Page Range | 27983-28686 | |
FR Document |
Page and Subject | |
---|---|
81 FR 28107 - Sunshine Act Meetings; National Science Board | |
81 FR 28154 - Environmental Impact Statement for the California High Speed Rail System San Francisco to San Jose Section, CA | |
81 FR 27983 - National Day of Prayer, 2016 | |
81 FR 28088 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0049 | |
81 FR 28094 - Information Collection Request to Office of Management and Budget; OMB | |
81 FR 28089 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0066 | |
81 FR 28091 - Information Collection Request[s] to Office of Management and Budget; OMB Control Number: 1625-new | |
81 FR 28090 - Collection of Information Under Review by Office of Management and Budget; OMB Control Numbers: 1625-0023 | |
81 FR 28093 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0027 | |
81 FR 28092 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0052 | |
81 FR 28019 - Safety Zone: San Francisco State Graduation Fireworks Display, San Francisco, CA | |
81 FR 28136 - Qualification of Drivers; Exemption Applications; Vision | |
81 FR 28119 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators | |
81 FR 28054 - Quadrennial Energy Review: Notice of Public Meetings | |
81 FR 28121 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
81 FR 28100 - Proposed Habitat Conservation Plan/Natural Community Conservation Plan for Western Butte County, California: Environmental Impact Statement | |
81 FR 28102 - Public Land Order No. 7852; Withdrawal of Public Land for the Buffalo Bill Dam and Reservoir; Wyoming | |
81 FR 28054 - Meeting of the Ocean Research Advisory Panel | |
81 FR 28048 - Notice of Request To Renew an Approved Information Collection (Import of Undenatured Inedible Product) | |
81 FR 28049 - Retail Exemptions Adjusted Dollar Limitations | |
81 FR 28051 - Foreign-Trade Zone (FTZ) 26-Atlanta, Georgia; Notification of Proposed Production Activity; Eastman Kodak Company; Subzone 26N (Aluminum Printing Plates); Columbus, Georgia | |
81 FR 28069 - Sulfoxaflor; Receipt of Application for Emergency Exemption, Solicitation of Public Comment | |
81 FR 28113 - In the Matter of the Designation of Musa Abu Dawud, aka Moussa Abu Daoud, aka Moussa Bourahla, aka Abou Daoud, aka Bourahla Moussa, as a Specially Designated Global Terrorist Pursuant to Section 1(b) of Executive Order 13224, as Amended | |
81 FR 28113 - Bureau of Political-Military Affairs; Modification of Statutory Debarment Imposed Pursuant to Section 127.7(c) of the International Traffic in Arms Regulations-Rocky Mountain Instrument Company | |
81 FR 28114 - Notice of Availability of the Draft Environmental Assessment and Preliminary Finding of No Significant Impact for the NuStar Burgos Pipelines Presidential Permit Applications Review, Hidalgo County, Texas | |
81 FR 28050 - Public Availability of Department of Commerce FY 2015 Service Contract Inventory | |
81 FR 28158 - Notice of Request for the Extension of a Currently Approved Information Collection | |
81 FR 28157 - Notice of Request for the Extension of a Currently Approved Information Collection | |
81 FR 28031 - State Safety Oversight; Corrections | |
81 FR 28102 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
81 FR 28112 - Notice of Information Collection Under OMB Emergency Review: Employee Self Certification and Ability To Perform in Emergencies (ESCAPE) Program | |
81 FR 28052 - Marine Mammals; File Nos. 19436 and 19592 | |
81 FR 28032 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Vessels Using Trawl Gear in the Bering Sea and Aleutian Islands Management Area | |
81 FR 28140 - Agency Request for Regular Processing of Collection of Information by the Office of Management and Budget | |
81 FR 28071 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
81 FR 28040 - Eligibility Requirements for Minor Dependents To Attend DoD Domestic Dependent Elementary and Secondary Schools (DDESS) | |
81 FR 28115 - Hours of Service (HOS) of Drivers; American Pyrotechnics Ass'n. (APA) Application for Exemption From the 14-Hour Rule; Extension of Current APA Exemption Period | |
81 FR 28072 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2016 | |
81 FR 28108 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Digital I&C; Cancellation of the May 17, 2016, ACRS Subcommittee Meeting | |
81 FR 28069 - Information Collection Being Reviewed by the Federal Communications Commission | |
81 FR 28109 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on T-H Phenomena; Notice of Meeting | |
81 FR 28101 - U.S. Extractive Industries Transparency Initiative Multi-Stakeholder Group (USEITI MSG) Advisory Committee Meetings Change Notice | |
81 FR 28109 - Submission of Information Collection for OMB Review; Comment Request; Administrative Appeals | |
81 FR 28106 - Notice of Information Collection | |
81 FR 28106 - NASA Advisory Council; Science Committee; Planetary Science Subcommittee; Meeting. | |
81 FR 28095 - Agency Information Collection Activities: Declaration of Owner and Declaration of Consignee When Entry Is Made by an Agent | |
81 FR 28096 - Agency Information Collection Activities: African Growth and Opportunity Act Certificate of Origin | |
81 FR 28047 - Office of the Under Secretary, Research, Education, and Economics; Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture Meeting | |
81 FR 28105 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Workforce Innovation and Opportunity Act Common Performance Reporting; Correction | |
81 FR 28052 - Public Availability of Consumer Product Safety Commission FY 2015 Service Contract Inventory | |
81 FR 28053 - Commission Agenda and Priorities; Notice of Hearing | |
81 FR 28097 - Agency Information Collection Activities: Application for Relief Under Former Section 212(c) of the Immigration and Nationality Act, Form I-191; Revision of a Currently Approved Collection | |
81 FR 28065 - Record of Decision for the San Luis Transmission Project (DOE/EIS-0496) | |
81 FR 28056 - Public Availability of Department of Energy FY 2015 Service Contract Inventory | |
81 FR 28035 - The Food and Drug Administration Food Safety Modernization Act: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs; Public Meetings | |
81 FR 28083 - Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Extension of Comment Period | |
81 FR 28138 - Qualification of Drivers; Exemption Applications; Vision | |
81 FR 28130 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
81 FR 28131 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
81 FR 28134 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
81 FR 28107 - Comment Request: National Science Foundation Proposal-Large Facilities Manual | |
81 FR 28120 - Qualification of Drivers; Application for Exemptions; Hearing | |
81 FR 28100 - Renewal of Agency Information Collection for Indian Self-Determination and Education Assistance Contracts | |
81 FR 28059 - Saddlehorn Pipeline Company, LLC; Notice of Amended Petition for Declaratory Order | |
81 FR 28056 - Notice of Complaint | |
81 FR 28065 - MidAmerican Energy Company; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
81 FR 28060 - Atlantic Coast Pipeline, LLC; Supplemental Notice of Intent To Prepare an Environmental Impact Statement and Proposed Land and Resource Plan Amendment(s) for the Proposed Atlantic Coast Pipeline, Request for Comments on Environmental Issues Related to New Route and Facility Modifications, and Notice of Public Scoping Meetings | |
81 FR 28051 - Sanctuary System Business Advisory Council: Public Meeting | |
81 FR 28087 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting | |
81 FR 28086 - National Institute on Drug Abuse; Notice of Closed Meetings | |
81 FR 28087 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
81 FR 28086 - Government-Owned Inventions; Availability for Licensing | |
81 FR 28087 - Center for Scientific Review; Notice of Closed Meetings | |
81 FR 28085 - Agency Information Collection Activities; Proposed Collection; Public Comment Request | |
81 FR 28154 - Northeast Corridor Safety Advisory Committee; Notice of Meeting | |
81 FR 28018 - Drawbridge Operation Regulation; Youngs Bay, Astoria, OR | |
81 FR 28105 - Extension of Comment Period for Proposed Revisions to the LSC Grant Assurances for Calendar Year 2017 Basic Field Grants | |
81 FR 28065 - Indicated RTO Transmission Owners; Notice of Petiton for Declaratory Order | |
81 FR 28064 - Combined Notice of Filings | |
81 FR 28057 - Combined Notice of Filings #1 | |
81 FR 28084 - Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal | |
81 FR 28103 - Certain Overflow and Drain Assemblies for Bathtubs and Components Thereof: Institution of Investigation | |
81 FR 28110 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees Schedule | |
81 FR 28068 - Agency Information Collection Activities OMB Responses | |
81 FR 28037 - Equal Access to Housing in HUD's Native American and Native Hawaiian Programs-Regardless of Sexual Orientation or Gender Identity | |
81 FR 28097 - Filipino World War II Veterans Parole Policy | |
81 FR 28071 - Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager | |
81 FR 28070 - Notice to All Interested Parties of the Termination of the Receivership of 10490 Bank of Jackson County, Graceville, Florida | |
81 FR 28158 - Increase in Maximum Tuition and Fee Amounts Payable Under the Post-9/11 GI Bill | |
81 FR 27985 - United States Standards for Grades of Canned Baked Beans | |
81 FR 28104 - Certain Corrosion-Resistant Steel Products From China, India, Italy, Korea, and Taiwan: Revised Hearing Schedule | |
81 FR 28046 - United States Standards for Grades of Cauliflower | |
81 FR 27992 - Cargo Securing Manuals | |
81 FR 28115 - Meeting of the Regional Energy Resource Council | |
81 FR 28033 - Airworthiness Directives; Airbus Airplanes | |
81 FR 28112 - Council on Underserved Communities Advisory Board | |
81 FR 28071 - Change in Medicaid and CHIP Payment and Access Commission Terms | |
81 FR 27989 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 28658 - Nondiscrimination on the Basis of Disability; Accessibility of Web Information and Services of State and Local Government Entities | |
81 FR 28022 - Safety Zones; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone | |
81 FR 27986 - Airworthiness Directives; Airbus Airplanes | |
81 FR 28162 - 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 28588 - Energy Conservation Program for Certain Commercial and Industrial Equipment: Test Procedure for Commercial Water Heating Equipment |
Agricultural Marketing Service
Food Safety and Inspection Service
Foreign-Trade Zones Board
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Western Area Power Administration
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Transit Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Agricultural Marketing Service, USDA.
Final notice.
This document revises the United States Standards for Grades of Canned Baked Beans. The U.S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS) revised the standards to replace process-specific language “Product Description” in the standard with language reflective of current canned baked bean manufacturing practices. Additionally, AMS separated the canned dried beans, canned pork and beans, and canned baked beans grade standards from one shared standard document into three separate documents. These revisions bring the grade standards for canned baked beans in line with the present quality levels being marketed today and provide guidance in the effective use of these products.
Brian E. Griffin, Agricultural Marketing Specialist, Specialty Crops Inspection Division, Specialty Crops Program, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Room 1536, South Building; STOP 0240, Washington, DC 20250; telephone (202) 720-5021; fax (202) 690-1527; or, email
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.”
AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The U.S. standards for grades of fruits and vegetables that are not connected with Federal marketing orders or U.S. import requirements no longer appear in the Code of Federal Regulations, but are maintained by USDA, AMS, Specialty Crops Program, and are available on the Internet at:
AMS revised the voluntary U.S. Standards for Grades of Canned Baked Beans using the procedures that appear in part 36 of Title 7 of the Code of Federal Regulations (7 CFR part 36).
In September 2013, AMS received a petition from a professor emeritus in food science at Michigan State University asking the Agency to consider revising the current U.S. grade standards for canned baked beans to account for advances in industry processing technology. The petitioner requested the removal of the following text from the Product Description: “The product is prepared by washing, soaking, and baking by the application of dry heat in open or loosely covered containers in a closed oven at atmospheric pressure for sufficient prolonged time to produce a typical texture and flavor” and replacing it with: “The product is prepared by heating beans and sauce in a closed or open container for a period of time sufficient to provide texture, flavor, color, and consistency attributes that are typical for this product.”
Additional proposed changes to the U.S. Standards for Grades of Canned Baked Beans included separating the shared standard for canned dried beans, canned pork and beans, and canned baked beans into three individual standard documents and make minor editorial changes. These grade standards are recognized as three individual standards, but are contained in one document.
AMS published a proposed notice in the
This notice announces revisions to the third issuance of the U.S. Standards for Grades of Canned Baked Beans, which became effective on September 1, 1976, as follows:
Additionally, the U.S. Standards for Grades of Canned Dried Beans, Canned Pork and Beans, and Canned Baked Beans are separated into individual documents for the canned dried beans grade standards, canned pork and beans grade standards, and canned baked beans grade standards. There are no changes to the content of the canned dried beans or canned pork and beans grade standards.
The official grade of a lot of canned baked beans covered by these standards will be determined by the procedures set forth in the Regulations Governing Inspection and Certification of Processed Products, Thereof, and Certain Other Processed Food Products (7 CFR 52.1 to 52.83).
The revisions to the canned baked bean grade standard in this notice provide a common language for trade and better reflect the current marketing of canned baked beans. The changes are effective June 8, 2016.
7 U.S.C. 1621-1627.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200 and -300 series airplanes. This AD was prompted by reports that cracks were found on an adjacent hole of certain frames of the center wing box (CWB). This AD requires removing fasteners, doing a rototest inspection of fastener holes, installing new fasteners, oversizing the holes and doing rototest inspections for cracks if necessary, and repairing any cracking that is found. We are issuing this AD to detect and correct cracking on certain holes of certain frames of the CWB that could affect the structural integrity of the airplane.
This AD becomes effective June 13, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of June 13, 2016.
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200 and -300 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0149, dated June 13, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200 and -300 series airplanes. The MCAI states:
During accomplishment of A330 Airworthiness Limitation Item (ALI) task 57-11-04 on the rear fitting of the Frame (FR) 40 between stringers 38 and 39 on both [left-hand] LH/[right-hand] RH sides, cracks were found on an adjacent hole. After reaming at second oversize of the subject hole, the crack was still present.
Other crack findings on this adjacent hole have been reported on A330 and A340-200/300 aeroplanes as a result of sampling inspections.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.
For the reasons described above, this [EASA] AD requires removal of the fasteners and repetitive rototest inspections of fastener holes at FR40 vertical web located above Center Wing Box (CWB) lower panel reference and/or below CWB lower panel reference on both sides and, depending on findings, accomplishment of the applicable corrective actions.
Required actions also include oversizing certain holes, installing new fasteners, and repairing any cracking that is found. The initial compliance times range from 13,500 to 30,900 flight cycles, or 57,000 to 162,000 flight hours, depending on airplane operation and utilization. The repetitive compliance times are 7,400 flight cycles/24,300 flight hours or 5,950 flight cycles/40,400 flight hours from ALI embodiment. You may examine the MCAI in the AD docket on the Internet at
At the request of the Office of the Federal Register, we have revised the format of paragraph (g) of this AD by converting the table to text. This change to the format does not affect the requirements of that paragraph.
We gave the public the opportunity to participate in developing this AD. We considered the comment received. The commenter, Bowen Gass, supported the NPRM.
We reviewed the relevant data, considered 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.
Airbus has issued the following service information. The service information describes procedures for removing the fasteners and doing a repetitive rototest inspection of fastener holes at FR40 vertical web on both sides, installing new fasteners in transition fit, and oversizing the holes.
• Airbus Service Bulletin A330-57-3114, dated March 12, 2013.
• Airbus Service Bulletin A330-57-3115, dated April 4, 2013.
• Airbus Service Bulletin A330-57-3116, dated March 12, 2013.
• Airbus Service Bulletin A340-57-4123, dated March 12, 2013.
• Airbus Service Bulletin A340-57-4124, Revision 01, dated August 22, 2013.
• Airbus Service Bulletin A340-57-4125, dated March 12, 2013.
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 35 airplanes of U.S. registry.
We also estimate that it will take about 78 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $232,050, per inspection cycle, or $6,630 per product, per inspection cycle.
In addition, we estimate that any necessary follow-on actions will take about 98 work-hours and require parts costing $136,400, for a cost of up to $144,730 per product. We have no way of determining the number of aircraft that might need this action.
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 becomes effective June 13, 2016.
None.
This AD applies to the airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certificated in any category, all manufacturer serial numbers, except those on which Airbus Modification (Mod) 55792 or Mod 55306 has been embodied in production, and except those on which Airbus Repair Instruction R57115092 has been embodied in service on both right-hand (RH) and left-hand (LH) sides.
(1) Airbus Model A330-201, -202, -203, -223, -223F, -243 -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(2) Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by reports that cracks were found on an adjacent hole of certain frames of the center wing box (CWB). We are issuing this AD to detect and correct cracking on certain holes of the CWB, which could affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Do a rototest inspection of the fastener holes at the frame (FR) 40 vertical web, on both sides, as specified in paragraphs (g)(1) through (g)(6) of this AD, except as required by paragraph (k) of this AD.
(1) For Model A330-300 series airplanes in pre-mod 44360 configuration: At the later of the times specified in paragraphs (g)(1)(i) and (g)(1)(ii) of this AD, inspect below the CWB lower panel reference, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-57-3114, dated March 12, 2013.
(i) At the applicable time specified in paragraph 1.E., “Compliance” of Airbus Service Bulletin A330-57-3114, dated March 12, 2013.
(ii) Within 2,400 flight cycles or 24 months after the effective date of this AD, whichever occurs first.
(2) For Model A330-200 series airplanes in post-mod 44360 and pre-mod 49202 configuration: At the later of the times specified in paragraphs (g)(2)(i) and (g)(2)(ii) of this AD, inspect below the CWB lower panel reference, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-57-3116, dated March 12, 2013.
(i) At the applicable time specified in paragraph 1.E., “Compliance,” of Airbus Service Bulletin A330-57-3116, dated March 12, 2013.
(ii) Within 2,400 flight cycles or 24 months after the effective date of this AD, whichever occurs first.
(3) For Model A330-200 and -300 series airplanes in pre-mod 55306 and pre-mod 55792 configuration: At the later of the times specified in paragraphs (g)(3)(i) and (g)(3)(ii) of this AD, inspect above the CWB lower panel reference, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-57-3115, dated April 4, 2013.
(i) At the applicable time specified in paragraph 1.E., “Compliance” of Airbus Service Bulletin A330-57-3115, dated April 4, 2013.
(ii) Within 2,400 flight cycles or 24 months after the effective date of this AD, whichever occurs first.
(4) For Model A340-200 and -300 series airplanes in pre-mod 44360 configuration: At the later of the times specified in paragraphs (g)(4)(i) and (g)(4)(ii) of this AD, inspect below the CWB lower panel reference, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-57-4123, dated March 12, 2013.
(i) At the applicable time specified in paragraph 1.E., “Compliance” of Airbus
(ii) Within 1,300 flight cycles or 24 months after the effective date of this AD, whichever occurs first.
(5) For Model A340-200 and -300 series airplanes in pre-mod 55306 and pre-mod 55792 configuration: At the later of the times specified in paragraphs (g)(5)(i) and (g)(5)(ii) of this AD, inspect above the CWB lower panel reference, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-57-4124, Revision 01, dated August 22, 2013.
(i) At the applicable time specified in paragraph 1.E., “Compliance,” of Airbus Service Bulletin A340-57-4124, Revision 01, dated August 22, 2013.
(ii) Within 1,300 flight cycles or 24 months after the effective date of this AD, whichever occurs first.
(6) For Model A340-200 and -300 series airplanes in post-mod 44360 and pre-mod 49202 configuration: At the later of the times specified in paragraphs (g)(6)(i) and (g)(6)(ii) of this AD, inspect below the CWB lower panel reference, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-57-4125, dated March 12, 2013.
(i) At the applicable time specified in paragraph 1.E., “Compliance,” of Airbus Service Bulletin A340-57-4125, dated March 12, 2013.
(ii) Within 1,300 flight cycles or 24 months after the effective date of this AD, whichever occurs first.
If no crack is found during any inspection required by paragraph (g) of this AD, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD.
(1) Before further flight, install new fasteners in the transition fit, in accordance with the Accomplishment Instructions of the applicable service information identified in paragraph (g) of this AD.
(2) Repeat the inspection required by paragraph (g) of this AD thereafter at the applicable time identified in paragraph 1.E., “Compliance,” of the applicable service information identified in paragraph (g) of this AD.
If any crack is found during any inspection required by paragraph (g) of this AD: Before further flight, oversize the holes to the first oversize in comparison with the current hole diameter, and do a rototest inspection for cracks, in accordance with the Accomplishment Instructions of the applicable service information identified in paragraph (g) of this AD.
(1) If no cracking is found during the rototest inspection required by paragraph (i) of this AD, do the actions specified in paragraphs (i)(1)(i) and (i)(1)(ii) of this AD.
(i) Before further flight: Install new fasteners in the transition fit, in accordance with the Accomplishment Instructions of the applicable service information identified in paragraph (g) of this AD.
(ii) Repeat the inspection required by paragraph (g) of this AD thereafter at the applicable time identified in paragraph 1.E., “Compliance,” of the applicable service information identified in paragraph (g) of this AD.
(2) If cracking is found during the rototest inspection required by paragraph (i) of this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
Accomplishment of the initial and repetitive inspections required by this AD terminates accomplishment of Airworthiness Limitation Items Tasks 57-11-04 and 57-11-02 of the Airworthiness Limitation Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT ALI).
(1) Installation of new fasteners, as specified in paragraph (h)(1) of this AD, does not terminate the repetitive inspections required by paragraph (g) of this AD.
(2) Accomplishment of the corrective actions specified in the introductory text of paragraph (i) and paragraph (i)(1) of this AD does not terminate the repetitive inspections required by paragraph (g) of this AD.
(3) Accomplishment of the repair specified in paragraph (i)(2) of this AD does not terminate repetitive inspections required by paragraph (g) of this AD, unless the approved repair method specifies otherwise.
(1) If the applicable service information identified in paragraph (g) of this AD specifies contacting Airbus for appropriate action: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA.
(2) Where paragraph 1.E., “Compliance,” of the applicable service information specified in paragraph (g) of this AD specifies a compliance time in terms of a “Threshold” and “Grace Period,” this AD requires compliance at the later of the applicable threshold and grace period.
(3) Where paragraph 1.E., “Compliance,” of the applicable service information specified in paragraph (g) of this AD specifies a threshold as “before next flight,” this AD requires compliance before the next flight after the applicable finding.
This paragraph provides credit for actions required by paragraphs (g) and (i) of this AD, if those actions were performed before the effective date of this AD using the applicable service information specified in paragraph (l)(1), (l)(2), (l)(3), (l)(4), (l)(5), (l)(6), (l)(7), (l)(8), or (l)(9) of this AD. This service information is not incorporated by reference in this AD.
(1) Airbus Technical Disposition LR57D11023270, Issue B, dated July 12, 2011.
(2) Airbus Technical Disposition LR57D11029171, Issue B, dated September 6, 2011.
(3) Airbus Technical Disposition LR57D11029173, Issue B, dated September 6, 2011.
(4) Airbus Technical Disposition LR57D11030741, Issue B, dated September 22, 2011.
(5) Airbus Technical Disposition LR57D11029170, Issue C, dated September 6, 2011.
(6) Airbus Technical Disposition LR57D11023714, Issue B, dated July 12, 2011.
(7) Airbus Technical Disposition LR57D11029172, Issue B, dated September 6, 2011.
(8) Airbus Technical Disposition LR57D11030740, Issue C, dated September 22, 2011.
(9) Airbus Service Bulletin A340-57-4124, dated April 4, 2013.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0149, dated June 13, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(3) and (o)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A330-57-3114, dated March 12, 2013.
(ii) Airbus Service Bulletin A330-57-3115, dated April 4, 2013.
(iii) Airbus Service Bulletin A330-57-3116, dated March 12, 2013.
(iv) Airbus Service Bulletin A340-57-4123, dated March 12, 2013.
(v) Airbus Service Bulletin A340-57-4124, Revision 01, dated August 22, 2013.
(vi) Airbus Service Bulletin A340-57-4125, dated March 12, 2013.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
(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 737-300, -400, and -500 series airplanes. This AD was prompted by reports of fatigue cracking found at the left-side and right-side upper frames, at a certain area. This AD requires repetitive medium frequency eddy current (MFEC) inspections for cracking of the left-side and right-side upper frames, and repair (including open hole high frequency eddy current (HFEC) inspections for cracking of fastener holes) if necessary. This AD also provides an optional preventive modification, which terminates the repetitive inspections at the modified location. We are issuing this AD to detect and correct fatigue cracking of the upper frame, which can grow in size and result in a severed frame, leading to rapid decompression and consequent reduced structural integrity of the airplane.
This AD is effective June 13, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 13, 2016.
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
You may examine the AD docket on the Internet at
Galib Abumeri, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, California 90712-4137; phone: 562-627-5324; fax: 562-627-5210; 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 737-300, -400, and -500 series 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.
Europe Airpost and Boeing requested that we revise the NPRM to clarify the “Condition” column of table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, which specifies airplanes with certain flight cycles “on the original issue date of this service bulletin.” The commenters questioned whether the corresponding compliance time should be “on the effective date of the AD.”
For the reasons suggested by both commenters, we agree to add paragraph (i)(3) to this AD to state that the corresponding reference point is on the effective date of this AD, and we have included reference to paragraph (i)(3) in all appropriate paragraphs in this AD.
Boeing requested that we revise paragraph (g) of the proposed AD to address the inspection requirements in areas of an existing repair to eliminate cracking approved by a Boeing Organization Designation Authorization (ODA) via FAA Form 8100-9. Boeing explained that this condition is addressed in note (c) of table 1 of paragraph 1.E., “Compliance,” of Boeing
We agree that clarification is necessary. Boeing ODA-approved repairs installed prior to the effective date of this AD are acceptable to terminate the initial and repetitive inspections in the area under the repair. We have revised paragraph (g) of this AD accordingly, and added a new paragraph (g)(1) in this AD.
Southwest Airlines requested that we clarify paragraph (l)(4) of the proposed AD. Southwest Airlines explained that note 15 in paragraph 3.A., “General Information,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, states that steps in the Work Instructions that are identified as RC must be accomplished once the actions specified in Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, becomes mandated by an AD. Southwest Airlines stated that note 15 also states that deviations to steps that are not identified as RC do not require approval of an Alternative Method of Compliance (AMOC). Southwest Airlines stated that paragraph (l)(4) of the proposed AD specifies that any service information that is identified as RC requires AMOC approval except as required by paragraph (i)(1) of the proposed AD. Paragraph (k) of the proposed AD states that the post-repair and post-modification inspections are not mandated by the AD, so it is unclear whether the proposed AD would require the operator to contact Boeing if there are crack findings during the post-repair and post-modification inspections, and whether or not the resulting repairs are subject to the requirements of the AD.
We agree to provide clarification. Paragraph (k) of this AD states that the post-repair and post-modification inspections specified in tables 4 and 5 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, are not required by this AD (tables 4 and 5 correspond to Parts 6 and 7, respectively, of the service information.). The RC steps in those parts are also not required by this AD. Any cracking found—whether during accomplishment of the actions required by an AD or during routine maintenance—is required by 14 CFR 43.13(b) to be repaired before further flight. However, for clarity, we have revised paragraph (i)(1) of this AD to refer only to Part 3 and Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014. In addition, we have revised paragraph (l)(4) of this AD to refer to Part 2, Part 3, and Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014.
Southwest Airlines stated that the NPRM does not specifically address existing repairs that prevent accomplishment of the inspections proposed in paragraph (g) of the proposed AD. Note (c) in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, specifies that an ODA-approved repair, via FAA Form 8100-9, installed to eliminate previously found cracking, eliminates the need for the repetitive inspections at the repaired locations. Southwest requested that we revise the NPRM to apply this provision to repairs for damage other than cracking. Southwest Airlines also requested that we specifically state that any repair approved by Boeing via an FAA 8100-9 combined with approval of an AMOC to paragraph (h) of the proposed AD terminates both the initial and repetitive inspections required by paragraph (g) of the proposed AD.
We agree to add clarification regarding initial and repetitive inspections. To provide additional clarification in the rule we have revised the wording in paragraphs (g) and (h) of this AD. Also, we agree to revise the NPRM to include in this final rule, the provision for repairs for cracking in paragraph (g)(1) of this AD, and the provision for repairs that were installed for damage other than cracking that have been re-evaluated and approved by the Boeing ODA with an FAA Form 8100-9 combined with an AMOC statement, in paragraph (g)(2) of this AD.
Aviation Partners Boeing stated that accomplishing Supplemental Type Certificate (STC) ST01219SE (
We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) in this AD, and have added new paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this final rule. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” AMOC approval request is not necessary to comply with the requirements of 14 CFR 39.17.
We have revised paragraph (k) of this AD to clarify that the post-modification inspections are airworthiness limitations that are required by maintenance and operational rules; therefore, these inspections are not required by this AD.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM 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.
Boeing has issued Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014. The service information describes procedures for repetitive MFEC inspections for cracking, repair the cracking including doing an open hole HFEC inspections for cracking of the holes, and an optional modification of an inspection area including open hole and surface HFEC inspections for cracking of the area to be modified. 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 109 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary on-condition actions that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these actions:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
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 June 13, 2016.
None.
(1) This AD applies to The Boeing Company Model 737-300, -400, and -500 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014.
(2) Installation of Supplemental Type Certificate (STC) ST01219SE (
Air Transport Association (ATA) of America Code 53: Fuselage.
This AD was prompted by reports of fatigue cracking found at the left-side and right-side upper frames, at station 360 between stringer 13 and stringer 14. We are issuing this AD to detect and correct fatigue cracking of the upper frame, which can grow in size and result in a severed frame, leading to rapid decompression and consequent reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraphs (i)(2) and (i)(3) of this AD: At the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, do a medium frequency eddy current (MFEC) inspection for cracking on the left-side and right-side of the upper frame at station 360 between stringer 13 and stringer 14, in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014. If no cracking is found, repeat the inspections at the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014. Accomplishment of the actions specified in paragraph (j) of this AD terminates the repetitive inspections required by this paragraph at the modified area only. The initial and repetitive inspections required by this paragraph may be terminated in the area under repairs installed prior to the effective date of this AD, provided they meet the requirements of paragraph (g)(1) or (g)(2) of this AD.
(1) Repairs were installed to eliminate previously found cracking and were
(2) Repairs were installed for damage other than cracking that have been re-evaluated and approved by the Boeing ODA with an FAA Form 8100-9 that includes an alternative method of compliance (AMOC) statement to paragraph (h) of this AD.
If any cracking is found during any inspection required by paragraph (g) of this AD: Before further flight, repair the cracking including doing an open hole high frequency eddy current (HFEC) inspection for cracking of the holes, in accordance with Part 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, except as required by paragraph (i)(1) of this AD. Repair of any crack terminates the initial and repetitive inspection requirements of paragraph (g) of this AD for the repaired area only. If any cracking is found during any inspection required by this paragraph, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (l) of this AD.
(1) Where Part 3 and Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, specifies contacting Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (l) of this AD.
(2) Where Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified time after the effective date of this AD.
(3) Where the Condition column of table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, specifies a reference point “on the original issue date of this service bulletin,” for this AD the corresponding reference point is on the effective date of this AD.
Modification of an inspection area specified in paragraph (g) of this AD, including open hole and surface HFEC inspections for cracking of the area to be modified, in accordance with Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, except as required by paragraph (i)(1) of this AD, terminates the repetitive inspections required by paragraph (g) of this AD at the modified location only.
Tables 4 and 5 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, specify post-modification airworthiness limitation inspections in compliance to 14 CFR 25.571(a)(3) at the modified locations, which support compliance with 14 CFR 121.1109(c)(2) or 129.109(b)(2). As airworthiness limitations, these inspections are required by maintenance and operational rules. It is therefore unnecessary to mandate them in this AD. Deviations from these inspections require FAA approval, but do not require an alternative method of compliance.
(1) The Manager, Los Angeles 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 (m) 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 required by this AD if it is approved by Boeing Commercial Airplanes ODA that has been authorized by the Manager, Los Angeles ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) Except as required by paragraph (i)(1) of this AD: Where Part 2, Part 3, and Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1339, dated August 12, 2014, contains steps that are labeled as RC, the provisions of paragraphs (l)(4)(i) and (l)(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. 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 Galib Abumeri, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, California 90712-4137; phone: 562-627-5324; fax: 562-627-5210; 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 Alert Service Bulletin 737-53A1339, dated August 12, 2014.
(ii) Reserved.
(3) For Boeing 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 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:
Coast Guard, DHS.
Interim rule and request for comment.
The Coast Guard is issuing an interim rule to require U.S. and foreign self-propelled cargo vessels of 500 gross tons or more, traveling on international voyages and carrying cargo that is other than solid or liquid bulk cargo, to have cargo securing manuals (CSMs) on board. The rule also requires those vessels to comply with certain provisions of the International Convention for the Safety of Life at Sea, 1974 as amended (SOLAS), authorizes recognized classification societies or other approval authorities to review and approve CSMs on behalf of the Coast Guard; and prescribes when and how
The Coast Guard requests public comment on its intention to extend, in a subsequent final rule, this interim rule's requirement for vessel CSMs to self-propelled cargo vessels under 500 gross tons, if these vessels carry dangerous goods in packaged form on international voyages. This interim rule promotes the Coast Guard's maritime safety and stewardship (environmental protection) missions, helps fulfill U.S. treaty obligations, and could help prevent or mitigate the consequences of vessel cargo loss.
This interim rule is effective June 8, 2016. Comments must be received by August 8, 2016. The incorporation by reference of certain documents in this rule is approved by the Director of the Federal Register as of June 8, 2016.
You may submit comments identified by docket number USCG-2000-7080 using the Federal eRulemaking Portal at
For information about this document, call or email Mr. Ken Smith, Project Manager, U.S. Coast Guard Headquarters, Vessel and Facility Operating Standards Division, Commandant (CG-OES-2); telephone 202-372-1413, email
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
We are not planning to hold a public meeting but will consider doing so if public comments indicate a meeting would be helpful. We would issue a separate
Sections 2103 and 3306 of Title 46, United States Code (U.S.C.), provide the statutory basis for this rulemaking. Section 2103 gives the Secretary of the department in which the Coast Guard is operating general regulatory authority to implement Subtitle II (Chapters 21 through 147) of Title 46, which includes statutory requirements in 46 U.S.C. Chapter 33 for inspecting the vessels to which this rulemaking applies. Section 3306 gives the Secretary authority to regulate an inspected vessel's operation, fittings, equipment, appliances, and other items in the interest of safety. The Secretary's authority under both statutes has been delegated to the Coast Guard in DHS Delegation No. 0170.1, para. II (92.a) and (92.b).
The purpose of this rule is to align Coast Guard regulations with the requirements for cargo securing manuals in the International Convention for the Safety of Life at Sea, 1974 as amended (SOLAS), and apply those requirements to certain self-propelled U.S. cargo vessels operating anywhere in the world, and to certain foreign-flagged self-propelled cargo vessels operating in U.S. waters. Another purpose of this rule is to specify when and how the loss or jettisoning of cargo at sea must be reported.
This rule aims to help ensure that maritime cargo is properly secured. A recent survey by the World Shipping Council (WSC) estimated that an average of 1,679 containers are lost overboard annually.
Several incidents since the early 1990s demonstrated that improperly secured cargo can cause serious injury or death, vessel loss, property damage, and environmental damage. For example, a Coast Guard board of inquiry
The SOLAS CSM requirements are included as an annex to a Coast Guard guidance document issued in 1997,
Previously in this rulemaking, we issued a notice of proposed rulemaking (NPRM)
This section summarizes the changes made in this interim rule.
Section 97.100 contains the applicability provisions of subpart A and provides for electronic submission of any documents required by the part. Subpart A applies to self-propelled cargo vessels of 500 gross tons or more traveling on international voyages and carrying any cargo other than solid or liquid bulk cargo. We expect very few vessels to be affected by the new requirements, as most foreign vessels operating in U.S. waters are already subject to their flag state's SOLAS CSM-aligned requirements, and all U.S. vessels already voluntarily comply with those requirements in order to obtain SOLAS certificates that are necessary for entering foreign ports. Subpart A also applies to self-propelled vessels less than 500 gross tons if their owners or operators choose voluntarily to have it apply to them and submit CSMs for approval.
We have revised the text of § 97.100 as it appeared in the SNPRM by removing seagoing barges and other non-self propelled vessels from the applicability of subpart A, which were inadvertently included in the proposed regulatory text of the SNPRM. This interim rule applies only to self-propelled cargo vessels that are subject to SOLAS Chapter VI/5.6 or Chapter VII/5.
As we discussed in Part V, Discussion of Comments, in our SNPRM, a commenter suggested extending the applicability of subpart A to self-propelled cargo vessels below 500 gross tons carrying dangerous goods in packaged form on international voyages. We agree with the commenter's assessment that the cargo securing manual requirements of Chapter VII/5 of SOLAS apply to all vessels covered by other SOLAS provisions
Section 97.105 defines terms used in subpart A, and § 97.110 provides for the incorporation in subpart A, by reference, of pertinent IMO circulars describing how vessels may comply with the SOLAS CSM requirements, as well as an IMO resolution providing guidelines for third parties acting on behalf of a government agency like the Coast Guard.
