recommended direct PE inputs. For the service period clinical labor activity “Provide preservice education/obtain consent,” we are proposing 5 minutes for CPT code 70544, 7 minutes for CPT code 70545, and 7 minutes for CPT code 70546 so that the times for this activity are consistent with other magnetic resonance (MR) services performed without-contrast materials, with-contrast materials, and without-and-with contrast materials, respectively. For the clinical labor task “Acquire images,” we are proposing to use the RUC-recommended clinical time of 26 minutes for CPT code 70544. We considered proposing 20 minutes of clinical time to maintain the relativity among the three codes in this family and for consistency with other MRA and magnetic resonance imaging (MRI) codes, which do not typically assign more clinical labor time to this task for services without contrast material than for services with contrast material. We seek comments as to the appropriate time value for this clinical labor task.
CPT code 70549 was identified through a high expenditure screen. CPT codes 70547 and 70748 were also reviewed as part of this family of codes. We are proposing the RUC-recommended work RVUs of 1.20 for CPT code 70547, 1.50 for CPT code 70548, and 1.80 for CPT code 70549.
We are also proposing several refinements to the RUC-recommended direct PE inputs for these services. For the service period clinical labor activity “Provide preservice education/obtain consent”, we are proposing 5 minutes for CPT code 70547, 7 minutes for CPT code 70548, and 7 minutes for CPT code 70549 so that the times for this activity are consistent with other MR services performed without contrast material, with contrast material, and without-and-with contrast material, respectively.
For the intraservice clinical labor task acquire images, for CPT code 70547, we are proposing to use the RUC-recommended 26 minutes. We considered applying 20 minutes to this clinical labor task, which would have maintained consistency with the 20 minutes recommended by the RUC for CPT code 70548 (the service that includes with-contrast material). We are concerned about the lack of evidence that a non-contrast MRA would require more clinical labor time than the with-contrast MRA service. We are seeking comment as to the appropriate time value for this clinical labor task.
CMS identified this code family through the high expenditures screen. We are proposing the RUC-recommended work RVUs of 1.16 for CPT code 71250, 1.24 for CPT code 71260, and 1.38 for CPT code 71270.
For CPT code 71250, we considered maintaining the CY 2017 work RVU of 1.02. We are concerned with the lack of evidence that the physician time or intensity of furnishing this service has changed since it was last valued. In addition, a comparison to other CT codes indicates that the RUC-recommended work values could be overvalued relative to other CT services and compared to similar, non-contrast CT studies such as CPT codes 72131 (Computed tomography, lumbar spine; without contrast material) and 73700 (Computed tomography, lower extremity; without contrast material), both of which have work RVUs of 1.00.
For CPT code 71260, we considered proposing a work RVU of 1.10 by applying the RUC-recommended increment between CPT code 71250 and 71260 (0.08) to CPT code 71260. For CPT code 71270, we considered a work RVU of 1.24 by applying the RUC-recommended increment between CPT codes 71260 and 71270 (0.22) to CPT code 71270. In addition to maintaining relatively among the codes in this family, we considered further supporting these alternative values based on a comparison to other CT studies, such as with-contrast material CT studies, and without-and-with contrast CT studies.
While we have concerns about the RUC-recommended work RVUs for these codes, for CY 2018, we are proposing the RUC recommended work RVUs for CPT code 71250, 71260, and 71270 and are seeking comment on whether our alternative values would improve relativity.
CPT codes 74182 and 72196 were identified as part of the screen of high expenditure services across specialties with Medicare allowed charges of $10 million or more. CPT codes 74181, 74183, 72195, and 72197 were also reviewed as part of this code family. We are proposing the RUC-recommended work RVUs of 1.46 for CPT code 72195, 1.73 for CPT code 72196, 2.20 for CPT code 72197, 1.46 for CPT code 74181, 1.73 for CPT code 74182, and 2.20 for CPT code 74183.
While we are proposing the RUC-recommended direct PE inputs, we considered 30 minutes for clinical labor task “Acquire images” for CPT codes 74181 and 74182, which appears to be more consistent with the codes in this family and more consistent with other MR codes. We also note that for CPT codes 74181 and 74182, the clinical labor time for acquired images appears to have been developed through a consensus panel from the specialty society over 15 years ago. Given that these times are estimates based on expert panel consensus rather than survey data, we seek comments on whether using a structure that matches other MR code families would be more appropriate to value these clinical labor times.
CPT codes 73718 and 73720 were identified as part of the screen of high expenditure services, and CPT code 73719 was included for review as part of the code family. We are proposing the RUC-recommended work RVUs of 1.35 for CPT code 73718, 1.62 for CPT code 73719, and 2.15 for CPT code 73720.
We are also proposing the following refinements to the RUC-recommended direct PE inputs. For the service period clinical labor activity “Provide preservice education/obtain consent,”
CPT codes 74000 (Radiologic examination, abdomen; single anteroposterior view) and 74022 (Radiologic examination, abdomen; complete acute abdomen series, including supine, erect, and/or decubitus views, single view chest) were identified via a high expenditure screen. The CPT Editorial Panel created CPT codes 740X1, 740X2, and 740X3 to replace CPT codes 74000, 74010, and 74020. For CY 2018, we are proposing the RUC-recommended work values for these codes.
As part of their recommendations, the RUC's utilization crosswalk suggests that 25 percent of services currently reported with CPT code 74010 will be reported with CPT code 740X2 and 75 percent will be reported with CPT code 740X3; and 75 percent of services currently reported with CPT code 74020 will be reported with CPT code 740X2 and 25 percent will be reported with CPT code 740X3. However, we did not identify evidence or a rationale for these assumptions. For purposes of calculating the proposed RVUs, we used an even distribution of services previously reported as CPT codes 74010 and 74020 to CPT codes 740X2 and 740X3 instead of the RUC-recommended distribution because we think that the services previously reported with codes 74010 and 74020 will be reported in equal volume between the code representing two views and the code representing three views. We seek comment on information that would help us improve on this distribution for purposes of developing final RVUs, including rationale for the distribution reflected in the RUC's utilization crosswalk.
This code family was identified through the $10 million or more screen of high expenditure services. We are proposing the RUC-recommended work RVUs of 1.75 for CPT code 75710 and 1.97 for CPT code 75716. We are also proposing to use the RUC-recommended direct PE inputs for both CPT codes 75710 and 75716, with the following refinements. For the clinical labor task “Technologist QC's images in PACS, checking for all images, reformats, and dose page,” we are proposing refinements consistent with the standard clinical labor times for tasks associated with the PACS Workstation.
We are also proposing to refine the clinical labor by removing the 2 minutes associated with the task “prepare room, equipment, and supplies.” CPT codes 75710 and 75716, which represent radiological supervision and interpretation, are billed with codes that include activities such as needle placement and imaging, and the “prepare room, equipment, supplies,” activity will be accounted for with the codes that are billed with these interpretation codes.
In the CY 2016 PFS final rule with comment period, CMS identified CPT codes 76519 and 92136 as potentially misvalued on the high expenditure screen. For CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family as follows: A work RVU of 0.40 for CPT code 76516, a work RVU of 0.54 for CPT code 76519, and a work RVU of 0.54 for CPT code 92136.
For both CPT codes 76519 and 92136, the RUC recommended adding an additional 8 minutes of immediate postservice time for dictating the report of the procedure for the medical record, review and sign report, communicate results to the patient, discussing lens implant options for desired post-operative refractive result, and entering an order for the intraocular lens implant. We considered time and work values that would not include the additional 8 minutes of immediate postservice time in either of these codes, due to the concern that the additional time may not reflect the typical case. Were we to not include those 8 minutes, each of these procedures would have a total time of 14 minutes. We considered applying the total time ratio (decrease from 17 minutes to 14 minutes; ratio of 0.824) to the RUC-recommended work RVU of 0.54, which would have resulted in a work RVU of 0.44 for both CPT codes 76519 and 92136. We are seeking comment on whether these alternative values would improve relativity.
The RUC identified CPT codes 76881 and 76882 for review of PE inputs. For CPT code 76881, we are proposing the recommended inputs with refinements. We are proposing to remove 1 minute from the clinical labor task “Exam documents scanned into PACS. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue,” because this code does not include any equipment time for the PACS workstation proxy or professional PACS workstation. We note that the RUC-recommended inputs shift the general ultrasound room from the PE inputs for CPT code 76881 to the PE inputs for CPT code 76882. We are proposing to make this change, consistent with the RUC recommendations. We are also seeking comment on whether a portable ultrasound unit would be a more accurate PE input for both codes, given that the dominant specialty for both of these services is podiatry based on available 2016 Medicare claims data. However, we are proposing that these codes would not be subject to the phase-in of significant RVU reductions given the significance of this shift of resource costs between codes in the same family. In the CY 2016 PFS final rule (80 FR 70927 through 70931), we finalized a policy to identify services that are not subject to the phase-in because they are new or revised codes. We excluded as new and revised codes those codes that describe a different set of services in the update year when compared to the current year by virtue of changes in other related codes or codes that are part of a family with significant coding revisions. Significant coding revisions within a family of codes can change the relationships among codes to the extent that it changes the way that all services in the group are reported, even if some individual codes retain the same number or, in some cases, the same descriptor. Moving the general ultrasound room input from CPT code 76881 to CPT code 76882 as recommended by the RUC would represent a significant shift in direct PE due to the high cost nature of this equipment item. As a result, these codes describe different services in the update year than in the current year, producing a substantial revision in the valuation of the coding. We are seeking comment on this proposed application of the phase-in policy.
CPT code 77263 was identified through a screen of high expenditure services across specialties. CPT codes 77261 and 77262 were included for review. For CY 2018, we are proposing the RUC-recommended work RVUs of
However, we have concerns regarding the RUC-recommended work RVUs given the decreases in service times as recommended by the RUC and reflected in the survey data compared to the current values. For CPT code 77263, we considered a work RVU of 2.60 based on a crosswalk to CPT code 96111 (Developmental testing, (includes assessment of motor, language, social, adaptive, and/or cognitive functioning by standardized developmental instruments) with interpretation and report), which has an identical intraservice time, and similar total time to the RUC-recommended time values for CPT code 77263. We are concerned that despite a 15 minute decrease in intraservice time, the RUC did not recommend a work RVU decrease.
We note that the majority of the utilization among the codes in this family would be reported with CPT code 77263. Therefore, we considered using a work RVU of 2.60 for CPT code 77263 as a base for alternative valuations for CPT codes 77261 and 77262 by applying the ratio of the crosswalk work RVU of CPT code 96111 (Developmental test extend) to the RUC-recommended work RVU of CPT code 77263 (that is, 2.60/3.14 = 0.83) to the RUC-recommended work RVU for CPT code 77261 (that is, 0.83 × 1.30 = 1.08) and CPT code 77262 (that is, 0.83 × 2.0 = 1.66), which would have resulted in work RVUs of 1.08 for CPT code 77261 and 1.66 for CPT code 77262. We seek comments on whether the alternative valuation would be more appropriate for these codes.
CPT codes 88333 and 88334 were surveyed for both work and PE for the CY 2018 rule cycle. We are proposing the RUC-recommended work RVU of 1.20 for CPT code 88333 and the RUC-recommended work RVU of 0.73 for CPT code 88334. For the direct PE inputs, we are proposing to remove the clinical labor for the “Prepare room. Filter and replenish stains and supplies (including setting up grossing station with colored stains)” activity from CPT code 88333. This clinical labor is not currently included in the direct PE inputs for CPT code 88333, and we continue to believe that this is a form of indirect PE that is not individually allocable to a particular patient for a particular service. While we agree that replenishing stains and supplies is a necessary task, under the established methodology, it is more appropriately classified as indirect PE.
We are proposing to refine the clinical labor time for “Clean room/equipment following procedure” activity for CPT code 88333, consistent with the standard clinical labor time assigned for room cleaning when used by laboratory services. We seek comments related to the equipment time assigned to the “grossing station w-heavy duty disposal” (EP015) for both CPT codes 88333 and 88334. Although the recommended equipment time of 10 minutes maintains the current equipment time assigned to the grossing station, and we have no reason to believe that this time is incorrect, it is unclear to us how this equipment time is derived.
CPT codes 88360 and 88361 appeared on a high expenditure services screen across specialties with Medicare allowed charges of over $10 million. We are proposing the RUC-recommended work RVU of 0.85 for CPT code 88360 and the RUC-recommended work RVU of 0.95 for CPT code 88361. We are proposing to refine the clinical labor time for the “Enter patient data, computational prep for antibody testing, generate and apply bar codes to slides, and enter data for automated slide stainer” activity for both codes, consistent with the standard time for this clinical labor activity across different pathology services. For CPT code 88361, we are also proposing to remove the 1 minute of clinical labor time from the “Performing instrument calibration, instrument qc and start up and shutdown” and the “Gate areas to be counted by the machine” activities. These clinical labor activities do not appear in other recently reviewed computer-assisted pathology codes. We believe that these clinical labor activities would not be typical for CPT code 88361 and are already included in the allocation of indirect PE consistent with our established methodology.
We are proposing to remove the clinical labor time for “Clean room/equipment following procedure” for CPT codes 88360 and 88361, as we believe that this clinical labor is duplicative of the 4 minutes of clinical labor assigned to “Clean equipment and work station in histology lab”. We are also proposing to remove the clinical labor time for the “Verify results and complete work load recording logs” and the “Recycle xylene from tissue processor and stainer” activities for CPT codes 88360 and 88361. As we have stated in previous rules, such as in the CY 2017 PFS final rule (81 FR 80319), we believe these clinical labor activities to be already included in the allocation of indirect PE consistent with our established methodology.
We are proposing to refine the equipment time for the “Benchmark ULTRA auto slide prep & E-Bar Label system” (EP112) from 18 minutes to 16 minutes for both codes. The RUC-recommended equipment time of 18 minutes was an increase of 3 minutes from the current EP112 equipment time to incorporate the equipment time of the “E-Bar II Barcode Slide Label System” (EP113), which the recommended materials have clarified is part of the EP112 equipment item. We are proposing to add 1 minute over the current value of 15 minutes to the EP112 equipment time to reach the aforementioned 16 minutes, as we believe that this would be more typical for the slide labeling taking place.
For CPT code 88361, we are proposing to maintain the current price of $195,000.00 for the DNA image analyzer (EP001) equipment, as the submitted invoice contains a series of unrelated items that have been crossed out, making it difficult to determine the cost of the equipment. We considered refining the equipment time for the DNA image analyzer from 30 minutes to 5 minutes. The equipment literature for the DNA image analyzer states that the machine can run 50 slides per hour, and CPT code 88361 only requires 3 slides per procedure. This works out to 3.6 minutes of equipment usage (3 slides divided by 50 slides per hour multiplied by 60 minutes in an hour), to which we considered adding 1 minute for preparing the slides. The resulting figure of 4.6 minutes would then round up to 5 minutes, which we considered as the potential equipment time for EP001 assigned to CPT code 88361. We seek comments on additional pricing information for the EP001 DNA image analyzer equipment, specifically invoices solely for this equipment containing a rationale for each component part, as well as the appropriate equipment time typically required for use in CPT code 88361.
As part of the CY 2016 PFS final rule (80 FR 70914), several services in this family (reported with CPT codes 93288, 93293, 93294, 93295, and 93296) were identified as potentially misvalued through the high expenditure by
For CPT code 93293, we considered a work RVU of 0.91 (25th percentile survey result) and seek comment on whether this alternative work RVU for this service would better maintain relativity between single and dual lead pacemaker systems and cardioverter defibrillator services. We considered reducing the work RVU for CPT code 93282 by 0.11 work RVUs and seek comments on whether this alternative value would better reflect relativity between the single and dual lead systems that exist within pacemaker services and within cardioverter defibrillator services. We also noted that there is a difference of 0.10 work RVUs between the RUC-recommended values for CPT codes 93289 and 93282. Therefore, we considered a proportionate reduction for CPT code 93289 to a work RVU of 0.69. For CPT code 93283, we considered a work RVU of 0.91, consistent with the 25th percentile from the survey results, and seek comment on whether this value would improve relativity.
As noted in this section of the proposed rule, several of the CPT codes (99392, 99294, 99295, 99297, and 99298) reviewed by the RUC in January 2017 involve remote monitoring services for cardiac devices. We agree with the RUC that these services are difficult to value considering that the monitoring duration (number of days between 30 and 90) and the average number of transmissions vary. We also note that these codes were surveyed twice, and in both cases the intraservice and total times were considered by the specialty societies to be inconsistent with existing times. The RUC explained that they extrapolated total and intraservice time data for these codes and warned against making comparisons. Without additional information about the methods and sources used for extrapolation, however, we have no basis for assuming the imputed values are of higher quality and/or accuracy than those from the survey. We do not agree, therefore, that survey results should not be used as a point of comparison in the context of other factors, particularly when they are used to support other considerations.
Although we are proposing the RUC-recommended work RVUs for each of these CPT codes, we considered alternative values. The RUC recommended a work RVU of 0.31 for CPT code 93293, which is 0.01 work RVUs lower than the existing work RVU for this code. We have concerns that the amount of the reduction in the work RVU recommended by the RUC may not be consistent with the decrease in total time of 7 minutes. We considered an alternative crosswalk for CPT code 93293 (Pm phone r-strip device eval) (5 minutes intraservice time and 13 minutes total time) to CPT code 94726 (Pulm funct tst plethysmograp), which has 5 minutes intraservice time and 15 minutes total time and a work RVU of 0.26. We seek comments our proposed and alternative valuations for this code.
For CPT code 93294, we considered a work RVU of 0.55, crosswalking from CPT code 76706 (Us abdl aorta screen aaa), and we seek comments on whether it would better align with the RUC-recommended service times. We are concerned that a work RVU of 0.60 may not account for the difference between existing service times and the RUC-recommended service times. Similarly, the RUC recommended a work RVU for CPT code 93294 of 0.60, which is 0.05 work RVUs less than the existing work RVU. The total time for furnishing services reported with CPT code 93294 decreased by 10 minutes, however, and we believe this reduction in time may not be appropriately reflected by a decrease of 0.05 work RVUs. Compared to services with similar total and intraservice times, we identified CPT code 76706 (Us abdl aorta screen aaa) as potentially a more appropriate crosswalk. CPT code 76706 has identical intraservice and total service times as CPT code 93294, with a work RVU of 0.55. We seek comments on whether our alternative value would better reflect the time and intensity involved in furnishing this service.
For CPT code 93295, we considered a work RVU of 0.69, crosswalking to CPT code 76586, which has identical intraservice and total times compared to CPT code 93295. We considered using a work RVU of 0.69 to maintain the differential between CPT code 93295 and the work RVU we considered for the previous code in this family (a work RVU of 0.11 for CPT code 93295). We are concerned about the decrease in service time compared to the work RVU. We note that the existing intraservice time is 22.5 minutes, compared to the RUC-recommended intraservice time of 10 minutes. We seek comments on whether our alternative value would better reflect the time and intensity involved in furnishing this service.
For CPT code 93298, the RUC recommended a work RVU of 0.52, which is unchanged from the current work RVU for this code. We are concerned about that recommendation given the reduction in both intraservice and total time for this service. The intraservice time decreased from 24 to 7 minutes, while total time decreased from 44 to 17 minutes. We acknowledge that the current times for this CPT code and others in this family are extrapolations. However, without additional information about the extrapolation of data from survey results, we question whether the survey results should be excluded from consideration altogether. We considered a work RVU of 0.37 for CPT code 93297, crosswalking to CPT code 96446 (Chemotx admn prtl cavity). We also considered a work RVU of 0.37 for CPT code 93298 based on a crosswalk to CPT code 96446, since the RUC indicated that the work RVUs for CPT codes 93297 and 93298 should be the same. We are seeking comment on our proposed valuation and whether our alternative valuation would be more appropriate for this code.
We propose the RUC-recommended direct PE inputs with the following refinements. We propose to remove 2 minutes for “review charts” from CPT codes 93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 93288, 93289, 93290, 93291, and 93292 to maintain relativity since it is not typically incorporated for similar PFS codes. We also propose removing 2 minutes for “complete diagnostic forms, lab & X-ray requisitions” for the labor category “med tech/asst” (L026A) for these services because we believe the same activity is being performed by labor category RN/LPN/MTA (L037D). We seek comments regarding whether this row was included in error. Also for the same group of CPT codes, we also propose standard refinements for the time for equipment items EF023 and EQ198.
We propose to use the RUC-recommended direct practice expense inputs and times for all other CPT codes in this family (CPT codes 93293, 93294,
In the CY 2016 PFS final rule with comment period (80 FR 70914), CMS identified CPT code 93306 through the high expenditures screen. Subsequently, the RUC reviewed CPT codes 93307 and 93308, in addition to CPT code 93306 as part of this family of codes that describe transthoracic echocardiograms. For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 99306 (a work RVU of 1.50), 99307 (a work RVU of 0.92), and 99308 (a work RVU of 0.53), and proposing the RUC-recommended direct PE inputs for CPT codes 93306, 93307, and 93308 without refinement.
For CPT code 93306 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography, and with color flow Doppler echocardiography), we considered maintaining the CY 2017 work RVU of 1.30. The surveyed total time for this code dropped slightly due to changes in the immediate postservice time. The median preservice and intraservice time remained unchanged.
For CPT code 93307 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, without spectral or color Doppler echocardiography), we considered a work RVU of 0.80, crosswalking to services with similar service times (CPT codes 93880 (Extracranial bilat study), 93925 (Lower extremity study), 93939, 93976 (Vascular study), and 93978 (Vascular study)). The surveyed total time dropped 3 minutes (from the intraservice time) compared to the existing service times for this code.
For CPT code 93308 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, follow-up or limited study), we considered a work RVU of 0.43, crosswalking to CPT code 93292 (Wcd device interrogate) based on similar service times. The surveyed total time dropped by 5 minutes (from the intraservice time) compared to the existing service times for this code.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 93306, 93307, and 93308 and seek comments on whether our alternative values would better reflect the time and intensity of these services.
CPT code 93351 was identified as potentially misvalued and the RUC reviewed CPT code 93350 as part of the same code family. For CY 2018, we are proposing the RUC-recommended work RVUs for CPT codes 93350 (a work RVU of 1.46) and 93351 (a work RVU of 1.75).
We are proposing the following refinements to the RUC-recommended direct PE inputs for CPT codes 93350 and 93351. For both codes, we applied the standard formula in developing the minutes for equipment item ED053 (professional PACS workstation), which results in 18 minutes for CPT code 93350 and 25 minutes for CPT code 93351. We are also proposing standard clinical labor times for providing preservice education/obtaining consent. We are not proposing to include clinical labor time for the task setup scope since there is no scope used in the procedure and we do not agree with the RUC's statement that this replicates 5 minutes in CPT code 93015 when the RN prepares patients for 10-lead ECG. We have found that there is no corresponding time of 5 minutes for setup scope in the PE inputs for CPT code 93015. We are proposing refinements to the equipment time for ED050 (PACS workstation proxy) for CPT code 93351, consistent with our standard equipment times for PACS Workstation Proxy.
We have issued a national coverage determination (NCD) for Medicare coverage of supervised exercise therapy (SET) for the treatment of peripheral artery disease (PAD). Information regarding the NCD can be found on the CMS Web site at
For CY 2018, we are proposing to make payment for Medicare-covered SET for the treatment of PAD, consistent with the NCD, reported with CPT code 93668. For CPT code 93668, we are proposing to use the most recent RUC-recommended work and direct PE inputs. We are also seeking comment on the coding structure and valuation assumptions. Since the RUC has not reviewed CPT code 93668 since 2001, we seek comments on the direct PE inputs assigned to the code, which appear in the direct PE input database. We also note that CPT code 93668 is a PE only code and does not include physician work.
CPT prefatory language states that CPT code 93668 may be separately reported with appropriate E/M services, including office and/or outpatient services (CPT codes 99201 through 99215), initial hospital care (CPT codes 99221 through 99223), subsequent hospital care (CPT codes 99231 through 99233), and critical care services (CPT codes 99291 through 99292). Our understanding of CPT's prefatory language is that these E/M codes may only be billed when review or exam of the patient is medically indicated and must conform to all existing E/M documentation requirements. E/M visit codes should not be billed to account for supervision of SET for the treatment of PAD by a physician or other qualified healthcare practitioner. We seek comments on whether to develop professional coding to reflect the supervision of clinical staff, and on the potential overlap with CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient, that may not require the presence of a physician or other qualified health care professional. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services.) and any distinctions between time spent by clinical staff for CPT code 99211 and time spent by clinical staff for CPT code 93668.
CPT code 94620 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. CPT code 94621 was added to the family for review. The CPT Editorial Panel deleted CPT code 94620 and split it into two new codes, CPT codes 946X2 and 946X3, to describe two different tests commonly performed for evaluation of dyspnea. We are proposing the RUC-recommended work RVUs of 1.42 for CPT code 94621, 0.70 for CPT code 946X2, and 0.48 for CPT code 946X3.
We are proposing to refine the clinical labor time for the “Provide preservice education/obtain consent” activity from 10 minutes to 5 minutes for CPT code 94621, which is the current time assigned for this task. While we agree that CPT code 94621 requires additional time above the standard for this clinical
We are proposing to refine the clinical labor time for the “Complete diagnostic forms, lab & X-ray requisitions” activity, consistent with the standard clinical labor time for this activity. We also propose to refine the equipment times for CPT codes 94621 and 946X2 to account for 1:4 patient monitoring time, and to refine the equipment times for CPT code 946X3 consistent with standards for non-highly technical equipment.
We considered refining the clinical labor time for the “pre exercise ECG, VC, Min Vent. Calculation” activity from 27 minutes to 15 minutes for CPT code 94621. We considered proposing this value of 15 minutes based on assigning 5 minutes apiece for the ECG, the MVV, and the spirometry. We believe that each of these three components of this clinical labor activity would typically take no longer than 5 minutes based on a comparison to the use of these tasks in other CPT codes. We also considered refining the clinical labor time for the “Clinical staff performs procedure” activity from 55 minutes to 35 minutes for CPT code 946X2 and from 14 minutes to 12 minutes for CPT code 94621. The RUC-recommended materials for the PE inputs state that this clinical labor task consists of performing 5 spirometries at 9 minutes each plus 10 minutes of exercise time for CPT code 946X2; we believe that the spirometries typically take 5 minutes each, which would reduce this activity from 55 minutes to 35 minutes. For CPT code 94621, we considered maintaining the current value of 12 minutes due to a lack of justification for increasing the time to 14 minutes.
While we remain concerned about the intraservice period clinical labor times, for CY 2018, we are proposing the RUC-recommended work RVUs for each code in this family and seek comment on whether our alternative clinical labor times would better reflect the work and times for these services.
In the CY 2016 PFS proposed rule (80 FR 41706), CPT code 95004 was identified through the high expenditures screen as potentially misvalued. The RUC suggested in its comments on the CY 2016 PFS proposed rule (80 FR 41706), that CPT code 95004 should be removed from the list of potentially misvalued codes because it has a work RVU of 0.01 and that it would serve little purpose to survey physician work for this code. The RUC and CMS previously determined that there is physician work involved in providing this service since the physician must interpret the test and prepare a report. In the CY 2016 PFS final rule with comment period (80 FR 70913), CMS reiterated an interest in the review of work and PE for this service. We note that our interest in stakeholder review of a particular code should not be considered a directive for survey under the RUC process. We intend to more clearly state our interests in the future, so that under similar circumstances, such effort need not be undertaken based on a mistaken impression. To reiterate, we believe that whether or not a code should be surveyed in response to our interest in receiving recommendations regarding the work RVUs should be at the RUC and the specialties' discretion. In many cases, we have used recommendations developed through means other than surveys in developing RVUs. For example, for many PFS services, the direct PE inputs are the primary drivers of overall RVUs and Medicare payment. In most of these cases, the recommended inputs are not derived from survey data. In some cases, especially for resource-intensive and highly technical services, we have expressed some concern about the lack of survey or other broad-based data that we have relied on in developing rates across the PFS for many years.
For CY 2018, we are proposing the RUC-recommended work RVU of 0.01 for CPT code 95004.
Regarding direct PE inputs, we are proposing to refine the equipment times for exam table (EF023) and mayo stand (EF015) to 79 minutes each to account for clinical 1:4 patient monitoring time. We received invoices with new pricing information for two supplies: SH101 “negative control, allergy test” ($5.17) and SH102 “positive control, allergy test” ($26.12). Using this information, we are proposing a price of $0.03 per test for supply item SH101 and a price of $0.13 per test for supply item SH102.
CPT codes 95250 (Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording) and 95251 (Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; interpretation and report) are used to report the technical and professional component for continuous glucose monitoring. In April 2013, CPT code 95251 was identified through the high volume growth services screen and subsequently this code family was reviewed at the RUC's October 2016 meeting.
For CY 2018, we are proposing the RUC-recommended work RVU of 0.70 for CPT code 95251. However, we are concerned and seek comments on whether the 2 minutes of physician preservice time is necessary. Since CPT code 95251 is typically billed with an E/M service on the same day, we believe the 2 minutes of preservice time may be duplicative. Furthermore, we seek comment on whether it would be typical for the physician to spend 2 minutes to obtain the CGM reports for review since we believe the report would typically be obtained by clinical staff on behalf of the physician.
For the direct PE inputs, the RUC submitted 19 invoices to update the price of the medical supply item “glucose monitoring (interstitial) sensor” (SD114) for CPT code 95250. We are proposing to use these invoice prices for the glucose monitoring (interstitial) sensor (SD114), with an average cost of $53.08. Therefore, we are proposing to use the average price of $53.08 for this supply item.
As part of our review of this service, we obtained publicly available pricing information for the CGM system (EQ125). We reviewed the information provided in a study titled, “The cost-effectiveness of continuous glucose monitoring in type 1 diabetes,” (Huang, SE., O'Grady, M., Basu, A. et al.,
In the CY 2017 PFS final rule (81 FR 80330), we discussed that in October 2015, the CPT Editorial Panel created two new PE-only codes, CPT code 96160 (Administration of patient focused health risk assessment instrument (
The RUC submitted updated recommendations for the direct PE inputs for CPT codes 96160 and 96161 after reviewing new specialty society surveys. The RUC recommended 7 total minutes of clinical staff time, and we are proposing to adopt this number of minutes in valuing the services. The PE worksheet included several distinct tasks with minutes for each; however, in keeping with the standardization of clinical labor tasks, we are proposing to designate all 7 minutes under “administration, scoring, and documenting results of completed standardized instrument” rather than dividing the minutes into the four categories as shown in the RUC recommendations.
In the CY 2016 PFS proposed rule, CPT codes 96401 (Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic), 96402 (Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic), 96409 (Chemotherapy administration; intravenous, push technique, single or initial substance/drug), and 96411 (Chemotherapy administration; intravenous, push technique, each additional substance/drug (List separately in addition to code for primary procedure)) were identified through the high expenditure services screen across specialties with Medicare allowed charges of over $10 million.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT code 96401 (a work RVU of 0.21), CPT code 96402 (a work RVU of 0.19), CPT code 96409 (a work RVU of 0.24) and CPT code 96411 (a work RVU of 0.20).
For CPT code 96402, we are proposing the RUC-recommended equipment times with refinements for the biohazard hood (EP016) and exam table (EF023) from 31 minutes to 34 minutes to reflect the service period time associated with this code. We are proposing the RUC-recommended direct PE inputs for CPT codes 96401, 96409, and 96411 without refinements.
CPT code 96910 appeared on a high expenditure services screen across specialties with Medicare allowed charges of over $10 million, which is a PE-only code that does not have work RVUs.We are proposing to refine the clinical labor time for the “Provide preservice education/obtain consent” from 3 minutes to 1 minute for CPT code 96910. We believe that 1 minute would be typical for patient education, as CPT code 96910 is a repeat procedure where there would not be a need to obtain consent again. We are also proposing to remove the 2 minutes of clinical labor for the “Complete diagnostic forms, lab & X-ray requisitions” activity, as this item is considered indirect PE consistent with our established methodology. We are also proposing to create a new supply code (SB054) for the sauna suit, and proposing to price at $9.99 based on the submitted invoice. Finally, we are also proposing to adjust the equipment times to reflect changes in the clinical labor for CPT code 96910.
We are proposing the RUC-recommended clinical labor time of 15 minutes for the “Prepare and position patient/monitor patient/set up IV” activity, the RUC-recommended clinical labor time of 16 minutes for the “Monitor patient during procedure” activity, and the RUC-recommended clinical labor time of 15 minutes for the “Clean room/equipment by physician staff” activity, but seeking additional information regarding the rationale for these values. Given the lack of explanation, we considered using the current clinical labor time of 7 minutes for the “Prepare and position patient/monitor patient/set up IV” activity, the current clinical labor time of 4 minutes for the “Monitor patient during procedure” activity, and the current clinical labor time of 10 minutes for the “Clean room/equipment by physician staff” activity. We seek comment on whether maintaining the current values would improve relativity.
We considered removing the “Single Patient Discard Bag, 400 ml” (SD236) supply and replacing it with the “biohazard specimen transport bag” (SM008). We are concerned about whether the single patient discard bag is the appropriate size for storing the sauna suit used in this procedure, and whether use of a biohazard specimen transport bag would be typical. We seek comments on our proposed and alternative values for these direct PE inputs.
CPT code 96567 was identified as potentially misvalued through a CMS screen for codes with high expenditures. This code describes a service furnished by clinical staff and does not include physician work. For CY 2018, the CPT Editorial Panel created two new codes, CPT codes 96X73 and 96X74, to describe photodynamic therapy by external application of light to destroy premalignant skin lesions, including the physician work involved in furnishing the service. CPT codes 96567, 96X73, and 96X74 were reviewed during the RUC's January 2017 meeting.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT code 96X73 (a work RVU of 0.48) and CPT code 96X74 (a work RVU of 1.01).
We are proposing the RUC-recommended PE inputs with refinements due to inconsistencies between the stated description of clinical activities and the submitted spreadsheets. First, we propose to add assist physician clinical staff time to CPT codes 96X73 (10 minutes) and 96X74 (16 minutes), which is equivalent to the physician intraservice times for these services. For both CPT codes 96X73 and 96X74, we propose a reduction from 35 minutes to 17 minutes for clinical activity in the postservice time, consistent with the description of clinical work in the summary of recommendations, which states that the patient receives activation of the affected area with the BLU-U Photodynamic Therapy Illuminator for approximately 17 minutes. For CPT codes 96X73 and 96X74, we are
We identified several vendors with publically available prices available for supply item LMX 4 percent cream (SH092) for significantly less than the existing $1.60 per gram. Based on our research of vendors, we are proposing to set the price of supply item SH092 to $0.78 per gram. Other CPT codes affected by the proposed change in the price of supply item LMX 4 percent cream (SH092) are: CPT code 46607 (Anoscopy; with high-resolution magnification (HRA) (eg, colposcope, operating microscope) and chemical agent enhancement, with biopsy, single or multiple), CPT code 17000 (Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); first lesion), CPT code 17003 (Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); second through 14 lesions, each (List separately in addition to code for first lesion)), and CPT code 17004 (Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses), 15 or more lesions)).
In addition, the RUC forwarded an invoice for a new supply item, safety goggles, at $6.00 and requested three goggles each for CPT codes 96X73 and 96X74. Because we do not have a basis for distinguishing the requested new goggles from the existing UV-blocking goggles, we consider this invoice to be an additional price point for SJ027 rather than an entirely new item. We propose a price of $4.10 for supply item SJ027 (the average of the two prices for this supply item ($2.30 + $6.00)/2=$4.10)). Other CPT codes affected by the proposed change in the price of supply item UV-blocking goggles (SJ027) are: CPT code 36522 (Photopheresis, extracorporeal), CPT code 96910 (Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B), CPT code 96912 (Photochemotherapy; psoralens and ultraviolet A (PUVA)), and CPT code 96913 (Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least 4-8 hours of care under direct supervision of the physician (includes application of medication and dressings)), CPT code 96920 (Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm), CPT code 96921 (Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm), and CPT code 96922 (Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm). We seek comments on our proposed PE refinements, including our proposed supply item prices.
In our CY 2015 PFS final rule (79 FR 67576) and CY 2016 PFS final rule (80 FR 70917), we identified a total of ten codes through the high expenditure by specialty screen for services primarily furnished by physical and occupational therapists: CPT codes 97032, 97035, 97110, 97112, 97113, 97116, 97140, 97530, 97535, and HCPCS code G0283. An additional nine codes in this PM&R family were identified for review by the physical therapy (PT) and occupational therapy (OT) specialty societies: CPT codes 97012, 97016, 97018, 97022, 97033, 97034, 97533, 97537, and 97542. Many of these code values had not been reviewed since they were established in 1994, 1995 or 1998.
After review during its January 2017 meeting, the HCPAC submitted recommendations for all 19 codes. While the HCPAC included recommendations for CPT code 97014, we note that this is a code we have not recognized for PFS payment since 2002 when we implemented our wound care electrical stimulation policies. For payment under the PFS, instead of CPT code 97014, we recognize HCPCS code G0281 for wound care electrical stimulation and HCPCS code G0283 for all other electrical stimulation scenarios, when covered. For CY 2018, we are proposing the HCPAC recommendations for CPT code 97014, HCPCS code G0283, and HCPCS code G0281.
CMS considers all 19 codes as “always therapy” which means they are always considered to be furnished under a physical therapy (PT), occupational therapy (OT), or speech-language pathology (SLP) plan of care regardless of who furnishes them and the payment amounts are counted towards the appropriate statutory therapy cap—either the therapy cap for PT and SLP services combined, or the single therapy cap for OT services. These always therapy codes are also subject to the therapy MPPR.
For CY 2018, we are proposing the HCPAC's recommended work RVUs for CPT codes 97012, 97016, 97018, 97022, 97032, 97033, 97533, 97034, 97035, 97110, 97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537, 97542, and G0283 (97014).
For supervised modality services reported with CPT codes 97012, 97016, 97018, and 97022, and HCPCS code G0283 (97014), we considered maintaining the current values for these codes rather than the HCPAC recommendations. We note that the work times recommended by the HCPAC reflect use of the survey data even though the HCPAC explained in its recommendations that the survey results were not deemed credible because of a lack of evidence to support higher work RVUs of each survey's 25th percentile or median values. We note total time decreases among these codes ranging from 1 to 8 minutes.
While we are proposing the HCPAC-recommended work RVUs and work times for each code in this family, we seek comments on whether maintaining the current times, given the HCPAC's lack of confidence in the survey data, would better reflect the work times for these services.
We are proposing to maintain the existing CY 2017 PE inputs for all 19 codes. We note that section 1848(b)(7) of the Act requires a 50 percent therapy MPPR instead of the 25 percent therapy MPPR established during CY 201l PFS rulemaking. One of the primary rationales for the MPPR policy developed through the rulemaking process was that the direct PE inputs for these services did not fully recognize the redundant inputs when these services were furnished together, or in multiple units. After reviewing the recommended direct PE inputs, it is evident that they were developed based on an acknowledgement of the efficiencies of services typically furnished together as well as codes billed in multiple units. Given this assessment, we believe that were we to use the recommended inputs to develop the PE RVUs, the 50 percent MPPR on the PE for these services, as required by current law, would functionally duplicate the payment adjustments to account for efficiencies that had already been addressed through code-level valuation. Therefore, for CY 2018, we are proposing to retain the existing CY 2017 PE inputs for these services and seek comments on whether there is an
We note that we believe that the always therapy codes subject to the therapy MPPR on PE are unique from other therapeutic and diagnostic procedure codes paid under the PFS and subject to MPPRs. For example, unlike most surgical services, these “always therapy” codes are typically billed either with other therapy codes or in multiple units, or both. Generally, MPPRs are used when codes are often, but not typically, furnished with other particular codes. When full sets of related codes are almost all typically billed with other codes, or billed in multiple units, coding and valuation have changed to reflect these practices. For example, new codes have been introduced to describe combined services or some related services are described by add-on codes. In other cases, the MPPR is considered in the valuation for individual services.
For CY 2018, the CPT Editorial Panel revised the set of codes that comprise the CPT manual's PM&R subsection for orthotic management and prosthetic management at its September 2016 meeting. According to the CPT Editorial Panel, these revisions were made at the request of the specialty societies representing physical and occupational therapists to differentiate between the initial and subsequent encounters and to describe the ongoing management and/or training that is involved in subsequent encounters. These changes include:
• Revising the code descriptors by adding the term “initial encounter” to CPT code 97760 (Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) encounter, each 15 minutes), and CPT code 97761 (Prosthetic(s) training, upper and/or lower extremity(ies), initial prosthetic(s) encounter, each 15 minutes);
• Creating a new CPT code 977X1 (Orthotic(s)/prosthetic(s) management and/or training, upper extremity(ies), lower extremity(ies), and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 minutes); and
• Deleting CPT code 97762 (checkout for orthotic/prosthetic use, established patient, each 15 minutes).
Intended for the management and/or training of patients with orthotics and/or prosthetics, CPT codes 97760 and 97761 were previously used to report both the initial and subsequent encounters, that, when furnished under the Medicare outpatient therapy services benefit, included services occurring during the same PT or OT episode of care. CPT code 97762 was used to separately report the assessment and fitting (including any adjustments) of an orthotic or prosthetic for an established patient when these services were not bundled into another code or service. For CY 2018, CPT codes 97760 and 97761 are intended to be reported only for the initial encounter, and CPT code 977X1 is intended to be reported for all other orthotic and/or prosthetic services for an established patient that occur on a “subsequent encounter” or a different date of service from that of the initial encounter service.
The HCPAC submitted work and PE recommendations for CPT codes 97760, 97761, and 977X1 from their January 2017 meeting. For CY 2018, we propose the HCPAC recommended work RVU of 0.5 for CPT code 97760, a work RVU of 0.5 for CPT code 97761, and a work RVU of 0.48 for CPT code 977X1. We note that for budget neutrality purposes, the HCPAC recommendations also included utilization crosswalks for each of the three codes that were each assigned a one-to-one crosswalk to the utilization of the prior codes: All the prior services of CPT codes 97760 and 97761 were each crosswalked to the same newly revised codes; and, all the utilization from CPT code 97762 was crosswalked to the new CPT code 977X1.
For CPT code 977X1, we considered a work RVU of 0.33, crosswalking to CPT code 92508 (Speech/hearing therapy), which has a similar total therapist time (22 minutes). We are concerned and seek comments on the HCPAC one-to-one utilization crosswalk recommendations for all three codes in this family since the utilization assumptions are potentially flawed when viewed in the context of the new CPT code descriptors. For instance, for CPT code 977X1, the new descriptor indicates that the services inherent to CPT code 97762 (over 14,000 in 2015), as well as the new services for subsequent encounters previously reported via CPT codes 97760 and 97761 will also be encompassed, although it is difficult to estimate the number of additional services the latter represents. We are concerned that the HCPAC's valuation is inconsistent with the submitted information regarding how services will be reported under the new coding. We seek comments on our proposed and alternative values for CPT code 977X1. We are also interested in receiving comments from stakeholders and clinicians with expertise in furnishing these orthotic management and/or prosthetics training services about the utilization and types of services that would be furnished under the new CPT coding structure, particularly those of the newly created CPT code 977X1 and how these services differ from the services reported with the predecessor CPT code 97762.
We propose to maintain the current PE inputs for CPT codes 97760, 97761, and 977X1, as we discussed in our proposals for the PM&R codes discussed above; the same therapy MPPR applies. We are proposing the current direct PE inputs for CPT code 97762 and for new CPT code 977X1, though we are seeking comment as to whether or not a different crosswalk or other adjustment would be appropriate given the change in code descriptor.
We also note that these codes are designated as always therapy, meaning that they always represent therapy services regardless of who furnishes them; and that a GO or GP therapy modifier is always required to indicate that the services are furnished under an OT or PT plan of care, respectively. As always therapy, these codes are subject to the therapy MPPR and the statutory therapy caps.
We received HCPAC recommendations for new CPT code 97X11 that describes services currently reported under CPT code 97532 (Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes). CPT code 97532 is scheduled to be deleted for CY 2018 and replaced by CPT code 97X11.
The existing code is reported per 15 minutes and the new code is reported once. Under current coding, Medicare utilization for these services is heterogeneous and indicates that practitioners of different disciplines incur significantly different resource costs (especially in time) when furnishing these services to Medicare beneficiaries. As described by both the existing and new code, the service might be appropriately furnished both by therapists under the outpatient therapy (OPT) services benefit (includes physical therapy (PT), occupational therapy (OT) or speech-language pathology (SLP)); and outside the therapy benefit by physicians, certain
According to the HCPAC, professional claims data indicate that CPT code 97532 was most often billed in 4 units. The HCPAC recommended a work RVU of 1.50 for CPT code 97X11, which is only 3.4 times greater than the work RVU for the predecessor code (0.44). Assuming professional billing patterns remain the same, the recommended coding and valuation could result in a significant reduction in overall Medicare payment under the PFS.
However, our analysis of the claims data indicates that the number of units typically reported for the current code suggests a significant difference in the amount of time spent with the patient, depending on which discipline (and implicitly under which benefit) bills Medicare for services described by this single code.
Based on our review of claims data by specialty, SLP-PPs, OT-PPs and PT-PPs furnishing the same services under the OPT benefit would receive overall payment increases due simply to the change in coding because they typically bill for fewer than 4 units, while overall payment for clinical psychologists furnishing therapeutic interventions for cognitive function would decrease because they typically bill in units of four or more.
We are seeking additional information regarding the potential impact of this coding and payment change prior to proposing its use under the PFS. For CY 2018, we are proposing to maintain the current coding and valuation for these cognitive function services. If the CPT Editorial Panel deletes the existing CPT code for CY 2018, we would effectuate this proposal through use of a new a G-code, GXXX1, which would maintain the descriptor and values from existing CPT code 97532. Under this proposal, new CPT code 97X11 would be given a procedure status of “I” (Invalid for Medicare).
We also note that this change in coding and payment could have significant impact for payment to Medicare institutions for OPT services. Under section 1834(k) of the Act, when reported by Medicare institutional providers, OPT services are paid at PFS non-facility payment rates. Institutional claims data for CPT code 97532 when furnished by the three therapist disciplines show a much higher utilization overall than that for professional claims but significantly fewer 15 minute units reported. This suggests that professionals generally spend significantly less time with patients in the institutional setting. Use of the new CPT code could therefore result in significant additional expenditure to the Medicare program, as well as other payers, including Medicaid programs, based on the change in coding alone.
In October 2015, AMA staff assembled a list of all services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2008 through 2013 and these services were identified on that list. The RUC recommended that HCPCS codes G0248, G0249 and G0250, which describe related INR monitoring services, be referred to the CPT Editorial Panel to create Category I codes to describe these services. For CY 2018, the CPT Editorial Panel is deleting CPT codes 99363 and 99364 and creating new CPT codes 993X1 (Patient/caregiver training for initiation of home INR monitoring under the direction of a physician or other qualified health care professional, including face-to-face, use and care of the INR monitor, obtaining blood sample, instructions for reporting home INR test results, and documentation of patient's/caregiver's ability to perform testing and report results) and 993X2 (Anticoagulant management for a patient taking warfarin, must include review and interpretation of a new home, office, or lab International Normalized Ratio (INR) test result, patient instructions, dosage adjustment (as needed), and scheduling of additional test(s) when performed). CPT code 993X1 is a technical component-only code. With the creation CPT codes 993X1 and 993X2, the RUC recommended that CMS delete HCPCS codes G0248, G0249 and G0250.
For CPT code 993X2, we are proposing the RUC-recommended work RVU of 0.18. Because HCPCS codes G0248, G0249 and G0250 are used to report related services under a national coverage determination, we do not intend to delete the G-codes.
In reviewing the recommended PE inputs for these services, we obtained updated invoices for prices for particular items. We are proposing to use the invoices to update the price of the supply “INR test strip” (SJ055). We obtained publically available pricing information from two vendors. The pricing from one vendor indicated the price for a box of 24 of supply item SJ055 item (INR test strip) to be $150.00, which equated to a unit price of $6.25. Pricing from a second vendor indicated the price of a box of 48 of the supply item SJ055 to be $233.00, which equated to a unit price of $5.06. The average price of these two unit prices is $5.66.
Therefore, we are proposing to re-price SJ055 from $21.86 to $5.66 for CPT code 993X1. We are seeking public comments on current pricing for the INR test strip supply.
In the CY 2017 PFS final rule (81 FR 80230), we established separate payment for three services (HCPCS codes G0502, G0503, and G0504) under the psychiatric collaborative care model that paralleled CPT codes that were being created to report these services as well as a G-code for general behavioral health integration (BHI) services (HCPCS code G0507).
For CY 2018, the CPT Editorial Panel is creating CPT codes 994X1, 994X2, 994X3, and 99XX5 to describe these services. We are proposing the RUC-recommended work RVUs for each of these services, which are identical to the current values for HCPCS codes G0502, G0503, G0504, and G0507.
We are proposing the RUC-recommended PE inputs, with one refinement. The RUC-recommended values included clinical labor inputs in the facility setting, but we are not proposing to include these minutes in developing the facility PE RVUs.
Were we to develop facility PE RVUs for these services that included clinical staff time, when a practitioner working in a provider-based department of a hospital was furnishing these services, both the professional and the hospital would be paid for the same clinical labor costs. We presume that this aspect of the RUC's recommendation reflects the circumstance where the patient receiving the services spends a significant period of time in a facility setting, but the billing practitioner is nonetheless incurring the cost associated with the non-face-to-face clinical staff time over the course of a month. We recognize that the binary site of service differential may not recognize the different models of this kind of care and may not be appropriate in some cases. We seek comments on how to best address this valuation issue for these and other monthly care
We stated in the CY 2017 PFS final rule (81 FR 80236) that the general BHI code (CPT code 99XX5) may be used to report a range of models of BHI services and that we expected this code to be refined over time as we receive more information about other BHI models in use. We remain interested in how this code is being used and look forward to hearing from stakeholders regarding its use in reporting different models of BHI services. Additionally, we have received inquiries from stakeholders about whether or not professionals who cannot report E/M services to Medicare might nonetheless serve as a primary hub for BHI services. For example, stakeholders have suggested that a clinical psychologist might serve as the primary practitioner that integrates medical care and psychiatric expertise. For purposes of future rulemaking, we are seeking comment on the circumstances under which this model of care is happening and whether additional coding would be needed to accurately describe and value other models of care.
In the CY 2016 PFS final rule (80 FR 71005), we discussed the CY 2015 valuation of hyperbaric oxygen therapy services (79 FR 67677). Prior to CY 2015, CPT code 99183 was used to report both the professional attendance and supervision, and the costs associated with treatment delivery were included in the nonfacility direct PE inputs for the code. We created HCPCS code G0277 to be used to report the treatment delivery separately, consistent with the OPPS coding mechanism, to allow the use of the same coding structure across settings. In establishing interim final direct PE inputs for HCPCS code G0277, we used the RUC-recommended direct PE inputs for CPT code 99183, which assumed a 120-minute treatment interval and adjusted them to align with the 30-minute treatment interval of HCPCS code G0277. We observed that the quantity of oxygen increased significantly relative to the previous inputs for CPT code 99183.
To better understand why the oxygen supply increased, we reviewed the instruction manual for the Sechrist Model 3600E Hyperbaric Chamber, which was the model noted on the invoice that was included with the RUC recommendations for use in pricing the capital equipment. The instruction manual for the Sechrist 3600E model provided guidance regarding the quantity of oxygen to be used in furnishing the service described by HCPCS code G0277. Based on our review at that time, we determined that 12,000 liters, rather than 47,000 liters, was the typical number of units for the oxygen gas. Therefore, in aligning the direct PE inputs as described in this section of the proposed rule, we first adjusted the units of oxygen to 12,000 liters for the recommended 120 minute time, and subsequently adjusted it to align with the 30-minute G-code by dividing by 4. We stated that we agreed that an initial high purge flow rate is needed to reach maximum pressure/O
For CY 2018, we received requests from stakeholders to update the direct PE inputs for HCPCS code G0277. In the CY 2016 PFS final rule (80 FR 71005), we explained that we had previously established values for this service based on information suggesting that the Sechrist Model 3600E Hyperbaric Chamber was typically used in furnishing the service in the non-facility setting. As we noted in that rule, we established the amount of oxygen used in furnishing the service based on use of the equipment item described as part of the RUC recommendation, instead of the RUC-recommended amount of oxygen, which appeared to be based on use of a different equipment product, the Sechrist Model 3200. Based on information received from stakeholders, we are proposing to update both the equipment item and the amount of oxygen so that the amount of oxygen conforms to the RUC-recommended value of 47,600 liters of oxygen, which we divided by 4 to conform to the 30-minute service period for HCPCS code G0277, and that the equipment item is consistent with that recommendation. The proposed direct PE inputs for HCPCS code G0277 are displayed in the proposed CY 2018 direct PE input database, available on the CMS Web site under the downloads for the CY 2018 PFS proposed rule at
We are also proposing to exclude this change in direct PE inputs from calculation of the misvalued code target since we view this proposed change as a refinement of a single recommendation over several years. Since the initial recommendation (79 FR 67677) was undertaken in a year without the misvalued code target, we believe it would be consistent with our previously established policy (80 FR 70923) to exclude this change from the calculation. We note that this change would represent an increase from the current PE RVUs for this service.
We met with representatives from the American Society of Addiction Medicine (ASAM) in April 2016 to discuss the possibility of making separate payment for insertion and removal of buprenorphine hydrochloride, formulated as a 4-rod, 80 mg, long-acting subdermal drug implant for the treatment of opioid addiction. There are existing CPT codes that broadly describe the insertion and removal of non-biodegradable drug delivery implants (CPT codes 11981 through 11983). However, ASAM contended that the resources associated with the administration of this particular drug are greater than that of other drug delivery implants, stating that the physician must insert four rods using a newly designed applicator and obturator and use a specially designed clamp to remove the four rods, which in some cases requires careful shaving of tissue that has attached to the rods during the 6-month period that the rods have been inserted. They noted that these procedures can have unique
ASAM informed CMS that the CPT Editorial Panel did not approve their application; therefore, they repeated their request that CMS establish separate payment for the insertion, removal, and removal with reinsertion of the buprenorphine subdermal implants.
To improve payment accuracy, for CY 2018, we are proposing to make separate payment for the insertion, removal, and removal with reinsertion of Buprenorphine subdermal implants using HCPCS G codes:
• HCPCS code GDDD1: Insertion, non-biodegradable drug delivery implants, 4 or more.
• HCPCS code GDDD2: Removal, non-biodegradable drug delivery implants, 4 or more.
• HCPCS code GDDD3: Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more.
For HCPCS code GDDD1, ASAM states that performing the procedure according to the FDA-required Risk Evaluation and Mitigation Strategies (REMS) program takes approximately 23-25 minutes for the a physician who is not a trainer/proctor for this procedure. They state that in developing crosswalk recommendations for physician work values, they used a total time of 35-40 minutes, which is based on a preservice time of 10 minutes, an intraservice time of 20-25 minutes, and a postservice time of 5 minutes. Based on ASAM's recommendations, we are proposing a work RVU of 1.82 for HCPCS code GDDD1, which is supported by a direct crosswalk to CPT code 64644 (Chemodenervation of one extremity; 5 or more muscles).
For HCPCS code GDDD2, ASAM states that data from physicians who perform this procedure indicated that it takes approximately 15-20 additional minutes compared to the insertion procedure (HCPCS code GDDD1) based on the FDA-required REMS program for removal of the implant. They note that this procedure is of a higher intensity compared to CPT code 11982 as this service requires identification and removal of multiple subdermal implants. They state that in developing crosswalk recommendations for physician work values, they used a total time of 45-60 minutes, which is based on a preservice time of 10 minutes, an intraservice time of 30-45 minutes, and a postservice time of 5 minutes. Based on ASAM's recommendations, we are proposing a work RVU of 2.10 for HCPCS code GDDD2, which is supported by a direct crosswalk to CPT code 96922 (Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm).
For HCPCS code GDDD3, ASAM indicated that there is minimal consolidation of effort since the removal of the implants from one arm is followed by insertion of a new set of implants in the contralateral arm. Physician data from those who have performed this procedure indicated that it takes approximately 70 minutes of total intra-service time. They state that in developing crosswalk recommendations for physician work values, they assumed a preservice evaluation time of 10 minutes (7 minutes for removal and 3 minutes for insertion), positioning of 4 minutes (2 minutes for each arm), and wait time of 2 minutes (1 minute for each arm). They state that using the multiple surgical procedure rule, they calculated an intraservice time of 40-58 minutes based on 100 percent of the intraservice time for HCPCS code GDDD2 (30-45 minutes) and 50 percent of the intraservice time for HCPCS code GDDD1 (0.5 × (20 - 25) = 10 - 13). They used a postservice time of 8 minutes based on 100 percent of the postservice time for the removal arm and 50 percent of the postservice time for the insertion arm, equaling a total time of 58-76 minutes. Based on ASAM's recommendations, we are proposing a work RVU of 3.55 for HCPCS code GDDD3, which is supported by a direct crosswalk to CPT code 31628 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with transbronchial lung biopsy(s), single lobe).
We are proposing to use the direct PE inputs requested by ASAM for HCPCS codes GDDD1, GDDD2, and GDDD3, which are reflected in the Direct PE Inputs public use files for clinical labor, supplies, and equipment, available on the CMS Web site at
In addition to seeking comment on the proposal to make separate payment for these services using HCPCS G codes, we are also seeking comment on the appropriateness and accuracy of our proposed work RVUs and direct PE inputs.
In the CY 2015 PFS final rule with comment period (79 FR 67666 through 67667), we noted that changes to the CPT prefatory language limited the codes that could be reported when describing services associated with superficial radiation treatment (SRT) delivery, described by CPT code 77401 (radiation treatment delivery, superficial and/or ortho voltage, per day). The changes effectively meant that many other related services were bundled with CPT code 77401, instead of being separately reported. For example, CPT guidance clarified that certain codes used to describe clinical treatment planning, treatment devices, isodose planning, physics consultation, and radiation treatment management cannot be reported when furnished in association with superficial radiation treatment. Stakeholders stated that these changes to the CPT prefatory language prohibited them from billing Medicare for codes that were previously frequently billed in addition to CPT code 77401. We solicited comments as to whether the coding for SRT allowed for accurate reporting of the associated services.
In the CY 2016 PFS final rule with comment period (80 FR 70955), we noted that the RUC did not review the inputs for superficial radiation therapy procedures, and therefore, did not assess whether changes in its valuation were appropriate in light of the bundling of associated services. In addition, we solicited recommendations from stakeholders regarding whether or not it would be appropriate to add physician work for this service, even though physician work is not included in other radiation treatment services. As commenters were not in agreement as to whether the service should be valued with physician work, we introduced the possibility of creating a HCPCS G code to describe total work associated with the course of treatment for these services.
The 2016 National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services states that radiation oncology services may not be separately reported with E/M codes. While this edit is no longer active, stakeholders have stated that MACs have denied claims for E/M services associated with SRT based on the NCCI policy manual language. According to stakeholders, the bundling of services associated with SRT, as well as the confusion regarding the appropriate use of E/M coding to report associated physician work, means
In recognition of these concerns, we are proposing to make separate payment for the professional planning and management associated with SRT using HCPCS code GRRR1 (Superficial radiation treatment planning and management related services, including but not limited to, when performed, clinical treatment planning (for example, 77261, 77262, 77263), therapeutic radiology simulation-aided field setting (for example, 77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for example, 77300), treatment devices (for example, 77332, 77333, 77334), isodose planning (for example, 77306, 77307, 77316, 77317, 77318), radiation treatment management (for example, 77427, 77431, 77432, 77435, 77469, 77470, 77499), and associated evaluation and management per course of treatment). We intend for this code to describe the range of professional services associated with a course of SRT, including services similar to those not otherwise separately reportable under CPT guidance and the NCCI manual.
To value this code, we are including the physician work and work time associated with radiation management-related services that we think would be typical for a course of SRT treatment. These services include: CPT code 77261 (Therapeutic radiology treatment planning; simple), CPT code 77280 (Therapeutic radiology simulation-aided field setting; simple), CPT code 77300 (Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician), CPT code 77306 (Teletherapy isodose plan; simple (1 or 2 unmodified ports directed to a single area of interest), includes basic dosimetry calculation(s)), CPT code 77332 (Treatment devices, design and construction; simple (simple block, simple bolus)), and CPT code 77427 (Radiation treatment management, 5 treatments). Therefore, for CY 2018, we are proposing a work RVU of 7.93 for HCPCS code GRRR1.
To develop the proposed direct PE inputs for this code, we are proposing to use the RUC-recommended direct PE inputs from the aforementioned codes with several adjustments. We are proposing to apply the staff type “RN/LPN/MTA” for all of the clinical labor inputs for this code because we believe that the typical office performing SRT will be staffed with this labor type, rather than with another clinical labor type such as radiation therapists, and we seek comments as to the appropriateness of the staff type “RN/LPN/MTA” for this SRT-related service. Some stakeholders have suggested that many services related to SRT are personally performed by the billing practitioner rather than by clinical staff.
We are proposing to remove the supply items “gown, patient” and “pillow case” that are associated with CPT code 77280, as these items are included in the minimum multi-specialty visit pack that is associated with CPT code 77427. We are not proposing to include the equipment items “radiation virtual simulation system,” “room, CT” and “PACS Workstation Proxy” that are associated with CPT code 77280, as we do not believe that a typical office furnishing SRT uses this kind of equipment. Instead, we are including additional time for the capital equipment used in delivering SRT in the proposed direct PE inputs. For “radiation dose therapy plan,” we are proposing to apply the clinical labor time that is associated with CPT code 77300 to HCPCS code GRRR1 for purposes of developing a proposed value, but we seek comments as to whether the clinical staff would typically perform the radiation dose therapy planning for this service, or if the physician would perform this and/or other tasks, and, in the case of the latter, what the appropriate physician time would be. Likewise, we are soliciting comment as to whether the clinical labor associated with the teletherapy isodose plan would be performed by the physician. We are proposing to assign 14 minutes each to the equipment items “radiation therapy dosimetry software (Argus QC)”, “computer workstation”, and “3D teletherapy treatment planning” as these are the times assigned to these equipment items for CPT code 77300.
We are not proposing to include inputs related to radiation physics consultation, described by CPT code 77336, as we think that a typical course of SRT would not require this service, and the typical practitioner providing SRT would not be performing physics consultation, and we are seeking comment as to whether inputs associated with this code or other inputs used in furnishing analogous services should be included. We are not proposing to include the post-operative office visits included in the valuation of CPT code 77427, as we do not believe that a typical course of SRT will require post-operative visits; however, we are seeking comment regarding the amount of face-to-face time typically spent by the practitioner with the patient for radiation treatment management associated with SRT.
As discussed in the CY 2016 PFS final rule (80 FR 70924 through 70927), in the case of new codes that describe services that were previously included in the payment for other codes, we finalized the policy that these new codes are excluded from the misvalued code target when they were previously bundled into a set of broadly reported E/M codes and services that include E/M visits. We noted that we did not believe that the change to separate payment for these kinds of services should be counted as increases that are included in calculating “net reductions” in expenditure attributable to adjustments for misvalued codes. Therefore, we are proposing to exclude HCPCS code GRRR1 from the misvalued code target.
Most services paid under the PFS are coded to reflect differential resource costs associated with different levels of care. However, this level of granularity is not applied evenly across the PFS. For example, there are far fewer Evaluation and Management (E/M) visit codes than there are codes that describe procedures. While not a comprehensive solution to address the differential resource costs of certain E/M visits, prolonged services codes can be used to report medically necessary E/M visits that require additional amounts of time. Like E/M visit codes, many of the Medicare-covered preventive services codes describe a service that has an atypically broad range of potential resource costs, including differential amounts of time required to furnish services. However, unlike for most E/M visit codes, there are not prolonged services codes that apply to Medicare-covered preventive services.
Some stakeholders have expressed concerns to CMS that there is no coding mechanism for practitioners to report the additional time sometimes required to appropriately furnish care to a patient receiving a Medicare-covered preventive service. We note that Medicare covers a broad range of preventive services, such as a “Welcome to Medicare Preventive Visit”, yearly wellness visits, cancer screenings, and many types of counseling. Medicare beneficiary coinsurance and deductible payments are not applicable for certain Medicare-covered preventive services. Additional information about preventive services
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We are proposing to use prolonged services codes in 30-minute increments instead of the 60-minute increments that apply for the parallel office/outpatient prolonged services codes, since some Medicare-covered preventive services have a shorter duration than E/M visits. For purposes of valuation for both initial and additional 30 minute codes, we are proposing to use one half of the current work RVUs and direct PE inputs for CPT code 99354 (Prolonged evaluation and management or psychotherapy service(s) beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)). CPT code 99354 has a total time of 60 minutes and a work RVU of 2.33. Therefore, we are proposing a work RVU of 1.17 and 30 minutes of total work time for HCPCS codes GYYY1 and GYYY2. We are proposing to use one half of the direct PE inputs for CPT code 99354, which results in a proposal of 7 minutes of clinical labor type L037D (RN/LPN/MTA) and 15 minutes for equipment type EF031 (table, power) for HCPCS code GYYY1 and HCPCS code GYYY2 as the best reflection of typical direct PE costs. We understand that these specific clinical labor and equipment types may be functioning as proxy inputs for some Medicare-covered preventive services.
As described in this section of the rule, we propose that HCPCS codes GYYY1 and GYYY2 be billed for prolonged preventive services beyond the typical service time of the primary procedure. For preventive services with both physician work and practice expense, we are considering the typical service time of the primary procedure to be the intraservice work time used for the purposes of ratesetting. For Medicare-covered preventive services with no face-to-face physician work, the typical time is the service period clinical staff time that best represents the face-to-face time with the patient. The counted time requirements (derived from the typical times assumed for ratesetting) for all eligible companion Medicare-covered preventive services are available in the file called “CY 2018 Preventive Services Billed with Prolonged Preventives Code” on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
In recent years, we have sought to recognize significant changes in health care practice, especially innovations in the active management and ongoing care of chronically ill patients. We have been engaged in an ongoing incremental effort to identify gaps in appropriate coding and payment for care management/coordination, cognitive services and primary care within the PFS. This has included working with the CPT Editorial Panel (CPT) to develop and value (or revalue) the following service codes:
• Transitional care management (TCM) services (2013).
• Chronic care management services (CCM) (2015, 2017).
• Behavioral health integration (BHI) services (2017).
• Assessment/care planning services for cognitive impairment (2017).
• Prolonged E/M services without direct patient contact (2017).
In response to public feedback regarding the initial implementation of TCM and CCM, in the CY 2017 PFS final rule (81 FR 80225 through 80256), we finalized significant administrative burden reduction for CCM and focused on limiting as much as possible the ways in which Medicare's rules differed from the CPT guidance that generally applies for all payers. We also worked with the CPT Editorial Panel and other stakeholders to develop coding and improve payment accuracy for BHI, cognitive impairment assessment/management, and prolonged services. In the CY 2017 PFS final rule (81 FR 80255), we also reiterated our commitment to addressing disparities for individuals with disabilities and advancing health equity, and noted that we will continue to explore improvements in payment accuracy for services furnished to individuals with disabilities. We look forward to continued work with stakeholders to ensure that the coding and valuation of these services accurately reflects the resource costs involved in furnishing these services. We are soliciting public comments on ways we might further reduce administrative burden for these and similar services under the PFS.
Most physicians and other billing practitioners bill patient visits to the PFS under a relatively generic set of codes that distinguish level of complexity, site of care, and in some cases between new or established patients. These codes are called Evaluation and Management (E/M) visit codes. For example, there are generally three levels of hospital and nursing facility inpatient E/M visit codes, and five levels of office or hospital outpatient E/M visit codes, that vary based on complexity. The latter also distinguish whether or not the patient is new to the billing practitioner.
Billing practitioners must maintain information in the medical record to document that they have reported the appropriate level of E/M visit code. CMS maintains guidelines that specify the kind of information that is required to support Medicare payment for each level. According to these documentation guidelines, there are three key components to selecting the appropriate level:
• History of Present Illness (HPI or History);
• Physical Examination (Exam); and
• Medical Decision Making (MDM).
There are two versions of the documentation guidelines, commonly referenced based on the year of their
Stakeholders have long maintained that both the 1995 and 1997 guidelines are administratively burdensome and outdated with respect to the practice of medicine, stating that they are too complex, ambiguous, and that they fail to distinguish meaningful differences among code levels. In general, we agree that there may be unnecessary burden with these guidelines and that they are potentially outdated, and believe this is especially true for the requirements for the history and the physical exam. The guidelines have not been updated to account for significant changes in technology, especially electronic health record (EHR) use, which presents challenges for data and program integrity and potential upcoding given the frequently automated selection of code level.
While CMS conducts few audits on E/M visits relative to the volume of PFS services they comprise, we have repeatedly heard from practitioners that compliance with the guidelines is a source of significant audit vulnerability and administrative burden. Our prior attempts to revise the guidelines met with a lack of stakeholder consensus and support, which contributed to the current policy that allows practitioners to use either the 1995 guidelines or 1997 guidelines, resulting in further complexity in determining or selecting the applicable requirements.
We continue to agree with stakeholders that the E/M documentation guidelines should be substantially revised. We believe that a comprehensive reform of E/M documentation guidelines would require a multi-year, collaborative effort among stakeholders. We believe that revised guidelines could both reduce clinical burden and improve documentation in a way that would be more effective in clinical workflows and care coordination. We also think updated E/M guidelines coupled with technological advancements in voice recognition, natural language processing and user-centered design of EHRs could improve documentation for patient care while also meeting requirements for billing and population health management. We recognize that achieving the goal of reduced clinician burden and improved, meaningful documentation for patient care will require both updated E/M guidelines, as well as changes in technology, clinician documentation practices and workflow. We are seeking input from a broad array of stakeholders, including patient advocates, on the specific changes we should undertake to reform the guidelines, reduce the associated burden, and better align E/M coding and documentation with the current practice of medicine. We are specifically seeking comment on how we might focus on initial changes to the guidelines for the history and physical exam because we believe documentation for these elements may be more significantly outdated, and that differences in MDM are likely the most important factors in distinctions between visits of different levels. We are also specifically seeking comment on whether it would be appropriate to remove our documentation requirements for the history and physical exam for all E/M visits at all levels. We believe medical decision-making and time are the more significant factors in distinguishing visit levels, and that the need for extended histories and exams is being replaced by population-based screening and intervention, at least for some specialties. In addition, an increase in the utilization of EHRs, and to some extent, shared health information via EHRs, may have changed the character of extended patient histories since the guidelines were established. As long as a history and physical exam are documented and generally consistent with complexity of MDM, there may no longer be a need for us to maintain such detailed specifications for what must be performed and documented for the history and physical exam (for example, which and how many body systems are involved). We are seeking comment on whether clinicians and other stakeholders believe removing the documentation requirements for the history and physical exam would be a good approach.
While we believe MDM guidelines may also need to be updated, we believe in the nearer term it may be possible to eliminate the current focus on details of history and physical exam, and allow MDM and/or time to serve as the key determinant of E/M visit level. We are seeking public comment on this approach. We are also seeking comment on how such reforms may differentially affect physicians and practitioners of different specialties, including primary care clinicians, and how we could or should account for such effects as we examine this issue. We note, however, that there may still be clinical or legal reasons for individual practitioners to document an extended history or physical exam (for example, where there are negative findings for certain body systems in support of differential diagnosis). We are additionally seeking comment on whether CMS should leave it largely to the discretion of individual practitioners to what degree they should perform and document the history and physical exam. We also welcome comments on specific ideas that stakeholders may have on how to update MDM guidelines to foster appropriate documentation for patient care commensurate with the level of patient complexity, while avoiding burdensome documentation requirements and/or inappropriate upcoding.
We note that through letters, meetings, public comment letters in past rulemaking cycles, and other avenues, we have heard from many stakeholders that the E/M code set itself is outdated and needs to be revised. For example, some stakeholders recommend an extensive research effort to revise and revalue E/M services, especially physician work inputs (see 81 FR 46200). In prior rulemaking cycles, we acknowledged the limitations of the current E/M code set and agree that the structure of the underlying code set and its valuation relative to other PFS services are also important issues that we expect to continue to explore, though we are immediately focused on revision of the current E/M guidelines in order to reduce unnecessary administrative burden.
We continue to be interested in the ongoing work of the medical community and other stakeholders to refine the set of codes used to describe care
We have been engaged in a multi-year examination of coordinated and collaborative care services in professional settings, and as a result established codes and separate payment in the Physician Fee Schedule (PFS) to separately recognize and pay for these important services. As part of this initiative, the CY 2016 PFS proposed rule (80 FR 41708) solicited public comments on (1) improving payment for the professional work of care management services; (2) establishing separate payment for collaborative care, particularly inter-professional consultation between primary care physicians, psychiatrists, and other practitioners; and (3) assessing whether current PFS payment for Chronic Care Management (CCM) services is adequate and whether the administrative burden associated with furnishing and billing these services should be reduced.
As a result of the comments we received in response to our request, we established in the PFS separate payment for complex CCM services, and temporary codes to make separate payment for general behavioral health integration (BHI) services and a psychiatric collaborative care model (CoCM). We established four G codes to describe BHI and psychiatric CoCM services and stated that we would consider whether to adopt and establish values for any associated new CPT codes being developed under our standard process once those codes are active. The separate payment for complex CCM services, general BHI, and psychiatric CoCM services were finalized in the CY 2017 PFS final rule (81 FR 80225) beginning January 1, 2017, for practitioners billing under the PFS. Based on these payments and codes, we are proposing revisions to the CCM payment for RHCs and FQHCs, and proposing requirements and payment for general BHI and psychiatric CoCM services furnished in RHCs and FQHCs, beginning on January 1, 2018.
RHC and FQHC visits are face-to-face encounters between a patient and one or more RHC or FQHC practitioners during which time one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners (NPs), physician assistants (PA), certified nurse midwives (CNMs), clinical psychologists, and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a homebound RHC or FQHC patient. A Transitional Care Management (TCM) service can also be an RHC or FQHC visit, and a Diabetes Self-Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) service furnished by a certified DSMT or MNT provider may also be an FQHC visit. Only medically-necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner are RHC or FQHC billable visits. Services furnished by auxiliary personnel (for example, nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per-visit payment.
RHCs are paid an all-inclusive rate (AIR) for medically necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). In general, the A/B Medicare Administrative Contractor (MAC) calculates the AIR for each RHC by dividing total allowable costs by the total number of visits for all patients. Productivity, payment limits, and other factors are also considered in the calculation. Allowable costs must be reasonable and necessary and may include practitioner compensation, overhead, equipment, space, supplies, personnel, and other costs incident to the delivery of RHC services. The AIR is subject to a payment limit, except for certain provider-based RHCs that have an exception to the payment limit.
FQHCs were paid under the same AIR methodology until October 1, 2014, when, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Affordable Care Act), they began to transition to an FQHC PPS system in which they are paid based on the lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC PPS geographic adjustment factor (GAF). The rate is increased by 34 percent when an FQHC furnishes care to a patient that is new to the FQHC, or to a beneficiary receiving an Initial Preventive Physical Examination (IPPE) or has an Annual Wellness Visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to reflect the cost of all services and supplies that an RHC or FQHC furnishes to a patient in a single day. The rates are not adjusted for the complexity of the patient health care needs, the length of the visit, or the number or type of practitioners involved in the patient's care.
In the CY 2016 PFS final rule with comment period (80 FR 71080), we finalized policies for payment of CCM services in RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was effective beginning on January 1, 2016, for RHCs and FQHCs that furnish a minimum of 20 minutes of qualifying CCM services during a calendar month to patients with multiple (two or more) chronic conditions that are expected to last at least 12 months or until the death of the patient, and that would place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. The requirement that RHC or FQHC services be furnished face-to-face was waived for CCM services.
In the CY 2017 PFS final rule (81 FR 80256), we finalized revisions to the CCM requirements for RHCs and FQHCs. Specifically, we revised § 405.2413(a)(5) and § 405.2415(a)(5) to state that services and supplies furnished incident to CCM and TCM services can be furnished under general supervision of an RHC or FQHC practitioner, consistent with § 410.26(b)(5), which allows CCM and TCM services and supplies to be furnished by clinical staff under general supervision when billed under the PFS. We also revised requirements pertaining to the provision of CCM services, consistent with the same revisions for practitioners billing under the PFS to reduce the burden of furnishing these services and promote beneficiary access to these services. These revisions were effective beginning on January 1, 2017, and included:
• Revising the requirement that CCM be initiated during a comprehensive evaluation and management (E/M), AWV, or IPPE visit, to require a separately billable initiating visit only for new patients or patients that have not had an E/M, AWV, or IPPE visit within the previous year;
• Revising the requirement that CCM services be available 24/7 with an RHC or FQHC practitioner who has access to the patient's electronic care plan, to allow 24/7 access to auxiliary personnel with a means to make contact with an RHC or FQHC practitioner;
• Removing the restriction on faxing information, and no longer requiring that care plan information be available on a 24/7 basis;
• Removing the requirement that clinical summaries must be formatted according to certified EHR technology, and instead requiring that the RHC or FQHC create, exchange, and transmit continuity of care document(s) in a timely manner with other practitioners and providers;
• Removing the description of the format of the care plan that is given to the patient or caregiver; and
• Revising the requirement that RHCs and FQHCs obtain a written agreement that the elements of CCM were discussed, to allowing this information to be documented in the medical record.
In the CY 2017 PFS final rule, we stated that although CCM is typically associated with primary care conditions, patient eligibility is determined by the RHC or FQHC practitioner, and mental health conditions are not excluded. We invited comments on whether an additional code specifically for mental health conditions is necessary for RHCs and FQHCs that want to include beneficiaries with mental health conditions in their CCM services. We received a few comments regarding mental health services in RHCs and FQHCs and appreciate the information that was provided.
The CCM payment rate for RHCs and FQHCs is set annually based on the PFS national non-facility payment rate, and is paid when CPT code 99490 is billed alone or with other payable services on an RHC or FQHC claim. The 2017 rate for RHCs and FQHCs is $42.71 for 20 minutes or more of CCM services. This is the only RHC and FQHC service that is paid in this manner, and RHCs and FQHCs are not currently authorized to be paid for any other CCM or other care management codes. Also, RHCs and FQHCs cannot bill for CCM services for a beneficiary during the same service period as billing for TCM or any other program that provides additional payment for care management services (outside of the RHC AIR or FQHC PPS payment) for the same beneficiary.
Additional information on CCM requirements is available on the CMS Care Management Web page at
As we stated in the CY 2017 PFS final rule (81 FR 80244), the initial claims data for CCM services billed under the PFS showed that although utilization was increasing steadily, use of CPT code 99490 was still relatively low, and interviews with practitioners indicated that many believed that they were exceeding the 20-minute time threshold for billing this code. To pay as accurately as possible and to encourage access to CCM services, the CY 2017 PFS final rule established separate payment for two additional CCM codes, CPT code 99487 and CPT code 99489, effective beginning on January 1, 2017, for practitioners billing under the PFS. These codes are for complex CCM services that reflect additional clinical staff time, more extensive care planning, and higher complexity of the patient.
CPT code 99487 is for complex CCM services. It requires multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; establishment or substantial revision of a comprehensive care plan; moderate or high complexity medical decision making; and 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.
CPT code 99489 is for each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.
Practitioners paid under the PFS can bill either complex (CPT code 99487 and CPT code 99489) or non-complex (CPT code 99490) CCM services during a given service period, and can submit only one professional claim for CCM services for that service period.
The types of chronic conditions that are eligible for CCM services are not specified and could include chronic mental health or behavioral health conditions or chronic cognitive disorders as long as the CCM requirements are met. However, because not all behavioral health issues fit into the CCM model, and Medicare beneficiaries with behavioral health conditions often require extensive care management discussions, information-sharing, and planning between a primary care practitioner and a behavioral health specialist, the CY 2017 PFS final rule established HCPCS code G0507 for 20 minutes or more of general BHI services. Payment for this code was effective beginning on January 1, 2017, for practitioners billing under the PFS.
BHI is a team-based, collaborative approach to care that focuses on integrative treatment of patients with primary care and mental or behavioral health conditions. As finalized in the CY 2017 PFS final rule, requirements for this code include an initial assessment or follow-up monitoring (including the use of applicable validated rating scales); behavioral health care planning in relation to behavioral/psychiatric health problems (including revision for patients who are not progressing or whose status changes); facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; and continuity of care with a designated member of the care team.
Psychiatric CoCM is a specific model of care provided by a primary care team consisting of a primary care provider and a health care manager who works in collaboration with a psychiatric consultant. As finalized in the CY 2017 PFS final rule, we provide Medicare payment for psychiatric CoCM services to practitioners billing under the PFS when these services are directed by a treating physician or other qualified health care professional. We also finalized that the treating physician or other qualified health care professional directs the behavioral health care manager, who must be an individual with formal education or specialized training in behavioral health, including social work, nursing, or psychology, working under the oversight and direction of the physician or qualified health care professional. We finalized that a psychiatric consultant must be a medical professional trained in psychiatry and qualified to prescribe the full range of medications. Finally, psychiatric CoCM services may be furnished to beneficiaries with any psychiatric or behavioral health condition(s) and may include substance use disorders. The three psychiatric CoCM codes established in the CY 2017 PFS final rule were G0502, G0503, and G0504.
HCPCS code G0502 is for 70 minutes or more of initial psychiatric CoCM services in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional. Required elements include: outreach to and treatment of a patient as directed by the treating physician or other qualified health care professional; initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan; review by the psychiatric consultant with modifications of the plan, if recommended; entering of the patient into a registry and tracking patient follow-up and progress using the registry (with appropriate documentation), participation in weekly caseload consultation with the psychiatric consultant; and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies.
HCPCS code G0503 is for 60 minutes of subsequent psychiatric CoCM services in a subsequent month and includes: tracking patient follow-up and progress using the registry (with appropriate documentation); participation in weekly caseload consultation with the psychiatric consultant; ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers; additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant; provision of brief interventions using evidence-based techniques (such as behavioral activation, motivational interviewing, and other focused treatment strategies); monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.
HCPCS code G0504 is for each additional 30 minutes of initial or subsequent psychiatric CoCM services in a calendar month.
To ensure that RHC and FQHC patients have access to new care management services in a manner consistent with the RHC and FQHC per diem payment methodologies, we are proposing the establishment of two new G codes for use by RHCs and FQHCs. The first new G code, GCCC1, would be a General Care Management code for RHCs and FQHCs, with the payment amount set at the average of the national non-facility PFS payment rates for CCM codes 99490 and 99487 and general BHI code G0507. The second new G code for RHCs and FQHCs, GCCC2, would be a Psychiatric CoCM code,with the payment amount set at the average of the national non-facility PFS payment rates for psychiatric CoCM codes G0502 and G0503. The following is a detailed discussion of our proposal, as well as alternatives that we considered.
The RHC AIR and the FQHC PPS rate, which include all costs associated with an RHC or FQHC visit, are based on the RHC's and FQHC's costs. Although many RHCs and FQHCs have always provided some coordination of care within and outside their facilities, the type of structured care management services that are now billable under the PFS are generally not included in the RHC AIR or the FQHC PPS rate. Because CCM services are not required to be face-to-face encounters, and do not require the skill level of an RHC or FQHC practitioner, they do not meet the requirements for an RHC or FQHC billable visit. In addition, RHC and FQHC services cannot be separately billed to the PFS. Therefore, in the CY 2016 PFS final rule with comment period, we established payment for CCM services at the PFS national non-facility rate when CPT code 99490 is billed alone or with other payable services on an RHC or FQHC claim to pay for the costs of CCM services that are not already captured in the RHC AIR or the FQHC PPS payment.
When CCM services were first established for RHCs and FQHCs, CPT code 99490 was the only CCM code that was billable under the PFS. Now that there are additional codes for more complex CCM services and for general BHI and psychiatric CoCM services, we believe it is necessary to revise our payment approach for payment of care management services.
RHCs and FQHCs are paid per-visit rates that are not adjusted based on the complexity of a service or the time spent furnishing services, and the payment rate is not designed to be equal to the payment under the PFS for a specific service. We sought to develop a methodology for payment of care management services that is consistent with the RHC and FQHC payment principles of bundling services and not paying for services based on time increments. We also sought to develop a methodology that would support the provision of care management services without creating additional reporting burdens, while promoting beneficiary access to comprehensive CCM and BHI services furnished by RHCs and FQHCs.
Therefore, effective for services furnished on or after January 1, 2018, we are proposing to create General Care Management code GCCC1 for RHCs and FQHCs, with the payment amount set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes and updated annually based on the PFS amounts. The 3 codes are:
• CPT 99490—20 minutes or more of CCM services
• CPT 99487—at least 60 minutes of complex CCM services
• HCPCS G0507—20 minutes or more of BHI services
RHCs and FQHCs could bill the new General Care Management code when the requirements for any of these 3 codes (CPT codes 99490, 99487, or HCPCS code G0507) are met. The General Care Management code would be billed alone or in addition to other services furnished during the RHC or FQHC visit. This code could only be billed once per month per beneficiary, and could not be billed if other care management services (such as TCM or home health care supervision) are billed for the same time period. We note that CPT 99489 is an add-on code when CPT 99487 is furnished, and is therefore not included as RHCs and FQHCs are not paid for additional time once the minimum requirements have been met.
As previously noted, the program requirements for RHCs and FQHCs furnishing CCM services were established in the CY 2016 PFS final rule with comment period (80 FR 71080) and revised in the CY 2017 PFS final rule (81 FR 80256). We are not proposing any changes to these requirements at this time.
BHI refers to care management services that integrate behavioral health services with primary care and other clinical services. To bill for this service using the proposed General Care Management Code for RHCs and FQHCs, 20 minutes or more of clinical staff time, directed by an RHC or FQHC practitioner, must be furnished per calendar month. We are proposing the following requirements for RHCs and FQHCs furnishing BHI services:
• Initiating Visit: An E/M, AWV, or IPPE visit with an RHC or FQHC primary care practitioner (physician, NP, PA, or CNM) occurring no more than one-year prior to commencing BHI services. This could be the same initiating visit that is used for initiating CCM services, and would be billed separately as an RHC or FQHC visit (if the RHC or FQHC has not already billed for this visit).
• Beneficiary Consent: Documentation in the medical record that the beneficiary has consented to receive BHI services, given permission to consult with relevant specialists as needed, and been informed that there may be beneficiary cost-sharing, including deductible and coinsurance amounts as applicable, for both in-person and non-face-to-face services that are provided. The beneficiary consent process would also include informing the patient that only one practitioner/facility can furnish and be paid for these services during a calendar month, and that the patient can stop care coordination services at any time (effective at the end of the calendar month). This could be obtained at the same time that beneficiary consent is obtained for CCM services.
• Billing Requirements: At least 20 minutes of care management services per calendar month, furnished under the direction of the RHC or FQHC primary care physician, NP, PA, or CNM, and furnished by an RHC or FQHC practitioner, or by clinical personnel under general supervision. These are the same billing requirements as for CCM services. If both CCM and BHI services are furnished in the same month, the time would be combined and billed as one under the new care coordination code.
• Patient Eligibility: One or more new or pre-existing behavioral health or psychiatric conditions being treated by the RHC or FQHC primary care practitioner, including substance use disorders, that, in the clinical judgment of the RHC or FQHC primary care practitioner, warrants BHI services.
• Required Service Elements: An initial assessment or follow-up monitoring, including the use of applicable validated rating scales; behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes; facilitating and
Both CCM and general BHI services are intended to provide a structured and coordinated approach to care management that is not typically included in the RHC's AIR or the FQHC PPS payment methodology. Care management services are directed by the RHC or FQHC primary care practitioner, who remains involved through ongoing oversight, management, collaboration and reassessment, while care management services are typically furnished in a non-face-to-face setting primarily by a non-RHC or FQHC practitioner working under general supervision requirements. Time spent by administrative or clerical staff cannot be counted towards the time required to bill these services.
Table 16 compares the requirements for CCM and general BHI services. We believe that even though there are some differences in the requirements of CCM and general BHI, bundling them together will help to promote integrated care management services for Medicare beneficiaries who have either or both primary care and behavioral health needs. It will also result in the least amount of reporting burden for RHCs and FQHCs because once the 20-minute threshold is met for either CCM or general BHI, reporting and tracking of additional time increments is not required.
If this policy had been adopted for CY 2017, the payment amount for General Care Management for RHCs and FQHCs would have been approximately $61 (CPT 99490 at $42.71, + CPT 99487 at $93.67, + G0507 at $47.73 = $184.11/3 = $61.37). This is more than is the CY 2017 PFS national non-facility rates for CPT code 99490 and HCPCS code G0507, and less than the PFS national non-facility rate for CPT code 99487. We believe that this bundling methodology is consistent with the RHC and FQHC payment methodology of averaging costs to determine a payment rate rather than paying for each individual service.
We expect that utilization of care coordination services will continue to increase as more health care practices, including RHCs and FQHCs, implement these services. Because the separate payments for the complex CCM codes have only been implemented this year for practitioners billing under the PFS, we do not have adequate data to determine the frequency of billing for CCM codes CPT codes 99487 by practitioners billing under the PFS compared with CPT code 99490. Although billing practices may vary between physician offices and RHCs and FQHCs (and within and between RHCs and FQHCs), we believe that utilization patterns under the PFS can provide a reasonable proxy for utilization practices in RHCs and FQHCs of care coordination utilization. If the PFS data starts to show definitive trends in billing certain CCM and BHI codes, or if data becomes available that provides information on the extent of these services in RHCs and FQHCs, we may consider using a weighted average
Psychiatric CoCM is a defined model of care that integrates primary health care services with care management support for patients receiving behavioral health treatment, and includes regular psychiatric inter-specialty consultation with the primary care team, particularly regarding patients whose conditions are not improving. We recognize that the requirements of this model may be challenging for some RHCs and FQHCs, especially those who have difficulty maintaining adequate primary care and mental health staffing in rural and or underserved areas. For those RHCs and FQHCs that choose to offer these services, we believe this model may be particularly helpful, especially for patients with primary care and mental health conditions who have not benefited from standard treatment.
Effective for services furnished on or after January 1, 2018, we are proposing to create a psychiatric CoCM code for RHCs and FQHCs, GCCC2, with the payment amount set at the average of the 2 national non-facility PFS payment rates for CoCM codes, to be updated annually based on the PFS amounts. The 2 codes are:
• G0502—70 minutes or more of initial psychiatric CoCM services
• G0503—60 minutes or more of subsequent psychiatric CoCM services
RHCs and FQHCs could bill the new psychiatric CoCM code when the requirements for any of these 2 codes (G0502 or G0503) are met. The psychiatric CoCM code would be billed alone or in addition to other services furnished during the RHC or FQHC visit. To prevent duplication of payment, this code could only be billed once per month per beneficiary, and could not be billed if other care management services, including the proposed General Care Management code, are billed for the same time period. We note that G0504 is an add-on code when G0503 is furnished and is therefore not included as RHCs and FQHCs are not paid for additional time once the minimum requirements have been met.
If this policy had been adopted for CY 2017, the payment amount for psychiatric CoCM for RHCs and FQHCs would have been approximately $134.58 (G0502 at $142.84 + G0503 at $126.33 = $269.17/2 = $134.58).
All care management services, including psychiatric CoCM, require a separately billable initiating visit (E/M, AWV, or IPPE) for new patients or beneficiaries not seen within 1 year prior to commencement of care management services. Prior to commencement of psychiatric CoCM services, the beneficiary must provide consent for this service, including permission to consult with a psychiatric consultant and relevant specialists. Advance consent must also include information on cost sharing for both face-to-face and non-face-to-face services, and acceptance of these requirements must be documented in the medical record.
Patients with mental health, behavioral health, or psychiatric conditions, including substance use disorders, who are being treated by an RHC or FQHC practitioner, may be eligible for psychiatric CoCM services, as determined by the RHC or FQHC practitioner. Psychiatric CoCM services, like CCM and general BHI services, are intended to provide a structured and coordinated approach to care management that is not typically included in the RHC's AIR or the FQHC PPS payment methodology.
The psychiatric CoCM team must include the RHC or FQHC practitioner, a behavioral health manager, and a psychiatric consultant. Proposed specific requirements of the psychiatric CoCM team are as follows:
For psychiatric CoCM, the RHC or FQHC practitioner may be a primary care physician, NP, PA, or CNM. The psychiatric CoCM requirements of the RHC or FQHC practitioner are to:
• Direct the behavioral health care manager and any other clinical staff;
• Oversee the beneficiary's care, including prescribing medications, providing treatments for medical conditions, and making referrals to specialty care when needed; and
• Remain involved through ongoing oversight, management, collaboration and reassessment.
For psychiatric CoCM, the behavioral health care manager is a designated individual with formal education or specialized training in behavioral health such as social work, nursing, or psychology. A behavioral health care manager in an RHC or FQHC would be expected to have a minimum of a bachelor's degree in a behavioral health field (such as in clinical social work or psychology), or be a clinician with behavioral health training, including RNs and LPNs. The behavioral health care manager furnishes both face-to-face and non-face-to-face services under the general supervision of the RHC or FQHC practitioner and may be employed by or working under contract to the RHC or FQHC. The psychiatric CoCM requirements of the behavioral health care manager are:
• Providing assessment and care management services, including the administration of validated rating scales; behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes; provision of brief psychosocial interventions; ongoing collaboration with the RHC or FQHC practitioner; maintenance of the registry; acting in consultation with the psychiatric consultant;
• Being available to provide services face-to-face with the beneficiary; having a continuous relationship with the patient and a collaborative, integrated relationship with the rest of the care team; and
• Being available to contact the patient outside of regular RHC or FQHC hours as necessary to conduct the behavioral health care manager's duties.
For CoCM, a psychiatric consultant is a medical professional trained in psychiatry and qualified to prescribe the full range of medications. The psychiatric consultant is not required to be on site or to have direct contact with the patient and does not prescribe medications or furnish treatment to the beneficiary directly. The CoCM requirements of the psychiatric consultant are:
• Participating in regular reviews of the clinical status of patients receiving psychiatric CoCM services;
• Advising the RHC or FQHC practitioner regarding diagnosis and options for resolving issues with beneficiary adherence and tolerance of behavioral health treatment; making adjustments to behavioral health treatment for beneficiaries who are not progressing; managing any negative interactions between beneficiaries'
• Facilitating referral for direct provision of psychiatric care when clinically indicated.
RHCs and FQHCs could bill the new psychiatric CoCM code, GCCC2, when the requirements for HCPCS code G0502 or G0503 are met. This code could only be billed once per month per beneficiary, and could not be billed if other care management services, including the General Care Management code GCCC1, are billed for the same time period.
As with the proposed General Care Management code GCCC1, we would monitor PFS data to determine if a weighted average would be more appropriate in determining the psychiatric CoCM payment rate for RHCs and FQHCs, and whether any additional codes that may be added to the PFS in the future should also be factored into the RHC and FQHC psychiatric CoCM code. Any changes would be done through future rulemaking.
Table 17 compares the requirements for general BHI, which would be billed using the proposed General Care Management code GCCC1, and psychiatric CoCM services, which would be billed using the proposed psychiatric CoCM code, GCCC2.
We considered allowing RHCs and FQHCs to bill for the complex CCM codes, the BHI code, and the psychiatric CoCM codes by allowing the individual CPT or HCPCS codes to be added to an RHC or FQHC claim, in the same manner as we currently allow CPT code 99490 to be added to a claim. We do not believe this approach is in the best interest of RHCs and FQHCs. There are now 5 separate care management codes that are applicable to RHCs and FQHCs, and more codes could be added in the future as we learn more about the benefits of non-face-to-face care management services. Each of these codes has specific time increments that must be tracked and reported for payment under the PFS. We believe that bundling the CCM and BHI codes and the psychiatric CoCM codes into 2 G codes is more consistent with the RHC and FQHC payment methodology of averaging actual costs to determine a payment rate and not paying for services based on time increments. It also requires less record keeping, monitoring, and coding expertise, while maintaining the same quality of care standards.
We also considered bundling all 5 codes together into one G code, or developing 3 G codes—one for the CCM codes, one for the BHI code, and one for the psychiatric CoCM codes. We did not choose either of these approaches because CCM and BHI are similar services that complement each other, and bundling them together is consistent with an integrated approach to care with reduced reporting requirements. We also believe that psychiatric CoCM is different enough from both CCM and BHI in its requirements, particularly in staffing and required services, that it warrants a separate G code. We believe that our proposal of creating 2 new G codes to encompass the 5 care management codes is the best option for RHCs and FQHCs now and in the future if new care management codes are developed. We welcome comments on the proposal.
RHCs and FQHCs are familiar with billing G codes. If this proposal is finalized as proposed, RHCs and FQHCs would continue to receive payment for CCM when CPT code 99490 is billed alone or with other payable services on an RHC or FQHC claim until December 31, 2017. Beginning on January 1, 2018, we propose that RHCs and FQHCs would use the new General Care Management G code GCCC1 when billing for CCM or general BHI services, and the new psychiatric CoCM G code GCCC2 when billing for psychiatric CoCM services, either alone or with other payable services on an RHC or FQHC claim. Claims submitted using CPT 99490 on January 1, 2018, or after, will not be paid.
Both the current RHC and FQHC payment rate for CCM, and the proposed RHC and FQHC payment rates for General Care Management and Psychiatric CoCM codes, are based on the PFS national non-facility rates. The PFS rates are updated annually, and the new G codes for RHCs and FQHCs would be updated accordingly and finalized when the PFS rates are finalized for the year. No geographic adjustment would be applied to the General Care Management or Psychiatric CoCM G codes. RHCs and FQHCs are required to submit claims for RHC and FQHC services on an institutional claim (electronically per the HIPAA compliant ANSI X12 837I or the Form CMS 1450, also known as the UB-04,) and are not authorized to bill RHC or FQHC services separately to the PFS. Specific information on billing and claims processing for the new G codes will be provided when the policy is finalized.
We note that in section X of this proposed rule, G0502, G0503, and G0507 are proposed to be replaced by new CPT codes. Corresponding changes would be made for RHCs and FQHCs when the new CPT codes become available.
As previously noted, § 405.2413(a)(5) and § 405.2415(a)(5) was revised
Section 303(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003) revised the payment methodology for most Medicare-covered Part B drugs and biologicals by adding section 1847A to the Act, which established a new average sales price (ASP) drug payment methodology beginning January 1, 2005. However, section 303(b) of the MMA specified payments for certain drugs using methodologies other than the ASP pricing methodology. Specifically, section 303(b) of the MMA added section 1842(o)(1)(D)(i) of the Act that required that an infusion drug furnished through an item of DME covered under section 1861(n) of the Act be paid 95 percent of the average wholesale price (AWP) for that drug in effect on October 1, 2003.
Section 5004(a) of the 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted on December 13, 2016) revised sections 1842(o)(1)(C) and (D) of the Act, changing the payment methodology for DME infusion drugs from being based on AWP to the methodologies in sections 1847, 1847A, 1847B, or 1881(b)(13) of the Act, as the case may be for the drug or biological. To implement the pricing changes required by section 5004(a) of Cures Act, which modifies the payment for DME infusion drugs to the amount under section 1847A of the Act (ASP payment methodology), by the statutorily mandated effective date of January 1, 2017, we incorporated the ASP-based infusion drug payment amounts into the January 2017 quarterly ASP drug pricing files and instructed claims processing contractors to use the updated payment limits for DME infusion drugs.
To conform regulations with the new payment requirements in section 5004(a) of the Cures Act as they pertain to section 1847A of the Act, we propose revising § 414.904(e)(2). Currently, this describes an exception to ASP-based payments and requires pricing DME infusion drugs at 95 percent of the 2003 AWP. Consistent with section 5004(a) of the Cures Act, the proposed revision limits the exception to infusion drugs furnished before January 1, 2017. In addition, we propose at § 414.904(e)(2) to delete the phrase “and is not updated in 2006.” We believe this language is not relevant since there was no update for pricing DME infusion drugs in 2006, and the proposed revision will serve to simplify the language. Effective January 1, 2017, payment limits for these drugs are determined under section 1847A of the Act.
In the final rule published in the June 23, 2016
Under the CLFS final rule, reporting entities are required to report to CMS certain applicable information for their component applicable laboratories. The applicable information includes, for each CDLT furnished during a data collection period, the specific HCPCS code associated with the test, each private payor rate for which final payment has been made, and the associated volume of tests performed corresponding to each private payor rate. In general, the payment amount for a test on the CLFS furnished on or after January 1, 2018, will be equal to the weighted median of private payor rates determined for the test, based on the applicable information that is collected during a data collection period and reported to us during a data reporting period.
In the CLFS final rule, we established a data collection period that is the 6 months from January 1 through June 30 during which applicable information is collected and that precedes the data collection period. We established a data reporting period that is the 3-month period, January 1 through March 31, during which a reporting entity reports applicable information to CMS and that follows the preceding data collection period. The first data collection period was January 1, 2016 through June 30, 2016. The first data reporting period was January 1, 2017 through March 31, 2017. This 6-month data collection period and 3-month data reporting period schedule will be repeated every 3 years for CDLTs that are not advanced diagnostic laboratory tests (ADLTs), and every year for ADLTS that are not new ADLTs.
For the first data reporting period, industry feedback suggested that many reporting entities would not be able to submit a complete set of applicable information to us by the March 31, 2017 deadline, and that entities required additional time to review collected data, address any issues identified during such review, and compile the data into our required reporting format. As a result, on March 30, 2017, we announced that we would exercise enforcement discretion until May 30, 2017, with respect to the data reporting period for reporting applicable information under the Medicare CLFS and the application of the Secretary's potential assessment of civil monetary penalties for failure to report applicable information.
The announcement stated that the enforcement discretion period would not prevent reporting entities prepared to report applicable information from doing so before May 30, 2017. We explained in the announcement that we were committed to the successful implementation of the new private payor rate-based CLFS and looked forward to working with the laboratory industry to ensure accurate payment rates. Over the coming months, we will be analyzing the applicable information we received, holding our Annual
To better understand the applicable laboratories' experiences with the data reporting, data collection, and other compliance requirements for the first data collection and reporting periods, we are interested in public comments from applicable laboratories and reporting entities on the following questions:
• Was the CMS data reporting system easy to use? Please describe your overall experience with navigating the CMS data reporting system. For example, describe the aspects of the CMS data reporting system that worked well for your reporting entity and/or any problems the reporting entity experienced with submitting applicable information to us.
• Did the applicable laboratory (or its reporting entity) request and receive assistance from our Help Desk regarding the CMS data reporting system? Please describe your experience with receiving assistance.
• Did the applicable laboratory (or its reporting entity) request and receive assistance from the CMS CLFS Inquiries Mailbox regarding policy questions? Please describe your experience with receiving assistance.
• Did the applicable laboratory (or its reporting entity) use the subregulatory guidance on data reporting provided on the CMS CLFS Web site?
• Was the information that the applicable laboratory was required to report readily available in the applicable laboratory's record systems?
• Did the reporting entity have a manual, automated, or semi-automated remittance process for data reporting?
• If the reporting entity used a manual or semi-automated remittance process for data reporting, what percentage of the process was manual?
• How much time (hours) was required to assemble and report applicable information to CMS?
• Is there any other information that will inform us regarding the reporting, recordkeeping, and other compliance requirements from the first data collection and reporting periods?
We believe that industry feedback on these issues will help inform us regarding potential refinements to the private payor rate-based CLFS for future data collection and reporting periods. We welcome comments on these questions from the public.
In the CY 2016 Physician Fee Schedule (PFS) final rule with comment period, we finalized a proposal to amend the regulation text at § 414.904(j) to make clear that the payment amount for a biosimilar biological product is based on the ASP of all NDCs assigned to the biosimilar biological products included within the same billing and payment code (80 FR 71096 through 71101, November 16, 2015
The comments received on the rule revealed that stakeholders had varying opinions about payment for biosimilar biological products under Part B. The commenters included individuals, pharmaceutical manufacturers, patient advocate groups, providers, insurers, and members of Congress. A number of commenters opposed a single payment amount for all biosimilars that rely on a common reference product. Most of these commenters believed that the proposed regulation would decrease incentives for biosimilar development and that grouping payment for biosimilar biological products is inconsistent with the statute. Some commenters also expressed concerns that prescribers' choices will be limited, that tracking or pharmacovigilance activities will be impaired, and that innovation and product development will be harmed, leading to market consolidation and increased costs for biosimilar biological products. Many commenters who opposed our proposal suggested that we determine a payment amount for each biosimilar biological product. These stakeholders have expressed concerns that the finalized policy restricts and threatens the viability of their business models and expressed support for a market-based solution. Some of these stakeholders believe that determining a payment for each biosimilar product by using individual HCPCS codes, would drive and reward innovators producing potential cost savings, of at least 10-15 percent compared to the reference biologic ASP, necessary for biosimilar products to compete with the reference biological.
However, some commenters supported our proposed regulation, stating that the potential marketplace for biosimilar biological products is large and it is less risky than the marketplace for reference biologicals. Commenters also expressed concern that separate payment for each biosimilar biological product would result in less competition among manufacturers, which in turn could lead to higher payment amounts for Medicare and beneficiaries. Some commenters stated that separate billing codes could be perceived as a type of price protection and could artificially increase prices for biosimilars. Commenters who supported the proposed regulation suggested that we remain mindful of our policy as the biosimilar biological product marketplace evolves. Several commenters requested that policy decisions be delayed while issues such as naming conventions and interchangeability standards are finalized by the FDA.
As CMS expected, since the regulation was finalized, the biosimilar product marketplace has continued to grow, and several biosimilar biological products that are paid under Part B have been licensed, including one product that we expect will share a HCPCS code with another biosimilar biological product. Over the next year or so, we anticipate that several more biosimilar biological products will be licensed for use in the United States and that during the following years, the marketplace will continue to grow steadily. We also anticipate that biological products will continue to be heavily utilized in Part B. At the same time, we are aware of concerns that current policy may discourage development of new biosimilars and other innovation in this area potentially resulting in higher costs over time due to a lack of competition in the market place.
In the 2016 PFS final rule, we stated that it is desirable to have fair reimbursement in a healthy marketplace that encourages product development (80 FR 71101). CMS seeks to promote innovation, to provide more options to patients and physicians, and competition to drive prices down, recognizing that even though these two goals may be difficult to achieve concurrently, to delink them would be counterproductive.
Although we believe that the United States biosimilar biological product marketplace is still in an early phase (because only a few products are on the market), we are interested in assessing
Thus, we are requesting comments regarding our Medicare Part B biosimilar biological product payment policy. This comment solicitation is seeking new or updated information on the effects of the current biosimilar payment policy that is based on experience with the United States marketplace. We are particularly interested in obtaining material, such as market analyses or research articles that provide data and insight into the current economics of the biosimilar market place. This includes patient, plan, and manufacturer data both domestic and, where applicable, from European markets that may be more established than, and provide insight for, the current United States' market.
We also seek data to demonstrate how individual HCPCS codes could impact the biosimilar market, including innovation, the number of biosimilar products introduced to the market, patient access, and drug spending. Finally, we also seek comment regarding other novel payment policies that would foster competition, increase access, and drive cost savings in the biological product marketplace. These solutions may include legislation, demonstrations, and administrative options. Please note that this is a solicitation for comments on this issue for future consideration. We are not making a proposal to change the existing payment policy in this proposed rule.
Section 218(b) of the Protecting Access to Medicare Act (PAMA) amended Title XVIII of the Act to add section 1834(q) of the Act directing us to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. The CY 2016 PFS final rule with comment period addressed the initial component of the new Medicare AUC program, specifying applicable AUC. In that rule (80 FR 70886), we established an evidence-based process and transparency requirements for the development of AUC, defined provider-led entities (PLEs) and established the process by which PLEs may become qualified to develop, modify or endorse AUC. The first list of qualified PLEs was posted on the CMS Web site at the end of June 2016 at which time their AUC libraries became specified applicable AUC for purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the second component of this program, specification of qualified clinical decision support mechanisms (CDSMs). In that rule (81 FR 80170), we defined CDSM, identified the requirements CDSMs must meet for qualification including an opportunity for preliminary qualification for mechanisms still working toward full adherence, and established a process by which CDSMs may become qualified. We also defined applicable payment systems under this program, specified the first list of priority clinical areas and identified exceptions to the requirements that ordering professionals consult specified applicable AUC when ordering applicable imaging services. The first list of qualified CDSMs will be posted on the CMS Web site in conjunction with this proposed rule.
This rule proposes the start date of the Medicare AUC program for advanced diagnostic imaging services. It is on and after this date that ordering professionals must consult specified applicable AUC using a qualified CDSM when ordering applicable imaging services and furnishing professionals must report consultation information on the Medicare claim. This rule also proposes to modify the policy related to significant hardship exceptions and requests public feedback on details regarding how AUC consultation information must be included on the Medicare claim. To further this iterative process of implementation, we also discuss briefly the potential for alignment with other Medicare quality programs.
AUC present information in a manner that links: a specific clinical condition or presentation, one or more services and, an assessment of the appropriateness of the service(s). For purposes of this program AUC is a set or library of individual appropriate use criteria. Each individual criterion is an evidence-based guideline for a particular clinical scenario. Each scenario in turn starts with a patient's presenting symptoms or condition. Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual clinical presentation.
AUC need to be integrated as seamlessly as possible into the clinical workflow. CDSMs are the electronic portals through which clinicians access the AUC during the patient workup. While CDSMs can be standalone applications that require direct entry of patient information, they may be more effective when they automatically incorporate information such as specific patient characteristics, laboratory results, and lists of co-morbid diseases from Electronic Health Records (EHRs) and other sources. Ideally, practitioners would interact directly with the CDSM through their primary user interface, thus minimizing interruption to the clinical workflow.
Consistent with descriptions of clinical decision support by the Agency for Healthcare Research and Quality (AHRQ) (
Section 218(b) of the PAMA added a new section 1834(q) of the Act entitled, “Recognizing Appropriate Use Criteria for Certain Imaging Services,” which
There are four major components of the AUC program under section 1834(q) of the Act, and each component has its own implementation date: (1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of the Act); (2) identification of mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by ordering professionals, and reporting on AUC consultation by furnishing professionals by January 1, 2017 (section 1834(q)(4) of the Act); and (4) annual identification of outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5) of the Act). As we will discuss later in this preamble and in prior PFS rules, we did not identify mechanisms for consultation by April 1, 2016. Therefore, we did not require ordering professionals to consult CDSMs or furnishing professionals to report information on the consultation by the January 1, 2017 date.
In the CY 2016 PFS final rule with comment period, we addressed the first component of the Medicare AUC program under section 1834(q)(2) of the Act—the requirements and process for establishment and specification of applicable AUC, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term PLE and finalizing requirements for the rigorous, evidence-based process by which a PLE would develop AUC, upon which qualification is based, as provided in section 1834(q)(2)(B) of the Act and in the CY 2016 PFS final rule with comment period. Using this process, once a PLE is qualified by CMS, the AUC that are developed, modified or endorsed by the qualified PLE are considered to be specified applicable AUC under section 1834(q)(2)(A) of the Act. We defined the term PLE to include national professional medical societies, health systems, hospitals, clinical practices and collaborations of such entities such as the High Value Healthcare Collaborative or the National Comprehensive Cancer Network. Qualified PLEs may collaborate with third parties that they believe add value to their development of AUC, provided such collaboration is transparent. We expect qualified PLEs to have sufficient infrastructure, resources, and the relevant experience to develop and maintain AUC according to the rigorous, transparent, and evidence-based processes detailed in the CY 2016 PFS final rule with comment period.
In the same rule we established a timeline and process under § 414.94(c)(2) for PLEs to apply to become qualified. Consistent with this timeline the first list of qualified PLEs was published at
In the CY 2017 PFS final rule, we addressed the second major component of the Medicare AUC program—the specification of qualified CDSMs for use by ordering professionals for consultation with specified applicable AUC under section 1834(q)(3) of the Act, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term CDSM and finalizing functionality requirements of mechanisms, upon which qualification is based, as provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS final rule. We included an opportunity for mechanisms still working toward full adherence to these requirements to receive preliminary qualification during the preliminary qualification period that begins June 30, 2017, and ends when the AUC consulting and reporting requirements become effective. The preliminarily qualified CDSMs must meet all requirements by that time. We defined CDSM as an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient's specific clinical condition. Tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4) of the Act) or private sector mechanisms independent from certified EHR technology or established by the Secretary.
In the CY 2017 PFS final rule we established a timeline and process in § 414.94(g)(2) for CDSM developers to apply to have their CDSMs qualified. Consistent with this timeline, the first list of qualified CDSMs will be posted on the CMS Web site
The third major component of the Medicare AUC program is in section 1834(q)(4) of the Act, Consultation with Applicable Appropriate Use Criteria. This section establishes, beginning January 1, 2017, the requirement for an ordering professional to consult with a qualified CDSM when ordering an applicable imaging service that would be furnished in an applicable setting and paid for under an applicable payment system; and for the furnishing professional to include on the Medicare claim information about the ordering professional's consultation with a qualified CDSM. The statute distinguishes between the ordering and furnishing professional, recognizing that the professional who orders an applicable imaging service is usually not the same professional who bills Medicare for that service when furnished. Since a list of qualified CDSMs was not available by January 1, 2017, we did not require ordering professionals to meet the consultation requirement by that date.
Section 1834(q)(4)(C) of the Act provides for certain exceptions to the AUC consultation and reporting requirements including in the case of certain emergency services, inpatient services paid under Medicare Part A, and ordering professionals who obtain an exception due to a significant hardship. In the CY 2017 PFS final rule, we identified the circumstances specific to ordering professionals under which consulting and reporting requirements are not required. These include orders for applicable imaging services: (1) For emergency services when provided to individuals with emergency medical conditions as defined in section 1867(e)(1) of the Act; (2) for an inpatient and for which payment is made under Medicare Part A; and (3) by ordering professionals who are granted a significant hardship exception to the Medicare EHR Incentive Program payment adjustment for that year under 42 CFR 495.102(d)(4), except for those granted such an exception under § 495.102(d)(4)(iv)(C). We propose changes to the significant hardship exception later in this preamble.
Section 1834(q)(4)(D) of the Act specifies that the applicable payment systems for the AUC consultation and reporting requirements, and, in the CY 2017 PFS final rule we defined them as:
The fourth component of the Medicare AUC program is in section 1834(q)(5) of the Act, Identification of Outlier Ordering Professionals. The identification of outlier ordering professionals under this paragraph facilitates a prior authorization requirement for outlier professionals beginning January 1, 2020, as specified under section 1834(q)(6) of the Act. Given that we are proposing a program start date of January 1, 2019, we anticipate that implementation of the prior authorization component would be delayed. We expect to discuss details around outlier calculations and prior authorization in the CY 2019 PFS proposed rule. However, we did finalize in the CY 2017 PFS final rule the first list of priority clinical areas to guide identification of outlier ordering professionals as follows:
• Coronary artery disease (suspected or diagnosed).
• Suspected pulmonary embolism.
• Headache (traumatic and non-traumatic).
• Hip pain.
• Low back pain.
• Shoulder pain (to include suspected rotator cuff injury).
• Cancer of the lung (primary or metastatic, suspected or diagnosed).
• Cervical or neck pain.
As established in § 414.94(e)(4) of our regulations, priority clinical areas may be used in the identification of outlier ordering professionals. By starting to identify these areas now, we believe ordering professionals will have the opportunity to become familiar with AUC within identified priority clinical areas prior to Medicare claims for those services being part of the input for calculating outlier ordering professionals.
We are not including proposals to expand or modify the list of priority clinical areas in this rule.
We propose to amend § 414.94 of our regulations, “Appropriate Use Criteria for Certain Imaging Services,” to reflect the following proposals.
We are proposing that ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2019. This proposed effective date for the consulting and reporting requirements is necessary to allow time for ordering practitioners who are not already aligned with a qualified CDSM to research and evaluate the qualified CDSMs so they may make an informed decision. Although there will be another rulemaking cycle next year before the consulting and reporting requirement is effective as proposed on January 1, 2019, we are establishing this date through rulemaking this year because the agency expects practitioners and other stakeholders to begin preparing themselves to report on that date and, in response to public comment and stakeholder feedback, we want to ensure all impacted parties have sufficient time to prepare to meet the requirements of this program.
After proposing the timeline and process for qualification of CDSMs in the CY 2017 PFS proposed rule (81 FR 46392), we anticipated that furnishing professionals may begin reporting as early as January 1, 2018. However, we received comments that these timelines did not allow enough time to address the needs of different stakeholder groups. Some commenters requested that CMS delay the timeline and process to give practitioners sufficient time to obtain a qualified CDSM. Other commenters cited insufficient time for CDSMs to incorporate requirements between the release of the final CDSM requirements and January 1, 2018, and requested that CMS fully implement the program at a later date. Additionally, in the CY 2017 PFS final rule (81 FR 80411) we discussed commenters' recommendations that CMS develop and launch an educational campaign, including a Town Hall meeting. Some commenters requesting additional time suggested that, for purposes of both CDSM vendor readiness and practitioner readiness, consulting and reporting requirements should not go into effect for an additional 12-18 months after the initial list of CMS qualified CDSMs is posted.
By proposing the consulting and reporting requirements begin on January 1, 2019 we believe that we are allowing needed time for education and outreach efforts, time for practitioners and stakeholders to prepare, and time for CDSMs to continue current strides in being more user-friendly and less burdensome. We note that the statute required publication of qualified CDSMs by April 1, 2016, and required AUC consultation and reporting by January 1, 2017; therefore, our proposal substantially lags the statutory requirements. As noted above and in previous rulemaking, a delay in the statutory timeline is necessary to maximize the opportunity for public comment and stakeholder engagement, also a statutory requirement, and allows for adequate advance notice to practitioners, beneficiaries, AUC developers, and CDSM developers.
Consistent with section 1834(q)(4)(B) of the Act, we are also proposing that furnishing professionals report the following information on Medicare claims for applicable imaging services, furnished in an applicable setting, paid for under an applicable payment system as defined in § 414.94(b), and ordered on or after January 1, 2019: (1) Which qualified CDSM was consulted by the ordering professional; (2) whether the service ordered would adhere to specified applicable AUC, would not adhere to specified applicable AUC, or whether specified applicable AUC were not applicable to the service ordered; and (3) the NPI of the ordering professional (if different from the furnishing professional).
We believe that, unless a statutory exception applies, an AUC consultation must take place for every order for an applicable imaging service furnished in an applicable setting and under an applicable payment system. We further believe that section 1834(q)(4)(B) of the Act accounts for the possibility that AUC may not be available in a particular qualified CDSM to address every applicable imaging service that might be ordered; and thus, the furnishing professional can meet the requirement to report information on the ordering professional's AUC consultation by indicating that AUC is not applicable to the service ordered. We remind readers as required under § 414.94(g)(1)(iii) that qualified CDSMs must make available, at a minimum, AUC that reasonably address common and important clinical scenarios within all priority clinical areas. As discussed in the CY 2017 PFS final rule (81 FR 80170), the current list of priority clinical areas represents about 40 percent of advanced diagnostic imaging services paid for by Medicare in 2014. We also remind readers that consistent with section 1834(q)(4)(A) of the Act, ordering professionals must consult AUC for every advanced diagnostic
Section 1834(q)(4)(B) requires that payment may only be made if the claim for the service includes the specific information discussed in this proposed rule. This information, to the extent feasible, is required across claim types (including both the furnishing professional and facility claims) and across all three applicable payment systems (PFS, hospital outpatient prospective payment system and ambulatory surgical center payment system). In other words, we would expect this information to be included on the practitioner claim that includes the professional component of the imaging service and on the hospital outpatient claim for the technical component of the imaging service. Claims for services for which payment is not made under the three identified payment systems would not be required to include consultation related information.
To implement this requirement we propose to establish a series of HCPCS level 3 codes. These G-codes would describe the specific CDSM that was used by the ordering professional. Ultimately there would be one G-code for every qualified CDSM with the code description including the name of the CDSM. However, because the claims processing system can only recognize new codes quarterly, we may not be able to update the G-code descriptors simultaneously with the announcement of any new qualified CDSMs which is expected to occur in June of each year. To ensure that there is a code available to immediately describe newly qualified CDSMs, we propose to establish a generic G-code that would be used to report that a qualified CDSM was consulted, but would not identify a specific qualified CDSM; clinicians would only be permitted to use this code if a more specific named code did not yet exist for that clinician's CDSM. Furnishing professionals would report this code temporarily until a specific G-code describing the newly qualified CDSM by name becomes available. We also propose to establish a G-code to identify circumstances where there was no AUC consultation through a qualified CDSM. The description of this code would indicate that a qualified CDSM was not consulted by the ordering professional.
G-codes would be a line-item on both practitioner claims and facility claims. We would expect that one AUC consulatation G-code would be reported for every advanced diagnostic imaging service on the claim. If there are two codes billed for advanced imaging services on the claim then we would expect two G-codes. Each G-code would be expected, on the same claim line, to contain at least one new HCPCS modifier. We propose to develop a series of modifiers to provide necessary information as to whether, when a CDSM is used to consult AUC: (1) The imaging service would adhere to the applicable appropriate use criteria; (2) the imaging service would not adhere to such criteria; or (3) such criteria were not applicable to the imaging service ordered. We propose to create additional modifiers to describe situations where an exception applies and a qualified CDSM was not used to consult AUC: (1) The imaging service was ordered for a patient with an emergency medical condition or (2) the ordering professional has a significant hardship exception. Based on this proposal we specifically seek comments on any additional HCPCS modifiers that might be needed to separately identify allowable scenarios for which a qualified CDSM was not consulted by the ordering professional.
The proposed AUC consultation and reporting start date of January 1, 2019 is expected to allow adequate time for us to operationalize the claims-based procedures and systems changes needed to accomplish the processing of Medicare claims with AUC consultation information.
There are aspects of the AUC program that are novel and complex for the CMS claims processing system and for ordering and furnishing professionals. An AUC consultation by an ordering professional has never before been required by fee-for-service Medicare with such a broad application (all professionals ordering advanced diagnostic tests). Additional considerations for the complex communication of AUC consultation information from the ordering professional to the furnishing professional and facility that must include that information when billing for the service are warranted. Their billing systems will need to translate the AUC consultation information onto Medicare claims in the form of G-codes and HCPCS modifiers. These processes are new for many professionals, and there are many areas for potential error. For these reasons an educational and operations testing period is needed. During this period, ordering professionals would consult AUC and furnishing professionals would report AUC consultation information on the claim, but we would continue to pay claims whether or not they correctly include such information. This educational period allows professionals to actively participate in the program while avoiding claims denials during the learning curve. It also gives us an opportunity to make any needed claims processing adjustments before payments are impacted.
We believe it is preferable to begin implementation using a single year educational and operations testing period, rather than possibly further delaying the start-date of the program. We do not expect to continue this educational and operations testing period beyond the first year of the AUC program.
We look forward to receiving public comments on all aspects of our proposal, and specifically, comments related to whether the program should be delayed beyond the proposed start date of January 1, 2019. Although our proposal is based in part on comments received in prior rulemaking cycles, it is important to receive comments that help us understand the current readiness of stakeholders. In addition, we have proposed that the program begin with an educational and operations testing period and are interested in comments regarding how long, if longer than one year, such a period should be available.
We expect a voluntary reporting period to be available ahead of January 1, 2019 and anticipate such a period will begin July 2018. The timing for this opportunity for voluntary reporting is dependent on the readiness of the Medicare claims system to accept and process claims that include AUC consultation information. When the voluntary period becomes available we will make announcements through our educational channels such as the CMS Web site and listservs. It is important to note that the proposed educational and operations testing period beginning January 1, 2019, is separate from the anticipated voluntary reporting period that we expect to allow before January 1, 2019. During the voluntary reporting period, AUC consultation and reporting are not required. However, for applicable imaging services ordered on and after January 1, 2019, consulting specified applicable AUC and reporting consultation information on the
The CY 2017 Merit-based Incentive Payment System and Alternative Payment Model final rule with comment period (Quality Payment Program final rule) (81 FR 77008) finalized policies to improve physician and other clinician payments by changing the way Medicare incorporates quality measurement into payments and developing new policies to address and incentivize participation in Advanced Alternative Payment Models (APMs). We expect the Quality Payment Program to evolve over multiple years and to continue iterating on these policies. To this end, the AUC program has the potential to provide new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families and caregivers as well as improving care coordination and patient health management.
Therefore, we have proposed in the CY 2018 Quality Payment Program proposed rule to develop a direct tie between MIPS and the AUC program (See CY 2018 Quality Payment Program Proposed Rule (82 FR 30010) published in the June 30, 2017
We are also considering how the AUC program could serve to support a quality measure under the MIPS quality performance category and seek feedback from the public regarding feasibility and value of pursuing this idea further.
We are proposing to modify § 414.94(i)(3) of our regulations to reflect the sunsetting of the payment adjustments under the Medicare EHR Incentive Program and to substitute an alignment with the advancing care information performance category of MIPS. The categories that we included in the CY 2017 PFS final rule for purposes of the AUC program significant hardship exceptions were the following from § 495.102(d)(4):
• Insufficient Internet Connectivity (as specified in § 495.102(d)(4)(i)).
• Practicing for less than 2 years (as specified in § 495.102(d)(4)(ii)).
• Extreme and Uncontrollable Circumstances (as specified in § 495.102(d)(4)(iii)).
• Lack of Control over the Availability of CEHRT (as specified in § 495.102(d)(4)(iv)(A)).
• Lack of Face-to-Face Patient Interaction (as specified in § 495.102(d)(4)(iv)(B)).
In addition, in the CY 2017 Quality Payment Program final rule, we finalized a policy (81 FR 77240-77243) to reweight the advancing care information performance category to zero in the MIPS final score for the year for MIPS eligible clinicians who meet the criteria in one of the above listed categories of § 495.102(d)(4), with the exception of the category for clinicians practicing for less than 2 years. Under section 1848(q)(1)(C)(v) of the Act, eligible clinicians who first enroll in Medicare during the performance period for a year and have not previously submitted claims under Medicare are not considered MIPS eligible clinicians, and thus are excluded from MIPS. We believe it is likely that many clinicians who have been practicing for less than 2 years would be excluded from MIPS on the basis that they are new Medicare-enrolled MIPS eligible clinicians as defined in § 414.1305. Because these clinicians are not MIPS eligible clinicians, they would never meet the criteria for re-weighting of their MIPS advancing care information performance category for the year. Therefore, to implement a hardship exception for purposes of the AUC program that is both operationally consistent and administratively efficient, we propose to remove as a criterion for a significant hardship exception for the AUC program the criterion specified in § 495.102(d)(4)(ii) of our regulations for those practicing for less than 2 years. We propose to keep the remaining listed categories including insufficient internet connectivity, extreme and uncontrollable circumstances, lack of control over availability of CEHRT and lack of face-to-face patient interaction. We note that section 1843(q)(4)(C)(iii) of the Act only allows the ordering professional to seek a significant hardship exception, not the furnishing professional.
As such, we propose to amend the AUC significant hardship exception regulation to specify that ordering professionals who are granted re-weighting of the advancing care information performance category to zero percent of the final score for the year under MIPS per § 414.1380(c)(2) due to circumstances that include the criteria listed in § 495.102(d)(4)(i), (iii), (iv)(A) and (iv)(B) would be excepted from the AUC consultation requirement during the same year that the re-weighting applies for purposes of the MIPS payment adjustment.
There will be scenarios when a clinician's experience of a significant hardship or extraordinary circumstance does not align with the prospective identification of these ordering professionals with reference to MIPS criteria and processes. However, we believe the prospective identification process allows us to apply exceptions in real-time for claims submitted for advanced imaging services. There are timing differences between the MIPS and the AUC program (the MIPS payment adjustment year is based on performance in a prior year while the Medicare AUC program requires real-time AUC consultation and claims-based reporting). In addition to the timing, there will be instances when a clinician who is not a MIPS eligible clinician will need to seek a significant hardship exception to the Medicare AUC program. To accommodate these two separate scenarios, we propose to establish a process to identify ordering professionals in need of a significant hardship exception to the Medicare AUC program requirements that is outside the MIPS re-weighting process. For purposes of these scenarios, we propose to use the criteria for clinicians seeking an AUC significant hardship exception described under § 495.102(d)(4) to include (i), (iii), (iv)(A) and (iv)(B) of our regulations. We propose these criteria to align with the criteria used under MIPS for re-weighting under the advancing care information performance category, and to provide predictability and consistency to the determination of significant hardship. We further propose that a significant hardship exception from the Medicare AUC program requirements would be granted for no longer than 12 months, and that we could establish an exception for a shorter period where warranted by the circumstances.
Therefore we propose that ordering professionals who have not received a re-weighting to zero for the MIPS
In addition to the proposals above, we invite the public to comment on additional circumstances for which it may be appropriate for an ordering professional to be granted a significant hardship exception under the AUC program.
Section 1834(q) of the Act includes rapid timelines for establishing a Medicare AUC program for advanced diagnostic imaging services. The impact of this program is extensive as it will apply to every physician or other practitioner who orders or furnishes advanced diagnostic imaging services (for example, magnetic resonance imaging (MRI), computer tomography (CT) or positron emission tomography (PET)). This crosses almost every medical specialty and could have a particular impact on primary care physicians since their scope of practice can be quite broad. Stakeholders have expressed concern that program requirements may inadvertently encourage physicians to order imaging services that they do not believe are right for their patients. The goal of evidence-based AUC is to assist clinicians in ordering the most appropriate imaging service for their patients' specific clinical scenarios. However, to ensure we are implementing the program effectively, we are asking for public comment on such potential unintended consequences. Additionally, as we continue to develop the AUC program, we continue to engage a variety of stakeholders interested in participating in the development of AUC. We seek comment about how we can continue to engage interested participants, consistent with statutory requirements at section 1834(q) of the Act, in developing AUC in a transparent and scientifically robust manner. We are particularly interested in how qualified PLEs develop or modify AUC in collaboration with non-PLE entities and what additional challenges such entities might face.
We continue to believe the best implementation approach is one that is diligent, maximizes the opportunity for public comment and stakeholder engagement, and allows for adequate advance notice to physicians and practitioners, beneficiaries, AUC developers, and CDSM developers. It is for these reasons we propose to continue a stepwise approach, adopted through notice and comment rulemaking. We propose policies to implement the third component of the AUC program—the consulting and reporting requirements and the effective date on which these requirements would begin. Under this proposal, ordering professionals must begin consulting specified applicable AUC through qualified CDSMs for applicable imaging services ordered on and after January 1, 2019, and furnishing professionals must begin reporting AUC consultation information on Medicare claims for advanced diagnostic imaging services for which payment is made under an applicable payment system as defined in § 414.94(b) and ordered on or after January 1, 2019.
We also propose modifications to the significant hardship exception to better align these exceptions under the AUC program with those under existing quality programs.
In summary, we are proposing requirements necessary to implement the third component of the AUC program. We invite the public to submit comments on these proposals.
Section 1848(a)(8) of the Act provides that for covered professional services furnished by an EP during each of 2015 through 2018, if the EP does not satisfactorily report data on quality measures for covered professional services for the reporting period for the year, the PFS amount for services furnished by such professional during the year (including the PFS amount for purposes of determining a payment based on such amount) shall be equal to the applicable percent of the PFS amount that would otherwise apply to such services. For 2016 through 2018, the applicable percent is 98.0 percent. Thus, individual EPs and group practices who did not satisfactorily report data on quality measures for the CY 2016 reporting period are subject to a downward payment adjustment of 2.0 percent to the PFS payment amount for covered professional services they furnish in 2018.
We previously finalized the satisfactory reporting criteria for individual EPs and group practices for the CY 2016 reporting period to avoid the 2018 PQRS payment adjustment in the CY 2016 PFS final rule (80 FR 71140 through 71250) at § 414.90(j)(8) and (9) and § 414.90(k)(5).
Table 18 summarizes the previously finalized satisfactory reporting criteria for individual EPs at § 414.90(j)(8) and § 414.90(k)(5).
Table 19 summarizes the previously finalized satisfactory reporting criteria for group practices via the group practice reporting option (GPRO) at § 414.90(j)(9) and § 414.90(k)(5).
Since we finalized these requirements, we have heard from stakeholders that EPs have had difficulty with the previously finalized satisfactory reporting criteria for the CY 2016 reporting period, which is the final reporting period for the PQRS. Specifically, we have heard from stakeholders through written communications to CMS that EPs have found the requirements complex, and had difficulty in understanding the requirements to be a satisfactory reporter for PQRS. Stakeholders have also requested that the requirements for the CY 2016 reporting period be aligned with those of the Quality Payment Program, specifically the Merit-based Incentive Payment System (MIPS). In particular, we have heard requests to lower the previously finalized requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain requirement associated with these measures. While the PQRS and the MIPS are separate programs, we understand that stakeholders would like to see greater continuity between the final year of the PQRS and the beginning of the MIPS.
The final reporting period for the PQRS was CY 2016. The Quality Payment Program, authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), consolidates and replaces three existing programs (the Medicare EHR Incentive Program for EPs, the PQRS, and the Value-Based Payment Modifier (VM)). There are two ways eligible clinicians can participate in this program: (1) Through the MIPS; and (2) through Advanced Alternative Payment Models (APMs). The initial performance period for the MIPS began on January 1, 2017. Under MIPS, there are four connected pillars that affect how MIPS eligible clinicians will be paid by Medicare: Quality; Improvement Activities; Advancing Care Information; and Cost. For more information on the Quality Payment Program, see
While we understand that the data submission period for the CY 2016 reporting period has already ended and that all data that has been submitted to CMS is based on the previously finalized satisfactory reporting criteria for the CY 2016 reporting period, we are revisiting our previously finalized policy because we want individual EPs and groups to be assessed for purposes of the 2018 PQRS payment adjustment based on satisfactory reporting criteria that are simpler, more understandable, and more consistent with the beginning of MIPS. We believe that such criteria will help clinicians more accurately gauge their readiness for the beginning of MIPS and transition into the Quality Payment Program successfully. Additionally, we want to be responsive to the concerns of the clinician community. Therefore, while we are not proposing to collect any additional data for the CY 2016 reporting period, we are proposing to modify the criteria we would apply to the data already submitted for the CY 2016 reporting period to determine whether an individual EP or group practice has satisfactorily reported for purposes of avoiding the 2018 PQRS payment adjustment. Specifically, we are proposing to revise the previously finalized satisfactory reporting criteria for the CY 2016 reporting period to lower the requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain or cross-cutting measure requirement. For individual EPs, this would apply to the following reporting mechanisms: claims, qualified registry (except for measures groups), QCDR, direct EHR product and EHR data submissions vendor product. This proposal would not affect the criteria used to determine whether an individual EP or group practice has satisfactorily reported for purposes of avoiding the 2017 PQRS payment adjustment, with the exception of the criteria applicable to individual EPs and group practices reporting using the secondary reporting period established under § 414.90(j)(1)(ii) for the 2017 PQRS payment adjustment (hereinafter referred to as the “ACO Secondary Reporting Period”), as discussed in section III.F.4. of this proposed rule.
Table 20 summarizes our proposed modifications to the previously finalized satisfactory reporting criteria for individual EPs to avoid the 2018
Additionally, we are also proposing that individual EPs and group practices reporting via claims or qualified registry, as applicable, would no longer be required to report a cross-cutting measure and that individual EPs and group practices reporting via QCDR would no longer be required to report an outcome or “high priority” measure (that is, for purposes of PQRS, a resource use, patient experience of care, efficiency/appropriate use, or patient safety measure). We note that what is considered to be a “high-priority” measure in PQRS is different from what is considered a “high-priority” measure in MIPS, and we are not proposing to align this requirement with MIPS for the last year of PQRS as this could cause confusion. While certain MIPS eligible clinicians are required to report at least one outcome or other high-priority measure (see § 414.1335(a)(1)(i)), we are also not aligning with that requirement because, while we agree that outcome and high-priority measures are valuable for reporting, we want to revise the satisfactory reporting criteria for the last year of PQRS to be less complex for individual EPs and groups to understand.
Lastly, where we are proposing to lower the requirement to only 6 measures, if less than 6 measures apply to the individual EP or group practice, each measure that is applicable would need to have been reported. We define “applicable” to mean measures relevant to a particular individual EP's or group practice's services or care rendered. As previously finalized, individual EPs and group practices would continue to be subject to the measure application validity (MAV) process (80 FR 71140 through 71145). The MAV process seeks to identify clinically similar measures and creates clusters of measures that can be reported if one of the measures in the cluster is reported. We would maintain the requirement that each required measure be reported for at least 50 percent of the individual EP's or group practice's patients to which the measure applies.
Accordingly, we are proposing to revise § 414.90(j)(8) and (k)(5) consistent with our proposals above. We believe these proposals will result in fewer individual EPs being subject to the 2018 PQRS payment adjustment, and will impose no additional burden on individual EPs because this data has already been submitted to CMS. We request comment on these proposals.
As discussed above, while we are not proposing to collect any additional data for the CY 2016 reporting period, we are proposing to modify the satisfactory reporting criteria for the CY 2016 reporting period for purposes of the 2018 PQRS payment adjustment. Specifically, we are proposing to lower the requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain or cross-cutting measure requirement. For group practices, this would apply to the following reporting mechanisms: Qualified registry; QCDR; direct EHR product; and EHR data submissions vendor product. This proposal would not affect the criteria used to determine whether an individual EP or group practice has satisfactorily reported for purposes of avoiding the 2017 PQRS payment adjustment, with the exception of the criteria applicable to individual EPs and group practices reporting using the ACO Secondary Reporting Period, as discussed in section III.F.4. of this proposed rule.
Table 21 summarizes our proposed modifications to the previously finalized satisfactory reporting criteria for group practices to avoid the 2018 PQRS payment adjustment, based on data previously submitted for the CY 2016 reporting period. We are not proposing to collect any additional data for the CY 2016 reporting period, as the data submission period for the CY 2016 reporting period has already ended. As summarized in Table 21, the NQS domain requirement would no longer apply. No changes are being proposed for the Web Interface criteria.
Additionally, as discussed above, we are proposing that individual EPs and group practices reporting via claims and qualified registry, as applicable, would no longer be required to report a cross-cutting measure and that individual EPs and group practices reporting via QCDR would no longer be required to report an outcome or high priority measure. We note that what is considered to be a “high-priority” measure in PQRS is different from what is considered a “high-priority” measure in MIPS, and are not proposing to align this requirement with MIPS for the last year of PQRS as this could cause confusion. While certain MIPS eligible clinicians are required to report at least one outcome or other high-priority measure (see § 414.1335(a)(1)(i)), we are also not aligning with that requirement because, while we agree that outcome and high-priority measures are valuable for reporting, we want to revise the satisfactory reporting criteria for the last year of PQRS to be less complex for individual EPs and groups.
Where we are proposing to lower the requirement to only 6 measures, if less than 6 measures apply to the individual EP or group practice, each measure that is applicable would need to have been reported. We define “applicable” to mean measures relevant to a particular individual EP's or group practice's services or care rendered. As previously finalized, individual EPs and group practices would continue to be subject to the MAV process (80 FR 71140 through 71145). The MAV process seeks to identify clinically similar measures and creates clusters of measures that can be reported if one of the measures in the cluster is reported. We would maintain the requirement that each required measure be reported for at least 50 percent of the individual EP's or group practice's patients to which the measure applies.
Lastly, for purposes of the 2018 PQRS payment adjustment, § 414.90(j)(9)(viii) currently provides that if the CAHPS for PQRS survey is applicable to the practice, group practices comprised of 100 or more eligible professionals that register to participate in the GPRO must administer the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism selected. For the reasons discussed above, we are proposing to revise § 414.90(j)(9)(viii) to provide that such group practices may administer the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism selected, but are not required to do so. This change would be consistent with the data submission criteria for the MIPS quality performance category, under which groups may voluntarily elect to participate in the CAHPS for MIPS survey (see § 414.1335(a)(3)(i)). As summarized in Table 21, the previously finalized satisfactory reporting criteria for group practices administering the CAHPS for PQRS survey would continue to apply to group practices that elected to administer the survey.
Accordingly, we are proposing to revise § 414.90(j)(9) and (k)(5) consistent with our proposals above. We believe these proposals will result in fewer group practices being subject to the 2018 PQRS payment adjustment, and will impose no additional burden on group practices because this data has already been submitted to CMS. We request comment on these proposals.
As discussed in the CY 2017 PFS final rule (81 FR 80441 through 80445), individual EPs and group practices who bill under the TIN of an ACO participant may report separately from the ACO, if the ACO failed to report on behalf of such individual EPs or group practices for the applicable reporting period, during the CY 2016 reporting period for purposes of the 2017 and 2018 PQRS payment adjustments, as applicable. Please note that, in accordance with our previously established policies for the ACO Secondary Reporting Period, our proposed modifications to the satisfactory reporting criteria for individual EPs and group practices for the CY 2016 reporting period would apply to such individual EPs and group practices for purposes of the 2017 PQRS payment adjustment. This proposal would not affect the 2017 PQRS payment adjustment for any other individual EP or group practice.
We previously finalized in the CY 2016 PFS final rule (80 FR 71129 through 71130) a decision to publicly report three data points for the 2018 VM based on 2016 data in the Physician Compare downloadable file in late 2017:
• 2018 VM quality tiers for cost and quality, based on the 2016 data, noting if the EP or group is high, low, or average on cost and quality per the VM.
• A notation of the payment adjustment received based on the cost and quality tiers—upward, downward, or neutral—for each EP or group.
• An indication if the EP or group was eligible to but did not report quality measures to CMS for CY 2016 under PQRS.
In light of the proposals to change the 2016 reporting criteria to avoid the 2018 payment adjustment for PQRS (see section III.F. of this proposed rule) and subsequent VM proposed policies to hold all physician groups and solo practitioners who met minimum quality reporting requirements harmless from downward payment adjustments for performance under quality-tiering for the last year of the program (see section III.I. of this proposed rule), and because the proposed policies for PQRS and VM in this rule would change the nature of how the PQRS data will be used under the VM, we are now proposing not to report this data specific to the VM. Given the fact that VM data would be available for posting in the Physician Compare downloadable database for only one year and the VM data may not reflect an EP or group's actual performance or payment adjustment given they could have chosen to report fewer measures, we believe that proceeding with the posting of this data could be confusing for the public.
Additionally, we have created other VM data files intended to promote transparency. For each VM performance year, we will publish a Public Use File (PUF) that contains VM performance results of de-identified practices. Supporting documentation for each PUF that contains the field name, length, type, label, description, and notes for each variable included in the PUF. The Value Modifier program years 2015 and 2016 (performance year 2013 and 2014) are currently available at
All other previously finalized policies related to 2016 PQRS data available for public reporting on Physician Compare in late 2017 remain unchanged (80 FR 71116 through 71132). Appreciating this, we believe the best course of action is to not move forward with publicly reporting this VM data for 2016. All data required to be reported by law will remain available for public reporting as previously finalized (80 FR 71116 through 71132). For more information on the public reporting policies previously finalized and proposed for MIPS, we refer readers to the Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models (81 FR 77390 through 77399) and Medicare Program; CY 2018 Updates to the Quality Payment Program (82 FR 30163 through 30170), respectively. We request comment on this proposal and specifically, if we were to release this data, how it could be used by the public.
Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statutory basis for the Medicare incentive payments made to eligible professionals (EPs), Medicare Advantage (MA) organizations (for certain qualifying EPs and hospitals), subsection (d) hospitals, and critical access hospitals (CAHs) that demonstrate meaningful use of certified electronic health record (EHR) technology (CEHRT). Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward adjustments to Medicare payments, beginning with calendar or fiscal year (FY) 2015, for EPs, MA organizations, subsection (d) hospitals, and CAHs that are not meaningful users of CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for the Medicaid incentive payments made to EPs and eligible hospitals for the adoption, implementation, upgrade, and meaningful use of CEHRT. We have implemented these statutory provisions in prior rulemakings to establish the Medicare and Medicaid EHR Incentive Programs.
Under these statutory provisions and the regulations at 42 CFR 495.4, one of the requirements of being a meaningful EHR user is successfully reporting the clinical quality measures selected by CMS to CMS or the states, as applicable, in the form and manner specified by CMS or the states, as applicable. Section 1848(o)(2)(B)(iii) of the Act requires that in selecting clinical quality measures (CQMs) for EPs to report under the EHR Incentive Program, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required, including reporting under section 1848(k)(2)(C) of the Act (the Physician Quality Reporting System). As such, we have taken steps to establish alignments among various quality reporting and payment programs that include the submission of CQMs.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the Act and the definition of “meaningful EHR user” at § 495.4, EPs must report on CQMs selected by CMS using CEHRT, as part of being a meaningful EHR user under the Medicare and Medicaid EHR Incentive Programs. In the final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 Through 2017,” we finalized the options for CQM submission for EPs in the Medicare EHR Incentive Program in 2016 as follows (80 FR 62888 through 62889):
• EP Options for Medicare EHR Incentive Program Participation (single program Participation—EHR Incentive Program only):
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• EP Options for Electronic Reporting for Multiple Programs (for example: EHR Incentive Program plus PQRS participation):
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(NOTE: Under option 2, this may include an EP reporting using the group
For the Medicaid EHR Incentive Program, we specified (80 FR 62888) that states would continue to be responsible for determining whether and how electronic reporting of CQMs would occur, or if they wish to allow reporting through attestation. Any changes that states make to their CQM reporting methods must be submitted through the state Medicaid Health IT Plan (SMHP) process for our review and approval prior to being implemented.
We maintained a requirement that EPs report 9 CQMs covering at least 3 NQS domains (80 FR 62888 through 62889). This requirement was established in the final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2” (77 FR 54058).
We also continued (80 FR 62888 through 62889) our existing policy that under Medicare, healthcare providers in any year of participation for the EHR Incentive Program for 2015 through 2017 may electronically report CQM data using the options previously outlined for electronic reporting either for single program participation in the Medicare EHR Incentive Program, or for participation in multiple programs if the requirements of the aligned quality program are also met.
We noted that an EHR certified for CQMs under the 2014 Edition certification criteria does not need to be recertified each time it is updated to a more recent version of the eCQMs (80 FR 62889).
As we discussed in section III.F. in this proposed rule, since we finalized these requirements, we have heard from stakeholders through written communications that EPs and groups have found the previously finalized reporting criteria for the CY 2016 reporting period to be complex and had difficulty in understanding the requirements to be a satisfactory reporter, and these same EPs and groups subsequently requested that the CQM reporting requirements for EPs and groups participating in the Medicare EHR Incentive Program in 2016 who chose to report CQMs electronically through the Physician Quality Reporting System (PQRS) Portal be aligned with those of the Quality Payment Program, specifically the Merit-based Incentive Payment System (MIPS).
Therefore, while we are not proposing to collect any additional data for 2016, we are proposing to change the reporting criteria for EPs and groups who chose to electronically report CQMs through the PQRS Portal for purposes of the Medicare EHR Incentive Program. Specifically, we are proposing to change the reporting criteria from 9 CQMs covering at least 3 NQS domains to 6 CQMs with no domain requirement. We are proposing this change so that the reporting criteria for the Medicare EHR Incentive Program would be in alignment with the modified requirement that we are proposing for the final PQRS reporting period (2016) in section III.F. of this proposed rule, as well as the transition year of the Quality Payment Program. We are proposing that an EP or group who satisfies the proposed reporting criteria may qualify for the 2016 incentive payment under section 1848(o) of the Act and may avoid the downward payment adjustment in 2017 and/or 2018 under section 1848(a)(7)(A) of the Act, depending on the EP or group's applicable EHR reporting period for the payment adjustment year. This proposed change would help maintain alignment with PQRS per the requirement under section 1848(o)(2)(B)(iii) of the Act for the Secretary to seek to avoid redundant or duplicative reporting otherwise required, including reporting under section 1848(k)(2)(C) of the Act (the PQRS). We are not proposing to change the previously finalized requirements for CQM reporting in 2016 for eligible hospitals and CAHs; or the previously finalized requirements for EPs who chose to report CQMs through attestation in 2016 for the Medicare EHR Incentive Program (80 FR 62888). Our reasoning for not proposing to change the eligible hospital or CAH requirements for CQM reporting is because the changes proposed for PQRS in section III.F. of this proposed rule and the policies established for the transition year of the Quality Payment Program would only affect clinicians and groups, and therefore, there is no reason to propose changes to the established policy for eligible hospitals or CAHs. We are not proposing to change the requirements for EPs who reported CQMs through attestation because those who attested were successful, therefore we believe there is no need to change the requirement. Additionally, the Registration and Attestation portal is scheduled to sunset as of October 1, 2017 before this final rule is published.
Lastly, we are also not proposing to change the previously finalized requirements for 2016 for EPs participating in the Medicaid EHR Incentive Program. We have already proposed in “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices” that, for 2017, Medicaid EPs would be required to report on any six CQMs that are relevant to the EP's scope of practice (82 FR 20135). In proposing that change, we indicated that it is our intention to align CQM requirements for Medicaid EPs with requirements under the Medicare quality improvement programs, to the extent practicable. However, we believe that due to the timing of when any changes we might propose for 2016 through this rulemaking would take effect (if finalized), the benefits of proposing to extend the policy proposed for Medicare EPs for 2016 to Medicaid EPs for 2016 would not be realized, and the burden on states to implement such a policy would be significant. There is no negative payment adjustment for not participating in the Medicaid EHR Incentive Program, so it is likely that applying the proposed policy for Medicare EPs to Medicaid EPs for 2016 would benefit Medicaid EPs only if they are able to submit new data to states for a Medicaid EHR incentive payment for 2016. Because we anticipate that most states will have completed processing and paying 2016 Medicaid EHR incentive payments by the time such a proposal (if finalized) would take effect, we believe that applying this change to the Medicaid EHR Incentive Program for 2016 would significantly burden states. We seek comment on our assessment of the difficulty states might face implementing this policy for 2016 for Medicaid EPs, and on the number of Medicaid EPs who might benefit if we instead decided to apply this policy in the Medicaid EHR Incentive Program for 2016, to the extent that doing so would be legally permissible.
Under section 1899 of the Act, we established the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and
In this CY 2018 PFS proposed rule, we propose further refinements to the Shared Savings Program rules. This rule includes two proposed modifications to the Shared Savings Program beneficiary assignment methodology: (1) Revisions to the assignment methodology under 42 CFR part 425, subpart E to reflect the requirement under section 17007 of the 21st Century Cures Act (Pub. L. 114-255, December 13, 2016), that for performance years beginning on or after January 1, 2019, the Secretary determine an appropriate method to assign Medicare FFS beneficiaries to an ACO based on their utilization of services furnished by rural health clinics (RHCs) or federally qualified health centers (FQHCs), and (2) addition of new chronic care management and BHI service codes to our definition of primary care services. In addition, we propose to revise the methodology used in our quality validation audits and the manner in which the results of these audits may be used to adjust an ACO's sharing rate. We also propose to reserve the discretion to redesignate a measure reported through the CMS web interface as pay-for-reporting when substantive changes are made to the measure under the Quality Payment Program.
We also address proposals intended to reduce application burden for stakeholders by reducing certain documentation submission requirements included in the initial Shared Savings Program application and the application for use of the skilled nursing facility (SNF) 3-Day Rule Waiver. We also propose to establish specific procedures to address situations where a Taxpayer Identification Number (TIN) that is an ACO participant in more than one ACO begins to submit claims for services used in the beneficiary assignment process and becomes out of compliance with the “exclusivity” requirement in § 425.306(b)(2). Finally, we propose that, for performance year 2018 and subsequent years, we would only include individually beneficiary identifiable payments made under a demonstration, pilot or time limited program that are final and not subject to further reconciliation in financial calculations related to establishing and updating benchmarks and determining performance year expenditures under the Shared Savings Program.
As originally enacted in the Affordable Care Act, section 1899(c) of the Act requires us to assign FFS beneficiaries to an ACO participating in the Shared Savings Program based on the beneficiary's utilization of primary care services rendered by physicians participating in the ACO. Medicare FFS beneficiaries do not enroll in the Shared Savings Program or with a particular ACO, and they retain the right to seek Medicare-covered services from any Medicare-enrolled provider or supplier of their choosing. Furthermore, no exclusions or restrictions based on health conditions or similar factors are applied in the assignment of Medicare FFS beneficiaries. Thus, a beneficiary's choice to receive primary care services during a prior 12 month period (the “assignment window”) furnished by physicians and certain nonphysician practitioners that are ACO professionals in the ACO determines the beneficiary's assignment to an ACO under the Shared Savings Program.
The regulations governing the assignment methodology under the Shared Savings Program are in part 425, subpart E. Consistent with the statutory requirement to base assignment on the utilization of primary care services furnished by physicians who are ACO professionals, a beneficiary is eligible for assignment to an ACO under § 425.402 if the beneficiary had at least one primary care service during the applicable assignment window furnished by a physician who is an ACO professional in the ACO and who is a primary care physician as defined under § 425.20 or has one of the primary specialty designations specified in § 425.402(c). This initial process for determining whether a beneficiary is eligible for assignment is referred to as the assignment “pre-step”. Under the first step of the assignment process, a beneficiary who is eligible for assignment to the ACO will be assigned to the ACO if the allowed charges for primary care services furnished to the beneficiary during the assignment window by all primary care physicians who are ACO professionals and non-physician ACO professionals in the ACO are greater than the allowed charges for such services provided during the assignment window by primary care physicians, nurse practitioners, physician assistants, and clinical nurse specialists who are ACO professionals in another ACO or not affiliated with any ACO and are identified by a Medicare-enrolled billing TIN. The second step of the assignment process considers the remainder of beneficiaries who have received at least one primary care service during the assignment window from an ACO physician who is a primary care physician as defined under § 425.20 or who has one of the primary specialty designations specified in § 425.402(c),
As discussed in detail in the November 2011 final rule we finalized a claims-based hybrid approach (called preliminary prospective assignment with retrospective reconciliation) for assigning beneficiaries to an ACO (76 FR 67851 through 67870), which is currently applicable to ACOs participating under Track 1 or Track 2 of the Shared Savings Program. Under this approach, beneficiaries are preliminarily assigned to an ACO at the beginning of a performance year and quarterly thereafter during the performance year, but the final beneficiary assignment is determined after each performance year based on where beneficiaries chose to receive a plurality of their primary care services during the performance year. We adopted this policy because we believe that the methodology balances beneficiary freedom to choose healthcare providers under FFS Medicare during the performance year with the ACO's desire to know in advance about beneficiaries who have chosen to receive such services from practitioners participating in the ACO in the past and who are likely to continue to choose to receive such services during the performance year. Knowing in advance which beneficiaries are likely to receive a plurality of their primary care from ACO practitioners during the performance year gives ACOs greater opportunities to proactively impact the quality and cost of care for beneficiaries who may be assigned to the ACO at the end of the performance year.