Section 97.115 requires any accidental loss or deliberate jettisoning of a container or other cargo at sea to be reported immediately under 33 CFR 160.215. This is because any such loss or jettisoning creates a “hazardous condition” within the meaning of 33 CFR 160.204. The section also requires the loss or jettisoning of cargo containing hazardous material to be reported as soon as possible in accordance with the U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration regulations at 49 CFR 176.48.
Section 97.120 requires each vessel to which subpart A applies to have a flag state-approved CSM that complies with applicable IMO resolutions. Coast Guard personnel may board any vessel in U.S. waters to verify compliance with this section. Note that any container vessel with a keel laid on or after January 1, 2015, needs to include a cargo safe access plan. Under the applicable IMO guidance, such a plan must provide detailed information on safe access for persons stowing and securing cargo on vessels that are specifically designed and fitted for carrying containers.
Section 97.200 describes how a U.S.-flagged vessel owner or operator applies for Coast Guard approval of the vessel's CSM. Third-party approval authorities review and approve CSMs on the Coast Guard's behalf. This section also describes the contents of approval statements, the procedure to follow when a CSM is disapproved, and document retention requirements.
Section 97.205 describes when a CSM must be resubmitted for approval, and § 97.210 contains provisions for appeal from a CSM approval authority's decision.
Section 97.300 designates the organizations that are initially authorized to act as CSM approval authorities, and §§ 97.305 through 97.315 discuss who may request that authorization in the future, the criteria for authorization, and the requirements for approval authorities. We modified this section from what we originally published in the SNPRM by removing specific reference to the American Bureau of Shipping (ABS) and Lloyd's Register, because they are already included on the list of recognized classification societies to which the Coast Guard has delegated authority for the issuance of a Cargo Ship Safety Equipment Certificate in accordance with 46 CFR 8.320(b)(4) and covered
The SNPRM drew public comments from 12 sources: 7 Individuals (one of whom submitted 2 comments, which we consider together), 2 barge companies, 1 shipping industry organization, 1 trade association, and 1 environmental advocacy organization. The docket also contains 1 comment from another Federal agency.
The environmental advocacy organization and two individuals said that the loss of cargo containers is a serious problem. The organization said container loss has an immediate impact by changing deep sea habitats, and a long term impact by changing the natural distribution of species, including the threat of introducing invasive species. One individual said container loss is a major threat to the environment, to pleasure craft, and to commercial shipping. This commenter suggested that the insurance industry should welcome our proposal because of the economic impact of container losses. The other individual said we should require containers to be weighed so that weight can be distributed for safety.
We share these commenters' concern for the safety and environmental hazards that can be caused by the loss of containers or other cargo at sea, and we agree with most of their comments. However, we decline to require containers to be weighed, because this information is the subject of several existing Federal and International Maritime Organization (IMO) requirements. The Occupational Safety and Health Administration requires a container to be weighed before it can be handled by U.S. workers, and the Department of Transportation has stringent notification and certification requirements for intermodal containers.
The shipping organization said that, whereas the SNPRM based its cost analysis on an IMO estimate of 4,000 containers lost at sea per year worldwide, the shipping organization's own analysis found that, on average, only 1,679 containers are lost at sea each year. We appreciate the shipping organization's analysis and are using their most current estimate in the regulatory analysis for this interim rule. Please see Section VIII, Regulatory Analyses, for details.
The two towing companies expressed appreciation that we do not propose to regulate cargo securing on barges in coastwise trade, but opposed our SNPRM's proposed extension
The Director of the Federal Register has approved the material in 33 CFR 97.110 for incorporation by reference under 5 U.S.C. 552 and 1 CFR part 51. Copies of the material are available from the sources listed in § 97.110. The following paragraphs summarize the material incorporated by reference.
IMO Assembly Resolution A.739(18) (Res.A.739(18)), Guidelines for the Authorization of Organizations Acting on Behalf of the Administration, November 22, 1993: International guidelines developed to establish a uniform program for controlling and assigning authority of organizations to act on behalf of administrations in conducting surveys, certifications, and determination of tonnages.
IMO Maritime Safety Committee Circular 1352 (MSC.1/Circ.1352), Amendments to the Code of Safe Practice for Cargo Stowage and Securing (CSS Code) Annex 14, Guidance on Providing Safe Working Conditions for Securing of Containers on Deck, June 30, 2010: International guidance developed to ensure persons engaged in carrying out container securing operations on deck have safe working conditions including safe access, and appropriate securing equipment.
IMO Maritime Safety Committee Circular 1353 (MSC.1/Circ. 1353/Rev.1), Revised Guidelines for the Preparation
We developed this interim rule after considering numerous statutes and Executive Orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes or E.O.s.
Executive Orders 12866, Regulatory Planning and Review, and 13563, Improving Regulation and Regulatory Review, direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
This rule has not been designated a “significant regulatory action” under section 3(f) of E.O. 12866, Regulatory Planning and Review, as supplemented by E.O. 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that E.O. Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB). A final Regulatory Assessment for the interim rule follows.
This interim rule amends the CFR by adding the following provisions:
• Requirements for the reporting of lost or jettisoned cargo;
• The CSM requirements of SOLAS, for vessels of 500 gross tons or more;
• Extending the CSM requirements to self-propelled cargo vessels that travel on international voyages and carry cargo other than solid or liquid bulk cargo that is designated as a dangerous good carried in packaged form; and
• Procedures for authorization of third-party organizations to review and approve CSMs on the Coast Guard's behalf.
Table 1 presents a summary of our analysis.
Table 2 presents a summary of the 10-year cost schedule, showing total costs on an undiscounted basis and discounted at 7-percent and 3-percent interest rates.
Because there are no changes between the requirements proposed in the SNPRM and those contained in this interim rule, and because we received no public comments that affect the Regulatory Assessment, we retained the structure of the economic analyses from the SNPRM, but updated our analysis with the most current data. The data elements that we revised for this analysis are as follows:
• Affected vessel population, U.S.- and foreign-flagged vessels used 2011 through 2013 data.
• Visits to U.S. ports, updated with data from 2011 through 2013.
• Wage rates for commercial and Coast Guard employees, updated with current data.
• Container ship traffic data, updated with current data.
The affected population, those vessels subject to the regulations in this interim rule, consists of U.S.- and foreign-flagged self-propelled vessels that—
• Are engaged in international trade as indicated by currently having a SOLAS Cargo Ship Safety Certificate;
• Are 500 gross tons or more; and
• Carry any cargo other than solid or liquid bulk commodities.
The United States is a signatory state to SOLAS, and U.S.-flagged vessels in international trade must meet SOLAS requirements, including the CSM rules, to receive a SOLAS certificate. A 2013 extract from the Coast Guard's Marine Information for Safety and Law Enforcement (MISLE) database identified 83 U.S.-flagged vessels as meeting the above tonnage and cargo criteria.
The applicable foreign-flagged vessels are those that transit U.S. waters. The source for data on these vessels was the Coast Guard's Ship Arrival Notification System (SANS) database. This database contains data on notifications of arrival and departure of vessels to and from U.S. ports and is supplemented by data from MISLE. We extracted from SANS the most recent 3 years of data available, 2011 through 2013. This data produced a list of 6,353 foreign-flagged vessels that had one or more visits to a U.S. port and met the tonnage and cargo-type criteria. Table 3 presents the affected population of 6,436 vessels categorized by flag status, SOLAS status, and tonnage class (less than 500 gross tons, 500 gross tons or more).
The economic analyses include—
• An analysis of the costs, benefits, and alternatives for each of the interim rule's three provisions: (a) Requirements for the reporting of lost or jettisoned cargo, (b) CSM requirements, and (c) Approval of authorized organizations. A summary of the costs and benefits for the entire rule; and
• A preliminary analysis of expanding the affected population.
In this interim rule we include requirements for the immediate reporting of lost or jettisoned cargo. We anticipate that adoption of these requirements will correct this underreporting and lead to some increased costs to industry. Table 4 presents the change matrix for modifying the reporting of hazardous conditions and summarizes the specific edit or change, the affected population, and the economic impact.
For the years 2009 through 2013, there were only five incidents of containers lost or damaged at sea and reported to the Coast Guard. As previously noted, industry experts assert that many incidents of lost or jettisoned cargo are not reported to the appropriate authorities. To test this assertion, we developed an estimate of lost or jettisoned cargo incidents that are subject to Coast Guard rules.
As the base of our estimate, we used the annual estimate of 1,679 containers lost at sea worldwide, as reported by the World Shipping Council (WSC) in its 2014 report
However, the WSC report was not categorized by route or flag of the vessel. We derived the U.S. share of global container traffic using data reported by the U.S. Department of Transportation's Maritime Administration (MARAD), which reported in 2011 that there were 376,389 container ship visits worldwide,
We used that 5.9 percent share to estimate that about 99 containers in U.S. traffic are lost annually (1,679 containers lost world-wide × 5.9 percent U.S. share of traffic, rounded). The 5 incidents resulted in a loss of a total of 25 containers, so we estimate on average there were 5 lost containers per incident. Using those data, we estimate that there will be 20 reports of lost containers to the Coast Guard (99 containers lost/5 containers per incident, rounded to the nearest 10) in the first year the rule becomes effective.
The Tioga Group, a freight transportation services consulting firm,
The wage rate for the Master was obtained from the U.S. Bureau of Labor Statistics (BLS), using Occupational Series 53-5021, Captains, Mates, and Pilots of Water Vessels. The BLS reports that the hourly rate for a Master is $36.34 per hour.
Similarly, we estimate that it will take a quarter of an hour for Coast Guard personnel at the E-4 level to record the data. The fully loaded wage rate for an E-4 rating is $42, per Commandant Instruction 7310.1N.
As shown in Table 5, the unit cost for reporting lost or jettisoned cargo is $23.75.
The baseline estimate of lost or jettisoned cargo incidents, the growth rate, and the unit cost data provide the inputs into the 10-year cost schedule. Table 6 displays the input data and the resulting cost estimates on an undiscounted basis and discounted at 7-percent and 3-percent interest rates.
To provide an estimate of costs by flag status, we extracted from the Coast Guard's SANS database the vessels calling on U.S. ports in 2011.
We produced an estimate for U.S. costs of lost or jettisoned cargo by applying the 11.8 percent of visits by U.S.-flagged vessels from Table 7 to the cost estimates from Table 6. Note that U.S. costs include both costs to U.S.-flagged vessels and the Coast Guard. Table 8 displays the data for the U.S. costs.
We obtained the costs of reporting lost or jettisoned cargo for non-U.S.-flagged vessels by subtracting the U.S. costs, as reported in Table 8, from the costs as displayed in Table 6. Table 9 presents the results of these calculations.
The immediate benefit of the reporting provisions is that they will enhance the Coast Guard's ability to identify potential problems with securing equipment, locate and warn mariners about drifting containers that endanger safe navigation, and assess and respond to any potential environmental hazard created by the cargo loss. In the longer term, having complete and accurate data on lost cargo incidents will enable the Coast Guard and other parties to identify industry trends and track potential long-term threats to the marine environment from sunken containers.
Another alternative we considered was to reduce the amount of information to be sent to the Coast Guard in order to minimize recordkeeping burden. We examined the data specified in this rule and determined that all of it would be needed by the Coast Guard in order to completely evaluate the situation and determine the appropriate response. Therefore, we believe that the reporting requirements in this rule will provide the Coast Guard with sufficient
Under the Coast Guard's safety and security vessel examinations program, the Coast Guard checks that the subject vessels in U.S. ports have CSMs and that the crews follow them. MISLE data show that from 2011 through 2013, the 83 U.S.-flagged vessels that are part of the affected population were subject to 646 inspections. In all of these inspections there were no citations for a deficient CSM.
MISLE also recorded that from 2011 through 2013, the Coast Guard conducted 14,358 vessel inspections of foreign-flagged vessels and found problems relating to CSMs in only 9 instances. These data indicate an ongoing compliance process for both U.S.- and foreign-flagged vessels subject to CSM rules. Therefore, the Coast Guard anticipates that the only costs regarding the CSM requirement, once the requirements of SOLAS and Coast Guard guidance are moved into the CFR, would be those associated with owners or operators of the few deficient vessels who are prompted to ensure their CSMs are fully compliant with SOLAS prior to entering U.S. waters.
Tables 10 and 11 present the change matrix for the edits to Titles 33 and 46 of the CFR, respectively, that relate to the CSM requirements of the interim rule. Each matrix summarizes the specific edit or change, the affected population, and the economic impact.
Additionally, the interim rule requires that a CSM must be revised if one of these two criteria are met:
1. The vessel changes its type. As an example, a former break-bulk carrier is modified to become a container ship.
2. An existing vessel changes 15 percent of its cargo securing systems or more than 15 percent of its portable securing devices.
MISLE data indicates that none of the subject U.S.-flagged vessels have changed vessel type from 2001 through 2012. We assume that this trend will continue and that no vessels will change type during our analysis period. From information provided by an approved
Foreign-flagged vessels that are 500 gross tons or more follow SOLAS rules and current Coast Guard guidance. We estimated the costs of compliance for these vessels based on the following assumptions:
(1) In the absence of the rule, the current deficiency rate for subject foreign-flagged vessels would continue.
(2) Under the rule, the increased enforceability posture from codifying the CSM rules will lead all vessels to comply with the SOLAS standards and current Coast Guard guidance prior to entering U.S. waters. That is, the deficiency rate will be reduced to zero for foreign-flagged vessels.
We reported above that there were nine deficiencies related to CSMs from 2011through 2013. These deficiencies are comprised of five that were missing approval from an authorized organization, three that did not have a CSM on the vessel, and one that had a CSM with missing sections. Table 12 presents the data from 2011 through 2013 for the calculation of a deficiency rates by year and an annual average for the 3 years.
We used the average deficiency rate of 0.06 percent throughout our 10-year analysis period. The estimate of the number of deficient CSMs in any year equals the estimate of the vessel population for that year multiplied by the deficiency rate.
As reported in Table 3 in the “SOLAS Class” subtotal, there are 6,353 foreign-flagged vessels that are currently subject to the CSM requirements. Applying the 0.06 percent deficiency rate from Table 12 yields an estimate of four vessels that will need to remedy deficient CSMs in the first year the rule comes into effect.
In the analysis of the reporting requirements, we cited the Tioga Group's report on the container market that growth in container shipments to the United States is expected to increase,
We used the Tioga Group's estimate of a 4.9 percent rate for our estimate for growth in our 10-year analysis period. Currently, we do not have detailed information on the current and projected capacity utilization of container ships visiting U.S. ports, so we posited that the trips per year of the affected vessels would remain constant through the analysis period. With that assumption, we applied the 4.9 percent annual growth rate to the fleet of foreign-flagged vessels serving U.S. ports.
For Years 2 through 10, the base population is the base population from the previous year multiplied by the 4.9 percent growth rate. The resulting estimates of the base populations are shown in the “Base Population” column of Table 14.
We anticipate that a CSM will be revised to either remedy a deficiency or because the vessel met the previously discussed criterion of new cargo securing systems. We do not have detailed descriptions of each deficiency or changes in cargo securing equipment, so for the unit cost, we assume that a vessel will revise the CSM using an existing survey of the vessel. A 2013 study conducted by ABS Consulting, Inc. for the Coast Guard provided estimates on the costs of a suite of marine engineering and naval architecture services.
The costs to the Federal government are accounted for by the oversight actions performed by the authorized approval organizations. These actions include reviewing new or revised CSMs, issuing letters of approval, and, for CSMs that are not approved, issuing letters that explain why the CSMs were not approved. We anticipate that the reviews of the CSM will be conducted by a marine engineer or naval architect. We estimate that each review will take on average 2 working days and another hour will be needed to prepare the appropriate correspondence to the vessel's managers. Thus, the attributed burden to the Federal government for each review is 17 hours ((2 × 8) + 1 = 17).
We estimate that the average loaded (including benefits) hourly wage for a marine architect or naval engineer is
As foreign-flagged vessels are obtaining and revising CSMs under the auspices of their flag states, their only cost for this interim rule is to remedy deficiencies. The cost in each year is the number of deficient vessels times the unit cost of $7,625. Table 13 presents the undiscounted cost estimate for foreign-flagged vessels over the 10-year period.
As discussed previously, all 83 U.S.-flagged vessels have CSMs and have operated under them for over a decade. In addition, current business practices, particularly the requirements of insurers, would also indicate the use of a CSM. For these reasons, and as presented in the Regulatory Analysis of the NPRM, the requirements in this interim rule are not expected to result in a change in practice or incur a cost for the 83 U.S.-flagged vessels.
For the purposes of this regulatory analysis, we also compute costs assuming a baseline without CSMs for the 83 U.S.-flagged vessels. The cost for U.S.-flagged vessels to develop CSMs is presented in Table 14.
Table 15 presents the total costs for foreign-flagged vessels and U.S.-flagged vessels assuming a pre-CSM baseline on an undiscounted basis and the total costs discounted at rates of 7 percent and 3 percent. As shown in Table 15, the total 10-year cost for upgrading CSMs at a 7-percent discount rate is $1,490,587, or $212,226 on an annualized basis.
The options presented in the NPRM were only outlined and did not have cost estimates. We developed a cost estimate for Option 1 that would extend SOLAS requirements to domestic vessels. We added these details to Option 1 to make the calculations:
• The affected population will be U.S.-flagged vessels in coastwise trade. The geographic identification was vessels with coastwise route certifications. We identified 688 vessels from MISLE that met these requirements, comprised of 195 freight barges, 160 freight ships, and 333 offshore supply vessels.
• In general, the vessels in the U.S. affected population for this alternative are smaller than the foreign-flagged vessels that comprise the affected population of the regulation. Data comparisons for the U.S. fleet shows average gross tons of 8,165 and average length of 326 feet. The comparable data for the foreign-flagged vessels is average gross tonnage of 31,306 and average length of 619 feet. Therefore, for the unit cost of the U.S. coastwise vessels, we assigned the low-end value of $7,500, which came from the range supplied by the subject matter experts we contacted. The recent history of new builds is projected to continue through the 10-year analysis period. MISLE reported 22 new vessels per year from 2009 through 2012, and we used this in our analysis.
• A phase-in period was not in the NPRM, but we added a 3-year phase-in period to this interim rule to mitigate the burden on both vessel owners and the authorized approval organizations. We assume that vessel owners will distribute the certification of the manuals for their vessels evenly over the phase-in period. This will enable vessel owners and authorized approval organizations to schedule cargo securing approvals in conjunction with vessel down-time, such as scheduled examinations or times of vessel repairs and upgrades.
With these parameters, we developed a 10-year cost schedule for Option 1. Because the costs to foreign-flagged vessels would be the same for Option 1 as for the preferred alternative, the data presented show the marginal costs for Option 1. The annualized cost, using a 7-percent discount rate, would be $807,605. The cost estimates are displayed in Table 17.
The goal of Option 1 is to reduce the occurrence and impacts of lost containers in U.S. coastwise trade. However, the comments to the NPRM indicate that this is not a significant problem. One commenter stated that cargo losses from barges are rare, another stated that seagoing barges “are generally safe from cargo loss,” and another commenter stated that “most cargo losses result from container structural problems that the vessel owner or operator cannot know about or prevent.” However, as described above, the reporting of these incidents is uncertain. We anticipate that, with the more accurate reporting required by this interim rule, we will be able to validate this assertion. Additionally, our initial cost estimates, as presented in Table 17, indicate that industry would incur annualized costs, discounted at 7 percent, of $807,605 beyond what is in this rule. Therefore, this interim rule focuses exclusively on vessels in international trade. However, the Coast Guard can reevaluate this position and initiate another rulemaking for the U.S. coastwise trade if new information indicates either underreporting or an upward trend of lost containers.
The Coast Guard authorizes classification societies and other organizations to review and approve CSMs on its behalf. The procedures for these organizations are currently found in Coast Guard guidance and cover selection criteria, information required by organizations applying for authorization status, and the Coast Guard's application review procedures, termination of authorization procedures, and appeals procedures.
Following the procedures in current Coast Guard guidance, the Coast Guard has authorized these six classification societies to review and approve CSMs: American Bureau of Shipping (ABS), Det Norske Veritas (DNV), Lloyd's Register of Shipping (LR), Germanischer Lloyd (GL), RINA S.p.A, and ClassNK (NK).
However, current Coast Guard guidance is not legally enforceable. This interim rule will incorporate these procedures from guidance into the CFR with only some minor editorial changes, such as updating the address of Coast Guard Headquarters. Therefore, we believe there will be no additional regulatory costs associated with the codification of these application procedures. Table 18 presents the change matrix for the codification of the class society approval guidance into the CFR and summarizes the specific edit or
We considered alternatives to these changes and edits, and we concluded that there were no viable alternatives. The procedures in current Coast Guard guidance provide a complete description of all processes needed for approval and oversight of the subject organizations. Reducing or eliminating any of them, such as the one covering appeals, would leave a gap in the approval or oversight processes. We did not identify any weaknesses or gaps in the current Coast Guard guidance, other than the editorial changes. We also concluded that the recordkeeping information in the current Coast Guard guidance provides complete documentation for all the involved parties—vessel owners or operators, and approved organizations. Reducing or eliminating any of the recordkeeping rules would run the risk of producing a gap in the documentation. Conversely, adding additional recordkeeping rules would only increase associated burdens, but not provide any additional useful information.
In summary, the rules governing organizations approved to issue CSMs will codify current procedures with no associated costs to industry or the government. The benefit of these rules is that they will provide a regulatory basis for the Coast Guard's oversight of organizations authorized to approve CSMs.
Table 20 summarizes the undiscounted costs disaggregated by flag, requirement, and sector.
The primary benefit of this interim rule is that it places into the CFR rules and procedures for the cargo securing plans, the approval and oversight of organizations authorized to approve CSMs, and the reporting of lost or jettisoned cargo. Additionally, the reporting requirements for the lost or jettisoned cargo will provide the Coast Guard with additional information to track and monitor the effects on both navigation and the environment, and to take any appropriate enforcement actions. Overall, the interim rule will support the Coast Guard's missions of maritime safety and stewardship.
In Section V, Summary of the Rule, and Section VI, Discussion of Comments on SNPRM and Changes, we requested comments on our proposal to include self-propelled vessels less than 500 gross tons in the affected population. We conducted a preliminary analysis of the economic impacts of the proposal and summarize our findings below.
The proposal would add an additional 45 foreign-flagged vessels, resulting in a new total of 6,398 foreign-flagged vessels. Combined with the 83 U.S.-flagged vessels, the total affected population would be 6,481 vessels.
The only requirement that would be affected is the one requiring a subject vessel to have and follow an approved CSM. Of the 45 new vessels, 42 currently hold SOLAS cargo safety certificates. For this preliminary analysis we assumed that the three vessels without a cargo safety certificate would need to obtain an approved CSM. This would add an additional 26,250 (3 vessels × 8,750 per new CSM). A revised 10-year cost estimate for this requirement based on these assumptions is presented in Table 21.
The 7-percent annualized cost for the proposed modification to the CSM requirement is 215,270, compared to 212,226 for the interim rule, as shown in Table 15. Table 22 presents a revised 10-year schedule. It adds the 26,250 cost of new CSMs for the 3 vessels under 500 gross tons to the other requirements for reporting lost or jettisoned cargo and approval of classification societies.
With the addition of self-propelled vessels that are less than 500 gross tons, the annualized cost at a 7-percent discount rate increases to 215,848, compared to 212,804 for the interim rule, as shown in Table 19.
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601
Under the RFA, we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
We determined that this interim rule affects a variety of large and small businesses, not-for-profit organizations, and governments (see the “Description of the Potential Number of Small Entities” section below). Based on the information from this analysis, we found—
• Using size standards from the Small Business Administration (SBA), the 83 U.S-flagged vessels are controlled by 21 entities, none of which are small. The 6,353 foreign-flagged vessels are controlled by 1,023 entities. A review of the entities that control these vessels found that one foreign-flagged vessel is controlled by a non-U.S. not-for-profit entity that is not considered to be small, 7 foreign-flagged vessels are controlled by government agencies, and the remaining 6,345 foreign-flagged vessels are controlled by businesses. An analysis of a sample of the businesses controlling these vessels indicates that 48 percent are considered small.
• Compliance actions will consist of upgrading deficient CSMs and reporting lost or jettisoned cargo.
• Of the small entities in our sample with revenue information, 62 percent of them had an impact of less than 1 percent, and 28 percent had an impact within the 1 percent to 3 percent range.
The Regulatory Flexibility Act also requires an agency to conduct a final
The RFA establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.”
This FRFA was developed in accordance with Section 604(a) of the RFA. An FRFA must provide and/or address—
a. A statement of the need for, and objectives of, the rule;
b. A statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the rule as a result of such comments;
c. The response of the agency to any comments filed by the Chief Counsel for Advocacy of the SBA in response to the rule, and a detailed statement of any change made to the interim rule as a result of the comments;
d. A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;
e. A description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record;
f. A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the interim rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected;
g. For a covered agency, as defined in section 609(d)(2), a description of the steps the agency has taken to minimize any additional cost of credit for small entities.
Sections 2103 and 3306 of 46 U.S.C. provide the statutory basis for this rule. Section 2103 gives the Secretary of the department in which the Coast Guard is operating general regulatory authority to implement Subtitle II (Chapters 21 through 147) of Title 46, which includes statutory requirements in 46 U.S.C. Chapter 33 for inspecting the vessels to which this rule applies. Section 3306 gives the Secretary authority to regulate an inspected vessel's operation, fittings, equipment, appliances, and other items in the interest of safety. The Secretary's authority under both statutes has been delegated to the Coast Guard in Department of Homeland Security Delegation No. 0170.1(92)(a) and (b). Additionally, the United States is a party to SOLAS. Where SOLAS must be enforced through U.S. regulations, those regulations are authorized by E.O. 12234.
• U.S.-flagged vessels engaged in international trade; or
• Foreign-flagged vessels that are in the U.S. trade.
Section VII.A.3, Affected Population, of this preamble presents an estimate of 6,436 vessels that will be subject to the interim rule. As described in Section VIII, Regulatory Analyses, of this preamble, we found that 83 vessels in the affected population were U.S.-flagged. For the cost analysis, we found that these vessels were currently in compliance with the CSM requirements. Also for the cost analysis, we assumed that compliance would continue throughout the 10-year forecast period and we continue with that assumption in this FRFA. The focus of this FRFA is on the 4,353 foreign-flagged vessels, which may be under the control of U.S. entities or foreign entities. Table 23 displays a break-out of this population by the type of entity that owns or operates these vessels.
All the government entities exceed the threshold for being classified as a small entity, as they are either agencies of a foreign government or exceed the 50,000 population threshold. We excluded these government entities from the revenue impact analysis. The single not-for-profit entity is also deemed not small, as it is part of an international organization.
To analyze the potential impact on these businesses, we produced a
We researched and compiled the employee size and revenue data for the 67 U.S. businesses and we compared this information to the SBA “Table of Small Business Size Standards” to determine if an entity is small in its primary line of business as classified in the North American Industry Classification System (NAICS).
These 32 businesses that are below the SBA size thresholds are distributed among 16 NAICS classified industries. Table 25 lists the frequency, percentage, size standard, and size threshold of NAICS codes for the 32 small businesses found in the sample.
We selected the two industries that appeared most frequently in the random sample of entities. Businesses from these two industries accounted for 17 entities, or 53 percent of the entities in the random sample. Therefore, we assume that approximately 53 percent of all entities affected by this regulation will be in one of these industries. A brief description of the two industries affected most by this rule follows.
• Deep Water Freight Transportation (483111): This industry comprises establishments primarily engaged in providing deep sea transportation of cargo to or from foreign ports.
• Freight Transportation Arrangement (488510): This industry comprises establishments primarily engaged in arranging transportation of freight between shippers and carriers. These establishments are usually known as freight forwarders, marine shipping agents, or customs brokers, and offer a combination of services spanning transportation modes.
As discussed in Section VIII.A, Regulatory Planning and Review, from 2011 through 2013, the Coast Guard conducted 14,358 vessel inspections and found problems relating to CSMs in only 9 instances, which amounts to approximately 0.1 percent of the foreign-flagged vessels whose CSMs were deficient. We anticipate that the owners or operators of these vessels will upgrade their CSMs to meet standards and comply with this rule. We do not have detailed descriptions on each of the deficiency cases. To estimate a cost for this compliance action, we apply the estimate of $7,625 to remedy a CSM, as used in the Regulatory Analysis.
For reporting lost or jettisoned cargo, we noted in Section VIII.A, Cost Discussions, that when one of these incidents occurs, the vessel staff already collects the needed information for company purposes. Thus, the only additional cost to the vessel is to report this information to the Coast Guard. We estimate the additional reporting will take 0.25 hours for the vessel's Master or other senior officer to compile and transmit the report to the Coast Guard. We estimate that the loaded wage rate for the Master or senior officer is $53.00 per hour. The cost of reporting is $13.25 (0.25 hours × $53 per hour).
As discussed in Section VIII.A, Regulatory Planning and Review, we adjusted the affected population to account for anticipated growth in container traffic. In our 10-year analysis, we estimate that the number of vessels that will need to upgrade their CSMs will be 4 in Years 1 through 5, and will increase to 6 in Year 10. We also accounted for this growth in container traffic in our estimate of lost or jettisoned cargoes. In Section VIII.A, Cost Discussions, we estimate that in the first year the rule becomes effective, 20 incidents of lost or jettisoned cargo will occur. We estimate that the affected population in that year consists of 6,436 U.S.- and foreign-flagged vessels, yielding an incident rate of 0.3 percent (20 incidents/6,436 vessels). To execute a revenue impact analysis, we posited that in any given year, each business would have one vessel that will need to upgrade its CSM and one vessel that will experienc an incident of lost or jettisoned cargo. Given these assumptions, the total annual compliance cost for any company is $7,638.25, as shown in Table 26.
For each business in our sample with revenue data, we calculated the impact as the assumed cost of $7,638.25 as a percentage of that business's annual revenue. This produced a range of potential revenue impacts across the sample. Table 27 presents the impact data in ranges of less than 1 percent, 1 to 3 percent, 3 to 5 percent, and greater than 5 percent. As shown in this table, for approximately 62 percent of the companies, the revenue impact is less than 1 percent of annual revenue, and for approximately 28 percent of the companies, the revenue impact is between 1 percent and 3 percent.
As shown in Table 22, the highest cost to industry in any one year on an undiscounted basis is $114,786, which occurs in Year 10.
The revenue impact analysis indicates that 62 percent of the affected population will have an impact of less than 1 percent and the other 28 percent will have an impact between 1 percent and 3 percent.
For CSMs, this interim rule is based solely on current requirements contained in SOLAS and current Coast Guard guidance. Our regulatory analysis indicates that 99 percent of the subject vessels currently comply with these requirements. This rule enhances the Coast Guard's maritime safety mission without adding any new requirements to vessel owners and operators.
Alternatives were considered in this interim rule and are discussed in section VIII.A, Cost Discussions, of this preamble. Alternatives include various ways to apply the requirements to prepare and implement CSMs to U.S.-flagged vessels in coastwise trade. However, we concluded that standards developed for international trade cannot be economically justified for vessels operating only domestically at this time. Therefore, the focus of this interim rule is exclusively on vessels in international trade.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we offered to assist small entities in understanding this rule so that they could better evaluate its effects on them and participate in the rulemaking. 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).
This rule calls for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other similar actions. The title and description of the information collection, a description of those who must collect the information, and an estimate of the total annual burden follow. The estimate covers the time for preparing and reporting for the development of a CSM, revising a CSM, notification of other hazardous conditions, and notification of lost or jettisoned cargo.
This collection of information applies to rulemaking procedures regarding CSMs. Specific areas covered in this information collection include 33 CFR part 97, “Cargo Securing Manuals;” 33 CFR part 160, “Ports and Waterways Safety-General;” and 46 CFR part 97, “Operations.” This rule will align the CFR with SOLAS.
TITLE: Cargo Securing Manuals.
OMB CONTROL NUMBER: 1625-0122.
SUMMARY OF COLLECTION OF INFORMATION: The rule will add a new part 97, “Cargo Securing Manuals” to chapter 33 of the CFR. The collection of information burden for CSMs derives from one of these three events:
• A SOLAS container vessel built after the rule becomes effective will need to develop and implement a CSM. The new vessel will need an approved CSM.
• If a vessel changes its type, the CSM must be revised. An example of a type change is when a general break-bulk carrier is modified to become a containership.
• If an existing vessel either changes 15 percent of its cargo securing systems or more than 15 percent of its portable securing devices, the CSM must be revised.
Additionally, this interim rule will impose burdens for the notification of hazardous conditions. Currently, these notifications are made via VHS radio, satellite radio, cell phones, and other forms of electronic communication. The rule specifically allows for electronic communications, and we anticipate this will continue to be how the notifications are transmitted.
• Owners or operators of U.S.-flagged vessels that will need to submit new or revised CSMs to the recognized classification societies.
• Recognized classification societies and other approved third-party organizations that will review the CSMs on behalf of the Coast Guard.
• The operators of vessels that will be required to report hazardous conditions.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that we consider the impact of paperwork and other information collection burdens imposed on the public. According to the 1995 amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid OMB control number.
This interim rule will impose new information collection requirements. As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we will submit these new information collection requirements to OMB for its review. Notice of OMB information collection will be published in a future
A rule has implications for federalism under E.O. 13132, Federalism, if it has 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. We have analyzed this rule under E.O. 13132 and have determined that it does not have implications for federalism. Our analysis follows.
It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. It is also well settled, now, that all of the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel qualification, and manning of vessels), as well as the reporting of casualties and any other category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, are within the field foreclosed from regulation by the States. (See the decision of the Supreme Court in the consolidated cases of
This rule on cargo securing falls into the category of vessel operation. Because the States may not regulate within this category, the rule is consistent with the principles of federalism and preemption requirements in E.O. 13132.
Additionally, 33 CFR 160.215 is promulgated under the authority of the Ports and Waterways Safety Act, Title I, and therefore, under the principles of
The Coast Guard recognizes the key role that State and local governments may have in making regulatory determinations. Additionally, for rules with federalism implications and preemptive effect, E.O. 13132 specifically directs agencies to consult with State and local governments during the rulemaking process. If you believe this interim rule has implications for federalism under E.O. 13132, please contact the person listed in the
Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 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.
This rule will not cause a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it
We have analyzed this rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under E.O. 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.
The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule uses technical standards other than voluntary consensus standards. It incorporates two circulars and one resolution adopted by arms of the International Maritime Organization, an international organization under United Nations auspices, of which the United States is a member state. The two circulars describe in detail how a vessel's owner or operator may comply with CSM requirements contained in the International Convention for the Safety of Life at Sea. The resolution provides guidelines for third parties acting on behalf of a government agency like the Coast Guard.
All three documents may be obtained from the IMO using the address given in the regulatory text for new 33 CFR 97.110.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded under section 2.B.2, figure 2-1, paragraph (34)(d) and under section 6(a) of the “Appendix to National Environmental Policy Act: Coast Guard Procedures for Categorical Exclusions, Notice of Final Agency Policy” (67 FR 48244, July 23, 2002). This rule involves regulations which concern documentation and equipping of vessels, as well as regulations concerning vessel operation safety standards. An environmental analysis checklist and a categorical exclusion are available in the docket where indicated under
Cargo stowage and securing, Cargo vessels, Hazardous materials, Incorporation by reference, Reporting and recordkeeping requirements.
Administrative practice and procedure, Harbors, Hazardous materials transportation, Marine safety, Navigation (water), Personally identifiable information, Reporting and recordkeeping requirements, Seamen, Vessels, Waterways.
Cargo vessels, Marine safety, Navigation (water), Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR chapter I and 46 CFR part 97 as follows:
46 U.S.C. 2103, 3306; E.O. 12234; Department of Homeland Security Delegation No. 0170.1(92)(a) and (b).
(a) This subpart applies to—
(1) A self-propelled cargo vessel of 500 gross tons or more, on an international voyage, that must comply with Chapter VI/5.6 or Chapter VII/5 of the International Convention for the Safety of Life at Sea, 1974 as amended (SOLAS), that does not solely carry liquid or solid cargoes in bulk, and that is either a U.S.-flagged self-propelled cargo vessel, or a foreign-flagged self-propelled cargo vessel that is operating in waters subject to the jurisdiction of the United States;
(2) A U.S.-flagged self-propelled cargo vessel that chooses to have this subpart applied to it by submitting a cargo securing manual for approval in accordance with § 97.200(a)(3);
(3) A foreign-flagged self-propelled cargo vessel of 500 gross tons or more on an international voyage from a country that is not a signatory to SOLAS, that would otherwise be required to comply with Chapter VI/5.6 or Chapter VII/5 of SOLAS, that does not solely carry liquid or solid cargoes in bulk, and that is operating in waters subject to the jurisdiction of the United States; and
(4) Any organization applying to be selected as a cargo securing manual approval authority.
(b) This subpart does not apply to a vessel owned by the Maritime Administration that is part of the Ready Reserve Force or the title of which is vested in the United States and which is used for public purposes only.