In the June 2015 final rule, and in response to stakeholders' suggestions, we implemented an option for ACOs to participate in a new two-sided performance-based risk track, Track 3 (80 FR 32771 through 32781). Under Track 3, beneficiaries are prospectively assigned to the ACO at the beginning of the performance year using the same two-step methodology described previously, based on where the beneficiaries have chosen to receive a plurality of their primary care services during a 12-month assignment window offset from the calendar year that reflects the most recent 12 months for which data are available prior to the start of the performance year. The ACO is held accountable for beneficiaries who are prospectively assigned to it for the performance year. Under limited circumstances, a beneficiary may be excluded from the prospective assignment list during or after the performance year. For example, a beneficiary will be excluded from the prospective assignment list if the beneficiary enrolls in Medicare Advantage during the performance year or no longer lives in the United States or U.S. territories and possessions, based on the most recent available data regarding the beneficiary's residence at the end of the performance year. A beneficiary is not excluded from the ACO's prospective assignment list during the performance year or at the time of reconciliation for most other reasons, such as if the beneficiary chose to receive most or all of his or her primary care during the performance year from providers and suppliers outside the ACO. Additionally, no beneficiaries are added to the ACO's prospective assignment list during the performance year or at the time of reconciliation even if they chose to receive a plurality of their primary care during the performance year from ACO professionals participating in the ACO and were not previously identified on the prospective assignment list. Offering this alternative approach to beneficiary assignment responds to stakeholders who expressed a desire for a prospective assignment approach. These stakeholders believe prospective assignment will provide more certainty about the beneficiaries for whom the ACO will be held accountable during the performance year, thus enabling ACOs to redesign their patient care processes to more efficiently and effectively improve care for specific FFS beneficiaries rather than for all FFS beneficiaries. We note, however, that such certainty is limited because prospectively assigned beneficiaries who meet the exclusion criteria specified in § 425.401(b) during the performance year will not be assigned to the ACO at the end of the year; further, as noted, beneficiaries remain free under FFS Medicare to choose the healthcare providers from whom they receive services.
Finally, in the CY 2017 Physician Fee Schedule final rule (81 FR 80501 through 80510), we further enhanced the claims-based beneficiary assignment methodology by finalizing a policy to incorporate data gathered directly from beneficiaries who designate a “main doctor” they believe is responsible for coordinating their overall care. Beginning in performance year 2017, beneficiaries may designate a provider or supplier as responsible for coordinating their overall care using
RHCs and FQHCs are facilities that furnish services that are typically furnished in an outpatient clinic setting. Prior to October 1, 2014, FQHCs were paid an all-inclusive rate (AIR) per visit for qualified primary and preventive health services furnished to Medicare beneficiaries. On October 1, 2014, FQHCs began to transition to a new FQHC prospective payment system (PPS). FQHCs were required to use HCPCS coding on all their claims starting on January 1, 2011, to inform the development of the PPS and for limited other purposes, and are now required to use HCPCS coding for payment purposes under the FQHC PPS.
RHCs are paid an AIR per visit for qualified primary and preventive health services furnished to Medicare beneficiaries. Prior to April 1, 2016, RHCs were required to report HCPCS codes for a few services, such as certain preventive services eligible for a waiver of the deductible and/or coinsurance, services subject to frequency limits, and services eligible for payments in addition to the AIR. Effective April 1, 2016, all RHCs are required to report the appropriate HCPCS code for each service furnished during the visit, along with the appropriate revenue code (For additional background, please see the CMS Web site at
As we noted in the November 2011 final rule, RHC and FQHC claims contain very limited information concerning the individual practitioner, or even the type of health professional (for example, physician, PA, or NP) who provided the service because this information is not necessary to determine payment rates for services in RHCs and FQHCs s (76 FR 67858 through 67861). Therefore, unlike physician fee schedule claims, there is no direct way for us to determine if a claim was for a service furnished by a physician at the RHC or FQHC.
In spite of the difference in claims billing, based on detailed comments from some RHC and FQHC representatives, in the November 2011 final rule, we established a process that allows primary care services furnished in RHCs and FQHCs to be considered in the assignment process for any ACO that includes an RHC or FQHC as an ACO participant. This process is set forth in § 425.404. We assign beneficiaries to ACOs that include RHCs or FQHCs as ACO participants in a manner generally consistent with how we assign beneficiaries to other ACOs based on primary care services performed by certain physicians and non-physician practitioners who are ACO professionals in the ACO, as described previously. However, to address the requirement under section 1899(c) of the Act that beneficiaries be assigned to an ACO based on their use of primary care services furnished by physicians, we require ACOs that include RHCs or FQHCs to identify, through an attestation, the physicians that directly provide patient primary care services in their ACO participant RHCs or FQHCs (see §§ 425.204(c)(5)(iii) and 425.404(a)). We use the combination of the RHC or FQHC ACO participant TIN (and another unique identifier, such as a CCN, where appropriate) and the NPIs of the RHC or FQHC physicians provided to us through the attestation process to identify those beneficiaries who received a primary care service from a physician in the RHC or FQHC and who are therefore eligible to be assigned to the ACO as provided under § 425.402(b)(1), which we refer to as the assignment “pre-step”. Then, we assign those beneficiaries to the ACO, using the step-wise assignment methodology under § 425.402(b), if they received the plurality of their primary care services, as determined based on allowed charges for the HCPCS codes and revenue center codes included in the definition of primary care services at § 425.20, from ACO professionals in the ACO.
The special procedures that we have established for using RHC and FQHC services in the assignment methodology are discussed in detail in the June 2015 final rule (80 FR 32755 through 32756). RHC and FQHC services are billed on an institutional claim form and require special handling to incorporate them into the beneficiary assignment process. For RHCs and FQHCs that are ACO participants, we treat an RHC or FQHC service reported on an institutional claim as a primary care service performed by a primary care physician if the claim includes a HCPCS or revenue center code that is included in the definition of a primary care service at § 425.20 and the service was furnished by a physician who was identified as directly providing primary care services on the attestation provided under § 425.404(a). All such physicians are considered primary care physicians for purposes of the assignment methodology and no specialty code is required for these claims. If the claim is for a primary care service furnished by someone other than a physician listed on the attestation, we treat the service as a primary care service furnished by a non-physician ACO professional. As a result, all primary care services furnished by an ACO professional in an RHC or FQHC to a beneficiary eligible for assignment to the ACO are considered in step 1 of the assignment methodology. Finally, for RHCs and FQHCs that are not ACO participants, we assume a primary care physician performed all primary care services so that all primary care services furnished by non-ACO RHCs/FQHCs are considered in step 1 of the assignment methodology. We believe this approach helps to ensure that we do not disrupt established relationships between beneficiaries and their caregivers in non-ACO participant RHCs and FQHCs by inappropriately assigning beneficiaries to ACOs that are not primarily responsible for coordinating their overall care.
We developed and implemented these regulatory and operational policies to facilitate full participation of rural providers, including RHCs and FQHCs, in the Shared Savings Program, within the statutory requirements for the program. In general, stakeholders have been appreciative of our policies to include rural providers and suppliers in the Shared Savings Program. However, some stakeholders have expressed concerns that the special conditions required for us to consider RHC and FQHC institutional claims in beneficiary assignment are burdensome and discourage ACOs from including RHCs and FQHCs as ACO participants in the Shared Savings Program. Stakeholders have commented that the requirement for ACOs that include an RHC or FQHC as an ACO participant to provide an attestation identifying ACO professionals who are physicians who directly furnish primary care services at the RHC or FQHC is particularly burdensome. In addition, due to the operational complexities of collecting identifying information about ACO participants, screening them for program integrity and other potential issues, and incorporating claims data for approved ACO participants into beneficiary assignment and financial calculations, we have implemented a policy that limits the addition of entities to the ACO participant list, absent unusual circumstances, to an annual basis. The limitation also applies to changes to the attestation to identify additional physicians who directly furnish primary care services at an ACO participant RHC or FQHC. In contrast, when a new ACO professional begins billing for primary care services under the TIN of an ACO participant that is not an RHC or FQHC, those services will be considered for purposes of assignment in the current performance year. As a result, there are a number of unique burdens and anomalies in the way in which RHC and FQHC institutional claims are used for purposes of assignment under the Shared Savings Program. First, as noted by stakeholders, the required attestation process for submitting physician identifiers requires more effort to ensure the accuracy of the ACO participant list (including the attestation that includes the physician identifiers) than the level of effort required for ACOs that do not include RHCs and FQHCs. Second, we have recognized that the required attestation process for submitting physician identifiers is also prone to error because some RHCs and FQHCs
Section 17007 of the 21st Century Cures Act, amended section 1899(c) of the Act (42 U.S.C. 1395jjj(c)) to require the Secretary to assign beneficiaries to ACOs participating in the Shared Savings Program based not only on their utilization of primary care services furnished by physicians but also on their utilization of services furnished by RHCs and FQHCs, effective for performance years beginning on or after January 1, 2019. The statute provides the Secretary with broad discretion to determine how to incorporate services provided by RHCs and FQHCs into the Shared Savings Program beneficiary assignment methodology.
We believe that the 21st Century Cures Act provides the Secretary with broad discretion to revise the assignment methodology to address the concerns expressed by certain stakeholders regarding the burdens placed on ACOs that include RHCs and FQHCs as ACO participants, as described above. Section 17007 of the 21st Century Cures Act provides that for performance years beginning on or after January 1, 2019, Medicare services furnished in an FQHC or RHC should be considered in beneficiary assignment for the Shared Savings Program, as may be determined by the Secretary. Accordingly, in implementing section 17007 of the 21st Century Cures Act, we believe it would be appropriate to reduce operational burdens for ACOs that include RHCs or FQHCs as ACO participants and bring greater consistency to the operational method of using claims to assign beneficiaries to ACOs. In order to promote participation of RHCs and FQHCs under the Shared Savings Program, we propose to remove the burdensome attestation requirement and instead treat a service reported on an RHC or FQHC institutional claim as a primary care service furnished by a primary care physician. Consistent with the 21st Century Cures Act, under this proposal: (1) The requirement for an attestation identifying physicians who directly provide primary care services in each RHC or FQHC that is an ACO participant and/or ACO provider/supplier in the ACO would be removed; (2) all RHC and FQHC claims would be used to establish beneficiary eligibility to be assigned to the ACO (pre-step); and (3) all RHC and FQHC claims would be included in step 1. We would note that in considering all services billed under the TIN of the ACO participant RHC or FQHC, we would include services that do not meet the definition of primary care services, and such services would not be limited to those provided by a primary care physician, as defined under program rules. This means that under the proposal, a beneficiary could be furnished services in an RHC and FQHC only by a nurse practitioner, physician assistant, clinical nurse specialist, or any other practitioner in an RHC and FQHC and still be eligible for assignment to the ACO.
More specifically, we are proposing the following changes to our regulations: (1) Remove § 425.204(c)(5)(iii) in its entirety; (2) revise § 425.404; and (3) make conforming changes to the definition of primary care physician found at § 425.20. Under our proposal, for performance year 2019 and subsequent performance years, ACOs with ACO participants that are RHCs and FQHCs would no longer be required to submit NPIs or other identifying information for physicians who directly provide primary care services in the ACO participant RHCs and FQHCs as indicated in § 425.204(c)(5)(iii)(A) and § 425.404(a). Therefore we propose to remove § 425.204(c)(5)(iii) in its entirety. Additionally, we propose revisions to § 425.402 and § 425.404 to reflect that for performance year 2019 and subsequent performance years, we would assign beneficiaries to ACOs based on services furnished in RHCs or FQHCs consistent with the general assignment methodology in § 425.402, by treating a service reported on an RHC or FQHC institutional claim in the same way as a primary care service performed by a primary care physician. We also propose to remove revenue center codes from the definition of primary care services (§ 425.20) for performance year 2019 and subsequent performance years because all RHC and FQHC services will be used for purposes of assignment for benchmark and performance years; therefore, we believe it is appropriate to modify our definition of primary care services for performance year 2019 and subsequent years to no longer include revenue center codes. Additionally, we note that the requirement for an attestation under § 425.404 is also referenced in the definition of primary care physician at § 425.20; accordingly, we propose to make a conforming revision to that definition to remove the reference to the attestation requirement for performance year 2019 and subsequent years.
Consistent with how we have implemented other changes to the assignment methodology (see, for example, 80 FR 32757 through 32758), we propose to adjust all ACO benchmarks at the start of the first performance year in which the new assignment rules are applied so that the ACO benchmarks reflect the use of the same assignment rules as will apply in the performance year. Also consistent with how we have implemented previous changes to the Shared Savings Program assignment methodology, we would use the new methodology each time assignment is determined for purposes of performance year 2019, including using the new methodology in late CY 2018 to determine the eligibility of ACOs wishing to enter into or renew a participation agreement beginning January 1, 2019. Under the Shared Savings Program, ACOs must have and maintain at least 5,000 assigned beneficiaries.
We believe this proposal would reduce administrative burden for ACOs that include RHCs or FQHCs as ACO participants and support our policy goal of assigning beneficiaries to the entity that is primarily responsible for the beneficiary's overall care. That is, including all services furnished by RHCs or FQHCs to establish beneficiary eligibility to be assigned to an ACO (pre-step) and in the stepwise assignment methodology should help to ensure that a beneficiary is assigned to an ACO when the ACO participants in that ACO are providing the plurality of care for that beneficiary and thus the ACO should be accountable for the patient's overall care.
We welcome comments on our proposal to: (1) Remove § 425.204(c)(5)(iii) and modify § 425.402 and § 425.404, for performance year 2019 and subsequent performance years, to eliminate the requirement for ACOs that include an RHC or FQHC as an ACO participant to provide an attestation identifying physicians who directly provide primary care services in each RHC or FQHC that is an ACO participant and/or ACO provider/supplier in the ACO, and make conforming changes to the definition of primary care physician at § 425.20; and (2) for performance year 2019 and subsequent performance years, to: (a)
We recognize the unique needs and challenges of rural and underserved communities and the important role played by providers and suppliers serving these communities in assuring access to primary health care. RHCs, FQHCs, and other providers furnishing care in rural and underserved communities play an important role in the nation's health care delivery system by serving as safety net providers of primary care and other health care services, and we believe these proposed changes will enhance their ability to participate in the Shared Savings Program.
We also invite suggestions on how we might further support participation of RHCs and FQHCs in the Shared Savings Program.
Section 1899(c) of the Act requires the Secretary to assign beneficiaries to an ACO “based on their utilization of primary care services” provided by a physician. However, the statute does not specify which kinds of services may be considered primary care services for this purpose, nor the amount of those services that would be an appropriate basis for making assignments. In this section of this proposed rule, we summarize how we currently identify the appropriate primary care services on which we base assignment. In addition, we propose a revision to our current policies for defining primary care services for purposes of beneficiary assignment, consistent with our statement in the November 2011 final rule (76 FR 67853), that we intended to monitor this issue and would consider making changes to the definition of primary care services to add or delete HCPCS codes used to identify primary care services, if there were sufficient evidence that revisions were warranted.
We currently define primary care services for purposes of the Shared Savings Program in § 425.20 as the set of services identified by the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99318 (excluding claims including the POS 31 modifier), 99319 through 99340, 99341 through 99350, 99495, 99496, 99490, the Welcome to Medicare visit (G0402), and the annual wellness visits (G0438 and G0439). In addition, we have established a cross-walk for these codes to certain revenue center codes used by FQHCs (for services furnished prior to January 1, 2011) and RHCs so that their services can be included in the beneficiary assignment process. Lastly, we include G0463 for services furnished in electing teaching amendment (ETA) hospitals.
In the November 2011 final rule (76 FR 67853), we established the initial list of codes that we considered to constitute primary care services for several reasons. First, we believed the listed codes represented a reasonable approximation of the kinds of services that are described by the statutory language which refers to assignment of “Medicare fee-for-service beneficiaries to an ACO based on their utilization of primary care services” furnished by physicians. In addition, we selected this list to be largely consistent with the definition of primary care services in section 5501 of the Affordable Care Act. That section establishes the Primary Care Incentive Payment Program to expand access to primary care services, and thus its definition of primary care services provides a compelling precedent for adopting a similar list of codes for purposes of the beneficiary assignment process under the Shared Savings Program. We slightly expanded the list of codes found in section 5501 of the Affordable Care Act to include the Welcome to Medicare visit (HCPCS code G0402) and the annual wellness visits (HCPCS codes G0438 and G0439) as primary care services for purposes of the Shared Savings Program. These codes clearly represent primary care services frequently received by Medicare beneficiaries, and in the absence of the special G codes the services provided during these visits would be described by one or more of the regular office visit codes that are included in the list under Section 5501 of the Affordable Care Act.
In the June 2015 final rule (80 FR 32746 through 32748), we expanded the definition of primary care services to include two transitional care management (TCM) codes (CPT codes 99495 and 99496), and one chronic care management (CCM) code, (CPT 99490). As discussed in the final rule, the TCM codes were established to pay a patient's physician or practitioner to coordinate the patient's care in the 30 days following a hospital or skilled nursing facility (SNF) stay. Including these codes in the definition of primary care services reflects our belief that the work of community physicians and practitioners in managing a patient's care following discharge from a hospital or nursing facility to ensure better continuity of care for these patients and help reduce avoidable readmissions is a key aspect of primary care.
In the CY 2017 PFS Final Rule, we finalized a separate payment for three additional CCM service codes, CPT codes 99487 and 99489 (see 81 FR 80251), and an additional add-on code G0506 (see 81 FR 80245), to support care management for the most complex and time-consuming cases of beneficiaries with multiple chronic conditions. These codes are used to report complex CCM services furnished to patients with multiple (two or more) chronic conditions. CCM services generally include regular development and revision of a plan of care, communication with other treating health professionals, and medication management. We explained in the CY 2017 PFS final rule that we believe the addition of the complex CCM codes will retain elements of the CCM service that are characteristic of the changes in medical practice toward advanced primary care, while eliminating redundancy, simplifying provision of the services, and improving access to the services. Additional explanation of required elements for billing CCM services can be found in the CY 2017 PFS Final Rule (81 FR 80243 through 80251).
Finally, in the 2017 PFS final rule (81 FR 80230 through 80243), we finalized a policy to make separate payments to physicians and non-physician practitioners for behavioral health integration (BHI) services they furnish to beneficiaries over a calendar month service period using four new Medicare Part B billing codes. Three of these BHI codes (G0502, G0503, G0504) are used to bill for monthly services furnished using the Psychiatric Collaborative Care Model (CoCM), an approach to BHI shown to improve outcomes in multiple studies. CoCM is a model of BHI that enhances “usual” primary care by adding two key services: Care management support for patients receiving behavioral health treatment; and regular psychiatric inter-specialty consultation to the primary care team, particularly regarding patients whose conditions are not improving. The fourth BHI service code (G0507) is used to bill monthly services furnished using BHI models of care other than CoCM that similarly include “core” service elements such as systematic assessment and monitoring, care plan revision for
As discussed above, we previously finalized the inclusion of CCM code 99490 in the definition of primary care services for the Shared Savings Program. For the same reason that we included CCM code 99490, we believe that it would be also be appropriate to include the complex CCM service codes 99487, 99489, and G0506 in the definition of primary care services and to utilize these codes in the beneficiary assignment methodology under the Shared Savings Program beginning in 2018 for performance year 2019 and subsequent years. These three additional CCM codes reflect the changes in medical practice toward advanced primary care and differ from each other only in the amount of clinical staff service time provided; the complexity of medical decision-making as defined in the Evaluation and Management guidelines (determined by the problems addressed by the reporting practitioner during the month); and the nature of care planning that was performed (establishment or substantial revision of the care plan for complex CCM versus establishment, implementation, revision, or monitoring of the care plan for non-complex CCM).
In addition, we believe that it would be also be appropriate to include the four BHI codes G0502, G0503, G0504 and G0507 in the definition of primary care services and to utilize these codes in the beneficiary assignment methodology under the Shared Savings Program beginning in 2018 for performance year 2019 and subsequent years. These BHI codes reflect important enhancements in primary care to support improvement and integration of care provided for patients receiving behavioral health treatment. As discussed above, the BHI service codes may be billed by the treating practitioner (a physician and/or non-physician practitioner (PA, NP, CNS, CNM)). Physicians billing for these services would typically be primary care physicians, but may be of another specialty such as cardiology or oncology. (See fact sheet available on our Web site at
Therefore, we propose to revise the definition of primary care services currently located in § 425.20 to include three additional CCM service codes 99487, 99489, and G0506, and four BHI service codes G0502, G0503, G0504 and G0507, beginning in 2018 for performance year 2019 and subsequent performance years and to include these codes when performing beneficiary assignment under § 425.402. In addition, we propose to move the list of service codes currently listed in the definition in § 425.20 to § 425.400(c). We believe § 425.400, which specifies general requirements related to the assignment methodology and currently contains a cross-reference at § 425.400(c) to the definition of primary care services under § 425.20, is the more appropriate place to specify the particular primary care codes that will be considered in the assignment methodology. We also propose to reorganize the list of service codes, grouping HCPCS codes, G codes, and revenue center codes together, respectively, by relevant performance year(s). We seek comments on this proposal. In addition, we seek comments as to whether there are any additional existing HCPCS/CPT codes, that we should consider adding to the definition of primary care services in future rulemaking for purposes of assignment of beneficiaries to ACOs under the Shared Savings Program.
We also propose to remove paragraph (3) from the definition of primary care services. Paragraph (3) indicates that we will include additional codes designated by us as primary care services, including new HCPCS/CPT and revenue center codes and any subsequently modified or replacement codes for the HCPCS/CPT and revenue center codes identified in the definition. We finalized this policy in the June 2015 final rule (80 FR 32746), explaining that it was intended to promote flexibility for the Shared Savings Program and allow us to respond more quickly to HCPCS/CPT coding changes made in the annual PFS rulemaking process. We now believe this paragraph which directs CMS to respond to HCPCS/CPT coding changes though rulemaking is unnecessary because we always have the flexibility to propose, through the annual PFS rulemaking (or other rulemaking for the Shared Savings Program), to make changes to the definition of primary care services to reflect HCPCS/CPT coding changes made elsewhere in the same PFS rulemaking or in a previous PFS final rule. We therefore believe it would be reasonable to remove this paragraph rather than move it to subpart E under part 425 along with the other paragraphs making up the definition of primary care services.
Section 1899(b)(3)(A) of the Act requires the Secretary to determine appropriate measures to assess the quality of care furnished by ACOs, such as measures of clinical processes and outcomes; patient and, wherever practicable, caregiver experience of care; and utilization, such as rates of hospital admission for ambulatory sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to submit data in a form and manner specified by the Secretary on measures that the Secretary determines necessary for ACOs to report to evaluate the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act states that the Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs and seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. We designate the quality performance standard that will apply for each performance year. The quality performance standard is the overall standard the ACO must meet in order to be eligible for shared savings.
In the November 2011 final rule (76 FR 67973), we initially established a quality performance standard consisting of 33 measures across 4 domains (see § 425.502(d)), including patient experience of care, care coordination/patient safety, preventive health, and at-risk population and a methodology for scoring the measures submitted by ACOs (see § 425.502(e)). Quality measures are submitted by the ACO through the CMS web interface, calculated by us from administrative and claims data, and collected via a patient experience of care survey based on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey. To qualify for shared savings (see §§ 425.604(c), 425.606(c), and 425.610(c)), an ACO must meet or exceed its minimum savings rate, meet the minimum quality performance standards established under § 425.502, and otherwise maintain its eligibility to participate in the Shared Savings Program. For example, under the
Since the November 2011 Shared Savings Program final rule, we have continued to review the quality measures used for the Shared Savings Program to ensure that they are up to date with current clinical practice and are aligned with the CMS web interface reporting for PQRS, and most recently, with reporting requirements under the Quality Payment Program. Through the annual rulemaking for the PFS we have reviewed and updated the quality measures reported by ACOs through the CMS web interface, including adding new measures and retiring measures that were redundant or no longer met the goals for group reporting, and ensuring that the ACO CMS web interface reported measures align with the measures reported through the CMS web interface by group practices in other CMS initiatives such as PQRS and the Quality Payment Program. The quality measure set currently includes 31 quality measures (see Tables 42 and 43 at 81 FR 80488 and 80489). To avoid confusion and duplication of rulemaking, and reduce provider burden, we also finalized a policy in the 2017 PFS final rule that future changes to the CMS web interface measure will be made through rulemaking for the Quality Payment Program and will be applicable to ACO quality reporting under the Shared Savings Program (81 FR 80499 and 80500). Under the APM scoring standard finalized in the CY 2017 Quality Payment Program final rule (81 FR 77255 through 77256), measures reported by Shared Savings Program ACOs through the CMS web interface will also be used to determine the Merit-Based Incentive Payment System (MIPS) quality performance category score for eligible clinicians participating in a Shared Savings Program ACO in 2017.
When scoring ACO quality performance in the Shared Savings Program, we designate a performance benchmark and minimum attainment level for each measure. Performance below the minimum attainment level for a measure will receive zero points for that measure and performance equal to or greater than the minimum attainment level for the measure will receive points on a sliding scale based on the level of performance. We update the quality performance benchmarks every 2 years. For the first performance year of an ACO's first agreement period, we define the quality performance standard at the level of complete and accurate reporting for all quality measures. During subsequent performance years of the ACO's first agreement period, the quality performance standard is phased in such that the ACO must continue to report all measures but the ACO will be assessed on performance based on the quality performance benchmark and minimum attainment level for certain measures that are designated a pay for performance. The quality performance standard that applies to an ACO's final year in its first agreement period also applies for each performance year of an ACO's subsequent agreement period. A newly introduced measure is set at the level of complete and accurate reporting for the first 2 reporting periods the measure is required. For subsequent reporting periods, the quality performance standard for the measure will be assessed according to the phase-in schedule for the measure. Pay for reporting measures are worth 2 points each for complete and accurate reporting, whereas pay for performance measures are worth 0-2 points based on ACO performance compared to the established benchmark. The EHR measure (ACO-11), however, is double-weighted and ACOs can earn up to 4 points based on their performance on this measure.
Additionally, as discussed in the CY 2016 PFS final rule with comment period (see 80 FR 71269), occasionally issues arise with measures that cause us to reevaluate whether it is appropriate to hold an ACO accountable for performance on a measure. For instance, in the CY 2015 PFS final rule with comment period we retired measures that were no longer consistent with updated clinical guidelines for cholesterol targets, but we were unable to finalize retirement of the measures for the 2014 reporting year due to the timing of the guideline updates and rulemaking cycle. Because these measures did not align with updated clinicial guidance, in February 2015, we issued an update to the guidance document on the Medicare Shared Savings Program Quality Measure Benchmarks for the 2014 Reporting Year that maintained these measures, including the Diabetes Composite measure, as pay for reporting for the 2014 reporting year. In order to address such issues in the future, we finalized a policy in the CY 2016 PFS final rule with comment period (80 FR 71269) under which we reserve the right to maintain a measure as pay for reporting or revert a pay for performance measure to pay for reporting when the measure owner determines the measure no longer aligns with clinical practice or continued application of the measure may result in patient harm (see § 425.502(a)(5)).
As previously noted in the background section, we finalized a policy that future changes to the CMS web interface measures will be adopted through rulemaking for the Quality Payment Program and will be applicable to ACO quality reporting under the Shared Savings Program (81 FR 80501). We also note that, as discussed in the CY 2017 Quality Payment Program final rule with comment period (81 FR 77136), section 1848(q)(2)(D)(i)(II) of the Act requires the Secretary to update the final list of quality measures from the previous year (and publish an updated list in the
Substantive changes to other CMS web interface measures are also proposed. A substantive change is proposed to the Influenza Immunization measure (ACO-14), however, the changes apply only to the Registry and EHR data submission methods and not the CMS web interface reporting method (82 FR 30472). Finally, a substantive change is proposed for the Body Mass Index Screening and Follow-Up Plan (ACO-16); specifically, the frequency of documenting BMI will change from 6 to 12 months (82 FR 30471).
Consistent with how we have addressed previous changes to measures, we reviewed the proposed substantive changes to the CMS web interface measures proposed in the CY 2018 Quality Payment Program proposed rule to assess whether the changes, if finalized, would warrant a change in how the measures are used to assess ACO performance under the Shared Savings Program. As part of this review, we considered whether the proposed substantive changes might raise sampling issues or require that we recalculate the measure benchmarks for purposes of the Shared Savings Program. Based on our preliminary review of the Quality Payment Program proposals, we believe the proposed “substantive” changes to the CMS web interface measures would not require that we revert these measures to pay for reporting for the 2018 performance year. The Quality Payment Program proposals do not appear to modify the current structure and reporting of the measures for which substantive changes are proposed; rather, in the case of the Tobacco Use: Screening and Cessation Intervention measure, the proposed change would only modify the way the data are manipulated and calculated after the data are submitted. Similarly, we do not believe that the proposed substantive change to the BMI measure to change the frequency of reporting would impact an ACO's ability to perform well compared to the established benchmark for this measure. Finally, the substantive change to the Influenza Immunization measure does not apply to the CMS web interface reporting method. Therefore, we believe that we will have the data necessary from past submission periods to calculate appropriate benchmarks that could be used to assess ACO performance for the CMS web interface measures under consideration for performance year 2018 and subsequent years. Additionally, the recalculation of the benchmark coincides with the biannual timing of the benchmark updates. Therefore, if the proposed changes to the measures are finalized under the Quality Payment Program, we do not believe it would be necessary or appropriate, to revert the measures to pay for reporting under the Shared Savings Program. Instead, we believe it would be appropriate under the Shared Savings Program to: (1) Update the measure specifications through subregulatory guidance in order to continue to align the measures with the measure specifications used under the Quality Payment Program and Million Hearts initiative, and (2) retain the current phase-in schedule for the measures rather than redesignating any of the measures as pay for reporting.
Because the particular substantive changes that are proposed in the CY 2018 Quality Payment Program proposed rule do not appear to change the information that must be collected for these measures (which makes it possible for us to use data submitted previously to determine prior performance under the new measure rate, and therefore calculate an appropriate prospective quality benchmark), we do not believe any changes to the measures' phase-in schedules are necessary. However, the statutory directive under the Quality Payment Program to address substantive changes to measures in rulemaking and the proposals in the CY 2018 Quality Payment Program proposed rule to address substantive changes to certain web interface measures have caused us to evaluate what recourse we might have in the future under the Shared Savings Program rules to modify a measure's phase-in in instances where a substantive change to the measure makes it inappropriate to hold ACOs accountable for performance on a measure that has been substantively modified. We anticipate that there could be future substantive changes to the CMS web interface measures made under the Quality Payment Program that would give us reason to redesignate a measure as pay-for-reporting under the Shared Savings Program. Currently, although the Shared Savings Program rules afford flexibility to redesignate a measure as pay for reporting whem the measure owner determines the measure no longer aligns with clinical practice or causes patient harm, there is no discretion to modify how we assess CMS web interface measures in the event substantive changes are made to those measures under the Quality Payment Program that make it inappropriate to hold ACOs accountable for performance on the measure. Given the timing of the Quality Payment Program proposals in relationship to the timing for when the quality performance benchmarks must be established under the Shared Savings Program, it may in some cases be necessary to have flexibility to designate a pay for performance measure as pay for reporting just before or following the start of a performance year outside of the formal rulemaking process, consistent with the way in which we have redesignated measures in the past when measure owners have made changes after the start of a performance year. Accordingly, we believe it would be appropriate to modify the Shared Savings Program regulations to provide additional flexibility to address substantive changes to CMS web interface measures that are made under the Quality Payment Program and to continue to facilitate alignment of measures with the Quality Payment Program and other CMS initiatives.
We are therefore proposing to modify § 425.502(a)(5) to include the right for CMS to redesignate a measure as pay-for-reporting when a substantive change to a CMS web interface measure is made under the Quality Payment Program. This proposed revision would supplement CMS's existing discretion to redesignate a measure as pay-for-reporting when the measure owner determines the measure no longer aligns with clinical practice or causes patient harm. Specifically, we are proposing to revise the regulation at § 425.502(a)(5) to reserve CMS's right to redesignate CMS web interface measures that have undergone a substantive change as determined under the Quality Payment Program to pay-for-reporting status. Such measures would not necessarily be automatically redesignated as pay for reporting when a substantive change occurs (for example, as indicated previously, we do not believe the currently proposed substantive changes present an impediment to holding ACOs accountable for performance on these measures in performance year 2018 and
In the November 2011 final rule, we finalized a proposal to retain the right to validate the quality measure data ACOs enter into the web interface (76 FR 67893 through 67894). We believe that the data validation process implicitly incentivizes ACOs to keep organized and up-to-date medical records and is necessary to protect against gaming. This validation process, referred to as the Quality Measures Validation audit, was based on the process used in Phase I of the Physician Group Practice (PGP) demonstration. The policy was finalized at § 425.500(e) and involved a process under which we selected a subset of web interface measures and a random sample of 30 confirmed and completely reported beneficiaries for each measure in the subset. The ACO was required to provide medical records to support the data reported in the web interface for those beneficiaries. A measure-specific audit performance rate was then calculated using a multi-phased audit process. If at the conclusion of the third phase there was a discrepancy greater than 10 percent between the quality data reported and the medical records provided during the audit, the ACO was not given credit for meeting the quality target for any measure(s) for which the mismatch rate existed.
In the CY 2017 PFS final rule (81 FR 80489 through 80492), we revisited the quality validation audit process and finalized several significant changes as a result of our experience in conducting audits and in an effort to increase the statistical rigor of the audit methodology while streamlining audit operations. We expressed our intent to align the quality measures validation audit used in the Shared Savings Program more closely with other CMS quality program audits, including those performed in the Physician Quality Reporting Program and the Hospital Inpatient and Outpatient Quality Reporting programs. We therefore finalized four improvements to our audit process that addressed the number of records to be reviewed per measure, the number of audit phases, the calculation of an audit match rate and the consequences if the audit match rate falls below 90 percent. Specifically, we finalized a policy under which we will audit enough medical records to achieve a 90 percent confidence interval; conduct the audit in a single phase; and calculate an overall audit performance rate. If at the conclusion of the audit process the overall match rate between the quality data reported and the medical records provided by the ACO is less than 90 percent, absent unusual circumstances, we will adjust the ACO's overall quality score proportional to the ACO's audit performance. The audit-adjusted quality score is calculated by multiplying the ACO's overall quality score by the ACO's overall audit match rate. For example, if an ACO's quality score is 75 percent and the ACO's audit match rate is 80 percent, the ACO's audit-adjusted quality score would be 60 percent. The audit-adjusted quality score is the quality score that will be used to determine the percentage of any earned savings that the ACO may share or the percentage of any losses for which the ACO is accountable. We note that under the revised audit methodology, our intent was to continue to audit a subset of ACOs, which we would identify by looking for data anomalies such as high skip rates, although we have flexibility to randomly select ACOs or specific measures for audit as we have done in the past.
We also finalized a new requirement at § 425.500(e)(3) that an ACO that has an audit match rate of less than 90 percent may be required to submit a corrective action plan (CAP) under § 425.216 for our approval. In the CAP, the ACO would be required to explain the reasons for the low audit match rate and how it plans to improve the accuracy of its quality reporting in the future. In addition, we noted that we maintain the right, as described in § 425.500(f), to terminate or impose other sanctions on any ACO that does not report quality data accurately, completely, or timely. We indicated that we would begin applying these policies to the quality validation audits beginning in 2017 with the quality validation audits of quality reporting for the 2016 performance year.
Since publication of the CY 2017 PFS final rule, we have gained additional experience with the quality validation audits, and have performed additional analyses related to these audits. Our analysis of the 2016 quality measure validation audit results for Shared Savings Program ACOs indicates that the average match rate of ACOs audited in calendar year 2016 was 72 percent and the median performance was 80 percent. Typically, during the audit, we review medical record documentation and work with ACOs to better understand the mismatch between what was reported and what was documented and have determined through our analyses that ACOs continue to experience challenges in understanding certain aspects of the measure specifications, coordinating collection of information across many different providers and practices, and satisfying the requirements for supporting documentation. Many of these errors are not indicative of poor quality of care but rather reflect minor errors in process or
Under our newly finalized single-phase approach to quality validation audits, minor errors are more likely to affect the final audit results and impact the calculation of shared savings or shared losses when the overall match rate is below 90 percent. Additionally, we note that the match rate threshold under the Hospital Inpatient Quality Reporting (HIQR) Program is 75 percent. The HIQR validates data submitted by hospitals, which are entities that generally have more experience with quality reporting, greater health record accessibility and integration, and a longer history of validation of quality data submitted to CMS.
In light of our analyses of the 2016 quality measure validation audit results, we believe it is appropriate to consider making additional modifications to our quality validation audit process. First, we are concerned that the 90 percent match rate adopted in CY 2017 PFS final rule may be too high and could inappropriately penalize ACOs that make quality data reporting errors that are unrelated to care quality. In the early years of phasing in this new audit methodology, we believe that the match rate should instead be based on actual ACO experience in order to focus on holding ACOs accountable for clinically related mismatches in reporting quality measures as they continue to gain experience with how to measure, report and improve quality under the program. We believe that basing the audit match rate threshold on actual validation audit results would strike an appropriate balance between ensuring the accuracy of ACO quality reporting while not unduly penalizing ACOs for minor quality reporting errors that are not necessarily indicative of poor quality care. Accordingly, we believe it would be appropriate to set the audit match rate threshold based on the median match rate (80 percent) for ACOs audited in calendar year 2016 rather than an alternative approach such as the mean match rate because the median match rate would be less affected by data outliers. Therefore, we are proposing to revise § 425.500(e)(2) to indicate that if an ACO has a match rate below 80 percent, absent unusual circumstances, we would adjust the ACO's overall quality score proportional to the ACO's audit performance.
Second, we propose to amend the method by which we adjust an ACO's overall quality score to reflect the ACO's audit performance. Specifically, we propose to revise the methodology described in the 2017 PFS final rule (81 FR 80490) under which the audit-adjusted quality score is calculated by multiplying the ACO's overall quality score by the ACO's audit match rate. Instead, we propose that for each percentage point difference between the ACO's match rate and the match rate considered passing the audit, the ACO's overall quality score would be adjusted downward by 1 percent. That is, if we finalize the proposal to establish an 80 percent match rate as the threshold for passing the quality validation audit, and the ACO's match rate is 75 percent, then under this proposal we would adjust the ACO's overall quality score downward by 5 percent. To illustrate, assuming a match rate threshold of 80 percent, an ACO with an overall quality score of 90 percent would have an audit-adjusted quality score of 85.50 percent, that is, (90−[.05×90]) = 85.50.
Finally, we propose a conforming change to § 425.500(e)(3) to reflect the 80 percent threshold such that if at the conclusion of the audit process CMS determines there is an audit match rate of less than 80 percent, the ACO may be required to submit a CAP.
We believe that over time, as ACOs become more experienced with quality reporting requirements, improve their quality reporting processes and become better clinically integrated, quality validation audit results that show a significant mismatch between the information reported and the underlying medical records will more consistently reflect meaningful, clinically related quality reporting errors for which ACOs should be held accountable. In addition, because the audit process involves the exchange of information regarding medical record review and communication between ACOs and us, the audit process, itself, provides additional education on the quality measures and quality reporting. Accordingly, we will periodically review the audit match threshold and seek to increase the match rate over time. We may also consider requiring a higher match rate for ACOs that have been in the program longer. Therefore, we anticipate that we will continue to closely monitor quality validation audit results and the reasons for mismatches and, over time, seek to increase the audit match rate threshold.
Although at this time we are proposing the change the audit match rate threshold to 80 percent, we also seek comment on an alternative approach we considered to address the quality validation audit match rate and the resulting impact on an ACO's overall quality score.
Consistent with the approach used under the HIQR program, we considered revising § 425.500(e)(2) to provide that we would adjust the ACO's overall quality score if an ACO has a match rate below 75 percent. We did not propose this approach because the results of the Quality Measures Validation Audits conducted on Shared Savings Program ACOs in calendar year 2016 yielded a median match rate of 80 percent, suggesting that a match rate of 75 percent would be too low.
We invite comment on the proposed refinements to the process used to validate ACO quality data reporting and to adjust an ACO's overall quality score to reflect the ACO's audit performance, and on the alternative that was considered, but not proposed.
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. Under 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. In the June 2015 final rule (80 FR 32804 through 32806, 32808), we provided ACOs participating in Track 3 with additional flexibility to attempt to increase quality and decrease costs by allowing these ACOs to apply for a waiver of the SNF 3-day rule to permit their prospectively assigned beneficiaries to receive coverage for inpatient SNF care without a prior 3-day inpatient hospital stay when they are admitted to a “SNF affiliate,” that is, a SNF with which the ACO has executed a SNF affiliate agreement, and certain additional eligibility criteria are met (see § 425.612(a)(1)). Waivers are effective upon our notification to the ACO of approval for the waiver or the start date of the ACO's participation agreement, whichever is later (see § 425.612(c)). We stated in the June 2015 final rule that the SNF 3-day rule waiver
We believe that clarity regarding whether SNF services furnished to a particular beneficiary are eligible for payment under the SNF 3-day rule waiver is important to help ensure compliance with the conditions of the waiver and also improve our ability to monitor waivers for misuse. Therefore, in the June 2015 final rule, we limited the waiver to ACOs in Track 3 because under the prospective assignment methodology used in Track 3, beneficiaries are assigned in advance to the ACO for the entire performance year (unless they meet any of the exclusion criteria under § 425.401(b)), so it will be clearer to a Track 3 ACO and its SNF affiliates whether the waiver applies to SNF services furnished to a particular beneficiary than it would be to an ACO in Track 1 or 2, where beneficiaries are assigned using a preliminary prospective assignment methodology with retrospective reconciliation (80 FR 32804). An ACO's use of the SNF 3-day rule waiver will be associated with a distinct and easily identifiable event, specifically, admission of a prospectively assigned beneficiary to a previously identified SNF affiliate without prior inpatient hospitalization or after an inpatient hospitalization of fewer than 3 days.
Based on our experiences under the Pioneer ACO Model, and in response to comments, we established certain requirements under § 425.612 that ACOs, ACO providers/suppliers, SNF affiliates, and beneficiaries must meet for SNF services to be covered under the SNF 3-day rule waiver under the Shared Savings Program. All ACOs electing to participate in Track 3 are offered the opportunity to apply for a waiver of the SNF 3-day rule for their prospectively assigned beneficiaries at the time of their initial application to participate in Track 3 of the program and annually thereafter while participating in Track 3. The program rules for a waiver of the SNF 3-day rule are under § 425.612 and are discussed in detail in the 2015 final rule (80 FR 32804 through 32806).
To qualify to use the SNF 3-day rule waiver, ACOs must submit a SNF 3-Day Rule Waiver application that includes supplemental information sufficient to demonstrate that the ACO has the capacity to identify and manage beneficiaries who would be either directly admitted to a SNF or admitted to a SNF after an inpatient hospitalization of fewer than 3 days. Required application materials include but are not limited to the following:
• Narratives describing how the ACO plans to implement the waiver. Narratives must include a communication plan between the ACO and its SNF affiliates, a care management plan for beneficiaries admitted to a SNF affiliate, a beneficiary evaluation and admission plan approved by the ACO medical director and the health care professional responsible for the ACO's quality improvement and assurance processes, and a description of any financial relationships between the ACO, SNF, and acute care hospitals.
• A list of SNFs with which the ACO will partner along with executed written SNF affiliate agreements between the ACO and each listed SNF. The agreements must include elements determined by CMS including but not limited to the following:
++ Agreement to comply with the requirements and conditions of the Shared Savings Program.
++ The effective dates of the SNF affiliate agreement.
++ Agreement to implement and comply with the ACO's beneficiary evaluation and admission plan and care management plan.
++ Agreement to validate the eligibility of a beneficiary to receive covered SNF services in accordance with the waiver prior to admission.
++ Remedial processes and penalties that will apply for non-compliance.
• Documentation demonstrating that each SNF included on the submitted list of SNF affiliates has an overall rating of 3 or higher under the CMS 5-star Quality Rating System as reported on CMS's Nursing Home Compare Web site.
In addition, § 425.612(b)(3) provides that we will evaluate the information submitted with the ACO's application for the SNF 3-day rule waiver and any supplemental information submitted in response to a CMS request for information to determine whether the ACO's waiver request satisfies the requirements of § 425.612(a)(1). The effective date and termination date of the waiver are determined in accordance with § 425.612(c). Section 425.612(d) provides for monitoring of the use of the waiver and termination of the waiver, and includes a requirement that ACOs that have been approved for the SNF 3-day rule waiver post their approval to use the waiver as part of public reporting under § 425.308. If our monitoring of an ACO's use of the waiver reveals misuse of the waiver, we may revoke the ACO's approval to use the waiver. Additionally, we may revoke an ACO's approval to use a waiver if the ACO does not successfully meet the quality performance standard or we identify another program integrity issue affecting the ACO's use of the waiver.
To be eligible to receive covered services under the SNF 3-day rule waiver, a beneficiary must be prospectively assigned to the ACO for the performance year in which he or she is admitted to the SNF affiliate, may not reside in a SNF or other long-term care setting, must be medically stable and have an identified skilled nursing or rehabilitation need that cannot be provided as an outpatient, and must meet the other requirements set forth in § 425.612(a)(1)(ii).
We noted in the 2015 final rule that we would continue to evaluate the waiver of the SNF 3-day rule including further lessons learned from Innovation Center models in which a waiver of the SNF 3-day rule is being tested (80 FR 32806). We indicated that in the event we determined that changes were necessary, we would propose these changes through future rulemaking. Subsequently, based on initial experiences with the SNF 3-day rule waiver under the Pioneer ACO Model and Next Generation ACO Model, we proposed and finalized additional SNF 3-day rule waiver beneficiary protections under § 425.612(a)(1)(iv) and (v). (See the CY 2017 PFS final rule (81 FR 80510 through 80515)).
We began accepting SNF 3-Day Rule Waiver applications in the summer of 2016 and approved 26 Track 3 ACOs to begin using the SNF 3-day rule waiver under the Shared Savings Program effective January 1, 2017.
As discussed in this proposed rule, the SNF 3-day rule waiver requirements are primarily based on criteria previously developed under the Pioneer
First, the requirement under § 425.612(a)(1)(i)(A)(4) that ACOs submit, as part of their application for the SNF 3-day rule waiver, a narrative describing any financial relationships that exist between the ACO, SNF affiliates, and acute care hospitals is burdensome for ACOs and CMS. As explained in the 2015 final rule (81 FR 32806), the SNF 3-day rule waiver only provides for coverage of SNF services that meet all applicable requirements except the requirement for a prior 3-day inpatient stay. The waiver does not protect financial or other arrangements between or among ACOs, ACO participants, ACOs providers/suppliers, or other individuals or entities providing services to Medicare beneficiaries from liability under the fraud and abuse laws or any other applicable laws (§ 425.612(e)(1)). The Shared Savings Program regulations do not prohibit ACOs or SNFs from having financial arrangements with acute care hospitals, nor do they require such arrangements. Therefore, we have found that the narratives are not useful to us for purposes of determining whether to approve a waiver request. Based on our experience with the implementation of SNF 3-day rule waivers, we are proposing to remove the requirement at § 425.612(a)(1)(i)(A)(
Second, we believe that the requirement under § 425.612(a)(1)(i)(C) that ACOs submit documentation demonstrating that each SNF included on their list of SNF affiliates has an overall rating of 3 or higher under the CMS 5-star Quality Rating System is unnecessarily burdensome. In order to meet this requirement, ACOs typically submit a screen shot from the CMS Nursing Home Compare Web site or other Nursing Home Compare information that reflects the star rating for each listed SNF. The submission of this documentation by the ACO does not add value to our review and approval of SNFs included on the ACO's SNF affiliate list. Instead, we obtain the information directly from our Web site during the application review process. In this way, we insure that the most current information is used during the application review process. We also periodically monitor this information after an ACO has been approved to use the waiver because SNF affiliates are required to maintain an overall rating of 3 stars or higher, under § 425.612(a)(1)(iii)(A). Because we are able to obtain the required information directly from the CMS Nursing Home Compare Web site, the additional documentation submitted by the ACO as part of its application does not add value to our ability to review and approve SNF affiliates. Accordingly, we are proposing to eliminate this documentation submission requirement by removing § 425.612(a)(1)(i)(C). We note that we are not proposing to remove or modify the requirement in § 425.612(a)(1)(iii)(A) that SNF affiliates must have and maintain an overall rating of 3 or higher under the CMS 5-star Quality Rating System in order to remain eligible to partner with the ACO for purposes of the SNF 3-day rule waiver. The requirement for SNF affiliates to have and maintain a 3-star or higher rating is retained. Furthermore, as part of the application process, we intend to continue to verify that the ACO has met all requirements related to the SNF 3-day rule waiver, but we believe that the burdensome and duplicative submission of CMS 5-star Quality Rating System documentation is not necessary to ensure compliance with the requirement that the ACO's SNF affiliates have a star rating of 3 or more.
We welcome comments on our proposal to remove § 425.612(a)(1)(i)(A)(
In order to participate in the Shared Savings Program, organizations must meet certain eligibility requirements, including the statutory requirement to define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care. Additionally, the ACO
Section 425.204(c)(1) articulates the supporting documents and materials an ACO must submit to demonstrate that the ACO satisfies the eligibility requirements to participate in the Shared Savings Program.
To obtain a determination regarding whether an ACO meets the requirements to participate in the Shared Savings Program, a prospective ACO must submit a complete application in the form and manner required by us by the deadline established by us (§ 425.202(a)(1)). The content of the application is outlined at § 425.204. Section 425.204(c) states that as part of the application, and upon request thereafter, an ACO must submit to us certain supporting documentation to demonstrate that the ACO satisfies the requirements of the Shared Savings Program. Supporting documentation in this section includes:
• Documents (for example, ACO participant agreements, agreements with ACO providers/suppliers, employment contracts, and operating policies) sufficient to describe the ACO participants' and ACO providers'/suppliers' rights and obligations in and representation by the ACO, and how the opportunity to receive shared savings or other financial arrangements will encourage ACO participants and ACO providers/suppliers to adhere to the quality assurance and improvement program and evidence-based clinical guidelines.
• A description, or documents sufficient to describe, how the ACO will implement the required processes and patient-centeredness criteria under § 425.112, including descriptions of the remedial processes and penalties (including the potential for expulsion) that will apply if an ACO participant or an ACO provider/supplier fails to comply with and implement these processes.
• Materials documenting the ACO's organization and management structure, including an organizational chart, a list of committees (including names of committee members) and their structures, and job descriptions for senior administrative and clinical leaders.
• Evidence that the ACO's governing body is an identifiable body, represents a mechanism for shared governance for ACO participants, is composed of representatives of its ACO participants; and is at least 75 percent controlled by its ACO participants.
• Evidence that the governing body includes a Medicare beneficiary representative(s) served by the ACO who does not have a conflict of interest with the ACO, and who has no immediate family member with a conflict of interest with the ACO.
• A copy of the ACO's compliance plan or documentation describing the plan that will be put in place at the time the participation agreement with CMS becomes effective. Additionally, § 425.204(d) states that as part of the application to participate in the Shared Savings Program, an ACO must describe the following:
++ How it plans to use shared savings payments, including the criteria it plans to employ for distributing shared savings among its ACO participants and ACO providers/suppliers.
++ How the proposed plan will achieve the specific goals of the Shared Savings Program.
++ How the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures.
Section 425.204(c)(1)(ii) includes a reference to the required processes and patient centeredness criteria under § 425.112. Of note, § 425.112(b)(4)(ii) requires that, as part of its application, an ACO must submit a description of its individualized care program, along with a sample individual care plan, that explains how the ACO's program is used to promote improved outcomes for, at a minimum, its high risk and multiple chronic condition patients (§ 425.112(b)(4)(ii)(A)). The ACO must also, as part of its application, describe additional target populations that would benefit from individualized care plans (§ 425.112(b)(4)(ii)(B)) and describe how it will encourage and promote the use of enabling technologies for improving care coordination for beneficiaries (§ 425.112(b)(4)(ii)(C)). Finally, as part of its application, the ACO must describe how it intends to partner with long-term and post-acute care providers, both inside and outside the ACO, to improve care coordination for its assigned beneficiaries (§ 425.112(b)(4)(ii)(D)).
Once an applicant has submitted the information required under § 425.204, we evaluate it to determine whether the applicant satisfies the Shared Savings Program requirements. We notify ACO applicants during the application review process when information is missing or when supplemental documentation or other information is necessary to make a determination on the ACO's application and provide opportunities for the ACO to submit the requested additional information for review. At the end of the application review process, we approve or deny the application and notify the ACO of our determination.
In conducting Shared Savings Program application reviews, we have found that many of the document submission requirements in § 425.204(c)(1) substantially increase application and review burden without lending significant value to our review of an organization's application to confirm that the ACO meets the eligibility requirements for participation in the Shared Savings Program. We believe it would meet program needs and reduce applicant burden if we were to revise § 425.204(c)(1) to remove the requirement to submit supporting documents or narratives and instead provide that we may request these materials if additional information is needed in order to fully assess the ACO's application before making a decision to approve or deny the application.
To illustrate, as discussed in this proposed rule, we require under § 425.204(c)(1)(ii), as part of the application process, that the ACO submit documentation addressing the required processes and patient centeredness criteria under § 425.112. This requirement is addressed in the Medicare Shared Savings Program Initial Application (see application on the CMS Web site at
• Process to promote evidence-based medicine. The ACO must describe how it will:
++ Encourage the use of protocols grounded in evidence-based medicine in the case of diagnoses with significant potential for the ACO to achieve quality improvements, while taking into account the circumstances of individual beneficiaries; and
++ Use the internal assessments of this process to continuously improve the ACO's care practices.
• Process to promote beneficiary engagement. The ACO must describe how it will:
++ Evaluate the health needs of its assigned beneficiary population (including consideration of diversity in its patient population) and develop a plan to address the needs of its population;
++ Communicate clinical knowledge/evidence-based medicine to beneficiaries in a way they can understand;
++ Engage beneficiaries in shared decision-making in ways that consider beneficiaries' unique needs, preferences, values and priorities;
++ Establish written standards for beneficiary access and communication as well as a process for beneficiaries to access their medical records; and
++ Use the internal assessments of this process to continuously improve the ACO's care practices.
• Process to internally report quality and cost metrics. The ACO must describe how:
++ The ACO will use these results to improve care and service over time; and
++ The ACO will use the internal assessments of this process to continuously improve the ACO's care practices.
• Process to promote coordination of care. The ACO must describe:
++ The ACO's methods and processes to coordinate care throughout an episode of care and during care transitions, such as discharge from a hospital or transfer of care from a primary care physician to a specialist (both inside and outside the ACO).
++ The ACO's individualized care program, along with a sample individual care plan, and explain how the ACO uses this program to promote improved outcomes for, at a minimum, high-risk and multiple chronic-condition patients.
++ How individual care plans take into account the community resources available to beneficiaries.
++ Additional target populations that would benefit from individualized care plans.
++ How the ACO will use the internal assessments of this process to continuously improve the ACO's care practices.
++ How the ACO will encourage and promote use of enabling technologies for improving care coordination for beneficiaries.
++ How the ACO intends to partner with long-term and post-acute care providers, both inside and outside of the ACO, to improve care coordination for their assigned beneficiaries.
As a result of our experience in reviewing these narratives, we have determined that while they can be helpful to verify that the ACO has established the required processes and defined patient-centeredness criteria prior to its entry into the Shared Savings Program, the specific details of the processes the ACO has established are not particularly important or relevant for purposes of assessing whether the ACO is eligible to participate in the program. In fact, ACOs have indicated that their initial plans for the processes required under § 425.112 as articulated in their program application often change as a result of obtaining additional information about their ACO participants' and ACO providers/suppliers' processes and gaining additional experience during implementation of the processes. We believe such improvements to ACO processes based on program experience are reasonable to expect and should be encouraged. First, under § 425.112(b), ACOs are required to evaluate and periodically update each process and as they do so, initially implemented processes will necessarily change to accommodate lessons learned. Moreover, once the ACO begins to request claims information and other CMS data and to incorporate this information into its operations, the ACO may discover that certain assumptions it made at the time of application should be adjusted to maximally improve the quality of care or cost efficiencies for the ACO's assigned population. In rare instances, particularly in the early days of the program before stakeholders fully understood the implications of program participation, we found review of such narratives useful to understand the level of an ACO's readiness for participation in the Shared Savings Program. However, such narratives have not been particularly useful in determining if the ACO meets the requirements for participation in the Shared Savings Program. In a vast majority of cases, we now believe it is sufficient that the ACO certify at the time of application that it has defined the required processes and patient centeredness criteria consistent with the requirements specified in section § 425.112. Therefore, we believe it would reduce burden for ACOs, without compromising our ability to determine whether an ACO meets the criteria for participation in the Shared Savings Program, to require that the ACO certify that it meets the requirements in § 425.112, and only submit a narrative or other documentation describing how the ACO will implement the required processes and patient-centeredness criteria upon our request. Further, we do not anticipate that this change would have a significant effect on beneficiaries receiving services from ACO providers/suppliers because as noted earlier, we anticipate that ACOs would update each process as they gain experience and, as they do so, initially implemented processes that might have been reflected in the narrative or other supporting documentation submitted with their application would necessarily change to accommodate lessons learned.
Similarly, as part of the application process, the Shared Savings Program regulations require the ACO to submit materials documenting the ACO's organization and management structure, including an organizational chart, a list of committees (including names of committee members) and their structures, and job descriptions for senior administrative and clinical leaders (§ 425.204(c)(1)(iii)). While we have found the organizational chart useful for purposes of our review and approval of an ACO's application, and we anticipate continuing to request this chart from many applicants, we have found that further detail including lists of committees and job descriptions for senior administrative and clinical leaders have not added particular value to our review and approval of applications. Moreover, the receipt of such materials as part of the ACO's application has not significantly impacted our ability to determine whether the ACO meets the requirements regarding leadership and management in § 425.108. We believe, on balance, that our need for such detailed information from all applicants is outweighed by our desire to reduce application burden. In particular circumstances where additional information would aid our review, we believe our need for such detailed information can be reasonably met by requiring applicants to submit such materials upon our request. As a result, we believe it would be less burdensome for us to require ACO applicants to certify that, for example, they meet the leadership and management requirements found at § 425.108 rather than requiring all ACO applicants to submit detailed materials (such as job descriptions) or narratives about the ACO's committees and leadership.
While we do not anticipate having to routinely request such materials to supplement our review and approval of ACO applications to participate in the Shared Savings Program, we believe it is important to retain the discretion to do
Additionally, we do not believe it is necessary for ACO applicants to submit narratives describing how they would distribute shared savings payments or how the proposed plan would achieve the specific goals of the Shared Savings Program and the general aims of better care for individuals, better health for populations, and lower growth in expenditures, as required by § 425.204(d). Based on our experience, such narratives have not been useful in determining if the ACO meets requirements for participation in the program or whether an ACO's application should be approved. We believe it would be more useful to us and less burdensome for ACOs if we were instead to require that, an ACO, as part of its application to participate in the Shared Savings Program, certify that it has a method and plan to receive shared savings payments and to distribute those payments to its ACO participants and ACO providers/suppliers, as required by the statute. We note, however, that we continue to believe it is useful to stakeholders to know how various ACOs have chosen to use or distribute the shared savings they earn. Therefore, in the interest of transparency, we will continue to require ACOs to publicly report information on their dedicated Web pages about their shared savings and shared losses, including information about the total proportion of shared savings invested in infrastructure, redesigned care processes, and other resources to support the three-part aim goals of better health for populations, better care for individuals, and lower growth in expenditures, including the proportion distributed among ACO participants, as required under § 425.308(b)(4).
In light of our experience with the review of the documentation submitted as part of the ACO's initial application, we are proposing several modifications to our requirements for document submission. Under this proposal, we would retain all requirements related to ACO eligibility criteria and public reporting, as currently specified under the Shared Savings Program regulations. However, in order to reduce application burden without compromising our ability to evaluate applications effectively for compliance with Shared Savings Program requirements, we propose to modify certain sections of our regulations that require ACOs to submit supporting materials and documentation at the time of application. Instead of requiring submission of certain materials, narratives, or supporting documentation, as discussed in this section, we propose to require ACOs to certify that they meet the applicable eligibility and documentation requirements as specified under our program rules. At the same time, while we are interested in reducing burden, we recognize that there have been instances when the review of supporting documentation and/or narratives has been helpful in making a determination about an ACO's eligibility for participation in the program. Therefore, although we are proposing to eliminate the general requirement that ACOs submit certain documentation as part of their initial application to participate in the Shared Savings Program, we propose to retain the right to request the submission of supporting materials and documentation in cases when such additional information would be useful in making a determination regarding the ACO's application. We believe that this proposed modification to the regulations governing ACO applications would introduce additional flexibility that would reduce the level of burden inherent in the Shared Savings Program application process while also ensuring we are still able to appropriately evaluate an ACO's eligibility for program participation.
Accordingly, in order to reduce application burden while retaining flexibility to obtain additional documentation when necessary to determine ACO eligibility and compliance with program rules, we propose to remove the requirements in §§ 425.204(c)(1) and (d), 425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the submission of certain specified documents and narratives as part of an ACO's application to participate in the Shared Savings Program. Specifically, we propose to revise paragraph § 425.204(c)(1) to require an ACO, as part of its application, to certify that it satisfies the Shared Savings Program requirements and to submit, upon CMS request, supporting materials (including narratives) and documentation demonstrating that the ACO satisfies program requirements indicated in proposed revised § 425.204(c). Additionally, we propose to revise § 425.204(d) to indicate that the ACO must certify, as part of its application to participate in the Shared Savings Program, that it has a mechanism and plan to receive and use payments for shared savings, including criteria for distributing shared savings among its ACO participants and ACO providers/suppliers. We also propose to make a conforming change to remove paragraphs (d)(1) through (3) of § 425.204, which relate to the submission of narratives related to the ACO's use of shared savings payments. This proposal does not include a requirement that the ACO submit information regarding its mechanism and plan for receiving and using shared savings upon request. We do not intend to request this information as part of the application process because in our experience, how an ACO intends to use or distribute shared savings has not been a relevant consideration during any application cycle to determine whether the ACO has met the eligibility requirements to participate in the Shared Savings Program. However, we note that we continue to believe that information on how an ACO uses and distributes its shared savings is useful for the public, and therefore ACOs will continue to be required to publicly report this information under § 425.308(b)(4)(ii).
We also propose similar changes to the requirements in § 425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove reference to the submission of narratives to explain or describe how the ACO will implement the required elements of the ACO's care processes and patient-centeredness criteria. ACOs must still implement these care processes and adopt a focus on patient-centeredness, however, they will no longer need to submit descriptions of how they will satisfy these requirements as part of their initial application. We note, however, that ACOs may still be required to submit upon request a description or documentation sufficient to describe how the ACO will implement the required processes and patient-centeredness criteria found at § 425.112 because under the proposed revisions to § 425.204(c)(1)(ii), CMS would retain the discretion to request such documentation from the ACO at any time.
In summary, we believe these modifications to the application requirements will significantly reduce
Under the Shared Savings Program, ACO participant TINs are not required to be exclusive to one Shared Savings Program ACO unless the TIN submits claims for primary care services used to determine the ACO's assigned population (§ 425.306(b)). The purpose behind this requirement is to ensure that we are able to assign a unique set of beneficiaries to each ACO participating in the Shared Savings Program. Therefore, as part of the Shared Savings Program application process and upon an ACO's request to add an ACO participant TIN, we check the TIN against all other Shared Savings Program ACO participant lists. If the TIN appears on the ACO participant list one or more other ACOs, the TIN is considered to be “overlapping.” We then determine whether the overlap is permissible under our program rules. If the overlap is not permissible (because the TIN has a history of billing for primary care services used in our assignment methodology) then we require the ACO that is seeking to add the TIN to its ACO participant list to rectify the overlap by the deadline we have established for making changes to the next performance year's ACO participant list. If the overlap is permissible (because the TIN does not have a history of billing for primary care services used in our assignment methodology) then the ACO participant TIN can be approved to be an ACO participant in more than one ACO for the performance year. Each time we run the assignment algorithm during the course of the performance year, we monitor overlaps to ensure that the overlaps continue to be in compliance with § 425.306(b).
In a few instances, as a result of our monitoring, we have discovered that ACO participant TINs that had been approved to participate in multiple ACOs subsequently began billing for primary care services used in assignment during a benchmark or performance year. For example, for performance year 2016, we identified four TINs that were initially permitted to overlap and participate in more than one ACO because they had not previously billed Medicare for primary care services used in our assignment methodology. At some point during the performance year, however, the TINs began billing Medicare for primary care services that are used to assign beneficiaries to the ACO (including claims for services furnished during the performance year, but submitted during the three-month claims runout for the performance year). This can occur, for example, if a single specialty practice made up of physician specialty types not used in assignment (for example, a practice of ophthalmologists) hires a nurse practitioner who then begins billing Medicare under the billing TIN of the ACO participant for primary care services as defined under the Shared Savings Program rules. Thus, the ACO participant TIN would be used to bill Medicare for primary care services furnished by a practitioner used in our assignment methodology (the nurse practitioner) and would therefore trigger our requirement under § 425.306(b)(2) that the ACO participant TIN be exclusive to a single Shared Savings Program ACO. Although our program rules permit us to take compliance action against ACOs for violations of Shared Savings Program requirements, they do not specifically address what compliance actions we would impose on ACOs in instances where an ACO participant falls out of compliance with § 425.306(b)(2) during a benchmark or performance year or when non-compliance with § 425.306(b)(2) is discovered during the 3-month claims runout for a benchmark or performance year. Moreover, the program rules do not address what modifications to our assignment methodology could be made to account for this overlap. In the case of the four overlapping TINs discovered during the 2016 performance year, we notified the respective ACOs of the overlap and the ACO participant TINs were required to terminate their participation in the ACO of their choice. As a result, each ACO from which the TINs terminated was required to recertify its ACO participant list for the 2016 performance year. Depending on the timing of recertification, such changes to an ACO participant list may also require us to recalculate performance year beneficiary assignment and financial benchmarks. For example, if a TIN, that was previously allowed to appear on more than one ACO participant list, hires a nurse practitioner who begins billing primary care claims in the month of December for the ACO's third benchmark year, we would discover the now impermissible overlap when we begin creating the historical benchmark reports after the 3-month claims runout. We would contact the ACOs involved, each ACO would contact the TIN and ask the TIN to select the ACO it wishes to remain aligned with. The ACO not selected would be asked to remove the TIN from its ACO Participant List and recertify the list. As a result of the recertification of the list, the ACO's assigned population would need to be redetermined and calculation of its benchmark would be delayed. We are therefore concerned about the uncertainty the current process (which includes recertification of ACO participant lists, recalculation of assignment, and resulting delay of calculations for the benchmark or performance year) could introduce for ACOs that may have little influence over or knowledge of ACO participant TIN billing practices.
We believe it is important for ACOs, ACO participants, and ACO providers/suppliers to have updated and accurate information regarding their participation status in the Shared Savings Program. For example, participation in a Shared Savings Program ACO has implications for ACO providers/suppliers under the new Quality Payment Program (see 81 FR 80496 through 80501). The Quality Payment Program replaces a patchwork system of Medicare programs with a flexible system that allows eligible clinicians to choose from two paths that link payments to quality: The Merit-Based Incentive Payment System (MIPS) and participation in Advanced Alternative Payment Models (APMs). The Quality Payment Program, through MIPS and the APM incentive, will impact eligible clinicians' payments
Under the CY 2017 Quality Payment Program final rule with comment period, eligible clinicians participating in Advanced APMs (including Tracks 2 and 3 under the Shared Savings Program) may become Qualifying APM Participants and receive a 5 percent APM Incentive Payment if they have a sufficient percentage of payments for Part B covered professional services, or a sufficient percentage of Medicare patients that are attributable to services furnished through an Advanced APM for a year. In addition to earning a 5 percent APM Incentive Payment, Qualifying APM Participants are not subject to the MIPS reporting requirements and payment adjustment for the year. As a result, revisions to ACO participant lists that occur mid-year or following the end of a benchmark or performance year could have widespread implications not only for the ACO but also for its ACO providers/suppliers under the Quality Payment Program.
As participation in the Shared Savings Program grows and more ACOs and ACO participants join the program, we believe the overlap situation described previously is likely to become more common. We also believe that changes to our program rules regarding the claims that will be considered in assigning FFS beneficiaries to an ACO (specifically, the policy finalized in the June 2015 final rule to exclude services furnished by several physician specialty types from the assignment methodology) may result in a greater number of permissible ACO participant TIN overlaps (see 80 FR 32753 and 32754). As a result, we anticipate there could also be an increased number of cases where ACO participant TINs with initially permissible overlaps could become out of compliance with the requirement at § 425.306(b)(2) that an ACO participant TIN be exclusive to a single Shared Savings Program ACO if the TIN bills for primary care services that are used to assign beneficiaries to the ACO. This could occur, for example, if a group practice that initially includes only physician specialty types whose services are excluded from the assignment methodology were to subsequently employ a non-physician practitioner who bills for primary care services. We believe these types of practice arrangements are becoming increasingly common.
We therefore believe it is necessary to streamline our approach to handling such situations in order to reduce the burden and uncertainty for ACOs when changes in ACO participant billing practices result in an ACO participant falling out of compliance with the exclusivity requirement at § 425.306(b)(2). Rather than the current policy under which an ACO may be required to remove an overlapping ACO participant and recertify its ACO participant list for the performance year (thus necessitating redetermination of beneficiary assignment and delays in or revisions to benchmark or performance year calculations), we believe it would be less disruptive for ACOs if we were to permit overlapping TINs that begin billing for services used in assignment during a benchmark or performance year (including claims for services furnished during the benchmark of performance year, but submitted during the 3-month claims runout) to remain on the ACO participant lists for all affected ACOs for the remainder of the performance year in which we determine that an overlap exists. For example, assume that, based on an analysis of claims for services furnished in performance year 2018, we were to identify an impermissibly overlapping TIN in January 2019 after the ACO participant lists for performance year 2019 had already been certified. Under this proposal, the TIN would be able to remain on the ACO participant lists of all affected ACOs for the 2018 performance year as well as the remainder of performance year 2019. In order to ensure that the TIN overlap does not inadvertently result in assignment of the same beneficiaries to multiple ACOs, we would simply exclude any claims for services furnished by the overlapping TIN from the assignment methodology when conducting final beneficiary assignment for any benchmark or performance year in which the TIN bills Medicare for services used in our assignment methodology. The affected ACOs would be required to resolve the overlap prior to recertification of their ACO participant lists for the subsequent performance year. If the overlap remains unresolved when the ACOs certify their ACO participant lists for the next performance year, we would remove the TIN from the ACO participant lists of all ACOs seeking to include the TIN, in accordance with our current policy for resolving overlaps. For example, in the hypothetical case above, if the overlap were to remain unresolved when the ACOs certify their ACO participant lists for performance year 2020, we would remove the TIN from the ACO participant lists for all ACOs seeking to include the TIN as an ACO participant for performance year 2020.
We therefore propose to modify our program rules in § 425.306 and subpart E of part 425 to address this issue. We propose to modify § 425.306(b) to indicate that if, during a benchmark or performance year (including the 3-month claims run out period for such benchmark or performance year), an ACO participant that participates in more than one ACO begins billing for services that would be used in assignment, we would not consider any services billed through that TIN during the relevant performance year when performing beneficiary assignment for the applicable benchmark or performance year. As part of this proposed modification, we would also eliminate the references to “primary care” when describing the services used to determine the ACO's assigned beneficiary population in order to conform with our proposal to implement section 17007 of the 21st Century Cures Act under which we would consider all services furnished in FQHCs and RHCs in the assignment methodology as primary care services starting in the 2019 performance year. In addition, the ACOs in which the overlapping TIN is an ACO participant may be subject to compliance action (as provided under § 425.216) or termination under § 425.218. Compliance actions may include requiring each ACO that includes the TIN as an ACO participant to submit a corrective action plan explaining how the ACO plans to work with the overlapping ACO participant to resolve the overlap for the next performance year. If the overlap remains unresolved by the date specified by us in our request for a corrective action plan, we would remove the overlapping ACO participant TIN from the ACO participant list of each ACO for the subsequent performance year.
We also propose to revise our general assignment methodology at § 425.400(a)(1) to add new paragraph (a)(1)(iii) to indicate that when we determine final assignment after the end of each benchmark or performance year, we will exclude claims for services furnished during the benchmark or performance year by an ACO participant that participates in more than one ACO. We believe that this policy will ensure a uniquely assigned beneficiary population for each ACO and prevent the same beneficiaries from being included in determining benchmark or performance year expenditures for more than one ACO.
We believe that implementing this proposed process would improve ACO
Under section 1899(d) of Act, ACOs participating in the Shared Savings Program are accountable for the total Parts A and B costs for the Medicare fee-for-service beneficiaries assigned to the ACO. Therefore, we include all payments made from the Medicare Trust Fund for Parts A and B services furnished to assigned Medicare FFS beneficiaries, including individually beneficiary identifiable non-claims based payments made under a demonstration, pilot or time limited program, when computing average per capita Medicare expenditures for an ACO during both the benchmark period and performance years. We believe it is appropriate to take into account non-claims based payments from a demonstration, pilot, or time limited program in Medicare Shared Savings Program financial calculations to ensure that the final shared savings payments that are made to ACOs are accurate and reflect all Parts A and B expenditures for the ACO's assigned beneficiaries. We also review individually beneficiary identifiable payments made under a demonstration, pilot, or time-limited program as part of our efforts to ensure there is no duplication of payments for beneficiaries that may be assigned to both the Shared Savings Program and other Innovation Center models. This general policy of considering individually beneficiary identifiable non-claims based payments made under a demonstration, pilot or time limited program was initially established in the 2011 final rule implementing the Shared Savings Program (76 FR 67915) for:
• Establishing, adjusting, and updating the benchmark for an ACO's first agreement period under § 425.602(a)(1)(ii),
• Calculation of savings under the one-sided model (Track 1) at § 425.604(a)(6)(ii), and
• Calculation of shared savings and losses under Track 2 at § 425.606(a)(6)(ii).
This policy has also been included in subsequent program modifications to the program for:
• Resetting, adjusting, and updating the benchmark for a subsequent agreement period under §§ 425.603(c)(1)(ii) and 425.603(e)(2)(ii), and
• Calculation of shared savings and losses under Track 3 at § 425.610(a)(6)(ii).
More specifically, in addition to Medicare Parts A and B claims, we include non-claims based individually beneficiary identifiable payments when performing financial calculations for the Shared Savings Program, including setting the preliminary and final benchmarks, updating the financial benchmark at the time of reconciliation and calculating performance year expenditures. We internally track non-claims based beneficiary identifiable payments (that is, payments made outside the Medicare fee-for-service claims system) through a separate CMS system that receives and stores these non-claims based payments made from the Medicare Trust Funds under a demonstration, pilot or time limited program. The non-claims based payments are loaded into the separate system at various points in time, depending on the terms of payment under each specific demonstration, pilot or time limited program. The amounts that are reflected in this separate system include interim payment amounts that are subject to final reconciliation and may not reflect the actual final payments to the provider or site. For example, the Bundled Payments for Care Improvement (BPCI) initiative is comprised of four broadly defined models of care, which link payments for the multiple services beneficiaries receive during an episode of care. (See the CMS Web site at
To date, when we perform ACO benchmarking and financial calculations under the Shared Savings Program, we have included (in addition to all Medicare Parts A and B claims) all non-claims based beneficiary identifiable payments for the applicable benchmark or performance year that are included in the separate CMS system, including any payments made during the benchmark or performance year's 3-months claims run-out period. This means that to date we have included some interim payments made under a demonstration, pilot or time limited program that will undergo subsequent reconciliation to determine the final payment amount in the calculation of historical benchmarks and performance year expenditures. However, because the various demonstrations, pilots or time limited programs may have different operational schedules to the Shared Savings Program, it is not possible for us to include all interim and final beneficiary identifiable payments made under these initiatives in benchmarking and financial reconciliation calculations for the Shared Savings Program; and, as a result, these calculations have excluded some interim and final non-claims based beneficiary identifiable payments made under certain demonstrations, pilots or time limited programs. For example, because of the timing and availability of BPCI non-claims based payment amounts, to date we have included only up to two quarters of interim payment data for BPCI in ACO benchmarking and financial reconciliation calculations for the
To date, non-claims based individually beneficiary identifiable payments represent a relatively minor proportion of an ACO's total Part A and B beneficiary expenditure amounts as determined under the Shared Savings Program (mean of 0.09 percent overall impact of ACO non-claims based payments on total per capita expenditures and a mean of 137 person-years in an ACO's assigned beneficiary population with a non-claims based payment during the year; minimum -0.72 percent, 0 person-years; maximum 1.24 percent, 1,865 person-years). For the demonstrations, pilots or time limited programs that include interim and final reconciliations, the impact of including the non-claims based payments could be positive or negative for an ACO for a given performance year. Additionally, a preliminary analysis suggests that interim payments made under select demonstrations, pilots or time-limited program fluctuate on a quarterly basis. An examination of trends in total per capita non-claims based payments in 2016 quarterly program reports across 416 Track 1 and 2 ACOs found a mean decline of 14 percent from Quarter 1 to Quarter 2, followed by a mean increase of 144 percent from Quarter 2 to Quarter 3, and a mean increase of 742 percent from Quarter 3 to Quarter 4. Quarterly trends for individual ACOs also tended to fluctuate. Per capita amounts in this analysis were based on those ACOs with at least one non-claims based payment in each quarterly report period. Almost half of the ACOs in the analysis (201 out of 416) had at least one quarter in 2016 with a net negative per capita payment across all beneficiaries with at least one non-claims based payment and at least one quarter with a net positive per capita payment. A review of non-claims based payments incorporated in PY 2017 preliminary historical benchmarks also found similar swings between negative and positive amounts, with roughly one third of ACOs receiving a benchmark (156 of 480) having at least one benchmark year with a net negative per capita payment across all beneficiaries with at least one non-claims based payment and at least one benchmark year with a net positive per capita payment.