(c) Any manual, letter, request, appeal, or ruling required by this
As used in this subpart—
(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection by contacting Mr. Ken Smith of the Coast Guard's Vessel and Facility Operating Standards Division, Commandant (CG-OES-2); telephone 202-372-1413, email
(b)
(1) MSC.1/Circ.1352, Amendments to the Code of Safe Practice for Cargo Stowage and Securing (CSS Code), June 30, 2010 (Maritime Safety Committee Circular), IBR approved for § 97.120(b).
(2) MSC.1/Circ. 1353/Rev.1, Revised Guidelines for the Preparation of the Cargo Securing Manual, December 15, 2014 (Maritime Safety Committee Circular), IBR approved for § 97.120(a).
(3) Resolution A.739(18) (Res.A.739(18)), Guidelines for the Authorization of Organizations Acting on Behalf of the Administration, November 22, 1993 (Assembly Resolution), IBR approved for § 97.310(a).
(a) In the event a vessel loses or jettisons at sea any cargo described in paragraph (b) of this section, it must comply with the immediate notification requirements of 33 CFR 160.215, and if the cargo contains hazardous material as defined in paragraph (c) of this section, the vessel must also report it as soon as possible in accordance with 49 CFR 176.48.
(b) The cargo to which this section applies includes any container and any other cargo the loss or jettisoning of which could adversely affect the safety of any vessel, bridge, structure, or shore area or the environmental quality of any port, harbor, or navigable waterway of the United States.
(c) As used in this section, “hazardous material” means a substance or material designated by the Secretary of Transportation as capable of posing an unreasonable risk to health, safety, and property when transported in commerce. The term includes hazardous substances, hazardous wastes, marine pollutants, and elevated temperature materials as defined in 49 CFR 171.8, materials designated as hazardous under the provisions of 49 CFR 172.101, and materials that meet the defining criteria for hazard classes and divisions in 49 CFR part 173.
(a) Any vessel to which this subpart applies must have a cargo securing manual (CSM) on board that has been approved by the government of the country whose flag the vessel is entitled to fly; and a CSM approved after June 30, 2010, must, at a minimum, meet the guidelines in MSC.1/Circ. 1353/Rev.1, (incorporated by reference, see 33 CFR 97.110).
(b) A container vessel with a keel laid on or after January 1, 2015, must include a cargo safe access plan that, at a minimum, meets the guidelines in MSC.1/Circ.1352, Annex 14, Guidance on Providing Safe Working Conditions for Securing of Containers on Deck (incorporated by reference, see 33 CFR 97.110).
(c) While operating in waters under the jurisdiction of the United States, the Coast Guard may board any vessel to which this subpart applies to determine that the vessel has the document(s) required by paragraph (a) of this section on board. Any foreign-flagged vessel found not to be in compliance with paragraph (a) of this section may be detained by order of the Captain of the Port at the port or terminal where the noncompliance is found until the COTP determines that the vessel can go to sea without presenting an unreasonable threat of harm to the port, the marine environment, the vessel, or its crew.
(a) Owners of U.S.-flagged vessels on international voyages must have Cargo Securing Manuals (CSMs) approved in accordance with this part.
(1) An applicant for CSM approval may be the owner or operator of the vessel, or a person acting on the owner or operator's behalf.
(2) The Commandant is responsible for overseeing and managing the review and approval of CSM approval authority applications and providing an up-to-date list of organizations authorized to act under this subpart, which is available at
(3) The applicant must submit two dated copies of a CSM that meets the requirements of this subpart to a CSM approval authority for review and approval. If any amendments are submitted, they must be dated. The CSM must include a “change page” document to ensure continuous documentation of amendments made and the dates they were completed.
(4) The approval authority will retain one copy of the CSM for its records.
(b) If the approval authority completes the review process and approves the CSM, the approval authority will provide a CSM approval letter on its letterhead, containing—
(1) Date of CSM approval;
(2) A subject line reading: “APPROVAL OF CARGO SECURING MANUAL (AMENDMENT—if applicable) FOR THE M/V ____, OFFICIAL NUMBER ____”;
(3) The following statement: “This is to certify that the Cargo Securing Manual (Amendment—if applicable) dated ____ for the M/V ____, Official Number ____, has been approved on behalf of the United States. The Cargo Securing Manual (Amendment—if applicable) was reviewed for compliance with Maritime Safety Committee Circular 1353 (MSC.1/Circ. 1353/Rev.1) for content, and correctness of the calculations on which the approval is based. This approval letter is to be kept with the Cargo Securing Manual, as proof of compliance with regulations VI/5.6 and VII5 of the 2004 amendments to the International Convention for the Safety of Life at Sea (SOLAS) 1974.”;
(4) Signature of the approval authority official responsible for review and approval of the CSM; and
(5) The approval authority's seal or stamp.
(c) If the approval authority completes the review process and disapproves the CSM, the approval authority will provide a letter on its letterhead, containing—
(1) Date of CSM disapproval; and
(2) Explanation of why the CSM was disapproved and what the submitter must do to correct deficiencies.
(d) The submitter of a disapproved CSM may resubmit the CSM with amendments for further review, either to correct deficiencies noted by the approval authority or to expand the CSM to fully meet the requirements of this part.
(e) The original copy of the CSM approval letter must be kept with the approved CSM and its amendments, together with supporting documents and calculations used in granting the approval, on board the vessel for review by Coast Guard personnel upon request.
Resubmission and re-approval by a CSM approval authority are required after any of the following events occurs:
(a) Reconfiguration of a vessel from one type of cargo carriage to another (
(b) Reconfiguration or replacement of 15 percent or more of the vessel's fixed cargo securing or tie-down systems with different types of devices or systems.
(c) Replacement of 15 percent or more of the vessel's portable cargo securing devices, with different types of devices for securing the cargo not already used aboard the vessel (
(a) A vessel owner or operator, or person acting on their behalf, who disagrees with a decision of a CSM approval authority may submit a written appeal to the approval authority requesting reconsideration of information in dispute. Within 30 days of receiving the appeal, the approval authority must provide the submitter with a final written ruling on the request, with a copy to the Commandant.
(b) A submitter who is dissatisfied with the approval authority's final written ruling may appeal directly to the Commandant. The appeal must be made in writing and include the documentation and supporting evidence the submitter wants to be considered, and may ask the Commandant to stay the effect of the appealed decision while it is under review by the Commandant.
(c) The Commandant will make a decision on the appeal and send a formal response to the submitter and a copy to the approval authority. The Commandant's decision will constitute final agency action on the appeal request.
The following organizations are authorized to act on behalf of the United States for the review and approval of CSMs:
(a) Any recognized classification society to which the Coast Guard has delegated issuance of a Cargo Ship Safety Equipment Certificate in accordance with 46 CFR 8.320(b)(4). A list of these organizations can be found at
(b) The National Cargo Bureau, Inc., 17 Battery Place, Suite 1232, New York, NY 10004-1110, 212-785-8300,
An organization seeking authorization as a CSM approval authority must make a request to the Commandant for authorization. The request must include, in writing, the items listed in this section or as otherwise specified by the Commandant.
(a) A certified copy of the organization's certificate of incorporation or partnership on file with a U.S. State, including the name and address of the organization, with written statements or documents which show that—
(1) The organization's owners, managers, and employees are free from influence or control by vessel shipbuilders, owners, operators, lessors, or other related commercial interests as evidenced by past and present business practices;
(2) The organization has demonstrated, through other related work, the capability to competently evaluate CSMs for completeness and sufficiency according to the requirements of SOLAS and this part;
(3) The organization has an acceptable degree of financial security, based on recent audits by certified public accountants over the last 5 years; and
(4) The organization maintains a corporate office in the United States that has adequate resources and staff to support all aspects of CSM review, approval, and recordkeeping.
(b) A listing of the names of the organization's principal executives, with titles, telephone, and telefax numbers.
(c) A written general description of the organization, covering the ownership, managerial structure, and organization components, including any directly affiliated organizations, and their functions utilized for supporting technical services.
(d) A written list of technical services the organization offers.
(e) A written general description of the geographical area the organization serves.
(f) A written general description of the clients the organization is serving, or intends to serve.
(g) A written general description of similar work performed by the organization in the past, noting the
(h) A written listing of the names of full-time professional staff employed by the organization and available for technical review and approval of CSMs including—
(1) Naval architects and naval engineers, with copies of their professional credentials, college degrees, and specialized training certificates;
(2) Merchant mariners with Coast Guard-issued credentials, with a summary of their working experience on board cargo vessels (including vessel tonnage and types of cargo); and
(3) Written proof of staff competence to perform CSM review and approval, evidenced by detailed summaries of each individual's experience (measured in months) during the past 5 years of evaluating maritime cargo securing systems. Experience summaries must be documented on company letterhead and endorsed by a company executive who has had direct observation of the individual and quality of his or her work product.
(j) A complete description of the organization's internal quality control processes, including written standards used by the organization to ensure consistency in CSM review and approval procedures by qualified professionals.
(k) A description of the organization's training program for assuring continued competency of professional employees performing CSM review and approval who are identified in the application.
(l) Evidence of financial stability over the past 5-year period, such as financial reports completed independently by certified public accountants.
(m) A list of five or more business references, including names, addresses, and telephone numbers of principal executives, who can attest to the organization's competence within the past 2 years.
(n) A statement to the Coast Guard that gives its officials permission to inspect the organization's facilities and records of CSM review and approval on behalf of the United States at any time with reasonable advance notice.
(o) Any additional information the organization deems to be pertinent.
(a) The Commandant will evaluate the organization's request for authorization and supporting written materials, looking for evidence of—
(1) The organization's clear assignment of management duties;
(2) Ethical standards for managers and cargo securing manual (CSM) reviewers;
(3) Procedures for personnel training, qualification, certification, and re-qualification that are consistent with recognized industry standards;
(4) Acceptable standards available for the organization's internal auditing and management review;
(5) Recordkeeping standards for CSM review and approval;
(6) Methods used to review and certify CSMs;
(7) Experience and knowledge demonstrating competency to evaluate CSMs for completeness and sufficiency according to the requirements of SOLAS;
(8) Methods for handling appeals; and
(9) Overall procedures consistent with Res.A.739(18), (incorporated by reference, see § 97.110).
(b) After a favorable evaluation of the organization's request, the Commandant may arrange to visit the organization's corporate and port offices for an on-site evaluation of operations.
(c) When a request is approved, the organization and the Coast Guard will enter into the written agreement provided for by 33 CFR 97.315. If the request is not approved, the Commandant will give the organization a written explanation, and the organization may resubmit its request if it corrects any noted deficiencies.
Approved organizations will enter into a written agreement with the Coast Guard that specifies—
(a) The period the authorization is valid;
(b) Which duties and responsibilities the organization may perform and what approval letters it may issue on behalf of the U.S.;
(c) Reports and information the organization must send to the Commandant;
(d) Actions the organization must take to renew the agreement when it expires; and
(e) Actions the organization must take if the Commandant revokes authorization pursuant to 33 CFR 97.320.
The Commandant may revoke a cargo securing manual (CSM) approval authority's authorization and remove it from the list of CSM approval authorities if it fails to maintain acceptable standards. For the purposes of 46 CFR subpart 1.03, such a revocation would be treated as involving the recognition of a classification society and could be appealed pursuant to 46 CFR 1.03-15(h)(4). Upon revocation, the former approval authority must send written notice to each vessel owner whose CSM it approved. The notice must include the current list of CSM approval authorities and state—
(a) That its authorization as a CSM approval authority has been revoked;
(b) The Coast Guard's explanation for the revocation; and
(c) That the vessel's CSM remains valid as long as amendments have not been completed which require it to be re-approved pursuant to 33 CFR 97.200 or 97.205.
33 U.S.C. 1223, 1231; 46 U.S.C. Chapter 701; Department of Homeland Security Delegation No. 0170.1. Subpart C is also issued under the authority of 33 U.S.C. 1225 and 46 U.S.C. 3715.
(a) Whenever there is a hazardous condition either on board a vessel or caused by a vessel or its operation, the owner, agent, master, operator, or person in charge must immediately notify the nearest Coast Guard Sector Office or Group Office, and in addition submit any report required by 46 CFR 4.05-10.
(b) When the hazardous condition involves cargo loss or jettisoning as described in 33 CFR 97.115, the notification required by paragraph (a) of this section must include—
(1) What was lost, including a description of cargo, substances involved, and types of packages;
(2) How many were lost, including the number of packages and quantity of substances they represent;
(3) When the incident occurred, including the time of the incident or period of time over which the incident occurred;
(4) Where the incident occurred, including the exact or estimated location of the incident, the route the ship was taking, and the weather (wind and sea) conditions at the time or approximate time of the incident; and
(5) How the incident occurred, including the circumstances of the incident, the type of securing equipment that was used, and any other material failures that may have contributed to the incident.
33 U.S.C. 1321(j); 46 U.S.C. 2103, 3306, 6101; 49 U.S.C. 5103, 5106; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757; 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.
Each U.S.-flagged vessel that must comply with Chapter VI/5.6 or Chapter VII/5 of the International Convention for the Safety of Life at Sea, 1974 as amended must have on board a cargo securing manual that meets the requirements of 33 CFR part 97.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is temporarily changing the operating schedule that governs the Oregon State (Old Youngs Bay) highway bridge, mile 2.4, across Youngs Bay foot of Fifth Street at Astoria, OR. The Oregon Department of Transportation (ODOT) requested to change the operating schedule of the Old Youngs Bay Bridge for work on both bascule lifts. This change will allow ODOT to operate the double bascule draw in single leaf mode, one lift at a time, which will reduce the vertical clearance of the non-operable half of the span by five feet.
This temporary final rule is effective from 12 a.m. on June 16, 2016 through 11:59 p.m. on October 31, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this temporary final rule, call or email Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District Bridge Program Office, telephone 206-220-7282; email
The Coast Guard is issuing this temporary final rule (TFR) without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because to do so would be unnecessary. This deviation is already in place and waterway users are already acting in accordance with the schedule with no actual or anticipated impacts. Additionally, in response to the initial request from the ODOT, the Coast Guard published a notice of deviation on February 3, 2016, 81 FR 6758, which temporarily changed the operating schedule of the Old Youngs Bay Bridge through June 15, 2016. The Coast Guard contacted known waterway users who indicated such a deviation would have no significant impact. Therefore, it is unnecessary to provide an opportunity for notice and comment.
The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The ODOT owns and operates the Old Youngs Bay Bridge in accordance with 33 CFR 117.899(b). This bridge provides a vertical clearance approximately 19 feet above mean high water when in the closed-to-navigation position. ODOT is conducting bridge repairs, which are scheduled to be complete on October 31, 2016. In order to facilitate bridge repairs, one half of the double bascule bridge will have a containment system installed on the non-opening half of the span. This containment system will reduce the vertical clearance of the bridge by 5 feet, or 14 feet above mean high water. Both the previous notice of temporary deviation and this TFR allow the drawtender to open only half the draw span in single leaf mode.
Marine traffic on Youngs Bay consists of vessels ranging from small pleasure craft, sailboats, small tribal fishing boats, and commercial tug and tow, and mega yachts.
We are amending 33 CFR 117.899 to indicate that half of the double bascule span of the Youngs Bay Bridge will be opened instead of both spans once notice has been provided to the drawtender at the Lewis and Clark River Bridge. The draw span will be operable from 7 a.m. to 5 p.m. on weekdays and from 8 a.m. to 4 p.m. on weekends. This amendment will be in effect from 12 a.m. on June 16, 2016 through 11:59 p.m. on October 31, 2016, after which the bridge will be able to open both spans as before. The TFR is necessary to accommodate extensive maintenance and restoration efforts on the Old Youngs Bay Bridge. The TFR will allow construction workers to complete bridge and highway upgrades before winter, while having minimal impact on maritime navigation.
We developed this rule after considering numerous statutes and Executive Orders (E.O.(s)) related to rulemaking. Below we summarize our analyses based on these statutes and E.O.(s), and we discuss First Amendment rights of protestors.
E.O. 12866 and E.O. 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This regulatory action determination is based
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 operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this rule would not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule would call 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 E.O. 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 E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
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 expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed 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 preliminary 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 proposed rule simply promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination 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.
The addition reads as follows:
(d) The draw of the Oregon State (Old Youngs Bay) highway bridge, mile 2.4, across Youngs Bay foot of Fifth Street, shall open half of the double bascule span on signal for the passage of vessels, if at least one half-hour notice is given to the drawtender, at the Lewis and Clark River Bridge by marine radio, telephone, or other suitable means from 7 a.m. to 5 p.m. Monday through Friday and from 8 a.m. to 4 p.m. Saturday and Sunday through October 31, 2016. At all other times, including all Federal holidays, but Columbus Day, at least a two-hour notice by telephone is required. The opening signal is two prolonged blasts followed by one short blast.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone in the navigable waters near AT&T Park in San Francisco, CA in support of the San Francisco State University Graduation Fireworks Display on May 28, 2016. This safety zone is established to ensure the safety of mariners and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.
This rule is effective from 1 p.m. through 10 p.m. on May 28, 2016.
Documents mentioned in this preamble are part of docket USCG-2016-0177. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399-3585 or email at
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Because of the dangers posed by the pyrotechnics used in this fireworks display, the safety zone is necessary to provide for the safety of event participants, spectators, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event in order to minimize potential danger to the public during the event. However, the Coast Guard received the information about the fireworks display on February 26, 2016. There is not enough time to complete the rulemaking process before the fireworks display is scheduled to occur.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish safety zones.
The San Francisco State University Graduation will feature a finale fireworks display on May 28, 2016, near AT&T Park in San Francisco, CA in approximate position 37°46′36″ N. 122°22′56″ W. (NAD 83) as depicted in National Oceanic and Atmospheric Administration (NOAA) Chart 18650. During the loading, transit, and arrival of the fireworks barge and until the start of the fireworks display, the temporary safety zone applies to the navigable waters around and under the fireworks barge within a radius of 100 feet. From 1 p.m. until 5 p.m. on May 28, 2016, the fireworks barge will be loading at Pier 50 in San Francisco, CA. The fireworks barge will remain at Pier 50 until the start of the transit. From 8 p.m. until 8:30 p.m. on May 28, 2016, the loaded fireworks barge will transit from Pier 50 to the launch site near AT&T Park in San Francisco, CA in approximate position 37°46′36″ N. 122°22′56″ W. (NAD 83), where it will remain until the commencement of the fireworks display. Prior to the commencement of the 10-minute fireworks display, at 9:30 p.m. on May 28, 2016, the safety zone will expand to encompass the navigable waters within 700 feet of approximate position 37°46′36″ N. 122°22′56″ W. (NAD 83). The fireworks display is meant for entertainment purposes. This restricted area around the fireworks launch site is necessary to protect spectators, vessels, and other property from the hazards associated with pyrotechnics.
The proposed safety zone will encompass the navigable waters around the barge near AT&T Park in San Francisco, CA. During the loading, transit, and arrival of the fireworks barge and until the start of the fireworks display, the temporary safety zone applies to the navigable waters around and under the fireworks barge within a radius of 100 feet. From 1 p.m. until 5 p.m. on May 28, 2016, the fireworks barge will be loading at Pier 50 in San Francisco, CA. The fireworks barge will remain at Pier 50 until the start of the transit. From 8 p.m. until 8:30 p.m. on May 28, 2016, the loaded fireworks barge will transit from Pier 50 to the launch site near AT&T Park in San Francisco, CA in approximate position 37°46′36″ N. 122°22′56″ W. (NAD 83), where it will remain until the commencement of the fireworks display. Prior to the commencement of the 10-minute fireworks display, at 9:30 p.m. on May 28, 2016, the safety zone will expand to encompass the navigable waters within a radius of 700 feet of approximate position 37°46′36″ N. 122°22′56″ W. (NAD 83). The safety zone shall terminate at 10 p.m.
The effect of the temporary safety zone will be to restrict navigation in the vicinity of the launch site until the conclusion of the scheduled display. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the restricted area. These regulations are needed to keep spectators and vessels away from the immediate vicinity of the launch site to ensure the safety of participants, spectators, and transiting vessels.
We developed this rule after considering numerous statutes and Executive Orders (E.O.'s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.'s, and we discuss First Amendment rights of protestors.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly,
We expect the economic impact of this rule will not rise to the level of necessitating a full Regulatory Evaluation. The safety zone is limited in duration, and is limited to a narrowly tailored geographic area. In addition, although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.
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 operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
This rule may affect owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing. This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This safety zone would be activated, and thus subject to enforcement, for a limited duration. When the safety zone is activated, vessel traffic could pass safely around the safety zone. The maritime public will be advised in advance of this safety zone via Broadcast Notice to Mariners.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, 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 determined that this rule does not have implications for federalism.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone of limited size and duration. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative.
(3) Vessel operators desiring to enter or operate within the safety zone must contact the COTP or a designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or a designated representative. Persons and vessels may request permission to enter the safety zone may contact the Patrol Commander (PATCOM) on VHF-23A or through the 24-hour Command Center at telephone (415) 399-3547.
Coast Guard, DHS.
Final rule.
The Coast Guard is amending its safety zones regulation for Annual Events in the Captain of the Port Lake Michigan zone. This amendment updates 18 permanent safety zones and adds 3 new permanent safety zones. These amendments and additions are necessary to protect spectators, participants, and vessels from the hazards associated with annual maritime events, including fireworks displays, boat races, and air shows.
This rule is effective June 8, 2016.
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 Petty Officer Joseph McCollum, U.S. Coast Guard Sector Lake Michigan; telephone 414-747-7148, email
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
§ Section
U.S.C. United States Code
On January 20, 2016, the Coast Guard published a Notice of Proposed Rulemaking entitled Safety Zones; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone in the
The legal basis for this rule is the Coast Guard's authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5; Department of Homeland Security Delegation No. 0170.1.
The purpose of this rulemaking is to update the safety zones in § 165.929 to ensure that they match the times, dates, and dimensions for various marine and triggering events that are expected to be conducted with the Captain of the Port Lake Michigan Zone throughout the year. The purpose of the rulemaking is also to ensure vessels and persons are protected from the specific hazards related to the aforementioned events. These specific hazards include obstructions to the waterway that may cause marine casualties; collisions among vessels maneuvering at a high speed within a channel; the explosive dangers involved in pyrotechnics and hazardous cargo; and flaming/falling debris into the water that may cause injuries.
As noted above, we received no comments on our NPRM published on January 20, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule amends 18 permanent safety zones found within table 165.929 in 33 CFR 165.929. These 18 amendments involve updating the location, size, and/or enforcement times for: 11 fireworks displays in various locations; 1 regatta in Spring Lake, Michigan; 3 Air Shows; 1 Facility in Marinette, Wisconsin; 1 boat race from Chicago, Illinois; and 1 ski show in Sister Bay, Wisconsin.
Additionally, this rule adds 3 new safety zones to table 165.929 within § 165.929 for annually-reoccurring events in the Captain of the Port Lake Michigan Zone. These 3 zones were added in order to protect the public from the safety hazards previously described. The 3 additions include 2 safety zones for fireworks displays, and 1 safety zone for a boat parade in Chicago Harbor, Chicago, Illinois. A list of specific changes and additions are available in the attachments within this Docket.
The Captain of the Port Lake Michigan has determined that the safety zones in this rule are necessary to ensure the safety of vessels and people during annual marine or triggering events in the Captain of the Port Lake Michigan zone. Although this rule will be effective year-round, the safety zones in this rule will be enforced only immediately before, during, and after events that pose a hazard to the public and only upon notice by the Captain of the Port Lake Michigan.
The Captain of the Port Lake Michigan will notify the public that the zones in this rule are or will be enforced by all appropriate means to the affected segments of the public, including publication in the
All persons and vessels must comply with the instructions of the Coast Guard Captain of the Port Lake Michigan or his or her designated representative. Entry into, transiting, or anchoring within the safety zones is prohibited unless authorized by the Captain of the Port or his or her designated representative. The Captain of the Port or his or her designated representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of the statutes and Executive orders, and we discuss First Amendment rights of protestors.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zones created by this rule will be relatively small and effective during the time to ensure safety of spectator and participants for the listed triggering or marine events. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zones, and the rule will allow vessels to seek permission to enter the zones.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V(A), above this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the regional Small Business regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of safety zones for yearly triggering and marine events on and around Lake Michigan. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. An environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(1) The general regulations in 33 CFR 165.23.
(2) All vessels must obtain permission from the Captain of the Port Lake Michigan or his or her designated representative to enter, move within, or exit a safety zone established in this section when the safety zone is enforced. Vessels and persons granted permission to enter one of the safety zones listed in this section must obey all lawful orders or directions of the Captain of the Port Lake Michigan or his or her designated representative. Upon being hailed by the U.S. Coast Guard by siren, radio, flashing light or other means, the operator of a vessel must proceed as directed.
(3) The enforcement dates and times for each of the safety zones listed in Table 165.929 are subject to change, but the duration of enforcement would remain the same or nearly the same total number of hours as stated in the table. In the event of a change, the Captain of the Port Lake Michigan will provide notice to the public by publishing a Notice of Enforcement in the
(b)
(1)
(2)
(3)
(c)
(d)
(e)
Federal Transit Administration, DOT.
Final rule; corrections.
The Federal Transit Administration (FTA) is correcting a final rule that appeared in the
Effective on May 9, 2016.
For program matters, Brian Alberts, Program Analyst, FTA Office of Transit Safety and Oversight, telephone 202-366-1783 or
In FR Doc. 2016-05489 published in the
1. On page 14255, in the second column, the third full paragraph that starts with “
2. On page 14255, in the second column, the fifth full paragraph that starts with “
FTA estimates that the annual information collection burden for States implementing 49 CFR part 674 requirements is 336,843 total hours. This equates to approximately 11,228 hours devoted to information collection activities for each of the estimated 30 States in the SSO Program. FTA estimates that the annual information collection burden for RTAs is approximately 249,600 total hours, or approximately 4,160 hours for each of
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the B season apportionment of the 2016 Pacific cod total allowable catch allocated to trawl catcher vessels in the BSAI.
Effective 1200 hours, Alaska local time (A.l.t.), May 4, 2016, through 1200 hours, A.l.t., June 10, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The B season apportionment of the 2016 Pacific cod total allowable catch (TAC) allocated to trawl catcher vessels in the BSAI is 5,460 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the B season apportionment of the 2016 Pacific cod TAC allocated to trawl catcher vessels in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 5,000 mt and is setting aside the remaining 460 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of May 3, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and Airbus Model A340-200, -300, -500, and -600 series airplanes. This proposed AD was prompted by reports of fuel leaking through fuel pump electrical connectors and fuel pump electrical connector damage caused by the build-up of moisture behind the electrical connector. Electrical connectors that become damaged by moisture can create an ignition source and a fuel leak. This proposed AD would require an inspection of the fuel pumps to identify their part numbers and replacement of affected pumps. We are proposing this AD to prevent a potential ignition source and a fuel leak due to damaged fuel pump electrical connectors. This condition creates a flammability risk in an area adjacent to the fuel tank.
We must receive comments on this proposed AD by June 23, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0194, dated September 22, 2015, to correct an unsafe condition for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and Airbus Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:
Operators reported cases of fuel leak through fuel pump electrical connectors. Subsequent investigation revealed fuel pump electrical connector damage caused by moisture build up behind the electrical connector.
This condition, if not detected and corrected, could create concurrently an ignition source and fuel leak as a result of a single failure, resulting in exposure to a flammability risk in an adjacent area to the fuel tank.
To address this unsafe condition, Airbus published Service Bulletins (SB) A330-28-3127, SB A340-28-4138 and SB A340-28-5060, providing inspection/identification instructions, and instructions for replacement of the fuel pumps.
For the reasons described above, this [EASA] AD requires identification and replacement of the affected fuel pumps.
You may examine the MCAI in the AD docket on the Internet at
Airbus has issued the following service information:
• Airbus Service Bulletin A330-28-3127, Revision 01, dated September 24, 2015.
• Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015.
• Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015.
The service information describes procedures to identify and replace
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 99 airplanes of U.S. registry.
We also estimate that it will take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $33,660, or $340 per product.
In addition, we estimate that any necessary follow-on actions would take about 17 work-hours and require parts costing $10,400, for a cost of $11,845 per product. We have no way of determining the number of aircraft that might need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by June 23, 2016.
None.
This AD applies to Airbus Model A330-223F and -243F airplanes; A330-201, -202, -203, -223, and -243 airplanes; A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Airbus Model A340-211, -212, and -213 airplanes; A340-311, -312, and -313 airplanes; A340-541 airplanes; and A340-642 airplanes, certificated in any category, all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports of fuel leaking through fuel pump electrical connectors and fuel pump electrical connector damage caused by the build-up of moisture behind the electrical connector. Electrical connectors that become damaged by moisture can create an ignition source and a fuel leak. We are issuing this AD to prevent a potential ignition source and a fuel leak due to damaged fuel pump electrical connectors. This condition creates a flammability risk in an area adjacent to the fuel tank.
Comply with this AD within the compliance times specified, unless already done.
Within 48 months after the effective date of this AD, inspect each fuel pump to identify the part number (P/N) in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-28-3127, Revision 01, dated September 24, 2015; Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015; or Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015; as applicable to airplane type. A review of airplane delivery or maintenance records is acceptable in lieu of this inspection if the part number of the fuel pump can be conclusively determined from that review.
If, during the inspection required by paragraph (g) of this AD, it is determined that an affected fuel pump is installed: Within the compliance time specified in paragraph (h)(1) or (h)(2) of this AD, depending on the configuration of the affected fuel pumps installed, replace each affected fuel pump with a serviceable fuel pump in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-28-3127, Revision 01, dated September 24, 2015; Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015; or Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015; as applicable to airplane type.
(1) For affected fuel pumps that have a part number or combination of part numbers that are specified in paragraphs (h)(1)(i) through (h)(1)(vi) of this AD: Do the replacement within 72 months after the effective date of this AD.
(i) All of the affected fuel pumps haveP/N 568-1-28300-001.
(ii) All of the affected fuel pumps haveP/N 568-1-28300-002.
(iii) The affected fuel pumps have a combination of P/Ns 568-1-28300-001 and 568-1-28300-002.
(iv) The affected fuel pumps have a combination of P/Ns 568-1-28300-001 and 568-1-28300-101.
(v) The affected fuel pumps have a combination of P/Ns 568-1-28300-002 and 568-1-28300-101.
(vi) The affected fuel pumps have a combination of P/Ns 568-1-28300-001, 568-1-28300-002, and 568-1-28300-101.
(2) For affected fuel pumps that have a part number or combination of part numbers that are specified in paragraphs (h)(2)(i) through (h)(2)(iii) of this AD: Do the replacement within 96 months after the effective date of this AD.
(i) All of the affected fuel pumps have P/N 568-1-28300-100.
(ii) All of the affected fuel pumps have P/N 568-1-28300-101.
(iii) The affected fuel pumps have a combination of P/Ns 568-1-28300-100 and 568-1-28300-101.
(1) For the purpose of this AD, an “affected fuel pump” is defined as any pump having P/N 568-1-28300-001, 568-1-28300-002, 568-1-28300-100, or 568-1-28300-101.
(2) For the purpose of this AD, a “serviceable fuel pump” is a pump having a part number not listed in paragraph (i)(1) of this AD.
Although Airbus Service Bulletin A330-28-3127, Revision 01, dated September 24, 2015; Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015; or Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015, specifies to submit certain information to the manufacturer, and specifies that action as “RC” (Required for Compliance), this AD does not include that requirement.
After the identification of the fuel pump part numbers as required by paragraph (g) of this AD, comply with the prohibition required by paragraph (k)(1) or (k)(2) of this AD, as applicable.
(1) For an airplane that does not have an affected fuel pump installed: After the identification of the fuel pump part numbers as required by paragraph (g) of this AD, do not install an affected fuel pump.
(2) For an airplane that has an affected fuel pump installed: After modification of an airplane as required by paragraph (h) of this AD, no person may install an affected fuel pump on any airplane.
This paragraph provides credit for actions required by paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using service information included in paragraphs (l)(1), (l)(2), and (l)(3) of this AD, which are not incorporated by reference in this AD.
(1) Airbus Service Bulletin A330-28-3127 dated July 14, 2015.
(2) Airbus Service Bulletin A340-28-4138 dated July 14, 2015.
(3) Airbus Service Bulletin A340-28-5060 dated July 14, 2015.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Continuing Airworthiness Information (MCAI) EASA AD 2015-0194, dated September 22, 2015, for related information. You may examine the MCAI on the Internet at
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
Food and Drug Administration, HHS.
Notification of public meetings.
The Food and Drug Administration (FDA or we) is announcing three one-day public meetings in different regions throughout the United States to provide importers and other interested persons an opportunity to have an in-depth discussion on the implementation of the FDA Food Safety Modernization Act (FSMA) import safety programs (
See section III for dates and times of the regional outreach meetings, closing dates for advance registration, and requests for special accommodations due to disability.
See section III for meeting locations.
On May 2, 2014, we released our “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA),” electronically at
On April 23, 2015, FDA hosted a public meeting as an opportunity for interested persons to share views concerning how FDA should address the operational aspects of FSMA implementation as suggested by the guiding principles. We provided an update on current planning efforts and received input from the public to inform the development of operational work plans in the areas of produce safety, preventive controls for foods for humans and animals, measures to address intentional adulteration, FSVP, and the FDA third-party accreditation program. In addition, we established a docket to obtain comments on a range of operational issues that we might consider in our FSMA implementation approach.
On March 21, 2016, FDA hosted a kick-off public meeting to brief participants on the key components of the FSVP and third-party certification final rules; brief participants on the status of the VQIP; discuss the plans for guidance documents related to import safety, as well as training, education, and technical assistance; provide an update on the development of a risk-based industry oversight framework that is at the core of FSMA; and answer questions about these import programs. The public meeting was an opportunity for FDA to share its current thinking on implementation plans for programs related to import safety. During that public meeting, we mentioned plans to continue dialogue on implementation of these import safety programs with a series of regional meeting across the United States.
The agendas, recordings, and transcripts for the FSMA implementation and prevention-oriented import system public meetings are accessible on our FSMA Web site at
FDA plans to hold three one-day public meetings in different regions throughout the United States to provide importers and other interested persons an opportunity to have an in-depth discussion on the implementation of FSMA import safety programs (
We are holding three one-day public meetings in different regions throughout the United States.
Due to limited space and time, we encourage all persons who wish to attend the meeting to register in advance. There is no fee to register for the regional outreach meetings, and registration will be on a first-come, first-served basis. Early registration is recommended because seating is very limited.
Table 1 provides information on participation in the regional outreach meetings.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Proposed rule.
This proposed rule would revise regulations for HUD's Native American and Native Hawaiian programs to incorporate existing rules that require HUD programs to be open to all eligible individuals and families regardless of sexual orientation, gender identity, or marital status. Since HUD promulgated the “Equal Access to Housing in HUD Programs Regardless of Sexual Orientation or Gender Identity” final rule in February, 2012, HUD has required that HUD-assisted and HUD-insured housing be made available in accordance with program eligibility requirements and without regard to sexual orientation, gender identity, or marital status, and has generally prohibited inquiries into sexual orientation or gender identity. In applying these non-discrimination requirements to HUD's Native American and Native Hawaiian programs, this proposed rule would further the Federal goal of providing decent housing and a suitable living environment for all.
Interested persons are invited to submit comments regarding this proposed rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.
1.
2.
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
Public Inspection of Public Comments. All properly submitted comments and communications submitted to HUD will be available for public inspection and copying between 8 a.m. and 5 p.m., weekdays, at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service, toll free, at 800-877-8339. Copies of all comments submitted are available for inspection and downloading at
[Contact Name to be Inserted], Office of Native American Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 5206, Washington, DC 20410-8000; telephone number 202-708-2333 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
On February 3, 2012, HUD published in the
In publishing the Equal Access Rule, HUD noted that establishment of the equal access policy in HUD's Native American programs would be undertaken by separate rulemaking. (See 77 FR 5662, at footnote 3.) Since implementing the Equal Access Rule, it has been HUD's intention to apply the same non-discrimination requirements to HUD's Native American and Native Hawaiian programs, after undergoing tribal consultation to solicit feedback on this proposal.
Since the publication of the Equal Access Rule, the Federal Government has continued to broaden protections for LGBT individuals and families where Federal funding is involved. For example, the Violence Against Women Reauthorization Act of 2013 (VAWA) includes a provision that prohibits discrimination based on gender identity and sexual orientation by recipients of VAWA funds or assistance administered by the U.S. Department of Justice's Office on Violence Against Women. Additionally, on July 21, 2014, President Obama signed Executive Order 13672, titled, “Further Amendments to Executive Order 11478, Equal Employment Opportunity in the Federal Government, and Executive Order 11246, Equal Employment Opportunity,” which prohibits the Federal Government and Federal contractors from discriminating on the basis of sexual orientation or gender identity.