These fluctuations in the non-claims based payments for certain initiatives like BPCI have generated stakeholder concern. Further, stakeholders note that the impact of including interim payments in financial calculations may become greater in the future, given the increasingly widespread interest in participation in alternative payment models and the growing number of such models being tested through the CMS Innovation Center. Stakeholders have therefore suggested that we should revise our policies to clarify that only final non-claims based payments made within the 3 months claims run out period under a demonstration, pilot or time limited program will be included in the calculation of an ACO's benchmark and performance year expenditures.
Our preliminary analysis, as discussed in the background section, suggests that interim non-claims based payments (that is, payments that are subject to reconciliation at a later date) made under a demonstration, pilot, or time limited program can fluctuate significantly from quarter to quarter and may not reflect the actual final reconciled payment amount. Thus, we agree with the stakeholders who have suggested that only final non-claims based payments made under a demonstration, pilot or time limited program should be included in financial calculations related to benchmarks and performance year expenditures under the Shared Savings Program. We believe this would be a reasonable approach to determining Parts A and B expenditures for assigned beneficiaries for both benchmark and performance years given the uncertain impact on ACOs' financial calculations of including interim payments that will be subsequently revised to reflect the final reconciled payment amounts. We also agree that use of interim payments made under a demonstration, pilot or time limited program could have an increasingly large effect on ACO benchmarks and performance year expenditure calculations in the future given widespread stakeholder interest in participating in alternative payment models and CMS interest in testing and expanding additional payment models that may lead to higher quality and more coordinated care at a lower cost to Medicare.
Therefore, we are proposing to revise the applicable regulations to make clear that we would include only final individually beneficiary identifiable payments made under a demonstration, pilot or time limited program in financial calculations related to establishing and updating benchmarks and determining performance year expenditures under the Shared Savings Program. We propose that this policy would be applied to calculations that are necessary to determine ACO performance for the 2018 performance year and subsequent performance years. For ACOs that are in the middle of an agreement period when this revised policy takes effect, we would adjust the benchmarks for these ACOs at the start of the 2018 performance year and each subsequent performance year so that the benchmark for the ACO reflects the use of the same payment information that would apply in expenditure calculations for the performance year. More specifically, we propose to modify our regulations at §§ 425.602(a)(1)(ii), 425.603(c)(1)(ii), and 425.603(e)(2)(ii) to add new provisions to indicate that, (1) when establishing benchmarks for agreement periods before 2018, we will include all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot, or time limited program, (2) for agreement periods beginning in 2018 and subsequent years, we would only include individually beneficiary identifiable payments made under a demonstration, pilot or time limited program that are final and not subject to further reconciliation, and (3) For the 2018 performance year and subsequent performance years in agreement periods beginning in 2015, 2016 and 2017, the benchmark would be adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program. Additionally, we propose to add new §§ 425.604(a)(6)(ii)(A), 425.606(a)(6)(ii)(A) and 425.610(a)(6)(ii)(A) indicating that when calculating expenditures for performance years before 2018, we will include all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot, or time limited program. We also propose to add new §§ 425.604(a)(6)(ii)(B), 425.606(a)(6)(ii)(B) and 425.610(a)(6)(ii)(B) indicating that when calculating expenditures for performance year 2018 and subsequent performance years, we would only include individually beneficiary identifiable payments made under a demonstration, pilot or time limited program that are final and not subject to further reconciliation. To be consistent with our treatment of claims-based payments, such final payments would have to be available in the separate CMS system by the end of the 3-month claims run out period.
We invite comments on this proposal.
Section 1848(p) of the Act requires the establishment of a value-based payment modifier (VM) that applies to specific physicians and groups of physicians the Secretary determines appropriate starting January 1, 2015, and to all physicians and groups of physicians by January 1, 2017. On or after January 1, 2017, section 1848(p)(7) of the Act provides the Secretary discretion to apply the VM to eligible professionals (EPs) as defined in section 1848(k)(3)(B) of the Act. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. The VM and Physician Feedback programs continue our initiative to recognize and reward clinicians based on the quality and cost of care provided to their patients, increase the transparency of health care quality information and to assist clinicians and beneficiaries in improving medical decision-making and health care delivery. As stated in the CY 2016 PFS final rule with comment period (80 FR 71277), the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted on April 16, 2015. Under section 1848(p)(4)(B)(iii) of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not be applied to payments for items and services furnished on or after January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) of MACRA, establishes the Merit-based Incentive Payment System (MIPS) that shall apply to payments for items and services furnished on or after January 1, 2019.
In the CY 2013 PFS final rule with comment period, we discussed the goals of the VM and also established that specific principles should govern the implementation of the VM (77 FR 69307). We refer readers to that rule for a detailed discussion. In the CY 2013 PFS final rule with comment period (77 FR 69310), we finalized policies to phase-in the VM by applying it beginning January 1, 2015, to Medicare PFS payments to physicians in groups of 100 or more EPs. A summary of the existing policies that we finalized for the CY 2015 VM can be found in the CY 2014 PFS proposed rule (78 FR 43486 through 43488). Subsequently, in the CY 2014 PFS final rule with comment period (78 FR 74765 through 74787), we finalized policies to continue the phase-in of the VM by applying it starting January 1, 2016, to payments under the Medicare PFS for physicians in groups of 10 or more EPs. Then, in the CY 2015 PFS final rule with comment period (79 FR 67931 through 67966), we finalized policies to complete the phase-in of the VM by applying it starting January 1, 2017, to payments under the Medicare PFS for physicians in groups of 2 or more EPs and to physician solo practitioners. In the CY 2016 PFS final rule with comment period (80 FR 71277 through 71279), we finalized that in the CY 2018 payment adjustment period, the VM will apply to non-physician EPs who are physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs), and certified registered nurse anesthetists (CRNAs) in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo practitioners.
In the CY 2016 PFS final rule with comment period (80 FR 71288 to 71291), we finalized that we would apply the following adjustments to payments, for items and services furnished under the Medicare PFS in CY 2018, to physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician:
• Negative 4 percent (−4.0 percent) for those that fall into Category 2, meaning that they did not meet the criteria to avoid the 2018 PQRS payment adjustment.
• Negative 4 percent (−4.0 percent) under the quality-tiering methodology for those classified as low quality/high cost and negative 2 percent (−2.0 percent) for those classified as either low quality/average cost or average quality/high cost.
• An upward adjustment of four times an adjustment factor (+4.0x) under the quality-tiering methodology for those classified as high quality/low cost and two times an adjustment factor (+2.0x) for those classified as either average quality/low cost or high quality/average cost.
We finalized that we would apply the following adjustments to payments, for items and services furnished under the Medicare PFS in CY 2018, to physician solo practitioners and physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs and at least one physician:
• Negative 2 percent (−2.0 percent) to those that fall into Category 2, meaning that they did not meet the criteria to avoid the 2018 PQRS payment adjustment.
• Negative 2 percent (−2.0 percent) under the quality tiering methodology for those classified as low quality/high cost and negative 1 percent (-1.0 percent) for those classified as either low quality/average cost or average quality/high cost.
• An upward adjustment of two times an adjustment factor (+2.0x) under the quality-tiering methodology for those classified as high quality/low cost and one times an adjustment factor (+1.0x), for those classified as either average quality/low cost or high quality/average cost.
We finalized that we would apply the following adjustments to payments, for items and services furnished under the Medicare PFS in CY 2018, to non-physician solo practitioners who are PAs, NPs, CNSs, and CRNAs and to PAs, NPs, CNSs, and CRNAs in groups comprised solely of non-physician EPs:
• Negative 2 percent (−2.0 percent) for those who fall in Category 2, meaning that they did not meet the criteria to avoid the 2018 PQRS payment adjustment.
• No downward adjustments under the quality-tiering methodology in CY 2018.
• An upward adjustment of two times an adjustment factor (+2x) under the quality-tiering methodology, for those classified as high quality/low cost and one times an adjustment factor (+1.0x) for those classified as either average quality/low cost or high quality/average cost.
In the CY 2017 PFS final rule with comment period (81 FR 80520-80524), we finalized the following, with regard to Medicare Shared Savings Program ACO participant TINs whose ACO did not successfully report quality data on behalf of its EPs for purposes of PQRS as required by the Shared Savings Program under § 425.504 for the CY 2017 and CY 2018 PQRS payment adjustments:
• For the CY 2017 VM payment adjustment period, we will use the data reported to the PQRS by the EPs under the ACO participant TIN (as a group or as individuals) outside of the ACO during the secondary PQRS reporting period in 2016 to determine whether the TIN would fall in Category 1 or Category 2 under the VM.
• We will apply the two-category approach finalized for the CY 2017 VM based on participation in the PQRS by groups and solo practitioners to determine whether groups and solo practitioners that participate in a Shared Savings Program ACO, but report to the PQRS outside of the ACO, would fall in Category 1 or Category 2 under the VM.
• We will assess the individual EP or group's 2016 data submitted outside the ACO and during the secondary PQRS reporting period against the reporting requirements for the CY 2018 PQRS payment adjustment. Therefore, groups that meet the criteria to avoid the PQRS payment adjustment for CY 2018 as a
For the CY 2018 payment adjustment period, if groups that participate in a Shared Savings Program ACO in 2016 report quality data to the PQRS outside of the ACO and meet the criteria to avoid PQRS payment adjustment for CY 2018 as a group or by having at least 50 percent of the group's EPs meet the criteria to avoid the PQRS payment adjustment for CY 2018 as individuals by reporting quality data to PQRS outside of the ACO, then they will be included in Category 1 for the CY 2018 VM. If solo practitioners that participate in a Shared Savings Program ACO in 2016 report quality data to the PQRS outside of the ACO and meet the criteria to avoid the PQRS payment adjustment for CY 2018 as individuals, then they will also be included in Category 1. We will classify their quality composite for the VM for the CY 2018 payment adjustment period as “average quality.” As finalized in the CY 2015 PFS final rule with comment period (79 FR 67943), the cost composite for groups and solo practitioners that participate in a Shared Savings Program ACO is classified as “average cost.”
As a general summary, we are proposing the following modifications to the VM policies for the CY 2018 payment adjustment period:
• Reduce the automatic downward adjustment for groups and solo practitioners in Category 2 (those who do not meet the criteria to avoid the 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or groups that have at least 50 percent of the group's EPs meet the criteria as individuals) to negative 2 percent (−2.0 percent) for groups with 10 or more EPs and at least one physician, and negative 1 percent (−1.0 percent) for groups with between 2 to 9 EPs, physician solo practitioners, and for groups and solo practitioners that consist only of non-physician EPs.
• Hold all groups and solo practitioners who are in Category 1 (those who meet the criteria to avoid the 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or groups that have at least 50 percent of the group's EPs meet the criteria as individuals) harmless from downward payment adjustments under quality tiering for the last year of the program.
• To provide a smoother transition to the MIPS and to align incentives across all groups and solo practitioners, reduce the maximum upward adjustment under the quality-tiering methodology to two times an adjustment factor (+2.0x) for groups with 10 or more EPs. This is the same maximum upward adjustment under the quality-tiering methodology that we finalized and will maintain for groups with between 2 to 9 EPs, physician solo practitioners, and for groups and solo practitioners that consist only of non-physician EPs.
Section 1848(p)(4)(B)(iii)(II) of the Act requires the Secretary to apply the VM to items and services furnished under the PFS beginning not later than January 1, 2017, for all physicians and groups of physicians. Therefore, as mentioned in this proposed rule, in the CY 2016 PFS final rule with comment period (80 FR 71277 through 71279), we established that for the CY 2018 payment adjustment period, the VM will apply to non-physician EPs who are PAs, NPs, CNSs, and CRNAs in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo practitioners.
In the CY 2016 PFS final rule with comment period (80 FR 71280), we adopted a two-category approach for the CY 2018 VM based on participation in the PQRS by groups and solo practitioners. For the purposes of the CY 2018 VM, Category 1 includes the following groups and solo practitioners:
(1) Groups that meet the criteria to avoid the CY 2018 PQRS payment adjustment as a group practice participating in the PQRS GPRO;
(2) Groups that have at least 50 percent of the group's EPs meet the criteria to avoid the PQRS payment adjustment for CY 2018 as individuals;
(3) Solo practitioners that meet the criteria to avoid the CY 2018 PQRS payment adjustment as individuals; and
(4) Groups and solo practitioners that meet the criteria to avoid the CY 2018 PQRS payment adjustment through participation in a Shared Savings Program ACO, if the ACO in which they participate successfully reports quality data as required by the Shared Savings Program.
Category 2 includes those groups and solo practitioners that are subject to the CY 2018 VM payment adjustment and do not fall within Category 1. Groups in Category 1 have been eligible to receive upward, neutral, or downward adjustments under our quality tiering methodology, and groups and solo practitioners in Category 2 receive an automatic downward adjustment under the VM.
As noted in this proposed rule, under section 1848(p)(4)(B)(iii) of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not be applied to payments for items and services furnished on or after January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) of MACRA, establishes the MIPS that shall apply to payments for items and services furnished on or after January 1, 2019. In the interest of program alignment and providing a smooth transition between the VM and MIPS, as well as aligning with the proposed changes to the policies for satisfactory reporting under the final year of PQRS, modifications to the CY 2018 VM payment adjustments are proposed and described in section III.F. of this proposed rule. We are not proposing any change to our existing policy that TINs that avoid the downward payment adjustment under PQRS (either as a group practice participating in the PQRS GPRO or through the individual participation of at least 50 percent of the group's EPs, or as a solo practitioner) will be considered Category 1 under the VM. These TINs therefore will avoid an automatic downward adjustment under the VM.
In this section, we are proposing modifications to the VM policies for the CY 2018 payment adjustment period. As discussed in greater detail below, we are proposing these modifications based on our general policy goals of better
To maintain stability in the payment adjustment amounts applicable under the VM as we transition to the MIPS in 2019, we maintained generally the same VM payment adjustment amounts from the CY 2017 payment adjustment period to the CY 2018 payment adjustment period (80 FR 71288 through 71291). Under our existing policy (80 FR 71290), the estimated funds derived from the application of the downward adjustments to groups and solo practitioners in Category 1 and Category 2 are available to all groups and solo practitioners eligible for upward adjustments under the VM. The upward payment adjustment factor (the “x” factor) is determined after the performance period has ended based on the aggregate amount of downward payment adjustments. Despite our efforts to ensure a smooth transition from the VM to the MIPS, the 2017 VM adjustment factor has resulted in payment adjustments for some groups and solo practitioners that are significantly higher than the maximum upward adjustment under the MIPS, which will apply to payments starting in 2019, after the sunset of the VM in 2018. The magnitude of the 2017 VM adjustment factor is due in large part to the number of physician practices failing to satisfy the criteria to avoid the PQRS payment adjustment (Category 2). Furthermore, we believe it is likely that many physician practices that fail to meet these criteria and as a result are in Category 2 and are subject to automatic downward adjustments under the 2018 VM will be excluded from MIPS in 2019, due to the low-volume threshold. For example, as noted in the 2015 PQRS Experience Report, CMS foundthat, based on historical data, the participation rate for practices falling below the low volume threshold “low volume” (< $30k charges OR <100 beneficiaries) would be approximately 60 percent. Based on historical data, the participation rate among practices falling above the low volume threshold (>= $30k charges AND >=100 beneficiaries) would be approximately 80 percent.
The 2017 VM adjustment factor is 15.48 percent, which is similar to the 2016 VM adjustment factor of 15.92 percent. We would expect, absent any policy change, that the 2018 VM adjustment factor would be similar or higher. The 2018 VM adjustment factor could potentially be higher than the 2017 VM adjustment factor, because non-physician EPs who will be subject to the 2018 VM may be less familiar with quality reporting and may fail to meet the criteria to avoid the CY 2018 PQRS payment adjustment, which would result in a greater number of groups and solo practitioners in Category 2. In addition, groups with 2-9 EPs and solo practitioner physicians will no longer be held harmless from downward adjustments under the quality-tiering methodology in the CY 2018 payment adjustment period.
In section III.F. of this proposed rule, we are proposing to change certain policies for the 2018 PQRS payment adjustment. We discuss the implications of these proposed changes for PQRS with regard to the VM in greater detail below.
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In contrast to the existing policy for 2018 where only non-physician solo practitioners and groups comprised solely of non-physician EPs would be held harmless from downward adjustments under quality-tiering, this proposed policy would mean that all groups and solo practitioners that meet the criteria to avoid the 2018 PQRS payment adjustment would receive either a neutral or upward adjustment based on performance.
We also propose to reduce the maximum upward adjustment under the quality-tiering methodology in CY 2018 from four times an adjustment factor (+4.0x) to two times an adjustment factor (+2.0x) for those classified as high quality/low cost and from two times an adjustment factor (+2.0x) to one times an adjustment factor (+1.0x), for those classified as either average quality/low cost or high quality/average cost. This proposal would align the upward adjustments for groups with ten or more eligible professionals with the existing policy for smaller groups and solo practitioners, as well as groups comprised solely of non-physician EPs (80 FR 71290). We are proposing this change based on our concern that the 2018 VM adjustment factor (the “x” factor used to determine upward adjustments) could potentially be higher than the 2017 VM adjustment factor, as discussed above. Lowering the maximum upward adjustment in 2018 would mitigate the effect of a high adjustment factor and ensure a smoother transition from the VM adjustment in 2018 to the MIPS adjustment in 2019. We welcome public comment on this proposal.
We are not proposing any change to the existing policy (80 FR 71291) that groups and solo practitioners that are eligible for upward adjustments under the quality-tiering methodology and have average beneficiary risk score that is in the top 25 percent of all beneficiary risk scores will earn an additional upward adjustment of one times an adjustment factor (+1x). We are also not proposing any change to the existing policy (81 FR 80520 through 80524) (a) for the CY 2017 payment adjustment period for groups and solo practitioners that would be in Category 1 as a result of meeting the proposed reduced PQRS reporting criteria (see section III.F. of this proposed rule) outside of their Shared Savings Program ACO during the secondary PQRS reporting period in 2016 or (b) for the CY 2018 payment adjustment period for groups and solo practitioners that would be Category 1 as a result of reporting outside of their Shared Savings Program ACO because their ACO failed to successfully report on their behalf to avoid the PQRS payment adjustment. As stated
Tables 22 through 24 illustrate how the proposed policies differ from the existing policies for each group size and composition.
Table 25 displays the proposed 2018 VM adjustments under the quality-tiering methodology, for groups and solo practitioners in Category 1. Under the proposed policies, groups of any size and composition would be subject to the same upward adjustments under quality tiering and would be held harmless from any downward adjustments based on performance.
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For physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician, we propose to reduce the automatic downward VM adjustment from negative 4 percent (−4.0 percent) to negative 2 percent (−2.0 percent) for those that fall in Category 2, meaning they did not meet the criteria to avoid the 2018 PQRS payment adjustment. We welcome public comment on this proposal.
For physician, PA, NP, CNS, and CRNA solo practitioners; physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs; and for PAs, NPs, CNSs, and CRNAs who are in groups comprised solely of non-physician EPs, we propose to reduce the automatic downward VM adjustment from negative 2 percent (−2.0 percent) to negative 1 percent (−1.0 percent) for those that fall in Category 2. We welcome public comment on this proposal.
Section 1848(p) of the Act does not specify the amount of payment that should be subject to the adjustment for the VM; however, section 1848(p)(4)(C) of the Act requires the VM be implemented in a budget neutral manner. In the past, under the VM, we have achieved budget neutrality by increasing payments for some groups and solo practitioners based on high performance and decreasing them for others based on low performance or failing to meet the criteria to avoid the PQRS payment adjustment as a group or as individuals. Under the proposals discussed above for the CY 2018 payment adjustment period, we would not decrease payments to groups and solo practitioners based on performance under the quality-tiering methodology, provided that they are classified as Category 1 under the VM (meaning that they meet the criteria to avoid the CY 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or as a group that has at least 50 percent of the group's EPs meet the criteria). We would continue to decrease payments to groups and solo practitioners in Category 2 (meaning that they did not meet the criteria to avoid the CY 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or as a group that has at least 50 percent of the group's EPs meet the criteria). Regardless of the proposals discussed above for the CY 2018 payment adjustment period, the aggregate expected amount of Medicare spending in any given year for physician and non-physician EP services paid under the Medicare PFS will not change as a result of the application of the VM. As discussed above, because the VM must be implemented in a budget neutral manner, the amount available for upward adjustments for high performers would decrease under our proposals. In other words, groups and solo practitioners that performed well on cost and quality would receive a smaller increase in payment. For this reason, we seek comment on whether we have appropriately balanced the interests of high and low-performing groups and solo practitioners through this proposed change to the policy.
We propose to make conforming revisions to §§ 414.1270, and 414.1275(c)(4) and (d)(3) to reflect the proposals described in this section. We seek public comment on these proposed changes to the regulation text.
The Quality Payment Program (QPP) aims to improve health outcomes, promote smarter spending, minimize burden of participation, and provide fairness and transparency in operations. These aims are centered on improving beneficiary outcomes and engaging patients through patient-centered policies, and enhancing clinician experience through flexible and transparent program design and interactions with easy-to-use program tools.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted on April 16, 2015. Section 101(f) of MACRA amended section 1848 of the Act to create a new subsection (r) entitled Collaborating with the Physician, Practitioner, and Other Stakeholder Communities to Improve Resource Use Measurement. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups. To facilitate the attribution of patients and episodes to one or more clinicians, section 1848(r)(3) of the Act requires the development of patient relationship categories and codes that define and distinguish the relationship and responsibility of a physician or applicable practitioner with a patient at the time of furnishing an item or service. The categories shall include different relationships of the clinician to the patient and reflect various types of responsibility for and frequency of furnishing care. Pursuant to section 1848(r)(3)(C) of the Act, we posted a draft list of patient relationship categories in April 2016 and solicited public comment on the categories and the policy principles that were used in developing them.
Based on the public comments received and consultation with stakeholders and experts regarding the draft list of patient relationship categories posted in April 2016 and the list of modified patient relationship categories posted in December 2016, we posted the operational list of patient relationship categories on May 17, 2017, pursuant to section 1848(r)(3)(E) of the Act, which is available at
• Continuous/Broad Services.
• Continuous/Focused Services.
• Episodic/Broad services.
• Episodic/Focused Services.
• Only as Ordered by Another Clinician.
Section 1848(r)(3)(F) of the Act requires that after the posting of the operational list of patient relationship categories and codes, not later than November 1st of each year (beginning with 2018), the Secretary shall, through rulemaking, make revisions to the operational list of patient relationship categories and codes as the Secretary determines appropriate. The revisions may be based on experience, new information and input from stakeholders. In preparation for
Section 1848(r)(4) of the Act requires that claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, shall, as determined appropriate by the Secretary, include the applicable codes established for care episode groups, patient condition groups, and patient relationship categories under sections 1848(r)(2) and (3) of the Act, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). Applicable practitioners are defined in section 1848(r)(9)(B) of the Act as a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5)), and a certified registered nurse anesthetist (as defined in section 1861(bb)(2)), and beginning January 1, 2019, such other eligible professionals (as defined in subsection (k)(3)(B)) as specified by the Secretary.
We have been planning for the use of procedure code modifiers for the reporting of patient relationships codes on Medicare claims. In December 2016, as described above, when we solicited comments on the potential modifications to the patient relationship categories, we also sought comment on the use of Level II Healthcare Common Procedure Coding System (HCPCS) Modifiers for the patient relationship codes. Public comments indicated that Current Procedural Terminology (CPT) Modifiers would be the best way to operationalize the reporting of patient relationship codes.
We worked with the American Medical Association's (AMA) CPT Editorial Panel, which is responsible for maintaining the CPT code set. We submitted an application for the CPT modifiers for reporting of the patient relationship codes. The CPT Editorial Panel, at their June 2017 meeting determined that AMA would not include the modifiers in the CPT code set, pending future finalization of the modifiers by CMS, whereby CMS publishes the modifiers as Level II HCPCS Modifiers. Therefore, we are proposing the Level II HCPCS Modifiers in Table 26 as the patient relationship codes, which we would add to the operational list if we adopt them in the final rule.
We are proposing that Medicare claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, should include the applicable HCPCS modifiers in Table 26, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). We anticipate there will be a learning curve with the use of the modifiers to report patient relationships, and believe that time would be needed to work with clinicians to ensure they gain experience in using these modifiers. Therefore, for at least an initial period while clinicians gain familiarity, we are proposing that the HCPCS modifiers may be voluntarily reported on Medicare claims, and the use and selection of the modifiers would not be a condition of payment. Claims would be paid regardless of whether and how the modifiers are included. We would work with clinicians to educate them about the proper use of the modifiers.
The use of modifiers to report patient relationships would not change the meaning of the procedure codes used to report items and services and guidelines associated with use of such procedure codes. The modifiers would also not be tied or related to intensity of services (evaluation and management services). Finally, we note that, while we may work with clinicians to explore incorporating these codes into the QPP in future years, the measures we have proposed and finalized to date, those we have proposed for 2018, and those we are currently developing for future rulemaking for the MIPS performance categories do not require patient relationship codes to properly measure clinicians' quality and resource use in the Medicare program.
We solicit comment on our proposal for voluntary reporting of the proposed HCPCS modifiers on claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018 and on the proposed list of HCPCS modifiers in Table 26. We seek comments on our intention to resubmit these patient relationship modifiers to AMA for future consideration into the CPT modifier code set.
In the November 15, 2016
Section 1115A(c) of the Act provides the Secretary with the authority to expand, through rulemaking (including implementation on a nationwide basis), the duration and scope of a model that is being tested under section 1115A(b) of the Act if certain determinations specified in the Act are made, taking into account the evaluation of the model under section 1115A(b)(4) of the Act. The MDPP expanded model is an
The aim of the MDPP expanded model is to continue to test a method of prevention of the onset of type 2 diabetes among Medicare beneficiaries with an indication of prediabetes as defined by the MDPP beneficiary eligibility criteria (finalized at § 410.79(c)(1)). Services available through the MDPP expanded model are MDPP services furnished in community and health care settings by coaches, such as trained community health workers or health professionals. We have designated services under the MDPP expanded model to be covered as additional preventive services under Medicare, as defined in section 1861(ddd) of the Act.
For a detailed discussion of the DPP model test and the development of aspects of the MDPP expanded model, we refer readers to the July 15, 2016 MDPP proposed rule (“Proposed Expansion of the Diabetes Prevention Program (DPP) Model”) (81 FR 46413 through 46418), and the CY 2017 PFS final rule (81 FR 80459 through 80475).
In the CY 2017 PFS final rule, we responded to and incorporated certain suggestions from the public comments we received that were within the scope of the MDPP proposals presented in the July 15, 2016 MDPP proposed rule. We indicated in that final rule (81 FR 80459) that the MDPP expanded model would be implemented through at least two rounds of rulemaking. In the CY 2017 PFS final rule, we finalized MDPP policies that will enable CDC-recognized organizations to prepare for enrollment, including finalizing the framework for the MDPP expanded model, details of the MDPP expanded model (codified at § 410.79(a) and (b)), beneficiary eligibility criteria (codified at § 410.79(c) and (d)), supplier eligibility criteria and supplier enrollment requirements (codified at § 424.59, proposed in this rule to be redesignated as § 424.205). We also identified several issues, including some issues raised by commenters that we deferred to future rulemaking. The proposals in this proposed rule address a number of issues raised by the public in response to the July 15, 2016 MDPP proposed rule. We also are making additional proposals to implement the MDPP expanded model.
In the CY 2017 PFS final rule (81 FR 80465 through 80468), we finalized the structure of MDPP services. We provided that the MDPP core benefit consists of at least 16 weekly core sessions over months 1 through 6 and at least 6 monthly core maintenance sessions over months 7 through 12, furnished regardless of weight loss (§ 410.79(b) and (c)(2)). We also finalized that Medicare will cover ongoing maintenance sessions after the 12-month core set of MDPP services if beneficiaries achieve and maintain the required minimum weight loss of 5 percent. In section III.K.2.b. of this proposed rule, we are proposing to further revise the structure of MDPP services as a 3-year service period, generally contingent upon a beneficiary's attainment of two performance goals: achievement and maintenance of weight loss and attendance at a certain number of MDPP sessions.
As used in this proposed rule, the term “MDPP services period” refers to the time period in which MDPP services are furnished under the MDPP expanded model over a minimum of 12 consecutive months and a maximum of 36 consecutive months from the date of the first core session the beneficiary attends. We use the term “set of MDPP services” to include the entirety of MDPP services available under the MDPP expanded model, including core sessions, core maintenance sessions, and, subject to paragraph § 410.79(c)(3), ongoing maintenance sessions offered over the course of the MDPP services period. For purposes of this proposed rule and the expanded model, MDPP services would be covered under the “additional preventive services” benefit category under section 1861(ddd)(1) of the Act and paid through the Medicare Part B Trust Fund. As indicated in the CY 2017 PFS, we intended to begin supplier enrollment before MDPP services became available, and we finalized an expanded model start date of January 1, 2018.
In this proposed rule, we propose a new start date for the furnishing of MDPP services within the expanded model of April 1, 2018. That is, MDPP suppliers will not be able to furnish MDPP services, or to receive payment for these services, prior to April 1, 2018. We note that if finalized as part of the CY 2018 PFS, the supplier enrollment and compliance policies will become effective on January 1, 2018. This change to delay the furnishing of MDPP services would allow time for organizations to enroll in Medicare before they begin furnishing and billing for MDPP services.
In the CY 2017 PFS final rule (81 FR 80459), we described a possible payment structure for MDPP services, but deferred full development of the payment structure to future rulemaking. In section III.K.2.d. of this proposed rule, we discuss our proposed payment structure for MDPP services. This proposal takes into consideration the significant number of public comments we received in response to the possible payment structure we described in the July 15, 2016 MDPP proposed rule. We also are proposing payment policies for instances in which an MDPP beneficiary switches MDPP suppliers.
In the CY 2017 PFS final rule (81 FR 80471 through 80474), we required CDC-recognized organizations that will bill Medicare for MDPP services to enroll in Medicare as MDPP suppliers. We also finalized the requirements for coaches furnishing MDPP services. We finalized policies regarding CDC Diabetes Prevention Recognition Program (DPRP) full recognition for MDPP suppliers and we indicated an intention to propose policies in future rulemaking regarding whether a DPP organization without full CDC recognition could enroll as an MDPP supplier. We are proposing an interim MDPP preliminary recognition standard in section III.K.2.e. of this proposed rule. Also, in this section of this proposed rule, we are proposing revisions to the supplier eligibility and enrollment requirements, including establishment of standards and implementation of appropriate program integrity safeguards. In section III.K.2.f. of this proposed rule, we are proposing policies related to MDPP beneficiary engagement incentives furnished by MDPP suppliers.
In the CY 2017 PFS final rule (81 FR 80459), we deferred establishing policies related to organizations delivering “virtual” DPP services, where services are not furnished in person. In section III.K.3. of this proposed rule, we explain that the MDPP expanded model covers in-person MDPP services (other than ad hoc virtual make-up sessions discussed in section III.K.2.c.iv.(3) of this proposed rule), and thus, explain why we are not currently making any proposals related to MDPP services
In the CY 2017 PFS final rule, we established at § 410.79(a) that MDPP services would be available on January 1, 2018. We are proposing to change § 410.79(a) to state that MDPP services would be available on April 1, 2018. We are proposing this change because we want to ensure that MDPP suppliers have sufficient time to enroll in Medicare after the effective date of the CY 2018 PFS final rule.
Therefore, beneficiaries will not be able to receive MDPP services immediately on January 1, 2018 due to the time needed for supplier enrollment. For this reason, we are proposing April 1, 2018 as the expanded model start date, which we believe allows a sufficient amount of time (90 days) for eligible suppliers to enroll in Medicare before furnishing and billing for MDPP services. Subject to this proposed change, the following regulatory provisions, if finalized, would be effective April 1, 2018: § 414.84 related to payment for MDPP services; and § 424.210 related to beneficiary engagement incentives. All other sections, if finalized, will be effective on January 1, 2018, including the policies proposed in section III.K.2.e. related to supplier enrollment and compliance. We seek comment on this new expanded model start date and whether 90 days is a sufficient amount of time for organizations to enroll in Medicare and prepare to furnish and bill for MDPP services.
In the CY 2017 PFS final rule, we established the parameters of MDPP services. The policies and terms proposed in this proposed rule seek to clarify, build on, and at times change these previously finalized policies. In particular, we propose to refine and add terms related to the different aspects of “MDPP services.” In this proposed rule, we propose to slightly refine the term “MDPP services” to refer to structured health behavior change sessions that are furnished under the MDPP expanded model with the goal of preventing diabetes among Medicare beneficiaries with prediabetes, and that follow a CDC-approved curriculum (proposed § 410.79(b)). The sessions provide practical training in long-term dietary change, increased physical activity, and problem-solving strategies for overcoming challenges to maintaining weight loss and a healthy lifestyle.
In the preamble to the CY 2017 PFS final rule, we referenced the set of MDPP services covered under the expanded model as the “MDPP benefit.” In this proposed rule, we propose to update this terminology. In cases where we would have previously referred to the term “benefit” to describe the entire set of MDPP sessions covered under the MDPP model, we propose to use the phrase “set of MDPP services.” “Set of MDPP services” means the series of MDPP sessions, composed of core sessions, core maintenance sessions, and ongoing maintenance sessions, offered over the course of the MDPP services period (proposed § 410.79(b)).
In cases where we would have previously used the term “benefit” to describe a period of time, we propose to refer to the “MDPP services period.” The MDPP services period means the time period, beginning on the date an MDPP beneficiary attends his or her first core session, over which the set of MDPP services is furnished to the MDPP beneficiary, to include the core services period described in paragraph § 410.79(c)(2)(i) and, subject to paragraph § 410.79(c)(3), one or more ongoing maintenance session intervals during the ongoing services period described in paragraph § 410.79(c)(2)(ii) (proposed § 410.79(b)). The duration of the MDPP services period is discussed further in section III.K.2.c.iv. of this proposed rule. As noted throughout this section, the term “benefit” would no longer be used. We propose to remove the term “MDPP core benefit” from the list of definitions.
In the CY 2017 PFS final rule, we included a definition for “core sessions” that referred to the set of core sessions covered under the MDPP expanded model. We propose to revise the definition for “core sessions,” and instead define the singular “core session” as an MDPP service that is furnished by an MDPP supplier to an MDPP beneficiary during months 1 through 6 of the MDPP services period, is approximately 1 hour in length, and adheres to a CDC-approved DPP curriculum for core sessions (proposed § 410.79(b)). We believe that having a definition for the individual core session would be more uniform with other MDPP definitions, which are defined in the singular form. We propose to revise the definition of “core maintenance session” as an MDPP service that is furnished by an MDPP supplier to an MDPP beneficiary during a core maintenance session interval, is approximately 1 hour in length, and adheres to a CDC-approved DPP curriculum for maintenance sessions (under proposed revised § 410.79(b)).
We propose to revise the definition of an “ongoing maintenance session” as an MDPP service that is furnished by an MDPP supplier to an MDPP beneficiary during an ongoing maintenance session interval; is approximately 1 hour in length and adheres to a CDC-approved DPP curriculum for maintenance sessions (proposed revised § 410.79(b)). The proposed time period over which MDPP suppliers offer ongoing maintenance sessions, which differs from our previously finalized policy, is discussed in section III.K.2.b.i. of this proposed rule.
We propose to add a definition for “MDPP session,” which means a core session, a core maintenance session, or an ongoing maintenance session (proposed § 410.79(b)).
We invite public comments on these proposals.
In the CY 2017 PFS final rule, we finalized that “MDPP eligible beneficiaries,” a term we now propose to remove and replace with “MDPP beneficiary,” as described further in section III.K.2.c. of this proposed rule, would have Medicare coverage for ongoing maintenance sessions for an unspecified length of time, provided that they maintained the required minimum weight loss, which is 5 percent weight loss from baseline. Based on public comments indicating the limited administrative and operational capability of many MDPP suppliers to provide ongoing maintenance sessions for an individual indefinitely (81 FR 80468), we stated our intent to propose a limit on the number or duration of ongoing maintenance sessions to be covered in the set of MDPP services, although we did not finalize a policy that would do so.
In this rule, we propose a 2-year limit on Medicare coverage for ongoing maintenance sessions (proposed § 410.79(c)(2)(ii)). The CMS Chief Actuary noted in the certification of the expansion of the DPP model test that continued participation in a type 2 diabetes DPP after 3 years has generally been untested. In addition, a DPP clinical trial conducted by the National Institutes of Health from 1996 to 2001 followed participants in a DPP for 3 years and found that, at the end of the study, diabetes incidence was reduced by 58 percent in the group that received a DPP lifestyle intervention when
We considered alternatives to this proposal, such as limiting Medicare coverage for ongoing maintenance sessions to 1 year, which would limit the total MDPP services period to 2 years. Because the CDC DPRP does not require organizations to offer ongoing maintenance sessions, we also considered not covering ongoing maintenance sessions altogether, which would limit the total MDPP services period to 1 year. However, we believe that beneficiaries can benefit from maintenance sessions beyond the 6 months of core maintenance sessions because weight loss is difficult to achieve and can be even more difficult to sustain. We believe that the behavior changes necessary to sustain weight loss will be more deeply ingrained through beneficiary participation in ongoing maintenance sessions. Existing evidence also supports the effectiveness of participation in a DPP through 3 years.
We did not consider alternatives that would extend Medicare coverage for ongoing maintenance sessions beyond 2 years, and therefore, create an MDPP services period that would last longer than 3 years. Therefore, we propose to continue to include ongoing maintenance sessions, but with a limit of up to 2 years. As stated earlier, we believe there is not enough evidence available to support the effectiveness of participation in a DPP beyond 3 years. We also believe, based on public comments received in response to the July 15, 2016 MDPP proposed rule, that many suppliers have limited administrative and operational capacity to offer MDPP ongoing maintenance sessions indefinitely to all MDPP beneficiaries who maintain eligibility. As noted in section III.K.2.e.iv.4 of this proposed rule, an example of a capacity limit could include a situation where an MDPP supplier has met its class size maximum and therefore could not accept additional beneficiaries. We are inviting public comments on our proposal and the alternatives we considered.
At § 410.79(b), we propose to remove the existing definition of “maintenance session bundle,” and to establish new definitions for “core maintenance session interval,” and “ongoing maintenance session interval,” which we believe will more directly reflect the structure of the set of MDPP services, as well as support the proposed policies in this proposed rule. Through these proposed definition changes, we are seeking to clarify the differences between the two types of intervals. We propose to define “core maintenance session interval” as one of the two consecutive 3-month time periods during months 7 through 12 of the MDPP services period, during which an MDPP supplier offers an MDPP beneficiary at least one core maintenance session per month. We propose to define “ongoing maintenance session interval” as one of the up to eight consecutive 3-month time periods during the ongoing services period described in paragraph § 410.79(c)(2)(ii), during which an MDPP supplier offers at least one ongoing maintenance session to an MDPP beneficiary per month.
We are making the proposal to use the term “interval” instead of “bundle” because the proposed performance payments are tied to attendance and weight loss performance goals and, in aggregate, constitute the payment to MDPP suppliers for furnishing MDPP services during the MDPP services period, but they do not provide specific payments for a particular subset of sessions. Therefore, we believe that the term “bundle” is not appropriate for describing performance payments for these time intervals. The proposed new terms allow us to more appropriately describe the relationship of the performance payments to the specific time periods where performance is measured. Furthermore, we propose to define “make-up session” as a core session, a core maintenance session, or an ongoing maintenance session furnished to an MDPP beneficiary when the MDPP beneficiary misses a regularly scheduled core session, core maintenance session, or ongoing maintenance session (proposed at § 410.79(b)). We propose to define “virtual make-up session” as a make-up session that is not furnished in person and that is furnished in a manner consistent with the DPRP standards for virtual sessions (proposed § 410.79(b)). Policies describing the parameters of make-up sessions and virtual make-up sessions are described further in section III.K.2.c.iv.(3).
We propose an additional term that helps describe key aspects of the MDPP expanded model: “Performance goal.” This term refers to an attendance or weight loss goal that an MDPP beneficiary must achieve during the MDPP services period for an MDPP supplier to be paid a performance payment (proposed § 414.84(a)). Because we propose this term that more broadly speaks to the performance goals of this expanded model, we propose to remove the definition of “maintenance of weight loss.” We also propose to move the definition of “coach” from § 410.79(b) to § 424.205(a) (we propose in section III.K.2.e to redesignate § 424.59, Requirements for Medicare Diabetes Prevention Program suppliers to § 424.205). We propose to revise the definition of “MDPP supplier” to mean an entity that is enrolled in Medicare to furnish MDPP services as provided in § 424.59 (proposed to be redesignated as § 424.205).
We invite public comments on these proposals.
In the CY 2017 PFS final rule, we established the eligibility criteria for Medicare beneficiaries to have coverage of the set of MDPP services, codified at §§ 410.79(c)(1) and 410.79(d), respectively. We previously finalized that an individual who met these criteria would be referred as an “MDPP eligible beneficiary.” However, in this proposed rule, we propose to remove this term, and instead, add the definition of “MDPP beneficiary” to mean a Medicare beneficiary who meets the criteria specified in paragraph § 410.79(c)(1)(i), who has initiated the MDPP services period by attending the first core session, and for whom the MDPP services period has not ended as specified in paragraph § 410.79(c)(3) (proposed § 410.79(b)). We believe that this revised definition will provide more clarity about when a beneficiary qualifies to receive MDPP services. We propose to remove the definition of “MDPP eligible beneficiary” to avoid confusion between the two definitions, and we propose conforming changes to § 410.79 to remove the term “MDPP eligible beneficiary” and use the term “MDPP beneficiary” in its place, where appropriate.
In the CY 2017 PFS final rule (81 FR 80470), we specified at § 410.79(c)(1) that Medicare beneficiaries are eligible for MDPP services if they meet all of the following criteria:
• Are enrolled in Medicare Part B.
• Have, as of the date of attendance at the first core session, a body mass
• Have, within the 12 months prior to attending the first core session, a hemoglobin A1c test with a value between 5.7 and 6.4 percent, a fasting plasma glucose of 110-125 mg/dL, or a 2-hour plasma glucose of 140-199 mg/dL (oral glucose tolerance test).
• Have no previous diagnosis of type 1 or type 2 diabetes (other than gestational diabetes).
• Do not have end-stage renal disease (ESRD).
In this proposed rule, we propose changes to these eligibility criteria at § 410.79(c)(1) to clarify the eligibility limitations related to previous type 1 or type 2 diabetes diagnosis (described further in section III.K.2.c.ii. of this proposed rule), move and edit the regulation text that specifies that each beneficiary can only receive the set of MDPP services once in their lifetime (described further in section III.K.2.c.iii. of this proposed rule), and make editorial changes so that the provisions are specific to an individual beneficiary. We also are taking this opportunity to clarify some of these eligibility criteria.
We note that we are not excluding beneficiaries with a prior history of gestational diabetes from eligibility for MDPP services, while beneficiaries with a prior history of a diagnosis of type 1 or type 2 diabetes are ineligible. The eligibility criteria are intended to identify a beneficiary at high risk for the development of type 2 diabetes in an individual that has not been diagnosed with type 1 or type 2 diabetes. Gestational diabetes is a condition that develops during pregnancy and typically resolves after delivery, although an individual with a history of gestational diabetes is at increased risk of subsequent type 2 diabetes development and may benefit from the set of MDPP services. Because of the clinical differences between gestational diabetes and type 1 or type 2 diabetes, we determined that it was appropriate not to exclude a beneficiary with a prior history of gestational diabetes from eligibility for MDPP services.
We also are clarifying that a beneficiary who is diagnosed with ESRD after having begun receiving MDPP services would lose eligibility. We do not believe MDPP services are appropriate for beneficiaries with ESRD because beneficiaries with ESRD require dialysis, and the nutrition requirements for individuals on dialysis are very specific and therefore MDPP curriculum will not apply.
In summary, a beneficiary must maintain Medicare Part B coverage and not have ESRD throughout the duration of the MDPP services period to remain eligible to receive coverage for MDPP services. In conjunction with our proposal in this proposed rule related to diabetes diagnosis (explained further in section III.K.2.c.ii. of this proposed rule), a beneficiary must meet the eligibility requirements related to prediabetes and diabetes (including BMI, blood test results, and no diagnosis of diabetes other than gestational diabetes) as of the date of attendance at the first core session.
We invite public comments on these proposals.
In the CY 2017 PFS final rule, we finalized that to be eligible for coverage for the set of MDPP services, a Medicare beneficiary must have prediabetes, as shown through a qualifying BMI and blood test results, and must have no previous diagnosis of type 1 or type 2 diabetes (other than gestational diabetes). We received public comments in response to the July 15, 2016 MDPP proposed rule that asked whether a beneficiary would remain eligible for the set of MDPP services if the beneficiary developed diabetes during the MDPP services period. In the CY 2017 PFS final rule, we deferred action in response to these public comments and are now addressing them in this proposed rule.
We propose that the diabetes diagnosis exclusion applies only at the time of the first core session (that is, if a beneficiary develops diabetes during the MDPP services period, it would not affect the beneficiary's eligibility to continue receiving MDPP services). Specifically, we propose to revise the eligibility requirements for MDPP services to state that a beneficiary has, as of the date of attendance at the first core session, no previous diagnosis of diabetes, other than gestational diabetes (proposed § 410.79(c)(1)(i)(E)). This proposed policy is based in part on the fact that the DPP model test, which demonstrated cost savings, did not exclude from the model individuals who developed diabetes. Additionally, whereas suppliers can check HETS to verify a beneficiary's ESRD status fairly easily, we believe requiring a supplier to reassess other beneficiary eligibility criteria such as diabetes status and blood test results, and subsequently removing those who no longer meet the eligibility criteria is impractical and unduly burdensome.
Alternatively, we considered deeming any beneficiary who develops diabetes during the MDPP services period to be ineligible to continue to receive coverage for MDPP services because these services are intended to be preventive. If a beneficiary progresses to type 2 diabetes, other treatment options, such as Diabetes Self-Management Training (DSMT), may be more appropriate than services that seek to prevent a condition the beneficiary already has. However, it is important to note that the receipt of MDPP services does not preclude a beneficiary from accessing other treatments for diabetes during the time period that the beneficiary is covered for MDPP services. An MDPP beneficiary who ultimately also receives DSMT at some time during the MDPP services period because he or she develops diabetes after beginning the set of MDPP services will receive different types of information and training. For example, a beneficiary receiving DSMT furnished by certified diabetes educators acquires knowledge for self-care and life style
We are seeking public comments on our proposal and whether individuals who develop diabetes during the MDPP services period should continue to be eligible for coverage of MDPP services for the full duration of the MDPP services period.
In the CY 2017 PFS final rule, we specified that coverage for the set of core MDPP services is available only once per lifetime for each MDPP beneficiary (codified at § 410.79(d)(1)). In this rule, we propose to delete § 410.79(d)(1) and move this provision to proposed § 410.79(c)(1)(i)(B) to place it with other MDPP beneficiary eligibility criteria. We also propose to edit this provision to specify that coverage for the full set of MDPP services, inclusive of ongoing maintenance sessions as opposed to only core MDPP services, is available only once per lifetime per MDPP beneficiary. Now that we propose to limit the ongoing services period to 2 years, we believe that this proposed revision is necessary to clarify that coverage for the entire set of MDPP services is subject to this limitation—otherwise, the once-per-lifetime limitation has no practical effect because an MDPP beneficiary could continue to attend ongoing maintenance sessions long after the MDPP beneficiary has completed the core services period. In addition, for the reasons stated previously, we do not have evidence to support coverage of MDPP services for more than 3 years. We also are clarifying that the once-per-lifetime coverage limit applies to a beneficiary who receives a set of MDPP services under the MDPP model expansion. This limitation would not apply to beneficiaries who participated in a DPP as part of the DPP model test unless they receive the set of MDPP services under the MDPP expanded model. We invite public comments on our proposal.
In the CY 2017 PFS final rule, we stated that beneficiaries could self-report to MDPP suppliers that they had not previously received MDPP services. We recognize that self-reported information may not be the most reliable source for MDPP suppliers to use before submitting claims for MDPP beneficiaries, and there is a risk that information that is inaccurately self-reported could result in the denial of payments for MDPP services. We are considering ways MDPP suppliers would be able to reliably verify if a beneficiary has received coverage of MDPP services from another supplier, such as through a standardized tracker described in section III.K.2.d.v of this proposed rule, and we are seeking public comments on any additional ways MDPP suppliers could access this information. We intend to provide administrative guidance on any resources to assist MDPP suppliers in identifying beneficiaries' previous receipt of covered MDPP sessions, as appropriate.
In the CY 2017 PFS final rule, we specified the minimum number and frequency of sessions that MDPP suppliers must offer to MDPP beneficiaries (codified at §§ 410.79(c)(2)(i) and 410.79(c)(2)(ii)). We finalized that MDPP suppliers must furnish ongoing maintenance session intervals to MDPP eligible beneficiaries who have maintained 5 percent weight loss from their baseline weight as measured during the previous maintenance session interval. As defined at § 410.79(b), “baseline weight” is the MDPP beneficiary's body weight recorded during that beneficiary's first core session.
However, because in this proposed rule we propose to tie payment for MDPP services to the beneficiary's achievement of performance goals, we propose additional changes to tie the beneficiary's eligibility for continued coverage of ongoing maintenance session intervals to his or her achievement of performance goals, namely requiring a minimum level of attendance. Because our proposed policies for payment and coverage differ somewhat, we are addressing them separately below.
As discussed in section III.K.2.b. of this proposed rule, we propose to revise § 410.79(c)(2), which describes MDPP services periods, to specify that the MDPP services period means the time period, beginning on the date an MDPP beneficiary attends his or her first core session, over which the set of MDPP services is furnished to the MDPP beneficiary, to include the core services period described in paragraph § 410.79(c)(2)(i) and, subject to paragraph § 410.79(c)(3), one or more ongoing maintenance session intervals during the ongoing services period described in paragraph § 410.79(c)(2)(ii).
We propose to revise § 410.79(c)(2) to specify that there are two service periods in which Medicare will cover MDPP services for a beneficiary: The core services period; and the ongoing services period. Together these would make up the MDPP services period. The core services period is the first 12 months of the MDPP services period, and consists of core sessions and core maintenance sessions. There are 16 core sessions that are offered at least a week apart in months 1 through 6, beginning on the date of attendance at the first core session. Core maintenance sessions are offered at least once per month in months 7 through 12 of the core services period. We propose to move the requirements for MDPP suppliers to offer these services to § 424.205(d)(9) because they are more appropriately included among other requirements for MDPP suppliers. Consistent with our policies finalized in the CY 2017 PFS final rule, we do not condition coverage for the core services period upon weight loss or attendance. Medicare will pay for the set of core MDPP services, regardless of how many sessions the beneficiary attends and regardless of his or her weight loss. However, we note that an MDPP beneficiary must attend at least one core session to initiate the MDPP services period.
These proposals would align with CDC's 1-year curriculum, divided into two 6-month periods. We recognize that framing the MDPP services period in terms of months may cause some confusion because the CDC terminology uses weeks. However, we believe that framing the MDPP services period in months would better align with our proposed payment structure. We did not make eligibility for the core maintenance sessions contingent upon an attendance-based performance goal; because the CDC DPP curriculum covers 12 months of sessions, we believe that coverage for the 12 months of the core services period should be available to all MDPP beneficiaries, regardless of attendance. The 12-month CDC DPP curriculum is based on evidence from the original DPP randomized clinical trial, and the curriculum used in that trial, which achieved a 58 percent reduction in type 2 diabetes risk (with
As discussed in section III.K.2.e.iv.4 of this proposed rule, MDPP suppliers must offer a minimum of 16 core sessions, no more frequently than once each week, in months 1 through 6, and at least 1 core maintenance session each month in months 7 through 12 of the core services period. However, some MDPP suppliers may choose to furnish more than the minimum number of sessions, and these proposed coverage parameters would allow beneficiaries to receive more than the minimum number of sessions if the MDPP supplier elects to furnish them.
We invite public comments on our proposals.
As discussed in section III.K.2.b.i. of this proposed rule, we propose to revise § 410.79(c)(2)(ii) to clarify that the ongoing services period consists of up to eight 3-month ongoing maintenance session intervals offered during months 13 through 36 of the MDPP services period. Medicare's coverage of the ongoing services period is subject to limitations proposed subsequently in this section.
Our existing regulations at § 410.79(b) affirm that Medicare will cover MDPP services in the first 12 months of the MDPP services period, without regards to a beneficiary's achievement of performance goals, whereas § 410.79(d)(2) specifies that, for coverage of ongoing maintenance sessions, the beneficiary must have achieved weight loss of 5 percent from his or her baseline weight. In this proposed rule, we propose to delete § 410.79(d)(2) and move this provision to § 410.79(c)(1) with other MDPP beneficiary eligibility criteria. We also propose to add paragraph (c)(1)(ii) to § 410.79 to specify that beneficiaries must also attend at least one in-person core maintenance session in months 10 through 12 of the MDPP services period and achieve or maintain required minimum weight loss at a minimum of one in-person session during the final core maintenance session interval to be eligible for coverage of the first ongoing maintenance session interval. We propose to establish that a beneficiary must attend at least one in-person core maintenance session in months 10 through 12 of the MDPP services period because, as stated in the CY 2017 PFS final rule, an MDPP beneficiary must achieve at least 5 percent weight loss from baseline at least once during the previous maintenance session interval to have coverage of an ongoing maintenance session.
Because we propose that weight measurements used for determining beneficiary eligibility for coverage or supplier payment must be taken in person by an MDPP supplier at an MDPP core maintenance or ongoing maintenance session (proposed § 410.79(c)(1)(iv)), a beneficiary must attend at least one in-person core maintenance session during months 10 through 12 to have his or her weight measured to determine whether he or she qualifies for coverage of the first ongoing maintenance session interval. We believe that in-person measurements are the most feasible method for weight ascertainment at this time for services where the beneficiary would have regular in-person sessions with the MDPP supplier. We believe that self-reported weight loss is not reliable for the purposes of determining continued coverage of MDPP services for a beneficiary. We invite public comments on these proposals.
In addition to achieving weight loss performance goals, as previously finalized in the CY 2017 PFS final rule, we propose that beneficiaries must also meet an attendance-related performance goal in order for Medicare to cover ongoing maintenance session intervals. We propose to add paragraph (c)(1)(iii) to § 410.79 to specify that for coverage of ongoing maintenance session intervals 2 through 8, an MDPP beneficiary must attend at least 3 ongoing maintenance sessions during the previous ongoing maintenance session interval, in addition to maintaining 5 percent weight loss from baseline at least once during the previous ongoing maintenance session interval.
We believe that adding an attendance-related performance goal during the ongoing services period is important because it will provide an incentive to keep MDPP beneficiaries engaged after the core services period. MDPP beneficiaries who meet the specified attendance and weight loss goals will have Medicare coverage of ongoing maintenance sessions, which are a part of the set of MDPP services, but not a part of the CDC DPP curriculum. We believe that the subsequent attendance goal requirements during ongoing maintenance session intervals will motivate beneficiaries to take on more individual responsibility for their behavior changes over time because coverage of these services is dependent upon their attendance and achievement and maintenance of weight loss.
In addition, this proposed policy closely aligns with our proposed policy for supplier payment for ongoing maintenance session intervals. As described further in section III.K.2.d.iii.5. of this proposed rule, we propose that a supplier would be paid for furnishing an ongoing maintenance session interval only if the MDPP beneficiary both attended three sessions, as well as maintained a 5 percent weight loss from baseline measured at least once in that interval. However, in light of our proposal to pay MDPP suppliers upon the beneficiary's attendance of three ongoing maintenance sessions (in addition to maintaining at least a 5 percent weight loss), we believe that we similarly need to have attendance goals for beneficiaries to continue to have coverage of ongoing maintenance sessions. Without requiring attendance, an MDPP beneficiary who maintained 5 percent weight loss but only attended two ongoing maintenance sessions in an ongoing maintenance session interval would be eligible for coverage of ongoing maintenance sessions, but the supplier would not receive payment for furnishing that ongoing maintenance session interval. In effect, the MDPP supplier could be required to furnish up to 24 months of MDPP services without payment. For this reason, we propose to require beneficiaries to attend all three sessions within an ongoing maintenance session interval to have coverage of the subsequent interval.
We considered an alternative where a beneficiary would have continued coverage of ongoing maintenance session intervals if he or she attends at least one in-person ongoing maintenance session during an ongoing maintenance session interval, as long as that beneficiary maintained at least 5 percent weight loss from baseline at least once during that interval. However, we do not believe that this alternative would align with our proposed supplier payment requirements for ongoing maintenance sessions discussed in section III.K.2.d.iii.5 of this proposed rule, which would require suppliers to furnish, and the beneficiary to attend, all three sessions of the ongoing maintenance session interval for the supplier to receive payment for that
In this proposed rule, we propose to add § 410.79(c)(3) to specify that coverage of the MDPP services period would end upon completion of the core services period for a beneficiary that is not eligible for the first ongoing maintenance session interval as proposed under § 410.79(c)(1)(ii); that is, if the beneficiary does not attend at least one in-person core maintenance session during the second core maintenance session interval and/or does not achieve the required minimum weight loss during this interval. For any beneficiary who is eligible for at least one ongoing maintenance sessions interval, but who does not meet the requirements for coverage of a subsequent interval based on failure to meet attendance or weight loss goals proposed at § 410.79(c)(1)(iii), the beneficiary's coverage of the set of MDPP services would end upon completion of his or her current ongoing maintenance session interval. It is important to note that proposed performance payments, discussed in section III.K.2.d.iii.5. of this proposed rule, would be tied to the achievement of the same performance goals a beneficiary must meet to have coverage for the ongoing maintenance session intervals. Therefore, if an MDPP beneficiary does not meet weight loss or attendance goals to access the subsequent ongoing maintenance session interval, the supplier will not receive payment for that ongoing maintenance session interval or any subsequent performance payments related to that beneficiary.
We are inviting public comments on these proposed policies.
In the CY 2017 PFS final rule, we indicated that a beneficiary may change MDPP suppliers at any time. However, we deferred to future rulemaking specific policies to address coverage of and payment for MDPP services when beneficiaries change MDPP suppliers. In this proposed rule, we are clarifying that a beneficiary may change MDPP suppliers at any time during his or her MDPP services period, subject to beneficiary eligibility requirements. Based on evidence from the CDC DPRP, we believe that the instances of beneficiaries changing MDPP suppliers will be relatively infrequent. However, we intend to monitor how often beneficiaries change MDPP suppliers, as well as MDPP suppliers' billing patterns to detect any aberrant billing patterns suggestive of fraudulent or discriminatory practices. Payment policies related to when a beneficiary changes MDPP suppliers are discussed in section III.K.2.d.v.
In this proposed rule, we propose at § 410.79(d)(1) that suppliers may offer make-up sessions to an MDPP beneficiary who missed a regularly scheduled session. As defined at proposed § 410.79(b), “make-up session” means a core session, core maintenance session, or ongoing maintenance session furnished to an MDPP beneficiary when the MDPP beneficiary misses a regularly scheduled core session, core maintenance session, or ongoing maintenance session. Make-up sessions may be delivered in person or virtually, although virtual make-up sessions are subject to additional requirements proposed in this rule (and the term “virtual make-up session” is separately defined). We propose the availability of make-up sessions to be consistent with CDC's DPRP standards and to ensure that MDPP beneficiaries have the opportunity to receive the full DPRP curriculum, even if they are unable to attend a particular regularly scheduled MDPP session.
We propose that the curriculum delivered during a make-up session must address the same CDC-approved DPP curriculum topic as the session that the beneficiary missed (proposed § 410.79(d)(1)(i)). To be consistent with CDC's proposed 2018 DPRP standards, we propose that the MDPP supplier may furnish to the beneficiary a maximum of one make-up session on the same day as a regularly scheduled session (proposed § 410.79(d)(1)(ii)) and the MDPP supplier may furnish to the beneficiary a maximum of one make-up session per week (proposed § 410.79(d)(1)(iii)).
There is a growing area of research examining the effectiveness of DPP delivered virtually. CDC began recognizing Virtual DPP organizations in 2015 and emerging evidence suggests that virtual delivery of DPP services can show similarly successful participant weight loss and health benefits to DPP delivered in other settings, including among Medicare-age participants.
First, as indicated by the applicable definition, virtual make-up sessions must be furnished in a manner consistent with CDC's DPRP standards for virtual sessions (proposed § 410.79(d)(2)(i)). To align with CDC's DPRP standards, virtual make-up sessions refer to any modality, or method of furnishing MDPP services, that is not in person. This includes, but is not limited to:
(1) Furnishing services online where the behavior change program is furnished 100 percent online, with participants accessing course resources and a coach via a computer, laptop, tablet, smart phone, or other device with Internet access. This modality requires that the MDPP beneficiary have an Internet connection to participate in all aspects of the virtual make-up session;
(2) Furnishing services online with other means of support by a coach (for example, telecommunications, video conferencing). This modality requires that the MDPP beneficiary have an Internet connection for some aspects of the virtual make-up session, but not all; and
(3) Distance learning, where a coach is present in one location and participants are calling, video-conferencing, or otherwise using telecommunications technology to access the coach from another location.
By defining MDPP virtual make-up sessions as being consistent with CDC's DPRP standards for virtual sessions, we allow our definition to change over time as such standards are updated.
Second, a supplier may only offer virtual make-up sessions based on an individual MDPP beneficiary's request (proposed § 410.79(d)(2)(ii)). A supplier may not cancel a regularly scheduled MDPP session and offer the session to all MDPP beneficiaries virtually. However, the supplier may cancel a regularly scheduled MDPP session and offer the session to all MDPP beneficiaries in person. We believe that this is necessary to ensure that the MDPP expanded model remains a model predominantly delivered in person. Individual beneficiary needs may be accommodated, but suppliers should not use virtual make-up sessions as a means to move toward virtually-delivered MDPP sessions more generally.
Third, to further ensure that MDPP services are largely provided in-person, we propose at § 410.79(d)(2)(iii) that a supplier may offer: (a) No more than 4 virtual make-up sessions within the core services period to an MDPP beneficiary, of which no more than 2 virtual make-up sessions may be core maintenance sessions; and (b) no more than 3 virtual make-up sessions that are ongoing maintenance sessions to an MDPP beneficiary during any rolling 12-month time period. At § 410.79(d)(3), we propose that these same limitations on the number of virtual make-up sessions also apply for the purposes of determining whether a beneficiary has attended a sufficient number of MDPP sessions in order to be eligible for ongoing maintenance sessions (proposed § 410.79(c)(1)) and for assessing whether a beneficiary has met the attendance-related performance goals used to determine whether an MDPP supplier is eligible to receive a performance payment (proposed § 414.84(b)). The limitation on the number of make-up sessions is not applicable to in-person make-up sessions.
We assume not all suppliers will have the ability to offer virtual make-up sessions, and we are not requiring suppliers to offer virtual make-up sessions. Conversely, an MDPP supplier could offer only virtual make-up sessions and no in-person make up sessions if the supplier chooses as long as the proposed limits for these sessions are not exceeded. We believe that allowing fewer than these proposed number of virtual make-up sessions will make it difficult for suppliers to meet DPRP standards, and therefore remain enrolled as an eligible MDPP supplier. However, the DPP model test only offered in-person sessions (no virtual sessions) and therefore the MDPP expanded model is intended to predominantly offer services in person. Allowing more than the proposed number of virtual make-up sessions would not support an evaluation of an in-person MDPP curriculum. We seek comment on our proposals and specifically on the proposed limitations on virtual make-up sessions.
We considered the following alternatives to this proposal. We considered not allowing any make-up sessions to be furnished virtually. However, we believe that this would place undue restrictions on MDPP suppliers who are willing and would like to offer virtual make-up sessions to MDPP beneficiaries, particularly if these are offered to other DPP participants who are not Medicare beneficiaries.
We also considered allowing an MDPP supplier to furnish between one and three sessions within the core services period and either one or two ongoing maintenance sessions each year as virtual make-up sessions per MDPP beneficiary. However, we believe that allowing fewer sessions to be furnished as virtual make-up sessions than proposed would not provide sufficient flexibility for MDPP suppliers to meet CDC's DPRP standards, which require organizations to meet attendance requirements for their panel of participants. Organizations may struggle to meet DPRP attendance requirements without the flexibility to provide virtual make-up sessions.
We also considered permitting suppliers to offer any number of virtual make-up sessions, and for attendance at any number of virtual make-up sessions to count toward attendance goals. However, as stated previously, since the DPP model test only offered DPP services in person, the MDPP expanded model is intended to predominantly offer MDPP sessions in person as well. Therefore we believe that it is important to limit the number of virtual make-up sessions so that MDPP beneficiaries are predominantly receiving MDPP sessions in person.
We propose that the payment policies detailed in section III.K.2.d. of this proposed rule apply to virtual make-up sessions. Specifically, as indicated in sections III.K.2.c.1.iv. and III.K.2.d.iii.10.b. of this proposed rule, weight measurements used for the purposes of determining the achievement or maintenance of weight loss for weight loss performance payments, or for determining eligibility for coverage of ongoing maintenance sessions, would be required to be taken at an in-person session, not during a virtual make-up session. We are seeking public comments on these proposals and the alternatives considered.
In the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416), we discussed a potential MDPP payment structure and the associated payment amounts and sought information from the public to inform future MDPP proposals. We received a number of public comments on these topics and have considered this information in the development of our proposals for the MDPP payment structure, payment amounts, and related issues discussed in this section.
In this proposed rule, we are proposing to pay for the set of MDPP services through a performance-based payment methodology that makes periodic performance payments to MDPP suppliers during the MDPP services period. The aggregate of all performance payments constitutes the total performance-based payment amount for the set of MDPP services. As discussed in detail throughout this section, we are proposing a maximum total performance payment amount per beneficiary for the set of MDPP services of $810. Performance payments would be made to MDPP suppliers periodically during the course of a beneficiary's MDPP services period based upon a number of factors, including the beneficiary's completion of a specified number of MDPP sessions and the achievement of the required minimum weight loss that is associated with a reduced incidence of type 2 diabetes, rather than individual payments being made upon the furnishing of any service as is typical of payment in the traditional Medicare program.
The aggregate amount of the performance payments proposed in this section would equal the total performance-based payment amount for the set of MDPP services during the MDPP services period, including core sessions, core maintenance sessions, and ongoing maintenance sessions. Even though these performance payments would be made periodically and in amounts that would not be
Once the required minimum weight loss is achieved and the 12-month core services period, described at proposed § 410.79(c)(2)(i), concludes, we would make additional 3-month interval performance payments for ongoing maintenance sessions when the required minimum weight loss is maintained, whereas no additional interval performance payments would be made for ongoing maintenance sessions if the required minimum weight loss is not maintained. Finally, when a beneficiary achieves a significant percentage of weight loss, specifically a level of 5 percent (the required minimum weight loss) or 9 percent, we are proposing to make additional performance payments to the MDPP supplier. This proposal would provide performance payments in addition to the performance payments we may have already made for the previous MDPP sessions furnished to the beneficiary because those sessions resulted in the beneficiary achieving the weight loss performance goal.
In total, based on our consultation with DPP providers holding commercial contracts, review of information related to DPP providers that currently hold or are in the process of obtaining CDC recognition, and comments received on the discussion of the payment structure and payment amounts for the set of MDPP services included in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416), we believe the proposed performance-based payment methodology would pay MDPP suppliers appropriately for the resources used in furnishing MDPP services throughout the MDPP services period. We note that we sought public comment on the payment structure and payment amounts for the set of MDPP services in the July 15, 2016 MDPP proposed rule, and we have used the information provided by commenters in developing the proposed performance-based payments included in this proposed rule.
In this performance-based payment structure, it is important to note that a beneficiary's performance goals are not considered in the same way for beneficiary coverage and supplier payment during each specific period within the MDPP services period. During the core services period, a beneficiary would not be required to achieve attendance and/or weight loss performance goals for coverage of MDPP services, although a beneficiary would be required to achieve specified performance goals for an MDPP supplier to receive performance payments during this period. In contrast, achieving performance goals would be required for both coverage of MDPP services and performance payments during the ongoing services period.
For example, a supplier is required to offer a minimum of 16 core sessions during the core services period according to § 410.79(c)(2)(i) but a beneficiary would not need to achieve an attendance or weight loss performance goal to be eligible for coverage of core maintenance sessions. However, MDPP supplier performance payments during the core services period would be based on the beneficiary's achievement of attendance and/or weight loss performance goals. During the ongoing services period, achievement of performance goals would affect both coverage and supplier payment. We note that a beneficiary would need to attend at least 1 core session to initiate the core services period, and attend at least 1 core maintenance session during the final core maintenance session interval to determine whether he or she has achieved the required minimum weight loss to have coverage of ongoing maintenance sessions. Because we are proposing in section III.K.2.d.iii.4 of this proposed rule to make a performance payment for core maintenance sessions only when the beneficiary attends at least 3 sessions within a 3-month interval, it is possible that an MDPP supplier would not be paid a separate performance payment for the second core maintenance session interval, but the beneficiary would still have coverage of the first ongoing maintenance session interval. This would occur if the beneficiary attended only 1 or 2 core maintenance sessions during the second core maintenance session interval and achieved or maintained the required minimum weight loss as measured at 1 of those 2 sessions.
In addition to requests for clarification on certain details of the payment structure, such as the timing of beneficiary achievement of weight loss, which are addressed subsequently in this section, commenters on the discussion of payment for MDPP services in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416) expressed a variety of perspectives on the performance-based payment methodology presented in that proposed rule. In general, commenters urged us to set payment amounts that are sufficient to ensure MDPP supplier participation.
Several commenters recommended that a sustainable payment rate structure should mirror performance-based payment models in the existing employer marketplace. A number of commenters requested that we not tie Medicare payment to weight loss or that we make separate weight loss and attendance payments; that we tie payment to aggregate, rather than individual, beneficiary weight loss; or that we tie payment to other factors besides or in addition to weight loss. Other commenters urged us to provide payment based on sessions furnished by MDPP suppliers rather than basing payment on an individual beneficiary's success, arguing that the payment structure presented would not be a sustainable model for MDPP suppliers that would expend resources furnishing sessions but would have little influence over beneficiaries' achievement of attendance and/or weight loss performance goals.
Several commenters requested that we provide information on how the payment rates included in the discussion were determined. Some commenters expressed concern that the magnitude of MDPP payments was not consistent with payments for other similar services.
A number of commenters urged that higher payments be made at the beginning of the MDPP services period to cover program start-up costs, that we decrease supplier financial risk by providing sufficient payment for beneficiaries who do not achieve weight loss performance goals, and that we implement risk-stratification of payments to reduce the risk of MDPP suppliers preferentially seeking to
As discussed in this section, the proposed MDPP payment structure is generally similar to that which was discussed in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416). However, the proposed performance payment amounts for core sessions, core maintenance session 3-month intervals, and ongoing maintenance session 3-month intervals differ somewhat based on our consideration of the comments received in response to the July 15, 2016 MDPP proposed rule in the context of our policy goal to prioritize the achievement and maintenance of the required minimum weight loss that is associated with a reduction in the incidence of type 2 diabetes. In this proposed rule, we are proposing a payment structure for MDPP services that is performance-based in relation to two meaningful performance goals.
First, the proposed payment structure values beneficiary weight loss most significantly. Weight loss is a key indicator of success among individuals enrolled in a DPP due to the strong association between weight loss and reduction in the risk of type 2 diabetes.
In addition to weight loss, we considered linking other criteria such as hemoglobin A1c level to MDPP performance payments, or using aggregate instead of individual weight loss for MDPP payments. However, the MDPP expanded model was determined to meet the statutory requirements for expansion based on the DPP model test, which demonstrated that weight loss was associated with reductions in Medicare expenditures. Although elevated hemoglobin A1c levels were included as part of the beneficiary eligibility criteria in the DPP model test, hemoglobin A1c levels were not evaluated post-intervention in that model. Therefore, we are not proposing to use hemoglobin A1c blood values in the performance-based payment methodology for MDPP services. The use of hemoglobin A1c blood values in the MDPP payment methodology would have incorporated changes in values for which there was no evidence that could be used to support the determination that the MDPP expanded model meets the statutory requirements for expansion. We further note that the CDC does not require post-MDPP services hemoglobin A1c blood values to be determined as part of its 2015 DPRP standards, and we aim to align with the CDC DPRP standards as much as possible. While 5 percent weight loss is considered a performance measure for DPRP recognition, the CDC does not examine pre-post DPP differences in hemoglobin A1c as part of its DPRP standards.
The proposed MDPP payment structure incentivizes MDPP suppliers to prioritize the achievement and maintenance of beneficiary weight loss by furnishing MDPP services, and provides a balance between performance-based payments related to weight loss and session attendance. We do not believe that it would be appropriate for payment to be tied to attendance alone because weight loss is more directly associated with a reduction in the incidence of type 2 diabetes than attendance at MDPP sessions. We further believe that the proposed performance-based payment structure based on individual beneficiary success, rather than average weight loss across all MDPP beneficiaries who receive MDPP services from an MDPP supplier, maximizes the focus of MDPP suppliers on the achievement of the performance goals for all beneficiaries, including those beneficiaries who experience challenges with achieving attendance and/or weight loss performance goals. Therefore, we do not believe it would be appropriate to use aggregate beneficiary information (that is, average weight loss) in the proposed performance-based payment methodology.
We are proposing to establish the rules governing payment for MDPP services at new § 414.84. We note that as discussed in section III.K.2.a. of this proposed rule, we are proposing that MDPP services may be furnished and payment made under the MDPP expanded model starting April 1, 2018. Therefore, we are proposing that the effective date of § 414.84 would be April 1, 2018. Only MDPP services furnished on or after April 1, 2018, would be eligible for payment when all requirements for billing for performance payments for those services are met.
At proposed § 414.84(a)(1), we are proposing to define “performance goal” as an attendance or weight loss goal that an MDPP beneficiary must achieve for an MDPP supplier to be paid a performance payment. We are proposing to define “performance payment” as a payment to an MDPP supplier for furnishing certain MDPP services when an MDPP beneficiary achieves the applicable performance goal. These definitions are used in our proposals for payment of MDPP services.
To align with the once-per-lifetime policy, we are proposing at § 414.84(b) that each performance payment made based on attendance of a specified number of core sessions, for a specific 3-month core maintenance or ongoing maintenance interval during the MDPP services period, or for achieving a weight loss performance goal, is made only once per MDPP beneficiary.
As displayed in Table 27, we are proposing a maximum total performance payment amount per beneficiary for the set of MDPP services of $810. This amount is the aggregate of the maximum performance payments for core sessions, core maintenance sessions, and ongoing maintenance sessions furnished to MDPP beneficiaries who achieve weight loss of at least 9 percent over the 36 months of the MDPP services period. This performance payment amount would be made for a minimum of 46 MDPP sessions required to be offered to the beneficiary in the set of MDPP services. Although CMS would make performance payments to MDPP suppliers at intervals throughout the MDPP services period in varying amounts, payment for each session furnished would be included in the total
While we are not proposing that payment for MDPP services utilize a fee-for-service payment methodology, we note that, estimated on a per-session basis, the maximum MDPP payment amount for achievement of all the performance goals would equate to approximately $18 per session. For comparison, Medicare pays under the PFS approximately $10 (excluding physician work and malpractice) for CPT code 98962 (Education and training for patient self-management by a qualified, nonphysician health care professional using a standardized curriculum, face-to-face with the patient (could include caregiver/family) each 30 minutes; 5-8 patients), a service that may bear some resemblance to an MDPP session furnished by an MDPP supplier, although an MDPP session would be furnished by a coach (not necessarily a health care professional), has a duration of 1 hour, and has no explicit limitation on group size.