As discussed in the preamble to the January 24, 2011, proposed Equal Access Rule, at 76 FR 4194, and in the preamble to the final Equal Access Rule, the Federal government has a goal of providing everyone in the United States with a decent and suitable place to live. In furtherance of this, HUD has a responsibility to ensure that all who are otherwise eligible to participate in HUD programs will not be excluded based on sexual orientation, gender identity, or marital status, which are irrelevant to eligibility for or participation in those programs. By applying the core protections of the Equal Access Rule to HUD's Native American and Native Hawaiian programs, HUD will conform with its own precedent of equal access, as well as other Federal precedent, to ensure that Federal funds are not used to exclude persons from Federally-assisted programs because of sexual orientation, gender identity, or marital status. Applying the Equal Access Rule to HUD's Native American and Native Hawaiian programs will also ensure consistency where there is an overlap between HUD's Native American and Native Hawaiian programs and other HUD programs, which are already subject to the requirements in the Equal Access Rule.
With tribal consultation completed, as explained below in Section III, HUD is proposing to amend regulations for its Native American and Native Hawaiian programs so that they conform to the Equal Access Rule. The regulations would require that access be provided without regard to actual or perceived sexual orientation, gender identity, or marital status in housing assisted or insured under these programs. The proposed rule would add the equal access to HUD-assisted or insured housing requirements in 24 CFR 5.105(a)(2) to the Native American and Native Hawaiian programs identified below. HUD's rule at 24 CFR 5.105(a)(2) incorporates the definitions of “sexual orientation” and “gender identity” provided in § 5.100, and these definitions will apply to the Native American and Native Hawaiian programs. This proposed rule would not change the definition of “family” for Native American and Native Hawaiian programs. At the final rule stage, HUD intends to make conforming amendments to § 5.105(a)(2) to make explicit that the requirements in § 5.105(a)(2) apply to housing with loans guaranteed or insured under one of HUD's Native American or Native Hawaiian housing programs and not only the FHA mortgage insurance program.
Specifically, this proposed rule would amend HUD's regulations for Native American Housing Activities, at 24 CFR part 1000; Community Development Block Grants for Indian Tribes and Alaska Native Villages, at 24 CFR part 1003; the Section 184 Indian Home Loan Guarantee Program, at 24 CFR part 1005; the Native Hawaiian Housing Block Grant Program, at 24 CFR part 1006; and Section 184A Loan Guarantees For Native Hawaiian Housing, at 24 CFR part 1007 to incorporate the § 5.105(a)(2) requirements.
On November 20, 2015, HUD published in the
Specifically, the proposed rule seeks to remove the prohibition of inquiries at § 5.105(a)(2)(ii), which HUD believes may hinder a provider from making an appropriate placement decision with regard to transgender individuals and other persons who do not identify with the sex they were assigned at birth. For this reason, the CPD Equal Access Rule
HUD's policy is to consult with Indian tribes early in the rulemaking process on matters that have tribal implications. Accordingly, on January 28, 2015, HUD sent letters to Tribal leaders informing them of the nature of the forthcoming rule and soliciting comments. The deadline for comments under this informal consultation was February 27, 2015. HUD received one response to the consultation letter from a tribally designated housing entity, which said it opposed the proposed rule.
HUD received a second response on behalf of a housing development and management organization that states that section 106(b)(2)(A) of the Native American Housing Assistance and Self-Determination Act of 1996 (NAHASDA) (25 U.S.C. 4166(b)(2)(A)) requires HUD to use negotiated rulemaking in order to amend NAHASDA regulations.. The letter also stated that the rule should not prohibit tribes from considering marital status in making eligibility determinations for housing assisted or insured by HUD because tribes have authority to govern domestic relations of their members. This letter also asked for more specificity on the rule and more ways to participate in the consultation process. The requirement to undertake negotiated rulemaking pertains to regulations that implement NAHASDA statutory requirements. This rule pertains to nondiscrimination requirements and does not pertain to regulations that implement NAHASDA statutory requirements.
The entities that submitted comments in response to the consultation letter, and all other tribes and interested parties now have the opportunity to provide further comments on this proposed rule, and HUD welcomes such comments.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This proposed rule sets forth nondiscrimination standards. Accordingly, under 24 CFR 50.19(c)(3), this proposed rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either: (i) Imposes substantial direct compliance costs on state and local governments and is not required by statute, or (ii) preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This proposed rule would not have federalism implications and would not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and on the private sector. This proposed rule would not impose any federal mandates on any state, local, or tribal governments, or on the private sector, within the meaning of the UMRA.
Aged, Community development block grants, Grant programs—housing and community development, Grant programs—Indians, Indians, Individuals with disabilities, Public housing, Reporting and recordkeeping requirements.
Alaska, Community development block grants, Grant programs—housing and community development, Grant programs—Indians, Indians, Reporting and recordkeeping requirements.
Indians, Loan programs—Indians, Reporting and recordkeeping requirements.
Community development block grants, Grant programs—housing and community development, Grant programs—Indians, Hawaiian Natives, Low and moderate income housing, Reporting and recordkeeping requirements.
Hawaiian Natives, Loan programs—housing and community development, Loan programs—Indians, Reporting and recordkeeping requirements.
Accordingly, for the reasons stated in the preamble, HUD proposes to amend 24 CFR parts 1000, 1003, 1005, 1006, and 1007, as follows:
25 U.S.C. 4101
(e) The equal access to HUD-assisted or insured housing requirements in 24 CFR 5.105(a)(2).
42 U.S.C. 3535(d) and 5301
(c) A grantee shall comply with the equal access to HUD-assisted or insured housing requirements in 24 CFR 5.105(a)(2).
12 U.S.C. 1715z-13a; 15 U.S.C. 1639c; 42 U.S.C. 3535(d).
The equal access to HUD-assisted or insured housing requirements in 24 CFR 5.105(a)(2) apply to this part.
25 U.S.C. 4221
(a) Program eligibility under the Act and this part may be restricted to Native Hawaiians. Subject to the preceding sentence, no person may be discriminated against on the basis of race, color, national origin, religion, sex, familial status, or disability, or excluded from program eligibility because of actual or perceived sexual orientation, gender identity, or marital status. The following nondiscrimination requirements are applicable to the use of NHHBG funds:
(4) The equal access to HUD-assisted or insured housing requirements in 24 CFR 5.105(a)(2).
(b) [RESERVED]
12 U.S.C. 1715z-13b; 15 U.S.C. 1639c; 42 U.S.C. 3535(d).
(a) * * *
(b) The equal access to HUD-assisted or insured housing requirements in 24 CFR 5.105(a)(2) apply to this part.
Under Secretary of Defense for Personnel and Management, DoD.
Proposed rule.
This proposed rule updates policy and procedures for minor dependents attending schools operated by DOD pursuant to 10 U.S.C. 2164. The proposed rule outlines procedures for eligibility, application and enrollment in DOD schools and describes procedures for reimbursement of educational services. This proposed rule discusses provision for the elementary and secondary education to minor dependents of members of the armed forces and civilian employees of the Federal Government residing within the United States (including the territories, commonwealths, and possessions of the United States).
Comments must be received by July 8, 2016.
You may submit comments, identified by docket number and/or RIN number and title, by any of the following methods:
•
Marsha Jacobson, 571-372-1900.
The Federal government has provided educational services to the dependent children of Federal employees residing on Federal military installations under various legal authorities and Federal statutes since 1820. In 1950, schools were established on military installations under section 6 of Public Law 81-874, Impact Aid Act (codified at 20 U.S.C. 241). In 1994, Congress repealed Public Law 81-874 and passed Public Law 103-337, the FY1995 National Defense Authorization Act (codified at 10 U.S.C. 2164), creating the Domestic Dependent and Elementary and Secondary Schools (DDESS). Under 10 U.S.C. 2164, the Department of Defense operates approximately 65 elementary and secondary schools on federal installations in the United States and its territories, possessions, and commonwealths.
Since the passage of 10 U.S.C. 2164 in 1994, Congress has passed a number of minor changes to the statute's eligibility provisions in order to provide DDESS with the flexibility to meet developing real-world contingencies. While the overall student enrollment in DDESS schools has declined in recent years as a result of the reductions in the military force, the statutory changes have minimally expanded eligibility to certain categories of personnel.
These categories of personnel include the dependents of military personnel killed in combat-related operations (
Childhood education is essential, and DoD is determined to provide primary and secondary education for dependent children of members of the armed forces and civilian employees of the Federal Government residing on military installations.
This proposed rule updates the eligibility requirements and the policy and procedures for minor dependents attending schools operated by DOD pursuant to 10 U.S.C. 2164. The proposed rule outlines procedures for eligibility, application, and enrollment in DOD schools and describes procedures for reimbursement of educational services. The proposed rule applies to schools (prekindergarten through grade 12) operated by the Department of Defense within the United States (including the territories, commonwealths, and possessions of the United States).
This proposed rule also describes procedures for participation of eligible dependents in the DoDEA Virtual School (
Costs and Benefits:
The total operating costs for the DDESS schools for FY15 is $383.1M. Relative to the baseline of the Department of Defense Instruction 1342.26 where policies and responsibilities for enrollment of certain dependents in arrangements operated by or entered into by the Department of Defense pursuant to 10.U.S.C. 2164 are specified, the incremental costs associated with increasing the eligibility criteria is expected to be zero. This program is not a transfer program since the education of these dependents would not be assumed by the state governments where these military installations are located. The benefits of providing a tuition free education to certain dependents of members of the armed forces and civilian employees on military installations in the United States (including the territories, commonwealths, and possessions of the United States) remain the same.
Executive Orders 13563 and 12866 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 proposed rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the proposed rule has been reviewed by the Office of Management and Budget (OMB) under the requirements of these Executive orders.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This proposed rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.
The Department of Defense certifies that this proposed rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.
Section 71.6(f) of this proposed rule contains information collection requirements. DoD has submitted the following proposal to OMB under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (2) the accuracy of the estimate of the burden of the proposed information collection; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.
Written comments and recommendations on the proposed information collection should be sent to Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments, identified by docket number and title, by the following method:
*
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Marsha Jacobson, Department of Defense Education Activity, 4800 Mark Center Drive, Alexandria, VA 22350.
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 proposed rule will not have a substantial effect on State and local governments.
Aid to families with dependent children, Elementary and secondary education, Minors.
5 U.S.C. 2103, 10 U.S.C. 2164, 31 U.S.C. 1535.
This part establishes policy assigns responsibilities for enrollment in arrangements (as defined in § 71.3) operated by or entered into by the DoD in accordance with DoD Directive 1342.20 and 10 U.S.C. 2164.
This part applies to:
(a) The Office of the Secretary of Defense, the Military Departments (including the Coast Guard at all times, including when it is a Service in the Department of Homeland Security by agreement with that Department), the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this part as the “DoD Components”).
(b) Arrangements operated by or entered into by the DoD within the United States (including the territories, commonwealths, and possessions of the United States).
(c) Dependent children of active duty military members (as defined in § 71.3) and civilian employees of the Federal Government enrolled or seeking enrollment in arrangements.
(d) Dependent children of members of a foreign armed force assigned to and residing on a U.S. military installation enrolled or seeking enrollment in arrangements.
(e) Dependent children of employees of the American Red Cross residing in Puerto Rico enrolled or seeking enrollment in DDESS arrangements in Puerto Rico.
(f) Non-DoD federal agencies seeking enrollment of dependent children of full-time employees in arrangements on an agency reimbursable basis as determined by the Secretary of Defense.
These terms and their definitions are for the purposes of this part.
(1) Active duty for at least 365 consecutive days in accordance with 10 U.S.C. 2164 or title 14, U.S.C.; or
(2) Full-time National Guard duty for at least 365 consecutive days in accordance with title 32, U.S.C.
(1) Is the child of the sponsor, including an adopted child or step-child (but not after the divorce of the member from the stepchild's natural parent);
(2) Has been placed in the sponsor's home by a local, State, or foreign government placement agency or a government-approved process, provided the sponsor produces a document from such an agency establishing the fact of relationship and the effective date of the relationship;
(3) The sponsor has acknowledged, in writing, that the child is a full-time resident in the sponsor's household, the sponsor is providing more than one-half of the child's support, and the sponsor accepts financial and educational responsibility for the child as if the child were the sponsor's natural or legally adopted child; or
(4) Has been placed in the custody of the sponsor by a court of competent jurisdiction in the United States and:
(i) Is dependent on the sponsor for more than one-half of the person's support.
(ii) Is not a dependent of any sponsor in accordance with any other part of this definition.
It is DoD policy that arrangements are operated or entered into in accordance with 10 U.S.C. 2164. Enrollment is limited to eligible dependent children of active duty military members, DoD civilian employees, members of a foreign armed force, and certain employees of the American Red Cross residing in Puerto Rico, or non-DoD federal agencies seeking enrollment of dependent children of full-time employees in arrangements on an agency reimbursable basis as determined by the Secretary of Defense.
(a) The Under Secretary of Defense for Personnel and Readiness (USD(P&R)) ensures that the DDESS program fosters optimum communication on matters relating to DoDEA eligibility requirements for DDESS within DoDEA and the Military Departments.
(b) Under the authority, direction, and control of the USD(P&R), the Assistant Secretary of Defense for Readiness and Force Management (ASD(R&FM)) monitors compliance with this part.
(c) Under the authority, direction, and control of the ASD(R&FM), the Director, DoD Education Activity (DoDEA):
(1) Makes determinations of eligibility for enrollment in arrangements. Decisions by the Director, DoDEA, on requests to enroll dependents in arrangements in accordance with this part are final.
(2) Monitors implementation and compliance with this part.
(3) Ensures arrangements allow only those students authorized by this part to enroll in arrangements.
(a) In compliance with paragraph (f) of this section, DDESS arrangements within the United States will:
(1) Provide a tuition-free education to the dependent children of:
(i) Active duty military members residing in permanent living quarters for any part of the school year on a military installation served by a DDESS arrangement.
(ii) Full-time civilian DoD employees residing in permanent living quarters for any part of the school year on a military installation served by a DDESS arrangement.
(iii) A deceased member of the Military Services who died in the line of duty in a combat-related operation. The operation must have been designated as combat-related by the Secretary of Defense and the dependent children must reside on or near a military installation served by a DDESS arrangement.
(iv) A member of a foreign armed force residing in permanent living quarters for any part of the school year on a military installation served by a DDESS arrangement.
(v) Active duty military members occupying temporary housing, regardless of whether the housing is on federal property, when the Secretary of Defense has determined that the circumstances justify extending the enrollment authority to include the dependents, including:
(A) When adequate living quarters are unavailable on the military installation to which the active duty military member is assigned. Eligibility in accordance with this provision extends only to dependent children of active duty military members assigned by official orders to a military installation served by a DDESS arrangement.
(B) While the active duty military member is wounded, ill or injured. Eligibility in accordance with this provision extends only to dependent children of active duty military members assigned by official orders to a military installation served by a DDESS arrangement.
(vi) Active duty military members and federal employees overseas whose enrolled dependents have been evacuated and relocated within a reasonable commuting distance of an arrangement in accordance with the criteria set forth in subsection (k) of 10 U.S.C. 2164.
(2) Provide education on an agency-reimbursable basis to dependent children of full-time civilian employees of non-DoD federal agencies residing in permanent living quarters for any part of the school year on a military installation served by a DDESS arrangement.
(b) In compliance with paragraph (f) of this section, DDESS special arrangements within the United States will:
(1) Provide a tuition-free education to the dependent children of:
(i) Active duty military members residing in permanent living quarters for any part of the school year on a military installation served by a DDESS special arrangement.
(ii) Full-time civilian DoD employees residing in permanent living quarters for any part of the school year on a military installation served by a DDESS special arrangement.
(iii) A deceased member of the Military Services who died in the line of duty in a combat-related operation. The operation must have been designated as combat-related by the Secretary of Defense and the dependent children must reside on a military installation served by a DDESS special arrangement.
(iv) A member of a foreign armed force residing in permanent living quarters for any part of the school year on a military installation served by a DDESS special arrangement.
(2) Provide education on an agency reimbursable basis to dependent children of full-time civilian employees of non-DoD federal agencies residing in permanent living quarters for any part of the school year on a military installation served by a DDESS special arrangement.
(c) In compliance with paragraph (f) of this section, DDESS arrangements within a territory, commonwealth, or possession of the United States will:
(1) Provide a tuition-free education to dependent children of:
(i) Active duty military members residing in permanent living quarters for any part of the school year on a military installation served by a DDESS arrangement.
(ii) Full-time civilian DoD employees residing in permanent living quarters for any part of the school year on a military
(iii) A deceased member of the Military Services who died in the line of duty in a combat-related operation. The operation must have been designed as combat-related by the Secretary of Defense and the dependent children must reside on or near a military installation served by a DDESS arrangement.
(iv) A member of a foreign armed force residing in permanent living quarters for any part of the school year on any military installation served by a DDESS arrangement.
(v) Active duty military members stationed or home-ported in a territory, commonwealth, or possession of the United States and not residing in permanent living quarters on a military installation. Eligibility in accordance with this provision extends only to dependent children of active duty military members assigned by official orders to a military installation served by a DDESS arrangement.
(vi) Full-time civilian DoD employees, not residing in permanent living quarters on a military installation, who are subject by policy and practice to transfer or reassignment to a location where English is the language of instruction in the schools normally attended by dependent children of federal personnel. Dependents in this category may not be enrolled in the DDESS arrangement for more than 5 consecutive school years, unless:
(A) The Secretary of Defense, for good cause (as defined in § 71.3), extends the period; or
(B) Admission is granted based on eligibility in accordance with paragraph (c)(1)(vii) of this section.
(vii) Full-time, professional, excepted service employees (as defined in § 71.3) of the DDESS arrangement not residing in permanent quarters on a military installation.
(viii) Active duty military members, whose dependents reside on or off any military installation served by a DDESS arrangement with the dependents' designated location being in a territory, commonwealth, or possession of the United States, and who are assigned to:
(A) A remote location;
(B) A dependents' restricted unaccompanied tour of duty; or
(C) Unusually arduous sea duty.
(2) Provide education on an agency reimbursable basis to dependent children of:
(i) Full-time civilian employees of the non-DoD federal agencies residing in permanent living quarters for any part of the school year on a military installation served by a DDESS arrangement.
(ii) Full-time civilian employees of the United States Immigration and Customs Enforcement and the United States Customs and Border Protection residing in Puerto Rico.
(iii) Full-time civilian employees of non-DoD federal agencies not residing in permanent living quarters on a military installation, who are subject by policy and practice to transfer or reassignment to a location where English is the language of instruction in the schools normally attended by dependent children of federal personnel, when the Secretary of Defense determines that the circumstances of such living arrangements justify extending the enrollment authority to include the dependents. Dependents in this category may not be enrolled in the DDESS arrangement for more than 5 consecutive school years, unless the Secretary of Defense extends the period for good cause.
(iv) Full-time employees of the American Red Cross residing in Puerto Rico and performing emergency services on behalf of active duty military members.
(d) In compliance with paragraph (f) of this section, DDESS special arrangements within a territory, commonwealth, or possession of the United States will:
(1) Provide a tuition-free education to dependent children of:
(i) Active duty military members residing in permanent living quarters for any part of the school year on a military installation served by a DDESS special arrangement.
(ii) Full-time civilian DoD employees residing in permanent living quarters for any part of the school year on a military installation served by a DDESS special arrangement.
(iii) A deceased member of the Military Services who died in the line of duty in a combat-related operation. The operation must have been designated as combat-related by the Secretary of Defense and the dependent children must live in an area served by a DDESS special arrangement.
(iv) A member of a foreign armed force residing in permanent living quarters for any part of the school year on any military installation served by a DDESS special arrangement.
(v) Active duty military members stationed or home-ported in a territory, commonwealth, or possession of the United States and not residing in permanent living quarters on a military installation. Eligibility in accordance with this provision extends only to dependent children of active duty military members assigned by official orders to an area served by a DDESS special arrangement.
(vi) Full-time civilian DoD employees, not residing in permanent living quarters on a military installation but residing in an area served by a DDESS special arrangement, who are subject by policy and practice to transfer or reassignment to a location where English is the language of instruction in the schools normally attended by dependent children of federal personnel. Dependents in this category may not be enrolled in the DDESS special arrangement for more than 5 consecutive school years, unless the Secretary of Defense, for good cause, extends the period.
(vii) Active duty military members, whose dependents' reside in the area served by a DDESS special arrangement, with the dependents' designated location being in a territory, commonwealth, or possession of the United States who are assigned to:
(A) A remote location,
(B) A dependents' restricted unaccompanied tour of duty, or
(C) Unusually arduous sea duty.
(2) Provide education on an agency-reimbursable basis to dependent children of:
(i) Full-time civilian employees of non-DoD federal agencies residing in permanent living quarters for any part of the school year on any military installation served by a DDESS special arrangement.
(ii) Full-time civilian employees of the United States Immigration and Customs Enforcement and the United States Customs and Border Protection residing in Puerto Rico.
(e) In compliance with paragraph (f) of this section, the DoDEA Virtual School shall:
(1) Provide a tuition-free education to eligible dependent children currently enrolled in DDESS arrangements in accordance with paragraphs (a) and (c) of this section.
(2) Provide coursework on a tuition paying basis to dependent children of members of the Military Services on active duty who:
(i) Are enrolled in an elementary or secondary school operated by a local education agency (LEA) or other accredited educational program in the United States, and
(ii) Who immediately prior to such enrollment, were enrolled in an elementary or secondary school operated by the Department of Defense Dependents School (DoDDS).
(f) Procedures for application and enrollment:
(1) Application for enrollment will be made to the arrangement to which
(2) Eligibility based on residency on a military installation may be established by:
(i) Actual residence in permanent quarters on a military installation served by an arrangement; or
(ii) Written affirmation provided by the installation family housing manager that the sponsor has applied for and will be able to occupy permanent quarters on the military installation within 90 school days (or 180 school days if an exception for the installation has been approved by the Secretary of Defense) after the sponsor reports to the new duty station. Enrollment occurring pursuant to this paragraph obligates the sponsor to accept permanent quarters on the military installation when available and offered or the dependent child's eligibility to attend the arrangement terminates.
(3) Eligibility for dependent children of full-time employees of the Federal Government, will be established in accordance with these provisions:
(i) The sponsor seeking enrollment will provide proof of full-time employment with the Federal Government, or the agency employing the civilian sponsor will provide a written statement confirming the sponsor's position meets the eligibility requirements.
(ii) The written statement must be signed by the agency's Director of Personnel or principal administrative officer at its main headquarters.
(iii) Federal government employees residing in a territory, commonwealth, or possession of the United States seeking to continue the enrollment of their dependent(s) in a DDESS arrangement for more than 5 consecutive years pursuant to paragraph (a)(1)(v)(C), (c)(2)(iii), or (d)(1)(vi) of this section must submit a request for an exception to policy. The request must be made in writing and submitted through the employee's agency to the Director, DDESS, for consideration. The request must be received by the Director, DDESS before the start of the school year for which the exception is requested and must provide information showing that in the interest of the dependent's educational well-being, good cause exists for granting the exception. Reimbursement shall be obtained when required 10 U.S.C. 2164 (c)(2)(B).
(4) The sponsor seeking enrollment of a dependent child in the DoDEA Virtual School under paragraph (e)(2) of this section shall provide proof that:
(i) The dependent is currently enrolled in an elementary or secondary school operated by an LEA or other accredited educational program in the United States;
(ii) Immediately prior to enrollment in the LEA or other accredited educational program, the dependent was enrolled in an elementary or secondary school operated by DoDDS;
(iii) The LEA or other accredited educational program does not offer the requested coursework or extenuating circumstances exist to justify enrolling the dependent in the DoDEA Virtual School; and
(iv) The course(s) through the DoDEA Virtual School are taken for credit, or extenuating circumstances exist to justify enrolling the dependent in the DoDEA Virtual School.
(g) The Secretary of Defense may permit a currently enrolled student to continue:
(1) For the remainder of the year, if the status of the sponsor of a currently enrolled student changes so that the dependent child would no longer be eligible for enrollment in an arrangement.
(2) Beyond the current school year in a DDESS arrangement notwithstanding a change in the status of the sponsor which would otherwise terminate eligibility for good cause. Requests for continuation of enrollment, beyond the end of the school year, for good cause, must be in writing and submitted to the Director, DDESS. A good cause authorization for continued enrollment will cover only one school year at a time.
(h) Procedures for reimbursement of educational services:
(1) All non-DoD federal agencies whose employees enroll a dependent in an arrangement pursuant to 10 U.S.C. 2164 will reimburse the DoD for the cost of educational services provided on a school year basis.
(2) The non-DoD federal agency will certify school-aged dependents for their employees no later than May 1st each year for the following school year.
(3) DoDEA resource management (RM) will publish the ensuing school year's educational services tuition rates on or before May 31st each year.
(4) Each June, upon receipt of an official list of eligible employees and their school-aged dependents from the DDESS arrangement, DDESS RM will send each agency a tuition reimbursement notification letter for the entire upcoming school year. Tuition reimbursement payments from the agencies will be due by August of that school year for the first grading period and due by October for the remaining grading periods. These educational services are considered severable and subject to the provisions of 31 U.S.C. 1535, also known and referred to in this part as the “Economy Act”.
(5) At the beginning of each fiscal year, DoDEA RM allocates a portion of the agency's annual tuition reimbursement authority to DDESS, which grants explicit permission to collect and retain tuition reimbursements that directly offset agency operating expenses for providing educational services.
(6) Federally funded agencies are required to establish an interagency agreement with DDESS. This agreement serves as the authority for the Defense Finance and Accounting Service (DFAS) to centrally bill or transfer funds between the ordering agency and the provider of educational services based on DDESS tuition collection billings and refunds. DFAS will process reimbursable payment transactions via the Intra-Governmental Payment and Collection system.
(i) Procedures for payment of tuition for educational services provided by DoDEA Virtual School
(1) All members of the Military Services on active duty seeking to enroll dependents in the DoDEA Virtual School pursuant to paragraph (e)(2) of this section will pay tuition to the Department of Defense for the cost of the educational services provided.
(2) Tuition is based on the average market rate for virtual courses offered to the public in the U.S.
(3) DoDEA RM will publish the ensuing school year's educational services tuition rates on or before May 31st of each year.
(4) Tuition must be paid prior to enrollment.
(5) Tuition payments are reimbursable up to three weeks after enrollment in the DoDEA Virtual School on a pro-rated basis.
Agricultural Marketing Service, USDA.
Notice.
The Agricultural Marketing Service (AMS) is proposing to revise the United States Standards for Grades of Cauliflower. The current U.S. grade standards do not have provisions for grading purple, orange, or green cauliflower. The proposed revision would amend the color requirement to allow all colors of cauliflower to be certified to a U.S. grade. In addition, AMS proposes to amend the size requirement to allow curds less than 4 inches in diameter to be certified to a grade; to add marking requirements to sizes less than 4 inches in diameter; and, to remove the unclassified section.
Comments must be received by July 8, 2016.
Interested persons are invited to submit written comments to the Standardization Branch, Specialty Crops Inspection Division, Specialty Crops Program, Agricultural Marketing Service, U.S. Department of Agriculture, National Training and Development Center, Riverside Business Park, 100 Riverside Parkway, Suite 101, Fredericksburg, VA 22406; fax: (540) 361-1199; or, via the web at:
Dave Horner at the address above, or at phone (540) 361-1128; fax (540) 361-1199; or, email
Section 203(c) (7 U.S.C. 1622(c)) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables not connected with Federal marketing orders or U.S. import requirements no longer appear in the Code of Federal Regulations, but are maintained by USDA, AMS, Specialty Crops Program, and are available on the internet at
AMS proposes to revise the voluntary United States Standards for Grades of Cauliflower using the procedures that appear in Part 36, Title 7 of the Code of Federal Regulations (7 CFR part 36). These standards were last revised March 15, 1968.
On February 9, 2012, AMS published a notice in the
The U.S. grade standards presently require cauliflower curds to be white, creamy white, or cream color, but do not have provisions for grading other colors of cauliflower. AMS proposes to amend U.S. No. 1 color provisions by adding “unless otherwise specified” to the basic requirement for color. The phrase “unless otherwise specified” in regards to color would be interpreted as follows: When colors other than white, creamy white, or cream color are specified, those colors could be certified to a grade. Likewise, when designated as a mixed-color pack, a grade could be applied to all the colors in the pack, not just to the curds that are white, creamy white, or cream color. For example, a grade could be applied to a pack containing a green, an orange, a purple, and a white cauliflower curd when specified as a mixed-color pack. AMS applies the phrase “unless otherwise specified,” or similar terminology, to potatoes, peppers, and other commodities to allow other colors, or the comingling of colors, to be certified to a grade. This revision would also affect the U.S. Commercial grade.
Previously, in 2012, AMS proposed to add “unless otherwise specified” to the size requirement for the U.S. No. 1 grade to allow for smaller sizes. This too is a common practice for potatoes, onions, and many other commodities. However, after contacting the agricultural trade association, AMS discovered that they were concerned that unmarked containers with curds smaller than 4 inches may lose their specified designation after being resold to another party. For example, the original verbal or contractual agreement might not follow the product through the marketing chain. At final destination, unmarked product may fail to grade U.S. No. 1, since the cauliflower curds would be smaller than 4 inches in diameter.
Therefore, AMS now proposes to amend the U.S. No. 1 size provisions for cauliflower heads by adding “unless marked to a maximum diameter of less than 4 inches. Cauliflower curds marked less than 4 inches may not be comingled
The size revision and marking requirements would be interpreted as follows: When cauliflower curds are specified to be less than 4 inches in maximum diameter, at least 90 percent of the master containers in a lot must be marked by a maximum diameter of less than 4 inches. For example, a lot having curds no larger than 3
Furthermore, curds that are specified to be less than 4 inches in maximum diameter would not include cauliflower florets, since florets are pieces of curd and not considered small heads of cauliflower. Therefore, florets would not be certified to a grade.
This revision would also affect the U.S. Commercial grade.
The agricultural trade association had no objection to removing the “Unclassified” category from the standards. The unclassified section is being removed from all standards when they are revised. This category is not a grade and only serves to show that no grade has been applied to the lot. It is no longer considered necessary.
AMS believes that permitting all colors, mixed-color packs, and smaller sizes of cauliflower to be certified to a grade reflects current marketing practices and consumer demand, and will facilitate the marketing of cauliflower by providing the industry with more flexibility.
The official grade of a lot of cauliflower covered by these standards will be determined by the procedures set forth in the Regulations Governing Inspection, Certification, and Standards of Fresh Fruits, Vegetables and Other Products (Sec. 51.1 to 51.61).
This notice provides a 60-day period during which interested parties may comment on the proposed revisions to the standards. This period is deemed appropriate in order to implement these changes, if adopted, as soon as possible to reflect current marketing practices.
7 U.S.C. 1621-1627.
Agricultural Research Service, USDA.
Notice of public meeting.
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. App. 2, the United States Department of Agriculture announces a meeting of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21). The committee is being convened to: consider work of the three
The meeting will be held on Monday-Tuesday, June 13-14, 2016, 8:30 a.m. to 5:00 p.m. each day. This meeting is open to the public. On June 13, 2016, if time permits, reasonable provision will be made for oral presentations of no more than five minutes each in duration, starting at 3:30 p.m. Members of the public who wish to make oral statements should also inform Dr. Schechtman in writing or via Email at the indicated addresses below at least three business days before the meeting.
U.S. Access Board Conference Room, 1331 F Street NW., Suite 800, Washington, DC 20004.
General information about the committee can also be found at
The AC21 has been established to provide information and advice to the Secretary of Agriculture on the broad array of issues related to the expanding dimensions and importance of agricultural biotechnology. The committee is charged with examining the long-term impacts of biotechnology on the U.S. food and agriculture system and USDA, and providing guidance to USDA on pressing individual issues, identified by the Office of the Secretary, related to the application of biotechnology in agriculture. In recent years, the work of the AC21 has centered on the issue of coexistence among different types of agricultural production systems. The AC21 consists of members representing the biotechnology industry, the organic food industry, farming communities, the seed industry, food manufacturers, state government, consumer and community development groups, as well as academic researchers and a medical doctor. In addition, representatives from the Department of Commerce, the Department of Health and Human Services, the Environmental Protection Agency, the Council on Environmental Quality, and the Office of the United States Trade Representative serve as “ex officio” members.
In its last report, issued on November 17, 2012, entitled “Enhancing Coexistence: A Report to the Secretary of Agriculture,” and available on the Web site listed below, the AC21 offered a diverse package of recommendations, among which was a recommendation that “ . . . USDA should facilitate development of joint coexistence plans by neighboring farmers,” and that in a pilot program, USDA should, among other things, offer incentives for the development of such plans.
At its meeting on December 14-15, 2015, USDA offered a specific new charge to the AC21 building on its previous work. Recognizing that USDA currently lacks the legal authority to offer any such incentives, the committee has been charged with considering the following two questions: Is there an approach by which farmers could be encouraged to work with their neighbors to develop joint coexistence plans at the State or local level? If so, how might the
At the AC21's last meeting, on March 14-15, 2016, AC21 members reached a general agreement on the main content elements of the upcoming report. In devising their approach to respond to this charge, the AC21 has established 3
The three objectives for the meeting are:
• To consider work of the three
• to discuss a draft outline for the committee's next report and selected draft content, including a draft guidance document for producers and a draft model for facilitating local conversations around coexistence; and
• to continue overall discussions on the committee charge and planning the completion of its work.
Background information regarding the work and membership of the AC21 is available on the USDA Web site at
Food Safety and Inspection Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to renew the approved information collection regarding the importation of undenatured inedible meat and egg products into the United States. The approval for this information collection will expire on August 31, 2016.
Submit comments on or before July 8, 2016.
FSIS invites interested persons to submit comments on this information collection. Comments may be submitted by one of the following methods:
•
•
•
Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065, South Building, Washington, DC 20250; (202) 720-5627.
Foreign governments are to petition FSIS for approval to import
Firms will complete FSIS Form 9540-4, “Permit Holder—Importation of Undenatured Inedible Product” for the undenatured inedible product that they are importing into the United States. FSIS will use the information on the forms to keep track of the movement of imported undenatured inedible meat and egg products.
FSIS has made the following estimates on the basis of an information collection assessment.
Copies of this information collection assessment can be obtained from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and Inspection Service, USDA, 1400 Independence, SW., 6065, South Building, Washington, DC 20250; (202) 720-5627.
Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, Fax: (202) 690-7442, Email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Food Safety and Inspection Service, USDA.
Notice.
The Food Safety and Inspection Service (FSIS) is announcing the dollar limitations on the amount of meat and meat food products, poultry, and poultry products that a retail store can sell to hotels, restaurants, and similar institutions without disqualifying itself for exemption from Federal inspection requirements. In accordance with FSIS's regulations, for calendar year 2016, the dollar limitation for meat and meat food products is being increased from $76,900 to $79,200. The new value for the dollar limitation for poultry and poultry products remains unchanged at $58,200. FSIS is changing the dollar limitations from calendar year 2015 based on price changes for these products evidenced by the Consumer Price Index.
FSIS has provided an 18-month transitional period for mandatory inspection of Siluriformes fish and fish products. FSIS is currently considering the retail dollar limitations for this product. At this time, FSIS will not apply the meat retail dollar limitations to Siluriformes fish and fish products sold at retail because FSIS is assessing retail and similar institutions that produce this product during the 18-month period and because the Consumer Price Index for meat and meat products does not apply to Siluriformes fish and fish products.
Gina Kouba, Issuances Staff, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6067, South Building, Washington, DC 20250; (202) 690-6510.
The Federal Meat Inspection Act (21 U.S.C. 601
Under these regulations, sales to hotels, restaurants, and similar institutions (other than household consumers) disqualify a retail store for exemption if the product sales exceed either of two maximum limits: 25 percent of the dollar value of total product sales or the calendar year dollar limitation set by the Administrator. The dollar limitation is adjusted automatically during the first quarter of the year if the Consumer Price Index (CPI), published by the Bureau of Labor Statistics, shows an increase or decrease of more than $500 in the price of the same volume of product for the previous year. FSIS publishes a notice of the adjusted dollar limitations in the
The CPI for 2015 reveals an annual average price increase for meat and meat food products at 3.03 percent and for poultry products at 0.4 percent. When rounded to the nearest $100, the dollar limitation for meat and meat food products increased by $2,327 and the dollar limitation for poultry products increased by $231. In accordance with 9 CFR 303.1(d)(2)(iii)(b) and 381.10(d)(2)(iii)(b), because the dollar limitation of meat and meat food products and poultry products increased by more than $500, FSIS is increasing the dollar limitation on sales to hotels, restaurants, and similar institutions to $79,200 for meat and meat food products. Because the increase in poultry prices is less than $500, FSIS is making no adjustment in dollar limitation for poultry and poultry products. The dollar limitation for poultry and poultry products remains unchanged at $58,200.
FSIS will announce this rule online through the FSIS Web page located at
FSIS will also make copies of this
Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Office of the Secretary, Department of Commerce.