However, this estimated per-session MDPP payment amount would result only from the furnishing of MDPP services to those beneficiaries who achieve the highest attendance and weight loss performance goals under the proposed performance-based payment methodology for MDPP services. For beneficiaries who do not achieve the highest performance goals, the estimated per-session MDPP payment amount would generally be significantly lower, with the amount based upon the actual attendance and weight loss performance of the beneficiary. The differences between the estimated MDPP per-session payment amounts and between the MDPP and PFS payment amounts result from the proposed performance-based methodology for MDPP services. We note that under the PFS payments are based on suppliers' relative resources used to furnish services. On the other hand, we believe that that the estimated per-session MDPP payment amounts under our proposal for beneficiaries who achieve specified attendance and weight loss performance goals are appropriate in the context of a performance-based payment methodology for the set of MDPP services that differs from the methodology used under the PFS.
Finally, we note that there are also some administrative costs that MDPP suppliers would bear to enroll in Medicare and ensure compliance with the requirements for furnishing MDPP services. The total MDPP performance payment across all Medicare beneficiaries would provide some payment for the resources that would be used by MDPP suppliers to meet the administrative requirements for furnishing MDPP services.
In terms of the proposed distribution of the maximum total performance payment amount for MDPP services across the types of performance payments, as discussed in detail in sections III.K.2.d.iii.(3) and (4) of this proposed rule and displayed in Table 27, we are proposing that, for those beneficiaries achieving the highest core services period performance goals, approximately 13 percent of the maximum of $810 would be paid for attendance at core sessions during the initial 6 months of the core services period, while approximately 15 percent would be paid for core maintenance sessions during months 7 to 12 of the core services period. We believe that payment of a similar percentage of the maximum total performance payment amount during the initial 6 months of the core services period for beneficiaries who meet attendance performance goals and during months 7 to 12 for beneficiaries who meet both weight loss and attendance performance goals is appropriate to balance performance payment for attendance and weight loss throughout the core services period.
In addition, as discussed in detail in section III.K.2.d.iii.(5) of this proposed rule, we are proposing that approximately 49 percent of the maximum of $810 would be paid for ongoing maintenance sessions over a 24-month period, or 24.5 percent per each 12-month period, for those beneficiaries who maintain the required minimum weight loss. The focus of ongoing maintenance sessions is on maintenance of weight loss that has already been achieved, and there would typically be an established relationship between the MDPP supplier and the MDPP beneficiary during the ongoing services period. Therefore, the totality of MDPP sessions furnished during this 24-month period would result in a slightly lower performance payment per 12-month period than the totality of those sessions furnished when the required minimum weight loss is achieved during the 12 months of the core services period, when 28 percent of the maximum total performance payment amount would be paid.
Finally, due to the importance of weight loss as a meaningful outcome of MDPP services because of its association with a reduction in the incidence of type 2 diabetes, as discussed in detail in section III.K.2.d.iii.(6) of this proposed rule, we are proposing that 23 percent of the maximum total performance payment amount would be paid for weight loss performance payments to provide additional payments for MDPP sessions that are effective (that is, lead to specified percentages of weight loss). We note that, in the DPP model test, 44.7 percent of participants achieved 5 percent weight loss, which under our proposal would result in a weight loss performance payment of approximately 20 percent of the maximum total performance payment amount.
Table 27 summarizes the proposed maximum total amount and distribution of performance payments for the set of MDPP services.
We are inviting public comments on our proposals for the maximum total performance payment amount and the distribution of performance payments for MDPP services across the set of MDPP services.
We understand that social risk factors such as income, education, race and ethnicity, employment, disability, community resources, and social support play a major role in health. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering, and Medicine recently released reports on the issue of accounting for social risk factors in CMS programs.
In the CY 2017 PFS final rule (81 FR 80466), we acknowledged commenters' concerns regarding the potential unintended consequences if the MDPP expanded model were to result in low-income or other disadvantaged populations having less access to ongoing maintenance sessions due to their failure to achieve or maintain the weight loss performance goal required for coverage of these sessions. In addition, through listening sessions, stakeholders have provided us with anecdotal information suggesting that racial and ethnic minorities and low socioeconomic status populations lose about 1 percent less weight, on average, than higher socioeconomic groups and non-Hispanic whites.
We are proposing an MDPP payment structure for the set of MDPP services that is similar to the structure presented in the July 15, 2016 MDPP proposed rule (81 FR 46416), where performance payments are tied to attendance at MDPP sessions and/or weight loss. Based on information provided to us by stakeholders, we acknowledge that tying performance payment to a specific threshold of weight loss and/or attendance may make achieving the performance goals required for the highest performance payments and beneficiary eligibility for coverage of ongoing maintenance sessions more challenging for MDPP suppliers furnishing services to individuals with social risk factors. We note that our proposal for beneficiary engagement incentives as discussed in section III.K.2.f. of this proposed rule would provide MDPP suppliers with the flexibility under certain conditions to furnish in-kind patient engagement incentives, such as transportation, to support beneficiaries in achieving the MDPP expanded model performance goals, including session attendance and weight loss. We expect these beneficiary engagement incentives may be helpful to MDPP suppliers furnishing services to beneficiaries, including those with social risk factors that could increase their risk of not achieving the MDPP performance goals.
We are not proposing to risk-adjust MDPP payments for social risk factors or to adopt additional special payment policies to specifically encourage MDPP suppliers to furnish sessions to beneficiaries with social risk factors because, for the MDPP expanded model, we do not believe that such approaches are necessary to ensure access to MDPP services for all beneficiaries. This is because we believe that the proposed performance goals upon which the performance payments for the set of MDPP services would be based, as well as the payment policies that recognize that weight loss is a gradual process that may occur slowly over the 12 months of the core services period, should allow MDPP suppliers sufficient time to work with all eligible beneficiaries, including beneficiaries with social risk factors, toward achieving the attendance and weight loss performance goals of the MDPP expanded model. However, we may consider proposing additional payment policies for the MDPP expanded model in the future.
We are requesting comments about social risk factors in the context of the set of MDPP services that could inform any future considerations of additional payment policies for the MDPP expanded model. We also are inviting public comments on other types of strategies that we could utilize throughout the testing of the MDPP expanded model to assist MDPP suppliers in providing robust access to MDPP services for beneficiaries with social risk factors, such as learning activities to share best practices among MDPP suppliers in providing the set of MDPP services.
The payment structure presented in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416) would have made attendance-based payments of $25 for the first core session, $50 for 4 total core sessions, and $100 for 9 total core sessions. Based on our consideration of information provided in the public comments on that proposed rule and our increased emphasis in the performance payments on the achievement and maintenance of the required minimum weight loss as the outcome of MDPP services, our proposal for the attendance-based performance payments for 4 and 9 core sessions differs from these payment amounts.
We are proposing that an MDPP supplier would be paid a $25 performance payment the first time it furnishes an MDPP session to an MDPP beneficiary as displayed in Table 28. This performance payment would be
We are proposing that an MDPP supplier would be paid the performance payment upon furnishing the first core session to a beneficiary who initiates the MDPP services period, regardless of whether the MDPP supplier qualifies for any of the additional performance payments for that beneficiary. As we are proposing in the sections that follow, additional performance payments would depend upon the beneficiary's achievement of the performance goals for attendance and/or weight loss. We believe that making the first performance payment based on beneficiary attendance at the first core session is appropriate because the MDPP supplier would use significant resources to furnish the first session, including collecting administrative information on the beneficiary who is not already known to the supplier, regardless of whether the beneficiary goes on to receive further MDPP services from that supplier.
On a per-session basis, the performance payment for the first MDPP core session would be the highest performance payment amount for any core session during the core services period. Of note, the first core session performance payment also provides some payment for MDPP supplier activities to encourage the beneficiary's attendance at additional core sessions following the first session. Such supplier activities could include sending electronic messages or making reminder phone calls about upcoming sessions or providing transportation to the next session under the beneficiary engagement incentives policy proposed in section III.K.2.f. of this proposed rule. It is only through attendance at the first core session with an MDPP supplier that a beneficiary initiates the MDPP services period and has the potential to achieve weight loss through receiving MDPP services.
Further, we are proposing that suppliers would be paid a performance payment for the interval (which we are referring to in this proposed rule as an “interval performance payment” to distinguish it from other performance payments, such as the performance payment upon an MDPP beneficiary's achievement of the required minimum weight loss, that do not require attendance at multiple sessions) upon a beneficiary's attendance at 4 total core sessions, and again upon a beneficiary's attendance at 9 total core sessions—that is, attendance of 5 more core sessions after having attended his or her first 4. We are proposing an interval performance payment of $30 upon a beneficiary attending 4 core sessions and an interval performance payment of $50 upon a beneficiary attending 9 core sessions as displayed in Table 28. Although an MDPP supplier must offer at least 16 core sessions to a beneficiary during the initial 6 month of the MDPP core services period, we are not proposing any other interval performance payment for the core sessions after the performance payment for attendance at 9 core sessions. We note that while these proposed payment amounts are somewhat lower than the payment amounts for these milestones presented in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416), they follow a similar pattern of a higher payment amount associated with attendance at a larger cumulative number of core sessions to provide a significant financial incentive for MDPP suppliers to encourage MDPP beneficiary attendance at core sessions in the first 6 months of the core services period.
On a per-session basis, the payments for attendance at 4 total core sessions and 9 total core sessions would be approximately $10 and $4 to $10, respectively, depending upon the number of sessions attended by the beneficiary beyond the 9 required for the second interval performance payment up to the maximum of 16 core sessions that must be offered to the beneficiary by the MDPP supplier during the initial 6 months of the MDPP core services period. Because the performance payments for core sessions would be based solely on the achievement of attendance performance goals, we believe these per-session performance payment amounts that are lower than the proposed performance payment amount for the first core session are still appropriate because we expect that fewer MDPP supplier resources would be used to furnish sessions to beneficiaries with whom the MDPP supplier has an established relationship. The per-session payment amounts for core sessions are set based on attendance at these sessions, which is associated with ultimate achievement of the required minimum weight loss.
We are proposing to make the first interval performance payment for core sessions when the beneficiary has attended 4 core sessions for the following reasons. First, beneficiary attendance at 4 core sessions was a significant attendance milestone in the evaluation of the DPP model test, which provided evidence that meeting this milestone is tied to weight loss outcomes.
We are proposing to make the second interval performance payment when the beneficiary has attended 9 core sessions because attending a higher amount of sessions in the initial 6 months of the MDPP core services period, beginning at session 9, has been shown to greatly improve weight loss outcomes. Specifically, according to CDC data, there is a 125 percent increase in weight loss comparing beneficiaries who attend 4 to 8 sessions (1.6 percent weight loss on average) and beneficiaries who attend 9 to 16 sessions (3.6 percent weight loss on average).
MDPP suppliers would be paid these performance payments when beneficiaries achieve these core session
We considered alternatives to this proposed payment structure for core sessions, such as making higher payments for attendance at the earlier sessions to provide MDPP suppliers with additional funds for the resources necessary for start-up of the MDPP expanded model. Although we understand that there are some up-front supplier costs associated with implementing the MDPP expanded model, we believe these costs would disproportionately be related to start-up and not generally be ongoing costs borne by the MDPP supplier. In addition, because we expect that many MDPP suppliers are currently offering DPPs through contracts with commercial payers, MDPP suppliers may be able to minimize start-up costs by relying on their relevant experience with offering other DPPs. Finally, we believe that our proposal for payment of MDPP core sessions already includes substantial payment for session attendance early in a beneficiary's participation with the MDPP supplier, considering that MDPP suppliers would be paid an initial $25 performance payment for the first core session attended by the beneficiary and would then be paid performance payments for beneficiary attendance of up to 9 core sessions, regardless of weight loss. We believe that increasing the initial payments for attendance at MDPP sessions would shift the nature of the payment for the set of MDPP services from a performance-based structure based on a balance of attendance and weight loss considerations toward a payment structure that is based on attendance at each session furnished.
The proposed attendance-based performance payments for MDPP core sessions are included at proposed § 414.84(b)(1), (2), and (3). We are inviting public comments on these proposals. We also are inviting public comments on the alternative considered.
We are proposing that performance payments for core maintenance sessions would be tied to the beneficiary's achievement of attendance and weight loss performance goals during a core maintenance session interval. A core maintenance session interval, as we are proposing to define it at § 410.79(b), means one of the two consecutive 3-month time periods during months 7 through 12 of the MDPP services period, during which an MDPP supplier offers at least one core maintenance session per month to an MDPP beneficiary.
The payment structure presented in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416) would have required the MDPP beneficiary to attend 3 core maintenance sessions and achieve or maintain a minimum 5 percent weight loss for a $45 payment to be made to an MDPP supplier for the core maintenance session interval. If 5 percent weight loss was not achieved or maintained during the core maintenance session interval, no separate performance payment would be made. MDPP suppliers would still have been required to offer (and furnish if the beneficiary attended) MDPP services during core maintenance intervals to beneficiaries regardless of weight loss. Based on our consideration of information provided in the public comments on that proposed rule and our increased emphasis in the performance payments on the achievement and maintenance of the required minimum weight loss as the outcome of MDPP services, our proposal for the performance payments for core maintenance sessions differs from the payment amounts included in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416).
For the MDPP expanded model, we are proposing performance payments amounts for core maintenance session intervals that value achievement of both session attendance and the required minimum weight loss, with an emphasis on achieving the weight loss performance goal. We are proposing that an MDPP supplier would be paid a performance payment for a core maintenance session interval if a beneficiary achieves the performance goal of attending at least 3 core maintenance sessions during the interval. The specific performance payment amount would be determined by whether the beneficiary has also achieved or maintained the required minimum weight loss within the interval. The achievement or maintenance of the required minimum weight loss within the 3-month core maintenance session interval would be determined based on a measurement taken in-person during any 1 session within that 3-month interval. We are proposing that MDPP suppliers would be paid a performance payment for no more than two core maintenance session intervals for each MDPP beneficiary.
As discussed previously, we recognize that weight loss is a process that may still be ongoing for some beneficiaries during the final months of the core services period. According to an analysis of participant data from CDC's DPRP, the longer a participant remains in the lifestyle change program, the greater his or her average weight loss achieved.
Of further note, the National DPP's core maintenance sessions were developed based on results from the original 2002 DPP Randomized Control Trial and CDC's DPRP standards were developed with this science in mind.
Therefore, we believe that providing no performance payment to MDPP suppliers for furnishing core maintenance sessions to beneficiaries who have not achieved the required minimum weight loss prior to or during months 7 to 12 of the core services period could reduce the opportunity for MDPP beneficiaries to achieve the weight loss performance goal. Such a payment methodology could reduce the likelihood that MDPP suppliers would continue to work to engage beneficiaries in the weight loss process if those beneficiaries had not achieved the required minimum weight loss after completion of the initial 6 months of the MDPP core services period. We note that, as finalized in the CY 2017 PFS final rule (81 FR 80459), suppliers must offer a minimum of 1 core maintenance session per month in months 7 to 12 of the core services period to eligible beneficiaries, regardless of the beneficiary's weight loss. We believe that it is possible for some beneficiaries to have achieved the required minimum weight loss performance goal by the time the core sessions have been completed, and we want to incentivize MDPP suppliers to work toward the weight loss performance goal in that timeframe. However, we believe that it is also appropriate to place some value on achieving attendance performance goals alone through performance payments for core maintenance session intervals so that MDPP suppliers continue to work to engage all beneficiaries in striving to achieve the required minimum weight loss performance goal.
As discussed in section III.K.2.d.iii.(2)(a) of this proposed rule, we are proposing that the maximum total performance payment for MDPP core maintenance sessions would be $120 for beneficiaries who achieve both the attendance and weight loss performance goals during months 7 to 12 of the core services period. Specifically, we are proposing to pay MDPP suppliers $60 for a core maintenance session interval if a beneficiary attends 3 sessions and achieves or maintains the required minimum weight loss during that interval, and to pay MDPP suppliers $10 for a core maintenance session interval if the beneficiary attends 3 sessions but does not achieve or maintain the required minimum weight loss during that core maintenance session interval.
As compared to the payment amounts with and without achievement or maintenance of the required minimum weight loss that were presented for core maintenance session intervals in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416), these payment amounts are both higher. As discussed previously in this section, we believe it is appropriate in months 7 to 12 of the core services period to provide some performance payment for achievement of attendance performance goals even if the required minimum weight loss is not achieved, in order to provide the greatest opportunity for beneficiaries to achieve the required minimum weight loss over the full core services period. In addition, we are proposing a higher payment amount for core maintenance session intervals with achievement or maintenance of the required minimum weight loss to recognize that achievement and maintenance of the required minimum weight loss are necessary for the reduced incidence of type 2 diabetes and to encourage MDPP suppliers to work to engage beneficiaries in achieving weight loss and sustaining their weight loss over time.
Proposed performance payments for the core maintenance session intervals are displayed in Table 29. On a per-session basis, these payments would be approximately $20 and $3, respectively. While both of these payment amounts provide payment to MDPP suppliers for the resources involved with furnishing core maintenance sessions, we believe the relatively high per-session performance payment of $20 in comparison to the per-session performance payment amounts for core sessions is appropriate due to the achievement or maintenance of both the required minimum weight loss and beneficiary attendance at core maintenance sessions, as compared to core sessions where the performance payment is based solely on attendance. On the other hand, we believe that the relatively low per-session payment amount in our core maintenance session interval performance payment proposal for core maintenance sessions for those beneficiaries who do not achieve the weight loss performance goal, while providing some performance payment for attendance at core maintenance sessions by beneficiaries still working to achieve the required minimum weight loss, is appropriate because these sessions have not yet resulted in those beneficiaries achieving the weight loss performance goal.
The proposed core maintenance session interval performance payments for core maintenance sessions are included at proposed § 414.84(b)(4). We are inviting public comments on these proposals.
Similar to our proposal for the payment of core maintenance session intervals described previously, we are proposing to make performance payments to MDPP suppliers for 3-month ongoing maintenance session intervals. This payment would be made when suppliers furnish ongoing maintenance sessions during the 24 months of the ongoing services period after the 12-month MDPP core services period ends. We are proposing that an MDPP supplier would be paid a performance payment for an ongoing maintenance session interval if an MDPP beneficiary achieves the performance goals of attending at least 3 ongoing maintenance sessions and maintaining the required minimum weight loss from baseline measured in person during a session at least once within that interval. Under this proposal, an MDPP supplier would not be paid a performance payment unless the beneficiary has achieved these both of these performance goals within that 3-month interval. An ongoing maintenance session interval, as we are proposing to define it at § 410.79(b), means one of the up to eight consecutive 3-month time periods during the ongoing services period, during which an MDPP supplier offers at least one ongoing maintenance session to an MDPP beneficiary per month.
The payment structure presented in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416) would have required the MDPP beneficiary to attend 3 ongoing maintenance sessions and maintain the required minimum weight loss for a $45 payment to be made to an MDPP supplier for the ongoing maintenance session interval. Based on our consideration of information provided in the public comments on that proposed rule and our increased emphasis in the performance payments on the achievement and maintenance of weight loss as the outcome of MDPP services, our proposal for the performance payment for ongoing maintenance session intervals differs from that payment amount.
We are proposing that MDPP suppliers could be paid up to 8 performance payments of $50 each for ongoing maintenance session intervals. Just like the other proposals for performance payments, we are proposing this payment in CY 2018 dollars to ensure consistency in calendar year dollars among performance payments for a given calendar year. However, we note that no ongoing maintenance session interval payments, available only for intervals in the ongoing services period during months 13 through 36 of an MDPP beneficiary's MDPP services period, would be made in CY 2018 based on our proposal in section III.K.2.a. of this proposed rule that MDPP services be available on April 1, 2018. Under this proposal, MDPP services would only be available for 9 months of CY 2018 so no MDPP beneficiaries would attend ongoing maintenance sessions in CY 2018. The first ongoing maintenance session interval performance payments would be made in CY 2019 and would equal $50 adjusted by the percent change in the Consumer Price Index for All Urban Consumers (CPI-U) (U.S. city average) for the 12-month period ending June 30th, 2018, as discussed in section III.K.2.d.iii.(9) of this proposed rule.
This proposed payment amount is somewhat higher than the potential payment discussed in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416) to recognize that maintenance of the required minimum weight loss is necessary for the reduced incidence of type 2 diabetes and to encourage MDPP suppliers to work to engage beneficiaries in sustaining their weight loss over time. The maximum total performance payment for MDPP ongoing maintenance sessions would be $400, as displayed in Table 30. On a per-session basis, this payment would be approximately $17, which we believe is appropriate for MDPP suppliers that furnish ongoing maintenance sessions to beneficiaries who maintain the required minimum weight loss during ongoing maintenance session interval. We note that this per-session payment amount would be somewhat lower than the $20 per-session payment amount included in the core maintenance session interval performance payment for beneficiaries who achieve attendance and weight loss performance goals during the 3-month intervals in months 7 to 12 of the MDPP core services period. Like the proposed performance payment for core maintenance session intervals, the proposed performance payment for ongoing maintenance session intervals values both attendance and weight loss. However, during core maintenance session intervals it is likely that the required minimum weight loss would first be achieved, and we believe that a somewhat higher per-session payment amount is appropriate under these circumstances. In contrast, we believe that a somewhat lower per-session payment amount for ongoing maintenance sessions during intervals where the required minimum weight loss is maintained, rather achieved, is appropriate.
We considered an alternative policy in which an MDPP supplier would receive a payment for an ongoing maintenance session interval so long as the beneficiary attended at least
The proposed payment policy also would align with the service limitations for ongoing maintenance sessions at § 410.79(c)(1)(iii) in that beneficiaries also would be required to attend all 3 sessions within a given ongoing maintenance session 3-month interval to be covered for the subsequent 3-month interval. We note that the proposed coverage and payment policies are aligned for ongoing maintenance session intervals, where attendance at 3 sessions within an interval is required for a performance payment as well as for coverage of ongoing maintenance sessions in the next interval. In contrast, MDPP suppliers are required to offer core maintenance sessions in both core maintenance session intervals for all beneficiaries, regardless of a beneficiary's attendance at core maintenance sessions, although attendance is required for a performance payment to be made for the core maintenance session interval.
The proposed ongoing maintenance session interval performance payments for ongoing maintenance sessions are included at proposed § 414.84(b)(5). We are inviting public comments on these proposals. We also are inviting public comments on the alternative considered.
We are proposing that if a beneficiary achieves the required minimum weight loss measured at any session attended during the core services period, an MDPP supplier would be paid the weight loss performance payment of $160 displayed in Table 31. As discussed in section III.K.2.d.iii.(2)(a) of this proposed rule, we are proposing that 23 percent of the maximum total performance payment amount for the set of MDPP services would be paid for the achievement of weight loss, regardless of session attendance, because weight loss is the most important outcome for the MDPP expanded model. The proposed performance payment of $160 for the required minimum weight loss, which constitutes approximately 90 percent of the maximum total weight loss performance payment, was set to be the large majority of the available weight loss performance payment based on the strong evidence for the association of the required minimum weight loss with a reduction in the incidence of type 2 diabetes.
We note that this association is evidenced by the CDC's National DPP, which is based on the 2002 DPP Randomized Control Trial and follow-up efficacy trials.
We also are proposing that, in addition to the weight loss performance payment for the required minimum weight loss, an MDPP supplier would be paid an additional weight loss performance payment of $25 if the beneficiary achieves at least 9 percent weight loss from his or her baseline weight at any time during the MDPP services period as displayed in Table 31. We are proposing this additional weight loss performance payment based on information from stakeholders that commercial payers paying for DPPs frequently include an incentive payment for 9 percent weight loss as an incentive to try to encourage greater and/or continued weight loss and behavior change. We believe that making an additional weight loss performance payment for 9 percent weight loss at any time during the MDPP services period would provide an additional incentive for MDPP suppliers to continue weight loss efforts with beneficiaries, especially during the ongoing services period, which may extend for a period of up to 24 months.
We are proposing that MDPP suppliers may submit claims for these weigh loss performance payments on the date when the beneficiary first reaches the required minimum or 9 percent weight loss, as measured in person during a session, respectively, and each weight loss performance payment would be paid to only one supplier and only once per beneficiary. In the unusual circumstance where the beneficiary achieved 9 percent weight loss as the first weight loss change measured from baseline, the MDPP supplier could bill and be paid both the 5 percent and 9 percent weight loss performance payments.
The proposed weight loss performance payments are included at proposed § 414.84(b)(6) and (7). We are inviting public comments on these proposals.
In summary, for furnishing MDPP services during the MDPP services period, we are proposing that MDPP suppliers could be paid a minimum of $25 per beneficiary (if the beneficiary attends the first core session) and a maximum total of $810 per beneficiary (if the beneficiary achieves all performance goals, maintains eligibility for 36 months, and does not change
Although Medicare is a national program, it frequently adjusts fee-for-service payments to hospitals, physicians, and other providers and suppliers according to the geographic locations in which they furnish services. These adjustments generally account for differences in the relative costs of doing business in different geographic areas compared to the national average. For example, section 1886(d)(3)(E) of the Act requires that, as part of the methodology for determining prospective payments to hospitals, the Secretary must adjust the standardized amounts for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the national average hospital wage level. This adjustment factor for hospitals is the wage index, and we currently define hospital geographic areas (labor market areas) based on the definitions of Core-Based Statistical Areas (CBSAs) established by the Office of Management and Budget. Similarly, a geographic adjustment is also made for services paid under the PFS, and a geographic practice cost index (GPCI) has been established for every Medicare PFS payment locality, many of which are statewide, for each of the three components of a service's relative value units (that is, the relative value units for work, practice expense, and malpractice).
We are proposing to make performance-based payments to MDPP suppliers in intervals based on achievement of performance goals, rather than fee-for-service payments for individual services furnished. While we intend for those performance payments to make payment to MDPP suppliers for MDPP services that involve the use of supplier resources, we are unsure if there is notable variation in the relative costs of furnishing MDPP services among geographic areas. Because the DPP model test was carried out in only eight States, we do not have the data to determine whether there are geographic differences nationwide. In addition, because a substantial portion of the proposed MDPP performance payments are based on the beneficiary's achievement of weight loss performance goals, we are uncertain about the appropriateness of geographically adjusting such performance-based payments.
Therefore, we are not proposing geographic adjustment of performance payments for MDPP services. However, we are inviting public comments on issues related to geographic adjustment of payment for MDPP services in the context of the MDPP performance-based payment methodology, including appropriate sources of information for determining any geographic cost differences. We may consider proposing additional payment policies for the MDPP expanded model in the future. We request that commenters submitting information on these issues provide justification, including any relevant analysis, to support any suggestions regarding potential future geographic adjustment of performance-based payments for MDPP services.
To account for inflation, we are proposing to update MDPP payment amounts annually based on the CPI-U. The CPI-U is a measure of the average change over time in prices paid for a market basket of consumer goods and services, and is a measure of economy-wide inflation. There are no statutory requirements for the update factor for payments for MDPP services so there is no requirement that a productivity adjustment be applied to the MDPP services update factor as there are for certain other Medicare-covered items and services where prices are updated by the CPI-U, such as the Clinical Laboratory Fee Schedule; Durable Medical Equipment, Prosthetics/Orthotics, and Supplies Fee Schedule; Ambulance Fee Schedule; and Ambulatory Surgical Center payment system.
We considered using other indices such as the Medicare Economic Index (MEI) to update the MDPP payment amounts. The MEI measures price changes in the inputs required to operate a self-employed physician practice. We do not believe that the MEI would be appropriate to update MDPP payment amounts because MDPP suppliers are not similar to self-employed physician practices. We note that the CPI-U by definition is an economy-wide measure of inflation and, therefore, in the absence of an appropriate specific index for MDPP services, we believe the CPI-U to be the most technically appropriate index available to update payments for MDPP services. We further note that the CPI-U is used to update Medicare payments for other Medicare-covered items and services, such as ambulance, clinical laboratory, and ambulatory surgical center services.
We are proposing to update MDPP performance payments and the bridge payment (a proposed one-time payment to an MDPP supplier for furnishing its first session to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier as discussed in detail in section III.K.2.d.v. of this proposed rule) that may be paid to MDPP suppliers in the following manner:
• Beginning in CY 2019 and each year forward, the performance payment and bridge payment amounts will be adjusted by the 12-month percent change in the CPI-U (U.S. city average) for the period ending June 30th of the year preceding the update year. The percent change update will be calculated based on the level of precision of the index as published by the Bureau of Labor Statistics and applied based on one decimal place of precision. The annual MDPP services payment update will be published by CMS transmittal.
The proposed methodology to update MDPP performance payments and the bridge payment is included at proposed § 414.84(d). We are inviting public comments on this proposal.
We are proposing that performance payments and bridge payments to MDPP suppliers for MDPP services would be made only on an assignment-related basis in accordance with § 424.55. As described in Chapter 1, Section 30.3 of the Medicare Claims Processing Manual,
Consistent with our established requirements for these other types of suppliers, some of whom are similar to MDPP suppliers in that they furnish a limited breadth of Medicare-covered services, we believe it would be appropriate to require all MDPP suppliers, whether they are participating or not participating in Medicare, to accept assignment. We also believe that making performance payments for MDPP services solely on an assignment-related basis is the most appropriate methodology, given the performance-based MDPP payment methodology which is based on the achievement of weight loss and/or attendance performance goals and not based on the MDPP supplier resource expended to furnish individual MDPP services. We further note that as finalized in the CY 2017 PFS final rule (81 FR 80464), MDPP services are additional preventive services under section 1861(ddd) of the Act and, therefore, consistent with section 1833(a)(1)(W) of the Act, are not subject to the Medicare Part B coinsurance or deductible. Under our proposal Medicare would pay 100 percent of the Medicare allowed charge for MDPP services furnished to MDPP beneficiaries, and a beneficiary would have no liability for covered MDPP services. MDPP suppliers would be required to accept the Medicare allowed charge as payment in full and would not be able to bill or collect from the beneficiary any amount.
Finally, to minimize the potential administrative burden on beneficiaries related to payment for MDPP services on an assignment-related basis, we are proposing that for purposes of claims for services submitted by an MDDP supplier, Medicare would deem such claims to have been assigned by the beneficiary (or the person authorized to request payment on the beneficiary's behalf) and the assignment accepted by the MDDP supplier. This proposed treatment of claims from MDPP suppliers in new § 424.55(d) is consistent with the current exception in § 424.55(c) regarding payment to a supplier which specifies that when payment under the Act can only be made on an assignment-related basis or when payment is for services furnished by a participating physician or supplier, the beneficiary (or the person authorized to request payment on the beneficiary's behalf) is not required to assign the claim to the supplier in order for an assignment to be effective.
The proposed assignment-related basis for performance payments and bridge payments MDPP suppliers is included at proposed § 414.84(b) and (c). The proposal to not require the beneficiary to assign the claim for MDPP services to the MDPP supplier in order for assignment to be effective is included at proposed § 424.55(d). We are inviting comments on these proposals.
MDPP suppliers may only submit claims for a performance payment or bridge payment for MDPP services when all of the proposed requirements for the payment are met. Claims for services that do not meet these requirements will not be paid. In accordance with § 424.80, MDPP suppliers are reminded that there are exceptions to the prohibition of reassignment of claims by suppliers for certain arrangements provided the applicable requirements are met. Of specific note, Medicare may pay an agent who furnishes billing and collection services to the supplier if the conditions of § 424.80(b)(5) are met.
Proposed requirements for performance payments and the bridge payment include that the MDPP services were furnished to a beneficiary eligible for MDPP services as specified at § 410.79(c) and that the MDPP supplier complies with all applicable enrollment and program requirements. In addition, the MDPP services must be furnished by an eligible coach on or after his or her coach eligibility start date and, if applicable, before his or her coach eligibility end date, and the MDPP supplier must submit the National Provider Identifier (NPI) of the coach on MDPP claims. We describe additional details on how eligible coach information would be processed in section III.K.2.d.iii.(10)(d) of this proposed rule. All specific additional proposed requirements for the performance payment or bridge payment, as discussed in sections III.K.2.d.iii.(3) through (6) and III.K.2.d.v. of this proposed rule, must also be met.
In order to submit a claim for a performance payment under the MDPP expanded model, the billing supplier must have documentation in the beneficiary's MDPP record, as specified in proposed § 424.205(g), that all requirements for the payment, including the achievement of the performance goal(s) applicable to the performance payment, have been met. We note that the billing supplier's MDPP record for the beneficiary may include a copy of the beneficiary's MDPP record from a previous MDPP supplier that has been provided to the billing supplier at the request of the MDPP beneficiary. For purposes of an MDPP supplier submitting a claim for an interval performance payment based on attendance at more than one session, this copy of the MDPP record from the previously MDPP supplier may be used as part of the billing supplier's documentation demonstrating that the attendance and weight loss, if applicable, performance goal(s) for the performance payment were achieved. We note that as we finalized at § 424.59(b) in the CY 2017 PFS final rule (proposed to be redesignated and amended at § 424.205(g)), MDPP suppliers are required to maintain and handle any personally identifiable information (PII) and protected health information (PHI) in compliance with HIPAA, other applicable state and federal privacy laws, and CMS standards. Therefore, MDPP suppliers must follow these rules when providing any copies of information from a beneficiary's MDPP records to another MDPP supplier.
We are proposing that any weight loss measurement taken and recorded by an MDPP supplier for the purposes of performance payments must be taken in person during an MDPP core session, core maintenance session, or ongoing maintenance session by the MDPP supplier during the MDPP services period. We believe that in-person measurements are the most feasible method for weight ascertainment at this time for services because the beneficiary would attend regular in-person sessions with the MDPP supplier. Moreover, we believe that self-reported weight loss is not reliable for the purposes of performance payment in the MDPP expanded model. This proposal also would apply to our proposed policy regarding virtual make-up sessions, described in detail in section III.K.2.c.iv.(3) of this proposed rule, meaning that weight loss could not be measured or reported during a virtual make-up session for the purpose of the MDPP supplier submitting a claim for a performance payment. We also are proposing to require that weight loss be measured in person at an MDPP session to align with CDC's DPRP standards, which require for in-person sessions that weight be measured in person at the session.
In addition, we note that the achievement or maintenance of the required minimum weight loss that determines the performance payment amount for a core maintenance session interval and the maintenance of the required minimum weight loss that determines whether a performance payment for an ongoing maintenance session interval is made must be determined by an in-person weight measurement at a session furnished during the applicable interval. Thus, for these interval performance payments, achievement of the performance goal for minimum weight loss does not need to be determined based on attendance at a session furnished by the MDPP supplier billing for that performance payment. However, as discussed previously, if achievement of the performance goal for minimum weight loss was measured at a session furnished by a previous MDPP supplier in the interval, the subsequent supplier must have documentation through a copy of the beneficiary's MDPP record from that previous supplier that the weight loss performance goal was met in the interval to bill for the interval performance payment. Finally, the performance payments for the required minimum and 9 percent weight loss would only be billed by the MDPP supplier furnishing the session at which the weight loss performance goal is met during an in-person session.
Furthermore, we are proposing that the beneficiary must achieve the applicable attendance performance goal for core session, core maintenance session interval, or ongoing maintenance session interval performance payments upon attendance at a session furnished by the MDPP supplier billing for that specific performance payment. An MDPP supplier can only bill for a performance payment on the date the beneficiary has achieved all performance goals associated with that performance payment. We note that in order to bill for an interval performance payment that is based on attendance, the MDPP supplier that furnished the session where the attendance goal is met would bill for the performance payment, even if that supplier did not itself furnish all sessions attended by the MDPP beneficiary during that interval. In these circumstances, as discussed previously, if attendance at a session furnished by a previous MDPP supplier occurred in the interval, the subsequent supplier must have documentation through a copy of the beneficiary's MDPP record from that previous supplier of the session attendance in order to bill for the interval performance payment based on attendance at that session. An MDPP supplier may not bill for an interval performance payment when the MDPP supplier does not furnish the session where the attendance goal is met.
For all interval performance payments, we are proposing that the performance payment would be based on the date the MDPP supplier furnished the session where the interval attendance performance goal is met. Thus, for those intervals where the performance payment is based on MDPP beneficiary session attendance that spans two calendar years, the interval performance payment would be the amount applicable to the later calendar year, reflecting the annual update from the prior year as discussed in section III.K.2.d.iii.(9) of this proposed rule. The proposed conditions for payment by CMS of performance payments and bridge payments to MDPP suppliers are included at proposed § 414.84(b) and (c), as well as at the other provisions in these sections. We are inviting public comments on these proposals.
We are proposing to establish 19 unique Healthcare Common Procedure Coding System (HCPCS) G-codes so that MDPP suppliers may submit claims for payment when all the requirements for
We note that each MDPP supplier would be able to bill one of the 18 payable HCPCS G-codes on the date when all the requirements for billing the code have been met, including the session attendance for specific core and ongoing maintenance session intervals and achievement and/or maintenance of weight loss, as applicable to the specific HCPCS G-code. One of the proposed HCPCS G-codes would be nonpayable and assigned a payment amount of $0 because it would only be reported on a claim that also includes a payable HCPCS G-code for MDPP services as described subsequently in this section.
HCPCS G-codes GXXX1 through GXXX3 and GXXX8 through GXX17 may each be paid only once in a beneficiary's lifetime, and the Medicare claims processing system would ensure that no more than one of each specific performance payment per beneficiary reported with these HCPCS G-codes is made. In addition, because only one performance payment may be made for each core maintenance session interval per beneficiary, the claims processing system would also ensure that no more than one unit of HCPCS code GXXX4 or GXXX6 and no more than one unit of HCPCS code GXXX5 or GXXX7 was paid in a beneficiary's lifetime.
Due to these lifetime limitations on payment for certain HCPCS codes for each beneficiary, in the circumstances where two MDPP suppliers furnished sessions during the MDPP services period and both MDPP suppliers met all requirements for billing the same HCPCS G-code, based on our operational processes, we would pay the first valid claim received and deny the second claim. The first valid claim received for a beneficiary for a given HCPCS G-code with a lifetime limitation would be determined through the CMS' Common Working File (CWF), which processes claims for all MACs.
Based on information from the CDC's national DPP, we expect that circumstances where a beneficiary changes MDPP suppliers during the MDPP services period will be uncommon. In addition, in view of the typical structure of DPPs where core sessions are offered weekly for the first 6 months of the core services period, and then offered monthly, we believe it would be rare for more than one MDPP supplier to meet the requirements for billing for the same once-per-lifetime performance payment. However, as an example an MDPP beneficiary could maintain the required minimum weight loss throughout the first core maintenance session interval and attend 3 sessions furnished by one MDPP supplier in the first 1
Finally, as discussed in section III.K.2.d.v. of this proposed rule, we are not proposing to limit the number of bridge payments, which would be reported with HCPCS code GXX18, that may be paid for an MDPP beneficiary who changes MDPP suppliers during the MDPP services period.
We also plan to issue specific billing instructions to MDPP suppliers for those 14 proposed HCPCS G-codes (excluding GXXX1, GXXX8, GXXX9, GXX18, and GXX19) that represent an interval performance payment where attendance
For example, while beneficiary attendance at the 2nd and 3rd of the 4 core sessions would not result in a separate performance payment, we would instruct MDPP suppliers that the 2nd and 3rd core sessions furnished by the supplier submitting the claim for HCPCS code GXXX2 (4 total core sessions attended) be reported as 2 separate line-items of HCPCS code GXX19 on the claim for the performance payment for 4 core sessions attended. The 4th core session furnished by the billing supplier where the interval attendance goal was met would be represented on the claim line reporting HCPCS code GXXX2. Each of these line-items (one line-item of GXXX2 and 2 line-items of GXX19) would include the date of service and the NPI of the coach associated with that MDPP supplier who furnished the specific session reported as the line-item.
When billing for a HCPCS G-code that represents a cumulative number of MDPP sessions where some sessions already have been reported on a previous claim, only the sessions not previously reported on a claim would be reported by the MDPP supplier. For example, HCPCS code GXXX3 (9 total core sessions attended) would be used to bill for 9 core sessions attended, and the line-item of HCPCS code GXXX3 would represent the 9th core session furnished. Separate line-items of HCPCS code GXX19 would be reported on the same claim only for the 5th through 8th core sessions furnished by the MDPP supplier. Claims for HCPCS codes GXXX1 (1st core session attended) and GXXX2 (4 core sessions attended) would already have been submitted, and those claims would have included line-items for the 1st core session, and for the 2nd, 3rd, and 4th core sessions.
We believe that instructing MDPP suppliers to report a line-item for each session on a single claim submitted for an interval performance payment would simplify the tracking and administrative activities of MDPP suppliers and the reporting of the coach NPI on claims for MDPP services furnished to beneficiaries as discussed in section III.K.2.d.iii.(10)(d) of this proposed rule. We further believe that there should be no significant administrative burden for MDPP suppliers to include information on all sessions they furnished on interval performance payment claims for two reasons. First, the documentation requirements for MDPP sessions at § 424.205(g), including the beneficiary's eligibility, specific session topics attended, the NPI of the coach who furnished the session attended, the date and place of service of sessions attended, and weight, would require the MDPP supplier to document and retain this information.
Therefore, MDPP suppliers would have documentation of the date of each session and the NPI of the furnishing coach for reporting on each line-item on the claim for the interval performance payment. Second, MDPP suppliers would be instructed not to submit separate claims for each session represented in an interval performance payment. All sessions would be reported on the single claim that would be submitted for the interval performance payment.
In the case of an MDPP supplier submitting a claim for an interval performance payment where the billing supplier did not furnish all the sessions attributable to the interval because another supplier had furnished some of the first sessions in the interval, the billing supplier would report on the claim only the sessions it furnished. However, the supplier would need to maintain MDPP records documenting that all requirements, including session attendance and achievement or maintenance of weight loss, if applicable, for billing the HCPCS G-code for the interval for the beneficiary were met. Any sessions covered by the interval performance payment HCPCS G-code but not furnished by the supplier submitting the claim for that interval would not be reported as separate line-items on the claim. However, the billing supplier would need to maintain in the beneficiary's MDPP record a copy of his or her MDPP record from the previous supplier in order to consider sessions furnished by the previous supplier in determining that the performance goal(s) for the interval performance payment were met.
Although the NPIs of the coaches who furnished such sessions that would not be reported as separate line-items would also not be recorded on the claim, the billing supplier would still be required to maintain documentation in the beneficiary's MDPP record of the NPI of each coach who furnished each session through a copy of the beneficiary's MDPP record about those sessions from the previous supplier. Therefore, upon medical review, CMS and its contractors would be able to review and assess the remaining coaches who furnished sessions to Medicare beneficiaries associated with a claim submitted for a given interval performance payment HCPCS G-code, but who do not have an NPI reported on the claim. Because we expect it to be uncommon for suppliers not to furnish all sessions attributable to an interval and due to the administrative burden that could result from a requirement that an MDPP supplier report specific information on sessions on a claim that the particular supplier did not itself furnish, we believe the program integrity risk associated with the limitation in the completeness of information from administrative claims data under this scenario is low. However, we will monitor the completeness of reporting line-items on claims for interval performance payments and may consider revising our billing instructions in the future if we determine that we lack information from administrative claims on a significant number of sessions furnished to MDPP beneficiaries.
We are inviting public comments on the proposal to create 19 HCPCS G-codes for billing for the performance payments and bridge payment and reporting additional session line-items on claims for MDPP services. We also are inviting public comment on matters related to billing instructions for MDPP suppliers that we plan to issue so that information on the date and furnishing coach NPI for all sessions furnished by the billing supplier would be submitted on claims. However, we note that we intend to provide additional claims submission instructions in guidance.
In the CY 2017 PFS final rule, we established the policy that coaches will not enroll in Medicare for purposes of furnishing MDPP services, but that they will be required to obtain NPIs. Further details on these policies are described in section III.K.2.e.iii. of this proposed rule.
According to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual,
While only MDPP suppliers, not coaches, would be subject to potential Medicare administrative actions related to payments the suppliers may receive, we believe that our proposal to require the NPI of the coach who furnished the session to be reported as the rendering provider for each line-item HCPCS G-code on a claim for MDPP services would provide us with a number of program integrity protections, including the ability to monitor MDPP coach activity to identify suspected fraud or other improper payments and to determine the need for medical review or investigation as appropriate. We would only process claims for payment of MDPP services when all of the coach NPIs reported on the claim are associated with eligible coaches who have been submitted on the coach roster in the MDPP supplier's enrollment application, and when all of the coaches have successfully completed Medicare's screening processes. We would also only process claims for payment of MDPP services furnished by a coach on or after his or her coach eligibility start date, and, if applicable, prior to his or her coach eligibility end date, as the definitions of these terms are included in proposed § 424.205(a).
Without such program integrity protections, we would lack a sufficient method to verify that payment is being made for services furnished by a coach who has met the requirements outlined in section III.K.2.e.iii. of this proposed rule. This verification will help protect both Medicare beneficiaries and the Medicare Trust Funds. Including coach NPIs on claims may also encourage accuracy in reporting on the achievement of beneficiary attendance and/or weight loss performance goals because both CMS and MDPP suppliers would be able to identify on the claim in question which coaches furnished the sessions attributable to the performance payment. In addition, because the accuracy of information reported on the claim is ultimately the MDPP supplier's responsibility, and the MDPP supplier attests to the accuracy of each claim submitted, including the relevant coach NPIs on the claim may assist the MDPP supplier when conducting internal monitoring of claim accuracy.
These proposed requirements for reporting the coach NPI as the rendering provider on session line-items included on claims for performance payments and bridge payments to MDPP suppliers are included at proposed § 414.84(b) and (c). We are inviting public comments on these proposals.
As in the DPP model test under section 1115A(b) of the Act, MDPP services are based on a CDC-approved DPP curriculum and, therefore, MDPP suppliers must offer sessions in accordance with that curriculum. We are proposing to apply a performance-based payment methodology to MDPP services, which ties most payments to outcomes—in this case, weight loss and session attendance—to help incentivize suppliers to be engaged in their beneficiaries' weight loss efforts. Given this proposed methodology, we recognize that there would be an inherent amount of supplier financial risk, and that coverage of sessions and supplier requirements and payment would not always align. This section aims to clarify how we are proposing that these elements would fit together in the MDPP expanded model, as displayed in Table 34.
Once an MDPP supplier enrolls in Medicare to furnish MDPP services, it must offer the set of MDPP services in accordance with the MDPP supplier standards (noted in section III.K.2.e.iv.(4) of this proposed rule and at § 424.205(d), including that it must offer at least 16 core sessions, furnished no more frequently than once per week, over the first 6 months of the MDPP core services period; at least 1 core maintenance session per month over months 7 to 12 of the MDPP core services period; and at least 1 ongoing maintenance session per month for up to 24 additional months (months 13 through 36 of the MDPP services period), if the beneficiary maintains eligibility for coverage of ongoing maintenance sessions. We recognize that beneficiaries might not attend these sessions. However, they must be made available, in accordance with CDC's DPRP standards, to beneficiaries as long as they are eligible for coverage of MDPP sessions. We further note that the set of MDPP services must be furnished in compliance with all applicable federal laws and regulations.
Although a beneficiary is not required to use MDPP services at all, the MDPP services period is initiated by the beneficiary attending his or her first core session, which begins the MDPP services period timeline. To qualify for coverage of ongoing maintenance sessions, a beneficiary would also need to attend at least 1 session during the final core maintenance session interval where in-person weight measurement is performed that demonstrates the achievement or maintenance of the required minimum weight loss.
All of the proposed performance payments except for the weight loss performance payments require the achievement of an attendance performance goal, and if a beneficiary does not achieve attendance performance goals, an MDPP supplier would not be paid a performance payment that relies on achieving those goals. For example, if a beneficiary does not attend 3 sessions in the first core maintenance session interval, a supplier would not be paid a performance payment for the interval that spans months 7 to 9 of the MDPP core services period. However, a supplier must offer at least 1 core maintenance session per month to the beneficiary to ensure that the beneficiary has the opportunity to attend. Furthermore, while the proposed weight loss performance payments are based solely on the achievement of the required minimum or 9 percent weight loss, we note that all weight loss measurements must be obtained in person at a session so that if a beneficiary does not attend a session where weight loss can be measured and compared to baseline, the MDPP supplier would not be paid a performance payment that relies on achieving a weight loss performance goal.
In the CY 2017 PFS final rule (81 FR 80470), we confirmed that a beneficiary may change MDPP suppliers at any time. However, we deferred specific policies regarding attribution of beneficiaries who change MDPP suppliers as related to payment to future rulemaking. We are making proposals for payment policies when a beneficiary changes MDPP suppliers during the MDPP services period in this section.
At proposed § 414.84(a)(1), we are proposing to define “bridge payment” as a one-time payment to an MDPP supplier for furnishing its first MDPP services session to an MDPP beneficiary who has previously received one or more MDPP services from a different MDPP supplier. We use this definition in the proposed MDPP payment policies for the circumstances when a beneficiary changes MDPP suppliers for any reason during the MDPP services period after the beneficiary has attended at least the first core session.
In cases where the beneficiary changes MDPP suppliers, there is a shift in accountability for offering the set of MDPP services for which the beneficiary is eligible for coverage from one MDPP supplier to a subsequent MDPP supplier. Similar to our proposal for a performance payment to an MDPP supplier that furnishes the first core session to an MDPP beneficiary who initiates the MDPP services period as discussed in section III.K.2.d.iii.(3) of this proposed rule, we are proposing that an MDPP supplier would be paid a bridge payment of $25 for furnishing its first session to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier, regardless of whether the MDPP
We believe that making a bridge payment that is the same amount as the proposed performance payment for the first core session discussed in section III.K.2.d.iii.(3) of this proposed rule is appropriate because we expect the MDPP supplier's resources used to be similar under both of these circumstances. The subsequent supplier would expend resources for furnishing a first session to a beneficiary, including collecting administrative information on the beneficiary who is not already known to the supplier, regardless of whether the beneficiary goes on to receive further MDPP sessions from that supplier.
We are proposing that the bridge payment would be paid to the subsequent MDPP supplier any time a beneficiary changes suppliers during the MDPP services period, regardless of when during the core services period or ongoing services period the beneficiary changes MDPP suppliers. The bridge payment is not intended to be a performance payment, which could be paid to the subsequent MDPP supplier in addition to the bridge payment if a beneficiary achieves a performance goal while receiving MDPP services from that the subsequent supplier. Rather, the bridge payment accounts for the financial risk a subsequent MDPP supplier takes on by furnishing services to a beneficiary changing MDPP suppliers during the MDPP services period.
We believe that when suppliers furnish MDPP services to MDPP beneficiaries in these circumstances, they generally do not have the same opportunity for performance payments that they would have if the beneficiary had been receiving MDPP services from the supplier from the beginning of the MDPP services period because certain performance goals, such as the required minimum weight loss, might already have been achieved by the beneficiary. The proposed bridge payment policy would play an important role in ensuring access to MDPP services and freedom of choice of MDPP suppliers for those beneficiaries who either choose to or must change suppliers during the MDPP services period.
If we were to only make performance payments for MDPP services as proposed in sections III.K.2.d.iii.(3) through (6) of this proposed rule and not make a bridge payment to a subsequent supplier when an MDPP beneficiary changes suppliers during the MDPP services period, access problems could result due to the number of scenarios where subsequent MDPP suppliers offering and furnishing MDPP services would be paid no performance payment for the sessions furnished. The following examples illustrate such scenarios.
• A beneficiary changes from MDPP supplier A to MDPP supplier B after attending core session 4; attends core sessions 5 to 8 with supplier B; and then decides not to attend any more MDPP sessions. Supplier B does not meet the requirements for billing for the performance payment for the 9th core session because only 8 core sessions were attended, despite supplier B offering and furnishing core sessions 5 to 8.
• A beneficiary who has not met the required minimum weight loss performance goal changes from MDPP supplier A to MDPP supplier B after completing the first 3-month core maintenance session interval; attends 2 core maintenance sessions in months 9-12 with supplier B; and then fails to attend the 3rd core maintenance session in this interval. Supplier B does not meet the requirements for billing for the performance payment for the second core maintenance session interval despite offering and furnishing core maintenance sessions and the beneficiary eligibility for coverage of MDPP services then ends after month 12, the end of the core services period.
We believe that circumstances like these examples where subsequent MDPP suppliers would receive no payment for sessions furnished to MDPP beneficiaries who change suppliers during the MDPP services period in the absence of the bridge payment policy could lead to those MDPP suppliers preferentially seeking to furnish the remaining MDPP services during the MDPP services period to beneficiaries who have either already achieved the required minimum weight loss, or whom they believe will attend sessions and achieve weight loss, because the required minimum weight loss is tied to eligibility for ongoing maintenance sessions and higher performance payment for core maintenance session intervals.
We note that we are proposing in section III.K.2.e.iv.(4) of this proposed rule that MDPP suppliers may not deny access to MDPP services to eligible beneficiaries based on any reason other than the supplier's own capacity limits to furnish MDPP services to additional beneficiaries and on a discretionary basis if a beneficiary significantly disrupts the session for other participants or becomes abusive. However, MDPP suppliers could comply with this access requirement, while still preferentially seeking to furnish the remaining MDPP services in the MDPP services period to MDPP beneficiaries they believe are most likely to achieve the performance goals. To ensure beneficiary freedom of choice of MDPP supplier, including the choice to change suppliers, we believe the proposal to make a bridge payment helps mitigate the likelihood of MDPP suppliers acting on such preferences. The subsequent supplier would be paid a bridge payment for a beneficiary who changes suppliers, even if the beneficiary does not achieve performance goals that result in a performance payment being made to the subsequent supplier.
We considered an alternative policy in which the bridge payment would only be made in circumstances where the subsequent supplier would not be paid a performance payment that is based on attendance at the first session furnished by that supplier. For example, under this alternative if a beneficiary attends the 1st session during the ongoing maintenance session interval for months 13 through 15 at one MDPP supplier and then changes to a subsequent MDPP supplier that furnishes two additional ongoing maintenance sessions within that same interval and the beneficiary maintains the required minimum weight loss, the subsequent supplier would
We are proposing that an MDPP supplier can be paid either one performance payment for furnishing the first core session or one bridge payment per beneficiary, but not both. We are proposing this policy because we
While this proposed limit is intended to provide some protection against MDPP suppliers encouraging certain care patterns for the purposes of their financial gain alone, we understand there may be organizations enrolled in Medicare as the same supplier type but under separate MDPP supplier enrollment records that are part of a larger franchise or umbrella organization with shared financial interests. There is some program integrity risk that these organizations could coordinate to bill multiple bridge payments that would ultimately increase total MDPP payments to separately enrolled MDPP suppliers to serve the financial interests of the umbrella organization. This scenario could occur if MDPP suppliers systematically encourage beneficiaries to change suppliers for the purpose of being paid the bridge payment.
Although we believe that organizations under a larger umbrella organization may have a greater financial incentive and opportunity to engage in this behavior, we understand that any two or more MDPP suppliers could coordinate in this way, potentially affecting large numbers of MDPP beneficiaries. To mitigate this risk, we are proposing to prohibit MDPP suppliers and other individuals or entities performing functions or services related to MDPP services on an MDPP supplier's behalf from unduly coercing an MDPP beneficiary's decision to change or not to change to a different MDPP supplier, including through the use of pressure, intimidation, or bribery as described further in section III.K.2.e.iv.(4). of this proposed rule. We will monitor MDPP supplier billing patterns to detect how frequently bridge payments are paid and to determine whether patterns exists that may suggest fraudulent activity regarding bridge payment claim submissions across suppliers, conducting audits, medical reviews, and investigations as appropriate.
In the CY 2017 PFS final rule, we finalized at § 410.79(b) that a beneficiary's baseline weight refers to the MDPP beneficiary's body weight recorded during that beneficiary's first core session. This definition applies to determine weight loss throughout the MDPP services period. Additionally, the once-per-lifetime policy finalized at § 410.79(d)(1) applies if a beneficiary changes MDPP suppliers, and the services furnished by the subsequent supplier would begin where the beneficiary left off with the previous supplier. We recognize these policies may require the beneficiary to request that a copy of his or her MDPP record be provided by the previous supplier to the subsequent supplier so that subsequent supplier can determine whether the beneficiary achieves or maintains the required minimum weight loss and has information about the MDPP services already furnished. We also finalized at § 424.59(b) (proposed to be redesignated and amended as § 424.205(g)) that an MDPP supplier shall maintain documentation that includes services furnished and body weight measurements. Finally, we finalized at § 424.59(b) (proposed to be redesignated and amended as § 424.205(g)) that MDPP suppliers are required to maintain and handle any beneficiary PII and PHI in compliance with HIPAA, other applicable privacy laws and CMS standards. Any sharing of information from a beneficiary's MDPP record between MDPP suppliers must follow these rules.
We are considering ways to streamline the sharing of this information between suppliers, such as through the development of a model tracker that logs the contact information of a beneficiary's previous supplier and/or coach, and the beneficiary's attendance and weight loss. Beneficiaries could take the tracker with them if they change suppliers during the MDPP services period. Such a tracker would not supplant the previous supplier's beneficiary MDPP record which the subsequent supplier would need to have a copy of in order to consider sessions furnished by the previous supplier in determining whether the subsequent supplier could bill for a performance payment that was based in part on those prior sessions as discussed in section III.K.2.d.iii.(10)(b) of this proposed rule. If the subsequent supplier does not have the beneficiary's MDPP record from the previous supplier, the subsequent supplier cannot use information from the sessions furnished by the previous supplier, such as weight or session attendance, to determine that the performance goals for a performance payment were met so that the subsequent supplier can bill for the performance payment. However, it may help facilitate the process for subsequent suppliers to enroll beneficiaries partway through the MDPP services period while the subsequent supplier is coordinating with the previous supplier to obtain a copy of the beneficiary's MDPP record from that supplier. We are inviting public comments on additional ways this data sharing could be streamlined between suppliers.
The proposed bridge payment is included at proposed § 414.84(c). We are inviting public comments on this proposal and the alternative considered.
In the CY 2017 PFS final rule, we established MDPP supplier enrollment eligibility and revocation policies at § 424.59. We propose to add subpart I, which includes §§ 424.200, 424.205, and 424.210. This subpart specifies the requirements for Medicare Diabetes Prevention Program suppliers and beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model. We propose to redesignate all requirements under § 424.59 to § 424.205. These requirements previously finalized in the CY 2017 PFS final rule created MDPP suppliers as a new Medicare supplier type, and require that any organization seeking to furnish and receive payment for MDPP services must enroll as this supplier type. Given that the set of MDPP services utilizes CDC's DPRP curriculum, in the CY 2017 PFS final rule we established supplier eligibility criteria that closely match CDC's DPRP standards. The CY 2017 PFS final rule provides that any organization that meets full CDC DPRP recognition will be eligible to enroll as an MDPP
The CY 2017 PFS final rule also established other requirements related to MDPP suppliers. For example, we assigned MDPP suppliers to the high-risk screening category under § 424.518. We also established the policy that coaches will not enroll in Medicare for purposes of furnishing MDPP services, but that they would be required to obtain NPIs. We established that MDPP suppliers must submit the active and valid NPIs of all affiliated coaches and provide updates of this information to us within 30 days of a coach beginning or ceasing to furnish MDPP services. We provided that this roster of coach information must include the first and last name, social security number (SSN), and NPI. The proposals outlined in this section seek to build on these requirements.
In the CY 2017 PFS final rule, we acknowledged that many DPP organizations have not yet achieved full CDC DPRP recognition, and that it might take 36 months to meet CDC's performance standards for full recognition. We believe allowing only organizations with full recognition to enroll as an MDPP supplier would limit the number of organizations with demonstrated capacity to furnish MDPP services, and therefore, constrain beneficiary access to these services. However, we deferred to future rulemaking addressing the issue of allowing certain DPP organizations with less than full CDC recognition to enroll in Medicare.
We are proposing an MDPP interim preliminary recognition standard under CMS authority (proposed at § 424.205(c)). We also are proposing that organizations that meet this standard would be eligible to enroll in Medicare as an MDPP supplier.
The current CDC 2015 Diabetes Prevention Recognition Program (DPRP) Standards do not have standards for preliminary recognition. In the CY 2017 PFS final rule, we indicated that we would align the CDC's DPRP and the set of MDPP services, to the extent possible. It will not be possible for CMS to permit DPP organizations to enroll as MDPP suppliers based on achievement of any new CDC standard through this rulemaking because any updates to the CDC Standards are not expected to go into effect until 2018.
However, our intent is to allow organizations that do not yet have full recognition, but have demonstrated a capacity to furnish DPP services, to enroll in Medicare as of the effective date of the enrollment policies proposed in this rule. We believe this will increase access to MDPP services. For this reason, we are proposing, at § 424.205(c), to establish an MDPP interim preliminary recognition standard to permit DPP organizations who meet this standard to enroll in Medicare even if they do not have full CDC recognition. This MDPP interim preliminary recognition standard will be hereafter referred to as “interim preliminary recognition.” As we stated in CY 2017 PFS final rule, our intent with this policy is to bridge the gap until such time as any CDC preliminary recognition standards are established. Once we have established the transition process with CDC, we would expect DPP organizations that seek to enroll into Medicare to obtain CDC preliminary recognition, but MDPP suppliers who have enrolled in Medicare with interim preliminary recognition would maintain their enrollment eligibility as an MDPP supplier.
We are proposing, at § 424.205(c)(2)(ii), that DPP organizations with pending CDC recognition that meet the following additional criteria would meet the interim preliminary recognition standard:
• The organization must continue to follow the current 2015 CDC DPRP Standards for data submission and submit a full 12 months of performance data to CDC on at least one completed cohort (see Appendix D, 2015 CDC DPRP Standards,
• The 12-month data submission to CDC includes at least 5 participants who attended at least 3 sessions in the first 6 months, and whose time from first session attended to last session of the lifestyle change program was at least 9 months; and
• Of the participants eligible for evaluation in the first criterion, at least 60 percent attended at least 9 sessions in months 1 through 6 and at least 60 percent attended at least 3 sessions in months 7 through 12.
All proposed data requirements reflect current reporting requirements to progress from pending recognition to full recognition through CDC's DPRP; no new data collection would be required. To implement the proposed interim preliminary recognition standard, DPP organizations with pending recognition would submit data following CDC's typical recognition process. For the current standards, this includes data submission every 12 months, during the month of the anniversary of the effective date. The organization's data submission should include: (1) Data for all sessions attended by participants from the approval date to the day before the first anniversary of the effective date, (if the organization has a 2016 effective date; this should include at least 6 months of participant data)
Our regulations at § 424.59 (proposed to be redesignated and amended at § 424.205 in this proposed rule) specify that a DPP organization with full CDC recognition is eligible for enrollment as an MDPP supplier if it also meets all of the other conditions for enrollment in § 424.59(a) (proposed to be redesignated and amended at § 424.205(b) in this
We also are proposing that DPP organizations would be eligible to enroll as an MDPP supplier if they meet CDC DPRP Standards for preliminary recognition, once any such standards go into effect (proposed § 424.205(c)(2)(i)). We anticipate that CDC's preliminary recognition standards will be established on or after January 1, 2018. After the effective date of any updated CDC standards, we are proposing that MDPP suppliers who have enrolled in Medicare with MDPP interim preliminary recognition would continue to be eligible for MDPP enrollment (assuming they continue to meet all other requirements for enrollment, described in proposed § 424.205(b)).
We intend to ensure that any transition an MDPP supplier may make from interim preliminary recognition to CDC preliminary recognition does not disrupt its status as an MDPP supplier. We will address possible transition issues in future rulemaking or guidance, as appropriate.
We considered an alternative to wait until new CDC DPRP standards are effective to allow organizations other than those with full recognition to enroll as MDPP suppliers. However, as indicated in the CY 2017 PFS final rule, based on CDC data we believe that waiting until the new DPRP standards are effective would limit the number of organizations with demonstrated capacity to furnish the set of MDPP services from enrolling in Medicare when enrollment starts and offering MDPP services once they become effective. We are inviting public comments on this proposed MDPP interim preliminary recognition standard, including performance standards, and the use of this standard as a condition for enrollment in Medicare, and the alternative considered.
As described in section III.K.2.a. of this proposed rule, we are proposing to change the start date of the MDPP expanded model to April 1, 2018. All other policies not related to the furnishing or billing of MDPP services would, if finalized, be effective January 1, 2018. Thus, although MDPP suppliers would not be able to begin furnishing MDPP services on January 1, 2018, MDPP supplier enrollment would begin on January 1, 2018, if these proposals are finalized. In the CY 2017 PFS final rule, we established that any organization wishing to furnish MDPP services must enroll as an MDPP supplier, regardless of any existing enrollment in Medicare. As indicated in section J.4. of the CY 2017 PFS final rule, we believe that including an effective date for enrollment that precedes the implementation date for MDPP services is necessary to allow organizations sufficient time to enroll as MDPP suppliers. Thus, MDPP services would only become available after there is sufficient time to enroll MDPP suppliers that will furnish those services.
Under § 424.502, the definition of enroll/enrollment means “the process that Medicare uses to establish eligibility to submit claims for Medicare-covered items and services, and the process that Medicare uses to establish eligibility to order or certify Medicare-covered items and services.” Thus, the purpose of enrollment is to establish billing privileges in Medicare. In accordance with our proposal that MDPP services will be available beginning on April 1, 2018, we propose that MDPP suppliers may not have an effective date of billing privileges that precedes the date that MDPP services become available (proposed at § 424.205(e)(2). Given that it typically takes an enrollment application 45-60 days to process, if an MDPP supplier submitted its application in January, the application may be approved prior to when MDPP services become available. For this reason, we are specifying a proposal that, under no circumstances would an MDPP suppliers have an effective date for billing privileges for MDPP services prior to April 1, 2018.
We propose that for MDPP supplier enrollment applications that are submitted and subsequently approved, the effective date for billing privileges would be the date the application was submitted. However for applications submitted and subsequently approved prior to April 1, 2018, we propose that the effective date for billing privileges would be April 1, 2018. This proposal is consistent with other suppliers like physicians, non-physician practitioner organizations, ambulance suppliers, and independent diagnostic testing facilities (IDTFs). However, unlike physicians, non-physician practitioner organizations, and ambulance suppliers, MDPP suppliers would not be permitted to retrospectively bill for services rendered prior to their effective date for billing privileges. Given that MDPP suppliers do not furnish services with immediate impacts on health like the aforementioned Part B suppliers, we chose to utilize the approach of IDTFs. We have established MDPP supplier standards as a condition of enrollment, as described in section III.K.2.e.iv of this proposed rule (proposed at § 424.205(d)), and MDPP suppliers are required to certify in their enrollment application that they are in compliance and will continue to remain in compliance with all MDPP supplier standards. Therefore, generally, an MDPP supplier could begin furnishing services on the date the application was submitted, with the goal of having their application subsequently approved. However, payment for those services would depend upon whether the enrollment application is subsequently approved.
We propose that for any enrollment application that is denied under § 424.530(a)(1) for non-compliance, but then subsequently approved due to the submission of a corrective action plan (CAP), the effective date of enrollment would be the date of the CAP submission. This proposal is also consistent with practices for existing suppliers, and institutes an appropriate safeguard for Medicare beneficiaries and the program at-large by prohibiting services from being furnished from suppliers who are not compliant. We acknowledge, however, that if a supplier began furnishing services the date it submitted its application, but was then denied enrollment, it would not be paid for any services it furnished prior to the date it submitted the CAP, if approved. However, as described in section III.K.2.e.iv of this proposed rule (proposed at § 424.205(d)), upon submitting its enrollment application, an MDPP supplier certifies that—to its knowledge—it meets and agrees to continue to meet the following MDPP supplier standards, and all other applicable Medicare requirements. Thus, at the time the MDPP supplier applicant submits its application, it should believe that its enrollment application will be approved. Examples of actions the MDPP supplier could take to improve its certainty and increase the probability that the application will be approved may include reviewing any MDPP supplier supporting documentation to fully understand MDPP supplier enrollment requirements and accompanying CMS guidance or
We also propose that if an MDPP supplier adds a new administrative location (defined and discussed further section III.K.2.e.iii.(2) of this section of the proposed rule) that resulted in a new enrollment record or Provider Transaction Access Number (PTAN), the effective date for billing privileges would be the date the MDPP supplier began its MDPP operations at that location. We believe that this proposal is appropriate given that it follows a similar approach for an effective date that applies to when physician organizations, non-physician practitioner organizations, ambulance suppliers, and Independent Diagnostic Testing Facilities (IDTFs) add a new practice location to an existing enrollment record. Though the definition of administrative location differs from that of practice location, it provides a similar function. We seek comments on these proposals.
We are proposing to require the use of a new, CMS-approved enrollment application specific to MDPP suppliers. We believe that the creation of a new application will be more easily navigated by and reduce the burden on new, non-traditional suppliers because the new enrollment application will only solicit information relevant to the MDPP supplier type. As this new enrollment application is being created specifically for the MDPP expanded model, we have determined that this new enrollment application is exempt from the Paperwork Reduction Act in accordance with section 1115A(d)(3) of the Act. Further, this enrollment application would be considered an “enrollment application” for purposes of part 424 subpart P, and therefore, all existing regulations and administrative guidance that govern the CMS-855 enrollment applications would apply to this new form, unless otherwise specified. We also considered an alternative option to amend the current CMS-855B Medicare Enrollment Application for Clinics/Group Practices and Certain Other Suppliers (CMS-855B) for MDPP supplier enrollment, but we determined that the existing length and complexity of the CMS-855B enrollment application and its applicability to other non-MDPP suppliers may add burdens or unnecessary confusion to MDPP suppliers given that many sections of the current CMS-855B enrollment application would not apply to MDPP suppliers. In addition, we would need to add new sections to solicit information specific to MDPP suppliers, which would only further increase the length of the CMS-855B enrollment application. We invite public comments on this proposal.
On the new MDPP enrollment application, we intend to solicit information specific to MDPP suppliers, as well as information consistent with existing reporting requirements applicable to all suppliers who enroll through the CMS-855B enrollment application, while excluding all reporting requirements that do not apply to MDPP suppliers. As a Medicare supplier enrolling under part 424 subpart P, MDPP suppliers are required to provide complete and accurate information on the MDPP enrollment application, or be subject to enrollment denial under § 424.530(a)(4) or revocation under § 424.535(a)(4). This requirement would include all information solicited on the MDPP-specific enrollment application. The MDPP-specific enrollment application is under development and will be available prior to its use, if this proposal is finalized. While the application is being developed, we wish to indicate some of the information we intend to include on the MDPP enrollment application, as further described in this section.
As finalized in the CY 2017 PFS final rule, § 424.59(a)(5) requires that MDPP suppliers submit the active and valid NPIs of all coaches who will furnish services on the supplier's behalf, as well as their first name, last name, and SSN (in this proposed rule, § 424.59(a)(5) is proposed to be redesignated and amended at § 424.205(b)(4)). We are proposing, at § 424.205(b)(4), to require that MDPP suppliers provide this identifying information of the coaches directly through the enrollment application. This information will be used to complete background checks of the coaches. To accompany the coach identifying information, we propose to require MDPP suppliers to provide an eligibility start and end date, if applicable, for each coach on the supplier's roster. Coach eligibility start and end dates are described at length in section III.K.2.e.iv.(2). As described in more detail in section III.K.2.e.iv., the background checks would be used to prevent MDPP suppliers from allowing coaches to furnish MDPP services when certain adverse histories may indicate potential to harm Medicare beneficiaries or undermine program integrity. We outline further details on our proposed enforcement of this provision in section III.K.2.e.iv. of this proposed rule.
To enable us to conduct background checks of coaches, we are proposing that MDPP suppliers also submit to CMS the date of birth of all coaches who will furnish MDPP services (proposed § 424.205(b)(4)). Combined with other identifying information, date of birth plays a critical role in validating an individual's identity. By collecting date of birth, we would be able to more accurately screen coaches, including accurately conducting a background check, and distinguishing them in the Provider Enrollment, Chain and Ownership System (PECOS). In addition, we want to ensure that we have the capability to most accurately identify individuals reported on the form. To mitigate potential confusion or error found when individuals have common names, we are proposing to collect coach's middle initial (if applicable) on the enrollment application (proposed § 424.205(b)(4)). We believe that this proposal will help to lessen the possibility that CMS or its contractors misattribute the background of one individual for another.
We are proposing, at § 424.205(d)(4), that MDPP suppliers would identify their administrative location(s) by reporting these location(s) on their enrollment application. We are proposing, at § 424.205 (a), to define administrative location as the physical location associated with the supplier's operations, from where coaches are dispatched or based, and where MDPP services may or may not be furnished. We are proposing that an MDPP supplier must have at least one such administrative location, and report any additional administrative locations of the supplier, if MDPP services are either furnished at these locations and/or if the location reflects from where coaches are dispatched or based. For example, if an MDPP supplier operated 2 locations, but only 1 of the 2 locations associated with the entity offered MDPP, only the location offering MDPP would be considered an administrative location. If coaches began offering MDPP in community settings (described in the subsequent paragraph and proposed to be defined at § 424.205(a), but were
While we recognize that many suppliers furnish MDPP services outside of their administrative locations in community settings, we are proposing to only require enrollment of the administrative locations. In proposed § 424.205(a), we define “community setting” as a location where the MDPP supplier furnishes MDPP services outside of their administrative locations. A community setting is a location open to the public, not primarily associated with the supplier. Community settings may include, for example, church basements or multipurpose rooms in recreation centers. When determining whether a location is considered an administrative location or a community setting, MDPP suppliers should consider whether their organizational entity is the primary user of that space and whether coaches are based or dispatched from this location. If so, the location would be considered an administrative location, even if this location dually serves as a community setting. In comparison, community settings are locations not primarily associated with the supplier where many activities occur, including MDPP services.
We seek public comments on these proposals.
We are proposing, at § 424.205(d)(5), that MDPP suppliers must update their enrollment application within 30 days of any changes of ownership, changes to the coach roster, or new final adverse action history of any individual or entity required to report such information on the enrollment application. We are proposing that MDPP suppliers report all other changes to information required on the enrollment application within 90 days of the reportable event. Timely reporting and updating of information plays a critical role in our ability to protect Medicare beneficiaries and protect the integrity of the Medicare program and Trust Funds. We believe that these requirements are fair and consistent with existing reporting requirements for other Medicare suppliers.
All suppliers are required to report changes of ownership and new adverse action history within 30 days. Adding the requirement that any changes to the coach roster be reported within 30 days is consistent with IDTFs requirements at § 410.33(g)(2). Although IDTFs differ from MDPP suppliers in many ways, IDTFs must report a roster of supervising physicians who serve functions on the supplier's behalf and must also report changes to this roster within 30 days. Given this similarity with IDTFs, we modeled our approach after this process. However, we note that while MDPP suppliers would be required to submit changes to the coach roster within 30 days, we would encourage them to submit such changes as soon as possible, due to reasoning explained further in section III.K.2.e.iv.(2) of this proposed rule.
We invite public comments on these proposals.
In the CY 2017 PFS final rule, we finalized that MDPP suppliers would enroll in Medicare. We solicited comments on, but did not propose or finalize, an applicable application fee associated with the MDPP supplier's enrollment. In this proposed rule, we propose to amend the definition of “institutional provider” as defined under § 424.502, to include MDPP suppliers such that, § 424.514, which governs the application fee, would similarly apply to MDPP suppliers. “Institutional providers” that are initially enrolling in Medicare, revalidating their enrollment, or adding a new Medicare practice location are required to submit a fee with their enrollment application. We would like to highlight that while we are proposing to include MDPP suppliers as an institutional provider, MDPP suppliers utilize administrative locations, not practice locations, and therefore the fee would not apply when adding a new administrative location to an existing enrollment record. The application fee is adjusted annually, and additional information about how the adjustment is calculated may be found in the November 7, 2016
We are proposing to establish standards that MDPP suppliers must meet and remain in compliance with to be eligible to receive payment for an MDPP service (proposed § 424.205(d)). These supplier standards would build on the conditions for enrollment established under existing § 424.59(a) (which in this proposed rule is
We believe that the standards outlined in this section are generally consistent with standards established for other Medicare suppliers while adding safeguards to help ensure compliance with MDPP rules and regulations specific to this expanded model. Because this expanded model would pay MDPP suppliers based on a beneficiary's achievement of performance goals, we believe that it is prudent to include additional requirements consistent with the Office of the Inspector's General's compliance guidance,
In addition to establishing standards for MDPP suppliers with respect to their delivery of MDPP services, we also are proposing standards for MDPP suppliers' general eligibility to furnish services to Medicare beneficiaries. These standards would establish program integrity safeguards that would protect both Medicare beneficiaries and the Medicare program. We are proposing that MDPP suppliers must not currently have their billing privileges terminated for-cause from any State Medicaid program or be excluded from any State Medicaid program (proposed § 424.205(d)(2)). If a supplier's Medicaid billing privileges are currently terminated from or the supplier is excluded from any State Medicaid program, we do not believe that supplier should be able to furnish Medicare services. We believe that this proposal is warranted given that a supplier's improper behavior in another Federal health care program may be duplicated in Medicare. We believe that this proposed requirement would mitigate the MDPP expanded model's susceptibility to fraud, waste, and abuse. Consistent with all standards in this section, any MDPP supplier who does not meet this requirement would be subject to a Medicare enrollment denial or revocation. We believe that this proposed standard would serve to ensure continuity of safeguards across Federal health care programs, and will help preserve the integrity of the Medicare program and protect beneficiaries by prohibiting suppliers found to be noncompliant in one Federal health care program from enrolling in and furnishing services in another.