Notice of Public Availability of FY 2015 Service Contract Inventories and supplemental data.
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), the Department of Commerce is publishing this notice to advise the public of the availability of the Fiscal Year (FY) 2015 Service Contract Inventory, a report that analyzes the Department's FY 2014 Service Contract Inventory and an inventory supplement that identifies the amount invoiced and direct labor hours for covered service contract actions.
The service contract inventory provides information on service contract actions over $25,000 made in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance on service contract inventories issued on November 5, 2010, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP).
The Department of Commerce has posted its FY 2015 inventory, summary, FY 2014 Analysis Report and supplemental data on the Office of Acquisition Management homepage at the following link
Questions regarding the service contract inventory should be directed to Virna Winters, Director for Acquisitions Policy and Oversight Division at 202-482-4248 or
Georgia Foreign Trade Zone, Inc., grantee of FTZ 26, submitted a notification of proposed production activity to the FTZ Board on behalf of Eastman Kodak Company (Eastman Kodak), located within Subzone 26N, in Columbus, Georgia. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on April 26, 2016.
The facility is used for the production of aluminum printing plates. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Eastman Kodak from customs duty payments on the foreign-status materials and components used in export production. On its domestic sales, Eastman Kodak would be able to choose the duty rate during customs entry procedures that applies to aluminum printing plates (duty rate 3.7%) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: ethanaminium; 3H-indolium; benzenediazonium; finished aluminum printing plates; acetic acid; polyvinylphosphonsaure; co polymer-methacrylic acid; propenoic acid; naphthalenesulfonic acid; urethane acrylate polymer; phenolic resin solution; and, aluminum and aluminum alloy coils (duty rates range from 3% to 6.5%).
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is June 20, 2016.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Diane Finver at
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of open meeting.
Notice is hereby given of a meeting of the Sanctuary System Business Advisory Council (council). The meeting is open to the public, and participants may provide comments at the appropriate time during the meeting.
Members of the public wishing to participate in the meeting must register in advance by Friday, May 20, 2016. The meeting will be held Monday, May, 23, 2016 from 1:30 p.m. to 6:30 p.m. EDT, and an opportunity for public comment will be provided at 5:45 p.m. EDT. These times and the agenda topics described below are subject to change.
The meeting will be held at the Florida Keys Eco-Discovery Center, 35 East Quay Road, Key West, Florida 33040. Since the center is closed on Mondays, admittance may be limited to the conference room, except during the time allotted for a scheduled tour. Register by contacting Rebecca Holyoke at 240-533-0685 or
Rebecca Holyoke, Office of National Marine Sanctuaries, 1305 East West Highway, Silver Spring, Maryland 20910 (Phone: 240-533-0685; Fax: 301-713-0404; Email:
ONMS serves as the trustee for a network of underwater parks encompassing more than 170,000 square miles of marine and Great Lakes waters from Washington state to the Florida Keys, and from Lake Huron to American Samoa. The network includes a system of 13 national marine sanctuaries and Papahānaumokuākea and Rose Atoll marine national monuments. National marine sanctuaries protect our Nation's most vital coastal and marine natural and cultural resources, and through active research, management, and public engagement, sustain healthy environments that are the foundation for thriving communities and stable economies. One of the many ways ONMS ensures public participation in the designation and management of national marine sanctuaries is through the formation of advisory councils. The Sanctuary System Business Advisory Council (council) has been formed to provide advice and recommendations to the Director regarding the relationship of ONMS with the business community. Additional information on the council can be found at
16 U.S.C. Sections 1431,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of applications.
Notice is hereby given that the Aleut Community of St. Paul Island, Tribal Government, Ecosystem Conservation Office [File No. 19436], 2050 Venia Minor Road, P.O. Box 86, St. Paul Island, AK 99660 [Responsible Party: Pamela Lestenkof], and the St. George Traditional Council, Ecosystem Conservation Office [File No. 19592], P.O. Box 940, St. George Island, Alaska 99591 [Responsible Party: Chris Merculief], have applied in due form for a permit to conduct research on and export specimens of northern fur seals (
Written, telefaxed, or email comments must be received on or before June 8, 2016.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Rosa L. González or Amy Sloan, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicants (File Nos. 19436 and 19592) propose a series of activities to fulfill their Biosampling, Entanglement/Disentanglement, and Island Sentinel Program responsibilities as established under the co-management agreements between NMFS and the Aleut Communities. The activities include ground and aerial surveys (using Unmanned Aircraft Systems); behavioral observations; monitoring; mark-resight; capture for flipper-tagging, standard measurements, and weight; collection of scat, molt, spew, and other samples from the ground; photograph; video; and photo-id of Steller sea lions, northern fur seals, and harbor seals. It also includes incidental harassment of the pinnipeds while performing these activities including remote camera installation, maintenance, and removal. In addition, the applicants would be authorized to collect, salvage, and accept (from subsistence users) samples from dead stranded and subsistence-hunted marine mammals. Unintentional mortality of northern fur seals and Steller sea lions is requested. See tables in the applications for numbers of takes by species, stock and activity. The Aleut Community of St. Paul Island, Tribal Government, Ecosystem Conservation Office activities will be performed in the Pribilof Islands, including St. Paul, St. George, Walrus, and Otter Islands, and Sea Lion Rock, Alaska. The St. George Traditional Council, Ecosystem Conservation Office activities will be performed in St. George Island, Alaska. The permits are requested for 5 years.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
Consumer Product Safety Commission.
Notice.
The Consumer Product Safety Commission (“CPSC”), in accordance with section 743(c) of Division C of the Consolidated Appropriations Act, 2010 (Pub. L. 111-117, 123 Stat. 3034, 3216), is announcing the availability of CPSC's service contract inventory for fiscal year (“FY”) 2015. This inventory provides information on service contract actions that exceeded $25,000 that CPSC made in FY 2015.
Eddie Ahmad, Procurement Analyst, Division of Procurement Services, Division of Procurement Services, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814. Telephone: 301-504-7884; email:
On December 16, 2009, the Consolidated Appropriations Act, 2010 (Consolidated Appropriations Act), Public Law 111-117, became law. Section 743(a) of the Consolidated Appropriations Act, titled,
(A) A description of the services purchased by the executive agency and the role the services played in achieving agency objectives, regardless of whether such a purchase was made through a contract or task order;
(B) The organizational component of the executive agency administering the contract, and the organizational component of the agency whose requirements are being met through contractor performance of the service;
(C) The total dollar amount obligated for services under the contract and the funding source for the contract;
(D) The total dollar amount invoiced for services under the contract;
(E) The contract type and date of award;
(F) The name of the contractor and place of performance;
(G) The number and work location of contractor and subcontractor employees, expressed as full-time equivalents for direct labor, compensated under the contract;
(H) Whether the contract is a personal services contract; and
(I) Whether the contract was awarded on a noncompetitive basis, regardless of date of award.
Consequently, through this notice, we are announcing that the CPSC's service contract inventory for FY 2015 is available to the public. The inventory provides information on service contract actions of more than $25,000 that CPSC made in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the CPSC. We developed the inventory in accordance with guidance issued on December 19, 2011 by the OMB. (The OMB guidance is available at:
U.S. Consumer Product Safety Commission.
Notice of public hearing.
The U.S. Consumer Product Safety Commission (“Commission”) will conduct a public hearing to receive views from all interested parties about the Commission's agenda and priorities for fiscal year 2017, which begins on October 1, 2016, and for fiscal year 2018, which begins on October 1, 2017. We invite members of the public to participate. Written comments and oral presentations concerning the Commission's agenda and priorities for fiscal years 2017 and 2018 will become part of the public record.
The hearing will begin at 10 a.m. on June 15, 2016, and will conclude the same day. Requests to make oral presentations and the written text of any oral presentations must be received by the Office of the Secretary not later than 5 p.m. Eastern Daylight Time (“EDT”) on June 1, 2016.
The hearing will be in the Hearing Room, 4th Floor of the Bethesda Towers Building, 4330 East West Highway, Bethesda, MD 20814. Requests to make oral presentations, (along with the texts of oral presentations) and written comments should be captioned, “Agenda and Priorities FY 2017 and/or 2018,” and sent by electronic mail (email) to:
For information about the hearing, or to request an opportunity to make an oral presentation, please send an email, call, or write Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; email:
Section 4(j) of the Consumer Product Safety Act (“CPSA”) (15 U.S.C. 2053(j)) requires the Commission to establish an agenda for action under the laws the Commission administers, and to the extent feasible, select priorities for action at least 30 days before the beginning of each fiscal year. Section 4(j) of the CPSA provides further that before establishing its agenda and priorities, the Commission conduct a public hearing and provide an opportunity for the submission of comments.
The Commission is in the process of preparing the agency's fiscal year 2017 Operating Plan and fiscal year 2018 Congressional Budget Request. Fiscal year 2017 begins on October 1, 2016, and fiscal year 2018 begins on October 1, 2017. The Commission's priorities for fiscal years 2017 and 2018 will align with the CPSC's 2016—2020 Strategic Plan, which was released for public comment in February 2016. Through this notice, the Commission invites the public to comment on the following questions:
1. What are the priorities the Commission should consider emphasizing and dedicating resources toward in the fiscal year 2017 Operating Plan and/or the fiscal year 2018 Congressional Budget Request?
2. What activities should the Commission consider deemphasizing in the fiscal year 2017 Operating Plan and/or the fiscal year 2018 Congressional Budget Request?
3. Should the Commission consider making any changes or adjustments to the agency's proposed or ongoing education, safety standards activities, regulation, and enforcement efforts in fiscal years 2017 and/or 2018, keeping in mind the CPSC's existing policy on establishing priorities for Commission action (16 CFR 1009.8)? The CPSC's budget request for fiscal year 2017 can be found at:
4. Which candidates should the Commission consider for retrospective review of existing rules for fiscal year
Persons who desire to make oral presentations at the hearing on June 15, 2016 should submit their request, including the text of their oral presentation, by email to:
If you do not want to make an oral presentation, but would like to provide written comments, you may do so. Please submit written comments in the manner described in the previous paragraph. Written comments must be received no later than 5 p.m. EDT on June 1, 2016.
Department of the Navy, DoD.
Notice of open meeting.
The Ocean Research Advisory Panel (ORAP) will hold a regularly scheduled meeting. The meeting will be open to the public.
The meeting will be held on Tuesday, May 31, 2016, from 1:00 p.m. to 5:00 p.m. and on Wednesday, June 1, 2016, from 9:00 a.m. to 3:00 p.m. Members of the public should submit their comments in advance of the meeting to the meeting Point of Contact.
The meeting will be held at 4100 Fairfax Drive, Suite 800, Arlington, VA, 22203.
CDR Joel W. Feldmeier, Office of Naval Research, 875 North Randolph Street, Suite 1425, Arlington, VA 22203-1995, telephone 706-696-5121.
This notice of open meeting is provided in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2). The meeting will include discussions on ocean research, resource management, and other current issues in the ocean science and management communities.
Office of Energy Policy and Systems Analysis, Secretariat, Quadrennial Energy Review Task Force, Department of Energy.
Notice of public meetings and updating meeting start time.
At the direction of the President, the U.S. Department of Energy (DOE or Department), as the Secretariat for the Quadrennial Energy Review Task Force (QER Task Force), will convene public meetings for the second installment of the Quadrennial Energy Review, an integrated study of the U.S. electricity system from generation through end use. A mixture of panel discussions and a public comment period will frame multi-stakeholder discourse around deliberative analytical questions relating to the intersection of electricity and its role in promoting economic competitiveness, energy security, and environmental responsibility.
See the
Between February 4, 2016 and July 1, 2016, you may submit written comments online at
John Richards, EPSA-60, U.S. Department of Energy, Office of Energy Policy and Systems Analysis, 1000 Independence Avenue SW., Washington, DC 20585-0121.
On January 9, 2014, President Obama issued a
The Quadrennial Energy Review process itself involves robust engagement of federal agencies and outside stakeholders, and further enables the federal government to translate policy goals into a set of analytically based, integrated actions for proposed investments over a four year planning horizon. Unlike traditional federal Quadrennial Review processes, the QER is conducted in a multi-year installment series to allow for more focused analysis on particular sub-sectors of the energy system. The initial focus for the Quadrennial Energy Review was our Nation's transmission, storage and distribution infrastructures that link energy supplies to intermediate and end users, because these capital-intensive infrastructures tend to set supply and end use patterns, investments and practices in place for decades. On April 21, 2015, the Quadrennial Energy Review Task Force released its first Quadrennial Energy Review installment report entitled, “Energy Transmission, Storage, and Distribution Infrastructure”. Among the issues highlighted by the analysis in the first installment of the QER were the growing dependencies of all critical infrastructures and economic sectors on electricity, as well as, the increasing interdependence of the various energy subsectors. In response to these findings, and to provide an appropriate
Significant changes will be required to meet the transformational opportunities and challenges posed by our evolving electricity system. The Administration is seeking public input on key questions relating to possible federal actions that would address the challenges and take full advantage of the opportunities of this changing system to meet the Nation's objectives of reliable, affordable and clean electricity. Over the course of 2016, the Secretariat for the Quadrennial Energy Review Task Force will hold a series of public meetings to discuss and receive comments on the issues outlined above, and well as, others, as they relate to the second installment of the Quadrennial Energy Review.
The Department of Energy has a broad role in energy policy development and the largest role in implementing the Federal Government's energy research and development portfolio. Many other executive departments and agencies also play key roles in developing and implementing policies governing energy resources and consumption, as well as, associated environmental impacts. In addition, non-Federal actors are crucial contributors to energy policies. Because most energy and related infrastructure is owned by private entities, investment by and engagement of, input from the private sector is necessary to develop and implement effective policies. State and local policies, the views of non-governmental, environmental, faith-based, labor, and other social organizations, and contributions from the academic and non-profit sectors are also critical to the development and implementation of effective Federal energy policies.
The interagency Quadrennial Energy Review Task Force, which includes members from all relevant executive departments and agencies, will develop an integrated review of energy policy that integrates all of these perspectives. It will build on the foundation provided in the Administration's
The public meetings will be held on:
• May 9, 8:30 a.m., at the University of Texas, Peter O' Donnell, Jr. Applied Computational Engineering and Sciences Building, Avaya Auditorium (POB 2.302), 201 E. 24th Street, Austin Texas.
• May 10, 9:30 a.m., at City Hall, Tom Bradley Tower Room, 200 N. Spring St., Los Angeles, California.
• May 24, 10:00 a.m., at Georgia Tech GTRI Conference Center, 250 14th Street NW., Atlanta, Georgia.
Each meeting will feature facilitated panel discussions, followed by an open microphone session. People who would like to speak during the open microphone session at the public meeting should come prepared to speak for no more than five minutes and will be accommodated on a first-come, first-served basis, according to the order in which they register to speak on a sign-in sheet available at the meeting location, on the morning of the meeting. In advance of the meetings, DOE anticipates making publicly available a briefing memorandum providing useful background information regarding the topics under discussion at the meeting. DOE will post this memorandum on its Web site:
Do not submit information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (CBI)). Comments submitted through the DOE Web site cannot be claimed as CBI. Comments received through the Web site will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section, below.
If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information in a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English, and are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest. It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Department of Energy.
Notice of public availability of FY 2015 Service Contract Inventories.
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), the Department of Energy (DOE) is publishing this notice to advise the public on the availability of the FY 2015 Service Contract inventory. This inventory provides information on service contract actions over $25,000 that DOE completed in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at
Except for minor changes to reporting deadlines, the guidance for preparing and analyzing FY 2015 inventories is essentially unchanged from OFPP's November 5, 2010, guidance for preparing the FY 2010 inventory. DOE has posted its inventory and a summary of the inventory at:
Questions regarding the service contract inventory should be directed to Jeff Davis in the Strategic Programs Division at 202-287-1877 or
Take notice that on April 26, 2016, pursuant to sections 206 and 306 of the Federal Power Act
Complainants certify that copies of the Complaint were served on contacts for Respondents.
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 and 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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
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
Comment Date: 5:00 p.m. Eastern Time on May 16, 2016.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator 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 on April 29, 2016, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2015),
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 Petitioner.
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
On February 27, 2015, the Federal Energy Regulatory Commission (FERC or Commission) issued in Docket Nos. PF15-5-000 and PF15-6-000 a
Information about the facilities proposed by Atlantic and DTI can be found on our public dockets referenced above and on each applicant's Web site at
The FERC will be the lead federal agency for the preparation of the EIS. The U.S. Forest Service (USFS) is participating as a cooperating agency because the ACP would cross the Monongahela National Forest (MNF) and the George Washington National Forest (GWNF) in West Virginia and Virginia. As a cooperating agency, the USFS intends to adopt the EIS per Title 40 of the Code of Federal Regulations, Part 1506.3 to meet its responsibilities under the National Environmental Policy Act (NEPA) regarding Atlantic's application for a Right-of-Way Grant and Temporary Use Permit for crossing federally administered lands. In addition, there may be a need for the USFS to amend the MNF and GWNF Land and Resource Management Plans (LRMP) to allow for the ACP to be constructed on USFS lands. The EIS will also provide the documentation to support needed amendments to the LRMPs. Additional details on the USFS' LRMP Amendment Process is provided on page 8.
The Commission previously solicited public input on the ACP in the spring of 2015. We
You may submit comments in written form or verbally. In lieu of or in addition to sending written comments, the Commission invites you to attend the public scoping meetings scheduled as follows:
The purpose of these scoping meetings is to provide an opportunity to verbally comment on the project modifications. You may attend
Verbal comments will be recorded by a court reporter and transcripts will be placed into the docket for the project and made available for public viewing on FERC's eLibrary system (see page 12 “Additional Information” for instructions on using eLibrary). It is important to note that verbal comments hold the same weight as written or electronically submitted comments. If a significant number of people are interested in providing verbal comments, a time limit of 3 to 5 minutes may be implemented for each commenter to ensure all those wishing to comment have the opportunity to do so within the designated meeting time. Time limits will be strictly enforced if they are implemented.
This Supplemental Notice is being sent to the Commission's current environmental mailing list for this project, including those landowners that are newly affected by the proposed pipeline route modifications. State and local government representatives are asked to notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a newly affected landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if the easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.
A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility on My Land? What Do I Need To Know?” is available for viewing on the FERC Web site (
In its amended application, Atlantic proposes a major route change through the MNF and GWNF that would affect landowners in Randolph and Pocahontas Counties, West Virginia and Highland, Bath, and Augusta Counties, Virginia. Other, smaller route changes proposed in the amendment would affect landowners in Nelson and Dinwiddie Counties, Virginia; and Cumberland and Johnston Counties, North Carolina. The amended facilities would increase the total length of the pipeline from about 556 miles to 599.7 miles and compressor station horsepower from 40,715 horsepower to 53,515 horsepower at the proposed Buckingham County, Virginia compressor station, all as more fully described in the amended application. An overview map of the proposed ACP and SHP and illustrations of these alternatives are provided in Appendix 1. Detailed alternative route location information can be found on DTI's interactive web mapping application at
To reduce potential impacts on the Cheat Mountain salamander, West Virginia Northern flying squirrel, and Cow Knob salamander, and to avoid sensitive habitats and land uses, Atlantic incorporated the GWNF 6 Alternative into its proposed pipeline route between AP-1 mileposts (MPs) 47.5 and 115.2. Relative to Atlantic's originally proposed route, the GWNF 6 Route Modification initially heads south approximately 13 miles, passing east of Hicks Ridge and west of Kumbrabow State Forest. The route continues south/southeast approximately 13 miles, crossing Point Mountain and passing east of Elk Mountain and Mingo Knob. The route enters Pocahontas County, West Virginia southeast of Mingo Knob at Valley Mountain, and continues south approximately 8 miles, crossing Mace, Tallow, and Gibson Knobs, passing west of the Snowshoe Ski Resort. South of Gibson Knob, the route heads southeast approximately 17 miles, passing south of Cheat Mountain and Back Allegheny Mountain; crossing Cloverlick Mountain, Seneca State Forest, and Michael Mountain; and entering Highland County, Virginia just west of Big Crooked Ridge.
After entering Virginia, the GWNF 6 Alternative continues east approximately 3 miles then southeast approximately 8 miles, crossing Little Ridge, Big Ridge, and Little Mountain and passing east of Piney Ridge. The route enters Bath County, Virginia near U.S. Highway 220, and continues southeast approximately 14 miles, crossing Back Creek Mountain, Jack Mountain, and Tower Hill Mountain and passing south of Shenandoah Mountain at South Sister Knob. The route heads northeast approximately 20 miles, passing north of Chestnut Ridge; entering Augusta County, Virginia near Brushy Ridge; and crossing Deerfield Valley on the east side of Shenandoah Mountain. The GWNF 6 Alternative intersects Atlantic's filed route near MP 115.2 at Broad Draft near West Augusta, Virginia.
In addition to the route modification described above, Atlantic also proposes to increase the horsepower of its proposed Compressor Station 2 in Buckingham County, Virginia and install eight additional valve sites.
Atlantic incorporated the Snowshoe Route Variation into its proposed route between AP-1 MPs 66.7 and 70.1 to avoid modeled habitat for the Cheat Mountain salamander and the Cheat Mountain Civil War Battlefield, as well as reducing the amount of forest land and other sensitive environmental features crossed. Relative to Atlantic's originally proposed route, the Snowshoe Route Variation initially heads west/southwest for 0.8 mile, crossing the main ridge on Valley Mountain, then continuing for approximately 2.6 miles, descending Valley Mountain, crossing Dry Fork Spring and Middle Mountain, and entering the valley along Big Fork Spring. The route then crosses Highway 56 in the valley, and continues to the south/southwest for approximately 1.3 miles, ascending Tallow Knob and reconnecting to the originally proposed route at MP 70.1.
Atlantic incorporated the Singleton Route Adjustment into its proposed route between AP-1 MPs 91.9 and 92.7 to avoid an open-space conservation easement held by the Virginia Outdoors Foundation. Relative to Atlantic's originally proposed route, the Singleton Route Adjustment is generally parallel to and within 0.3 mile of the corresponding segment of the originally proposed route.
In response to our environmental information request dated December 4, 2015, and to avoid crossing the Spruce Creek Tributary Conservation Site, Atlantic incorporated the Horizons Village 2 Route Adjustment into its proposed pipeline route between AP-1 MPs 162.0 and 162.8. Relative to Atlantic's originally proposed route, the Horizons Village 2 Route Adjustment would pass approximately 310 feet south of the conservation site.
In response to our environmental information request dated December 4, 2015, and to avoid an area of high slip potential, improve the location for the crossing of Highway 29, and optimize the amount of agricultural and open land crossed, Atlantic incorporated the Highway 29 Route Variation into its proposed pipeline route between AP-1 MPs 167.0 and 171.1. Relative to Atlantic's originally proposed route, the Highway 29 Route Variation initially heads south for approximately 0.2 mile following a ridge to the top of Roberts Mountain, then continues southeast for approximately 1.7 miles following a ridge to the base of Roberts Mountain at the crossing of Davis Creek. This segment of the route crosses Highway 29 on the same north trending finger ridge as the proposed route, but in an area with flatter terrain at the crossing. On the south side of the highway, the route continues to the southeast for approximately 2.2 miles, including a 0.2-mile-long segment parallel to Starvale Lane. The Highway 29 Route Variation reconnects to the originally proposed route on the east side of Wheelers Cove Road at approximately MP 171.1.
In response to our environmental information request dated December 4, 2015, and to reduce the number of crossings of Beaver Pond Creek and address comments provided by the Ward Burton Wildlife Foundation, Atlantic incorporated the Beaver Pond Creek Route Variation into its proposed pipeline route between AP-1 MPs 256.5 and 259.3. Relative to Atlantic's originally proposed route, the Beaver Pond Creek Route Variation initially heads south/southwest for approximately 111.1 miles to a point just south of Whitmore Road, then heads south for approximately 1.6 miles over mostly upland terrain, crossing Beaver Creek Pond in one location, reconnecting with the originally proposed route near MP 259.3.
Atlantic incorporated the Juniper Farms Route Variation into its proposed route between AP-2 MPs 96.9 and 98.4 to avoid a wetland mitigation bank, and to reduce the amount of sensitive environmental features and constraints crossed. Relative to Atlantic's originally proposed route, the Juniper Farms Route Variation initially heads southwest for approximately 1.2 miles, passing east of the eastern boundary of the mitigation bank. The route variation then reconnects with the originally proposed route at MP 98.4 on the north side of the Neuse River crossing.
In response to our environmental information request dated December 4, 2015, and to increase collocation with an existing Progress Energy Carolinas (PEC) 500 kilovolt electric transmission line, and reduce the number of affected property owners, the number of waterbody crossings, and temporary wetland impacts, Atlantic incorporated the Fayetteville Major Route Alternative into its proposed pipeline route between AP-2 MPs 133.1 and 157.5. Relative to Atlantic's originally proposed route, the Fayetteville Major Route Alternative initially heads south/southeast for approximately 3.9 miles to the point where it intersects the existing PEC electric transmission line, crossing Drum Road, Interstate 95, and Goldsboro Road. The route then heads south for approximately 16.7 miles, parallel to and adjacent to the electric transmission line corridor, and crosses Clinton Road and Cedar Creek Road. The route continues west for approximately 5.5 miles, crossing Tabor Church Road, Cape Fear River, and North Carolina State Highway 87 reconnecting with the originally proposed route near MP 157.5.
NEPA requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us to discover and address concerns the public may have about proposals. This process is referred to as scoping. The main goal of the scoping process is to focus the analysis in the EIS on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EIS. We will consider all filed comments during the preparation of the EIS.
In the EIS we will discuss impacts that could occur as a result of the construction and operation of the proposed projects under these general headings:
We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EIS will present our independent analysis of the issues. We will publish and distribute the draft EIS for public comment. After the comment period, we will consider all timely comments and revise the document, as necessary, before issuing a final EIS. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section beginning on page 9.
The U.S. Army Corps of Engineers (USACE) and USFS also have responsibilities under NEPA and can adopt the EIS for their own agencies purposes. The USFS intends to use this EIS to evaluate the effects of the ACP on lands and facilities managed by the agency and to address any proposed amendments of applicable LRMPs that would be necessary to make provisions for the projects.
With this Supplemental Notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues related to these projects to formally cooperate with us in the preparation of the EIS.
On November 12, 2015 Atlantic submitted a right-of-way grant application to the USFS to construct, operate, maintain, and eventually decommission a natural gas pipeline that crosses lands and facilities administered by the USFS. In addition, there is a need for the USFS to consider amending affected LRMPs to make provision for the ACP right-of-way.
The proposed action before the USFS has two components. First, in accordance with the Minerals Leasing Act, the USFS would issue a right-of-way grant in response to ACP's application for the project to occupy federal lands. The USFS may submit specific stipulations, including mitigation measures, for inclusion in the right-of-way grant related to lands, facilities, and easements within its jurisdiction. Second, the USFS may need to amend its LRMPs for the Monongahela and George Washington National Forests if analysis shows that construction of the ACP would not be consistent with the LRMP standards or other plan components. In addition, the ACP, as proposed, does not follow a designated utility corridor through the GWNF. If the proposed route were authorized with the right-of-way grant, the GWNF LRMP would need to be amended to change the current Management Areas in the corridor to Management Area 5C-Designated Utility Corridors. The MNF does not have LRMP direction that would require a similar plan amendment to reallocate management prescriptions.
The USFS Regional Foresters of the respective national forests have authority to grant a right-of-way in response to Atlantic's application for natural gas transmission on federal lands under the Mineral Leasing Act of 1920. The Responsible Official for amendment of Forest Service LRMPs is the Forest Supervisor of the applicable national forest. However, the Regional Forester of the applicable national forest may elect to be the Responsible Official for the plan amendments as well, since the Regional Forester will be the Responsible Official for the right-of-way grant.
This NOI initiates the scoping process for the potential LRMP amendments and for the issuance of the right-of-way grant. The decisions will be tiered to the analysis contained in the FERC EIS for the ACP. The Notice of Availability for the FERC draft EIS will contain more detailed information associated with the LRMP amendments.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for Section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Offices, and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the projects' potential effects on historic properties.
You can make a difference by providing us with your specific comments or concerns about the ACP and proposed USFS LRMP amendments. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington DC on or before June 2, 2016. If you have previously provided comments on the ACP or Supply Header Projects, you do not need to resubmit them.
The USFS is participating as a cooperating agency with the FERC in this public scoping process. With this notice, the USFS is requesting public comments on the issuance of the ROW Grant that would allow the ACP to occupy federal land. The USFS is also requesting public comments on the potential amendments of USFS LRMPs to make provision for the ACP right-of-way on the Monongahela and George Washington National Forests.
Comments on actions by the USFS should be submitted through the FERC comment process and within the timeline described. The submission of timely and specific comments can affect a reviewer's ability to participate in subsequent administrative or judicial review of USFS decisions. Comments concerning USFS actions submitted anonymously will be accepted and considered; however, such anonymous submittals will not provide the commenters with standing to participate in administrative or judicial review of USFS decisions.
For your convenience, there are three methods you can use to submit your comments to the Commission. In all instances, please reference the appropriate project docket number (CP15-554-000 for the ACP) with your submission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature located on the Commission's Web site (
(2) You can file your comments electronically using the eFiling feature located on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, as well as anyone who submits comments on the projects. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the planned projects.
Copies of the completed draft EIS will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
In addition to involvement in the EIS scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the User's Guide under the “e-filing” link on the Commission's Web site.
Decisions by the USFS to issue ROW Grants and amend LRMPs are subject to administrative review. Pre-decisional objections to the ROW Grant decisions and project-specific MNF and GWNF LRMP amendments that are applicable only to the ACP, as provided under Title 36 of the Code of Federal Regulations Part 219.59(b) (36 CFR 219.59[b]), may be filed under the 36 CFR 218 regulations, Subparts A and B. For objection eligibility (218.5), only those who have submitted timely, specific written comments during any designated opportunity for public comment may file an objection. Issues to be raised in objections must be based on previously submitted specific written comments regarding the proposed project and attributed to the objector, unless the issue is based on new information that arose after a designated opportunity for comment (218.8(c)). The GWNF plan amendment for the reallocation of management areas to Management Area 5C-Designated Utility Corridors would be subject to the pre-decisional objection process under the regulations at 36 CFR 219, Subpart B. For objection eligibility (219.53), only those who have submitted substantive formal comments related to a plan amendment during the opportunities for public comment during the planning process for that decision may file an objection. Objections must be based on previously submitted substantive formal comments attributed to the objector unless the objection concerns an issue that arose after the opportunities for formal comment.
Additional information about the ACP is available from the Commission's Office of External Affairs, at (866) 208-FERC or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public meetings or site visits will be posted on the Commission's calendar located at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report 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 April 26, 2016, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2015), the Indicated RTO Transmission Owners (RTO)
Any person desiring to intervene or to protest in this proceeding must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. 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 Petitioner.
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 proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for 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
On May 2, 2016, the Commission issued an order in Docket No. EL16-59-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of MidAmerican Energy Company's proposed rate reduction.
The refund effective date in Docket No. EL16-59-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Western Area Power Administration, DOE.
Record of decision and statement of floodplain findings.
The Western Area Power Administration (Western), a power marketing administration within the U.S. Department of Energy (DOE), and the San Luis & Delta-Mendota Water Authority (Authority), a California joint powers agency, have prepared a joint Environmental Impact Statement (EIS)/Environmental Impact Report (EIR) for the San Luis Transmission Project (SLTP or Proposed Project). Western is the Federal lead agency under the National Environmental Policy Act (NEPA), and the Authority is the state lead agency under the California Environmental Quality Act (CEQA). The Bureau of Reclamation (Reclamation) is a NEPA Cooperating Agency. The California Department of Water Resources (DWR) is a CEQA Responsible Agency. Western proposes to construct, own, operate, and maintain approximately 95 miles of new transmission lines within easements ranging from 125 to 250 feet wide through Alameda, San Joaquin, Stanislaus, and Merced Counties along the foothills of the western San Joaquin Valley. Western also would upgrade or expand its existing substations, make the necessary arrangements to upgrade or expand existing Pacific Gas & Electric Company (PG&E) substations, or construct new substations to accommodate the interconnections of these new transmission lines. The Notice of Availability (NOA) of the Final EIS/EIR was published in the
Mr. Donald Lash, NEPA Document Manager, Western Area Power Administration, Sierra Nevada Region, 114 Parkshore Drive, Folsom, CA 95630-4710; telephone (916) 353-4048. Hard copies of the EIS/EIR are available from Mr. Lash upon request. For general information on DOE's NEPA review
For information related to Reclamation's participation, contact Mr. Russell Grimes, Chief, Environmental Compliance and Conservation, Bureau of Reclamation, Mid-Pacific Region, 2800 Cottage Way, Sacramento, CA 95818, telephone (916) 978-5051, email at
Western delivers Federal electric power (mostly hydroelectric power) to Federal preference customers defined to include municipalities, rural electric cooperatives, public utilities, irrigation districts, Federal and state agencies, and Native American tribes. Western also is responsible for making the necessary arrangements to deliver federal power to Federally authorized projects.
Reclamation is the largest wholesaler of water in the country, supplying more than 31 million people, and providing one out of five western farmers with irrigation water for 10 million acres of farmland. Reclamation is also the second largest producer of hydroelectric power in the western United States with 53 power plants that provide more than 40 billion kilowatt hours annually and generate nearly a billion dollars in power revenues. Reclamation's mission is to assist in meeting the increasing water demands of the West while protecting the environment and the public's investment in these structures. Reclamation emphasizes fulfilling its water delivery obligations, water conservation, water recycling, and reuse goals; developing partnerships with customers, states, and Native American tribes; and finding ways to address the competing needs for limited water resources.
The Authority is a California joint powers agency, comprised of water agencies representing approximately 28 Federal and exchange water service contractors within the western San Joaquin Valley, San Benito and Santa Clara counties. One of the primary purposes of establishing the Authority was to assume the operation and maintenance responsibilities of certain Reclamation facilities located in the Central Valley, and to do so at an optimum level and at a lower cost than Reclamation. The Authority also has the mission of pursuing additional reliable water supply for its member districts and delivering the water with a reliable system in a cost efficient manner.
Reclamation entered into a contract with PG&E in 1965 for power transmission and distribution service between Western's Tracy Substation and Reclamation's San Luis Unit (SLU) facilities. The existing transmission contract with PG&E expired in March 2016, and PG&E has stated it will not be renewed. Without the contract or a federal transmission line to serve the primary SLU facilities, the Federal Government will have to take transmission service under the California Independent System Operator Tariff. This would substantially increase Reclamation's transmission costs, which are paid by its water service contractors, including members of the Authority. Reclamation submitted a transmission service request to Western to consider various transmission service arrangements, including the construction of new Federal transmission lines for Reclamation's continued delivery of federal water after the PG&E contract expires. To meet its purpose and need Western must respond to Reclamation's request for transmission service consistent with Western's Open Access Transmission Tariff and existing laws. In October 2013, Duke American Transmission Company (DATC) submitted a transmission service request to Western for transmission service within the same corridor as requested by Reclamation. Western evaluated both requests jointly in order to determine if it can satisfy Reclamation's need and DATC's request with a single project.
The Notice of Intent (NOI) to prepare an EIS/EIR was published in the
The SLTP would consist of: (1) A new 500-kilovolt (kV) transmission line about 65 miles in length between the new Tracy East and Los Banos West Substations; (2) a new 230-kV transmission line about 3 miles in length between the new Los Banos West Substation and Western's existing San Luis Substation; (3) a new 230-kV transmission line about 20 miles in length between Western's existing San Luis Substation and Western's existing Dos Amigos Substation or a new 230-kV transmission line about 18 miles in length between the new Los Banos West Substation and Western's existing Dos Amigos Substation; (4) an interconnection with the existing Western 500-kV Los Banos-Gates No. 3 transmission line just south of PG&E's existing Los Banos Substation into the new Los Banos West Substation; and (5) a new 70-kV transmission line about 7 miles in length between the existing San Luis and O'Neill Substations.
Additional components of the SLTP would include new 230-kV line terminal bays at Western's San Luis and Dos Amigos Substations, as well as a new 230/70-kV transformer bank and interconnection facilities at the San Luis Substation. The SLTP also would include ancillary facilities, such as communication facilities, improvements to existing access roads, new permanent access roads, and temporary access roads to facilitate construction activities. Western would acquire the
Western implements Environmental Protection Measures (EPMs) and Construction Standards to reduce environmental consequences associated with its construction and maintenance activities. The Final EIS analysis of environmental consequences considered the EPMs listed in Table 2-5 and the Construction Standards presented in Appendix F to the Final EIS as integral components of the Proposed Action. These EPMs and Construction Standards would be implemented as part of the Proposed Project.