We seek comments on this proposal.
We are proposing, at § 424.205(d)(3), that the MDPP supplier must report coach information on its enrollment application and the MDPP supplier must only permit MDPP services to be furnished by individual coaches who meet the eligibility criteria. We propose, at § 424.205(e)(1) that MDPP coach eligibility criteria require that a coach must not:
• Currently have his or her Medicare billing privileges revoked and whose reenrollment bar has not yet expired. We believe that this proposed supplier standard would protect beneficiaries from receiving MDPP services from individuals already prohibited from furnishing other Medicare services. If an individual is precluded from maintaining enrollment in Medicare for a non-MDPP service, we believe that it is prudent that they similarly not furnish MDPP services.
• Currently have his or her Medicaid billing privileges terminated for-cause or is excluded from any State Medicaid Agency (proposed at § 424.205(e)(1)(ii)). We believe that this proposed supplier standard is warranted given that an individual's improper behavior in another Federal health care program may be duplicated in Medicare. We do not believe that we should permit MDPP suppliers to allow coaches with current for-cause terminations or exclusions in Medicaid to furnish MDPP services to Medicare beneficiaries.
• Currently be excluded from any other Federal health care program, as defined in § 1001.2 of this chapter, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. This includes, but is not limited to, the Office of Inspector General (OIG)'s List of Excluded Individuals and Entities (LEIE). We are proposing this supplier standard for similar reasons we are proposing not to permit coaches with revocations from Medicare or current exclusions from Medicaid to furnish MDPP services.
• Currently be debarred, suspended, or otherwise excluded from participating in any other Federal procurement or non-procurement program or activity in accordance with the Federal Acquisition Streamlining Act implementing regulations and the Department of Health and Human Services non-procurement common rule at 45 CFR part 76. We note that this includes individuals who have an active status on the General Service Administration's System for Award Management list. We may also utilize the Bureau of the Fiscal Service, U.S. Department of the Treasury's Do Not Pay (DNP) List as a resource for determining which individuals fall under this category. The Improper Payments Elimination and Recovery Improvement Act (IPERIA) of 2012 established the DNP to support Federal agencies with their efforts to prevent and detect improper payments by aggregating various data sources for pre-award, pre-payment eligibility verification. Data sources included in this list include Credit Alert System,
• Have, in the previous 10 years, one of the following state or federal felony convictions:
++ Crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
++ Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
++ Any felony that placed the Medicare program or its beneficiaries at immediate risk, such as a malpractice suit that results in the individual being convicted, as defined under 42 CFR 1001.2, having a guilty plea or having adjudicated pretrial diversion of criminal neglect or misconduct.
++ Any felonies that for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion that would result in mandatory exclusion under section 1128(a) of the Act.
We propose that CMS will screen each individual identified on the roster of coaches included with the supplier's enrollment application to verify that the individual coach does not meet any of these conditions and that the coach can provide MDPP services on behalf of an MDPP supplier (proposed at § 424.205(e)(2)). We are proposing these requirements as a means to ensure the integrity and safety of the Medicare program and the beneficiaries whom we serve. We have selected these types of felony convictions based on the risk we believe they could pose to the Medicare program and our beneficiaries. Additionally, it is consistent with existing criteria that we use to determine felonies that are detrimental to the best interest of the program and its beneficiaries as described in § 424.535(a)(3)(ii). While we selected these criteria to be consistent with how we evaluate other individuals, we also sought to create a more definite list such that MDPP suppliers would have the ability to conduct background checks on coaches prior to, as well as potentially after enrolling in Medicare, to avoid receiving an enrollment denial or revocation due to failure to meet this standard. While coaches are not directly enrolled, and therefore, not directly receiving payment, we believe that it is prudent to prohibit MDPP suppliers from utilizing individuals convicted of certain felonies to furnish services to Medicare beneficiaries. Because coaches will be directly interacting with beneficiaries, recording their attendance and weight loss, we believe that a coach's trustworthiness is vital. Consequentially, we do not believe that such coaches should have a criminal history such as those described in § 424.535(a)(3)(ii).
Coaches that meet any of these criteria would be considered ineligible to furnish MDPP services, and therefore, could not be on an MDPP supplier's roster. Coaches whose information was submitted in an MDPP supplier's enrollment application, screened, and determined as not meeting any of these criteria would be considered eligible coaches. Although the MDPP supplier is the entity that is enrolled in Medicare and submits claims, coaches furnish MDPP services, directly interacting with the beneficiary and documenting attendance and weight loss. Therefore, we believe that precluding individual coaches who meet any of the ineligibility criteria from directly furnishing MDPP services to Medicare beneficiaries would both help reduce fraud, waste, and abuse that could occur in the MDPP expanded model, as well as protect beneficiaries from harm.
If after screening, CMS or its contractors determine that a coach is eligible to furnish MDPP services, the coach would be assigned an eligibility start date, similar to a supplier's enrollment effective date. We are proposing to define coach eligibility start date as follows: The start date indicated by the MDPP supplier when submitting an eligible coach's information on the MDPP enrollment application (proposed at 424.205(a)). On the enrollment application, the MDPP supplier will include a date indicating when the coach began furnishing MDPP services. Consistent with proposals at § 424.205(d)(5), the MDPP supplier must report changes to the coach roster on its enrollment application, including any new coaches added, within 30 days of such a change. Thus, the start date associated with any new coach information must be within 30 days of the date the MDPP supplier actually reports the change on its application. If the coach has not yet begun furnishing MDPP services, the MDPP supplier should indicate the date the supplier is reporting the information. Though the date reflects either when the coach began furnishing services or when the coach could ultimately be determined as eligible to begin furnishing services, after the enrollment application was submitted, CMS must still determine whether the coach is eligible (proposed at § 424.205(e)(2)). If we determine the coach to be eligible, then his or her eligibility start date would be the date the MDPP supplier indicated on its enrollment application. As described in III.K.2.d.(10)(d), payment can be made for services furnished by this coach on or after his or her eligibility start date.
However, if a coach was determined to be ineligible at the onset, the coach would have its eligibility start and end date on the same date, effectively never being eligible to furnish MDPP services. If the coach later became ineligible, he or she would be assigned an eligibility end date. Consistent with proposals at 414.84, payment for MDPP services is made only if such services are furnished by an eligible coach, on or after his or her coach eligibility start date and, if applicable, before his or her coach eligibility end date, to an MDPP beneficiary. This could pose a situation in which an MDPP supplier could submit an updated coach roster that includes a new coach, and allow him or her to begin furnishing services based on the belief that he or she is eligible. Should, after screening, CMS or its contractors determine that the coach is ineligible, the MDPP supplier could be revoked for non-compliance. Though the MDPP supplier would have an opportunity to submit a corrective action plan that removes the ineligible coach from their enrollment application, any claims for services furnished by the ineligible coach would be denied, and the MDPP supplier would not be paid for such services. For this reason, we encourage suppliers to report changes to the coach roster as soon as possible. If the MDPP supplier submits a claim that
We believe that the majority of the coach ineligibility criteria described in this section is crafted in such a way that the MDPP supplier could, with reasonable certainty, conduct an independent background check on the coach, to determine whether he or she meets the ineligibility criteria. If the MDPP supplier has any uncertainty about whether the coach meets the ineligibility criteria, they may wish to preclude the coach from furnishing services to Medicare beneficiaries until CMS determines that the coach is eligible. This would avoid a potential situation of a coach furnishing services for which the MDPP supplier could not get paid. If the MDPP supplier believes the coach is eligible and wishes to allow the coach to furnish services prior CMS determining his or her eligibility, then the MDPP supplier would assume the risk not receiving payment for claims for serviced rendered by the ineligible coach.
If a coach no longer provides MDPP services for an MDPP supplier, the supplier must remove that coach from its roster and indicate the date of such event to designate an eligibility end date for that coach. If the MDPP supplier voluntarily terminates its Medicare enrollment or is revoked, CMS will automatically reflect the date of this action as the coach's eligibility end date for that MDPP supplier. We are proposing to define coach ineligibility end date as follows, the end date indicated by the MDPP supplier in submitting a change to the supplier's MDPP enrollment application that removed the coach's information, or the date the supplier itself was revoked from or withdrew its Medicare enrollment as an MDPP supplier.
We are proposing that CMS or its contractors would determine whether coaches submitted on MDPP rosters satisfy the previously stated criteria by using the identifying information MDPP suppliers submit on their enrollment applications (including any changes that MDPP suppliers would be required to report). This information would be checked against internal and publicly available data sources. We are proposing that, upon identification of evidence that a coach met any ineligibility criteria, we may take administrative action to deny or revoke the MDPP supplier's enrollment as appropriate under §§ 424.530(a)(1) and 424.535(a)(1) (proposed at § 424.205(g)(1)(ii)). Consistent with existing enrollment denial and revocation actions, we would notify the prospective or enrolled MDPP supplier via an enrollment denial or revocation notification and include the specific reason for the administrative action. The enrollment denial or revocation notification detailing the findings and the reasoning for the determination would follow requirements under § 488.18. Consistent with similar processes at §§ 424.530(c) and 424.535(e), we are proposing that an MDPP supplier could respond to the enrollment denial or revocation by submitting a corrective action plan (CAP) that would include the removal of the coach from its roster within 30 days of receiving the enrollment denial or revocation notification, and therefore, come into compliance and enroll or maintain its enrollment status. If MDPP suppliers believe that the decision was made in error, they could exercise existing appeal rights under part 498.
We also are proposing that if we determine that an MDPP supplier has continued to allow an ineligible coach to furnish MDPP services after having submitted a CAP removing the coach from its roster to enroll or maintain enrollment in Medicare, we would revoke the MDPP supplier without the opportunity for additional corrective action. This authority, outlined in proposed § 424.205(h)(1)(v), would allow us to revoke an MDPP supplier for knowingly using an “ineligible coach” to furnish MDPP services. “Knowingly,” in this context, means that the supplier received an enrollment denial or revocation notice based on failing to meet supplier standards at § 424.205(d)(3) (related to ineligible coaches), was provided notice by CMS or contractors working on its behalf of this action including the reason(s) for the administrative action, submitted a CAP to remove the coach, but continued to allow the coach to provide MDPP services in violation of the CAP. We are proposing to define an “ineligible coach” in § 424.205(a) as an individual whom CMS has screened and has determined ineligible to furnish MDPP services on behalf of an MDPP supplier based on the standard specified in § 424.205(e), and we are proposing in the same paragraph to define “eligible coach” in § 424.205(a) as an individual who CMS has screened and has determined can furnish MDPP services on behalf of an MDPP supplier based on the standard specified in proposed § 424.205(e).
While any individual may be eligible to become a DPP coach, provided that they meet requirements and trainings as dictated by the CDC's DPRP Standards, an individual can only become an eligible coach for purposes of furnishing MDPP services after having their required identifying information submitted on an MDPP supplier's enrollment application, being screened by CMS or its contractors, and as a result, being determined to be eligible to furnish MDPP services on behalf of an MDPP supplier. If CMS or its contractors deem a coach ineligible, this would apply only to the furnishing of MDPP services and would not preclude the DPP organization from continuing to allow this individual to furnish administrative services or DPP sessions to non-Medicare beneficiaries. However, serving as a coach for Medicare beneficiaries would be prohibited and would be subject the MDPP supplier to this revocation authority.
We are proposing this new revocation authority due to the novel program integrity risks that would be posed by MDPP suppliers who knowingly continue to permit ineligible coaches to furnish MDPP services to Medicare beneficiaries. We believe that this new basis for revocation is necessary because coaches are not enrolled in Medicare, even though they will undergo background checks by CMS or its contractors and must meet specified criteria. While we considered using existing revocation authorities under § 424.535(a)(1) (related to noncompliance), § 424.535(a)(4) (related to false or misleading information), and § 424.535(a)(9) (related to failure to report), we determined that these authorities were too general for purposes of specifically addressing MDPP coaches who become ineligible to furnish MDPP services. We are proposing that this revocation authority would follow similar requirements under § 424.535(c), (g), and (h). We do not believe that § 424.535(e) (related to reversal of the revocation) should apply in this case, given that the MDPP supplier already had an opportunity to remove the coach from their roster by submitting a CAP, but continued to allow the ineligible coach to furnish MDPP services. The proposals that we would apply from the provisions of § 424.535 stated in this section are as follows:
• The revocation becomes effective 30 days after CMS or the CMS contractor
• For the revocation authority, MDPP suppliers are barred from participating in the Medicare program from the date of the revocation until the end of the re-enrollment bar, which begins 30 days after CMS or its contractor mails notice of the revocation and lasts a minimum of 1 year, but not greater than 3 years, depending on the severity of the basis for revocation; and
• A revoked MDPP supplier must, within 60 calendar days after the effective date of revocation, submit all claims for items and services furnished before the date of the revocation letter.
We believe that these proposals would appropriately govern this proposed new revocation authority, given the consistency with existing revocation authorities. Given these consistencies, we do not believe that this proposal places an undue burden on MDPP suppliers, and any burden established would be warranted given the violation of the supplier standards that jeopardize both the integrity of the Medicare program and the safety of its beneficiaries.
We are inviting public comments on these proposals.
We are proposing a number of requirements that would help ensure that MDPP suppliers are operational, have the resources necessary to furnish MDPP services, and are in compliance with MDPP supplier standards. At § 424.205(d)(4), we are proposing that, regardless of whether the MDPP supplier furnishes services solely in community settings, it must maintain at least one administrative location. All administrative locations maintained by the MDPP supplier must be on an appropriate site available to the public and must be reported on the CMS-approved enrollment application. We are proposing that this administration location may not be a private residence. We are proposing that an appropriate site must have signage posted on the exterior of the building, as well as be open for business and have employees, staff, or volunteers present during operational hours. For the purposes of this requirement, such signage may include, for example, the MDPP supplier's legal business name or its “doing business as” (DBA) name, as well as hours of operation. This proposal seeks to utilize measurable objective indicators to determine that organizations are legitimately operating and able to furnish MDPP services to Medicare beneficiaries. We believe that, regardless of whether the MDPP supplier furnishes services at its administrative location, establishing a physical location is necessary for associated requirements for furnishing MDPP services, including recordkeeping requirements, training facilities, and storage for any educational materials distributed during sessions.
We are proposing, at § 424.205(d)(6), that a MDPP supplier must maintain a primary business telephone number listed under the name of the organization in public view. Public view could signify, for example, that the phone number is listed on a Web site, on flyers and materials. This proposed policy would require that calls must not automatically go to the answering machine or utilize an answering service during posted business hours. The purpose of this proposed requirement is to help verify that the organization is a legitimate organization and not simply posing as an organization and seeking to bill Medicare fraudulently.
We are further proposing, at § 424.205(d)(7), that an MDPP supplier must not knowingly sell to or allow another individual or entity to use its billing number, consistent with § 424.535(a)(7). We are including this proposal to avoid a situation in which another entity uses an existing MDPP supplier's billing number. We believe that this proposal plays an important role in ensuring that payments are only being made to the intended recipient who has met all of the supplier and compliance standards and that we continue to hold entities responsible for maintaining compliance. Otherwise, we risk making payments to suppliers potentially engaging in fraudulent or potentially harmful behavior.
We believe that the proposed requirements in this section would not pose an undue burden on MDPP suppliers as they are minimum requirements for any functional, operational organization. By establishing these requirements, we believe that we would ensure that MDPP suppliers that do not meet the baseline requirements for an operational organization would not be permitted to furnish MDPP services to or receive payment for such services. We are proposing, at § 424.205(d)(15), that an MDPP supplier must permit CMS or its agents to conduct onsite inspections to ascertain the supplier's compliance with these standards. While we believe that any operational business that truly furnishes MDPP services would be able to meet these requirements, we are inviting public comments on any aspects of these proposed standards.
We are proposing, at § 424.205(d)(8), that MDPP suppliers may not deny access to MDPP services to eligible beneficiaries based on any reason other than the supplier's own self-determined and published capacity limits to furnish MDPP services to additional people and, on a discretionary basis, if a beneficiary significantly disrupts the session for other participants or becomes abusive. Given that we do not yet currently have data on optimal class size for MDPP services, we are currently allowing MDPP suppliers to self-determine any upper limitation on class size. Should they establish such a limit and intent to turn beneficiaries away once the capacity limit is reached, the MDPP supplier must have previously made this limit publicly available; for example, denoting the limit in any brochures, Web sites, or other materials that outline their MDPP services. We are proposing that MDPP suppliers must maintain a record of the number of eligible Medicare beneficiaries turned away for each of these reasons, as well as the date the beneficiary was informed. We are further proposing that if an MDPP supplier denies a Medicare beneficiary access citing disruptive or abusive behavior, details of the occurrence(s), including date(s) of the behavior, any remediation efforts taken by the supplier, and final action (for example, dismissal from an MDPP session or denial from future sessions) must be documented in the beneficiary's MDPP records and adhere to documentation requirements outlined in § 424.205(g). We note that one supplier's decision to dismiss a beneficiary for this purpose would not limit that beneficiary from switching to another MDPP supplier.
We will seek to monitor compliance with this requirement, and investigate further if necessary, based on beneficiary complaints, rates of access denials citing capacity limits in comparison to estimated capacity based on claims submitted, as well as monitoring claims for success rates for achieving performance goals that are higher than what would be expected for a typical Medicare population. Illustrative examples of capacity limits could include that the MDPP supplier has met its self-determined and published class size maximum, or that the supplier is providing MDPP sessions in cohorts and does not have a new or upcoming cohort at the time the beneficiary is seeking MDPP services. Furnishing MDPP services in a cohort means that the DPP curriculum is delivered among a single group, or
Given that our proposed payment structure for MDPP services relies on the achievement of weight loss and attendance goals, there may be incentives for MDPP suppliers to seek to serve only those beneficiaries for which they are more likely to earn performance payments. This, in turn, could result in discriminatory treatment of beneficiaries. Through this proposed supplier standard, we would expressly prohibit MDPP suppliers from conditioning access to MDPP services on the basis of a beneficiary's weight or health status (except as provided in our proposed regulations). We also would prohibit MDPP suppliers from conditioning access to MDPP services on the basis of a beneficiary's achievement of performance goals, except where the beneficiary becomes ineligible for additional sessions as a result of not meeting those goals, as proposed elsewhere in this proposed rule. We believe that it is appropriate to prohibit suppliers from denying access to MDPP services except in certain limited circumstances. If a supplier were to deny access to a beneficiary citing lack of capacity, but then furnish MDPP services to a different beneficiary, this may signal a violation of such standards. In addition, and for the same reasons, we are proposing to prohibit MDPP suppliers, which includes any coaches or entities performing functions or furnishing services related to MDPP services on their behalf, from unduly coercing a beneficiary's decision to change or not change to a different or specific MDPP supplier, including through the use of pressure, intimidation, or bribery in proposed § 424.205(d)(9). Information that may result in a beneficiary changing to a different MDPP supplier provided in response to a beneficiary's request for information would not violate this provision.
At § 424.79, the CY 2017 PFS final rule established the set of services included in the expanded model, but did not stipulate that once a supplier began furnishing such services to a beneficiary, that it must continue to offer them to the beneficiary as a part of the MDPP expanded model. We are proposing, at § 424.205(d)(10), that MDPP suppliers must offer and provide beneficiary access to the
We also are soliciting public comments on a potential future policy to require a specific class size limit for MDPP sessions. While we acknowledge that MDPP services may be successfully furnished in group settings, we believe that it is important to ensure that the group's size is appropriately set such that each beneficiary gains the necessary interaction with the coach furnishing the session to properly learn the curriculum. We considered different mechanisms to ensure this program objective, and are requesting public comments on considerations to date. The mechanism that currently seems most viable would require a limitation on the number of total attendees in a given session taught by an individual coach. Based on CDC's experience with the DPP program and review of the literature on appropriate class sizes for educational settings, we considered including a class size limitation of 30 participants per coach in a given session (including Medicare beneficiaries). Given that limited data currently exist on this type of requirement among DPP sessions, we are soliciting public comments on what an appropriate class size limitation would be, including any evidence to support such a proposal.
Furthermore, we are soliciting public comments on how MDPP suppliers who furnish sessions in no specific sequential order and allow drop ins would balance the requirement of providing beneficiary access with a class size requirement for a given session. For example, if a supplier offers classes multiple times a week and gives beneficiaries flexibility regarding when to participate, we questioned whether a certain class size limitation could force a supplier to turn away a beneficiary seeking to attend a session at a time when attendance is high, and in so doing potentially discourage continued use of the set of MDPP services. In addition, we are unsure of any implications that would result from establishing a class size restriction for MDPP services while acknowledging that MDPP beneficiaries may participate in DPP sessions with non-Medicare beneficiaries who may not face the same class size limitation. Given these considerations, we are soliciting public comments on how we could structure this proposal in the future that would achieve the programmatic goals of effectively furnishing the DPP curriculum to Medicare beneficiaries in a manner and setting that contributes to positive behavioral changes and ultimately less progression to type 2 diabetes. In providing comments on this approach, we encourage the submission of data and evidence to justify what specific class size would be appropriate for MDPP suppliers.
We are proposing, at § 424.205(d)(11), that MDPP suppliers must provide information about the MDPP expanded model to each beneficiary to whom it furnishes MDPP services as specified by CMS. This includes detailed information on coverage for the set of MDPP services, the once-per-lifetime limit, on eligibility requirements, and the MDPP supplier standards. We recognize that many aspects of the MDPP expanded model are novel for both beneficiaries and suppliers, and we desire that both parties are well informed. Therefore, we believe that requiring the supplier to fully disclose information about the MDPP expanded model, coverage, and the MDPP supplier standards will help inform all parties. We intend to provide a specific template for the MDPP supplier to use to disclose this information to the beneficiaries. For this reason, we do not believe that requiring this type of disclosure places a significant burden on the supplier. While we believe that this approach will help to address the policy goals of the MDPP expanded model, we are inviting public comments on this approach, particularly upon the provision of a standard CMS disclosure
We invite public comments on these proposals.
We are proposing that MDPP suppliers must answer Medicare beneficiaries' questions about MDPP services and respond to MDPP related complaints within a reasonable timeframe in proposed § 424.205(d)(12). We also are proposing that MDPP suppliers implement a complaint resolution protocol and maintain documentation of all beneficiary contact regarding such complaints, including the name and Medicare Beneficiary Identifier of the beneficiary, a summary of the complaint, related correspondences, notes of actions taken, and the names and/or NPIs of individuals who took such action on behalf of the MDPP supplier. We are proposing that this information must be kept at a supplier's administrative location and made available to CMS or its contractors upon request. These records would adhere to the same recordkeeping requirements in § 424.205(g), and therefore, would need to be maintained for 10 years. While other records are typically required to be held only for 7 years (per § 424.516(f)), given that the MDPP expanded model includes beneficiary engagement incentive (described further in section III.K.2.f.v.) which typically requires an extended documentation requirement, we considered it important to align all recordkeeping requirements for the MDPP expanded model. As noted earlier in this section, we are proposing at § 424.205(d)(15) that an MDPP supplier must allow CMS or its agents to conduct recordkeeping reviews to ascertain the supplier's compliance with these standards, as well as documentation requirements as outlined in § 424.205(g).
We believe our proposal that MDPP suppliers must answer, respond to, and document beneficiary complaints and resolutions establishes a tracking mechanism to determine whether or not suppliers are adequately addressing beneficiary concerns. We find this requirement particularly important given that complaint procedures provide a good way to ensure best practices by suppliers. Moreover, DMEPOS supplier standards contain a requirement regarding maintaining complaint procedures. Although we acknowledge that this method requires the MDPP suppliers to self-attest to complaints, requiring such documentation as a required Medicare standard can help to build accountability to following through with complaint resolution. Additionally, mandating that suppliers take and maintain records of complaints may help to address situations where beneficiaries raise issues directly to us after failing to receive resolution from the supplier directly.
We believe that requiring this documentation would provide an additional mechanism for us to ensure that the supplier is fully disclosing information pertinent to the supplier standards, specifically those regarding beneficiary access, and other concerns. As an additional benefit of this policy, if a beneficiary is denied access, the MDPP supplier would be required to demonstrate the reasoning behind this approach, and we could have an opportunity to review if this reasoning complied with the proposed standard under § 424.205(d)(8).
This approach is consistent with supplier standards for other Medicare suppliers, including those for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. Given that CMS has imposed similar standards regarding supplier responsibility for addressing beneficiaries' complaints among other supplier types, we do not believe that requiring a similar such requirement poses an undue burden on MDPP suppliers. Rather, we believe that this approach can facilitate beneficiary satisfaction with the services suppliers furnish by requiring that beneficiary complaints are acknowledged, resolved, and tracked appropriately. We believe that this approach will help ensure that the supplier is meeting beneficiaries' needs as they relate to the MDPP expanded model. In addition, we believe that this will help ensure the integrity of the MDPP expanded model.
We invite public comments on these proposals.
In the CY 2017 PFS final rule, we finalized a requirement for MDPP suppliers to maintain and submit to CMS a crosswalk file that documented how the beneficiary identifiers submitted to CMS for billing and the beneficiary identifiers submitted to CDC for session-level performance data linked to the same beneficiary as a documentation retention and provision requirement (existing § 424.59(b), proposed to be redesignated and amended as § 424.205(e) in this proposed rule). CMS will use this crosswalk for evaluation purposes so CMS can review session level data that MDPP suppliers provide to CDC to supplement the claims data we receive directly from MDPP suppliers. We indicated that we would provide additional information on format and frequency of this reporting requirement in future rulemaking or administrative guidance as appropriate. We are proposing the maintenance and submission of the crosswalk as an MDPP supplier standard and are providing additional details regarding the format and frequency. We are proposing that the crosswalk file would contain Medicare Health Insurance Claims Numbers or Medicare Beneficiary Identifiers and the unique participant identifier assigned by the organization, for the purposes of CDC performance data reporting, for each beneficiary receiving MDPP services (proposed § 424.205(d)(13)). Beneficiaries for whom at least one Medicare claim was submitted by an MDPP supplier would be required to be included in the crosswalk. We are proposing that the crosswalk be supplied to CMS, or our contractor, beginning 6 months after the organization begins furnishing MDPP services, and quarterly thereafter. The crosswalk would be maintained in a spreadsheet (for example, an Excel file or a CSV file), in a form and manner as specified by CMS. We are inviting public comments on this approach.
Additionally, to enable evaluation of MDPP services for a beneficiary's entire MDPP services period (that is, up to 3 years), we are proposing that MDPP suppliers must submit performance data for any beneficiaries who attend ongoing maintenance sessions in a manner and form as specified by CMS (proposed § 424.205(d)(14)). This proposal serves to ensure that MDPP suppliers provide session-level data for ongoing maintenance sessions that are consistent with the data they are already providing to CDC for the core MDPP services period. This requirement is necessary given that session-level performance data plays a critical role in the Innovation Center's evaluation of the entirety of the MDPP expanded model. Without such data, the Innovation Center would lack any streamlined method of obtaining session-level data for ongoing maintenance sessions furnished to MDPP beneficiaries. We are proposing that this performance data must align with the performance date elements as
In the CY 2017 PFS final rule, we specified that newly enrolling MDPP suppliers as high categorical risk in accordance with § 424.518(c), but we did not address the risk level of MDPP suppliers upon revalidation. Section 6401(a) of the Affordable Care Act established that all Medicare suppliers must revalidate their enrollments as a program integrity measure. Upon revalidation, suppliers are screened for their continued enrollment in Medicare. While MDPP suppliers enroll at the high risk level, we are proposing, at § 424.205(b)(3)(ii), that MDPP suppliers would revalidate under a moderate risk level in accordance with § 424.518(b). We believe that this approach is appropriate, given that fingerprint-based criminal history record checks through the Federal Bureau of Investigation's Integrated Automated Fingerprint Identification System requirement for “high” categorical risk and will have already been completed upon initial enrollment. In addition, we believe that this approach is appropriate, given its consistency with other providers and suppliers who initially enroll under “high” categorical risk, but revalidate under “moderate” categorical risk, such as DMEPOS suppliers and Home Health Agencies. We also are proposing, at § 424.205(b)(6), as a condition of enrollment, that MDPP suppliers must agree to revalidate their enrollment every 3 years, consistent with DMEPOS suppliers who are initially screened under “high” categorical risk screening level. While we believe that this approach is appropriate for MDPP suppliers, we welcome public comments on these proposals. Interested parties can learn more information on revalidation available on the CMS Web site at
We invite comment on the proposed risk level upon revalidation, as well as the frequency with which MDPP suppliers must revalidate their enrollment.
We are proposing that the following requirements would apply to records related to a MDPP supplier's compliance with the MDPP expanded model (codified at § 424.59(b), redesignated as amended at § 424.205(g)). We believe that these proposals will increase supplier recordkeeping accuracy, and clarify documentation retention requirements. Specifically, we are proposing that an MDPP supplier must:
• Provide to CMS or its contractors, 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 supplier's compliance with MDPP requirements, including the MDPP expanded model requirements for in-kind beneficiary incentive engagements found in § 424.210 in the event that the MDPP supplier chooses to offer such incentives to any MDPP beneficiary.
• Maintain all such books, contracts, records, documents, and other evidence for a period of 10 years from the last day of the MDPP beneficiary's receipt of MDPP services furnished by the MDPP supplier or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
++ CMS determines that there is a special need to retain a particular record or group of records for a longer period and notifies the MDPP supplier at least 30 calendar days before the normal disposition rate; or
++ There has been a dispute or allegation of fraud or similar fault, as defined at § 405.902, against the MDPP supplier, 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 believe these modifications increase the likelihood of operationalizing MDPP program integrity strategies that include audits, evaluations, inspections, or investigations, and that they provide additional clarity on documentation retention for ongoing program integrity. In addition, in the CY 2017 PFS established supplier requirements for documentation and recordkeeping (codified at § 424.59(b), proposed to be redesignated and amended at § 424.205(g). In this proposed rule, we are modifying these requirements to improve clarity. We are proposing at § 424.205(g)(1) and (g)(2) to require that documentation must be established contemporaneous to the furnished MDPP services, which we believe is important for accuracy. We are also proposing that for the initial core session, these records must include the following organizational information:
• The organizational name, CDC DPRP organization number, and organizational NPI;
• Basic beneficiary information including but not limited to beneficiary name, HICN, and age; and
• Evidence that each such beneficiary satisfied the eligibility requirements under § 410.79(c) at the time of service.
For each additional session, we propose that these records must include:
• Documentation of the type of session, whether a core session, a core maintenance session, an ongoing maintenance session, an in-person make-up session, or a virtual make-up session.
• Identification of which CDC-approved DPRP curriculum was associated with each session.
• The NPI of the coach who furnished the session.
• The date and place of service of the session.
• Each MDPP's beneficiary's weight and date weight taken, in a form and manner as specified by CMS.
We believe that this information will play an important role in documenting the provision of MDPP services and fidelity to the requirements established for the expanded model. Finally, at § 424.205(g)(3), we are proposing that MDPP suppliers must maintain and handle any beneficiary Personally Identifiable Information (PII) and Personal Health Information (PHI) in compliance with HIPAA, other state and federal privacy laws, and CMS standards. We believe these proposals will improve supplier recordkeeping accuracy and lessen the possibility of incomplete records and supplier recordkeeping variations.
We are inviting public comments on our proposed documentation and maintenance of records requirements, including whether additional or different requirements may provide better program integrity safeguards.
We believe that the MDPP expanded model would encourage MDPP suppliers to furnish high quality and engaging health behavior change services to MDPP beneficiaries that lead to improved beneficiary health and reductions in Medicare spending. We further believe that one mechanism that may be useful to the MDPP suppliers in achieving these goals would be allowing MDPP suppliers to furnish certain in-kind items and services to their MDPP beneficiaries during the core services period and ongoing services period (described at proposed § 410.79(c)(2)). Under such an approach, the costs of these beneficiary engagement incentives would be borne by the MDPP supplier. However, we believe that certain
We are proposing to establish the rules governing the furnishing of beneficiary engagement incentives to MDPP beneficiaries under the MDPP expanded model at new § 424.210. As discussed in section III.K.2.a. of this proposed rule, we are proposing that MDPP services would be available beginning on April 1, 2018. Therefore, because there would be no MDPP beneficiaries who could receive beneficiary engagement incentives from MDPP suppliers until on or after April 1, 2018, we are proposing that the effective date of § 424.210 would be April 1, 2018.
We are proposing that if an MDPP supplier offers an in-kind beneficiary engagement incentive, the item or service offered as an incentive must be furnished by an MDPP supplier to a MDPP beneficiary during the engagement incentive period. An engagement incentive period would begin when an MDPP supplier furnishes any MDPP service to an MDPP beneficiary. As proposed at § 424.210(a), the term “engagement incentive period” means the period of time during which an MDPP supplier may furnish in-kind beneficiary engagement incentives to a given MDPP beneficiary to whom the MDPP supplier is furnishing MDPP services. The engagement incentive period would end upon the earliest of the following: The beneficiary's MDPP services period ends (as specified in proposed § 410.79(c)(3)) for any reason; the MDPP supplier knows the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier; or the MDPP supplier has not had direct contact, either in person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period.
We are proposing that items and services may only be furnished as in-kind beneficiary engagement incentives during the engagement incentive period. This is to ensure that the flexibilities that MDPP suppliers would be afforded under these proposed regulations to furnish free items and services to Medicare beneficiaries only apply while the beneficiary is an MDPP beneficiary being offered MDPP services by that MDPP supplier. Once the MDPP beneficiary's engagement incentive period ends with an MDPP supplier, all existing laws and regulations would apply to the furnishing of free items and services to a Medicare beneficiary by the entity that is an MDPP supplier. Limiting the furnishing of beneficiary engagement incentives under the MDPP expanded model to the engagement incentive period with a particular MDPP supplier serves as a safeguard against the furnishing of free items and services to Medicare beneficiaries to steer them toward particular providers, suppliers, or other services, rather than to engage MDPP beneficiaries in healthy behavior changes that reduce their incidence of type 2 diabetes.
During the course of the MDPP services period, an MDPP beneficiary may begin and end multiple engagement incentive periods, and, to the extent feasible, the MDPP beneficiary would not be in more than one engagement incentive period at the same time. For example, where, after receiving MDPP services from MDPP supplier A, an MDPP beneficiary notifies MDPP supplier A that he or she has chosen to receive MDPP services from MDPP supplier B and subsequently receives MDPP services from MDPP supplier B, the first engagement incentive period ends when MDPP supplier A is told by the MDPP beneficiary that he or she will no longer attend MDPP services with MDPP supplier A. A new engagement incentive period begins when the MDPP beneficiary receives his or her first MDPP service from MDPP supplier B. Additionally, where an MDPP beneficiary begins an engagement incentive period with an MDPP supplier and the engagement incentive period has ended because the MDPP supplier has not had direct contact, either in person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for 90 consecutive days during the MDPP services period, should that MDPP beneficiary receive MDPP services from that MDPP supplier on day 100, a new engagement incentive period would begin.
These proposals for the definitions specific to beneficiary engagement incentives are included at proposed § 424.210(a). We are inviting public comments on these proposed definitions specific to furnishing in-kind beneficiary engagement incentives.
We are proposing, at § 424.210(b), that an MDPP supplier may choose to furnish items or services as in-kind beneficiary engagement incentives to an MDPP beneficiary only during the engagement incentive period, subject to a number of additional conditions as program safeguards. Under this proposal, the in-kind items and services furnished as beneficiary engagement incentives under the MDPP expanded model would not be Medicare-covered items or services.
We are proposing that the engagement incentive must be furnished directly by an MDPP supplier or by an agent of the MDPP supplier under the MDPP supplier's direction and control, such as a coach, to an MDPP beneficiary. As established in the § 410.79(b) in the CY 2017 PFS final rule, coach refers to an individual who furnishes MDPP services on behalf of an MDPP supplier as an employee, contractor, or volunteer. We considered whether this policy on beneficiary engagement incentives should extend to entities other than MDPP suppliers and their agents that may refer to or furnish MDPP services during an engagement incentive period.
However, given that MDPP suppliers maintain the responsibility to ensure the integrity of MDPP programs and would be best positioned to comply with beneficiary engagement incentive documentation and technology retrieval requirements proposed at § 424.210(e) and (c), respectively, we believe that they are best suited to furnished beneficiary engagement incentives. We are proposing that the item or service furnished as a beneficiary engagement incentive must be reasonably connected to the CDC-approved curriculum taught by an MDPP supplier to an MDPP beneficiary during a core session, a core maintenance session, or an ongoing maintenance session. For example, under this proposal, an MDPP supplier could furnish beneficiary engagement incentives such as gym memberships to reduce barriers associated with beneficiary achievement of physical activity recommended as part of the CDC-approved curriculum, but they could not furnish theater tickets, which would bear no reasonable connection to the CDC-approved curriculum. Similarly, MDPP suppliers may offer incentives such as onsite child care when the MDPP beneficiary attends MDPP services or transportation vouchers to the site of MDPP services that may reduce barriers to beneficiary attendance at MDPP services, but they could not furnish attendance awards such as movie tickets or retail gift cards, which would have no reasonable connection to the CDC-approved curriculum. Likewise, this proposal would allow MDPP suppliers to furnish equipment that is reasonably necessary for the curriculum being taught to the
We also are proposing that the beneficiary engagement incentive must be a preventive care item or service, or an item or service that advances a clinical goal for an MDPP beneficiary as described in section III.K.2.f.iv. of this proposed rule by engaging him or her in better managing his or her own health. This ensures that a relationship between the incentive and the goals of the MDPP expanded model exists so that the beneficiary engagement incentive is necessary for testing the expanded MDPP model. Under this proposed condition, we note that beneficiary engagement incentives may not be offered to an MDPP beneficiary as a reward for achievement of a specified outcome, such as losing weight or attending a certain number of sessions, unless the beneficiary engagement incentive meets all the proposed conditions, including that it is reasonably connected to the CDC-approved DPP curriculum furnished to the MDPP beneficiary during a core session, a core maintenance session, or an ongoing maintenance session by the MDPP supplier and that it is a preventive care item or service or it advances a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health. Furnishing in-kind patient engagement incentives upon achievement of an outcome may not advance a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health unless there are clinical goals that the incentive itself can continue to advance. We are further proposing that the item or service furnished as a beneficiary engagement incentive must not be tied to the receipt of items or services outside the MDPP services, and that the item or service must not be tied to the receipt of items or services from a particular provider, supplier, or coach. These provisions provide safeguards against the furnishing of in-kind beneficiary engagement incentives to steer beneficiaries toward certain providers, suppliers, or coaches for services outside MDPP services.
We note that in some circumstances, an item or service may be linked to an MDPP supplier and be offered to the MDPP supplier's MDPP beneficiaries as part of the CDC-approved curriculum that must be furnished during the MDPP services period, rather than being offered to steer the MDPP beneficiary to a particular provider, supplier, or coach. In these situations, we believe the item or service may be furnished as a beneficiary engagement incentive without violating the requirement that the item or service not be tied to the receipt of the items or services from a particular provider, supplier, or coach. For instance, where an MDPP supplier offers a gym membership as a beneficiary engagement incentive, we understand that the gym membership must be tied to a particular supplier of services so that the beneficiary can use the membership. However, in this case, the gym membership would be linked to the MDPP supplier that, in compliance with the curriculum that must be furnished during the MDPP services period, is teaching MDPP beneficiaries how to utilize a physical fitness regime to meet the MDPP goal of reducing an MDPP beneficiary's risk of developing diabetes, rather than being furnished to steer the MDPP beneficiary to a particular supplier. Therefore, we believe that gym memberships may be furnished as a beneficiary engagement incentive without violating the requirement that the item or service not be tied to the receipt of items or services from a particular provider, supplier, or coach as long as the gym membership is reasonably connected to the CDC-approved curriculum and not being furnished to steer the MDPP beneficiary to a particular supplier.
We are proposing that, in general, the availability of the items or services furnished as beneficiary engagement incentives must not be advertised or promoted as in-kind beneficiary engagement incentives available to an MDPP beneficiary receiving MDPP services from the MDPP supplier. However, an MDPP beneficiary may be made aware of the availability of the items or services at the time the MDPP beneficiary could reasonably benefit from them during the engagement incentive period. This condition provides a safeguard against the advertisement of in-kind patient engagement incentives to beneficiaries based on their perceived ability to meet the performance goals of attendance and weight loss as described at proposed § 414.84(a) and associated with the MDPP performance payments proposed at § 414.84(b). The proposed payment structure for MDPP services largely relies on the achievement of these performance goals. Therefore, advertising patient engagement incentives to encourage participation of MDPP-eligible beneficiaries most likely to meet the attendance and weight loss performance goals could produce financial gain for MDPP suppliers that is not related to the quality and efficacy of the MDPP supplier's MDPP services.
In addition, prohibiting the advertisement or promotion of in-kind beneficiary engagement incentives available to an MDPP beneficiary receiving MDPP services from the MDPP supplier except that an MDPP beneficiary may be made aware of the availability of the items or services at the time the MDPP beneficiary could reasonably benefit from them during the engagement incentive period provides a safeguard against using the incentive to steer a beneficiary toward a particular MDPP supplier. Beneficiaries would not be made aware of the availability of beneficiary engagement incentives until the MDPP beneficiary was in an engagement incentive period, which would begin when an MDPP supplier furnished its first MDPP service to the beneficiary. At that point in time, the beneficiary would have already selected that MDPP supplier to furnish his or her MDPP services so the incentive could not be used to steer the beneficiary to that MDPP supplier. We note that we do not intend for beneficiary engagement incentives proposed for the MDPP expanded model to alter an MDPP supplier's market share for an MDPP or non-MDPP item or service.
Finally, we are proposing that the cost of the items or services offered as in-kind beneficiary engagement incentives must not be shifted to another Federal health care program, as defined at section 1128B(f) of the Act. This requirement affirms that the cost of any beneficiary engagement incentive offered by an MDPP supplier is the sole responsibility of the MDPP supplier, and the furnishing of a beneficiary engagement incentive, for instance, must not result in increased payments to the MDPP supplier by Federal health care programs for other items or services.
These proposals for the general conditions for in-kind beneficiary engagement incentives are included at proposed § 424.210(b). We are inviting public comments on these proposed general conditions for furnishing beneficiary engagement incentives. In addition, we are inviting public
In some cases, items or services involving technology may be useful as beneficiary engagement incentives because they can advance a clinical goal of the MDPP expanded model by engaging an MDPP beneficiary in managing his or her health. However, we believe specific enhanced safeguards are necessary for these items and services to prevent abuse.
First, we are proposing that items or services involving technology furnished by an MDPP supplier to its MDPP beneficiary may not, in the aggregate, exceed $1,000 in retail value for any one MDPP beneficiary. We believe that this proposed limit is appropriate, in conjunction with our proposed enhanced requirements for items of technology with a retail value greater than $100 as discussed subsequently in this section. The proposed $1,000 limitation would allow sufficient MDPP supplier flexibility to furnish items or services involving technology as beneficiary engagement incentives to improve the likelihood of the beneficiary's achievement and maintenance of the required minimum weigh loss. The proposed limitation would not allow the furnishing of items of technology that in the aggregate constitute an excessively high value to the beneficiary that could increase the risk that the items of technology would not be in compliance with all of the proposed requirements for beneficiary engagement incentives.
For example, under this proposal, an MDPP beneficiary who begins receiving MDPP services from an MDPP supplier and who, after receiving MDPP services from that MDPP supplier, is furnished items or services of technology with a total retail value of $1,000 may not receive additional items or services of technology from that MDPP supplier. Therefore, an MDPP beneficiary may receive from a MDPP supplier a tablet valued at $700 that is preloaded with weight loss and fitness tracking apps that would support the beneficiary's weight loss goals under the MDPP expanded model and also receive from the same MDPP supplier a fitness tracking watch valued at $200 that uploads and monitors fitness data to the tablet, but he or she could not then receive additional items of technology from the MDPP supplier with an aggregate retail value greater than $100 as this would exceed the $1,000 limit.
In addition, if the same MDPP beneficiary chooses to receive MDPP services from another MDPP supplier, the subsequent supplier is under no obligation to determine the value of any items or services of technology furnished to the MDPP beneficiary by other MDPP suppliers, and may furnish items or services of technology to the MDPP beneficiary so long as those items or services furnished by the subsequent supplier are the minimum necessary to advance a clinical goal for the MDPP beneficiary, are furnished during the engagement incentive period, and do not, in aggregate, exceed $1,000 in retail value. We note that, while items of technology must be furnished to the MDPP beneficiary during an engagement incentive period, the $1,000 limit for items of technology that may be furnished to any one MDPP beneficiary by any one MDPP supplier is not otherwise affected by the engagement incentive period. For example, if an MDPP beneficiary begins and ends multiple engagement incentive periods with the same MDPP supplier as described in section III.K.2.f.i. of this proposed rule, the $1,000 limit for items of technology would not “reset” at the beginning of a new engagement incentive period with that MDPP supplier.
We are further proposing that items or services involving technology furnished to an MDPP beneficiary must be the minimum necessary to advance a clinical goal for MDPP beneficiaries as discussed in section III.K.2.f.iv. of this proposed rule.
We are proposing enhanced requirements for items of technology exceeding $100 in retail value as an additional safeguard against misuse of these items as beneficiary engagement incentives. We believe it would be inappropriate for MDPP suppliers 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 continue to receive MDPP services from that supplier, or to receive items or services from the supplier other than MDPP services. Therefore, we are proposing that items of technology with a retail value of over $100 would remain the property of the MDPP supplier and be retrieved from the MDPP beneficiary at the end of the engagement incentive period. We do not believe that this requirement would substantially increase the administrative burden on MDPP suppliers because a central facilitator of the success of an MDPP beneficiary in meeting MDPP performance goals is the MDPP supplier's ability to maintain contact with the MDPP beneficiary and engage him or her in MDPP services. We note that items of technology with a retail value of $100 or less could be furnished as beneficiary engagement incentives and would remain the property of the beneficiary. In the case of these items of a technology with a lower retail value, we believe the administrative burden of retrieving these items would outweigh the program integrity benefits of retrieval.
We are further proposing that the MDPP supplier must document all technology retrieval attempts, including the ultimate date of retrieval. However, because we understand that MDPP suppliers may not always be able to retrieve these items, such as when a beneficiary dies or moves to another geographic area, documented, diligent, good faith attempts to retrieve items of technology would be deemed to meet the retrieval requirement.
Our proposals for enhanced requirements for technology furnished to MDPP beneficiaries as beneficiary engagement incentives under the MDPP expanded model are included at proposed § 424.210(c). We are inviting public comments on our proposed requirements for beneficiary engagement incentives that involve technology and welcome comments on additional or alternative program integrity safeguards for this type of beneficiary engagement incentive, including whether the financial thresholds proposed in this section are reasonable, necessary, and appropriate.
As established at § 410.79(b) in the CY 2017 PFS final rule, MDPP services furnished to MDPP beneficiaries must follow a CDC-approved curriculum, which outlines required and recommended topics for structured health behavior change sessions offered as MDPP services with the goal of preventing diabetes through long-lasting health behavior change. MDPP suppliers seeking recognition under the CDC's DPRP must furnish either the CDC-preferred curriculum, based on the current evidence base, or may develop their own curriculum. MDPP suppliers who wish to develop their own curriculum must submit it to the CDC for approval. This requirement ensures that all curricula furnished to MDPP beneficiaries meet the DPRP's curriculum content requirements and are based on evidence from efficacy and effectiveness trials consistent with the current evidence base. To be consistent with the current evidence base, all curricula offered by MDPP suppliers must furnish MDPP services focused on the overarching goal of preventing type
Therefore, we are proposing that the following would be the clinical goals of the MDPP expanded model, which may be advanced through beneficiary engagement incentives:
• Beneficiary attendance at MDPP core sessions, core maintenance sessions, or ongoing maintenance sessions during the MDPP services period.
• Beneficiary weight loss.
• Long-term dietary change for the beneficiary.
• Beneficiary adherence to long-term health behavior changes.
We note that under this proposal, the MDPP supplier may not furnish multiple free meals or meal replacement services to an MDPP beneficiary over a substantial portion of the engagement incentive period because such a practice would not advance a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health.
When a beneficiary engagement incentive does not qualify as a preventive care item or service, our proposals for the clinical goals of the MDPP expanded model that a beneficiary engagement incentive must be intended to advance are included at proposed § 424.210(d). We are inviting public comments on our proposed clinical goals of the MDPP, as well as whether the advancement of additional or different clinical goals through beneficiary engagement incentives may better advance the overarching goals of the MDPP expanded model, while maintaining appropriate program integrity safeguards.
As a program safeguard against misuse of beneficiary engagement incentives under the MDPP expanded model, we are proposing that, in addition to the documentation requirements for MDPP suppliers at proposed § 424.205(g), MDPP suppliers must maintain documentation of items and services furnished as beneficiary engagement incentives that individually exceed $25 in retail value. We recognize that an MDPP beneficiary could receive many incentives that are each of low dollar value but in the aggregate constitute an excessively high value to the beneficiary. Therefore, we believe it is important to incorporate a documentation threshold at a modest level for all beneficiary incentives in order to monitor compliance with the proposed conditions for furnishing these items and services. Moreover, we believe the proposed $25 retail value threshold strikes an appropriate balance between beneficiary and program protections and MDPP supplier administrative burden.
In addition, we are proposing to require that the documentation must be established contemporaneously with the furnishing of the items and services and must include at least the date the incentive was furnished; the identity of the beneficiary to whom the item or service was furnished; the agent of the supplier who furnished the item or service if applicable; a description of the item or service; the retail value of the beneficiary engagement incentive; and documentation establishing that the item or service was furnished to the MDPP beneficiary during the engagement incentive period.
In addition to the proposed requirements in the previous paragraph, we are further proposing that the documentation regarding items or services furnished to the MDPP beneficiary for use on an ongoing basis during the engagement incentive period, including items of technology exceeding $100 in retail value, must also include contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary possesses or has access to the item or service furnished by the MDPP supplier. For example, if an MDPP supplier furnishes a gym membership to an MDPP beneficiary, the MDPP supplier must maintain contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary has access to the gym via the membership furnished by the MDPP supplier.
In addition to the above requirements, we are further proposing that the documentation regarding items of technology exceeding $100 in retail value that MSPP suppliers are required to retrieve from the MDPP beneficiary must also include contemporaneous documentation of any attempts to retrieve the item of technology furnished by the MDPP supplier from the MDPP beneficiary as required at proposed § 424.210(c)(3)(ii). We reiterate that under our proposal documented, diligent, good faith attempts to retrieve items of technology would be deemed to meet the retrieval requirement.
Finally, we are proposing that the MDPP supplier must retain and provide access to the required documentation in accordance with proposed § 424.205(g).
Table 35 summarizes the proposed documentation requirements for beneficiary engagement incentives under the MDPP expanded model.
Our proposals for the documentation requirements for beneficiary engagement incentives under the MDPP expanded model are included at proposed § 424.210(e). We are inviting public comments on our proposed documentation requirements, including whether additional or different documentation requirements may provide better program integrity safeguards.
Certain arrangements between MDPP suppliers and beneficiaries may implicate the civil monetary penalty (CMP) law (sections 1128A(a)(5), (b)(1) and (b)(2) of the Act), or the Federal Anti-kickback statute (section 1128B(b)(1) and (2) of the Act). In many cases, arrangements that implicate these laws can be structured to comply with them by using existing safe harbors and exceptions. Section 1115A(d)(1) of the Act authorizes the Secretary to waive certain specified fraud and abuse laws as may be necessary solely for purposes of testing of models under section 1115A(b) of the Act. A waiver is not needed for an arrangement that does not implicate the fraud and abuse laws or that implicates the fraud and abuse laws, but either fits within an existing exception or safe harbor, as applicable, or does not otherwise violate the law. Accordingly, pursuant to section 1115A(d)(1) of the Act, the Secretary will consider whether waivers of certain fraud and abuse laws are necessary for the MDPP expanded model. Such waivers, if any, would be promulgated separately from this proposed regulation by OIG (as to sections 1128A and 1128B of the Act), to which the respective authorities have been delegated.
The requirements in the final rule for the MDPP expanded model will bear on the need for and scope of any fraud and abuse waivers that might be granted for the model. Because of the close nexus between the final regulations governing the structure and operations of the MDPP expanded model and the development of any fraud and abuse waivers necessary to carry out the provisions of the model, CMS and OIG may, when considering the need for or scope of any waivers, consider comments submitted in response to this proposed rule and the provisions of the final rule.
The CDC's DPRP standards allow evidence-based DPP curricula to be furnished through a variety of modes, including through remote technologies. Similar to the description noted in section III.K.2.c.iv.3 with respect to virtual make-up sessions, virtual DPP refers to any modality, or method of furnishing MDPP services, that is not in person. This includes, but is not limited to:
(1) Furnishing services online where the behavior change program is furnished 100 percent online, with participants accessing course resources and lifestyle coach via a computer, laptop, tablet, smart phone, or other device with internet access. This modality requires an internet connection to participate in all aspects of the DPP;
(2) Furnishing services online with other means of support by a coach (for example, telecommunications, video conferencing). This modality requires an internet connection for some aspects of the DPP, but not all; and
(3) Distance learning, where a coach is present in one location and participants are calling, video-conferencing, or otherwise using telecommunications technology to access the coach from another location. This modality does not require any internet connection for any of the aspects of the DPP.
These types of delivery modes are hereafter referred to as “virtual,” and DPP furnished
We acknowledge that the public comments in response to the MDPP expanded model in the CY 2017 PFS proposed rule supported the inclusion of virtual DPP in the MDPP expanded model. Many commenters stated that this proposal would increase access to MDPP services, referenced emerging evidence that suggests virtual DPP may be as effective as DPP furnished in a community setting, and stated that virtual delivery may be preferable to some beneficiaries. In the CY 2017 PFS final rule, we deferred policies pertinent
We note that some DPP suppliers currently offer DPP services through a combination of in-person and virtual delivery. We only propose to allow this combination of delivery subject to the requirements on virtual make-up sessions discussed in section III.K.2.c.iv.3. The combined-delivery DPP services that are currently offered are intended to offer a participant DPP services through both online and in-person methods. The MDPP expanded model, in contrast, is intended to offer participants in-person DPP services primarily, but allows a limited number of virtual make-up sessions on an individual basis. As discussed in section III.K.2.c.iv.3., there is substantial research on the effectiveness of DPP furnished virtually, and emerging evidence on DPP delivered virtually suggests that virtual delivery can show similarly successful participant weight loss and health benefits to DPP delivered in other settings, including among Medicare-age participants. However, since the DPP model test only included in-person delivery, we propose to limit the number of virtually-delivered make-up sessions to the limits discussed in section III.K.2.c.iv.3.
An organization may furnish separate DPPs where some participants receive only in-person DPP services, others receive only virtual DPP services, and others receive a combination program where some sessions are offered in person and others virtually. If an organization that offers multiple distinct DPPs through different delivery modes enrolls as an MDPP supplier, we propose that only DPP services furnished in person will be paid in the MDPP expanded model, with the exception of virtual make-up sessions as discussed in section III.K.2.c.iv.3 of this proposed rule.
We invite public comments on these policies.
We intend to evaluate the MDPP expanded model using a combination of encounter and claims data to analyze the long-term utilization of services by beneficiaries who have received the MDPP benefit. As discussed in the CY 2017 PFS final rule, we will continue to assess whether the MDPP expanded model is expected to improve the quality of care without increasing spending, reduce spending without reducing the quality of care, or improve the quality of care and reduce spending, and we will terminate or modify the MDPP expanded model if the expanded model is not expected to meet these criteria.
Among other possible questions we might explore, our analysis will specifically look at long-term utilization and expenditures that might suggest subsequent treatment of diabetes. We intend to use beneficiary-level encounter data and program data furnished by CDC and will match these data to Medicare claims using the crosswalk finalized at § 424.59(b)(3) of the CY 2017 PFS final rule (proposed to be redesignated and amended at § 424.205(d)(13)). As with other Innovation Center model evaluation reports (which are currently published online at
CMS is committed to transforming the health care delivery system—and the Medicare program—by putting an additional focus on patient-centered care and working with providers, physicians, and patients to improve outcomes. We seek to reduce burdens for hospitals, physicians, and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. These are the reasons we are including this Request for Information in this proposed rule.
As we work to maintain flexibility and efficiency throughout the Medicare program, we would like to start a national conversation about improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families. We aim to increase quality of care, lower costs improve program integrity, and make the health care system more effective, simple and accessible.
We would like to take this opportunity to invite the public to submit their ideas for regulatory, subregulatory, policy, practice, and procedural changes to better accomplish these goals. Ideas could include payment system redesign, elimination or streamlining of reporting, monitoring and documentation requirements, aligning Medicare requirements and processes with those from Medicaid and other payers, operational flexibility, feedback mechanisms and data sharing that would enhance patient care, support of the physician-patient relationship in care delivery, and facilitation of individual preferences. Responses to this Request for Information could also include recommendations regarding when and how CMS issues regulations and policies and how CMS can simplify rules and policies for beneficiaries, clinicians, physicians, providers, and suppliers. Where practicable, data and specific examples would be helpful. If the proposals involve novel legal questions, analysis regarding CMS' authority is welcome for CMS' consideration. We are particularly interested in ideas for incentivizing organizations and the full range of relevant professionals and paraprofessionals to provide screening, assessment and evidence-based treatment for individuals with opioid use disorder and other substance use disorders, including reimbursement methodologies, care coordination, systems and services integration, use of paraprofessionals including community paramedics and other strategies. We are requesting commenters to provide clear and concise proposals that include data and specific examples that could be implemented within the law.
We note that this is a Request for Information only. Respondents are encouraged to provide complete but concise responses. This Request for Information is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. This Request for Information does not commit the U.S.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 35), we are required to publish a 60-day notice in the
To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our burden estimates.
• The quality, utility, and clarity of the information to be collected.
• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.
We are soliciting public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements (ICRs): (1) The Medicare Diabetes Prevention Program (MDPP) Expanded Model, (2) the Physician Quality Reporting System (PQRS), (3) appropriate use criteria for advanced diagnostic imaging services, and (4) the Medicare Shared Savings Program.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2016 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
In §§ 410.79, 414.84, 424.200, 424.205, 424.210, 424.502, 424.516, 424.518 and 424.55 of this proposed rule, we discuss our proposals to further implement the Medicare Diabetes Prevention Program (MDPP) Expanded Model, which is aimed at preventing the onset of type 2 diabetes among Medicare beneficiaries with prediabetes. Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the MDPP expanded model, from the provisions of the PRA. Specifically, this section provides that the provisions of the PRA shall not apply to the testing and evaluation of Innovation Center models or expansions of such models.
While this rule proposes to revise our PQRS reporting criteria for the 2016 reporting period to avoid the 2018 payment adjustment, we are not proposing to accept any additional data for the 2016 reporting period. In this regard this rule does not set out any new or revised burden or requirements that would trigger the requirements of the PRA.
This rule proposes to revise § 414.94(i)(3) by reiterating the availability of a significant hardship exception for ordering professionals who demonstrate a significant hardship consistent with the criteria listed under § 495.102(d)(4)(i), (d)(4)(iii), (d)(4)(iv)(A) or (d)(4)(iv)(B). Consistent with a final rule that published on November 14,
Consistent with section 1834(q)(4)(A) of the Act (as amended by section 218(b) of the PAMA), § 414.94(j) proposes to require that ordering professionals consult specified applicable AUC through a qualified clinical decision support mechanism (CDSM) for applicable imaging services ordered on or after January 1, 2019. We propose a one-time burden associated with a possible 6-month voluntary consulting period beginning sometime in 2018, as well as a mandatory annual burden beginning January 1, 2019. Because general practitioners are the largest group of practitioners who order applicable imaging services and would be required to consult AUC under this program we use “family and general practitioner” for our estimates below.
During the 6-month voluntary participation period, we estimate 3,410,000 responses in the form of consultations based on market research from current applicants for the qualification of their CDSMs for advanced diagnostic imaging services. Based on feedback from CDSMs with experience in AUC consultation as well as standards recommended by the Office of the National Coordinator (ONC) and the Healthcare Information Management Systems Society (HIMSS), we estimate it would take 2 minutes at $193.08/hr for a family and general practitioner to use a qualified CDSM to consult specified applicable AUC. Per consultation, we estimate 2 minutes (0.033 hr) at a cost of $6.37 (0.033 hr × $193.08/hr). In aggregate, we estimate a one-time burden of 112,530 hours (0.033 hr × 3,410,000 consultations) at a cost of $21,727,292.40 (112,530 hr × $193.08/hr).
Annually, we estimate 37,510 hours (112,530 hr/3 yr) at a cost of $7,242,430.80 ($21,727,292.40/3 yr). We are annualizing the one-time burden (by dividing our estimates by OMB's 3-year approval period) since we do not anticipate any additional burden after the 6-month voluntary participation period ends.
Beginning January 1, 2019, we anticipate 43,181,818 responses in the form of consultations based on the aforementioned market research, as well as Medicare claims data for advanced diagnostic imaging services. As noted above, we estimate it would take 2 minutes (0.033 hr) at $193.08/hr for a family and general practitioner to use a qualified CDSM to consult specified applicable AUC. In this regard, we estimate 0.033 hours per consultation at a cost of $6.37 (0.033 hr × $193.08/hr). In aggregate, we estimate an annual burden of 1,425,000 hours (0.033 hr × 43,181,818 consultations) at a cost of $275,139,000 (1,425,000 hr × $193.08/hr).
The consultation requirements and burden will be submitted to OMB for approval under control number 0938-New (CMS-10654).
Consistent with section 1834(q)(4)(B) of the Act, we are also proposing to implement a one-time 6-month voluntary reporting period beginning sometime in 2018, as well as a mandatory annual reporting requirement beginning January 1, 2019. Specifically, § 414.94(k) proposes to require that furnishing professionals report on the Medicare claims for advanced diagnostic imaging services, paid for under an applicable payment system (as defined in § 414.94(b)) and ordered on or after January 1, 2019, the following information: (1) Identify which qualified CDSM was consulted by the ordering professional; (2) identify whether the service ordered would adhere to specified applicable AUC, would not adhere to specified applicable AUC, or whether specified applicable AUC was not applicable to the service ordered; and (3) identify the NPI of the ordering professional (if different from the furnishing professional). The proposed reporting requirement would not have any impact on any Medicare claim forms because the forms' currently approved data fields, instructions, and burden are not expected to change. Consequently, there is no need for review by OMB under the authority of the PRA.
The timing and implementation of the voluntary consultation and reporting period is dependent on the readiness of the Medicare claims systems to accept and process claims including AUC consultation information. Currently, 99 percent of all Medicare claims are submitted electronically as a result of The Administrative Simplification Compliance Act amendment to section 1862(a) of the Act, which prescribes that no payment may be made under Part B of the Medicare Program for any expenses incurred for items or services for which a claim is received in a non-electronic form. Consequently, absent an applicable exception, paper claims received by Medicare will not be paid. Continued developments in the deployment of CDSMs has produced research
Section 1899(e) of the Act provides that chapter 35 of title 44 of the U.S. Code, which includes such provisions as the PRA, shall not apply to the Shared Savings Program.
We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS' Web site at Web site address at
We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the
See the
Because of the large number of public comments we normally receive on
This proposed rule makes payment and policy changes under the Medicare PFS and makes required statutory changes under the MACRA, ABLE, PAMA, and the Consolidated Appropriations Act of 2016. This final rule also makes changes to payment policy and other related policies for Medicare Part B, Part D, and Medicare Advantage.
We examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), 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), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
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). 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, as discussed in this section, that the PFS provisions included in this final rule would redistribute more than $100 million in 1 year. Therefore, 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 prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details see the SBA's Web site at
The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.
Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities.
For example, the effects of changes to payment rates for practitioners, other providers, and suppliers are discussed in VI.C. of this proposed rule. Alternative options considered to the proposed payment rates are discussed generally in section VI.F of this proposed rule, while specific alternatives for individual codes are discussed throughout this rule, especially in section II.H.
In addition, section 1102(b) of the Act requires us to prepare an RIA if a 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, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We did not prepare an analysis for section 1102(b) of the Act because we
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on state, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2017, that threshold is approximately $148 million. This proposed rule will impose no mandates on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This proposed rule is subject to the requirements of E.O. 13771 because, if finalized as proposed, it is expected to result in regulatory costs.
We prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this proposed rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this proposed rule, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services, and implementing statutory provisions. We provide information for each of the policy changes in the relevant sections of this proposed rule. We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this proposed rule. The relevant sections of this proposed rule contain a description of significant alternatives if applicable.
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare expenditures for PFS services compare payment rates for CY 2017 with proposed payment rates for CY 2018 using CY 2016 Medicare utilization. The payment impacts in this proposed rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and would depend on the mix of services he or she furnishes. The average percentage change in total revenues would be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule.
The annual update to the PFS conversion factor (CF) was previously calculated based on a statutory formula; for details about this formula, we refer readers to the CY 2015 PFS final rule with comment period (79 FR 67741 through 67742). Section 101(a) of the MACRA repealed the previous statutory update formula and amended section 1848(d) of the Act to specify the update adjustment factors for calendar years 2015 and beyond. For CY 2018, the specified update is 0.5 percent before applying other adjustments.
Section 220(d) of the PAMA added a new paragraph at section 1848(c)(2)(O) of the Act to establish an annual target for reductions in PFS expenditures resulting from adjustments to relative values of misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act, if the net reduction in expenditures for the year is equal to or greater than the target for the year, reduced expenditures attributable to such adjustments shall be redistributed in a budget-neutral manner within the PFS in accordance with the existing budget neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act. Section 1848(c)(2)(O)(iii) of the Act specifies that, if the estimated net reduction in PFS expenditures for the year is less than the target for the year, an amount equal to the target recapture amount shall not be taken into account when applying the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act. We estimate the CY 2018 net reduction in expenditures resulting from adjustments to relative values of misvalued codes to be 0.31 percent. Since this amount does not meet the 0.5 percent target established by the Achieving a Better Life Experience Act of 2014 (ABLE) (Division B of Pub. L. 113-295, enacted December 19, 2014), payments under the fee schedule must be reduced by the difference between the target for the year and the estimated net reduction in expenditures, known as the target recapture amount. As a result, we estimate that the CY 2018 target recapture amount will produce a reduction to the conversion factor of −0.19 percent.
To calculate the proposed conversion factor for this year, we multiplied the product of the current year conversion factor and the update adjustment factor by the target recapture amount and the budget neutrality adjustment described in the preceding paragraphs. We estimate the CY 2018 PFS conversion factor to be 35.9903, which reflects the budget neutrality adjustment, the 0.5 percent update adjustment factor specified under section 1848(d)(18) of the Act, and the −0.31 percent target recapture amount required under section 1848(c)(2)(O)(iv) of the Act and described above. We estimate the CY 2018 anesthesia conversion factor to be 22.0353, which reflects the same overall PFS adjustments, as well as an additional adjustment due to an update to the malpractice risk factor for the anesthesia specialty.
Table 40 shows the payment impact on PFS services of the proposals contained in this proposed rule. To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues would be different from those shown in Table 40 (CY 2018 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 40.
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The most widespread specialty impacts of the final RVU changes are generally related to the changes to RVUs for specific services resulting from the Misvalued Code Initiative, including finalized RVUs for new and revised codes. The estimated impacts for some specialties, including behavioral health specialists, physical and occupational therapists, and radiation oncology, reflect increases relative to other physician specialties. These increases can largely be attributed to proposed increases in value for particular services following the American Medical Association Relative Value Update Committee and CMS review, the proposed change in allocation of indirect practice expense RVUs for office-based, face-to-face behavioral health services, and proposed changes based on updated professional liability premium data.
The estimated impacts for several specialties, including diagnostic testing facilities, allergy/immunology, otolaryngology, oral/maxillofacial surgery, and independent laboratories, reflect decreases in payments relative to payment to other physician specialties as a result of proposed revaluation of individual procedures reviewed by the American Medical Association Relative Value Update Committee and CMS, proposed changes based on updated professional liability premium data, proposed decreases in relative payment as a result of proposed updates to prices for particular medical supplies, and continued implementation of previously finalized code-level reductions that are being phased-in over several years. For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the Clinical Laboratory Fee Schedule. As a result, the estimated 2 percent reduction for CY 2018 is only applicable to approximately 17 percent of the Medicare payment to these entities.
We often receive comments regarding the changes in RVUs displayed on the specialty impact table, including comments received in response to the proposed rates. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes. The percentages in the table are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. They are therefore averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty.
Column F of Table 40 displays the estimated CY 2018 impact on total allowed charges, by specialty, of all the RVU changes. A table shows the estimated impact on total payments for selected high volume procedures of all
As discussed in section II.D. of this proposed rule, we are proposing to add several new codes to the list of Medicare telehealth services. Although we expect these changes to have the potential to increase access to care in rural areas, based on recent telehealth utilization of services already on the list, including services similar to the proposed additions, we estimate no significant impact on PFS expenditures from the proposed additions. For example, for services already on the list, they are furnished via telehealth, on average, less than 0.1 percent of the time they are reported overall.
As discussed in section II.G of this proposed rule, for CY 2018, we are proposing a PFS Relativity Adjuster of 25 percent, meaning that nonexcepted items and services furnished by nonexcepted PBDs would be paid under the PFS at a rate that is 25 percent of the OPPS rate. We estimate that this change will result in total Medicare Part B savings of $25 million for CY 2018 relative to maintaining the CY 2017 PFS Relativity Adjuster for CY 2018.
As discussed in section III.A of this proposed rule, we are proposing the establishment of two new G codes for use by RHCs and FQHCs. The first new G code would be a General Care Management code for RHCs and FQHCs with the payment amount set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes. The second new G code for RHCs and FQHCs would be a Psychiatric CoCM code with the payment amount set at the average of the 2 national non-facility PFS payment rates for psychiatric CoCM services. The payment rate for each code would be updated annually, based on the national non-facility PFS payment rates for each code contained in the G code.
The proposed methodology for payment of care coordination services is consistent with the RHC and FQHC payment principles of not paying for services based on time increments. It does not create additional reporting burden and is expected to promote beneficiary access to comprehensive care management services furnished by RHCs and FQHCs.
Establishment of the RHC and FQHC General Care Management code, which includes all levels of CCM and general BHI services, is projected to increase Medicare spending by $600,000 in CY 2018 and by $7.4 million over 10 years. This estimate is based on the proposed per service allowed charge increase (from approximately $42.71 to $61.37) applied to historical 2016 CCM and BHI volume in RHCs and FQHCs. This volume was adjusted with an assumed 10 percent behavioral volume increase to reflect the increase in allowed charges per service.
Establishment of the RHC and FQHC Psychiatric CoCM code, which includes all levels of psychiatric CoCM services, is projected to increase Medicare spending by approximately $100,000 in CY2018 and $3.7 million over 10 years. Because psychiatric CoCM is not billable currently by RHCs or FQHCs and is also new to practitioners billing under the PFS, this estimate is based on first quarter 2017 PFS psychiatric CoCM claims of 0.03 percent of psychiatric E/M visits, adjusted to an ultimate average rate of 0.16 percent based on the pattern of increase in CCM services in the PFS found in the first two years of implementation. This rate was then applied to the number of 2016 RHC and FQHC mental health visits to get an estimate of CoCM volume, and then projected forward on a per-capita basis. PFS price updates were applied to the initial approximate $135 psychiatric CoCM payment amount to project future costs.
The combined increase in Medicare spending for both new G codes is estimated to be approximately $600,000 in 2018, and approximately $11.1 million over 10 years. While these services are expected to increase quality and improve efficiency over time, the programs are still new and the data is not available yet to demonstrate any cost savings. Therefore, no healthcare cost reductions were assumed as a result of increased care management.
As discussed in section III.A. of this proposed rule, we considered 3 other options (for example, allowing any of the 7 codes to be separately added to a claim, bundling all 7 codes into one G code, and developing 3 separate G codes—one each for CCM, BHI, and CoCM services). We estimate that there would be no significant difference in the costs among the options because all of the options considered include the same services paid at the same rate and no data is available to estimate a different rate of billing for each code.
As discussed in section III.B. of this proposed rule, we proposed to conform the regulation text at § 414.904(e)(2) to section 5004 of the Cures Act, which transitioned payment for DME infusion drugs from AWP-based pricing to the ASP-pricing methodology on January 1, 2017. Table 43 shows the effect of changes in drug payments to DME suppliers. We estimate adoption of the ASP+6 pricing methodology will result in total Medicare Part B savings ranging over the 10-year period from $40 million in FY 2017 to $110 million in FY 2026 with a 10-year total Medicare Part B savings of $960 million.
We are proposing and requesting public comment on the appropriate use criteria (AUC) consulting and reporting requirements and the effective date on which these requirements will begin. We are also proposing modifications to the significant hardship exception to better align these exceptions under the AUC program with those under existing quality programs. In the COI section of this document, we have estimated the proposed consulting requirement to result in an annual burden of 1,425,000 hours at a cost of $275,139,000. Under these proposals, claims for advanced diagnostic imaging services would not be denied in CY 2018, and thus, these proposals would not impact CY 2018 physician payments under the PFS. The Congressional Budget Office estimates that section 218 of the PAMA would save approximately 200 million dollars over 10 years from FY 2014 through 2024, which could be the result of identification of outlier ordering professionals. Because we have not yet proposed a mechanism or calculation for outlier ordering professional identification and prior authorization, we are unable to quantify that impact at this time. We will provide an impact statement when applicable in future rulemaking.
We previously discussed the burden estimate for PQRS regarding the program year 2016 reporting criteria, which applies to the 2018 payment adjustment in the CY 2016 PFS final rule (see 80 FR 71362 through 71367). The burden estimates for reporting that data have not changed since these data for program year 2016 PQRS have already been reported; therefore, there are no added burden estimates for the proposed policy change in this rule in section III.F.
Amending the policy to reduce the amount of measures needed to satisfactorily report to avoid the 2018 payment adjustment from 9 measures across 3 NQS domains to 6 measures (see section III.F. of this proposed rule) would increase the amount of satisfactory reporters for the 2016 reporting period, which would decrease those subject to the 2018 payment adjustment. Using data from the 2015 reporting period as the basis for our estimates, there were roughly 525,000 eligible professionals who failed the PQRS reporting requirements for the 2015 reporting period and received a downward payment adjustment in 2017 (see
Based on the estimated average payment adjustment of $937.02 in program year 2015, which was negative 2 percent based on 2015 PFS charges, an estimated ($937.02 × 23,625 = $22,137,097.50) would be the amount EPs would receive as a result of not being subject to the 2018 payment adjustment due to the proposed measure reduction policy in this rule for PQRS program year 2016, which applies to the 2018 payment adjustment.
We are proposing certain modifications to our rules regarding ACO assignment and financial calculations, quality measures and quality validation audits, TIN overlaps, and application requirements. Specifically we are proposing: (1) Modifications to how services furnished by FQHCs and RHCs are used for purposes of beneficiary assignment to an ACO as a result of the 21st Century Cures Act, including reducing reporting burden for ACOs that include FQHCs and RHCs; (2) modifications to the assignment methodology to include new chronic care management and behavioral health integration codes in our definition of primary care services; (3) a policy to improve the quality validation audit process and, absent unusual circumstances, to use the results to proportionally modify an ACO's overall quality score; (4) a policy to address substantive changes to quality measures made under the Quality Payment Program; (5) revisions to our application requirements to reduce burden for ACO applicants seeking to participate in the Shared Savings Program and for ACOs applying to use the SNF 3-Day Rule Waiver; (6) changes to our program rules to address compliance with our ACO participant TIN overlap policies, specifically, to address situations in which overlapping ACO participant TINs begin billing for services that are used in beneficiary assignment during a benchmark or performance year; and (7) a policy to use final beneficiary identifiable non-claims based payments in establishing benchmarks and performing financial reconciliation.
Each of these proposed policies is generally expected to have a minimal impact on affected ACOs. We do not anticipate any overall impact for these proposed policies because potential individual ACO impacts are more likely to offset one another rather than build to a substantial total in terms of costs or savings.
Section 1848(p) of the Act requires that we establish a value-based payment modifier (VM) and apply it to specific physicians and groups of physicians the Secretary determines appropriate starting January 1, 2015, and to all physicians and groups of physicians by January 1, 2017. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. Budget-neutrality means that, in aggregate, the increased payments to high performing physicians and groups equal the reduced payments to low performing physicians and groups, as well as those physicians and groups that failed to meet the criteria to avoid the PQRS payment adjustment as a group or as individuals.