Western analyzed six corridor alternatives and the No Action/No Project alternative in the EIS/EIR. An additional seven alternatives were considered in a screening process and eliminated from further review based on feasibility considerations. Western divided the Proposed Project, at common points of the corridors, into four segments (North, Central, San Luis, South) and examined available alternatives. Alternative corridors are presented by segment in Table 1, with the Agency Preferred Alternative shown in highlight:
The No Action/No Project Alternative is the Environmentally Preferred Alternative because it would avoid any adverse direct, indirect, or cumulative environmental impacts. However, the No Action/No Project Alternative would not achieve the purpose and need or basic project objectives. Therefore, an environmentally preferred action alternative was identified among the other (
After analysis of public comments and further internal review of the EIS/EIR, Western has determined its Agency Preferred Alternative is the same as the Environmentally Preferred Action Alternative in the Northern and San Luis (500-kV and 70-kV) segments. In the Central Segment, the Proposed Route is the Agency Preferred Alternative. Although it would be closer to residences and have slight increases in the associated visual and temporary noise impacts, it would have less of an impact on biological resources. In particular, it would impact fewer special-status plant species. Additionally, it would require fewer crossings of the existing high voltage transmission lines, which would increase reliability by providing more space between circuits. In the South Segment, the Billy Wright Road Alternative is the Agency Preferred Alternative. Although it would have greater recreation impacts by crossing the Path of the Padres Trail and slightly greater soil disturbance due to its longer length, it would avoid conflicts with the Wright Solar Park, which is now fully permitted and expected to begin construction in 2016.
The Agency Preferred Alternative is comprised of:
All methods identified in Final EIS Table 6.1 to avoid, minimize, and mitigate environmental impacts from the selected alternative are adopted in this Record of Decision. Western's standard practices and project-specific protection measures, listed in the Final EIS/EIR, will be implemented as part of the Proposed Action, as will all terms and conditions of any required permits or consultation agreements.
In accordance with 10 CFR part 1022, Western considered the potential impacts of the Project on floodplains and wetlands. The Project could affect floodplains through ground disturbance associated with construction and operations and maintenance activities, including operation of heavy equipment, grading, and vegetation clearing for access roads, site leveling,
Western's decision is to construct the project along the Agency Preferred Alternative described in the Final EIS/EIR. The measures identified in Final EIS Table 6.1 are adopted as part of this decision. The selection of the Agency Preferred Alternative, the adopted measures from Final EIS Table 6.1, and all terms and conditions of required permits and consultation agreements satisfies Western's statutory mission while minimizing harm to the environment. This decision is based on the information in the Final EIS/EIR. The EIS including this Record of Decision was prepared according to the requirements of NEPA (42 U.S.C. 4321,
Environmental Protection Agency (EPA).
Notice.
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et. Seq.). 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 OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Courtney Kerwin (202) 566-1669, or email at
EPA ICR Number 1362.10; NESHAP for Coke Oven Batteries (Renewal); 40 CFR part 63, subparts A and L; was approved without change on 1/27/2016; OMB Number 2060-0253; expires on 1/31/2019.
EPA ICR Number 2491.02; Agricultural Worker Protection Standard Training, Notification and Recordkeeping (Final Rule); 40 CFR part 170; was approved without change on 1/21/2016; OMB Number 2070-0190; expires on 1/31/2019.
EPA ICR Number 1360.15; Revision of Information Collection Request for Underground Storage Tanks: Technical and Financial Requirements, and State Program Approval Procedures (Final Rule); 40 CFR parts 280 and 281; was approved without change on 1/14/2016; OMB Number 2050-0068; expires on 1/31/2019.
EPA ICR Number 1656.15; Risk Management Program Requirements and Petitions to Modify the List of Regulated Substances under Section 112(r) of the Clean Air Act (Renewal); 40 CFR part 68; was approved without change on 1/14/2016; OMB Number 2050-0144; expires on 1/31/2019.
EPA ICR Number 1867.06; Voluntary Aluminium Industrial Partnership (VAIP) (Renewal); was approved without change on 1/14/2016; OMB Number 2060-0411; expires on 1/31/2019.
EPA ICR Number 1821.08; NESHAP for Steel Pickling, HCI Process Facilities and Hydrochloric Acid Regeneration Plants (Renewal); 40 CFR part 63, subparts A and CCC; was approved without change on 1/12/2016; OMB Number 2060-0419; expires on 1/31/2019.
EPA ICR Number 2468.02; NPDES Electronic Reporting (Final Rule); 40 CFR parts 122, 123, 127, 403, 501, and 503; was approved without change on 1/11/2016; OMB Number 2020-0035; expires on 1/31/2019.
EPA ICR Number 2507.01; Lead Training, Certification, Accreditation and Authorization Activities (New); 40 CFR part 745; was approved with change on 1/8/2016; OMB Number 2070-0195; expires on 1/31/2019.
EPA ICR Number 0107.11; Air Stationary Source Compliance and Enforcement Information Reporting (Renewal); 40 CFR parts 51, 52, 60, 61, and 63; was approved without change on 1/5/2016; OMB Number 2060-0096; expires on 1/31/2019.
EPA ICR Number 2203.05; Amendments to the Protocol Gas Verification Program, and Minimum Competency Requirements for Air Emission (Renewal); 40 CFR parts 72 and 75; was approved without change on 1/5/2016; OMB Number 2060-0626; expires on 1/31/2019.
EPA ICR Number 1783.08; NESHAP for Flexible Polyurethane Foam Product (Final Rule); 40 CFR part 63, subparts A and III; was approved with change on 1/4/2016; OMB Number 2060-0357; expires on 1/31/2019.
EPA ICR Number 2475.02; Labeling Change for Certain Minimum Risk Pesticides under FIFRA Section 25(b) (New); 40 CFR part 152; was approved with change on 2/22/2016; OMB Number 2070-0187; expires on 2/28/2019.
EPA ICR Number 1426.11; EPA Worker Protection Standards for Hazardous Waste Operations and Emergency Response (Renewal); 40 CFR part 311; was approved without change on 2/3/2016; OMB Number 2050-0105; expires on 2/28/2019.
EPA ICR Number 2493.02; Categorical Non-Waste Determination for Selected Non Hazardous Secondary Materials (NHSM): Construction and Demolition Wood, Paper Recycling Residuals, and Creosote-Treated Railroad Ties (Additions to List of Section 241.4 Categorical Non-Waste Fuels) (Proposed Rule); 40 CFR parts 63 and 241; OMB filed comment on 1/20/2016.
Environmental Protection Agency (EPA).
Notice.
EPA has received a specific exemption request from the Idaho State Department of Agriculture to use the pesticide sulfoxaflor (CAS No. 946578-00-3) to treat up to 12,000 acres of alfalfa grown for seed to control lygus bugs. The applicants propose a use of a pesticide, sulfoxaflor, which is now considered to be unregistered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) owing to the vacature of sulfoxaflor registrations by the United States District court for the Central District of California. In accordance with 40 CFR 166.24(a)(7), EPA is soliciting public comment before making the decision whether or not to grant the exemption.
Comments must be received on or before May 24, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0188, by one of the following methods:
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Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
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Under section 18 of the FIFRA (7 U.S.C. 136p), at the discretion of the EPA Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the EPA Administrator determines that emergency conditions exist which require the exemption. The Idaho State Department of Agriculture has requested the EPA Administrator to issue a specific, exemption for the use of sulfoxaflor on alfalfa grown for seed to control lygus bugs. Information in accordance with 40 CFR part 166 was submitted as part of this request.
The Applicant proposes to make no more than two applications per year of Transform WG, 0.047 to 0.086 pounds of active ingredient per application. 12,000 total acres of alfalfa grown for seed are requested to be treated. Ground applications must be made in a minimum of 15 gallons of water per acre. The use season is May 30, 2016 through August 31, 2016. The chemical is requested to be used in the State of Idaho within the counties of Ada, Canyon, Cassia, Franklin, Jerome, Oneida, Owyhee, Payette, and Twin Falls.
This notice does not constitute a decision by EPA on the application itself. The regulations governing FIFRA section 18 require publication of a notice of receipt of an application for a specific exemption proposing a use of a pesticide that has been subject to a judicial vacature, however, EPA considers public notice appropriate in this instance. Accordingly, the notice provides an opportunity for public comment on the application.
The Agency, will review and consider all comments received during the comment period in determining whether to issue the specific exemption requested by the Idaho State Department of Agriculture.
7 U.S.C. 136
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before July 8, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The FCC Form 602 is comprised of the Main Form containing information regarding the filer and the Schedule A is used to collect ownership data pertaining to the Disclosable Interest Holder(s). Each Disclosable Interest Holder will have a separate Schedule A. Thus, a filer will submit its FCC Form 602 with multiple copies of Schedule A, as necessary, to list each Disclosable Interest Holder and associated information.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Federal Deposit Insurance Corporation.
Update Listing of Financial Institutions in Liquidation.
Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the
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 May 24, 2016.
A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
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Government Accountability Office (GAO).
Notice on terms of appointments.
In accordance with the Children's Health Insurance Program Reauthorization Act of 2009, the Comptroller General appoints the 17 members of the Medicaid and CHIP Payment and Access Commission (MACPAC). This notice announces the extension of all current members for an additional 4 months.
The Government Accountability Office is at 441 G St. NW., Washington, DC 20548. The Medicaid and CHIP Payment and Access Commission is at 1800 M St. NW., Suite 650 South, Washington, DC 20036.
Government Accountability Office: Mary Giffin, (202) 512-3710. Medicaid and CHIP Payment and Access Commission: Anne L. Schwartz, Executive Director, (202) 350-2000.
The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) established MACPAC to report to Congress on Medicaid and CHIP access and payment policies and make recommendations to Congress, the Secretary of Health and Human Services, and the states concerning access to Medicaid and CHIP covered services. CHIPRA gave the Comptroller General of the United States responsibility for appointing MACPAC's 17 members. Appointments are for 3 years, except for members appointed to fill vacancies and for initial members, for which staggered terms were required.
Pursuant to that authority, all initial appointments were effective January 1, 2010, but were staggered so that 5 ended in December 2010, 6 ended in December 2011, and 6 ended in December 2012. The Comptroller General has continued to make appointments effective in January of each year since the initial appointments.
In consultation with the Commission, the Comptroller General has concluded that members' terms should be changed to more closely match the Commission's business cycle. The current January 1 to December 31 terms are out of step with that cycle; the Commission carries out significant planning activities in the summer and finalizes its two reports in late January and April of each year. Terms that begin May 1 and end April 30 would coincide more closely with the Commission's work schedule and
To better align the terms of service with Commission operations, the terms of all current members are hereby extended for 4 months. The following members' terms will expire on April 30, 2017: Sharon Carte, Andrea Cohen, Herman Gray, Norma Martinez Rogers, and Sara Rosenbaum. The following members' terms will expire on April 30, 2018: Gustavo Cruz, Leanna George, Marsha Gold, Charles Milligan, Sheldon Retchin, and Peter Szilagyi. The following members' terms will expire on April 30, 2019: Brian Burwell, Toby Douglas, Christopher Gorton, Stacey Lampkin, Penny Thompson, and Alan Weil.
Subsequent appointments will be for 3 years.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other
It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice.
The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.
Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the
This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS Web site or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the Web site list provides more timely access for beneficiaries, providers, and suppliers. We also believe the Web site offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and “real time” accessibility. In addition, many of the Web sites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the Web site. These listservs avoid the need to check the Web site, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a Web site proves to be difficult, the contact person listed can provide information.
This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in
We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: April 24, 2015 (80 FR 23013) August 3, 2015 (80 FR 45980) November 13, 2015 (80 FR 70218) and February 4, 2016 (81 FR 6009). For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information.
The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System.
The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (IOM) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the IOM, send a message via the CMS Feedback tool.
Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at:
Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at
In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)—January 2016 (CMS-Pub. 100-04) Transmittal No. 3377.
Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our Web site at
Regulations and notices are published in the daily
The
This information is available on our Web site at:
For questions or additional information, contact Terri Plumb (410-786-4481).
CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters.
The rulings can be accessed at
Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information
Addendum V includes listings of the FDA-approved investigational device exemption (IDE) numbers that the FDA assigns. The listings are organized according to the categories to which the devices are assigned (that is, Category A or Category B), and identified by the IDE number. For the purposes of this quarterly notice, we list only the specific updates to the Category B IDEs as of the ending date of the period covered by this notice and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-786-6877).
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the notice published in the April 21, 1997
All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This information is available at
Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at:
Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection mechanism. On October 27, 2005, CMS announced that the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) ICD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR ICD Registry by April 2006.
Effective January 27, 2005, to obtain reimbursement, Medicare NCD policy requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention ICD procedure. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare NCD Manual, which is on the CMS Web site at
A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR ICD registry. The entire list of facilities that participate in the ACC-NCDR ICD registry can be found at
For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available by accessing our Web site and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at:
CMS issued a guidance document on November 20, 2014 titled “Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document”. Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at
There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at
Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR.
In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at
Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy.
For the purposes of this quarterly notice, there were no specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This information is available at
Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS):
• National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs);
• Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and
• Medicare approved for lung transplants.
Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at
Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006).
There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS's minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at
There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period.
This information is available on our Web site at
Food and Drug Administration, HHS.
Notification; extension of comment period.
The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop” that appeared in the
FDA is extending the comment period on the document published January 7, 2016 (81 FR 784). Submit either electronic or written comments by June 30, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Srinivas Nandkumar, Food and Drug Administration, Center for Devices and Radiological Health, Bldg. 66, Rm. 2436, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6480, FAX: 301-847-8126,
In the
The Agency has received requests for a 30-day extension of the comment period for the document. Each request conveyed concern that the current 30-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the document on “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids.”
FDA has considered the requests and is extending the comment period for the document on “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids” for 30 days, until June 30, 2016. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying regulation on these important issues.
Food and Drug Administration, HHS.
Notice; renewal of advisory committee.
The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2018.
Authority for the Anesthetic and Analgesic Drug Products Advisory Committee will expire on May 1, 2016, unless the Commissioner formally determines that renewal is in the public interest.
Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, (301) 796-9001,
Issued in 41 CFR 102-3.65 and approval by the Department of Health and Human Services issued in 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Anesthetic and Analgesic Drug Products Advisory Committee advises the Commissioner or designee in discharging responsibilities
The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of anesthesiology, analgesics (such as: abuse deterrent opioids, novel analgesics, and issues related to opioid abuse) epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.
Further information regarding the most recent charter and other information can be found at
This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at
Office of the Assistant Secretary for Health, Office of Adolescent Health, HHS.
Notice.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on the ICR must be received on or before July 8, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the document identifier OMB # 0990-0424-60D for reference.
OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
National Institutes of Health.
Notice.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702.
Information on licensing and co-development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email
Technology description follows.
Inventors at NIH have developed optical trapping procedures that provide significant improvements in spatial resolution and tissue depth. These improvements are particularly important for examining clinically relevant tissue samples. The viscoelastic measurements obtained using the disclosed systems and methods have a surprisingly high contrast-to-noise ratio compared to prior methods of obtaining viscoelastic measurements for complex materials. The increased contrast-to-noise ratio allows for more sensitive detection of changes in viscoelastic properties across materials than what was possible using prior methods. Thus, the disclosed systems and methods can be used to measure the properties of a wide variety of complex materials (such as biological materials), from 3D tissue culture models to tissue in or from living zebrafish to mammals, such as mice and humans.
• Microrheological measurements can increase knowledge of the cancer microenvironment.
• Diagnosis and/or treatment of a condition or disease associated with tissue/cell remodeling, including tumor state.
• Determine the effectiveness of a particular compound or treatment or regimen (e.g cosmetic products for reducing wrinkles, scarring, etc.).
• Evaluate wound healing.
• Increased sensitivity in the detection of changes in viscoelastic properties across materials.
• Improvements in spatial resolution and tissue depth.
• Localized, precise application of force compared to magnetic bead microrheology.
• Greater dynamic range and can probe outside the thermal energy range
• Selection of multiple probe sites at once allows for increased throughput.
• Automated probe selection reduces assay time.
Kandice Tanner, Ph.D. (NCI); Benjamin Blehm, Ph.D. (NCI); and Alexus Devine, B.S. (NCI)
HHS Reference No. E-251-2015/0-US-01 US Provisional Application 62/198,554 (HHS Reference No. E-251-2015/0-US-01) filed July 29, 2015 entitled “Optical Trap for Rheological Characterization of Complex Materials”.
Blehm BH, et al. In vivo tissue has non-linear rheological behavior distinct from 3D biomimetic hydrogels, as determined by AMOTIV microscopy. Biomaterials. 2016 Mar;83:66-78.
Requests for copies of the patent application or inquiries about licensing, research collaborations, and co-development opportunities should be sent to John D. Hewes, Ph.D., email:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the
Comments must reach the Coast Guard on or before July 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2016-0258] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek approval of revisions of the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2016-0258], and must be received by July 8, 2016.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of revisions to the following collection of information: 1625-0066, Vessel and Facility Response Plans (Domestic and International), and Additional Response Requirements for Prince William Sound, Alaska. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before July 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2016-0262] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek approval of revisions of the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2016-0262], and must be received by July 8, 2016.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Requests (ICRs), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a revision to the following collection of information: 1625-0023, Barge Fleeting Facility Records. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before June 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2015-1033] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
(3)
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2015-1033], and must be received by June 8, 2016
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (81 FR 3148, January 20, 2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collection.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a new collection of information: 1625-new, Maritime Transportation System Recovery Essential Elements of Information. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before July 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2016-0281] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2016-0281], and must be received by July 8, 2016.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0052, Nondestructive Testing of Certain Cargo Tanks on Unmanned Barges. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before June 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2015-1034] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
(3)
A copy of the ICR is available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2015-1034], and must be received by June 8, 2016.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (81 FR 3149, January 20, 2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collection.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a revision to the following collection of information: 1625-0027, Vessel Documentation. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before June 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2015-1097] to the Coast Guard using the Federal eRulemaking Portal at
(1) Email:
(2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503, attention Desk Officer for the Coast Guard.
(3) Fax: 202-395-6566. To ensure your comments are received in a timely manner, mark the fax, attention Desk Officer for the Coast Guard.
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2015-1097], and must be received by June 8, 2016.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (81 FR 3152, January 20, 2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Control Number: 1625-0063
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0063, Marine Occupational Health and Safety Standards for Benzene—46 CFR 197 Subpart C. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before July 8, 2016.
You may submit comments identified by Coast Guard docket number [USCG-2016-0261] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the Internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2016-0261], and must be received by July 8, 2016
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
U.S. Customs and Border Protection, Department of Homeland Security
60-Day Notice and request for comments; extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Declaration of Owner and Declaration of Consignee When Entry is made by an Agent (Forms 3347 and 3347A). CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before July 8, 2016 to be assured of consideration.
Written comments may be mailed to U.S. Customs and Border Protection, Attn: Tracey Denning, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177.
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Public Law 104-13). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual cost burden to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:
When entry is made in a consignee's name by an agent who has knowledge
CBP Forms 3347 and 3347A are authorized by 19 U.S.C. 1485 and are accessible at
CBP Form 3347:
CBP Form 3347A:
U.S. Customs and Border Protection, Department of Homeland Security.
60-Day notice and request for comments; extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: African Growth and Opportunity Act Certificate of Origin (AGOA). CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before July 8, 2016 to be assured of consideration.
Written comments may be mailed to U.S. Customs and Border Protection, Attn: Tracey Denning, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177.
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual cost burden to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:
For preferential treatment under AGOA, the exporter is required to prepare a certificate of origin and provide it to the importer. The certificate of origin includes information such as contact information for the importer, exporter and producer; the basis for which preferential treatment is claimed; and a description of the imported merchandise. The importers are required to have the certificate in their possession at the time of the claim, and to provide it to Customs and Border Protection (CBP) upon request. The collection of this information is provided for in 19 CFR 10.214, 10.215, and 10.216.
Instructions for complying with this regulation are posted on CBP.gov Web site at:
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invite the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until July 8, 2016.
All submissions received must include the OMB Control Number 1615-0016 in the subject box, the agency name and Docket ID USCIS-2006-0070. To avoid duplicate submissions, please use only
(1)
(2)
(3)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Acting Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
(7)
U.S. Citizenship and Immigration Services, Department of Homeland Security (DHS).
Notice.
This notice announces the implementation of U.S. Citizenship and Immigration Services' (USCIS) Filipino World War II Veterans Parole (FWVP) policy. Under this policy, USCIS will
On or after June 8, 2016, individuals will be able to request parole under the FWVP policy.
Maura Nicholson, Deputy Chief, International Operations Division, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Suite 3300, Washington, DC 20529, Telephone 202-272-1892. (This is not a toll-free number.)
More than 260,000 Filipino soldiers enlisted to fight for the United States during World War II. Estimates indicate that as many as 26,000 of these brave individuals became U.S. citizens. As U.S. citizens or lawful permanent residents (LPRs), these veterans may petition for certain of their family members to come to the United States. Estimates indicate that there are approximately between 2,000 to 6,000 Filipino American World War II veterans still alive in the United States today, many of whom greatly desire to have their family members in the United States during their final days.
With the exception of “immediate relatives” (
Recognizing the contributions and sacrifices of Filipino veterans who fought for the United States during World War II and their families, USCIS has decided to implement the FWVP policy. In many cases, paroling these family members may also allow them to provide support and care for elderly veterans or their surviving spouses. Under this policy, USCIS will consider individual requests for parole submitted for certain relatives who are the beneficiaries of approved family-based immigrant visa petitions filed by Filipino veterans or their surviving spouses.
In light of the circumstances described above, among other considerations, USCIS believes that the parole of qualified applicants who establish on a case-by-case basis that they are eligible for consideration under this policy and merit a favorable exercise of discretion would generally yield a “significant public benefit.” Additionally, considering the advanced age of World War II Filipino veterans and their spouses, and their increased need for care and companionship, grants of parole under the FWVP policy would often address urgent humanitarian concerns. In all cases, whether to parole a particular individual under this policy is a discretionary determination that will be made on a case-by-case basis. Accordingly, parole applications for individuals who fall within the general criteria but whose cases present overriding adverse factors (
Those who may benefit from the FWVP policy are individuals: (1) who are the beneficiaries of Forms I-130, Petition for Alien Relative, including any accompanying or following-to-join spouse and children,
The Filipino veteran's qualifying World War II military service must have previously been recognized by the Department of Defense and must be described in section 405 of the Immigration Act of 1990 (IMMACT'90),
1. Individuals who are
2. Individuals who are
3. Individuals who served honorably in an active duty status within the Philippine Scouts or within any other component of the United States Armed Forces in the Far East (other than a component described in clauses 1 or 2) at any time during the period beginning
USCIS will review government records to verify that the Filipino veteran's World War II military service was recognized by the Department of Defense. When this documentation is not available, USCIS will issue a Request for Evidence to allow the petitioner to submit evidence establishing the Filipino veteran's military service.
When the petitioning relative in the United States is the Filipino World War II veteran, individuals eligible for parole consideration could include beneficiaries under any family-sponsored preference category. Individuals who qualify as “immediate relatives” under section 201(b)(2)(A)(i) of the INA, 8 U.S.C. 1151(b)(2)(A)(i), however, will not be eligible for parole under this policy because immigrant visas for these individuals are already immediately available. Immediate relatives may seek immigrant visas for travel to the United States immediately upon the approval of immigrant visa petitions filed on their behalf. In situations where the petitioning relative in the United States is the surviving spouse of a Filipino World War II veteran, eligible individuals who may be considered for parole under this policy include only the child, son, or daughter of the surviving spouse who is also the child, son, or daughter of the Filipino World War II veteran.
In cases where the petitioning relative is deceased, eligible individuals described in this paragraph may also seek parole on their own behalf, under this policy, in cases where USCIS has reinstated the approval of Form I-130, Petition for Alien Relative, for humanitarian reasons. If such petition is reinstated, the self-petitioner must establish (1) a qualifying family relationship with the deceased Filipino veteran or spouse (
Seeking parole under the FWVP policy is voluntary.
On or after June 8, 2016, an eligible U.S.-based U.S. citizen or LPR Filipino World War II veteran, or surviving spouse, with an approved Form I-130 may request parole under the FWVP policy on behalf of his or her eligible beneficiary relatives (or, if a self-applicant, on his or her own behalf). An eligible petitioner or self-applicant must file a completed Form I-131, Application for Travel Document, and a completed Form I-134, Affidavit of Support, and submit the required fee(s) or fee waiver request
USCIS or Department of State consular officers will interview all individuals considered for parole under the FWVP policy to determine whether parole is appropriate on a case-by-case basis.
If an immigrant visa becomes available to an individual who is not an “immediate relative” while a Form I-131 filed under the FWVP policy is pending, the individual will be considered for parole under this policy, if desired. Alternatively, the beneficiary can choose to pursue immigrant visa processing, which will require payment of associated fees, but will enable the individual to apply for admission to the United States as an immigrant, if found eligible by the Department of State for the immigrant visa and admissible by CBP at a U.S. port of entry.
Under the PRA, 44 U.S.C. chapter 35, all Departments are required to submit to the Office of Management and Budget (OMB) for review and approval, any new reporting requirements they impose. The USCIS, Application for Travel Document, (Form I-131), has been approved by OMB and assigned OMB control number 1615-0013. USCIS is only revising the Form I-131 Instructions in connection with the implementation of the FWVP policy and this notice. USCIS filed an emergency request with OMB and obtained approval of the changes to the Form I-131 Instructions. More information regarding the annual burden impact resulting from the implementation of this new policy will be provided during the next renewal cycle of the Form I-131. Currently, USCIS estimates that the FWVP policy might result in approximately 6,000 new respondents filing Form I-131s. The current OMB-approved estimated number of respondents filing Form I-131 is 940,671. USCIS believes it has overestimated the number of individuals who will use this form to apply for immigration benefits to the degree that additional respondents who will use it to file a request under the FWVP policy will be covered within the 940,671 estimated.
Additional information about the consideration of parole requests under the FWVP policy will be posted on the USCIS Web site at
Fish and Wildlife Service, Interior; National Marine Fisheries Service, Commerce.
Notice; reopening of public comment period.
We, the U.S. Fish and Wildlife Service and the National Marine Fisheries Service, are reopening the comment period for our joint request for comments on the Butte Regional Conservation Plan (Plan) and the Draft Environmental Impact Statement/Report (DEIS/R) for Authorization of Incidental Take and Implementation of the Plan. As of January 19, 2016, we have received comments from four organizations and individuals requesting that the comment period be extended. In response to these requests, we are reopening the comment period.
If you previously submitted comments, you need not resubmit them; we have already incorporated them into the public record and will fully consider them in finalizing these documents.
1. Mike Thomas, Chief, Conservation Planning Division; or Eric Tattersall, Assistant Field Supervisor, by mail/hand-delivery at U.S. Fish and Wildlife Service, Sacramento Fish and Wildlife Office, 2800 Cottage Way, W-2605, Sacramento, California 95825; or by facsimile to (916) 414-6713. You may telephone (916) 414-6600 to make an appointment during regular business hours to drop off comments at the Sacramento Fish and Wildlife Office.
2. Maria Rea, Assistant Regional Administrator, by mail/hand-delivery at National Oceanic and Atmospheric Administration, West Coast Region, National Marine Fisheries Service, 650 Capitol Mall, Suite 5-100, Sacramento, California 95814; or by facsimile to (916) 930-3629. You may telephone (916) 930-3600 to make an appointment during regular business hours to drop off comments at the National Marine Fisheries Service.
Please send comments related specifically to the California Environmental Quality Act (CEQA) process to the Jon Clark, Executive Director, Butte County Association of Governments, 2580 Sierra Sunrise Terrace, Suite 100, Chico, California 95928. You may also submit comments by facsimile to (530) 879-2444.
(1) Rick Kuyper, Endangered Species Division; Mike Thomas, Chief, Conservation Planning Division; or Eric Tattersall, Deputy Assistant Field Supervisor, at the Sacramento Fish and Wildlife Office address above or at (916) 414-6600 (telephone); or
(2) Gretchen Umlauf, National Marine Fisheries Service, at the address above or at (916) 930-5646 (telephone).
If you use a telecommunications device for the deaf, please call the Federal Information Relay Service at (800) 877-8339.
We are reopening the comment period for the Butte Regional Conservation Plan and a DEIS/R for Authorization of Incidental Take and Implementation of the Plan. On November 18, 2015, we opened a 90-day public comment period via a
For background information, see our November 18, 2015, notice (80 FR 72108).
You may obtain copies of the Draft Plan and DEIS/R from any of the individuals in
• Butte County Association of Governments, 2580 Sierra Sunrise Terrace, Suite 100;
• Biggs Branch Library, 464A B Street;
• Chico Branch Library, 1108 Sherman Avenue;
• Gridley Branch Library, 299 Spruce Street; and
• Oroville Branch Library, 1820 Mitchell Avenue.
Bureau of Indian Affairs, DOI.
Notice of request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) is seeking comments on the renewal of Office of Management and Budget (OMB) approval for the collection of information for Indian Self-Determination and Education Assistance Contracts, authorized by OMB Control Number 1076-0136. This information collection expires July 31, 2016.
Submit comments on or before July 8, 2016.
You may submit comments on this information collection activities to Ms. Sunshine Jordan, Acting Division Chief, Office of Indian Services—Division of Self-Determination, 1849 C Street NW., MS 4513-MIB, Washington, DC 20240, telephone: (202) 513-7616, email:
Ms. Sunshine Jordan, email:
Representatives of the BIA seeks renewal of the approval for information collections conducted under their joint rule, 25 CFR part 900, implementing the Indian Self-Determination and Education Assistance Act (ISDEAA), as amended (25 U.S.C. 450
The BIA requests your comments on this collection concerning: (a) The necessity of this information collection 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 (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; (c) ways we could enhance the quality, utility, and clarity of the information to be collected; and (d) ways we could minimize the burden of the collection of the information on the respondents.
Please note that an agency may not conduct or sponsor, and an individual need not respond to, a collection of information unless it has a valid OMB Control Number.
It is BIA's policy to make all comments available to the public for review at the location listed in the
Office of the Secretary, Department of the Interior.
Notice.
This notice announces location and date changes to the upcoming meetings of the United States Extractive Industries Transparency Initiative (USEITI) Multi-Stakeholder Group (MSG) Advisory Committee. The location, date, and time for the June 28-29, 2016, meeting has changed and the November 2-3, 2016, meeting has been rescheduled.
The June 28-29, 2016, meeting has been rescheduled to June 27-28, 2016. The first day of the June meeting, June 27, 2016, will be from 1:00 p.m. to 6:00 p.m., and the second day, June 28, 2016, will be from 9:30 a.m. to 4:00 p.m. Eastern Time. The November 2-3, 2016, meeting has been rescheduled to November 16-17, 2016, from 9:30 a.m. to 4:00 p.m. Eastern Time, unless we indicate otherwise at
The meetings will be held at the U.S. Department of the Interior Stewart Lee Udall Building, 1849 C Street NW., Washington, DC 20240. The June 27-28, 2016, meeting will be held in the South Penthouse, and the November 16-17, 2016, meeting will be held in the North Penthouse. Members of the public may attend in person or view documents and presentations under discussion via WebEx at
Rosita Compton Christian, USEITI Secretariat, 1849 C Street NW., MS-4211, Washington, DC 20240. You may also contact the USEITI Secretariat via email at
The U.S. Department of the Interior established the USEITI Advisory Committee (Committee) on July 26, 2012, to serve as the initial USEITI multi-stakeholder group. More information about the Committee, including its charter, can be found at
Whenever possible, we encourage those participating by telephone to gather in conference rooms in order to share teleconference lines. Please plan to dial into the meeting and/or log into WebEx at least 10-15 minutes prior to the scheduled start time in order to avoid possible technical difficulties. Individuals with special needs will be accommodated whenever possible. If you require special assistance (such as an interpreter for the hearing impaired), please notify Interior staff in advance of the meeting at 202-208-0272 or via email at
We will post the minutes from these proceedings on the USEITI MSG Web site at
Bureau of Land Management, Interior.
Public Land Order.
This order withdraws 32.56 acres of public land from settlement, sale, location, and entry under the general land laws, including the United States mining laws, for a period of 20 years to protect the Buffalo Bill Dam and Reservoir and the recreational facilities near Cody, Wyoming.
This Public Land Order is effective on May 9, 2016.
Janelle Wrigley, Realty Officer, Bureau of Land Management (BLM), Wyoming State Office, 5353 N. Yellowstone Road, Cheyenne, Wyoming 82009, 307-775-6257 or via email at
This withdrawal protects the completed Buffalo Bill Dam and Reservoir Modification Project, Shoshone Project, Pick-Sloan Missouri Basin Program, Wyoming, as authorized by Public Law 97-293, dated October 12, 1982. The implementing Act for this project provides for 74,000 acre-feet of additional water storage annually for irrigation, municipal, and industrial use; increased hydroelectric power generation; outdoor recreation; fish and wildlife conservation and development; environmental quality; and other purposes. As part of a joint-venture agreement between the Bureau of Reclamation and the State of Wyoming, the land is used by the Wyoming State Parks and Historic Sites and is managed as a State campground. The land is centrally located within this site and major improvements in the form of a campground, roads, playgrounds, restrooms, and picnic and shelter facilities have been constructed.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:
1. Subject to valid existing rights, the following-described public land is hereby withdrawn from settlement, sale, location, and entry under the general land laws, including the United States mining laws, but not from leasing under the mineral leasing laws, to protect the Buffalo Bill Dam and Reservoir and recreation facilities:
The area described contains 32.56 acres, in Park County.
2. The jurisdiction for all surface uses of these lands is transferred to and exercised by the Bureau of Reclamation, subject to all previously issued leases, licenses, rights of way, and other agreements. The withdrawal made by this order does not alter the applicability of those public land laws governing the use of the land under lease, license, or permit, or governing the disposal of the mineral or vegetative resources other than under the mining laws.
3. This withdrawal will expire 20 years from the effective date of this order, unless, as a result of a review conducted prior to the expiration date pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be extended.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a first amended complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the first amended complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.
The Commission has received a first amended complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Rovi Corporation and Rovi Guides, Inc. on April 25, 2016. The first amended complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain digital video receivers and hardware and software components thereof. The first amended complaint names as respondents: Comcast Corporation, Philadelphia, PA; Comcast Cable Communications, LLC, Philadelphia, PA; Comcast Cable Communications Management, LLC, Philadelphia, PA; Comcast Business Communications, LLC, Philadelphia, PA; Comcast Holdings Corporation, Philadelphia, PA; Comcast Shared Services, LLC, Chicago, IL; Technicolor SA, France; Technicolor USA, Inc., Indianapolis, IN; Technicolor Connected Home USA LLC, Indianapolis, IN; Pace Ltd., England; Pace Americas, LLC, Boca Raton, FL; Arris International plc, Suwanee, GA; Arris Group Inc., Suwanee, GA; Arris Technology, Inc., Horsham, PA; Arris Enterprises Inc., Suwanee, GA; and Arris Solutions, Inc., Suwanee, GA. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the first amended complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3135”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 4, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of WCM Industries, Inc. of Colorado Springs, Colorado. Supplements were filed on April 13, 2016; April 19, 2016; and April 20, 2016. The complaint as supplemented alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain overflow and drain assemblies for bathtubs and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,302,220 (“the ’220 patent”); U.S. Patent No. 8,321,970 (“the ’970 patent”); U.S. Patent No. 8,584,272 (“the ’272 patent”); and U.S. Patent No. 9,200,436 (“the ’436 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained
The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain overflow and drain assemblies for bathtubs and components thereof by reason of infringement of one or more of claims 12 and 13 of the '220 patent; claim 1 of the '970 patent; claims 11 and 12 of the ’272 patent; and claims 1-16 of the ’436 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: WCM Industries, Inc., 2121 Waynoka Road, Colorado Springs, CO 80915.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
Bridging Partners Corporation, 4F-1, No. 26, Sec. 3, Ren Ai Road, Taipei 106, Taiwan.
Better Enterprise Co. Ltd., 7F., No. 77, Sec. 4, Nanjing East Road, Taipei 105, Taiwan.
Everflow Industrial Supply Corporation, 16F-1, No. 401, Sec. 1, Chung Shan Road, Changhua, Taiwan.
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
United States International Trade Commission.
Notice.
Effective April 28, 2016.
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 (
Effective January 4, 2016, the Commission established a schedule for the conduct of the final phase of the subject investigations (81 FR 7585, February 12, 2016). The Commission is revising its schedule by changing the time of the hearing. The Commission's hearing will be held at the U.S. International Trade Commission Building at 10:00 a.m. on May 26, 2016. All other aspects of the schedule are unchanged.
For further information concerning these investigations see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
Notice; Correction.
The Department of Labor published a document in the
Contact Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by email to
In the
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
On page 24655 of the same document, (81 FR 24655) in the second column, correct the 5th paragraph of the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
On page 24655 of the same document, (81 FR 24655) also in the second column, correct the 13th paragraph of the
On page 24655 of the same document, (81 FR 24655) also in the second column, correct the 15th through 18th paragraphs of the
Legal Services Corporation.
Notice of extended comment period for proposed changes.
The Legal Services Corporation (“LSC”) is extending the public comment period for the proposed Grant Assurances for calendar year 2017 Basic Field Grants. The proposed revisions affect Grant Assurances 7, 15, 20, and 22. LSC published the original request for comments in the
All comments and recommendations must be received on or before the close of business on May 16, 2016
You may submit comments by any of the following methods:
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Reginald J. Haley,
In response to recent requests, LSC is extending the comment period for proposed changes to the Grant Assurances for calendar year 2017 Basic Field Grants.
Grant Assurance 7 requires LSC recipients to provide legal services in accordance with: a) the grant proposal that LSC approved; b) the LSC Performance Criteria; c) the ABA Standards for the Provision of Civil Legal Aid; d) the ABA standards for Programs Providing Civil Pro Bono Legal Services to Persons of Limited Means; and e) any applicable code or rules of professional conduct, responsibility, or ethics. The proposed change clarifies the Grant Assurance and notifies the recipient that LSC's consent is required before the recipient makes significant changes to the delivery system described in the approved grant proposal or grant renewal application.
Grant Assurance 15 requires grantees to notify LSC of: a) an office closing or relocation; b) a change of board chairperson; c) a change of chief executive officer; d) a change in recipient's charter, articles of incorporation, by-laws, or governing body structure; and e) a change in recipient's main email and Web site address. The proposed change updates the instruction for submitting these notifications to LSC.
Grant Assurance 20 requires LSC recipients to provide advance notification to LSC of a proposed merger, consolidation, change in recipient's name, or status as a legal entity. In addition, Grant Assurance 20 directs recipients to LSC's instructions for planning an orderly conclusion of the role and responsibility of an LSC recipient. The proposed change clarifies and adds to the requirements for notifying LSC of a significant change in recipient's status and updates the Web site link to LSC's instructions for planning an orderly conclusion of the role and responsibility of an LSC recipient.
Grant Assurance 22 requires recipients to give recognition and
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Tuesday, June 7, 2016, 1:00 p.m. to 5:00 p.m., Eastern Daylight Time (EDT).
Ms. Ann Delo, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0750, fax (202) 358-2779, or
The meeting will be open to the public telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the USA toll free conference call number 1-877-918-923, passcode 1594921, to participate in this meeting by telephone. A toll number also is available, 1-630-395-0299, passcode 1594921. The WebEx link is
The agenda for the meeting includes the following topics:
It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration (NASA).
(16-032)
Notice of information collection.
The National Aeronautics and Space Administration, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).
All comments should be submitted within 60 calendar days from the date of this publication.
All comments should be addressed to Frances Teel, National Aeronautics and Space Administration, 300 E Streets SW., Washington, DC 20546-0001.
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Frances Teel, NASA Clearance Officer, NASA Headquarters, 300 E Street SW., JF000, Washington, DC 20546,
This collection of information supports the National Aeronautics and Space Act of 1958, as amended, to create opportunities to improve processes associated with the evaluation and selection of individuals to participate in the NASA Astronaut Candidate Selection Program. The NASA Astronaut Selection Office (ASO) located at the Lyndon B. Johnson Space Center (JSC) in Houston, Texas is responsible for selecting astronauts for the various United States Space Exploration programs. In evaluating an applicant for the Astronaut Candidate Program, it is important that the ASO have the benefit of qualitative and quantitative information and recommendations from persons who have been directly associated with the applicant over the course of their career.
This information will be used by the NASA ASO and Human Resources (HR) personnel, during the candidate selection process (approx. 2 year duration), to gain insight into the candidates' work ethic and professionalism as demonstrated in previous related employment activities. Respondents may include the astronaut candidate's previous employer(s)/direct-reporting manager, as well as co-workers and other references provided by the candidate.
Electronic and optionally by paper.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (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 respondents, including automated collection techniques or the use of other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
The National Science Board, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended, (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the addition of an agenda item in the plenary open session of the National Science Board meetings on May 6, 2016, as shown below. The original notice appeared in the
Please refer to the National Science Board Web site for additional information. Meeting information and schedule updates (time, place, subject matter or status of meeting) may be found at
Ron Campbell,
National Science Foundation.
Notice.
The National Science Foundation (NSF) is announcing plans to request renewed clearance of this collection. In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on the NSF Large Facilities Manual (LFM) and the accompanying Large Facilities Financial Data Collection Tool. The primary purpose of this revision is to implement financial management policy and requirements as well as to update and clarify existing content. The draft versions of the NSF LFM and the accompanying Large Facilities Financial Data Collection Tool are available on the NSF Web site at:
To facilitate review, a Change Log with brief comment explanations of the changes is provided in the manual. NSF is particularly interested in public comment on the financial management changes identified in the LFM and on the Large Facilities Financial Data Collection Tool for use in incurred cost reporting. After obtaining and considering public comment, NSF will prepare the submission requesting OMB clearance of this collection for no longer than 3 years.
In addition to the type of comments identified above, comments are also invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; 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.
Written comments should be received by July 8, 2016 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Written comments regarding the information collection and requests for copies of the proposed information collection request should be addressed to Suzanne Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Blvd., Rm. 1265, Arlington, VA 22230, or by email to
Suzanne Plimpton on (703) 292-7556 or send email to
OMB Approval Number: 3145-0239.
Type of Request: Intent to seek approval to extend with revision an information collection for three years.
“To promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense. * * *”
The Act authorized and directed NSF to initiate and support:
• Basic scientific research and research fundamental to the engineering process;
• Programs to strengthen scientific and engineering research potential;
• Science and engineering education programs at all levels and in all the various fields of science and engineering;
• Programs that provide a source of information for policy formulation; and
• Other activities to promote these ends.
Among Federal agencies, NSF is a leader in providing the academic community with advanced instrumentation needed to conduct state-of-the-art research and to educate the next generation of scientists, engineers and technical workers. The knowledge generated by these tools sustains U.S. leadership in science and engineering (S&E) to drive the U.S. economy and secure the future. NSF's responsibility is to ensure that the research and education communities have access to these resources, and to provide the support needed to utilize them optimally, and implement timely upgrades.
The scale of advanced instrumentation ranges from small research instruments to shared resources or facilities that can be used by entire communities. The demand for such instrumentation is very high, and is growing rapidly, along with the pace of discovery. For large facilities and shared infrastructure, the need is particularly high. This trend is expected to accelerate in the future as increasing numbers of researchers and educators rely on such large facilities, instruments, and databases to provide the reach to make the next intellectual leaps.
NSF currently provides support for facility construction from two accounts:
Facilities are defined as shared-use infrastructure, instrumentation and equipment that are accessible to a broad community of researchers and/or educators. Facilities may be centralized or may consist of distributed installations. They may incorporate large-scale networking or computational infrastructure, multi-user instruments or networks of such instruments, or other infrastructure, instrumentation and equipment having a major impact on a broad segment of a scientific or engineering discipline. Historically, awards have been made for such diverse projects as accelerators, telescopes, research vessels and aircraft, and geographically distributed but networked sensors and instrumentation.
The growth and diversification of large facility projects require that NSF remain attentive to the ever-changing issues and challenges inherent in their planning, construction, operation, management and oversight. Most importantly, dedicated, competent NSF and awardee staff are needed to manage and oversee these projects; giving the attention and oversight that good practice dictates and that proper accountability to taxpayers and Congress demands. To this end, there is also a need for consistent, documented requirements and procedures to be understood and used by NSF program managers and awardees for all such large projects.
• Provide step-by-step guidance for NSF staff and awardees to carry out effective project planning, management and oversight of large facilities while considering the varying requirements of a diverse portfolio;
• Clearly state the policies, processes and procedures pertinent at each stage of a facility's life cycle from development through construction, operations, and termination; and
• Document and disseminate “best practices” identified over time so that NSF and awardees can carry out their responsibilities more effectively.
This version of the Large Facilities Manual up-dates sections related to contingency policy, cost estimating requirements, and cost incurred audits. As part of the implementation of incurred cost reporting, a Large Facilities Financial Data Collection Tool is referenced in the Manual and included in the request for comment. This version also reflects revisions to improve readability and facilitate period revision. The Manual does not replace existing formal procedures required for all NSF awards, which are described in the
This Manual will be updated periodically to reflect changes in requirements, policies and/or procedures. Award Recipients are expected to monitor and adopt the requirements and best practices included in the Manual which are aimed at improving management and oversight of large facilities projects and at enabling the most efficient and cost-effective delivery of tools to the research and education communities.
The submission of proposals and subsequent project documentation to the Foundation related to the development, construction and operations of Large Facilities is part of the collection of information. This information is used to help NSF fulfill this responsibility in supporting merit-based research and education projects in all the scientific and engineering disciplines. The Foundation also has a continuing commitment to provide oversight on facilities development and construction which must be balanced against monitoring its information collection so as to identify and address any excessive reporting burdens.
NSF has approximately twenty-two (22) Large Facilities in various stages of development, construction, operations and termination. One to two (1 to 2) new awards are made approximately every five (5) years based on science community infrastructure needs and availability of funding. Of the twenty-two large facilities, there are approximately eight (8) facilities annually that are either in development or construction. These stages require the highest level of reporting and management documentation per the Large Facilities Manual.
The ACRS Subcommittee meeting on Digital I&C scheduled for May 17, 2016, 1:00 p.m. until 5:00 p.m., has been cancelled.
The notice of this meeting was previously published in the
Information regarding this meeting can be obtained by contacting Christina
The ACRS Subcommittees on T-H Phenomenon and Metallurgy & Reactor Fuels will hold a meeting on May 17, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will review the final draft of Regulatory Guide 1.20, “Comprehensive Vibration Assessment Program for Reactor Internals during Preoperation and Startup.” The Subcommittee will hear presentations by and hold discussions with the NRC staff regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Derek Widmayer (Telephone 301-415-5375 or Email:
DFO with a CD containing each presentation at least thirty minutes before the meeting. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
Pension Benefit Guaranty Corporation.
Notice of request for extension of OMB approval.
The Pension Benefit Guaranty Corporation (“PBGC”) is requesting that the Office of Management and Budget (“OMB”) extend approval, under the Paperwork Reduction Act, of a collection of information under its regulation on Rules for Administrative Review of Agency Decisions. This notice informs the public of PBGC's request and solicits public comment on the collection of information.
Comments should be submitted by June 8, 2016.
Comments should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Pension Benefit Guaranty Corporation, via electronic mail at
Copies of the collection of information may also be obtained without charge by writing to the Disclosure Division of the Office of the General Counsel of PBGC at the above address or by visiting the Disclosure Division or calling 202-326-4040 during normal business hours. (TTY and TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4040.) PBGC's regulation on Administrative Appeals may be accessed on PBGC's Web site at
Deborah C. Murphy, Deputy Assistant General Counsel for Regulatory Affairs, or Donald McCabe, Attorney, Regulatory Affairs Group, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005-4026, 202-326-4400. (For TTY and TDD, call 800-877-8339 and request connection to 202-326-4400).
PBGC's regulation on Rules for Administrative Review of Agency Decisions (29 CFR part 4003) prescribes rules governing the issuance of initial determinations by PBGC and the procedures for requesting and obtaining administrative review of initial determinations. Certain types of initial determinations are subject to administrative appeals, which are covered in subpart D of the regulation. Subpart D prescribes rules on who may file appeals, when and where to file appeals, contents of appeals, and other matters relating to appeals.
Most appeals filed with PBGC are filed by individuals (participants, beneficiaries, and alternate payees) in connection with benefit entitlement or amounts. A small number of appeals are filed by employers in connection with other matters, such as plan coverage under ERISA section 4021 or employer liability under ERISA sections 4062(b)(1), 4063, or 4064. Appeals may be filed by hand, mail, commercial delivery service, fax or email. For appeals of benefit determinations, PBGC has optional forms for filing appeals and requests for extensions of time to appeal.
OMB has approved the administrative appeals collection of information under control number 1212-0061 through May 31, 2016. PBGC is requesting that OMB extend approval of this collection of information for three years without change. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
PBGC estimates that an average of 900 appellants per year will respond to this collection of information. PBGC further estimates that the average annual burden of this collection of information is about forty-five minutes and $52 per appellant, with an average total annual burden of 643 hours and $46,680.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend the Fees Schedule to update references to quoting bandwidth. The text of the proposed rule change is available on the Exchange's Web site (
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 its Fees Schedule, effective April 21, 2016.
The Fees Schedule currently sets forth the quoting bandwidth allowance for a Market-Maker Trading Permit. The bandwidth allowance is referenced as a maximum number of quotes over the course of the trading day (currently 35,640,000). The Exchange notes however, that the current reference applies to the Regular Trading Hours session (“RTH”) only. In order to avoid confusion and maintain clarity and transparency in the rules, the Exchange proposes to add a reference to the quoting bandwidth allowance for an Extended Trading Hours
The Exchange next proposes to update the bandwidth currently set forth in Fees Schedule. The Fees Schedule currently states that the quoting bandwidth allowance for a Market-Maker Trading Permit is equivalent to a maximum of 35,640,000 quotes over the course of a trading day. The Exchange proposes to clarify that the stated quoting bandwidth reflects the maximum number of quotes over the course of a trading “session” instead of trading “day.” Particularly, RTH and ETH are separate trading sessions that are part of the same trading day. As such, the current expression of RTH bandwidth as quotes over the course of a trading “day” is inaccurate. Next, the Exchange notes that it increased quoting bandwidth allowance, effective April 18, 2016. The Exchange therefore seeks to make a corresponding amendment to the Fees Schedule. Specifically, the Exchange proposes to update the reference to the number of maximum quotes from 35,640,000 to 40,500,000. The Exchange notes that the increase of quoting bandwidth allowance applies to all RTH Market-Maker Trading Permits and all RTH Quoting and Order Entry Bandwidth Packets.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of section 6(b) of the Act.
In particular, the Exchange believes that adding a reference to the quoting bandwidth allowance during ETH avoids potential confusion and maintains transparency in the Fees Schedule, thereby removing
The Exchange believes that amending the Fees Schedule to accurately reflect the increase in quoting bandwidth allowance, alleviates confusion, thereby removing impediments to and perfecting the mechanism of a free open market and a national market system, and, in general, protecting investors and the public interest. The Exchange also notes that increasing quoting bandwidth helps ensure that Market-Makers have an adequate capacity and ability to continue to make active markets, which also removes impediments to and perfects the mechanism of a free open market and a national market system, and, in general, protects investors and the public interest.
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed change applies to all Market-Makers and is merely updating the Fees Schedule to accurately reflect an increase in quoting bandwidth, update outdated terminology, and reflect what the maximum bandwidth is for ETH. The Exchange believes that the proposed rule change will not cause an unnecessary burden on intermarket competition because it only applies to trading on CBOE. To the extent that the proposed changes make CBOE a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become CBOE market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing rule does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, provided that the self-regulatory organization has given the Commission written notice of its intent to file the proposed rule change at least five business days prior to the date of filing of the proposed rule change or such shorter time as designated by the Commission,
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change 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.
U.S. Small Business Administration.
Notice of open Federal Advisory Committee meetings.
The SBA is issuing this notice to announce the location, date, time and agenda for the initial meeting of the Council on Underserved Communities (CUC) Advisory Board.
The meeting will be held on Tuesday, May 24th at 1:00 pm EST.
These meeting will be held at the U.S. Small Business Administration, in the Administrator's Large Conference Room, located at 409 3rd St. SW., Suite 7000, Washington, DC 20416.
Pursuant to section 10(a) of the Federal Advisory Committee Act (5 U.S.C. Appendix 2), SBA announces the meeting of the Council on Underserved Communities Advisory Board. This Board provides advice and counsel to the SBA Administrator and Associate Administrator. CUC members will examine the obstacles facing small businesses in underserved communities and recommend to SBA policy and programmatic changes to help strengthen SBA's programs and services to these communities.
The purpose of this meeting is to discuss following issues pertaining to the CUC Advisory Board.:
The meeting is open to the public however advance notice of attendance is requested. Anyone wishing to be a listening participant must contact Amadi Anene by phone or email. His contact information is Amadi Anene, Senior Advisor to the Administrator, 409 Third Street SW., Washington, DC 20416, Phone, 202-205-0067 or email,
Additionally, if you need accommodations because of a disability or require additional information, please contact Amadi Anene at the information above.
Notice of request for emergency OMB approval and public comment.
The Department of State has submitted the information collection request described below to the Office of Management and Budget (OMB) for review and approval in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995 (5 CFR 1320.13). The purpose of this notice is to allow for public comment from all interested individuals and organizations. Emergency review and approval of this collection has been requested from OMB by May 23, 2016. If granted, the emergency approval is only valid for 180 days. The Department plans to follow this emergency request with a submission for a 3 year approval through OMB's normal PRA clearance process (5 CFR 1320.10).
All public comments must be received by May 16, 2016.
Direct any comments on this emergency request to both the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB) and to the Office of Medical Services, U.S. Department of State. All public comments must be received by May 16, 2016.
You may submit comments to OMB by the following methods:
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You may submit comments to the Office of Medical Services, U.S. Department of State by the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents to Catherine M. Kazmin who may be reached on 703-875-5413 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden of this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review
The goal of the “Employee Self Certification And Ability To Perform In Emergencies” (ESCAPE) program is to ensure that non-federal individuals who are being considered for a contracted position at a designated post are capable of the unique, potentially challenging and life threatening conditions at ESCAPE posts. These individuals are required to review with a medical provider the pre-deployment acknowledgement form (DS-6570) and then affirm that they understand the physical rigors and security conditions at these posts and can perform any specified emergency functions. Medical information is collected from medical providers and respondents during this review. The Department of State is requesting an emergency review and approval of this Information Collection so non-federal individuals who will be selected for assignments in June, 2016 can provide completed pre-deployment medical information. This Collection is allowed under the Foreign Service Act of 1980 (22 U.S.C. 3901) and the Basic Authorities Act of 1956 (22 U.S.C. 2651).
Information will be collected using a form (DS-6570) during a medical review between a non-federal individual and his/her medical provider. The individual will submit the completed form, signed by both the individual and provider, to the Office of Medical Services at the U.S. Department of State.
Acting under the authority of and in accordance with section 1(b) of Executive Order 13224 of September 23, 2001, as amended by Executive Order 13268 of July 2, 2002, and Executive Order 13284 of January 23, 2003, I hereby determine that the individual known as Moussa Abu Dawud, also known as Moussa Abu Daoud, also known as Moussa Bourahla, also known as Abou Daoud, also known as Bourahla Moussa committed, or poses a significant risk of committing, acts of terrorism that threaten the security of U.S. nationals or the national security, foreign policy, or economy of the United States. Consistent with the determination in section 10 of Executive Order 13224 that “prior notice to persons determined to be subject to the Order who might have a constitutional presence in the United States would render ineffectual the blocking and other measures authorized in the Order because of the ability to transfer funds instantaneously,” I determine that no prior notice needs to be provided to any person subject to this determination who might have a constitutional presence in the United States, because to do so would render ineffectual the measures authorized in the Order.
This notice shall be published in the
Notice.
Notice is hereby given that the Department of State will consider license applications for the indirect participation of Rocky Mountain Instrument Company (“RMI”) in certain transactions subject to the Arms Export Control Act (AECA) (22 U.S.C 2778) without the submission of a transaction exception request as an element of the application.
This notice is effective on May 9, 2016.
Sue Gainor, Director, Office of Defense Trade Controls Compliance, Bureau of Political-Military Affairs, U.S. Department of State (202) 632-2785.
On September 8, 2010, the Department notified the public of a statutory debarment imposed on RMI pursuant to ITAR § 127.7(c) related to RMI's criminal conviction, 75 FR 54692. The notice provided that RMI is “prohibited from participating directly or indirectly in the export of defense articles, including technical data, or in the furnishing of defense services for which a license or other approval is required.” Further, the notice provided that:
Exceptions, also known as transaction exceptions, may be made to this debarment determination on a case-by-case basis at the discretion of the Assistant Secretary of State for Political-Military Affairs, after consulting with the appropriate U.S. agencies. However, such an exception would be granted only after a full review of all circumstances, paying particular attention to the following factors: Whether an exception is warranted by overriding U.S. foreign policy or national security interests; whether an exception would further law enforcement concerns that are consistent with the foreign policy or national security interests of the United States; or whether other compelling circumstances exist that are consistent with the foreign policy or national security interests of the United States, and that do not conflict with law enforcement concerns. Even if exceptions are granted, the debarment continues until subsequent reinstatement.
Notwithstanding the prohibition on indirect participation referenced in the original notice of statutory debarment, and in conformance with the stated policy and procedures regarding transaction exceptions, based on overriding national security and foreign policy concerns and after a thorough review of the circumstances surrounding the conviction and a finding that appropriate steps have been taken to mitigate law enforcement concerns, the Under Secretary for Arms Control and International Security has determined to approve specific exceptions from the debarment of RMI, available to persons other than RMI but excluding persons acting for or on behalf of RMI in contravention of ITAR § 127.1(d), for the following categories of authorization requests:
1. Applications submitted by persons other than RMI for the export or
2. Application submitted by persons other than RMI for the export or temporary import of defense articles manufactured by persons other than RMI which incorporate a defense article manufactured by RMI as a component, accessory, attachment, part, firmware, software, or system;
3. The use of other approvals (
4. Applications submitted by persons other than RMI for agreements identified in ITAR Part 124 in which RMI is identified as a U.S. signatory to the agreement.
All requests for authorizations, or use of exemptions, involving RMI that fall within the scope of the specific categories above will be reviewed and action taken by the Directorate of Defense Trade Controls in the ordinary course of business and do not require the submission of a separate transaction exception request, but should include reference to, or a copy of, this notice. Including an explanation of how the proposed transaction falls within the scope of an exception category above will facilitate review of the request.
All requests for authorizations involving RMI that do not fall within the scope of the specific categories above must be preceded by the approval of a transaction exception request by the Department. The decision to grant a transaction exception will be made on a case-by-case basis after a full review of all circumstances.
This notice does not provide notice of reinstatement of export privileges for RMI pursuant to the statutory requirements of AECA Sec. 38(g)(4) (22 U.S.C. 2778), nor does this notice provide notice of rescission of the imposition of statutory debarment of RMI pursuant to ITAR § 127.7(c). As required by the statute, the Department will not consider applications from RMI unless accompanied by a specific transaction exception request. Any determination by the Department regarding reinstatement of export privileges for RMI or rescission of the imposition of statutory debarment of RMI will be made in accordance with statutory and regulatory requirements and will be the subject of a separate notice.
Department of State.
Notice of availability, solicitation of comments.
The U.S. Department of State (Department) announces availability for public review and comment of the
The Department invites the public, governmental agencies, tribal governments, and all other interested parties to provide comments on the Draft EA and Preliminary FONSI during the 30-day public comment period. The public comment period starts on May 9, 2016, with the publication of this
All comments received during the review period may be made public, no matter how initially submitted. Comments are not private and will not be edited to remove identifying or contact information. Commenters are cautioned against including any information that they would not want publicly disclosed. Any party soliciting or aggregating comments from other persons is further requested to direct those persons not to include any identifying or contact information, or information they would not want publicly disclosed, in their comments.
Comments on the Draft EA and Preliminary FONSI may be submitted at
Project details for the Burgos Pipelines and copies of the Presidential Permit applications, as well as information on the Presidential Permit process are available at the following:
The Department evaluates Presidential permit applications under E.O. 13337 and E.O. 14432. E.O. 13337 delegates to the Secretary of State the President's authority to receive applications for permits for the construction, connection, operation, or maintenance of facilities for the exportation or importation of petroleum, petroleum products, coal, or other fuels (except for natural gas), at the borders of the United States, and to issue or deny such Presidential Permits upon a national interest determination.
In December 2014, NuStar submitted two applications to the Department. The first application requests a new Presidential Permit to replace a 2006 Presidential Permit, that would: (1) Reflect NuStar's name change from Valero Logistics Operations, L.P. to NuStar Logistics, L.P. as the owner and operator of the Existing Burgos Pipeline, the 34-mile-long 8-inch outer diameter pipeline and border facilities issued a Presidential Permit in 2006 authorizing import and export of light naphtha and (2) allow the Existing Burgos Pipeline and border facilities to transport a broader range of petroleum products than originally authorized, including diesel, gasoline, jet fuel, liquefied
Availability of the Draft EA and Preliminary FONSI: Copies of the Draft EA and Preliminary FONSI have been distributed to state and governmental agencies, tribal governments and other interested parties. Printed copies of the document may be obtained by visiting the McAllen Public Library, 4001 N. 23rd St., McAllen, TX 78504, or by contacting the Burgos Project Manager at the above address. They are also available at
Tennessee Valley Authority (TVA)
Notice of meeting.
The TVA Regional Energy Resource Council (RERC) will hold a meeting on Tuesday, May 24 and Wednesday, May 25, 2016, regarding regional energy related issues in the Tennessee Valley.
The RERC was established to advise TVA on its energy resource activities and the priorities among competing objectives and values. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. App.2.
The meeting agenda includes the following:
The RERC will hear views of citizens by providing a public comment session starting at 9:00 a.m. EDT, on Wednesday, May 25. The public comment session may last up to one hour. Persons wishing to speak are requested to register at the door by 8:45 a.m. on Wednesday, May 25, and will be called on during the public comment period. Handout materials should be limited to one printed page. Written comments are also invited and may be mailed to the Regional Energy Resource Council, Tennessee Valley Authority, 400 West Summit Hill Drive, WT-9D, Knoxville TN 37902.
The meeting will be held on Tuesday, May 24, from 10:00 a.m. to 11:45 a.m. and on Wednesday, May 25, from 8:30 a.m. to noon EDT.
The meeting will be held at the Chattanoogan Hotel, 1201 South Broad Street, Chattanooga, Tennessee 37402, and will be open to the public. Anyone needing special access or accommodations should let the contact below know at least a week in advance.
Beth Keel, 400 West Summit Hill Drive, WT-9D, Knoxville, Tennessee 37902, (865) 632-6113.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for and extension of exemption; request for comments.
The American Pyrotechnics Association (APA), on behalf of its member companies, has requested additions to and deletions from the list of motor carriers previously granted exemptions for the 2015 and 2016 Independence Day fireworks shows. Fifty-one APA members currently hold such exemptions from the prohibition on driving commercial motor vehicles (CMVs) after the 14th hour after the driver comes on duty. APA requests discontinuance of the exemption for 4 carriers, and new exemptions for 4 carriers, with the total therefore remaining at 51. The “Fixing America's Surface Transportation Act” (FAST Act) extended the expiration date of hours-of-service (HOS) exemptions in effect on the date of enactment of the FAST Act to 5 years from the date of issuance. This notice therefore extends to July 8, 2020, the exemption for the 47 APA members approved in 2015 that wish to retain the exemption. Finally, FMCSA seeks comment on the applications of 4 APA members not previously exempted from the 14-hour rule. Because the FAST Act also authorized new exemptions for a period of up to 5 years, the Agency proposes to grant these 4 motor carriers exemptions that would run through July 8, 2020, and terminate at the same time as the other 47 exemptions. The APA maintains that the terms and conditions of the limited exemption would ensure a level of safety equivalent to, or greater than, the level of safety achieved without the exemption.
June 8, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2007-28043 using any of the following methods:
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Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, contact Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: (202) 366-4325. Email:
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2007-28043), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews the safety analyses and the public comments, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
Section 5206(a)(3) of the FAST Act amended 49 U.S.C. 31315 to permit FMCSA to grant exemptions for up to 5 years from the date of issuance, instead of the previous two years [§ 31315(b)(2)]. This statutory provision will be codified in 49 CFR part 381 in a forthcoming rulemaking. Section 5206(b)(2)(A) of the FAST Act also extended all HOS exemptions in effect on the date of enactment to a period of 5 years from the date of issuance.
The HOS rule in 49 CFR 395.3(a)(2) prohibits the driver of a property-carrying CMV from driving after the 14th hour after coming on duty following 10 consecutive hours off duty. The APA, a trade association representing the domestic fireworks industry, was granted an exemption for 51 member companies for the 2015 and 2016 Independence Day periods [80 FR 37040, June 29, 2015]. APA has requested discontinuing the exemptions for 4 carriers,
The initial APA application for relief from the 14-hour rule was submitted in 2004; a copy is in the docket. That application fully describes the nature of the pyrotechnic operations of the CMV drivers during a typical Independence Day period.
As stated in the 2004 request, the CMV drivers employed by APA member companies are trained pyro-technicians
The APA states that it is seeking an exemption for an additional 4 member companies because compliance with the current 14-hour rule in 49 CFR 395.3(a)(2) would impose a substantial economic hardship on numerous cities, towns and municipalities, as well as its member companies. To meet the demand for fireworks without the exemption, APA states that its member companies would be required to hire a second driver for most trips. The APA advises that the result would be a substantial increase in the cost of the fireworks shows—beyond the means of many of its members' customers—and that many Americans would be denied this important component of the celebration of Independence Day. The 47 APA member companies currently exempt, as well as the 4 carriers seeking an exemption for the first time, are listed in an appendix to this notice. The 4 new carriers are identified with an asterisk. A copy of the request for the exemption is included in the docket referenced at the beginning of this notice.
The APA believes that the new exemptions would not adversely affect the safety of the fireworks transportation provided by these motor carriers. According to APA, its member-companies have operated under this exemption for 10 previous Independence Day periods without a reported motor carrier safety incident. Moreover, it asserts, without the extra time provided by the exemption, safety would decline because APA drivers would be unable to return to their home base after each show. They would be forced to park the CMVs carrying HM 1.1G, 1.3G and 1.4G products in areas less secure than the motor carrier's home base. As a condition of holding the exemption, each motor carrier would be required to notify FMCSA within 5 business days of any accident (as defined in 49 CFR 390.5) involving the operation of any its CMVs while under this exemption. To date, FMCSA has received no accident notifications, nor is the Agency aware of any accidents reportable under terms of the prior APA exemptions.
In its exemption request, APA asserts that the operational demands of this unique industry minimize the risks of CMV crashes. In the last few days before July 4, these drivers transport fireworks over relatively short routes from distribution points to the site of the fireworks display, and normally do so in the early morning when traffic is light. At the site, they spend considerable time installing, wiring, and safety-checking the fireworks displays, followed by several hours off duty in the late afternoon and early evening prior to the event. During this time, the drivers are able to rest and nap, thereby reducing or eliminating the fatigue accumulated during the day. Before beginning another duty day, these drivers must take 10 consecutive hours off duty, the same as other CMV drivers.
The requested exemption from 49 CFR 395.3(a)(2) would be effective from June 28 through July 8, at 11:59 p.m. local time, each year through 2020.
During the 2016 Independence Day period, the exemption from 49 CFR 395.3(a)(2) would be limited to drivers employed by the 47 motor carriers already covered by the exemption, plus (if approved) the 4 carriers now seeking an exemption. The four carriers that were not included for the 2015 period are identified by an asterisk. Section 395.3(a)(2) prohibits a driver from driving a CMV after the 14th hour after coming on duty and does not permit off-duty periods to extend the 14-hour limit. Drivers covered by this exemption would be able to exclude off-duty and sleeper-berth time of any length from the calculation of the 14-hour limit. This exemption would be contingent on each driver driving no more than 11 hours in the 14-hour period after coming on duty, as extended by any off-duty or sleeper-berth time in accordance with this exception. The exemption would be further contingent on each driver having a full 10 consecutive hours off duty following 14 hours on duty prior to beginning a new driving period. The carriers and drivers must comply with all other requirements of the Federal Motor Carrier Safety Regulations (49 CFR parts 350-399) and Hazardous Materials Regulations (49 CFR parts 105-180).
In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR 381.600, during the period this exemption is in effect, no State shall enforce any law or regulation applicable to interstate commerce that conflicts with or is inconsistent with this exemption with respect to a firm or person operating under the exemption. States may, but are not required to, adopt the same exemption with respect to operations in intrastate commerce.
Exempt motor carriers would be required to notify FMCSA within 5 business days of any accidents (as defined by 49 CFR 390.5) involving the operation of any of their CMVs while under this exemption. The notification must include the following information:
a. Name of the exemption: “APA,”
b. Date of the accident,
c. City or town, and State, in which the accident occurred, or which is closest to the scene of the accident,
d. Driver's name and driver's license number,
e. Vehicle number and State license number,
f. Number of individuals suffering physical injury,
g. Number of fatalities,
h. The police-reported cause of the accident,
i. Whether the driver was cited for violation of any traffic laws, or motor carrier safety regulations, and
j. The total driving time and the total on-duty time of the CMV driver at the time of the accident.
The FMCSA does not believe the motor carriers and drivers covered by this exemption, if granted, would experience any deterioration of their safety record. However, should this occur, FMCSA would take all steps necessary to protect the public interest, including revocation of the exemption. The FMCSA will immediately revoke the exemption for failure to comply with its terms and conditions. Exempt motor carriers and drivers would be subject to FMCSA monitoring while operating under this exemption.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of denials of exemption applications.
FMCSA announces its decision to deny applications from 7 individuals seeking exemptions from the Federal cardiovascular standard applicable to interstate truck and bus drivers and discusses the reasons for the denials. The Agency reviewed the medical information of each the individuals who applied for an implantable cardioverter defibrillator (ICD) exemption. Based on a review of the applications and following an opportunity for public comment, FMCSA has concluded that the 7 individuals in the notice did not demonstrate they could achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained by complying with the regulation.
Denial letters were sent to each of the individuals listed in this notice on March 1, 2016.
Ms. Christine A. Hydock, Chief Medical Programs Division, 202-366-4001, U.S. Department of Transportation, FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except Federal holidays.
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for up to five years if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” FMCSA can renew exemptions for up to an additional five years at the end of each five-year period.
On November 27, 2015, FMCSA published for public notice and comment, FMCSA 2015-0371, listing 7 individuals seeking exemptions for ICDs. Accordingly, the Agency has evaluated each applicant's request to determine whether granting an exemption will achieve the required level of safety mandated by statute.
The individuals included in this notice have requested an exemption from the provisions of 49 CFR 391.41(b)(4), which applies to drivers who operate CMVs in interstate commerce, as defined in 49 CFR 390.5. Section 391.41(b)(4) states that:
The FMCSA provides medical advisory criteria as recommendations for use by medical examiners in determining whether drivers with certain medical conditions and drivers who have undergone certain procedures and/or treatments should be certified to operate CMVs in interstate commerce in accordance with the various physical qualification standards in 49 CFR part 391, subpart E. The advisory criteria are currently set out in Appendix A to 49 CFR part 391. The advisory criteria for section 391.41(b)(4) provide, in part, that:
In the case of persons with ICDs, the underlying condition for which the ICD was implanted places the individual at high risk for syncope (a transient loss of consciousness) or other unpredictable events known to result in gradual or sudden incapacitation. ICDs may discharge, which could result in loss of ability to safely control a CMV. See the Evidence Report on “Cardiovascular Disease and Commercial Motor Vehicle Driver Safety,” April 2007.
On November 27, 2015, FMCSA published in a
FMCSA acknowledges the commenters' reports of safe driving histories and concerns for the driving careers of the applicants. Based on the available medical literature cited above, however, FMCSA believes that a driver with an ICD is at risk for incapacitation if the device discharges. This risk is combined with the risks associated with the underlying cardiovascular condition for which the ICD has been implanted as a primary or secondary preventive measure.
FMCSA evaluated the 7 individual exemption requests on their merits, available data from Evidence Reports and Medical Expert Panel opinions on the impact of ICDs on Commercial Motor Vehicle driving, and the public comments received. The Agency has determined that the available medical literature and data does not support a conclusion that granting these exemptions would achieve a level of safety equivalent to or greater than the level of safety maintained without the exemptions. Each applicant has, prior to this notice, received a letter of final disposition on his/her exemption request. Those decision letters fully outlined the basis for the denial and constitute final Agency action. The list published today summarizes the Agency's recent denials as required under 49 U.S.C. 31315(b)(4).
The following 7 applicants are denied exemptions from the cardiovascular standard. Ellis James Benson, Jon Carey, Martin Carter, Carl Jeglum, William Kastner, Mark Todd Smith, Andre Williams.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 30 individuals for an exemption from the hearing requirement to operate commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals to operate CMVs in interstate commerce.
Comments must be received on or before June 8, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0329 using any of the following methods:
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Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. The 30 individuals listed in this notice have recently requested such an exemption from the hearing requirement in 49 CFR 391.41(b)(11), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
The physical qualification standard for drivers regarding hearing found in 49 CFR 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person
This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).
Mr. Adams, age 44, holds an operator's license in Georgia.
Mr. Bagby, age 66, holds an operator's license in Missouri.
Mr. Barnett, age 66, holds an operator's license in Michigan.
Mr. Beutal, age 39, holds an operator's license in Wisconsin.
Mr. Bottoms, age 37, holds an operator's license in Virginia.
Mr. Broeker, age 54, holds an operator's license in California.
Mr. Brown, age 59, holds a class A CDL in Minnesota.
Mr. Calogar, age 46, holds an operator's license in Ohio.
Mr. Carney, age 58, holds an operator's license in New York.