In the CY 2016 PFS final rule with comment period (80 FR 71277 and 71279), we established that, beginning with the CY 2018 payment adjustment period, the VM will apply to nonphysician EPs who are physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs), and certified registered nurse anesthetists (CRNAs) in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo practitioners.
In CY 2018, the VM will be waived for groups and solo practitioners, as identified by their TIN, if at least one EP who billed for Medicare PFS items and services under the TIN during 2016 participated in the Pioneer ACO Model, the Comprehensive Primary Care initiative, Next Generation ACO Model, the Oncology Care Model, and the Comprehensive ESRD Care Initiative in 2016 (80 FR 71286 through 71288).
In the CY 2016 PFS final rule with comment period (80 FR 71280), we adopted a two-category approach for the CY 2018 VM based on participation in the PQRS by groups and solo practitioners. For the purposes of the CY 2018 VM, Category 1 represents those groups and solo practitioners subject to
In section III.I. of this proposed rule, we are proposing to reduce the CY 2018 VM payment adjustment amount for groups and solo practitioners in Category 2. We proposed to reduce the automatic payment adjustment from −4.0 percent to −2.0 percent for Physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician and from −2.0 percent to −1.0 percent for Physicians, PAs, NPs, CNSs, and CRNAs in groups of 2 or more EPs, PAs, NPs, CNSs, and CRNAs in groups comprised solely of non-physician EPs and physician and non-physician solo practitioners.
Additionally, in section III.I. in this proposed rule, we are proposing that, under quality-tiering, which is the methodology for evaluating performance on quality and cost measures for the VM, there will be no downward adjustments for groups or solo practitioners in Category 1 for the VM for CY 2018. We are also proposing to reduce the maximum upward adjustment under the quality-tiering methodology in CY 2018 for physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician that are Category 1 from four times an adjustment factor (+4.0x) to two times an adjustment factor (+2.0x) for those classified as high quality/low cost and from two times an adjustment factor (+2.0x) to one times an adjustment factor (+1.0x) for those classified as either average quality/low cost or high quality/average cost. This proposal aligns the upward adjustment for groups of 10 or more EPs with those previously finalized for smaller groups and solo practitioners, as well as groups comprised solely of non-physician EPs and provides a smoother transition to MIPS by bringing the incentives in line with those in the first year of the MIPS.
Under the quality-tiering methodology, each group and solo practitioner's quality and cost composites will continue to be classified into high, average, and low categories depending upon whether the composites are at least one standard deviation above or below the mean and statistically different from the mean. We will compare their quality of care composite classification with the cost composite classification to determine their VM adjustment for the CY 2018 payment adjustment period according to the amounts in Table 44.
Under the quality-tiering methodology, for groups and solo practitioners that participated in a Shared Savings ACO that successfully reports quality data for CY 2016, the cost composite will be classified as “Average” and the quality of care composite will continue to be based on ACO-level quality measures. We will compare their quality of care composite classification with the “Average” cost composite classification to determine their VM adjustment for the CY 2018 payment adjustment period. For groups and solo practitioners that participate in a Shared Savings Program ACO that did not successfully report quality data for CY 2016 and are Category 1 as a result of quality data reported to the PQRS outside of the ACO, the quality and cost composites will continue to be classified as “Average”.
To ensure budget neutrality, we first aggregate the automatic downward payment adjustments of −1.0 percent or −2.0 percent for groups and solo practitioners subject to the VM that fall within Category 2. Using the aggregate downward payment adjustment amount, we then calculate the upward payment adjustment factor (x). Additionally, as we have done when calculating the upward payment adjustment factor for the 2017 VM, we will also incorporate adjustments made for estimated changes in physician behavior (that is, changes in the volume and/or intensity of services delivered and shifting of services to TINs that receive higher VM adjustments) and estimated impact of pending PQRS and VM informal reviews. These calculations will be done after the performance period has ended and announced around the start of the payment adjustment year after the informal review period ends.
At the time of this proposed rule, we have not completed the analysis of the impact of the VM in CY 2018 on physicians and non-physicians in groups of 2 or more EPs and physician and non-physician solo practitioners based on performance in 2016. However, preliminary estimates indicate that the implementation of the proposed policies discussed above, would reduce the adjustment factor to below 10 percent. In the CY 2018 PFS final rule, we will present the number of groups and solo practitioners that will be subject to the VM in CY 2018.
We are soliciting comments on these HCPCS codes. Our intention is to collect the codes beginning January 2018, and our plan not to tie the collection of the codes with payment until we are sure clinicians have gained ample experience and education in using these modifiers. Therefore, there is no impact to CY 2018 physician payments under the PFS. There may be a burden associated with clinicians and their administrative staff having to learn which codes to use and how to submit them properly.
In section III.K of the preamble of this proposed rule, we discuss our proposals to further implement the MDPP expanded model under the authority of section 1115A of the Act, which authorizes the Innovation Center 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 CHIP beneficiaries. The MDPP expanded model was established in the November 15, 2016 MDPP final rule as an additional preventive service with a model effective date of January 1, 2018. Many of the policies for the MDPP expanded model were deferred to future rulemaking and, therefore, are being proposed in this rule. On March 14, 2016, the Office of the Actuary (OACT) published a certification memorandum setting out the conditions for expansion of the Medicare Diabetes Prevention Program (MDPP). Prior to its implementation, OACT is required to review the parameters of the MDPP expansion and provide an updated certification. This regulatory impact assessment is not an updated certification; rather, it is based on estimates of the proposed rule.
Diabetes affects more than 25 percent of Americans aged 65 or older and its prevalence is projected to increase approximately two-fold for all U.S. adults (ages 18-79) by 2050 if current trends continue.
The MDPP expanded model is expected to have a positive impact on beneficiaries' health that will generally lead to reduced beneficiary spending on Part A, Part B, and Part D health care services over time due to a reduced need for Part A, Part B, and Part D services. As a new preventive service, the MDPP services are available to eligible Medicare beneficiaries without cost-sharing. The CDC estimates that approximately 50 percent of adults aged 65 and over living in the United States have prediabetes
To arrive at our participation estimate we developed projections for pent-up demand and ongoing demand. To develop the projection for pent-up demand we first analyzed data from the CDC National Diabetes Prevention Recognition Program (DPRP). Specifically, we analyzed State-by-State DPRP in-person utilization for ages 65 or older in 2015. Because the Health Care Innovation Award (HCIA) MDPP model test was still serving beneficiaries during this period, and the HCIA DPP suppliers are also part of the DPRP, we used its enrollment data to inform what Medicare beneficiary participation may look like when Medicare pays for MDPP. Given that HCIA participation seemed to drive most of the DPRP participation in an HCIA supplier's region, we determined that a well-defined HCIA region would be a reasonable proxy for the rest of the nation. We found the state with the highest HCIA saturation, and calculated the percentage of fee for service beneficiaries that received services from a DPRP DPP. This percentage was applied to all fee for service beneficiaries nationwide in order to get a national pent-up demand estimate. We added this pent-up demand to a stable level of demand based on the number of new beneficiaries utilizing the obesity management benefit each year. Given the limited nationwide Medicare DPP participation data, there is a great amount of uncertainty in these estimates.
We believe that the eligibility criteria for continued participation in the set of MDPP services incentivizes beneficiaries to lose 5-percent body weight from baseline. Beneficiaries are incentivized to lose weight because continued eligibility for the services benefit after the first 12 months is contingent upon achieving 5-percent weight loss and the set of MDPP services is a once per lifetime set of services. In addition to prevention of type 2 diabetes, we believe participating beneficiaries would likely receive other possible health benefits including prevention of obesity for those who are overweight upon receiving MDPP services, prevention of sleep apnoea, and reduced risk for heart disease, coronary artery disease and stroke.
Currently, more than 1,200 organizations nationally are providing DPP services with some level of recognition through the CDC. Service delivery is primarily to individuals with private or employer-sponsored insurance, as well as some Medicare Advantage plans. The majority of existing DPP organizations are not enrolled in the Medicare program. We anticipate that the addition of MDPP services as new preventive services in Medicare would result in growth in the market, including growth in the number of individuals served per year by existing DPP suppliers, as well as the introduction of new suppliers into the market. There are burdens associated with obtaining CDC recognition and enrolling into Medicare as an MDPP supplier. There is also burden associated with submitting claims to Medicare for payment. Below we have provided an estimate of the financial burden to suppliers.
To derive average costs for use throughout the subsequent sections, we used data from the U.S. Bureau of Labor Statistics' May 2015 National Occupational Employment and Wage Estimates for all salary estimates (
Our proposals under proposed § 424.205 would provide that an entity is eligible to enroll in Medicare as an MDPP supplier if it has MDPP interim preliminary recognition, as determined by CMS. In order to receive MDPP interim preliminary recognition, we are proposing that the entity must have pending CDC recognition and must submit a full 12 months of data on at least one completed cohort of participants to CDC. In order to receive pending recognition from CDC, organizations are required to submit an application for recognition to CDC and agree to CDC's curriculum, duration and intensity requirements. CMMI plans to engage CDC's services to assist CMMI in administering its interim preliminary recognition standard, if finalized. CMMI would make the final determination of which entities qualify to receive interim preliminary recognition.
The burden associated with the preceding requirements is the time for MDPP staff to: submit an application for pending recognition to CDC and then collect and submit a full 12 months of data (including session attendance, body weight documentation, physical activity minutes documentation, and weight loss achieved) on at least one completed cohort of participants to CDC for the purposes of being evaluated for interim preliminary recognition.
We estimate that it will take a medical records and health information technician 12 hours, at $38.88/hour to collect and report these data for one cohort of participants, and an office or administrative worker 1 hour, at $31.54/hour, to complete the CDC application for pending recognition. The estimated cost per supplier to achieve interim preliminary recognition is $498.10.
Our proposals under proposed revised § 424.59 (proposed in this rule to be redesignated at § 424.205) would require that an MDPP supplier must certify in its enrollment application, which is a new Medicare enrollment application that we are creating specific to MDPP suppliers, and that it meets a set of standards. As this new enrollment application is being created specifically for the MDPP expanded model, we have determined that it is exempt from the Paperwork Reduction Act in accordance with section 1115A(d)(3) of the Act. We estimate that it will take an office or administrative support worker 3 hours, at $31.54/hour, to complete the MDPP supplier enrollment application using the internet-based Provider Enrollment,
We also note that access to the HIPAA Eligibility Transaction System (HETS), which a supplier could use to check factors of eligibility for the MDPP services, including the beneficiary's Part B eligibility and whether the beneficiary has received coverage for end-stage renal disease (ESRD) is free to suppliers, as long as they are active Medicare fee-for-service providers or suppliers in PECOS.
Suppliers also would be required to maintain documentation of all beneficiary contact regarding complaints or questions, as specified in proposed § 424.205(d)(11), and maintain and submit to CMS a crosswalk file which indicates how participant identifications for the purposes of CDC performance data correspond to Medicare Beneficiary Identifiers (that is, beneficiary health insurance claims numbers) for each beneficiary receiving MDPP services. We estimate that creating and maintaining documentation of beneficiary contact regarding complaints or questions will take an office or administrative support worker 1 hour, at $31.54/hour, per complaint or question request to create and maintain documentation of the request. We have no way to estimate how many complaints or questions MDPP suppliers will receive from beneficiaries, and we expect that may differ based on many factors, so have not included an overall cost in this burden estimate. Further, we estimate that it will take an office and administrative support worker approximately 4 hours, at $31.54/hour, to create and submit the crosswalk file for a cohort of 100 beneficiaries participating in the MDPP services, for a total cost of $126.16 per cohort of 100 beneficiaries. The crosswalk is proposed to be submitted quarterly. Therefore, for a year of delivering the set of MDPP services the estimated total cost to create and submit the crosswalk file would be $504.64 per cohort of 100 beneficiaries. We believe the incremental costs to meet this requirement would decrease with the addition of beneficiaries to a cohort, because the work and time to establish the file and submit it would be the same for a cohort of 100 and a cohort of 1000. What would be different is the collection of the information from the beneficiaries, and the addition of these data points to the file. We estimate that, for every additional 100 beneficiaries added to the file, the office and administrative support worker would add 1 hour, at $31.54/hour. We estimate the total incremental cost over 1 year for each additional 100 beneficiaries above the cohort of 100 beneficiaries is $126.16.
Our proposals under proposed § 424.205 also would require that suppliers meet a set of standards that includes maintaining a physical facility on an appropriate site and maintain a primary business telephone that is operating at the appropriate site. Because we have no way to estimate how many beneficiaries each MDPP supplier may provide the set of MDPP services to, and we expect this will differ based on many factors, including but not limited to the size of the supplier, the number of coaches the supplier employs, the physical space the supplier uses to furnish MDPP services, and the supplier's geographic location, we have not included an overall cost for these requirements in this burden estimate.
Our proposals under proposed § 414.84 specify the proposed payments MDPP suppliers may be eligible to receive for furnishing MDPP services and meeting performance targets related to beneficiary weight loss and/or attendance. MDPP suppliers would be paid by CMS by submitting claims for MDPP beneficiaries using claim form CMS-1500 (
The set of MDPP services is an optional set of services for beneficiaries who meet the eligibility requirements described elsewhere in the proposed rule. MDPP services will be furnished by a new provider type in Medicare. The CDC recognizes DPPs nationwide; these programs effectively deliver lifestyle-changing services that reduce the incidence of type 2 diabetes. The number of CDC-recognized DPPs is growing rapidly, increasing by nearly 90 percent from September 2015 to March 2017. The historical participation rate suggests that the vast majority of these providers are not serving a significant volume of new participants, aside from those served in the DPP model test.
This estimate is based on the initial methodology used for the estimate of the MDPP expanded model as set out in the certification memorandum, but with differences in several program features including the payment parameters. It also includes the impact of improved longevity among those who participate in the MDPP expanded model. This cost of improved longevity was ignored for certification purposes, as noted in that memorandum.
The model is dependent on the number of eligible participants, the annual take-up rate, and the savings per participant, all of which are uncertain. The methodology determines gross savings as the result of an assumed reduction in the number of beneficiaries transitioning from prediabetes to diabetes and a marginal cost difference between the individuals with diabetes and those that are prediabetic. The Office of the Actuary assumed that the initial savings per beneficiary for avoiding diabetes is $3,000 per year. The progression rate from prediabetes to diabetes absent the intervention is expected to be roughly 5 percent per year. Based on observed results, we assume that the set of MDPP services will reduce the progression rate among those receiving the services by 50 percent in the first year and that the reduction will be 5 percent less in each subsequent year until leveling off at a rate of 10 percent. The program costs in
Table 46 shows the 10-year impact of the MDPP expanded model, net of payments to MDPP providers but gross of any other model costs, based on our expected enrollment per year. The 10-year impact is a savings to Medicare of $186 million. The estimate is expected to cross into a cumulative savings to Medicare in the sixth year of the MDPP expanded model.
MDPP is a new Medicare expanded model that was tested in the DPP model test using a small percentage of the population. As a result, the estimated impact from the expanded MDPP model is very uncertain. In particular, it is unknown how many beneficiaries will be interested in participating in MDPP and how quickly MDPP suppliers available will be able to serve those individuals. To understand how various participation scenarios would affect the financial results, we have prepared the estimates under two other participation scenarios. The first shows the results if half of the beneficiaries shown in the best estimate participate, and the second uses twice as many beneficiaries. The details are shown in Tables 47 and 48.
Section III.K. of the preamble of this proposed rule includes a range of proposed policies necessary to implement the MDPP expanded model, including benefit structure, payment, supplier enrollment, and supplier standards. Throughout section III.K., we present descriptions of the relevant statutory provisions; identify those policies when discretion has been exercised in our proposals, present rationale for our proposed policies; and discuss alternative to our proposals that where considered.
We considered alternatives to the MDPP services period that would significantly impact the potential payment. Specifically, we considered limiting the MDPP to a 12-month MDPP services period without any ongoing maintenance sessions available in months 13 through 36. It is estimated that the average payment to suppliers for the maintenance years is $75 per year per beneficiary. We also considered limiting the ongoing maintenance sessions to 12 months, culminating in a total MDPP service period of up to 2 years as opposed to up to 3 years. Either of these alternatives would reduce the total potential payment to MDPP suppliers by 52 percent or 28 percent, respectively, from a maximum of $810 for meeting all attendance and weight loss achievement goals under our proposals. We did not propose these alternatives because weight loss is difficult to achieve and can be more difficult to sustain. Our proposal to allow for up to 2 years of ongoing maintenance sessions for those beneficiaries who have achieved a minimum 5 percent weight loss from baseline during months 1 to 12 of the MDPP services period will allow for reinforcement of the lifestyle changes
In this proposed rule, we also considered linking additional outcomes beyond attendance and weight loss to payment in the value-based payment methodology. Specifically, we considered linking hemoglobin A1c level to MDPP payments. However, we did not adopt this alternative because the MDPP expanded model is certified based on the DPP model test, which demonstrated that weight loss was associated with reductions in Medicare expenditures. Although elevated hemoglobin A1c levels were included as part of the beneficiary eligibility criteria in the DPP model test, hemoglobin A1c levels were not evaluated post-intervention in the DPP model test. Therefore, the proposed MDPP payment structure would incentivize MDPP suppliers to prioritize the achievement of beneficiary weight loss by furnishing MDPP services, providing a balance between value-based payments related to weight loss and session attendance.
In conclusion, we estimate that the 10-year impact of the MDPP expanded model, net of payments to MDPP providers but gross of any other program costs, based on our expected enrollment per year would be a savings to Medicare of $186 million. The estimate is expected to cross into a cumulative savings to Medicare in the sixth year of the MDPP expanded model.
This proposed rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our final policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this proposed rule, we presented the estimated impact on total allowed charges by specialty. The alternatives we considered, as discussed in the preceding preamble sections, will result in different proposed payment rates, and therefore, result in different estimates than those shown in Table 40 (CY 2018 PFS Estimated Impact on Total Allowed Charges by Specialty).
There are a number of changes in this proposed rule that would have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through revisions to the inputs used to calculate payments under the PFS, would have a positive impact and improve the quality and value of care provided to Medicare beneficiaries.
Most of the aforementioned proposed policy changes could result in a change in beneficiary liability as relates to coinsurance (which is 20 percent of the fee schedule amount, if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in our public use file Impact on Payment for Selected Procedures available on the CMS Web site at
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcome any comments on the approach in estimating the number of entities which will review this proposed rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We seek comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $105.16 per hour, including overhead and fringe benefits
As required by OMB Circular A-4 (available at
The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides a Regulatory Impact Analysis. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
(a) * * *
(5) Furnished under the direct supervision of a physician, except that services and supplies furnished incident to Transitional Care Management, General Care Management, and the Psychiatric Collaborative Care model, can be furnished under general supervision of a physician when these services or supplies are furnished by auxiliary personnel, as defined in § 410.26(a)(1) of this chapter.
(a) * * *
(5) Furnished under the direct supervision of a nurse practitioner, physician assistant, or certified nurse-midwife, except that services and supplies furnished incident to Transitional Care Management, General Care Management, and the Psychiatric Collaborative Care model, can be furnished under general supervision of a nurse practitioner, physician assistant, or certified nurse-midwife, when these services or supplies are furnished by auxiliary personnel, as defined in § 410.26(a)(1) of this chapter.
Secs. 1102, 1834, 1871, 1881, and 1893 of the Social Security Act (42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd).
The revisions and additions read as follows:
(a) Medicare Diabetes Prevention Program (MDPP) services will be available beginning on April 1, 2018.
(b) * * *
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during a core maintenance session interval;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for maintenance sessions.
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during months 1 through 6 of the MDPP services period;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for core sessions.
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during an ongoing maintenance session interval;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for maintenance sessions.
(c) Coverage for
(1)
(A) Is enrolled under Medicare Part B;
(B) Attended the first core session within the most recent 12-month time period and, prior to attending this first core session, had not previously received the set of MDPP services in his or her lifetime;
(C) Has, on the date of attendance at the first core session, a body mass index (BMI) of at least 25 if not self-identified as Asian or a BMI of at least 23 if self-identified as Asian;
(D) Has received, within the 12-month time period prior to the date of attendance at the first core session, a hemoglobin A1c test with a value of between 5.7 and 6.4 percent, a fasting plasma glucose test with a value of between 110 and 125 mg/dL, or a 2-hour plasma glucose test (oral glucose tolerance test) with a value of between 140 and 199 mg/dL;
(E) Has, as of the date of attendance at the first core session, no previous diagnosis of diabetes, other than gestational diabetes; and
(F) Does not have end-stage renal disease (ESRD).
(ii) An MDPP beneficiary is eligible for the first ongoing maintenance session interval only if the beneficiary:
(A) Attends at least one in-person core maintenance session during the final core maintenance session interval; and
(B) Achieves or maintains the required minimum weight loss at a minimum of one in-person core maintenance session during the final core maintenance session interval.
(iii) An MDPP beneficiary is eligible for a subsequent ongoing maintenance session interval only if the beneficiary:
(A) Attends at least three ongoing maintenance sessions during the previous ongoing maintenance session interval, including at least one in-person ongoing maintenance session; and
(B) Maintains the required minimum weight loss at a minimum of one in-person ongoing maintenance session furnished during the previous ongoing maintenance session interval.
(iv) Weight measurements used to determine the achievement or maintenance of the required minimum weight loss must be taken in person by an MDPP supplier during an MDPP session.
(2)
(i) The core services period, which is the first 12 months of the MDPP services period, and consists of:
(A) At least 16 core sessions offered at least one week apart during months 1 through 6 of the MDPP services period; and
(B) Two 3-month core maintenance session intervals offered during months 7 through 12 of the MDPP services period.
(ii) Subject to paragraph (c)(3) of this section, the ongoing services period, which consists of up to eight 3-month ongoing maintenance session intervals offered during months 13 through 36 of the MDPP services period.
(3)
(ii) If the MDPP beneficiary qualifies for the first ongoing maintenance session interval as described in paragraph (c)(3)(i) of this section, the MDPP services period ends upon completion of this first ongoing maintenance session interval or any subsequent ongoing maintenance session interval, unless the beneficiary meets the eligibility requirements under paragraph (c)(1)(iii) of this section.
(iii) Unless sooner ended in accordance with this paragraph (c)(3), the MDPP services period ends automatically upon the completion of the eighth ongoing maintenance session interval.
(d)
(i) The curriculum furnished during the make-up session must address the same CDC-approved DPP curriculum topic as the regularly scheduled session that the beneficiary missed;
(ii) The MDPP supplier may furnish to the beneficiary a maximum of one make-up session on the same day as a regularly scheduled session; and
(iii) The MDPP supplier may furnish to the beneficiary a maximum of one make-up session per week.
(2) An MDPP supplier may offer virtual make-up sessions only if consistent with the requirements in paragraph (d)(1) of this section. Virtual make-up sessions are also subject to the following requirements:
(i) Virtual make-up sessions must be furnished in a manner consistent with the DPRP standards for virtual sessions;
(ii) An MDPP supplier may only offer virtual make-up sessions based on an individual MDPP beneficiary's request; and
(iii) An MDPP supplier may offer to an MDPP beneficiary:
(A) No more than 4 virtual make-up sessions within the core services period described in paragraph (c)(2)(i) of this section, of which no more than 2 virtual make-up sessions are core maintenance sessions; and
(B) No more than 3 virtual make-up sessions that are ongoing maintenance sessions during any rolling 12-month time period.
(3) Make-up sessions furnished in accordance with paragraph (d)(1) of this section that an MDPP beneficiary attends in person are counted toward meeting the attendance requirements described in paragraph (c)(1) of this section and toward achieving the performance goals described in § 414.84(b) of this chapter as if the MDPP beneficiary attended a regularly scheduled session. Virtual make-up sessions furnished in accordance with paragraph (d)(2) of this section are also counted toward such attendance requirements and performance goals, subject to the following limitations:
(i) The MDPP beneficiary receives no more than 4 virtual make-up sessions within the core services period described in paragraph (c)(2)(i) of this section, of which no more than 2 virtual make-up sessions may be core maintenance sessions; and
(ii) The MDPP beneficiary receives no more than 3 virtual make-up sessions that are ongoing maintenance sessions during any rolling 12-month period.
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(a)
(b)
(1)
(i) For a first core session furnished April 1 through December 31, 2018, the amount of the performance payment is $25.
(ii) For a first core session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(2)
(i) For a fourth core session furnished April 1 through December 31, 2018, the amount of the performance payment is $30.
(ii) For a fourth core session furnished during a calendar year subsequent to CY 2018, the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(3)
(i) For a ninth core session furnished April 1 through December 31, 2018, the amount of the performance payment is $50.
(ii) For a ninth core session furnished during a calendar year subsequent to CY 2018, the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(4)
(i) If the beneficiary also achieves or maintains the required minimum weight loss as measured in-person during a core maintenance session furnished during the applicable core maintenance session interval:
(A) For a third core maintenance session furnished April 1 through December 31, 2018, the amount of the performance payment is $60.
(B) For a third core maintenance session furnished during a calendar year subsequent to CY 2018., the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(ii) If the beneficiary does not achieve or maintain the required minimum weight loss as measured in-person during a core maintenance session furnished during the applicable core maintenance session interval:
(A) For a third core maintenance session furnished April 1 through December 31, 2018, the amount of the performance payment is $10.
(B) For a third core maintenance session furnished during a calendar year subsequent to CY 2018, the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(5)
(i) For a third ongoing maintenance session furnished April 1 through December 31, 2018, the amount of the performance payment is $50.
(ii) For a third ongoing maintenance session furnished during a calendar year subsequent to CY 2018, the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(6)
(i) For a core session or core maintenance session, as applicable, furnished April 1 through December 31, 2018, the amount of the performance payment is $160.
(ii) For a core session or core maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018, the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(7)
(i) For a core session, core maintenance session, or ongoing maintenance session, as applicable, furnished April 1 through December 31, 2018, the amount of the performance payment is $25.
(ii) For a core session, core maintenance session, or ongoing maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018, the performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(c)
(1) For a core session, core maintenance session, or ongoing
(2) For a core session, core maintenance session, or ongoing maintenance session furnished during a calendar year subsequent to CY 2018, the bridge payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(d)
(j) * * *
(8) * * *
(i) * * *
(A) * * *
(
(ii) * * *
(A) * * *
(
(
(iii)
(iv)
(9) * * *
(ii)
(iii)
(iv)
(v)
(vi)
(viii) If the CAHPS for PQRS survey is applicable to the practice, group practices comprised of 100 or more eligible professionals that register to participate in the GPRO may administer the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism selected.
(k) * * *
(3)
(5) * * *
(i)
(ii)
(i) * * *
(3) The significant hardship exception applies to ordering professionals who:
(i) Are granted re-weighting of the advancing care information performance category to zero percent of the final score for the year under MIPS pursuant to § 414.1380(c)(2) due to circumstances that include the criteria listed in § 495.102(d)(4)(i) and (iii) and (d)(4)(iv)(A) and (B) of this chapter. The AUC significant hardship exception is available for the same period the re-weight is applied for purposes of the MIPS payment adjustments, or
(ii) Demonstrate a significant hardship consistent with the criteria listed in § 495.102(d)(4)(i) and (iii) and (d)(4)(iv)(A) or (B) of this chapter. The AUC significant hardship exception may be available for a period no longer than 12 months.
(j)
(k)
(1) The qualified CDSM consulted by the ordering professional.
(2) Information indicating:
(i) Whether the service ordered would adhere to specified applicable AUC;
(ii) Whether the service ordered would not adhere to specified applicable AUC, or
(iii) Whether the specified applicable AUC consulted was not applicable to the service ordered.
(3) The NPI of the ordering professional who consulted specified applicable AUC as required in paragraph (j) of this section, if different from the furnishing professional.
(e) * * *
(2)
(d) * * *
(1) A downward payment adjustment of −1.0 percent will be applied to a solo practitioner, a group with two to nine eligible professionals, and a group consisting only of nonphysician eligible professionals subject to the value-based payment modifier and no physicians; and a downward payment adjustment of −2.0 percent will be applied to a group with 10 or more eligible professionals and at least one physician if, during the applicable performance period as defined in § 414.1215, the following apply:
(i) For groups:
(A) Such group does not meet the criteria as a group to avoid the PQRS payment adjustment for CY 2018 as specified by CMS; and
(B) Fifty percent of the eligible professionals in such group do not meet the criteria as individuals to avoid the PQRS payment adjustment for CY 2018 as specified by CMS.
(ii) For solo practitioners, such solo practitioner does not meet the criteria as an individual to avoid the PQRS payment adjustment for CY 2018 as specified by CMS.
(c) * * *
(4) The following value-based payment modifier percentages apply to the CY 2018 payment adjustment period, for physicians, physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists who are solo practitioners or who are in groups of any size:
(d) * * *
(3) * * *
(i) Classified as high quality/low cost receive an upward adjustment of +3x (rather than +2x); and
(ii) Classified as either high quality/average cost or average quality/low cost receive an upward adjustment of +2x (rather than +1x).
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(d) For purposes of claims for services submitted by an MDDP supplier (as defined at § 410.79(b)), Medicare deems such claims to have been assigned by the beneficiary (or the person authorized to request payment on the beneficiary's behalf) and the assignment accepted by the MDDP supplier.
This subpart specifies the requirements for Medicare Diabetes Prevention Program suppliers and beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model.
(a)
(b)
(1) Has either an MDPP preliminary recognition, as defined in paragraph (c)(1) of this section or a full CDC DPRP recognition.
(2) Maintains an active and valid TIN and NPI at the organizational level.
(3) Has passed screening requirements as follows:
(i) Upon initial enrollment, at a “high” categorical risk in accordance with § 424.518(c)(2); and
(ii) Upon revalidation, at a “moderate” categorical risk in accordance with § 424.518(b)(2).
(4) Maintains, and submits to CMS through the CMS-approved enrollment application, a roster of all coaches who will be furnishing MDPP services on the entity's behalf that includes each coach's first and last names, middle initial (if applicable), date of birth, Social Security Number (SSN), active and valid NPI, coach eligibility start date, and coach eligibility end date (if applicable). This roster must be updated in accordance with paragraph (d)(5) of this section.
(5) Meets and certifies in its CMS-approved enrollment application that it meets and will continue to meet the
(6) Revalidates its Medicare enrollment every 3 years after the effective date of enrollment.
(c)
(i) Any preliminary recognition established by CDC for the purposes of the DPRP; or
(ii) An MDPP interim preliminary recognition.
(A
(B)
(
(
(2) [Reserved]
(d)
(1) The MDPP supplier must have and maintain MDPP preliminary recognition, as defined under paragraph (c)(1) of this section, or a full CDC DPRP recognition.
(2) The MDPP supplier must not currently have its billing privileges terminated for-cause or be excluded by a State Medicaid agency.
(3) The MDPP supplier must not include on the roster of coaches, described in paragraph (b)(4) of this section and updated in accordance with paragraph (d)(5) of this section, nor permit MDPP services to be furnished by any individual coach who meets any of ineligibility criteria outlined in paragraph (e)(1) of this section.
(4) The MDPP supplier must maintain at least one administrative location. All administrative locations maintained by the MDPP supplier must be located at an appropriate site and be reported on the CMS-approved enrollment application. An appropriate site for such an administrative location would include all of the following characteristics:
(i) Signage posted on the exterior of the building. Such signage may include, for example, the MDPP supplier's legal business name or DBA, as well as hours of operation.
(ii) Open for business during stated operational hours.
(iii) Employees, staff, or volunteers present during operational hours; and
(iv) Not a private residence.
(5) The MDPP supplier must update its enrollment application within 30 days of any changes of ownership, changes to the coach roster (including due to coach ineligibility or because the coach is no longer an employee, contractor, or volunteer of the MDPP supplier), and final adverse action history, and report all other changes, including but not limited to changes in the MDPP supplier's administrative location(s), to CMS within 90 days of the reportable event.
(6) The MDPP supplier must maintain a primary business telephone that operates either at administrative locations described in paragraph (d)(4) of this section or directly where services are furnished, if services are furnished in community settings. The associated telephone number must be listed with the either the legal or doing business as name of the supplier in public view, including on Web sites, flyers, and materials.
(7) The MDPP supplier must not knowingly sell to or allow another individual or entity to use its supplier billing number.
(8) Subject to paragraph (d)(8)(i) of this section, the MDPP supplier must not deny an MDPP beneficiary access to MDPP services during the MDPP services period described in § 410.79(c)(2) of this chapter, including on the basis of the beneficiary's weight, health status, or achievement of performance goals.
(i) Suppliers may deny an MDPP beneficiary access to MDPP services during the MDPP services period only under one of the following conditions:
(A) The MDPP beneficiary no longer meets the eligibility criteria for MDPP services under § 410.79(c)(1) of this chapter.
(B) The MDPP supplier lacks the self-determined capacity to furnish MDPP services to additional MDPP beneficiaries.
(C) The MDPP supplier determines that the MDPP beneficiary significantly disrupts the session for other MDPP beneficiaries or becomes abusive.
(ii) MDPP suppliers must maintain a record of the number of MDPP beneficiaries turned away for the reasons outlined in paragraphs (d)(8)(i)(B) and (C) of this section, to include the date each such beneficiary was turned away. For beneficiaries turned away for reasons described in paragraph (d)(8)(i)(C) of this section, the MDPP supplier must document details of the occurrence(s), including date(s) of the behavior, any remediation efforts taken by the MDPP supplier, and final action (for example, dismissal from an MDPP session or denial from future sessions) in the beneficiary's MDPP records.
(9) The MDPP supplier and other individuals or entities performing functions or services related to MDPP services on the MDPP supplier's behalf must not unduly coerce an MDPP beneficiary's decision to change or not to change to a different MDPP supplier, including through the use of pressure, intimidation, or bribery.
(10) Except as allowed under paragraph (d)(8) of this section, the MDPP supplier must offer an MDPP beneficiary no fewer than all of the following:
(i) Sixteen in-person core sessions no more frequently than weekly for the first 6 months of the MDPP services period, which begins on the date of attendance at the first such core session.
(ii) One in-person core maintenance session each month during months 7 through 12 (6 months total) of the MDPP services period.
(iii) One in-person ongoing maintenance session each month for months 13 through 36 of the MDPP services period, as long as the beneficiary maintains eligibility to receive such services in accordance with § 410.79(c)(1)(ii) and (iii) of this chapter.
(11) Before the initial core session is furnished, the MDPP supplier must disclose detailed information about the set of MDPP services to each MDPP beneficiary to whom it wishes to begin furnishing MDPP services. Such information must include all of the following:
(i) Eligibility requirements under § 410.79(c)(1) of this chapter, including the once-per-lifetime nature of MDPP services.
(ii) The MDPP supplier standards as outlined in this section.
(12) The MDPP supplier must answer MDPP beneficiaries' questions about MDPP services and respond to MDPP-related complaints within a reasonable timeframe. An MDPP supplier must
(13) The MDPP supplier must maintain a crosswalk file which indicates how beneficiary identifications for the purposes of CDC performance data requirements correspond to corresponding beneficiary health insurance claims numbers or Medicare Beneficiary Identifiers for each MDPP beneficiary receiving MDPP services from the MDPP supplier. The MDPP supplier must submit the crosswalk file to CMS or its contractor.
(14) The MDPP supplier must submit performance data for MDPP beneficiaries who attend ongoing maintenance sessions with data elements consistent with the CDC's DPRP standards for data elements required for the core services period.
(15) The MDPP supplier must allow CMS or its agents to conduct onsite inspections or recordkeeping reviews in order to ascertain the MDPP supplier's compliance with these standards, and must adhere to the documentation requirements as outlined in paragraph (g) of this section.
(e)
(i) Currently have Medicare billing privileges revoked and be currently subject to the reenrollment bar.
(ii) Currently have its Medicaid billing privileges terminated for-cause or be excluded by a State Medicaid agency.
(iii) Currently be excluded from any other Federal health care program, as defined in 42 CFR 1001.2, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act.
(iv) Currently be debarred, suspended, or otherwise excluded from participating in any other Federal procurement or nonprocurement program or activity in accordance with the Federal Acquisition Streamlining Act implementing regulations and the Department of Health and Human Services nonprocurement common rule at 45 CFR part 76.
(v) Have, in the previous 10 years, one of the following State or Federal felony convictions:
(A) Crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
(B) Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
(C) Any felony that placed the Medicare or its beneficiaries at immediate risk, such as a malpractice suit that results in the individual being convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion of criminal neglect or misconduct.
(D) Any felonies for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion that would result in mandatory exclusion under section 1128(a) of the Act.
(2)
(f)
(i) The later of—
(A) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor;
(B) The date of filing of a corrective action plan that was subsequently approved by a Medicare contractor; or
(C) The date that the supplier first began furnishing services at a new administrative location that resulted in a new enrollment record or Provider Transaction Access Number
(ii) Under no circumstances should the effective date of billing privileges for any MDPP supplier be prior to April 1, 2018
(2) For any newly established administrative locations that do not result in a new enrollment record or Provider Transaction Access Number, the existing billing privilege effective date for their Provider Transaction Access Number will apply, but not earlier than April 1, 2018.
(g)
(1) The documentation for the first core session must be established contemporaneous with the furnishing of MDPP services and must include at least all of the following:
(i) Organizational information, including MDPP supplier name, CDC DPRP number, and NPI.
(ii) Basic beneficiary information for each MDPP beneficiary in attendance, including but not limited to beneficiary name, HICN, age.
(iii) Evidence that each such beneficiary satisfied the eligibility requirements under § 410.79(c) at the time of service.
(2) The documentation for each MDPP session attended must be established contemporaneous with the furnishing of MDPP services and must include at least all of the following:
(i) Documentation of the type of session, whether a core session, a core maintenance session, an ongoing maintenance session, an in-person make-up session, or a virtual make-up session.
(ii) Identification of which CDC-approved DPRP curriculum was associated with the session.
(iii) The NPI of the coach who furnished the session.
(iv) The date and place of service of the session.
(v) Each MDPP's beneficiary's weight and date weight taken, in a form and manner as specified by CMS.
(3) If an MDPP supplier chooses to offer in-kind beneficiary engagement incentives to MDPP beneficiaries as permitted under § 424.210, the records maintained by the MDPP supplier in accordance with this section must also include the information required by § 424.210(e).
(4) An MDPP supplier is required to maintain and handle any beneficiary Personally Identifiable Information (PII) and Protected Health Information (PHI) in compliance with HIPAA, other applicable state and federal privacy laws, and CMS standards.
(5) The MDPP supplier's records must include an attestation from the MDPP supplier that, as applicable, the MDPP beneficiary for which it is submitting a claim—
(i) Has attended their first, fourth or ninth core session, as applicable, if the claim submitted is for a performance payment under § 414.84(b)(1), (2), or (3) of this chapter.
(ii) Has attended at least three core maintenance sessions, achieved required minimum weight loss, or both, as applicable, if the claim submitted is for a performance payment under § 414.84(b)(4) of this chapter.
(iii) Has achieved the required minimum weight loss and attended at least three ongoing maintenance sessions within an ongoing maintenance session interval, if the claim submitted is for a performance payment under § 414.84(b)(5) of this chapter, if the claim submitted is for a performance payment under § 414.84(b)(6) of this chapter.
(iv) Has achieved required minimum weight loss as measured in-person during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(6) of this chapter.
(v) Has achieved at least a 9-percent weight loss percentage as measured in-person during a core session, core maintenance session, or ongoing maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(7) of this chapter.
(6) The MDPP supplier must maintain all records required under this section for a period of 10 years from the last day of the MDPP beneficiary's receipt of MDPP services provided by the MDPP supplier or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless either of the following apply:
(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 MDPP supplier 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 MDPP supplier, 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, as defined at § 405.902 of this chapter.
(h)
(i)
(A) An enrollment denial under this paragraph (h)(1)(i) is considered an enrollment denial under § 424.530(a)(1) of this chapter.
(B) A revocation under this paragraph (h)(1)(i) is considered a revocation under § 424.535(a)(1) of this chapter.
(C) An MDPP supplier that does not satisfy the requirements in paragraph (b)(1) of this section may become eligible to bill for MDPP services again if it successfully achieves MDPP preliminary recognition or full CDC DPRP recognition, and successfully enrolls again in Medicare as an MDPP supplier after any applicable reenrollment bar has expired.
(ii)
(A) An enrollment denial under this paragraph (h)(1)(ii) is considered an enrollment denial under § 424.530(a)(1) of this part.
(B) A revocation under this paragraph (h)(1)(ii) is considered a revocation under § 424.535(a)(1) of this part.
(iii)
(iv)
(v)
(B) Revocation under this paragraph (h)(1)(v) is subject to the following requirements:
(
(
(
(2) An MDPP supplier may appeal an enrollment denial or revocation decision in accordance with the procedures specified in part 498 of this chapter. References to suppliers in that section apply to MDPP suppliers.
(a)
(i) The MDPP beneficiary's MDPP services period ends as described in § 410.79(c)(3) of this chapter.
(ii) The MDPP supplier knows the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier.
(iii) The MDPP supplier has not had direct contact, either in-person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period.
(b)
(1) The item or service must be furnished directly to an MDPP beneficiary by an MDPP supplier or by an agent of the MDPP supplier, such as a coach, under the MDPP supplier's direction and control.
(2) The item or service must be reasonably connected to the CDC-approved DPP curriculum furnished to the MDPP beneficiary during a core session, a core maintenance session, or ongoing maintenance session furnished by the MDPP supplier.
(3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as specified in paragraph (d) of this section, for an MDPP beneficiary by engaging him or her in better managing his or her own health.
(4) The item or service must not be tied to the receipt of services outside of the MDPP services
(5) The item or service must not be tied to the receipt of services from a particular provider, supplier, or coach.
(6) The availability of the item or service must not be advertised or promoted as an in-kind beneficiary engagement incentive available to an MDPP beneficiary receiving MDPP services from the MDPP supplier except that an MDPP beneficiary may be made aware of the availability of the item or service at the time the MDPP beneficiary could reasonably benefit from it during the engagement incentive period.
(7) The cost of the item or service must not be shifted to another Federal health care program, as defined at section 1128B(f) of the Act.
(c)
(1) Items or services involving technology may not, in the aggregate, exceed $1,000 in retail value for any one MDPP beneficiary.
(2) Items or services involving technology must be the minimum necessary to advance a clinical goal, as listed in paragraph (d) of this section, for an MDPP beneficiary.
(3) Items involving technology exceeding $100 in retail value must—
(i) Remain the property of the MDPP supplier; and
(ii) Be retrieved from the MDPP beneficiary at the end of the engagement incentive period. The MDPP supplier must document all retrieval attempts, including the ultimate date of retrieval in accordance with paragraph (e)(3) of this section. Documented diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement.
(d)
(1) Attendance at core sessions, core maintenance sessions, or ongoing maintenance sessions.
(2) Weight loss.
(3) Long-term dietary change.
(4) Adherence to long-term health behavior changes.
(e)
(1) The documentation must be established contemporaneous with the furnishing of the in-kind items and services and must include at least the following:
(i) The date the item or service is furnished.
(ii) The identity of the MDPP beneficiary to whom the item or service is furnished.
(iii) The agent of the MDPP supplier who furnished the item or service, if applicable.
(iv) A description of the item or service.
(v) The retail value of the item or service.
(vi) Documentation establishing that the item or service was furnished to the MDPP beneficiary during the engagement incentive period.
(2) Documentation regarding items or services that are furnished to the MDPP beneficiary for use on an ongoing basis during the engagement incentive period, including items of technology exceeding $100 in retail value, must also include contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary possesses or has access to the item or service furnished by the MDPP supplier.
(3) The documentation regarding items of technology exceeding $100 in retail value must also include contemporaneous documentation of any attempt to retrieve technology as required by paragraph (c)(3)(ii) of this section.
(4) The MDPP supplier must retain and provide access to the documentation required in this section in accordance with § 424.205(g).
(e)
Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302, 1306 1395hh, and 1395jjjj).
(1) For performance years 2012 through 2015, a physician included in an attestation by the ACO as provided under § 425.404 for services furnished in an FQHC or RHC, or a physician who has a primary care specialty designation of internal medicine, general practice, family practice, or geriatric medicine;
(2) For performance years 2016 through 2018, a physician included in an attestation by the ACO as provided under § 425.404 for services furnished in an FQHC or RHC, or a physician who has a primary care specialty designation of internal medicine, general practice, family practice, geriatric medicine, or pediatric medicine; and
(3) For performance year 2019 and subsequent years, a physician who has a primary care specialty designation of internal medicine, general practice, family practice, geriatric medicine, or pediatric medicine.
The revision reads as follows:
(b) * * *
(4) * * *
(ii) Have a written plan to:
(A) Implement an individualized care program that promotes improved outcomes for, at a minimum, the ACO's high-risk and multiple chronic condition patients.
(B) Identify additional target populations that would benefit from individualized care plans. Individualized care plans must take into account the community resources available to the individual.
(C) Encourage and promote use of enabling technologies for improving care coordination for beneficiaries. Enabling technologies may include one or more of the following:
(
(
(
(
(D) Partner with long-term and post-acute care providers, both inside and outside the ACO, to improve care coordination for its assigned beneficiaries.
The revisions read as follows:
(c) * * *
(1) As part of its application, an ACO must certify that the ACO satisfies the requirements set forth in this part. Upon request, the ACO must submit the following supporting materials to demonstrate that it satisfies the requirements set forth in this part:
(d)
(b) * * *
(2) Each ACO participant that submits claims for services used to determine the ACO's assigned population under subpart E of this part must be exclusive to one Shared Savings Program ACO. If, during a benchmark or performance year (including the 3-month claims runout for such benchmark or performance year), an ACO participant that participates in more than one ACO submits claims for services used in assignment under subpart E of this part, then:
(i) CMS will not consider any services billed through the TIN of the ACO participant when performing assignment under subpart E of this part for the benchmark or performance year.
(ii) The ACO may be subject to the pre-termination actions set forth in § 425.216, termination under § 425.218, or both.
(a) * * *
(1) * * *
(iii) In determining final assignment for a benchmark or performance year, CMS will exclude any services furnished during the benchmark or performance year that are billed through the TIN of an ACO participant that is an ACO participant in more than one ACO.
(c) Primary care services for purposes of assigning beneficiaries are identified by selected HCPCS/CPT codes, or revenue center codes.
(1) Primary care service codes are as follows:
(i) For performance years 2012 through 2015:
(A) CPT codes:
(
(
(
(B) HCPCS codes G0402 (the code for the Welcome to Medicare visit) and G0438 and G0439 (codes for the annual wellness visits).
(C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
(ii) For performance year 2016 as follows:
(A) CPT codes:
(
(
(
(
(B) HCPCS codes:
(
(
(
(C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
(iii) For performance year 2017 and 2018 as follows:
(A) CPT codes:
(
(
(
(
(
(B) HCPCS Codes:
(
(
(
(C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
(iv) For performance year 2019 as follows:
(A) CPT codes:
(
(
(
(
(
(
(B) HCPCS Codes:
(
(
(
(
(
The revisions read as follows:
(a) For performance years 2012 through 2018—
(1) Such ACOs are required to identify, through an attestation, physicians who directly provide primary care services in each FQHC or RHC that is an ACO participant and/or ACO provider/supplier in the ACO.
(2) Under the assignment methodology in § 425.402, CMS treats a service reported on an FQHC/RHC claim as a primary care service—
(i) If the claim includes a HCPCS or revenue center code that meets the definition of primary care services under § 425.20;
(ii) Performed by a primary care physician if the NPI of a physician identified in the attestation provided under paragraph (a)(1) of this section is reported on the claim for a primary care service (as described in paragraph (a)(2)(i) of this section) as the attending provider; and
(iii) Performed by a non-physician ACO professional if the NPI reported on the claim for a primary care service (as described in paragraph (a)(2)(i) of this section) as the attending provider is an ACO professional but is not identified in the attestation provided under paragraph (a)(1) of this section.
(b) For performance year 2019 and subsequent performance years, under the assignment methodology in § 425.402, CMS treats a service reported on an FQHC/RHC claim as a primary care service performed by a primary care physician.
(a) * * *
(1) * * *
(ii) * * *
(A) For agreement periods beginning before 2018, this calculation considers all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For agreement periods beginning in 2018 and subsequent years, this calculation considers individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(C) For the 2018 performance year and subsequent performance years in agreement periods beginning in 2015, 2016 and 2017, the benchmark is adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(c) * * *
(1) * * *
(ii) * * *
(A) For agreement periods beginning before 2018, considers all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For agreement periods beginning in 2018 and subsequent years, considers individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(C) For the 2018 and 2019 performance years in agreement periods beginning in 2017, the benchmark is adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(e) * * *
(2) * * *
(ii) * * *
(A) For agreement periods beginning before 2018, considers all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For agreement periods beginning in 2018 and subsequent years, considers individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(C) For the 2018 and 2019 performance years in agreement periods beginning in 2017, risk adjusted county fee-for-service expenditures are adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning before 2018, these calculations will take into consideration all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For performance year 2018 and subsequent performance years, these calculations will take into consideration individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning before 2018, these calculations will take into consideration all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For performance year 2018 and subsequent performance years, these calculations will take into consideration individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning before 2018, these calculations will take into consideration all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For performance year 2018 and subsequent performance years, these calculations will take into consideration individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
Environmental Protection Agency (EPA).
Proposed rule.
Under section 211 of the Clean Air Act, the Environmental Protection Agency (EPA) is required to set renewable fuel percentage standards every year. This action proposes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in the year 2018. Relying on statutory waiver authority that is available when projected cellulosic biofuel production volumes are less than the applicable volume specified in the statute, the EPA is proposing volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel that are below the statutory applicable volumes, and lower than the 2017 requirements. In this action, we are also proposing the applicable volume of biomass-based diesel for 2019.
Comments must be received on or before August 31, 2017. EPA will announce the public hearing date and location for this proposal in a supplemental
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2017-0091, at
Julia MacAllister, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4131; email address:
Entities potentially affected by this proposed rule are those involved with the production, distribution, and sale of transportation fuels, including gasoline and diesel fuel or renewable fuels such as ethanol, biodiesel, renewable diesel, and biogas. Potentially regulated categories include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this proposed action. This table lists the types of entities that EPA is now aware could potentially be regulated by this proposed action. Other types of entities not listed in the table could also be regulated. To determine whether your entity would be regulated by this proposed action, you should carefully examine the applicability criteria in 40 CFR part 80. If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed in the
Outline of this preamble
The Renewable Fuel Standard (RFS) program began in 2006 pursuant to the requirements in Clean Air Act (CAA) section 211(o) that were added through the Energy Policy Act of 2005 (EPAct). The statutory requirements for the RFS program were subsequently modified through the Energy Independence and Security Act of 2007 (EISA), leading to the publication of major revisions to the regulatory requirements on March 26, 2010.
The statute includes annual volume targets, and requires EPA to translate those volume targets (or alternative volume requirements established by EPA in accordance with statutory waiver authorities) into compliance obligations that obligated parties must meet every year. In this action, we are proposing the annual percentage standards for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel that would apply to all gasoline and diesel produced or imported in 2018. We are also proposing the applicable volume of BBD for 2019.
Real-world challenges, such as the slower-than-expected development of the cellulosic biofuel industry, have slowed progress towards meeting Congressional goals for renewable fuels, even as progress has been made in some areas. Those challenges have made the volume targets established by Congress for 2018 beyond reach for all fuel categories other than BBD, for which the statute specifies a minimum requirement of 1.0 billion gallons. After careful review of the information before us, for 2018 we propose to use the cellulosic waiver authority provision provided by Congress to reduce the volume requirement for cellulosic biofuel to the projected volume available in 2018, and establish volume requirements for advanced biofuel and total renewable fuel that are lower than the statutory targets, but nevertheless will ensure these renewable fuels will continue to play a critical role as a complement to our petroleum-based fuels. We are not proposing to provide volume reductions through use of the general waiver authority.
We note that while we are proposing to reduce the required volume of all of the fuel categories other than BBD due to an anticipated shortfall in the production of cellulosic biofuel, the proposed BBD volume exceeds the statutory minimum and the proposed volumes of total renewable fuel, advanced biofuel and cellulosic biofuel would achieve the implied statutory volumes for conventional biofuel
The proposed volume requirements for 2018 are shown in Table I-1 below. Relative to the levels finalized in 2017, the proposed 2018 volume requirements for advanced biofuel and total renewable fuel are lower by 40 million gallons. For the first time EPA is proposing in 2018 to reduce the advanced biofuel and total renewable fuel volumes by the same amount as we would reduce the required volume of cellulosic biofuel. These reductions effectively preserve the implied statutory volumes for conventional renewable fuel and non-cellulosic advanced biofuels, rather than requiring additional volumes of non-cellulosic advanced biofuels to backfill for some of the shortfall in cellulosic biofuel, as EPA has done in previous years. We are proposing no increase, relative to the finalized 2018 levels, in the volume requirement for biomass-based diesel for 2019.
The Clean Air Act requires EPA to “reset” the statutory volume targets for future years when certain conditions are met. As discussed later in this Executive Summary, the Administrator has directed staff to begin technical analysis to inform a future reset rulemaking action.
The national volume targets of renewable fuel that are intended to be achieved under the RFS program each year (absent an adjustment or waiver by EPA) are specified in CAA section
Under the RFS program, EPA is required to determine and publish annual percentage standards for each compliance year. The percentage standards are calculated to ensure use in transportation fuel of the national “applicable volumes” of the four types of biofuel (cellulosic biofuel, BBD, advanced biofuel, and total renewable fuel) that are set forth in the statute or established by EPA in accordance with the Act's requirements. The percentage standards are used by obligated parties (generally, producers and importers of gasoline and diesel fuel) to calculate their individual compliance obligations. Each of the four percentage standards is applied to the volume of non-renewable gasoline and diesel that each obligated party produces or imports during the specified calendar year to determine their individual volume obligations with respect to the four renewable fuel types. The individual volume obligations determine the number of RINs of each renewable fuel type that each obligated party must acquire and retire to demonstrate compliance.
EPA is proposing the annual applicable volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2018, and for BBD for 2019.
As shown in Table I.A-2, the statutory authorities allowing EPA to modify or set the applicable volumes differ for the four categories of renewable fuel. Under the statute, EPA must annually determine the projected volume of cellulosic biofuel production for the following year. If the projected volume of cellulosic biofuel production is less than the applicable volume specified in section 211(o)(2)(B)(i)(III) of the statute, EPA must lower the applicable volume used to set the annual cellulosic biofuel percentage standard to the projected production volume. In Section III of this proposed rule, we present our analysis of cellulosic biofuel production and the
With regard to BBD, CAA section 211(o)(2)(B) specifies the applicable volumes of BBD to be used in the RFS program only through year 2012. For subsequent years the statute sets a minimum volume of 1 billion gallons, and directs EPA, in coordination with the U.S. Departments of Agriculture (USDA) and Energy (DOE), to determine the required volume after review of implementation of the renewable fuels program and consideration of a number of factors. The BBD volume requirement must be established 14 months before the year in which it will apply. In the 2017 final rule we established the BBD volume for 2018. In Section VI of this preamble we discuss our assessment of statutory and other relevant factors and our proposed volume requirement for BBD for 2019, which has been developed in coordination with USDA and DOE. We are proposing an applicable volume of 2.1 billion gallons of BBD for use in deriving the BBD percentage standard in 2019. This volume is equal to the applicable volume of BBD established in a prior rulemaking for 2018, and would provide continued support to an industry that is a significant contributor to the pool of advanced biofuel while at the same time setting the volume requirement in a manner anticipated to provide continued incentive for the development of other types of advanced biofuel.
Regarding advanced biofuel and total renewable fuel, Congress provided several mechanisms through which the statutory targets could be reduced if necessary. If we reduce the applicable volume of cellulosic biofuel below the volume specified in CAA section 211(o)(2)(B)(i)(III), we also have the authority to reduce the applicable volumes of advanced biofuel and total renewable fuel by the same or a lesser amount. We refer to this as the “cellulosic waiver authority.” We may also reduce the applicable volumes of any of the four renewable fuel types using the “general waiver authority” provided in CAA section 211(o)(7)(A) if EPA, in consultation with USDA and DOE, finds that implementation of the statutory volumes would severely harm the economy or environment of a State, region, or the United States, or if there is inadequate domestic supply. Sections II, IV, and V of this proposed rule describe our use of the cellulosic waiver authority alone to derive proposed volumes of advanced biofuel and total renewable fuel that are below the statutory target volumes, and our assessment that the resulting volumes can be met. We believe that reductions in the statutory targets for 2018 are necessary. However, in light of our review of available information, we are proposing to make those reductions under the cellulosic waiver authority alone and are not proposing any additional increment of reduction under the general waiver authority. Thus, the reductions proposed can be attributed to the significant shortfall in cellulosic biofuel production, as compared to the statutory targets. EPA, however, solicits comment on whether it would be appropriate to exercise the general waiver authority in the final rule, and will evaluate comments and updated data to consider whether such an approach is warranted.
This section briefly summarizes the major provisions of this proposed rule. We are proposing applicable volume requirements and associated percentage standards for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2018; for BBD we are proposing the percentage standard for 2018 and the applicable volume requirement for 2019.
The approach we have taken in this proposed rule to project cellulosic biofuel is modified from that presented in the 2017 final rule, as described in further detail below. The approach we have taken in this proposed rule of using the cellulosic waiver authority to reduce advanced biofuel and total renewable fuel is similar to that presented in the 2017 final rule, however, we are proposing to reduce the advanced biofuel and total renewable fuel volume requirements by the same amount as the cellulosic biofuel volume requirement. In previous years we have used the cellulosic waiver authority to reduce the advanced biofuel and total renewable fuel volume requirements by a lesser amount than the cellulosic biofuel volume requirement to allow reasonably attainable volumes of advanced biofuels to partially backfill for missing cellulosic biofuel volumes. In this rule we are proposing to reduce all three volume requirements by the same amount after considering the greenhouse gas (GHG), energy security benefits, and anticipated costs of advanced biofuels beyond the level proposed in this rule.
Section II provides a general description of our approach to setting volume requirements in today's rule, including a review of the statutory waiver authorities and our consideration of carryover RINs. Section III provides our assessment of the 2018 cellulosic biofuel volume based on a projection of production that reflects a neutral aim at accuracy. Sections IV and V describe our assessments of advanced biofuel and total renewable fuel, respectively. Finally, Section VI provides our determination regarding the 2019 BBD volume requirement, and reflects an analysis of a set of factors stipulated in CAA section 211(o)(2)(B)(ii).
In the past several years the cellulosic biofuel industry has continued to make progress towards increased commercial scale production. Cellulosic biofuel production reached record levels in 2016, driven largely by compressed natural gas (CNG) and liquefied natural gas (LNG) derived from biogas. Cellulosic ethanol, while produced in much smaller quantities than CNG/LNG derived from biogas, was produced consistently on a commercial scale in 2015. Cellulosic ethanol production levels increased from existing facilities in 2016, and significant work continues to be done to enable the production of cellulosic ethanol at new facilities, as well as to increase production volumes at existing facilities in 2017 and beyond. In this rule we are proposing a cellulosic biofuel volume requirement of 238 million ethanol-equivalent gallons for 2018 based on Renewable Identification Number (RIN) generation data available to EPA through EMTS, the information we have received regarding individual facilities' capacities, production start dates and biofuel production plans, a review of cellulosic biofuel production relative to EPA's projections in previous annual rules, input from other government agencies, and EPA's own engineering judgment. We expect to update all of this information for the final rule, and to take into account the Energy Information Administration's (EIA) projection of cellulosic biofuel availability, which should be available in October 2017.
As part of estimating the volume of liquid cellulosic biofuel that will be made available in the U.S. in 2018, we considered all potential production sources by company and facility. This included facilities still in the commissioning or start-up phases, as
For 2018, EPA is proposing to use an industry wide, rather than a facility-by-facility approach to project the production of CNG/LNG derived from biogas. We believe this approach is appropriate due to the mature state of this technology and the large number of facilities that are registered to produce cellulosic biofuel RINs for these fuels. Further discussion on our projection of cellulosic biofuel production in 2018, including the factors considered and the way these factors were used to determine our proposed cellulosic biofuel projection, can be found in Section III.
The conditions that compelled us to reduce the 2017 volume requirement for advanced biofuel below the statutory target remain relevant in 2018. As for 2017, we investigated the ability of volumes of non-cellulosic advanced biofuels to backfill unavailable volumes of cellulosic biofuel in 2018, through domestic production or import. We took into account the various constraints on the ability of the market to make advanced biofuels available, the ability of the standards we set to bring about market changes in the time available, the potential impacts associated with diverting biofuels and/or biofuel feedstocks from current use to the production of advanced biofuel used in the United States, and the potential impact of the expiration of the biodiesel tax credit. Based on these considerations, along with consideration of the estimated cost of the non-cellulosic advanced biofuels most likely to be used to backfill for the shortfall in cellulosic biofuel, we are proposing to make a determination that it would not be appropriate to set an advanced biofuel standard that would require the market to backfill a portion of the shortfall in cellulosic biofuel.
We are proposing to exercise our cellulosic waiver authority to reduce the statutory applicable volume of advanced biofuel to a proposed volume requirement of 4.24 billion gallons for 2018. This proposed applicable volume for 2018 is 40 million gallons lower than the applicable volume for advanced biofuel for 2017.
Following our proposed determination of the appropriate volume reduction for advanced biofuel for 2018 using the cellulosic waiver authority, we calculated what the total renewable fuel volume would be if we provide the same level of reduction using the cellulosic waiver authority. The resulting volume would be 19.24 billion gallons. We then evaluated this total renewable fuel volume to determine if it is reasonably attainable given assessments of individual fuel types, including biodiesel, renewable diesel, ethanol (in the form of E10 or higher ethanol blends such as E15 or E85), and other renewable fuels.
We note that this proposal includes an assessment of E0 (ethanol-free gasoline) use that marks a change in how we have addressed this issue in past standard-setting rulemaking actions. In previous years, stakeholders have provided comment to EPA concerning the amount of E0 that is used in the United States each year for transportation fuel, and how such information should be used in development of the annual volume requirements. EPA has reassessed this issue, and we have found that use of E0 in 2016 was higher than we had assumed in setting the 2016 standards. Our proposal for 2018 includes consideration of this fact (see Section V.B.1).
In EISA, Congress specified increasing applicable volumes of BBD through 2012. Beyond 2012 Congress stipulated that EPA, in coordination with DOE and USDA, was to establish the BBD volume taking into consideration implementation of the program to date and various specified factors, providing that the required volume for BBD could not be less than 1.0 billion gallons. For 2013, EPA established an applicable volume of 1.28 billion gallons. For 2014 and 2015 we established the BBD volume requirement to reflect the actual volume for each of these years of 1.63 and 1.73 billion gallons.
Given current and recent market conditions, the advanced biofuel volume requirement is driving the production and use of biodiesel and renewable diesel volumes over and above volumes required through the separate BBD standard, and we expect this to continue. For 2019, EPA continues to believe that it would still be appropriate to provide a floor above the statutory minimum of 1 billion gallons to provide a guaranteed level of support for the continued production and use of BBD. However, we also believe that the volume of biomass-based diesel supplied in previous years demonstrates that the advanced biofuel standard is capable of incentivizing additional supply of these fuels above the volume required by the biomass-based diesel standard.
Thus, based on a review of the implementation of the program to date and all the factors required under the statute, and in coordination with USDA and DOE, we are proposing to maintain the applicable volume of BBD for 2019 at the same level finalized for 2018, 2.1
The renewable fuel standards are expressed as a volume percentage and are used by each producer and importer of fossil-based gasoline or diesel to determine their renewable fuel volume obligations. The percentage standards are set so that if each obligated party meets the standards, and if EIA projections of gasoline and diesel use for the coming year prove to be accurate, then the amount of renewable fuel, cellulosic biofuel, BBD, and advanced biofuel actually used will meet the applicable volumes used to derive the percentage standards.
Four separate percentage standards are required under the RFS program, corresponding to the four separate renewable fuel categories shown in Table I.A-1. The specific formulas we use in calculating the renewable fuel percentage standards are contained in the regulations at 40 CFR 80.1405. The percentage standards represent the ratio of renewable fuel volume to projected non-renewable gasoline and diesel volume. The volume of transportation gasoline and diesel used to calculate the proposed percentage standards was derived from reports published by the EIA, and we intend to update this information for the final rule. The proposed percentage standards for 2018 are shown in Table I.B.6-1. Detailed calculations can be found in Section VII, including the projected gasoline and diesel volumes used.
The Clean Air Act requires EPA to “reset” the statutory volume targets for future years through 2022 if annual volume requirements are waived (reduced) beyond one of two specified thresholds:
(1) At least 20 percent of the statutory volume target for 2 consecutive years; or
(2) At least 50 percent of the statutory volume target for a single year.
If either of these thresholds is reached, EPA is required to promulgate a rule within one year of the triggering waiver action that modifies the applicable volume targets for future years for the affected standard. However, the statute also indicates that 2016 is the first year to which any reset volume would apply.
In light of these requirements, the Administrator has directed EPA staff to initiate the required technical analysis to inform a reset rule.
When resetting the statutory targets, the EPA must comply with the processes, criteria, and standards set forth in CAA section 211(o)(2)(B)(ii). In addition to reviewing the implementation of the program during previous years and coordinating with the Secretary of Energy and the Secretary of Agriculture, the EPA must also analyze a number of factors:
• The impact of the production and use of renewable fuels on the environment, including on air quality, climate change, conversion of wetlands, ecosystems, wildlife habitat, water quality, and water supply;
• The impact of renewable fuels on the energy security of the United States;
• The expected annual rate of future commercial production of renewable fuels, including advanced biofuels in each category (cellulosic biofuel and BBD);
• The impact of renewable fuels on the infrastructure of the United States, including deliverability of materials, goods, and products other than renewable fuel, and the sufficiency of infrastructure to deliver and use renewable fuel;
• The impact of the use of renewable fuels on the cost to consumers of transportation fuel and on the cost to transport goods; and
• The impact of the use of renewable fuels on other factors, including job creation, the price and supply of agricultural commodities, rural economic development, and food prices.
EPA is not undertaking the analysis of these factors in this rulemaking. We are not soliciting comments on the reset rulemaking process at this time, but we are including mention of it in this Executive Summary in recognition of the importance of, and widespread interest in, a potential “reset rule.” Any comments received related to a possible future reset rule will be deemed beyond the scope of this rulemaking.
Some stakeholders have expressed concerns the current provisions related to RIN trading render the RFS program vulnerable to market manipulation. EPA takes such issues seriously. The RIN system was originally designed with an open trading market in order to maximize its liquidity and ensure a robust marketplace for RINs. However, EPA is interested in further assessing whether and how the current trading structure provides an opportunity for market manipulation. To that effect, EPA seeks comment and input on potential changes to the RIN trading system that might help address these concerns. EPA is not soliciting comment on any aspect of the current RFS regulatory program other than those specifically related to RIN trading, as mentioned above, and the proposed annual standards for 2018 and biomass-based diesel applicable volume for 2019. In particular, EPA is not re-opening for public comment in this rulemaking the current definition of “obligated party. ”
Separate from evaluating the RIN trading options in the RFS program, the EPA is working with appropriate market regulators to analyze targeted concerns of some stakeholders. For example, the EPA has executed a memorandum of understanding with the Commodity Futures Trading Commission (CFTC) and welcomes CFTC involvement in evaluating RIN market concerns.
In the meantime, EPA has continued to explore additional ways to increase program transparency in order to support the program and share data with all stakeholders. EPA already publishes RFS program data on our Web site, including data related to RIN generation, sales and holdings, and annual compliance. We are interested in providing more information, to the extent consistent with our obligations to protect confidential business information. EPA seeks comment on specific data elements and posting frequency that stakeholders believe would be useful to help with market transparency and liquidity.
In establishing the RFS program, Congress sought to bolster energy security and independence by boosting the amount of renewable fuels used in
In recent years increasing volumes of renewable fuels have been imported and used by obligated parties to comply with their RFS obligations. For example, data from EPA's EMTS system show that in 2016, 46 million gallons of ethanol and 731 million gallons of advanced biodiesel and renewable diesel were imported into the United States.
EPA is interested in stakeholder views on this topic and on what steps EPA might take to ensure energy independence and security. Furthermore, and in light of these considerations, EPA requests comment on whether or not to reduce the biomass-based diesel required volume below the level specified in this proposed rule for 2019. Finally, we request comment on whether and to what degree these considerations could support the use of the general waiver authority, inherent authority or other basis consistent with general construction of authority in the statute to reduce the required volume of advanced biofuel (with a corresponding reduction to the total renewable fuel requirement) below the level proposed for 2018.
The statute provides the EPA with the authority to reduce volume requirements below the applicable volume targets specified in the statute under specific circumstances. This section discusses those authorities and our use of the cellulosic waiver authority alone to set 2018 volume requirements for cellulosic biofuel, advanced biofuel, and total renewable fuel that are below the statutory volume targets.
Within this rulemaking action under CAA section 211(o)(3)(i), EPA is using its authority under CAA section 211(o)(7) to take an administrative action to reduce the required volumes of cellulosic biofuel, advanced biofuel, and total renewable fuel below the statutory volume targets.
In CAA section 211(o)(2), Congress specified increasing annual volume targets for total renewable fuel, advanced biofuel, and cellulosic biofuel for each year through 2022, and for BBD through 2012, and authorized EPA to set volume requirements for subsequent years in coordination with USDA and DOE, and after consideration of specified factors. However, Congress also recognized that under certain circumstances it would be appropriate for EPA to set volume requirements at a lower level than reflected in the statutory volume targets, and thus provided waiver provisions in CAA section 211(o)(7).
Section 211(o)(7)(D)(i) of the CAA provides that if EPA determines that the projected volume of cellulosic biofuel production for a given year is less than the applicable volume specified in the statute, that EPA must reduce the applicable volume of cellulosic biofuel required to the projected production volume for that calendar year. In making this projection, EPA must take a “neutral aim at accuracy.”
CAA section 211(o)(7)(D)(i) also provides EPA with the authority to reduce the applicable volume of total renewable fuel and advanced biofuel in years where it reduces the applicable volume of cellulosic biofuel. The reduction must be less than or equal to the reduction in cellulosic biofuel. For 2018, we are also proposing to reduce applicable volumes of advanced biofuel and total renewable fuel under this authority.
The cellulosic waiver authority is discussed in detail in the preamble to the 2017 final rule. See also,
EPA is proposing an equal reduction from the statutory volume targets for advanced biofuels and total renewable fuel, as was our approach in using the cellulosic waiver authority for the 2014-2017 standards. EPA's reasoning for an equal reduction is explained in the 2017 final rule.
Section 211(o)(7)(A) of the CAA provides that EPA, in consultation with the Secretary of Agriculture and the Secretary of Energy, may waive the applicable volumes specified in the Act in whole or in part based on a petition by one or more States, by any person subject to the requirements of the Act, or by the EPA Administrator on his own motion. Such a waiver must be based on a determination by the Administrator, after public notice and opportunity for comment that (1) implementation of the requirement would severely harm the economy or the environment of a State, a region or the United States, or (2) there is an inadequate domestic supply.
Based on a preliminary evaluation of the availability of renewable fuel in the market, regarding which we seek public comment, EPA is not proposing to use the general waiver authority to further reduce volumes for 2018. However, EPA solicits comments on whether it is appropriate to exercise the general waiver authority and will evaluate comments and updated data in considering whether such an approach is warranted.
Consistent with our approach in the 2013, 2014-16, and 2017 final rules, we have also considered the availability and role of carryover RINs in evaluating whether we should exercise our discretion to use the cellulosic waiver authority in setting the cellulosic, advanced, and total volume requirements for 2018. Neither the statute nor EPA regulations specify how or whether EPA should consider the availability of carryover RINs in exercising its cellulosic waiver authority.
An adequate RIN bank serves to make the RIN market liquid. Just as the economy as a whole functions best when individuals and businesses prudently plan for unforeseen events by maintaining inventories and reserve money accounts, we believe that the RFS program functions best when sufficient carryover RINs are held in reserve for potential use by the RIN holders themselves, or for possible sale to others that may not have established their own carryover RIN reserves. Were there to be no RINs in reserve, then even minor disruptions causing shortfalls in renewable fuel production or distribution, or higher than expected transportation fuel demand (requiring greater volumes of renewable fuel to comply with the percentage standards that apply to all volumes of transportation fuel, including the unexpected volumes) could lead to the need for a new waiver of the standards, undermining the market certainty so critical to the RFS program. However, a significant drawdown of the carryover RIN bank leading to a scarcity of RINs may stop the market from functioning in an efficient manner, even where the market overall could satisfy the standards. For all of these reasons, the collective carryover RIN bank provides a needed programmatic buffer that both facilitates individual compliance and provides for smooth overall functioning of the program.
At the time of the 2017 final rule, we estimated that there would be at most 1.54 billion carryover RINs available for compliance with the 2017 standards and decided that carryover RINs should not be counted on to avoid or minimize the need to reduce the 2017 statutory volume targets. We also stated that we may or may not take a similar approach in future years, and that we would evaluate the issue on a case-by-case basis considering the facts present in future years. Since that time, obligated parties have submitted their compliance demonstrations for the 2015 and 2016 compliance years and we now estimate that there are now at most 2.06 billion carryover RINs available,
Therefore, for the reasons noted above, and consistent with the approach we took in the 2014-2016 and 2017 final rules, we are proposing that, under current circumstances, an intentional drawdown of the carryover RIN bank should not be assumed in establishing the 2018 volume requirements. The current bank of carryover RINs will provide an important and necessary programmatic buffer that will both facilitate individual compliance and provide for smooth overall functioning of the program. Therefore, we are not proposing to set the renewable fuel volume requirements at levels that would envision a drawdown in the bank of carryover RINs.
In the past several years the cellulosic biofuel industry has continued to make progress towards increased commercial-scale production. Cellulosic biofuel production reached record levels in 2016, driven largely by CNG and LNG derived from biogas.
In order to project the volume of cellulosic biofuel production in 2018 we considered data reported to EPA through EMTS along with information we collected through meetings with representatives of facilities that have produced or have the potential to produce qualifying volumes of cellulosic biofuel for consumption as transportation fuel, heating oil, or jet fuel in the U.S. in 2018. Upon receipt of EIA's projection of cellulosic biofuel production for 2018, EPA will consider these estimates, together with updated information regarding the potential for contributions from individual facilities and groups of facilities, in determining the projected volume of cellulosic biofuel production in 2018 for the final rule.
In this proposed rule we use the same general methodology as in the 2017 final rule to project the range of potential production volumes of liquid cellulosic biofuel, however we have adjusted the percentile values used to select a point estimate within a projected production range for each group of companies based on recent information, and with the objective of improving the accuracy of the projections. We use a new methodology to project the production of cellulosic biofuel RINs for CNG/LNG derived from biogas that reflects the mature status of this industry and the large number of facilities registered to generate cellulosic biofuel RINs from these fuels. These methodologies are described in more detail in Section III.C below.
New cellulosic biofuel production facilities projected to be brought online in the United States over the next few years could increase the production capacity of the cellulosic industry. Operational experience gained at the first few commercial scale cellulosic biofuel production facilities could also lead to increased production of cellulosic biofuel from existing production facilities. Section B, below, discusses the companies the EPA reviewed in the process of projecting qualifying cellulosic biofuel production in the United States in 2018. Information on these companies forms the basis for our projection of 238 million ethanol-equivalent gallons of cellulosic biofuel produced for use as transportation fuel, heating oil, or jet fuel in the United States in 2018.
The volumes of renewable fuel to be produced and used as transportation fuel under the RFS program each year (absent an adjustment or waiver by EPA) are specified in CAA section 211(o)(2). The volume of cellulosic biofuel specified in the statute for 2018 is 7 billion gallons. The statute provides that if EPA determines, based on EIA's estimate, that the projected volume of cellulosic biofuel production in a given year is less than the statutory volume, then EPA shall reduce the applicable volume of cellulosic biofuel to the projected volume available during that calendar year.
In addition, if EPA reduces the required volume of cellulosic biofuel below the level specified in the statute, the Act also indicates that we may reduce the applicable volumes of advanced biofuels and total renewable fuel by the same or a lesser volume, and we are required to make cellulosic waiver credits available.
In order to project cellulosic biofuel production for 2018, we have tracked the progress of several dozen potential cellulosic biofuel production facilities. As we have done in previous years, we have focused on facilities with the potential to produce commercial-scale volumes of cellulosic biofuel rather than small R&D or pilot-scale facilities. Larger commercial-scale facilities are much more likely to generate RINs for the fuel they produce and the volumes they produce will have a far greater impact on the cellulosic biofuel standard for 2018. The volume of cellulosic biofuel produced from R&D and pilot-scale facilities is quite small in relation to that expected from the commercial-scale facilities. R&D and demonstration-scale facilities have also generally not generated RINs for the fuel they have produced in the past. Their focus is on developing and demonstrating the technology, not producing commercial volumes. RIN generation from R&D and pilot-scale facilities in previous years has not contributed significantly to the overall number of cellulosic RINs generated.
From this list of commercial-scale facilities we used information from EMTS, publically available information (including press releases and news reports), and information provided by representatives of potential cellulosic
The methodology used by EPA to project cellulosic biofuel production in 2015-2017 has resulted in a total cellulosic biofuel production projection that was lower than the actual number of cellulosic RINs made available in 2015,
EPA's projections of liquid cellulosic biofuel, however, were higher than the actual volume of liquid cellulosic biofuel produced in both 2015 and 2016. We believe that new data warrants a change to the methodology for projecting liquid cellulosic biofuel in an effort to make the projections more accurate. We are therefore proposing to adjust the percentile values used to project liquid cellulosic biofuel production based on actual liquid cellulosic biofuel production in 2016. We believe that the use of this methodology, with the adjusted approach to developing the percentile values used to project production volumes for liquid cellulosic biofuels, results in a projection that reflects a neutral aim at accuracy since it accounts for expected growth in the near future, and does so in a way that directly reflects the accuracy of EPA's projections in the most recent year (2016) for which complete data is available.
In previous years we used the same methodology for CNG/LNG derived from biogas as for liquid cellulosic biofuel, but with different percentile values reflecting the more established nature of the CNG/LNG industry relative to liquid cellulosic biofuel production. For 2018, EPA is proposing to use an industry wide approach, rather than an approach that projects volumes for individual companies or facilities, to project the production of CNG/LNG derived from biogas. This updated approach reflects the fact that this industry is far more mature than the liquid cellulosic biofuel industry, and that there are a large number of facilities registered to generate cellulosic biofuel RINs from biogas, rendering a facility-by-facility analysis difficult and of questionable need for purposes of accuracy. As described in Section V.C.2 below, EPA is instead proposing to use the rate of growth in the renewable CNG/LNG industry observed between the first five months of 2016 and the first five months of 2017,
For the final rule we intend to review all available data with respect to cellulosic biofuel production in 2017 for the months for which data will be available. We will consider that information, together with comments received and updated information on the status of potential production facilities, to make any appropriate adjustments to the methodology and/or projected production volume in the final rule. The remainder of this Section discusses the companies and facilities EPA expects to be in a position to produce commercial-scale volumes of cellulosic biofuel by the end of 2018 and describes in more detail the methodology EPA is proposing to use to project cellulosic biofuel production in 2018 (including a review of cellulosic biofuel production and the accuracy of the projection methodology in previous years). This information forms the basis for the proposed applicable volume for cellulosic biofuel for 2018.
There are a number of companies and facilities
In addition to the potential sources of cellulosic biofuel located in the United States, there are several foreign cellulosic biofuel companies that may produce cellulosic biofuel in 2018. These include facilities owned and operated by Beta Renewables, Enerkem, Ensyn, GranBio, and Raizen. All of these facilities use fuel production pathways that have been approved by EPA for cellulosic RIN generation provided eligible sources of renewable feedstock are used and other regulatory requirements are satisfied. These companies would therefore be eligible to register these facilities under the RFS program and generate RINs for any qualifying fuel imported into the United States. While these facilities may be able to generate RINs for any volumes of cellulosic biofuel they import into the United States, demand for the cellulosic biofuels they produce is expected to be high in their own local markets.
EPA is charged with projecting the volume of cellulosic biofuel that will be produced or imported into the United States. For the purposes of this proposed rule we have considered all of the registered foreign facilities under the RFS program to be potential sources of cellulosic biofuel in 2018. We believe that due to the strong demand for cellulosic biofuel in local markets, the significant technical challenges associated with the operation of cellulosic biofuel facilities, and the time necessary for potential foreign cellulosic biofuel producers to register under the RFS program and arrange for the importation of cellulosic biofuel to the United States, cellulosic biofuel imports from foreign facilities not currently registered to generate cellulosic biofuel RINs are generally highly unlikely in 2018. For purposes of our 2018 cellulosic biofuel projection we have, with only one exception (described below) excluded from our proposal potential volumes from foreign cellulosic biofuel production facilities that are not currently registered under the RFS program. Two foreign facilities (Ensyn's Renfrew facility and the CNG/LNG facility Complexe Enviro Progressive Ltee) that have registered as cellulosic biofuel producers have already generated cellulosic biofuel RINs for fuel exported to the United States; projected volumes from each of these facilities are included in our projection of available volumes for 2018. Three additional foreign facilities (Gran Bio's Bioflex Agroindustrial S/A, Saint-Thomas Biomethane Plant, and Raizen's Costa Pinto) have registered as cellulosic biofuel producers, but have not yet generated any cellulosic RINs. EPA attempted to contact representatives from these facilities to inquire about their intentions to export cellulosic biofuel to the United States in 2018. In two cases (Gran Bio's Bioflex Agroindustrial S/A and Saint-Thomas Biomethane Plant), company representatives indicated they intended to export cellulosic biofuel to the United States, and EPA believes that there is sufficient reason to believe imports of cellulosic biofuel from these companies are likely. Finally, EPA has included projected volume from one foreign facility (Ensyn's Port-Cartier, Quebec facility) that is not currently registered to generate cellulosic biofuel RINs under the RFS program. We believe that it is appropriate to include volume from this facility in light of the facility's proximity to the United States, the proven technology used by the facility, the volumes of cellulosic biofuel exported to the United States by the company in previous years, and the company's stated intention to market all of the fuel produced at this facility to qualifying markets in the United States. All of the facilities included in EPA's cellulosic biofuel projection for 2018 are listed in Table III.B.3-1 below.
General information on each of the cellulosic biofuel producers (or group of producers in the case of producers of CNG/LNG derived from biogas and facilities using Edeniq's technology) that factored into our projection of cellulosic biofuel production for 2018 is shown in Table III.B.3-1. This table includes both facilities that have already generated cellulosic RINs, as well as those that have not yet generated cellulosic RINs, but are projected to do so by the end of 2018. As discussed above, we have focused on commercial-scale cellulosic biofuel production facilities. Each of these facilities (or group of facilities) is discussed further in a memorandum to the docket.
For our 2018 liquid cellulosic biofuel projection, we use a modified version the same general methodology we used in establishing the cellulosic biofuel volume standards for 2015 (the final three months for which data were not available), 2016, and 2017. This methodology is briefly described here, and is described in detail in the 2017 annual rule.
The projected ranges for liquid cellulosic biofuel production in 2016, along with the percentile values used to project a production volume within the calculated ranges and the actual number of cellulosic RINs generated in 2016 that are available for compliance, are shown in Table III.C.1-1 below.
Since
EPA also considered whether it would be appropriate to modify other individual components of the past methodology for liquid cellulosic biofuel based on a narrow consideration of each factor, but we do not believe there is currently sufficient information to support these changes. Making the single proposed adjustment to the percentile values used in the methodology should, we believe, provide an appropriate adjustment to the methodology that reflects recent past experience. We acknowledge, however, that using the calculated percentile values from previous years to project liquid cellulosic biofuel production in future years does not eliminate the possibility that actual production will differ from our projections. This is especially true for the liquid cellulosic biofuel industry, which is currently in the early stages of commercialization. We will continue to evaluate the success of this methodology, including a consideration of the data on cellulosic biofuel production in 2017 available at the time of the final rule, and will consider adjusting the methodology if it appears warranted. If the methodology appears to be projecting volumes that are significantly higher or lower than actual production volumes for months in 2017 for which data is available (after taking into account the seasonality of RIN generation and the expected ramp-up of production volumes in the latter half of 2017) we may consider adjustments to the methodology used in the final rule, such as further adjusting the percentile values used to project liquid cellulosic biofuel production within the projected range for a group of companies, or creating new groupings of companies with similar types and levels of risk associated with cellulosic biofuel production. We request comment on our methodology and adjustments that could be made to increase the accuracy of the projection.
Consistent with our approach for 2016 and 2017, to project liquid cellulosic biofuel production in 2018 we separated the list of potential producers of cellulosic biofuel into two groups according to whether or not the facilities have achieved consistent commercial-scale production and cellulosic biofuel RIN generation (See Table III.C.1-2 through Table III.C-.1-3). We next defined a range of likely production volumes for each group of potential cellulosic biofuel producers. The low end of the range for each group of producers reflects actual RIN generation data over the last 12 months for which data are available at the time our technical assessment was completed (April 2016-March 2017). For potential producers that have not yet generated any cellulosic RINs, the low end of the range is zero. For the high end of the range of production volumes for companies expected to produce liquid cellulosic biofuel we considered a variety of factors, including the expected start-up date and ramp-up period,
After defining likely production ranges for each group of companies we used the percentile values described earlier in this section to project a production volume within the production ranges. We used the 1st and 43rd percentiles, respectively, for liquid cellulosic biofuel producers without and with a history of consistent cellulosic biofuel production and RIN generation. The resulting projections for liquid cellulosic biofuel in 2018 are shown in Table III.C.1-4 below.
We believe our range of projected production volumes for each company (or group of companies for those using the Edeniq technology) reasonably represents the range of potential production volumes for each company, and that projecting overall production in 2018 in the manner described above results in a neutral estimate (neither biased to produce a projection that is either too high or too low) of likely liquid cellulosic biofuel production in 2018 (17 million gallons).
For 2018, EPA is proposing to use a new methodology to project production of CNG/LNG derived from biogas used as transportation fuel. We believe a new methodology is warranted for purposes of this rule for two primary reasons: The over-projection of CNG/LNG derived from biogas in 2016 and, the relative maturity of the CNG/LNG industry relative to the liquid cellulosic biofuel industry. EPA's projection of the production of CNG/LNG derived from biogas in 2016 was 207 million ethanol-equivalent gallons. Actual production of cellulosic biofuel RINs for CNG/LNG derived from biogas that were available for compliance in 2016 was 185 million gallons, suggesting that the approach we took to projecting CNG/LNG derived from biogas in 2016 resulted in an overestimate by 22 million ethanol-equivalent gallons. More importantly, we believe that the technology and market for CNG/LNG derived from biogas used as transportation fuel is sufficiently mature that a facility-by-facility assessment of potential production is unnecessary, and is not the most appropriate method for projecting the production of these fuels in 2018 across the entire industry.
EPA is proposing to use an industry-wide approach, rather than a projecting production from each specific facility or company, to project the 2018 production of CNG/LNG derived from biogas. EPA has calculated the observed year-over-year growth in the number of RINs generated for CNG/LNG derived from biogas based on data from the first five months of both 2016 and 2017.
Under the assumption that this growth rate based on five months of data is representative of the annual growth rate, EPA then applied this 9.3% growth rate to the total number of 2016 cellulosic RINs generated for CNG/LNG that were available for compliance (185.14 million) to project the production of cellulosic RINs from these fuels in 2017, and then repeated the calculation to arrive at a projection for 2018. This methodology results in a projection of 221.2 million gallons of CNG/LNG derived from biogas in 2018.
After projecting production of cellulosic biofuel from liquid cellulosic biofuel production facilities and producers of CNG/LNG derived from biogas, EPA combined these projections to project total cellulosic biofuel production for 2018. These projections are shown in Table III.C.3-1. Using the methodologies described in this section,
A brief overview of individual companies we believe will produce cellulosic biofuel and make it commercially available in 2018 can be found in a memorandum to the docket.
The national volume targets for advanced biofuel to be used under the RFS program each year through 2022 are specified in CAA section 211(o)(2)(B)(i)(II). Congress set annual renewable fuel volume targets that envisioned growth at a pace that far exceeded historical growth and, for years after 2011, prioritized that growth as occurring principally in advanced biofuels (contrary to previous growth patterns where most growth was in conventional renewable fuel, principally corn-ethanol). Congressional intent is evident in the fact that the portion of the total renewable fuel volume target in the statutory volume tables that is not required to be advanced biofuel is 15 billion gallons for all years after 2014, while the advanced volumes, driven by growth in cellulosic volumes, continue to grow through 2022 to a total of 21 billion gallons.
We have evaluated the capabilities of the market and are proposing to find that the 11.0 billion gallons specified in the statute for advanced biofuel cannot be reached in 2018. This is primarily due to the expected continued shortfall in cellulosic biofuel; production of this fuel type has consistently fallen short of the statutory targets by 95 percent or more, and as described in Section III, it will fall far short of the statutory target of 7.0 billion gallons again in 2018. In addition, although for the 2016 and 2017 standards we determined that the projected reasonably attainable supply of non-cellulosic advanced biofuel and other considerations justified establishing standards that include a partial backfill of the shortfall in cellulosic biofuel, for reasons described in this section we are not proposing such partial backfilling for 2018.
In previous years when exercising the cellulosic waiver authority to determine the required volume of advanced biofuel, we have taken into account the availability of advanced biofuels, their energy security and GHG benefits, and the apparent intent of Congress as reflected in the statutory volumes tables to substantially increase the use of advanced biofuels over time, as well as factors such as increased costs associated with the use of advanced biofuels and the environmental and food competition concerns raised by some commenters. In considering these factors, in those years, we have concluded that it was appropriate to set the advanced biofuel standard in a manner that would allow the partial backfilling of missing cellulosic volumes with non-cellulosic advanced biofuels. For purposes of this NPRM we are focusing primarily on the availability of advanced biofuels, their GHG and energy security benefits, and the costs associated with increased advanced biofuel mandates to propose no such backfilling with non-cellulosic advanced biofuel volumes in 2018. In other words, we propose to reduce the statutory volume target for advanced biofuel by the same amount as our proposed reduction in cellulosic biofuel. This action takes into account the fact that the substantial growth in advanced biofuel volumes after 2015 that was anticipated by Congress, and reflected in the statutory tables, was to be driven primarily by increases in cellulosic biofuel as opposed to non-cellulosic advanced biofuels. In addition, we recognize that the proposed approach involves placing a greater reliance on cost considerations than we have in past rulemakings. We believe this proposed new approach to balancing relevant considerations and exercising our discretion under the cellulosic waiver authority is permissible under the statute, and consistent with the principles articulated in
We note that the predominant non-cellulosic advanced biofuels available in the near term are advanced biodiesel and renewable diesel. We expect a decreasing rate of growth in the availability of feedstocks used to
We believe that the factors and considerations noted above are all appropriately considered in our exercise of the broad discretion provided under the cellulosic waiver authority, and that a comprehensive consideration of these factors supports our proposed approach.
If finalized, the net impact of today's proposal would be that the volume requirement for advanced biofuel for 2018 would be 40 million gallons less than the applicable volume used to derive the 2017 percentage standard.
As described in Section II.A, when making reductions in advanced biofuel and total renewable fuel under the cellulosic waiver authority, the statute limits those reductions to no more than the reduction in cellulosic biofuel. As described in Section III.D, we are proposing a 2018 applicable volume for cellulosic biofuel of 238 million gallons, representing a reduction of 6,762 million gallons from the statutory target of 7,000 million gallons. As a result, 6,762 million gallons is the maximum volume reduction for advanced biofuel and total renewable fuel that is permissible using the cellulosic waiver authority.
We are authorized under the cellulosic waiver authority to reduce the advanced biofuel and total renewable fuel volumes “by the same or a lesser” amount as the reduction in the cellulosic biofuel volume. Thus, we are not required to use the authority to its maximum extent. Indeed, in exercising the cellulosic waiver authority in setting standards for 2014-2017, we did not use the full extent of the authority. As discussed in Section II.A, EPA has broad discretion in using the cellulosic waiver authority in instances where its use is authorized under the statute, since Congress did not specify factors that EPA must consider in determining whether to use the authority or what appropriate volume reductions (within the range permitted by statute) should be. Thus, EPA could potentially set the 2018 advanced biofuel standard at a level that is designed to partially backfill for the shortfall in cellulosic biofuel. However, based on our consideration of the factors described in more detail below, we are proposing to use the full extent of the cellulosic waiver authority. The proposed advanced biofuel applicable volume is, therefore, 4.24 billion gallons.
After use of the cellulosic waiver authority to reduce volumes of cellulosic biofuel, the statute does not specify conditions or any criteria or factors that EPA should consider in determining whether, and to what extent, to use the authority to reduce advanced biofuel and total renewable
As noted above, a higher advanced biofuel volume requirement has a greater potential to increase the incentive for switching advanced biofuel feedstocks from existing uses to biofuel production. Such market reactions could cause disruptions and/or price increases in the non-biofuel markets that currently use these feedstocks. Increasing the required volumes of advanced biofuels without giving the market adequate time to adjust by increasing supplies could also result in diversion of advanced biofuels from foreign countries to the U.S. without increasing total global supply. Increasing the supply of advanced biofuels in this way (by shifting the end use of advanced feedstocks to biofuel production and satisfying the current markets for these advanced feedstocks with non-qualifying or petroleum based feedstocks or simply shifting advanced biodiesel or renewable diesel from foreign to domestic use) would likely not produce the additional GHG benefits that might otherwise be expected. We are proposing that we not set the advanced volume requirement at a level that would require such diversions. Our individual assessments of reasonably attainable volumes reflect this approach. That is, while we refer to them as “reasonably attainable” volumes for convenience, they represent those volumes that are not likely to lead to feedstock diversions. Greater volumes could likely be made available if feedstock diversions were not of concern.
The predominant available source of advanced biofuel other than cellulosic biofuel and BBD is imported sugarcane ethanol. For both the 2016 and 2017 standards, we used a volume of 200 million gallons of imported sugarcane ethanol for purposes of determining the reasonably attainable volume of advanced biofuel. In using this volume of sugarcane ethanol, we attempted to balance indications of lower potential imports from recent data with indications that higher volumes were possible based on older data. We also pointed to the high variability in ethanol import volumes in the past (including of Brazilian sugarcane ethanol, the predominant form of imported ethanol, and the only significant source of imported advanced ethanol), increasing gasoline consumption in Brazil, and variability in Brazilian production of sugar as reasons that it would be inappropriate to assume that sugarcane ethanol imports would reach the much higher levels suggested by some stakeholders.
The data currently available on 2016 ethanol imports suggests that we overestimated the volume of sugarcane ethanol imports for that year. Despite the fact that the applicable standards for 2016 were set prior to the beginning of 2016, and despite suggestions from UNICA
While the low import levels of sugarcane ethanol in 2014 and 2015 could, at least in part, be attributed to the fact that the applicable RFS standards had not been set prior to the beginning of the compliance period, this was not true for 2016. The experience in 2016 suggests that 200 million gallons may be too high for the purposes of projecting reasonably attainable volumes of advanced biofuel for 2018. At the same time, higher import volumes than those which occurred in 2016 are clearly possible, and could potentially be achieved under the influence of a higher RFS standard. Taking all of these considerations into account, we propose to use 100 million gallons of imported sugarcane ethanol for the purposes of projecting reasonably attainable volumes of advanced biofuel for 2018. This level takes into account the lower than expected import volumes that occurred in 2016, but also the fact that higher volumes have occurred in past years.
We recognize that there are factors that could result in lower import volumes of sugarcane ethanol in 2018 than 100 million gallons. These include weather and harvests in Brazil, world ethanol demand and prices, and constraints associated with the E10 blendwall in the U.S. Also, global sugar consumption has continued to increase steadily, while production has decreased. If the trend continues, Brazilian production of sugar could increase, with a concurrent reduction in production of ethanol.
With regard to biodiesel and renewable diesel, there are many different factors that could potentially influence the
However, the primary considerations in our determination of the reasonably attainable volumes of
The volume of advanced biodiesel and renewable diesel projected to be available based on a consideration of these factors is less than the total volume of biodiesel and renewable diesel we believe could be produced (based solely on an assessment of the available production capacity) or consumed (based on an assessment of the ability of the market to distribute and use biodiesel and renewable diesel). Production capacity and the ability for the market to distribute and use biodiesel and renewable diesel are therefore not constraining factors in our assessment of the reasonably attainable volume of advanced biodiesel and renewable diesel in 2018.
Before considering the projected growth in the production of qualifying feedstocks that could be used to produce advanced biodiesel and renewable diesel, it is helpful to review the supply of biodiesel and renewable diesel to the United States in recent years. While historic data and trends alone are insufficient to project the volumes of biodiesel and renewable diesel that could be provided in future years, historic data can serve as a useful frame of reference in considering future volumes. Past experience suggests that a high percentage of the biodiesel and renewable diesel used in the United States (from both domestic production and imports) qualifies as advanced biofuel.
Since 2011 the year-over-year changes in the volume of advanced biodiesel and renewable diesel in the United States have varied greatly, from a low of negative 61 million gallons from 2011 to 2012 to a high of 779 million gallons from 2015 to 2016. These changes were likely influenced by a number of factors such as the cost of biodiesel feedstocks and petroleum diesel, the status of the biodiesel blenders tax credit, growth in marketing of biodiesel at high volume truck stops and centrally fueled fleet locations, demand for biodiesel and renewable diesel in other countries, biofuel policies in both the United States and foreign countries, and the volumes of renewable fuels (particularly advanced biofuels) required by the RFS. This historical information does not indicate that the maximum previously observed increase of 779 million gallons of advanced biodiesel and renewable diesel would be reasonable to expect from 2017 to 2018, nor does it indicate that the low growth rates observed in other years represent the limit of potential growth in 2018. Rather, these data illustrate both the magnitude of the increases in advanced biodiesel and renewable diesel in previous years and the significant variability in these increases.
The historic data indicates that the biodiesel tax policy in the United States can have a significant impact on the supply of biodiesel and renewable diesel in any given year. While the biodiesel blenders tax credit has applied in each year from 2010-2016, it has only been in effect during the calendar year in 2011, 2013 and 2016, while other years it has been applied retroactively. The biodiesel blenders tax credit expired at the end of 2009 and was re-instated to apply retroactively in 2010 and extend through the end of 2011 in December 2010. Similarly, after expiring at the end of 2011, 2013, and 2014 the tax credit was re-instated in January 2013 (for 2012 and 2013), December 2014 (for 2014), and December 2015 (for 2015 and 2016). Each of the years in which the biodiesel blenders tax credit was in effect during the calendar year (2013 and 2016) resulted in significant increases in the supply of advanced biodiesel and renewable diesel over the previous year (653 million gallons and 779 million gallons respectively). However, following this large increase in 2013, the supply of advanced biodiesel and renewable diesel in 2014 and 2015 was minimal, only 33 million gallons from 2013 to 2015. This pattern is likely the result of both accelerated production and/or importation of biodiesel and renewable diesel in the final few months of 2013 to take advantage of the expiring tax credit as well as relatively lower volumes of biodiesel and renewable diesel production and import in 2014 and 2015 than would have occurred if the tax credit had been in place.
We believe it is reasonable to anticipate a similar production pattern in 2016 through 2018 as observed in 2013 through 2015; that increases in the volumes of advanced biodiesel and renewable diesel will be modest in 2017-2018, following a significant increase in 2016. Available RIN generation data further supports this pattern. Very high volumes of advanced biodiesel and renewable diesel were supplied in the last quarter of 2016, likely driven by a desire to capture the expiring tax credit, while significantly smaller volumes of these fuels were supplied in the first quarter of 2017.
In addition to a review of the historical supply of advanced biodiesel and renewable diesel and consideration of the possible impact of the expiration of the biodiesel tax credit (discussed above) EPA has also focused on the expected increase in the availability of advanced biodiesel and renewable diesel feedstocks in 2018 in projecting the reasonably attainable volume of biodiesel and renewable diesel in the context of the 2018 advanced biofuel standard. We acknowledge that the availability of advanced biodiesel and renewable diesel in 2018 is not strictly tied to the increase in the availability of the feedstocks used to produce these fuels, and that it may be possible to realize higher volumes of advanced biodiesel and renewable diesel in 2018 through a diversion of advanced feedstocks from other uses, or a diversion of advanced biodiesel and renewable diesel from existing markets in other countries. We perceive the net benefits associated with such increased advanced biofuel and renewable fuel supply to be significantly less than the net benefits associated with the production of additional advanced biodiesel and renewable diesel with the use of newly-available advanced feedstocks. This is both because of the potential disruption and associated cost impacts to other industries resulting from feedstock switching, as well as reduced GHG reduction benefit related to use of feedstocks for biofuel production that would have been used for other purposes, and must now be backfilled with other feedstocks with potentially lesser environmental benefits. By focusing our assessment of the reasonably attainable volume of biodiesel and renewable diesel on the expected growth in the production of advanced feedstocks (rather than the total supply of these feedstocks in 2018, which would include feedstocks currently being used for non-biofuel purposes), we are attempting to minimize the incentives for the RFS program to increase the supply of advanced biodiesel and renewable diesel through feedstock switching.
Advanced biodiesel and renewable diesel feedstocks include both waste oils, fats and greases and oils from planted crops. While we believe a small
Increasing the demand for advanced biodiesel and renewable diesel beyond the projected increase in the feedstocks used to produce these fuels would likely require diverting volumes of advanced biodiesel and renewable diesel (or the feedstocks used to produce these fuels) from existing markets to be used to produce biofuels supplied to the United States. Increasing the short-term supply of advanced biodiesel and renewable diesel to the United States in this manner (simply shifting the end use of advanced feedstocks to biodiesel and renewable diesel production and meeting non-biofuel demand for these feedstocks with conventional renewable and/or petroleum based feedstocks) may not advance the full GHG or energy security goals of the RFS program. In a worst case scenario, higher standards could cause supply disruptions to a number of markets as biodiesel and renewable diesel producers seek additional supplies of advanced feedstocks and the parties that previously used these feedstocks, both within and outside of the fuels marketplace, seek out alternative feedstocks. This could result in significant cost increases, for both biodiesel and renewable diesel as well as other products produced from renewable oils.
We believe the most reliable source for projecting the expected increase in vegetable oils in the United States is USDA's World Agricultural Supply and Demand Estimates (WASDE). At this time the most current version of the WASDE report only projects domestic vegetable oil production through 2017. Based on domestic vegetable oil production from 2011-2016 as reported by WASDE, the average annual increase in vegetable oil production in the United States was 0.288 million metric tons per year.
In addition to virgin vegetable oils, we also expect increasing volumes of distillers corn oil to be available for use in 2018. The WASDE report does not project distillers corn oil production, so EPA must use an alternative source to project the growth in the production of this feedstock. EPA is proposing to use the results of the World Agricultural Economic and Environmental Services (WAEES) model to project the growth in the production of distillers corn oil.
We have also considered the expected increase in the imports of advanced biodiesel and renewable diesel produced in other countries. In previous years, significant volumes of foreign produced advanced biodiesel and renewable diesel have been supplied to markets in the United States (see Table IV.B.2-1 above). These significant imports were likely the result of a strong U.S. demand for advanced biodiesel and renewable diesel, supported by both the RFS standards, the LCFS in California, and the biodiesel blenders tax credit. At this time the impacts of the expiration of the biodiesel blenders tax credit on the volumes of foreign-produced biodiesel and renewable diesel imported into the United States, is highly uncertain. In light of this uncertainty, we do not believe it is reasonable at this point to project increasing volumes of imported advanced biodiesel and renewable diesel in 2018, and for the purposes of projecting the reasonably attainable volume of advanced biodiesel and renewable diesel in 2018 we have assumed that imported volumes of biodiesel and renewable diesel will not increase from the volumes imported in 2017.
After a careful consideration of the historic supply of advanced biodiesel and renewable diesel to the United States in previous years, the likely impact of the expiration of the biodiesel tax credit, and an assessment of the availability of feedstocks used to produced advanced biodiesel and renewable diesel in 2018, EPA has determined, for the purposes of our proposal, that approximately 2.5 billion gallons of advanced biodiesel and renewable diesel is reasonably attainable for use in our determination of the advanced biofuel standard for 2018. This volume is 100 million gallons higher than the volume of advanced biodiesel and renewable diesel determined to be reasonably attainable and appropriate for the purposes of deriving the advanced biofuel standard in 2017.
The 100 million gallon increase in advanced biodiesel and renewable diesel that we project will be reasonably attainable for 2018 represents a smaller annual increase in advanced biodiesel and renewable diesel than we assumed in deriving the 2017 advanced biofuel standard (approximately 300 million gallons). We believe that this is reasonable because the circumstances we are facing in this action are different from those we were facing in the 2017 final rule. The primary differences are a smaller projected increase in advanced feedstock production in the United States and the expiration of the biodiesel tax credit. While the biodiesel blenders tax credit was still in effect at the end of 2016 when EPA completed the 2017 final rule, this tax credit has since expired. It is uncertain whether the tax credit will be renewed for 2017 and 2018 as it has in the past.
In addition to cellulosic biofuel, imported sugarcane ethanol, and advanced biodiesel and renewable diesel, there are other advanced biofuels that can be counted in the determination of reasonably attainable volumes of advanced biofuel for 2018. These other advanced biofuels include biogas, naphtha, heating oil, butanol, jet fuel, and domestically-produced advanced ethanol. However, the supply of these fuels has been relatively low in the last several years.
The downward trend over time in biogas as advanced biofuel with a D code of 5 is due to the re-categorization in 2014 of landfill biogas from advanced (D code 5) to cellulosic (D code 3).
We recognize that the potential exists for additional volumes of advanced biofuel from sources such as jet fuel, liquefied petroleum gas (LPG), and liquefied natural gas (as distinct from compressed natural gas), as well as non-cellulosic biogas such as from digesters. However, since they have been produced in only de minimis amounts in the past, we do not have a basis for projecting substantial volumes from these sources in 2018. For the final rule, we may modify our projection of 60 million gallons for other advanced biofuel as information becomes available.
The total volume of advanced biofuel that we believe is reasonably attainable in 2018 is the combination of cellulosic biofuel and the sources described above: Imported sugarcane ethanol, biodiesel and renewable diesel which qualifies as BBD, and other advanced biofuels such as advanced biogas that does not qualify as cellulosic biofuel, heating oil, naphtha, domestic advanced ethanol, and advanced renewable diesel that does not qualify as BBD. Our assessment of the reasonably attainable volumes of these sources, discussed in the preceding sections, is summarized below. We note that the reasonably attainable volumes of each of these advanced biofuels cannot themselves be viewed as volume requirements. These volumes are merely one part of the analysis used to determine the volume requirement for advanced biofuel. As discussed in more detail in Section V.C below, there are many ways that the market could respond to the percentage standards we establish, including use of higher or lower volumes of these fuel types than discussed in this section. In addition, as discussed below, we do not believe it would be appropriate to require use of all volumes we have determined to be reasonably attainable.
Based on the information presented above, we believe that 4.27 billion gallons of advanced biofuel would be reasonably attainable in 2018. This volume is 30 million gallons higher than the 4.24 billion gallons that would result from reducing the applicable volume of advanced biofuel by the same amount as the proposed reduction to the statutory applicable volume of cellulosic biofuel (see Section III for a discussion of the proposed cellulosic biofuel standard for 2018). Requiring use of the additional 30 million gallons to partially backfill for missing cellulosic volumes would be expected to result in GHG reduction and energy security benefits. In exercising the cellulosic waiver authority in past years, we sought to capture such benefits by requiring a partial backfilling of missing cellulosic volumes with volumes of non-cellulosic biofuel we determined to be reasonably attainable and appropriate. We did so, notwithstanding consideration of the increase in costs associated with our actions.
In Section V.D we present illustrative cost projections for sugarcane ethanol and soybean biodiesel in 2018, the two advanced biofuels that have been most widely supplied in previous years and that would be most likely to provide the marginal volume of advanced biofuel in 2018. Our projected costs for sugarcane ethanol range from $0.58-$1.53 per ethanol-equivalent gallon of gasoline displaced ($0.87-$2.29 for every gallon of gasoline displaced) and the costs for soybean biodiesel range from $0.83-$1.13 per ethanol-equivalent gallon of diesel displaced ($1.36-$1.85 for every gallon of diesel replaced).
Based on consideration of the volumes that may be reasonably attainable in 2018, along with a balancing of the costs and benefits associated with the option of setting the advanced biofuel standard at a level that would require use of all volumes that we have estimated could be reasonably attainable, we are proposing an advanced biofuel volume requirement of 4.24 billion gallons for 2018. This proposed reasonably attainable and appropriate volume requirement for advanced biofuel for 2018 would represent a decrease of 40 million gallons from the 2017 advanced biofuel volume requirement of 4.28 billion gallons. As discussed in Section I.E, we request comment on use of the general waiver authority to further reduce the required volume of advanced biofuel (with a corresponding reduction to the total renewable fuel requirement) in an effort to increase the energy independence impacts of the RFS program.
We propose to use the cellulosic waiver authority to provide an equivalent reduction in the applicable volume of total renewable fuel as the reduction we are proposing for advanced biofuel. That step is described in more detail in Section V.A, together with our proposed assessment that no further increment of reduction is required for total renewable fuel in 2018.
The national volume targets of total renewable fuel to be used under the RFS program each year through 2022 are specified in CAA section 211(o)(2)(B)(i)(I). For 2018 the statute stipulates a volume target of 26 billion gallons. Since we are proposing to reduce the statutory volume target for cellulosic biofuel to reflect the projected production volume of that fuel type in 2018, we are authorized under CAA section 211(o)(7)(D)(i) to reduce the advanced biofuel and total renewable fuel targets by the same or a lesser amount. We also have the authority to reduce any volume target pursuant to the general waiver authority in CAA section 211(o)(7)(A) under specific conditions as described in Section II.A.2, including based on a finding of “inadequate domestic supply.” Our proposed assessment indicates that there will be adequate supply of total renewable fuel in 2018 to meet a total renewable fuel volume requirement of 19.24 billion gallons that would result from the use of the cellulosic waiver authority alone. The use of the general waiver authority for 2018 to further reduce the total renewable fuel standard on the basis of supply considerations would therefore not be necessary. As a result, the implied volume for conventional renewable fuel (calculated by subtracting the advanced volume from the total volume) would be 15.0 billion gallons, consistent with the statutory targets provided in the statute for 2018.
In Section IV.B we explained our proposed use of the cellulosic waiver authority to reduce the 11 billion gallon 2018 statutory volume target for advanced biofuel to 4.24 billion gallons for purposes of setting the 2018 advanced biofuel volume standard. This represents a reduction of 6.76 billion gallons.
As discussed in Section II.A.1, we believe that the cellulosic waiver provision is best interpreted to require equal reductions in advanced biofuel and total renewable fuel. We have consistently articulated this interpretation.
Applying an equal reduction of 6.76 billion gallons to both the statutory target for advanced biofuel and the statutory target for total renewable fuel results in a total renewable fuel volume of 19.24 billion gallons as shown in Table IV.A-1. If we were to determine that there is a basis to exercise the general waiver authority, described in Section II.A.2, we could provide further reductions. However, as described below in Section V.B, we believe that there will be adequate supply to meet a total renewable fuel volume requirement of 19.24 billion gallons in 2018. This means that we believe that 15.0 billion gallons of conventional renewable fuel is reasonably attainable, and that further reductions in the total renewable fuel applicable volume using the general waiver authority are not necessary to address supply issues. We note that EPA has received numerous comments in previous annual standard rulemakings asserting that there are negative environmental impacts that may be associated with the RFS program.
As noted above, the proposed volume requirement for total renewable fuel was derived by applying the same volume reduction to the statutory volume target for total renewable fuel as we are proposing for advanced biofuel, using the cellulosic waiver authority. This section describes our proposed determination that there will be adequate renewable fuel to meet an applicable volume requirement of 19.24 billion gallons in 2018. We have evaluated available sources of renewable fuel to determine if in the aggregate it appears that a total renewable fuel volume of 19.24 billion gallons is reasonably attainable. Since we believe that this volume is indeed reasonably attainable, as discussed below, we propose that it is unnecessary to consider further reductions through use of the general waiver authority on the basis of an inadequate domestic supply. Therefore, in this assessment, we have not attempted to identify the maximum reasonably achievable volume of total renewable fuel based on the sum of estimates of each type of renewable fuel, such as total ethanol, biodiesel and renewable diesel, biogas, and other non-ethanol renewable fuels, as we would do if we were proposing to use the general waiver authority based on a finding of inadequate domestic supply. However, as noted previously, we are soliciting comment on whether it would be appropriate to exercise the general waiver authority.
As for previous annual standard-setting rulemakings, we note that it is a very challenging task to estimate the available volumes in light of the myriad complexities of the fuels market and how individual aspects of the industry might change in the future, and also because we cannot precisely predict how the market will respond to the standards we set. This is the type of assessment that is not given to precise measurement and necessarily involves considerable exercise of judgment.
Our investigation into whether the total renewable fuel volume shown in Table V.A-1 is reasonably attainable in 2018 was driven primarily by a consideration of the reasonable availability of ethanol, biodiesel, and renewable diesel. We also considered smaller contributions from non-ethanol cellulosic and other types of renewable fuels (
The proposed volume requirements are based on the data available to EPA at the time of this proposal. However, we recognize that there is uncertainty related to some of this data with respect to the volume of renewable fuels that can be supplied in the United States in 2018 and the economic and environmental impacts associated with requiring renewable fuel use. We request comment on the data presented in this proposed rule, and invite commenters to submit additional data relevant to these issues. Additional data could also indicate that it would be appropriate to finalize volume requirements lower than indicated in this proposed rule, through use of either the general waiver authority in CAA section 211(o)(7)(A) or as a result of a lower projection of cellulosic biofuel production, combined with corresponding increased waivers of advanced and total renewable fuel using the cellulosic waiver authority in CAA section 211(o)(7)(D).
We note that in prior annual RFS rulemaking actions, some stakeholders have commented to EPA that the Agency should exercise its discretion to use the general waiver authority to reduce volumes to avoid severe harm to the economy or environment of a state, region, or the United States. For example, some commenters suggested that standards that would result in ethanol use beyond the blendwall would cause severe economic harm, justifying use of the general waiver authority. Additionally, as discussed in Section I.E, we also request comment on use of the general waiver authority to reduce the required volume of renewable fuel in an effort to increase the energy independence impacts of the RFS program. EPA invites comment and data on these issues, including data and analysis that would support different use of the waiver authorities than we are proposing in today's action, such as use of the general waiver authority to achieve greater reductions than proposed.
Ethanol is the most widely produced and consumed biofuel, both domestically and globally. Since the beginning of the RFS program, the total volume of renewable fuel produced and consumed in the United States has grown substantially each year, primarily due to the increased production and use of corn ethanol. However, the rate of growth in the supply of ethanol to the U.S. market has decreased in recent years as the gasoline market has become saturated with gasoline that contains 10 volume percent ethanol (E10), favorable blending economics have diminished, and efforts to expand the use of higher ethanol blends such as E15 and E85
In the 2014-2016 final rule, we discussed in detail the factors that constrain growth in ethanol supply and the opportunities that exist for pushing the market to overcome those constraints.
Ethanol supply is not currently limited by production and import capacity, which is in excess of 15 billion gallons.
• Overall gasoline use and the volume of ethanol that can be blended into gasoline as E10 (typically referred to as the E10 blendwall).
• The number of retail stations that offer higher ethanol blends such as E15 and E85.
• The number of vehicles that can both legally and practically consume E15 and/or E85.
• Relative pricing of E15 and E85 versus E10 and the ability of RINs to affect this relative pricing.
• The supply of gasoline without ethanol (E0).
The applicable standards that we set under the RFS program provide incentives for the market to overcome many of these ethanol-related constraints.
While in the short term the RFS program is unlikely to have a direct effect on overall gasoline demand or the number of vehicles designed to use higher ethanol blends, it can provide incentives for changes in some other market factors, such as the number of retail stations that offer higher ethanol blends and the relative pricing of those higher ethanol blends in comparison to E10.
As stated in the 2014-2016 final rule and in the 2017 final rule, we continue to believe that there are real constraints on the ability of the market to exceed an average nationwide ethanol content of 10 percent. However, these constraints do not have the same significance at all ethanol concentrations above 10 percent. Instead, for the state of infrastructure that can be available in 2018, the constraints represent a continuum of mild resistance to growth at the first increments above 10 percent ethanol and evolve to significant obstacles at higher levels of ethanol. In short, the E10 blendwall is not the barrier that some stakeholders believe it to be, but neither are increases in poolwide ethanol concentrations above 10 percent unlimited in the 2018 timeframe. These views are demonstrated by the fact that the poolwide ethanol concentration of all gasoline increased dramatically until about 2010, after which growth has been much slower and has remained very close to 10.0 percent. In 2016, the average ethanol concentration reached 10.05 percent.
We continue to believe that the constraints associated with the E10 blendwall do not represent a firm barrier that cannot be crossed. Rather, the E10 blendwall marks the transition from relatively straightforward and easily achievable increases in ethanol consumption as E10 to those increases in ethanol consumption as E15 and E85 that are more challenging to achieve.
However, we also recognize that the market is not unlimited in its ability to respond to the standards we set. This is true both for expanded use of ethanol and for non-ethanol renewable fuels. The fuels marketplace in the United States is large, diverse, and complex, made up of many different players with different, and often competing, interests. Substantial growth in the renewable fuel volumes beyond current levels will require action by many different parts of the fuel market, and a constraint in any one part of the market can act to limit the growth in renewable fuel supply. Whether notable constraints are in the technology development and commercialization stages, as has been the case with cellulosic biofuels, the development of distribution infrastructure as is the case with ethanol, or in the accessibility of feedstocks as with biodiesel, the end result is that these constraints limit the annual growth rate in the availability of renewable fuel as transportation fuel, heating oil, or jet fuel. These constraints were discussed in detail in the 2014-2016 final rule and summarized in the 2017 final rule, and while the market continues to grow, we believe that the same constraints will operate to limit growth in the availability of renewable fuel in 2018 as well, both for ethanol and non-ethanol renewable fuels.
The total volume of ethanol that can be supplied is a function of total volume of gasoline that is used, as well as the potential for sales of different ethanol fuel blends (
The volumes of E15 and E85 used in the near term will continue to be primarily a function of the number of retail service stations that offer it since the number of vehicles that are legally permitted to use E15 (2001 model year and later) and E85 (flexible fuel vehicles, or FFVs) currently exceeds the retail dispensing capacity by a substantial margin. We acknowledge that a larger percentage of FFVs in the fleet could increase the volume of E85 consumed, but in the short term we believe that it is the relatively very small number of retail stations offering E85 that is operating as the primary constraint on the volumes of E85 sold, and to a lesser extent the relative price of higher ethanol blends and E10.
Growth in the number of retail stations offering E15 and/or E85 has been relatively slow, but accelerated in 2016 as a result of USDA's Biofuels Infrastructure Partnership (BIP) program and the ethanol industry's Prime the Pump program. While these grant programs have increased E15 and E85 offerings at retail, we expect the programs to be fully phased in by the end of 2017 and thus have no influence on further growth in the number of retail stations offering E15 and E85 in 2018. In the 2017 final rule, we noted that while the BIP program was intended to be fully phased in by the end of 2016, it was not expected to meet this deadline. The BIP program permits states to extend implementation by up to two additional years. Currently, we have no reason to believe that the BIP program will not be fully implemented by the end of 2017; indeed, this was our assumption in projecting attainable volumes in the context of the 2017 final rule. Similarly, the Prime the Pump program was expected to complete all projects by the end of 2017.
For the 2016 and 2017 standards, we based the total renewable fuel volume requirement in part on the expectation that the RFS program would result in all but a tiny portion—estimated at 200 million gallons—of gasoline to contain at least 10 percent ethanol. We based this determination on the fact that higher volume requirements would provide an incentive for the market to transition from E0 to E10 and other higher level ethanol blends through the RIN mechanism, but that recreational marine engines represented a market segment that we believed would be particularly difficult to completely transition from E0 since they are used in a water environment where there is a greater potential for water contamination of the fuel.
While we continue to believe that the market is capable of reaching a point wherein all but about 200 million gallons contains some amount of ethanol, we note that this did not occur in 2016 despite the fact that the 2016 standards were based in part on the expectation that it would occur. As described in a memorandum to the docket, we now estimate that the volume of E0 used in 2016 was about 500 million gallons.
Given that the BIP and Prime the Pump grant programs are expected to be fully phased in by the end of 2017, we expect less growth in E15 and E85 supply in 2018 than in 2017. Moreover, any growth in ethanol use due to higher volumes of E15 and E85 may be offset by a higher volume of E0 as discussed above in terms of total ethanol supply. For example, a 40 million gallon increase in the volume of E85 supplied in 2018 could be offset by a 250 million gallon increase in the volume of E0 supplied.
The market will ultimately determine the extent to which compliance with the annual standards is achieved through the use of greater volumes of ethanol versus other, non-ethanol renewable fuels. We nevertheless believe that while the market could supply a volume of ethanol greater than 14,479 million gallons, this volume represents a reasonably attainable level of ethanol supply in 2018 that takes into account the constraints to fuel supply that we have noted. For the final rule, we intend to use an updated version of the STEO as well as a more detailed assessment of the volumes of E15 and E85 that may be reasonably attainable in 2018.
As described in the 2017 final rule, we do not believe that setting the applicable standards at levels exceeding those we believe to be reasonably attainable would result in dramatic increases in the number of additional retail stations offering E15 or E85 in 2018 beyond those that may be upgraded through independent efforts.
While the market constraints on ethanol supply are relatively well understood, it is more difficult to identify and assess the market components that may limit potential growth in the use of all qualifying forms of biodiesel and renewable diesel in 2018. Therefore, as discussed in the introduction to Section V.B, after estimating the supply of ethanol in 2018, and taking into account the estimates of non-ethanol cellulosic biofuel supply discussed in Section III.D and estimates of other non-ethanol renewable fuel supply discussed in Section IV.B.3, we considered whether the supply of total biodiesel and renewable diesel would be adequate to satisfy the remainder of the volume needed to achieve a requirement of 19.24 billion gallons.
In Section V.A we described how use of the cellulosic waiver authority to provide a volume reduction for total renewable fuel that equals that provided for advanced biofuels yields a volume of 19.24 billion gallons. In addition to the ethanol volume discussed in Section V.B.1.iv above, cellulosic biogas can also contribute to this total volume of renewable fuel, as described more fully in Section III.C. While other renewable fuels such as naphtha, heating oil, butanol, and jet fuel can be expected to continue growing in 2018, collectively, we expect them to contribute considerably less than ethanol and biodiesel/renewable diesel to the total volume of renewable fuel supplied in 2018. These fuels were discussed in Section IV.B.3. Based on these estimates, about 2.9 billion gallons of biodiesel and renewable diesel, including both advanced and conventional biodiesel and renewable diesel, would be needed in order to meet a total renewable fuel volume requirement of 19.24 billion gallons (see Table V.B.2-1 below).
A starting point in developing a projection of the attainable supply of biodiesel and renewable diesel in 2018 is a review of the volumes of these fuels supplied for RFS compliance in previous years. In examining the data, both the absolute volumes of the supply of biodiesel and renewable diesel in previous years, as well as the rates of growth between years are relevant considerations. The volumes of biodiesel and renewable diesel (including D4, D5, and D6 biodiesel and renewable diesel) supplied each year from 2011 through 2016 are shown below, along with the volume of these fuels projected for 2017 in the 2017 final rule.
After examining the historical data (shown in the figure above) we believe it is very likely that there will be a sufficient supply of biodiesel and renewable diesel (volumes at least as high as 2.9 billion gallons) in 2018 to meet the total renewable fuel volume requirement after exercising the cellulosic waiver authority. Indeed, there would be sufficient supply of biodiesel and renewable diesel to meet the 2018 total renewable fuel volume requirement after using the cellulosic waiver authority even if there was no increase in the supply of these fuels from 2017 to 2018. Alternatively, even if the supply of biodiesel and renewable diesel in 2017 falls short of the projected supply from the 2017 final rule, an increase in supply from 2016 to 2018 equal to the average annual supply increase observed from 2011-2016 would be sufficient to meet the total renewable fuel requirement for 2018 after using the cellulosic waiver authority.
In assessing the probative value of historical data on the supply of biodiesel and renewable diesel, we must also consider the extent to which historic supply and growth rates can be seen as representing what is possible with the RFS standards and other incentives in place. The years with the highest historic growth rates (2013 and 2016) were years in which both tax incentives and RFS incentives were in place to incentivize growth through the entire year.
Ultimately, we believe the historic data provides a reasonable guide for assessing the potential growth of advanced biodiesel and renewable diesel in 2018. We recognize that there
In the 2017 final rule EPA assessed a number of factors that could potentially constrain the supply of biodiesel and renewable diesel to the United States. The list of factors considered included feedstock availability, the capacity of the market to produce, import, and distribute biodiesel and renewable diesel, the retail infrastructure capacity, the ability for the market to consume biodiesel and renewable diesel in approved engines, and consumer response. We noted that in each of these areas there are challenges that will need to be overcome to enable the continued growth in the supply of biodiesel and renewable diesel in the United States, but nevertheless concluded that the market was capable of supplying 2.9 billion gallons of biodiesel and renewable diesel (including both advanced and conventional biodiesel and renewable diesel) to the United States in 2017.
Since finalizing the 2017 rule, EPA has continued to monitor the development of the biodiesel and renewable diesel industry, including the ability for the market to produce/import, distribute, and consume these fuels. Based on the data available to EPA at this time, including data considered in the 2017 final rule, we believe that the market is capable of producing, distributing, and using 2.9 billion gallons of biodiesel and renewable diesel in 2018. EPA is unaware of any information that would lead us to conclude that our assessment that the biodiesel and renewable diesel market is capable of supplying 2.9 billion gallons to the United States in 2017 is no longer reasonable, nor are we aware of any factors (other than the absence of the biodiesel blenders tax credit) that will likely negatively impact the ability for the market to supply biodiesel and renewable diesel in 2018 relative to 2017. We therefore do not see any significant marketplace impediments that are likely to prevent the supply of 2.9 billion gallons of biodiesel and renewable diesel in 2018 and believe that despite the loss of the biodiesel blenders tax credit the 2.9 billion gallon supply of biodiesel and renewable diesel projected to be available in 2017 can also be supplied in 2018.
We recognize that the market may not necessarily respond to the proposed total renewable standard by supplying exactly 2.9 billion gallons of biodiesel and renewable diesel to the transportation fuels market in the United States in 2018, but that the market may instead supply a lower or higher volume of biodiesel and renewable diesel with corresponding changes in the supply of other types of renewable fuel. As a result, we believe there is less uncertainty with respect to the attainability of the total volume requirement of 19.24 billion gallons than there is concerning the projected 2.9 billion gallons of biodiesel and renewable diesel that we have used in determining the adequacy of supply of total renewable fuel for 2018.
In Section V.A we described how use of the cellulosic waiver authority to provide a volume reduction for total renewable fuel that equals that provided for advanced biofuels yields a volume of 19.24 billion gallons. Based on our assessment of supply of ethanol and biodiesel/renewable diesel, along with smaller amounts of non-ethanol cellulosic biofuel and other non-ethanol renewable fuels, we believe that a total of 19.24 billion gallons of renewable fuel is reasonably attainable in 2018. As a result, we do not propose any further reductions on the basis of an “inadequate domestic supply” using the general waiver authority.
Our use of the cellulosic waiver authority alone to set the advanced biofuel and total renewable fuel volume requirements would result in an implied volume for non-advanced (
Because the transportation fuel market is dynamic and complex, and the RFS standards that we set can be satisfied through use of a wide variety of renewable fuels, we cannot precisely predict the mix of different fuel types that will result from the standards we are proposing. In this section we describe a range of possible outcomes, and doing so provides a means of demonstrating that the proposed standards can reasonably be satisfied through multiple possible paths.
We evaluated a number of scenarios with varying levels of E0, E15, E85, imported sugarcane ethanol, advanced biodiesel and renewable diesel, and conventional biodiesel and renewable diesel. In doing so we sought to capture a reasonable range of possibilities for each individual source, based both on levels achieved in the past and how the market might respond to the applicable standards. Each of the rows in Table V.C-1 represents a scenario in which the proposed total renewable fuel and advanced biofuel standards would be satisfied.
The scenarios in the tables above are not the only ways that the market could choose to meet the total renewable fuel and advanced biofuel volume requirements that we are establishing in this action. Indeed, other combinations are possible, with volumes higher than the highest levels we have shown above or, in some cases, lower than the lowest levels we have shown. The scenarios above cannot be treated as EPA's views on the only, or even most likely, ways that the market may respond to the proposed 2018 volume requirements. Instead, the scenarios are merely illustrative of the various ways that it could play out. Our purpose in generating the list of scenarios above is only to illustrate a range of possibilities which demonstrate that the standards we are establishing in this action can reasonably be met.
We continue to believe, as we stated in previous rulemakings, that it would be inappropriate to construct a new scenario based on the highest or lowest volumes in each category that are shown in the table above. Thus, for instance, while every scenario in Table V.C-1 represents 4.24 billion gallons of advanced biofuel and 19.24 billion gallons of total renewable fuel, combining the lowest volume of E0 shown in the table with the highest volumes of E15, E85, sugarcane ethanol, total biodiesel and renewable diesel, and advanced biodiesel and renewable diesel shown in the table, would result in 4.74 billion gallons of advanced biofuel and 19.40 billion gallons of total renewable fuel. We do not believe that such volumes would be reasonably attainable for 2018. Conversely, combining the highest volume of E0 shown in the table with the lowest volumes of E15, E85, sugarcane ethanol, total biodiesel and renewable diesel, and advanced biodiesel and renewable diesel shown in the table, would result in 3.74 billion gallons of advanced biofuel and 19.08 billion gallons of total renewable fuel. Such volumes would be below the levels that we believe are reasonably attainable to require in 2018. We have more confidence in the ability of the market to attain the proposed volume requirements for advanced biofuel and total renewable fuel than we have in the ability of the market to achieve a specific level of, say, biodiesel, or E85.
With regard to E85, under highly favorable conditions related to growth in the number of E85 retail stations, retail pricing, and consumer response to that pricing, it is possible that E85 volumes as high as 350 million gallons could be reached. For instance, growth
Similarly, under favorable conditions, it is possible that E15 volumes as high as 1,200 million gallons could be reached in 2018 as shown in Table V.D-1. This volume could be reached through some combination of different changes such as the following:
• Following the conclusion of the BIP program and Prime the Pump program, it is possible that the growth rate for retail stations offering E15 could be higher than historical rates, potentially reaching as high as 2,700 in 2018 (average for the year).
• Sales of E15 could be as high as 50 percent of all gasoline sales at stations selling both E10 and E15 under favorable pricing conditions rather than the 15 percent we assumed in the 2017 final rule, based on limited data from Iowa.
• Additional terminals could produce E15 in 2018 beyond those that are expected to do so in 2017.
As the table above illustrates, the volume requirements could result in the consumption of 2.95 billion gallons of biodiesel and renewable diesel in 2018. This level is less than our estimate of the production capacity for all registered domestic biodiesel and renewable diesel production facilities, though slightly higher than the 2.9 billion gallons that we used in the context of determining whether a total renewable fuel volume requirement of 19.24 billion gallons in 2018 would be reasonably attainable. Given the necessarily imprecise nature of our estimate of the ability of the market to supply about 2.9 billion gallons of biodiesel and renewable diesel for purposes of meeting a total renewable fuel volume requirement of 19.24 billion gallons in 2018, volumes as high as 2.95 billion gallons and potentially higher are possible.
Finally, out of the maximum of about 2.9 billion gallons of biodiesel and renewable diesel shown in Table V.C-1, 2.54 billion gallons could be advanced biodiesel. While this is slightly higher than the 2.5 billion gallons that we used in determining the advanced biofuel volume requirement, it could be supplied from current biodiesel and renewable diesel domestic production capacity,
To provide an illustrative estimate of the cost of the proposed 2018 RFS volume requirements, EPA has compared the proposed 2018 volume requirements to the statutory volume that would be required absent the exercise of our cellulosic waiver authority under CAA section 211(o)(7)(D)(i) to reduce the applicable volume of cellulosic biofuel.
To estimate the overall cost savings from waiving the cellulosic renewable fuel volumes, EPA has taken the following steps. First, EPA determined the magnitude of the volume reduction of cellulosic biofuel we are proposing in this rule, relative to the statutory volume. In this rule we are proposing to reduce the required volume of cellulosic biofuel by approximately 6.76 billion gallons, with corresponding reductions in the advanced biofuel and total renewable fuel standards. Second, we estimated the per gallon costs of producing cellulosic ethanol derived from corn kernel fiber that would be expected in complying with the proposed standards. Third, the per gallon costs of cellulosic biofuel from corn fiber were multiplied by the volume of cellulosic renewable fuels being waived from the statutory levels to the proposed cellulosic renewable fuel volumes.
While there may be growth in other cellulosic sources, for this exercise we believe it is appropriate to use corn kernel fiber as the representative cellulosic renewable fuel since the majority of liquid cellulosic biofuel in 2018 is expected to be produced using this technology. The application of this technology in the future could result in significant incremental volumes of cellulosic biofuel. In addition, as explained in Section III, we believe that production of the major alternative cellulosic biofuel—CNG/LNG derived from biogas—is likely to plateau eventually due to a limitation in the number of vehicles capable of using this form of fuel. To estimate the per gallon costs of corn kernel fiber ethanol, we focus on wholesale level costs. These cost estimates do not consider taxes, retail margins, or other costs or transfers that occur at or after the point of blending (transfers are payments within
Table V.D-1 below presents the cost savings associated with this proposed rule.
We recognize that for the purpose of estimating the cost of the proposed 2018 RFS volume requirements that a number of different scenarios using different “baselines” would be of interest to stakeholders. Therefore, in this section we are also providing an illustrative cost analysis that shows the costs as compared to those associated with the preceding year's standard, which as discussed in section IV.C. is a reduction of 40 million gallons of advanced biofuel in comparison to 2017.
It is important to note that these “illustrative costs” do not attempt to capture the full impacts of this proposed rule. These estimates are provided solely for the purpose of showing how the cost to produce a gallon of a “representative” renewable fuel compares to the cost of petroleum fuel. There are a significant number of caveats that must be considered when interpreting these cost estimates. There are a number of different feedstocks that could be used to produce biofuels, and there is a significant amount of heterogeneity in the costs associated with these different feedstocks and fuels. Some renewable fuels may be cost competitive with the petroleum fuel they replace; however, we do not have cost data on every type of feedstock and every type of fuel. Therefore, we do not attempt to capture this range of potential costs in our illustrative estimates.
The annual standard-setting process encourages consideration of the RFS program on a piecemeal (
EPA is providing an illustrative cost analysis for the proposed reduction in the overall advanced biofuel volume of 40 million ethanol equivalent gallons using four different scenarios, assuming this reduction in advanced biofuel volumes is comprised of (1) cellulosic biofuel from CNG/LNG, (2) cellulosic biofuel from corn kernel fiber, (3) soybean oil BBD, or (4) sugarcane ethanol from Brazil. Showing the illustrative costs of soybean oil BBD and sugarcane ethanol is consistent with the methodology EPA developed for previous rulemakings. Since EPA has also developed per gallon cost estimates for corn kernel fiber ethanol and cellulosic biofuel from CNG/LNG, we are also including costs for these hypothetical scenarios for informational purposes. However, this discussion should not be interpreted as suggesting that the various renewable fuel types discussed are necessarily available in the marketplace. The availability of different types of renewable fuel is discussed in other sections of this preamble; in this section we assess costs
In previous annual RFS rules, EPA provided an illustrative cost estimate for the entire change in the total renewable fuel volume standard assuming it was satisfied with conventional (
As described earlier, we are focusing on the wholesale level in our cost scenarios, and do not consider taxes, retail margins, additional infrastructure, or other costs or transfers that occur at or after the point of blending. More background information on this section, including details of the data sources used and assumptions made for each of the scenarios, can be found in a Memorandum available in the docket.
Table V.D-2 below presents estimates of per energy-equivalent gallon costs for producing soybean biodiesel, Brazilian sugarcane ethanol, CNG/LNG derived from landfill biogas, and cellulosic ethanol derived from corn fiber relative to the petroleum fuels they replace at the wholesale level. For each of the four scenarios, these per gallon costs are then multiplied by the 40 million ethanol-equivalent gallon reduction in the proposed 2018 advanced standard relative to the previous 2017 standard to obtain an overall cost estimate.
Based
In this section we discuss the proposed BBD applicable volume for 2019. We are establishing this volume in advance of those for other renewable fuel categories in light of the statutory requirement in CAA section 211(o)(2)(B)(ii) to establish the applicable volume of BBD for years after 2012 no later than 14 months before the applicable volume will apply. We are not at this time establishing the BBD percentage standards that would apply to obligated parties in 2019 but intend to do so in the Fall of 2018, after receiving EIA's estimate of gasoline and diesel consumption for 2019. Although the BBD applicable volume sets a floor for required BBD use, because the BBD volume requirement is nested within both the advanced biofuel and the total renewable fuel volume requirements, any “excess” BBD produced beyond the mandated 2019 BBD volume can be used to satisfy both of these other applicable volume requirements. Therefore, these other standards also influence BBD production and use.
The statute establishes applicable volume targets for years through 2022 for cellulosic biofuel, advanced biofuel, and total renewable fuel. For BBD, applicable volume targets are specified in the statute only through 2012. For years after those for which volumes are specified in the statute, EPA is required under CAA section 211(o)(2)(B)(ii) to determine the applicable volume of BBD, in coordination with the Secretary of Energy and the Secretary of Agriculture, based on a review of the implementation of the program during calendar years for which the statute
1. The impact of the production and use of renewable fuels on the environment, including on air quality, climate change, conversion of wetlands, ecosystems, wildlife habitat, water quality, and water supply;
2. The impact of renewable fuels on the energy security of the United States;
3. The expected annual rate of future commercial production of renewable fuels, including advanced biofuels in each category (cellulosic biofuel and BBD);
4. The impact of renewable fuels on the infrastructure of the United States, including deliverability of materials, goods, and products other than renewable fuel, and the sufficiency of infrastructure to deliver and use renewable fuel;
5. The impact of the use of renewable fuels on the cost to consumers of transportation fuel and on the cost to transport goods; and
6. The impact of the use of renewable fuels on other factors, including job creation, the price and supply of agricultural commodities, rural economic development, and food prices.
The statute also specifies that the volume requirement for BBD cannot be less than the applicable volume specified in the statute for calendar year 2012, which is 1.0 billion gallons. The statute does not, however, establish any other numeric criteria, or provide any guidance on how the EPA should weigh the importance of the often competing factors, and the overarching goals of the statute when the EPA sets the applicable volumes of BBD in years after those for which the statute specifies such volumes. In the period 2013-2022, the statute specifies increasing applicable volumes of cellulosic biofuel, advanced biofuel, and total renewable fuel, but provides no guidance, beyond the 1.0 billion gallon minimum, on the level at which BBD volumes should be set. As shown in Table VI.B.1-1 below, we have raised the BBD standard above the statutory minimum each year beginning in 2013.
One of the primary considerations in determining the BBD volume for 2019 is a review of the implementation of the program to date, as it affects BBD. This review is required by the CAA, and also provides insight into the capabilities of the industry to produce, import, export, and distribute BBD. It also helps us to understand what factors, beyond the BBD standard, may incentivize the production and import of BBD. The number of BBD RINs generated, along with the number of RINs retired due to export or for reasons other than compliance with the annual BBD standards from 2011-2018 are shown in Table VI.B.1-1 below.
In
In establishing the BBD and cellulosic standards as nested within the advanced biofuel standard, Congress clearly intended to support development of BBD and cellulosic biofuels, while also providing an incentive for the growth of other non-specified types of advanced biofuels. That is, the advanced biofuel standard provides an opportunity for other advanced biofuels (advanced
The BBD industry is currently the single largest contributor to the advanced biofuel pool, one that to date has been largely responsible for providing the growth in advanced biofuels envisioned by Congress. We continue to believe that preserving space under the advanced biofuel standard for non-BBD advanced biofuels, as well as BBD volumes in excess of the BBD standard, will help to encourage the development and production of a variety of advanced biofuels over the long term without reducing the incentive for additional volumes of BBD beyond the BBD standard in 2019. A variety of different types of advanced biofuels, rather than a single type such as BBD, would positively impact energy security (
With the considerations discussed above and in Section IV.B.2 in mind, as well as our analysis of the factors specified in the statute, we are proposing to maintain the applicable volume of BBD at 2.1 billion gallons for 2019. We believe it is appropriate to continue to support the BBD industry through a guaranteed volume requirement, while allowing room within the advanced biofuel volume requirement for the participation of non-BBD advanced fuels. While in recent years we have annually increased this BBD guarantee, we note that there has been a very substantial cumulative increase since 2012, and that the 2018 guarantee is over twice the minimum BBD volume specified in the statute. While we believe it is important to provide continued support to the BBD industry, we do not believe it is necessary to increase the BBD set-aside in 2019 in order to do so. Our assessment of the required statutory factors, summarized in the next section and in a memorandum to the docket (the “2019 BBD docket memorandum”), supports our proposal.
We believe this approach strikes the appropriate balance between providing a market environment where the development of other advanced biofuels is incentivized, while also maintaining support for the BBD industry. Based on our review of the data, and the nested nature of the BBD standard within the advanced standard, we conclude that the advance standard continues to drive the ultimate volume of BBD supplied. This means that setting a marginally lower or higher BBD standard would not change the volume of BBD used in 2019. Given the success of the industry in the past few years, as well as the substantial increases in the BBD volume requirement since 2012, we are proposing that a higher volume requirement for BBD in 2019 is not necessary to provide support for the industry, and are proposing to maintain the volume requirement at the level specified for 2018. Setting the BBD standard in this manner would continue to allow a considerable portion of the advanced biofuel volume to be satisfied by either additional gallons of BBD or by other unspecified and potentially less costly types of qualifying advanced biofuels. As discussed in Section I.E., EPA also requests comment on decreasing the required volume of BBD for 2019 in an effort to increase the energy independence impacts of the RFS program.
As noted earlier in Section IV.B., the BBD volume requirement is nested within the advanced biofuel requirement and the advanced biofuel requirement is, in turn, nested within the total renewable fuel volume requirement. This means that any BBD produced beyond the mandated BBD volume can be used to satisfy both these other applicable volume requirements. The result is that in considering the statutory factors we must consider the potential impacts of increasing BBD in comparison to other advanced biofuels.
Consistent with our 2018 approach in setting the final BBD volume requirement, EPA's primary assessment of the statutory factors for the proposed 2019 BBD applicable volume is that because the BBD requirement is nested within the advanced biofuel volume requirement, we expect that the 2019 advanced volume requirement, when set next year, will determine the level of BBD production and imports that occur in 2019.
As an additional supplementary assessment, we have considered the potential impacts of selecting an applicable volume of BBD other than 2.1 billion gallons in 2019 based on the assumption that in guaranteeing the BBD volume at any given level there could be greater use of BBD and a corresponding decrease in the use of other types of advanced biofuels. However, setting a BBD volume requirement higher or lower than 2.1 billion gallons in 2019 would only be expected to impact BBD volumes on the margin, protecting to a lesser or greater degree BBD from being outcompeted by
Overall and as described in the 2019 BBD docket memorandum, we have determined that both the primary assessment and the supplemental assessment of the statutory factors specified in CAA section 211(o)(2)(B)(ii)(I)-(VI) for the year 2019 does not provide significant support for setting the BBD standard at a level higher or lower than 2.1 billion gallons in 2019.
The renewable fuel standards are expressed as volume percentages and are used by each obligated party to determine their Renewable Volume Obligations (RVOs). Since there are four separate standards under the RFS program, there are likewise four separate RVOs applicable to each obligated party. Each standard applies to the sum of all non-renewable gasoline and diesel produced or imported. The percentage standards are set so that if every obligated party meets the percentages by acquiring and retiring an appropriate number of RINs, then the amount of renewable fuel, cellulosic biofuel, BBD, and advanced biofuel used will meet the applicable volume requirements on a nationwide basis.
Sections III through V provide our rationale and basis for the proposed volume requirements for 2018.
For the purposes of converting these volumes into percentage standards, we generally use two decimal places to be consistent with the volume targets as given in the statute, and similarly two decimal places in the percentage standards. However, for cellulosic biofuel we use three decimal places in both the volume requirement and percentage standards to more precisely capture the smaller volume projections and the unique methodology that in some cases results in estimates of only a few million gallons for a single producer.
To calculate the proposed percentage standards, we are following the same methodology for 2018 as we have in all prior years. The formulas used to calculate the percentage standards applicable to producers and importers of gasoline and diesel are provided in § 80.1405. The formulas rely on estimates of the volumes of gasoline and diesel fuel, for both highway and nonroad uses, which are projected to be used in the year in which the standards will apply. The projected gasoline and diesel volumes are provided by EIA, and include projections of ethanol and biodiesel used in transportation fuel. Since the percentage standards apply only to the non-renewable gasoline and diesel produced or imported, the volumes of ethanol and biodiesel are subtracted out of the EIA projections of gasoline and diesel.
Transportation fuels other than gasoline or diesel, such as natural gas, propane, and electricity from fossil fuels, are not currently subject to the standards, and volumes of such fuels are not used in calculating the annual percentage standards. Since under the regulations the standards apply only to producers and importers of gasoline and diesel, these are the transportation fuels used to set the percentage standards, as well as to determine the annual volume obligations of an individual gasoline or diesel producer or importer.
As specified in the March 26, 2010 RFS2 final rule,
In CAA section 211(o)(9), enacted as part of the Energy Policy Act of 2005, and amended by the Energy Independence and Security Act of 2007, Congress provided a temporary exemption to small refineries
EPA has granted exemptions pursuant to this process in the past. In the Consolidated Appropriations Act of
The formulas in § 80.1405 for the calculation of the percentage standards require the specification of a total of 14 variables covering factors such as the renewable fuel volume requirements, projected gasoline and diesel demand for all states and territories where the RFS program applies, renewable fuels projected by EIA to be included in the gasoline and diesel demand, and exemptions for small refineries. The values of all the variables used for this proposed rule are shown in Table VII.C-1.
Projected
Using the volumes shown in Table VII.C-1, we have calculated the percentage standards for 2018 as shown in Table VII.C-2.
We request comment on all aspects of this proposal. This section describes how you can participate in this process.
We are opening a formal comment period by publishing this document. We will accept comments during the period indicated under the
Your comments will be most useful if you include appropriate and detailed supporting rationale, data, and analysis. Commenters are especially encouraged to provide specific suggestions for any changes that they believe need to be made. You should send all comments, except those containing proprietary information, to our Docket (see
You may submit comments electronically through the electronic public docket,
EPA will also hold a public hearing on this proposed rule. We will announce the public hearing date and location for this proposal in a supplemental
Do not submit information that you consider to be CBI electronically through the electronic public docket,
In addition to one complete version of the comments that include any information claimed as CBI, a copy of the comments that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. This non-CBI version of your comments may be submitted electronically, by mail, or through hand delivery/courier. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the
This action is an economically significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. The EPA prepared an analysis of illustrative costs associated with this action. This analysis is presented in Section V.D of this preamble.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2060-0637 and 2060-0640. The proposed standards would not impose new or different reporting requirements on regulated parties than already exist for the RFS program.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule.
The small entities directly regulated by the RFS program are small refiners, which are defined at 13 CFR 121.201. We have evaluated the impacts of this proposed rule on small entities from two perspectives: as if the 2018 standards were a standalone action or if they are a part of the overall impacts of the RFS program as a whole.
When evaluating the standards as if they were a standalone action separate and apart from the original rulemaking which established the RFS2 program, then the standards could be viewed as decreasing the advanced and total renewable fuel volumes required of obligated parties by 40 million gallons between 2017 and 2018. To evaluate the impacts of the proposed volumes on small entities relative to 2017, EPA has conducted a screening analysis
While the screening analysis described above supports a certification that this rule would not have a significant economic impact on small refiners, we continue to believe that it is more appropriate to consider the standards as a part of ongoing implementation of the overall RFS program. When considered this way, the impacts of the RFS program as a whole on small entities were addressed in the RFS2 final rule (75 FR 14670, March 26, 2010), which was the rule that implemented the entire program required by the Energy Independence and Security Act of 2007 (EISA 2007). As such, the Small Business Regulatory Enforcement Fairness Act (SBREFA) panel process that took place prior to the 2010 rule was also for the entire RFS program and looked at impacts on small refiners through 2022.
For the SBREFA process for the RFS2 final rule, EPA conducted outreach, fact-finding, and analysis of the potential impacts of the program on small refiners, which are all described in the Final Regulatory Flexibility Analysis, located in the rulemaking docket (EPA-HQ-OAR-2005-0161). This analysis looked at impacts to all refiners, including small refiners, through the year 2022 and found that the program would not have a significant economic impact on a substantial number of small entities, and that this impact was expected to decrease over time, even as the standards increased. For gasoline and/or diesel small refiners subject to the standards, the analysis included a cost-to-sales ratio test, a ratio of the estimated annualized compliance costs to the value of sales per company. From this test, it was estimated that all directly regulated small entities would have compliance costs that are less than one percent of their sales over the life
We have determined that this proposed rule would not impose any additional requirements on small entities beyond those already analyzed, since the impacts of this proposed rule are not greater or fundamentally different than those already considered in the analysis for the RFS2 final rule assuming full implementation of the RFS program. This rule proposes the 2018 advanced and total renewable fuel volume requirements at levels 40 million gallons lower than the 2017 volume requirements, and significantly below the statutory volume targets. This exercise of EPA's waiver authority reduces burdens on small entities, as compared to the burdens that would be imposed under the volumes specified in the Clean Air Act in the absence of waivers—which are the volumes that we assessed in the screening analysis that we prepared for implementation of the full program. Regarding the BBD standard, we are proposing to maintain the volume requirement for 2019 at the same level as 2018. While this volume is an increase over the statutory minimum value of 1 billion gallons, the BBD standard is a nested standard within the advanced biofuel category, which we are significantly reducing from the statutory volume targets. As discussed in Section VI, we are proposing to set the 2019 BBD volume requirement at a level below what is anticipated will be produced and used to satisfy the reduced advanced biofuel requirement. The net result of the standards being proposed in this action is a reduction in burden as compared to implementation of the statutory volume targets, as was assumed in the RFS2 final rule analysis.
While the rule will not have a significant economic impact on a substantial number of small entities, there are compliance flexibilities in the program that can help to reduce impacts on small entities. These flexibilities include being able to comply through RIN trading rather than renewable fuel blending, 20 percent RIN rollover allowance (up to 20 percent of an obligated party's RVO can be met using previous-year RINs), and deficit carry-forward (the ability to carry over a deficit from a given year into the following year, providing that the deficit is satisfied together with the next year's RVO). In the RFS2 final rule, we discussed other potential small entity flexibilities that had been suggested by the SBREFA panel or through comments, but we did not adopt them, in part because we had serious concerns regarding our authority to do so.
Additionally, as we realize that there may be cases in which a small entity may be in a difficult financial situation and the level of assistance afforded by the program flexibilities is insufficient. For such circumstances, the program provides hardship relief provisions for small entities (small refiners), as well as for small refineries.
Given that this proposed rule would not impose additional requirements on small entities, would decrease burden via a reduction in required volumes as compared to statutory volume targets and as compared to the 2017 volume requirements, would not change the compliance flexibilities currently offered to small entities under the RFS program (including the small refinery hardship provisions we continue to successfully implement), and available information shows that the impact on small entities from implementation of this rule would not be significant viewed either from the perspective of it being a standalone action or a part of the overall RFS program, we have therefore concluded that this action would have no net regulatory burden for directly regulated small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action implements mandates specifically and explicitly set forth in CAA section 211(o) and we believe that this action represents the least costly, most cost-effective approach to achieve the statutory requirements of the rule.
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.
This action does not have tribal implications as specified in Executive Order 13175. This proposed rule would be implemented at the Federal level and affects transportation fuel refiners, blenders, marketers, distributors, importers, exporters, and renewable fuel producers and importers. Tribal governments would be affected only to the extent they produce, purchase, and use regulated fuels. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it implements specific standards established by Congress in statutes (CAA section 211(o)) and does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action proposes to establish the required renewable fuel content of the transportation fuel supply for 2018, consistent with the CAA and waiver authorities provided therein. The RFS program and this rule are designed to achieve positive effects on the nation's transportation fuel supply, by increasing energy independence and lowering lifecycle GHG emissions of transportation fuel.
This rulemaking does not involve technical standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This proposed rule does not affect the level of protection provided to human health or the environment by applicable air quality standards. This action does not relax the control measures on sources regulated by the RFS regulations and therefore would not cause emissions increases from these sources.
Statutory authority for this action comes from section 211 of the Clean Air Act, 42 U.S.C. 7545. Additional support for the procedural and compliance related aspects of this proposed rule come from sections 114, 208, and 301(a) of the Clean Air Act, 42 U.S.C. 7414, 7542, and 7601(a).
Environmental protection, Administrative practice and procedure, Air pollution control, Diesel fuel, Fuel additives, Gasoline, Imports, Oil imports, Petroleum, Renewable fuel.
For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 80 as follows:
42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).
(a) * * *
(9)
(i) The value of the cellulosic biofuel standard for 2018 shall be 0.131 percent.
(ii) The value of the biomass-based diesel standard for 2018 shall be 1.74 percent.
(iii) The value of the advanced biofuel standard for 2018 shall be 2.34 percent.
(iv) The value of the renewable fuel standard for 2018 shall be 10.62 percent.
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 |