Mr. Cochran, age 32, holds an operator's license in Washington.
Mr. Deaken, age 27, holds a class A CDL in Montana.
Mr. Doiron, age 49, holds an operator's license in Massachusetts.
Mr. Ferguson, age 52, holds an operator's license in Texas.
Mr. Griffin, age 59, holds an operator's license in Tennessee.
Mr. Harris, age 55, holds an operator's license in Florida.
Ms. Hundorf, age 50, holds an operator's license in California.
Mr. Jones, age 55, holds a class A CDL in New Jersey.
Mr. Mansfield, age 39, holds an operator's license in Kansas.
Mr. Muniz, age 38, holds an operator's license in Oklahoma.
Mr. Panto, age 57, holds a class A CDL in New Jersey.
Mr. Pogue, age 31, holds a class B CDL in Missouri.
Mr. Prag, age 56, holds a class AM CDL in Georgia.
Mr. Prine, age 67, holds an operator's license in Arkansas.
Mr. Tipton, age 50, holds an operator's license in Iowa.
Mr. Trevino, age 30, holds an operator's license in Texas.
Mr. Turner, age 26, holds an operator's license in Illinois.
Mr. Wentworth, age 48, holds an operator's license in Texas.
Mr. Wickman, age 51, holds an operator's license in Iowa.
Mr. Wilson, age 64, holds an operator's license in Tennessee.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the date section of the notice.
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period. FMCSA may issue a final determination any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, go to
Federal Motor Carrier Safety Administration (FMCSA).
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 65 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.
Comments must be received on or before June 8, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2016-0039 using any of the following methods:
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Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. The 65 individuals listed in this notice have recently requested such an exemption from the diabetes prohibition in 49 CFR 391.41(b) (3), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
Mr. Alvarez, 32, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Alvarez understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Alvarez meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Kansas.
Mr. Ambrose, 39, has had ITDM since 2012. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ambrose understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ambrose meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Ohio.
Mr. Anderson, 41, has had ITDM since 1996. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Anderson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Anderson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Arkansas.
Mr. Arvizu, 45, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Arvizu understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Arvizu meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Florida.
Mr. Beining, 53, has had ITDM since 1996. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Beining understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Beining meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Ohio.
Mr. Belback, 57, has had ITDM since 1999. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Belback understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Belback meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Beller, 64, has had ITDM since 2014. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Beller understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Beller meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Texas.
Mr. Bragg, 47, has had ITDM since 2016. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bragg understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bragg meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from West Virginia.
Mr. Bu, 27, has had ITDM since 1999. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bu understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bu meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from New Jersey.
Mr. Ciesmelewski, 61, has had ITDM since 2012. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ciesmelewski understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ciesmelewski meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class C CDL from New Jersey.
Mr. Collett, 59, has had ITDM since 2006. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Collett understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Collett meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Texas.
Mr. Crider, 38, has had ITDM since 1991. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Crider understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Crider meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Minnesota.
Ms. Donahy, 38, has had ITDM since 2015. Her endocrinologist examined her in 2015 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. Her endocrinologist certifies that Ms. Donahy understands diabetes management and monitoring has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Donahy meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her optometrist examined her in 2015 and certified that she does not have diabetic retinopathy. She holds an operator's license from Texas.
Mr. Edington, 44, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Edington understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Edington meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Tennessee.
Mr. Florio, 44, has had ITDM since 1989. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Florio understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Florio meets the
Mr. Francis, 66, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Francis understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Francis meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Kansas.
Mr. Frew, 56, has had ITDM since 2014. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Frew understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Frew meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Idaho.
Mr. Friedman, 35, has had ITDM since 2013. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Friedman understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Friedman meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from New York.
Mr. Gage, 50, has had ITDM since 1986. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gage understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gage meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from New York.
Mr. Gallagher, 62, has had ITDM since 1990. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gallagher understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gallagher meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Gervasio, 58, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gervasio understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gervasio meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New York.
Mr. Gordon, 65, has had ITDM since 2010. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gordon understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gordon meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Massachusetts.
Mr. Gorman, 58, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gorman understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gorman meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Maryland.
Mr. Greene, 37, has had ITDM since 2004. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or
Mr. Guisewhite, 53, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Guisewhite understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Guisewhite meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Ms. Hallgren, 24, has had ITDM since 2016. Her endocrinologist examined her in 2016 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. Her endocrinologist certifies that Ms. Hallgren understands diabetes management and monitoring, has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Hallgren meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her optometrist examined her in 2016 and certified that she does not have diabetic retinopathy. She holds a Class B CDL from Illinois.
Mr. Harding, 56, has had ITDM since 2004. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Harding understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Harding meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Minnesota.
Mr. Hart, 34, has had ITDM since 2006. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hart understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hart meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Texas.
Mr. Hawkins, 69, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hawkins understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hawkins meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Hebbeln, 51, has had ITDM since 1986. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hebbeln understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hebbeln meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Iowa.
Mr. Hochmiller, 60, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hochmiller understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hochmiller meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Colorado.
Mr. Holloway, 53, has had ITDM since 2013. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Holloway understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Holloway meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Hubbard, 65, has had ITDM since 2015. His endocrinologist examined him
Ms. Jones, 62, has had ITDM since 2015. Her endocrinologist examined her in 2016 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. Her endocrinologist certifies that Ms. Jones understands diabetes management and monitoring has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Jones meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her optometrist examined her in 2016 and certified that she does not have diabetic retinopathy. She holds a Class A CDL from Texas.
Mr. Kelleher, 75, has had ITDM since 2010. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Kelleher understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Kelleher meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Massachusetts.
Mr. Kinney, 49, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Kinney understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Kinney meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Michigan.
Mr. Koehn, 65, has had ITDM since 2011. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Koehn understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Koehn meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. LaRue, 63, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. LaRue understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. LaRue meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable proliferative diabetic retinopathy. He holds a Class A CDL from Florida.
Mr. Lopes, 61, has had ITDM since 2014. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Lopes understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Lopes meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New Hampshire.
Mr. Mundt, 60, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Mundt understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Mundt meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Wisconsin.
Mr. Nailon, 35, has had ITDM since 2010. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Nailon understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Nailon meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist
Mr. Onimus, 46, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Onimus understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Onimus meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Orellana, 55, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Orellana understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Orellana meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Rhode Island.
Mr. Orta, 55, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Orta understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Orta meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Texas.
Mr. Partridge, 27, has had ITDM since 1998. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Partridge understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Partridge meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Iowa.
Mr. Pennings, 25, has had ITDM since 2001. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Pennings understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pennings meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Minnesota.
Mr. Pittsley, 24, has had ITDM since 2004. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Pittsley understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pittsley meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from North Dakota.
Mr. Powell, 46, has had ITDM since 1981. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Powell understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Powell meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Illinois.
Mr. Pulda, 58, has had ITDM since 1998. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Pulda understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pulda meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Wisconsin.
Mr. Renfroe, 27, has had ITDM since 2007. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or
Mr. Risk, 41, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Risk understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Risk meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Indiana.
Mr. Roberts, 40, has had ITDM since 1988. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Roberts understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Roberts meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from South Dakota.
Mr. Robinson, 62, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Robinson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Robinson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Michigan.
Mr. Rowe, 34, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Rowe understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Rowe meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Illinois.
Mr. Sawyer, 37, has had ITDM since 2002. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Sawyer understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Sawyer meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from New Mexico.
Mr. Schnacker, 44, has had ITDM since 2013. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Schnacker understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Schnacker meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Nebraska.
Mr. Smith, 47, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Smith understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Smith meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Maryland.
Mr. Stellatos, 52, has had ITDM since 2010. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Stellatos understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Stellatos meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015
Mr. Stuber, 31, has had ITDM since 2006. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Stuber understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Stuber meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Valle, 51, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Valle understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Valle meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Texas.
Mr. Wallin, 46, has had ITDM since 1990. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Wallin understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Wallin meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Minnesota.
Mr. Warren, 60, has had ITDM since 2016. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Warren understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Warren meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Minnesota.
Mr. Webb, 60, has had ITDM since 2014. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Webb understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Webb meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New York.
Mr. Wilson, 61, has had ITDM since 2013. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Wilson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Wilson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Florida.
Mr. Yauneridge, 24, has had ITDM since 2000. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Yauneridge understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Yauneridge meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Maryland.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the date section of the notice.
FMCSA notes that section 4129 of the Safe, Accountable, Flexible and Efficient Transportation Equity Act: A Legacy for Users requires the Secretary to revise its diabetes exemption program established on September 3, 2003 (68 FR 52441)
Section 4129 requires: (1) Elimination of the requirement for 3 years of experience operating CMVs while being treated with insulin; and (2) establishment of a specified minimum period of insulin use to demonstrate stable control of diabetes before being allowed to operate a CMV.
In response to section 4129, FMCSA made immediate revisions to the diabetes exemption program established by the September 3, 2003 notice.
Section 4129(d) also directed FMCSA to ensure that drivers of CMVs with ITDM are not held to a higher standard than other drivers, with the exception of limited operating, monitoring and medical requirements that are deemed medically necessary.
The FMCSA concluded that all of the operating, monitoring and medical requirements set out in the September 3, 2003 notice, except as modified, were in compliance with section 4129(d). Therefore, all of the requirements set out in the September 3, 2003 notice, except as modified by the notice in the
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period. FMCSA may issue a final determination at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt nine individuals from the regulatory requirement that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals to operate CMVs in interstate commerce.
The exemptions were effective on December 16, 2015. The exemptions expire on December 16, 2017.
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On November 12, 2015, FMCSA published a notice announcing receipt of applications from 13 individuals requesting an exemption from the prohibition against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to operate a CMV in interstate commerce and requested comments from the public (80 FR 70065). The public comment period closed on December 14, 2015, and seven comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting the exemptions to nine individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(8).
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person
Has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. The advisory criteria found in Appendix A to 49 CFR 391.41, states that:
If an individual has had a sudden episode of a non-epileptic seizure or loss of consciousness of unknown cause that did not require anti-seizure medication, the decision whether that person's condition is likely to cause the loss of consciousness or loss of ability to control a CMV should be made on an individual basis by the medical examiner in consultation with the treating physician. Before certification is considered, it is suggested that a 6-month waiting period elapse from the time of the episode. Following the waiting period, it is suggested that the individual have a complete neurological examination. If the results of the examination are negative and anti-seizure medication is not required, then the driver may be qualified.
In those individual cases where a driver had a seizure or an episode of loss of
Drivers who have a history of epilepsy/seizures, off anti-seizure medication and seizure-free for 10 years, may be qualified to operate a CMV in interstate commerce. Interstate drivers with a history of a single unprovoked seizure may be qualified to drive a CMV in interstate commerce if seizure-free and off anti-seizure medication for a 5-year period or more.
As a result of medical examiners misinterpreting advisory criteria as regulation, numerous drivers have been prohibited from operating a CMV in interstate commerce based on the fact that they have had one or more seizures and are taking anti-seizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner based on the physical qualification standards and medical best practices.
In reaching the decision to grant these exemption requests, the Agency considered the 2007 recommendations of the Agency's Medical Expert Panel (MEP). The January 15, 2013 (78 FR 3069)
These nine applicants have been seizure-free over a range of 5 to 44 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last two years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially. A summary of each applicant's seizure history was discussed in the November 12, 2015
Seven commenters responded to this notice, six of whom specifically expressed support for applicant Thomas Vivirito and one in support of her husband receiving an exemption. The Agency has determined that nine applicants should be granted an exemption.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows the applicants to operate CMVs in interstate commerce.
The Agency's decision regarding these exemption applications is based on an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a history of seizure and each applicant's driving record found in the Commercial Driver's License Information System (CDLIS) for commercial driver's license (CDL) holders, and interstate and intrastate inspections recorded in the Motor Carrier Management Information System (MCMIS). For non-CDL holders, the Agency reviewed the driving records from the State Driver's Licensing Agency (SDLA). The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.
Consequently, FMCSA finds that in each case exempting these applicants from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption will be provided to the applicants in the exemption document and includes the following: (1) Each individual must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each individual must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each individual must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each individual must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
Based upon its evaluation of the nine exemption applications, FMCSA exempts the following drivers from the epilepsy/seizure standard in 49 CFR 391.41(b)(8), subject to the requirements cited above: Kenneth Lee Brown (WY), Douglas Ray Burkhardt (SD); Curtis Alan Hartman (MD); Wendell Frank Headley, Jr. (MO); Gregory L. Hrutkay (PA); Michael William Ketchum, Sr. (MI); Marion Franklin Legg, Jr. (MD); Alvin Clarence Strite (PA); and Thomas B. Vivirito (PA).
In accordance with 49 U.S.C. 31315(b)(1), each exemption is valid for 2 years, unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The individual fails to comply with the terms and conditions of the exemption;
(2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315. If the exemption is still effective at the end of the 2-year period, the individual may apply to FMCSA for a renewal under procedures in effect at that time.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 27 individuals for an exemption from the prohibition against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these
Comments must be received on or before June 8, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0322 using any of the following methods:
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•
•
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Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001, or via email at
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for up to a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statutes allow the Agency to renew exemptions at the end of the 2-year period. The 27 individuals listed in this notice have requested an exemption from the epilepsy prohibition in 49 CFR 391.41(b)(8), which applies to drivers who operate CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person
Has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. The advisory criteria found in Appendix A to 49 CFR 391.41, states that
If an individual has had a sudden episode of a non-epileptic seizure or loss of consciousness of unknown cause that did not require anti-seizure medication, the decision whether that person's condition is likely to cause the loss of consciousness or loss of ability to control a CMV should be made on an individual basis by the medical examiner in consultation with the treating physician. Before certification is considered, it is suggested that a 6-month waiting period elapse from the time of the episode. Following the waiting period, it is suggested that the individual have a complete neurological examination. If the results of the examination are negative and anti-seizure medication is not required, then the driver may be qualified.
In those individual cases where a driver had a seizure or an episode of loss of consciousness that resulted from a known medical condition (
Drivers who have a history of epilepsy/seizures, off anti-seizure medication and seizure-free for 10 years, may be qualified to operate a CMV in interstate commerce. Interstate drivers with a history of a single unprovoked seizure may be qualified to drive a CMV in interstate commerce if seizure-free and off anti-seizure medication for a 5-year period or more.
As a result of medical examiners misinterpreting advisory criteria as regulation, numerous drivers have been prohibited from operating a CMV in interstate commerce based on the fact that they have had one or more seizures and are taking anti-seizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner based on the physical qualification standards and medical best practices.
Mr. Barnard is a 38 year-old driver in California. He has a history of a seizure disorder and has remained seizure free since 2005. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Barnard receiving an exemption.
Mr. Beaver is a 50 year-old class A CDL holder in Minnesota. He has a history of a single seizure in January 2015, likely secondary to cyclosporine use and posterior reversible encephalopathy syndrome. He discontinued taking anti-seizure in May 2015. His physician states that he is supportive of Mr. Beaver receiving an exemption.
Mr. Carlson is a 38 year-old driver in Minnesota. He has a history of a single seizure following brain surgery for treatment of an obstructive hydrocephalus ventricular colloid cyst in 2015. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Carlson receiving an exemption.
Mr. Carder is a 37 year-old driver in Ohio. He has a history of a single seizure in 2010. He takes anti-seizure medication with the dosage and
Mr. Crampton is a 24 year-old driver in Connecticut. He has a history of epilepsy and has remained seizure free since 2002. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Crampton receiving an exemption.
Mr. Counts is a 39 year-old driver in Maryland. He has a history of a seizure disorder and has remained seizure free since 2003. He takes anti-seizure medication with the dosage and frequency remaining the same since 2006. His physician states that he is supportive of Mr. Counts receiving an exemption.
Mr. Cox is a 53 year-old class B CDL holder in Kentucky. He has a history of epilepsy and has remained seizure free since 2014. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Cox receiving an exemption.
Mr. Davis is a 47 year-old class A CDL holder in Maine. He has a history of a seizure disorder and has remained seizure free since 1998. He takes anti-seizure medication with the dosage and frequency remaining the same since 2002. His physician states that he is supportive of Mr. Davis receiving an exemption.
Mr. Garvin is a 38 year-old driver in New Hampshire. He has a history of a seizure in 2015. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that she is supportive of Mr. Garvin receiving an exemption.
Mr. Getchell is a 57 year-old class B CDL holder in Wisconsin. He has a history of a single seizure and has remained seizure free since 1986. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Getchell receiving an exemption.
Mr. Giles is a 56 year-old class B CDL holder in Indiana. He has a history of a single seizure in 2010 and has remained seizure free since that time. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Giles receiving an exemption.
Mr. Gonzales is a 34 year-old class A CDL holder in Colorado. He has a history of a seizure disorder and has remained seizure free since 2009. He takes anti-seizure medication with the dosage and frequency remaining the same since 2013. His physician states that he is supportive of Mr. Gonzales receiving an exemption.
Mr. Goddard is a 53 year-old class B CDL holder in New Hampshire. He has a history of a seizure disorder and has remained seizure free since 2006. He takes anti-seizure medication with the dosage and frequency remaining the same since 2013. His physician states that he is supportive of Mr. Goddard receiving an exemption.
Mr. Haslip is a 54 year-old class A CDL holder in New York. He has a history of a seizure disorder and has remained seizure free since 2010. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Haslip receiving an exemption.
Mr. Hediger is a 59 year-old class A CDL holder in Illinois. He has a history of epilepsy and has remained seizure free since 2004. He takes anti-seizure medication with the dosage and frequency remaining the same since 2006. His physician states that he is supportive of Mr. Hediger receiving an exemption.
Mr. Lancaster is a 51 year-old driver in Maine. He has a history of a seizure disorder and has remained seizure free since 2001. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Lancaster receiving an exemption.
Mr. Logan is a 35 year-old driver in South Carolina. He has a history of a seizure disorder and has remained seizure free since 1998. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Logan receiving an exemption.
Mr. McVetty is a 29 year-old class B CDL holder in New Hampshire. He has a history of a seizure disorder and has remained seizure free since 2005. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. McVetty receiving an exemption.
Mr. Outfleet is a 55 year-old driver in California. He has a history of a seizure disorder and has remained seizure free since 2010. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Outfleet receiving an exemption.
Mr. Parris is a 22 year-old driver in Illinois. He has a history of a seizure disorder and has remained seizure free since 2012. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Parris receiving an exemption.
Mr. Richmond is a 63 year-old driver in South Carolina. He has a history of a seizure disorder and has remained seizure free since 1980. He takes anti-seizure medication with the dosage and frequency remaining the same since 2001. His physician states that he is supportive of Mr. Richmond receiving an exemption.
Mr. Sands is a 32 year-old driver in Illinois. He has a history of epilepsy and has remained seizure free since 2009. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Sands receiving an exemption.
Mr. Skinner is a 43 year-old driver in Ohio. He has a history of a brain tumor and has remained seizure free since 2007. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His
Mr. Smith is a 47 year-old driver in Minnesota. He has a history of epilepsy and has remained seizure free since 1998. He takes anti-seizure medication with the dosage and frequency remaining the same since 2013. His physician states that he is supportive of Mr. Smith receiving an exemption.
Mr. Sprinkle is a 35 year-old class A CDL holder in North Carolina. He has a history of juvenile epilepsy and has remained seizure free since 2005. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Sprinkle receiving an exemption.
Mr. Trimbo is a 53 year-old class A CDL holder in Minnesota. He has a history of a seizure disorder and has remained seizure free since 1996. He takes anti-seizure medication with the dosage and frequency remaining the same since 2008. His physician states that he is supportive of Mr. Trimbo receiving an exemption.
Mr. Washabaugh is a 57 year-old class A CDL holder in Pennsylvania. He has a history of a seizure disorder and has remained seizure free since 1996. He takes anti-seizure medication with the dosage and frequency remaining the same since that time. His physician states that he is supportive of Mr. Washabaugh receiving an exemption.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the date section of the notice.
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
To view comments, as well as any documents mentioned in this preamble, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt eight individuals from the regulatory requirement that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals to operate CMVs in interstate commerce.
The exemptions were effective on January 21, 2016. The exemptions expire on January 21, 2018.
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On December 21, 2015, FMCSA published a notice announcing receipt of applications from 17 individuals requesting an exemption from the prohibition against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to operate a CMV in interstate commerce and requested comments from the public (80 FR 70065). The public comment period closed on January 20, 2016, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting the exemptions to eight individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(8).
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person
Has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. The advisory criteria found in Appendix A to 49 CFR 391.41, states that:
If an individual has had a sudden episode of a non-epileptic seizure or loss of consciousness of unknown cause that did not require anti-seizure medication, the decision whether that person's condition is likely to cause the loss of consciousness or loss of ability to control a CMV should be made on an individual basis by the medical examiner in consultation with the treating physician. Before certification is considered, it is suggested that a 6-month waiting period elapse from the time of the episode. Following the waiting period, it is suggested that the individual have a complete neurological examination. If the results of the examination are negative and anti-seizure medication is not required, then the driver may be qualified.
In those individual cases where a driver had a seizure or an episode of loss of consciousness that resulted from a known medical condition (
Drivers who have a history of epilepsy/seizures, off anti-seizure medication and seizure-free for 10 years, may be qualified to operate a CMV in interstate commerce. Interstate drivers with a history of a single unprovoked seizure may be qualified to drive a CMV in interstate commerce if seizure-free and off anti-seizure medication for a 5-year period or more.
As a result of medical examiners misinterpreting advisory criteria as regulation, numerous drivers have been prohibited from operating a CMV in interstate commerce based on the fact that they have had one or more seizures and are taking anti-seizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner based on the physical qualification standards and medical best practices.
In reaching the decision to grant these exemption requests, the Agency considered the 2007 recommendations of the Agency's Medical Expert Panel (MEP). The January 15, 2013 (78 FR 3069)
These eight applicants have been seizure-free over a range of 13 to 43 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last two years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially. A summary of each applicant's seizure history was discussed in the December 21, 2015
There were no comments in response to this notice. The Agency has determined that eight applicants should be granted an exemption.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows the applicants to operate CMVs in interstate commerce.
The Agency's decision regarding these exemption applications is based on an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a history of seizure and each applicant's driving record found in the Commercial Driver's License Information System (CDLIS) for commercial driver's license (CDL) holders, and interstate and intrastate inspections recorded in the Motor Carrier Management Information System (MCMIS). For non-CDL holders, the Agency reviewed the driving records from the State Driver's Licensing Agency (SDLA). The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.
Consequently, FMCSA finds that in each case exempting these applicants from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption will be provided to the applicants in the exemption document and includes the following: (1) Each individual must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each individual must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each individual must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each individual must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
Based upon its evaluation of the eight exemption applications, FMCSA exempts the following drivers from the epilepsy/seizure standard in 49 CFR 391.41(b)(8), subject to the requirements cited above: James E. Allen (ME); Thomas A DeAngelo (IL); Nathan Dermer (AK); Daniel Lloyd Halstead (NV); Kevin Mathis (NJ); Toriano T. Mitchell (OH); Thomas A. Mitman (NY) and Tyler W. Schaefor (ME).
In accordance with 49 U.S.C. 31315(b)(1), each exemption is valid for 2 years, unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The individual fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315. If the exemption is still effective at the end of the 2-year period, the individual may apply to FMCSA for a renewal under procedures in effect at that time.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt 20 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. The Agency has concluded that granting these exemptions will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these CMV drivers.
The exemptions were granted March 10, 2016. The exemptions expire on March 10, 2018.
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at
On February 8, 2016, FMCSA published a notice of receipt of exemption applications from certain individuals, and requested comments from the public (81 FR 6573). That notice listed 20 applicants' case histories. The 20 individuals applied for exemptions from the vision requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate commerce.
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. Accordingly, FMCSA has evaluated the 20 applications on their merits and made a determination to grant exemptions to each of them.
The vision requirement in the FMCSRs provides:
A person is physically qualified to drive a commercial motor vehicle if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber (49 CFR 391.41(b)(10)).
FMCSA recognizes that some drivers do not meet the vision requirement but have adapted their driving to accommodate their vision limitation and demonstrated their ability to drive safely. The 20 exemption applicants listed in this notice are in this category. They are unable to meet the vision requirement in one eye for various reasons, including amblyopia, complete loss of vision, corneal dystrophy, corneal transplant, macular degeneration, macular hole, optic nerve hypoplasia, prosthetic eye, refractive amblyopia, and retinal detachment. In most cases, their eye conditions were not recently developed. Twelve of the applicants were either born with their vision impairments or have had them since childhood.
The 8 individuals that sustained their vision conditions as adults have had it for a range of 4 to 40 years.
Although each applicant has one eye which does not meet the vision requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected vision in the other eye, and in a doctor's opinion, has sufficient vision to perform all the tasks necessary to operate a CMV. Doctors' opinions are supported by the applicants' possession of valid commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before issuing CDLs, States subject drivers to knowledge and skills tests designed to evaluate their qualifications to operate a CMV.
All of these applicants satisfied the testing requirements for their State of residence. By meeting State licensing requirements, the applicants demonstrated their ability to operate a CMV, with their limited vision, to the satisfaction of the State.
While possessing a valid CDL or non-CDL, these 20 drivers have been authorized to drive a CMV in intrastate commerce, even though their vision disqualified them from driving in interstate commerce. They have driven CMVs with their limited vision in careers ranging for 3 to 35 years. In the past three years, 3 drivers were involved in crashes, and 1 driver was convicted of a moving violation in a CMV.
The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the February 8, 2016 notice (81 FR 6573).
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. Without the exemption, applicants will continue to be restricted to intrastate driving. With the exemption, applicants can drive in interstate commerce. Thus, our analysis focuses on whether an equal or greater level of safety is likely to be achieved by permitting each of these drivers to drive in interstate commerce as opposed to restricting him or her to driving in intrastate commerce.
To evaluate the effect of these exemptions on safety, FMCSA considered the medical reports about the applicants' vision as well as their driving records and experience with the vision deficiency.
To qualify for an exemption from the vision requirement, FMCSA requires a person to present verifiable evidence
FMCSA believes it can properly apply the principle to monocular drivers, because data from the Federal Highway Administration's (FHWA) former waiver study program clearly demonstrate the driving performance of experienced monocular drivers in the program is better than that of all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996). The fact that experienced monocular drivers demonstrated safe driving records in the waiver program supports a conclusion that other monocular drivers, meeting the same qualifying conditions as those required by the waiver program, are also likely to have adapted to their vision deficiency and will continue to operate safely.
The first major research correlating past and future performance was done in England by Greenwood and Yule in 1920. Subsequent studies, building on that model, concluded that crash rates for the same individual exposed to certain risks for two different time periods vary only slightly (See Bates and Neyman, University of California Publications in Statistics, April 1952). Other studies demonstrated theories of predicting crash proneness from crash history coupled with other factors. These factors—such as age, sex, geographic location, mileage driven and conviction history—are used every day by insurance companies and motor vehicle bureaus to predict the probability of an individual experiencing future crashes (See Weber, Donald C., “Accident Rate Potential: An Application of Multiple Regression Analysis of a Poisson Process,” Journal of American Statistical Association, June 1971). A 1964 California Driver Record Study prepared by the California Department of Motor Vehicles concluded that the best overall crash predictor for both concurrent and nonconcurrent events is the number of single convictions. This study used 3 consecutive years of data, comparing the experiences of drivers in the first 2 years with their experiences in the final year.
Applying principles from these studies to the past 3-year record of the 20 applicants, 3 drivers were involved in crashes, and 1 driver was convicted of a moving violation in a CMV. All the applicants achieved a record of safety while driving with their vision impairment, demonstrating the likelihood that they have adapted their driving skills to accommodate their condition. As the applicants' ample driving histories with their vision deficiencies are good predictors of future performance, FMCSA concludes their ability to drive safely can be projected into the future.
We believe that the applicants' intrastate driving experience and history provide an adequate basis for predicting their ability to drive safely in interstate commerce. Intrastate driving, like interstate operations, involves substantial driving on highways on the interstate system and on other roads built to interstate standards. Moreover, driving in congested urban areas exposes the driver to more pedestrian and vehicular traffic than exists on interstate highways. Faster reaction to traffic and traffic signals is generally required because distances between them are more compact. These conditions tax visual capacity and driver response just as intensely as interstate driving conditions. The veteran drivers in this proceeding have operated CMVs safely under those conditions for at least 3 years, most for much longer. Their experience and driving records lead us to believe that each applicant is capable of operating in interstate commerce as safely as he/she has been performing in intrastate commerce. Consequently, FMCSA finds that exempting these applicants from the vision requirement in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to that existing without the exemption. For this reason, the Agency is granting the exemptions for the 2-year period allowed by 49 U.S.C. 31136(e) and 31315 to the 20 applicants listed in the notice of February 8, 2016 (81 FR 6573).
We recognize that the vision of an applicant may change and affect his/her ability to operate a CMV as safely as in the past. As a condition of the exemption, therefore, FMCSA will impose requirements on the 20 individuals consistent with the grandfathering provisions applied to drivers who participated in the Agency's vision waiver program.
Those requirements are found at 49 CFR 391.64(b) and include the following:
(1) That each individual be physically examined every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirement in 49 CFR 391.41(b)(10) and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provide a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must have a copy of the certification when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
FMCSA received no comments in this proceeding.
Based upon its evaluation of the 20 exemption applications, FMCSA exempts the following drivers from the vision requirement in 49 CFR 391.41(b)(10), subject to the requirements cited above (49 CFR 391.64(b)):
In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for 2 years unless revoked earlier by FMCSA. The exemption will be revoked if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
If the exemption is still effective at the end of the 2-year period, the person may apply to FMCSA for a renewal under procedures in effect at that time.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 43 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Each group of renewed exemptions are effective from the dates stated in the discussions below. Comments must be received on or before June 8, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Numbers: Docket No. [Docket No. FMCSA-1999-6480; FMCSA-2000-7363; FMCSA-2004-17195; FMCSA-2005-23099; FMCSA-2007-0071; FMCSA-2009-0011; FMCSA-2009-0291; FMCSA-2009-0303; FMCSA-2010-0050; FMCSA-2011-0379; FMCSA-2011-0380; FMCSA-2012-0040; FMCSA-2012-0104; FMCSA-2012-0340; FMCSA-2013-0174; FMCSA-2014-0002; FMCSA-2014-0003; FMCSA-2014-0004; FMCSA-2014-0005], using any of the following methods:
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Christine A. Hydock, Chief, Medical Programs Division, Medical Programs Division, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption from the vision requirements in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381.
This notice addresses 43 individuals who have requested renewal of their exemptions in accordance with FMCSA procedures. FMCSA has evaluated these 43 applications for renewal on their merits and decided to extend each exemption for a renewable two-year period. Each individual is identified according to the renewal date.
The exemptions are extended subject to the following conditions: (1) That each individual has a physical examination every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirements in 49 CFR 391.41(b)(10), and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provides a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retains a copy of the certification on his/her person while driving for presentation to a duly authorized Federal, State, or local enforcement official. Each exemption will be valid for two years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application for additional two year periods. The following group(s) of drivers will receive renewed exemptions effective in the month of June and are discussed below.
As of June 3, 2016, and in accordance with 49 U.S.C. 31136(e) and 31315, the
The drivers were included in one of the following dockets: Docket Nos. FMCSA-1999-6480; FMCSA-2000-7363; FMCSA-2004-17195; FMCSA-2005-23099; FMCSA-2007-0071; FMCSA-2009-0011; FMCSA-2009-0291; FMCSA-2009-0303; FMCSA-2010-0050; FMCSA-2011-0379; FMCSA-2011-0380; FMCSA-2013-0174; FMCSA-2014-0002; FMCSA-2014-0003; FMCSA-2014-0004. Their exemptions are effective as of June 3, 2016 and will expire on June 3, 2018.
As of June 6, 2016, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 3 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (77 FR 23799; 77 FR 33558; 79 FR 27365):
The drivers were included in one of the following dockets: Docket No. FMCSA-2012-0040. Their exemptions are effective as of June 6, 2016 and will expire on June 6, 2018.
As of June 17, 2016, and in accordance with 49 U.S.C. 31136(e) and 31315, the following individual, DelRay V. Ryckman (SD), has satisfied the conditions for obtaining a renewed exemption from the vision requirements (79 FR 27681; 79 FR 38649).
The driver was included in the following docket: Docket No. FMCSA-2014-0005. The exemption is effective as of June 17, 2016 and will expire on June 17, 2018.
As of June 27, 2016, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 5 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (77 FR 27847; 77 FR 38386; 79 FR 29495):
The drivers were included on the following docket: Docket No. FMCSA-2012-0104. Their exemptions are effective as of June 27, 2016 and will expire on June 27, 2018.
Each of the 42 applicants listed in the groups above has requested renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the requirement specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption requirements.
These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
FMCSA will review comments received at any time concerning a particular driver's safety record and determine if the continuation of the exemption is consistent with the requirements at 49 U.S.C. 31136(e) and 31315. However, FMCSA requests that interested parties with specific data concerning the safety records of these drivers submit comments by June 8, 2016.
FMCSA believes that the requirements for a renewal of an exemption under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially granting the renewal and then requesting and evaluating, if needed, subsequent comments submitted by interested parties. As indicated above, the Agency previously published notices of final disposition announcing its decision to exempt these 42 individuals from the vision requirement in 49 CFR 391.41(b)(10). The final decision to grant an exemption to each of these individuals was made on the merits of each case and made only after careful consideration of the comments received to its notices of applications. The notices of applications stated in detail the qualifications, experience, and medical condition of each applicant for an exemption from the vision requirements. That information is available by consulting the above cited
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period. FMCSA may issue a final rule at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, go to
Federal Railroad Administration (FRA), United States Department of Transportation (DOT).
Notice.
Consistent with the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this document provides notice that FRA is submitting the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) to collect information on railroads' implementation of positive train control (PTC) systems on a quarterly form. FRA requests regular processing and OMB authorization to collect the information on the quarterly form identified below 30 days after publication of this notice for a period of three years.
A copy of this ICR, with any public applicable supporting documentation, may be obtained by calling FRA's Office of Safety Information Collection Clearance Officer, Robert Brogan at (202) 493-6292, or FRA's Office of Administration Information Collection Clearance Officer, Kimberly Toone at (202) 493-6132; these numbers are not toll-free; or by contacting Mr. Brogan via facsimile at (202) 493-6216 or Ms. Toone via facsimile at (202) 493-6497, or via email by contacting Mr. Brogan at
Under 49 U.S.C. 20157, as amended by the Positive Train Control Enforcement and Implementation Act of 2015 (PTCEI Act), FRA must conduct compliance reviews, at least annually, to ensure each railroad is complying with its revised PTC implementation plan (PTCIP). The PTCEI Act requires railroads to provide information to FRA that FRA determines is necessary to adequately conduct such compliance reviews.
To effectively monitor industry's implementation of PTC systems, FRA is proposing to require each subject railroad to submit quarterly reports on its implementation progress, in addition to the annual progress reports the PTCEI Act mandated, under FRA's statutory and regulatory investigative authorities.
FRA is proposing that each railroad must submit its quarterly progress reports on Form FRA F 6180.165 using FRA's Secure Information Repository (SIR) at
On March 7, 2016, FRA published a notice in the
On April 19, 2016, FRA held a meeting on the proposed Quarterly PTC Progress Report Form to offer the affected regulated entities a forum to provide additional comments and feedback to FRA. Representatives from, and members of, AAR, APTA, and the American Short Line and Regional Railroad Association (ASLRRA) attended the meeting. FRA will publish minutes from the meeting in the docket as soon as practicable.
FRA received the following summarized comments on the version of the Quarterly PTC Progress Report that FRA proposed on March 7, 2016. 81 FR 11878. FRA has modified the proposed form based on the industry's comments and requests for clarification in those comments and in the meeting discussed above. The revised form that FRA will submit to OMB for review and approval is attached to this notice.
AAR commented that the column heading “Quantity Completed As of Applicable Quarter” in the summary section was unclear and asked FRA to clarify whether that column refers to the quantity completed for the year as of the end of the quarter or just the quantity completed during the particular quarter. In response, FRA modified the heading to read “Cumulative Quantity Completed to Date” to clarify that FRA wants each railroad to provide a running cumulative total in the high-level summary table.
At the public meeting, CSX Transportation, Inc. (CSX) asked whether the row “Locomotives Fully Equipped” refers to locomotives with all necessary hardware installed or to locomotives with all necessary hardware installed that are mission capable and could begin operating in PTC service. FRA added the words “and PTC operable” to clarify its intent.
Additionally, FRA eliminated the rows “Back Office Locations Completely Installed and Fully Operable” and “Dispatching Locations Completely Installed and Fully Operable” from the summary section, as AAR requested.
Because several commenters requested FRA to make the Quarterly PTC Progress Report consistent with the Annual PTC Progress Report FRA published (see
Based on AAR's and ASLRRA's comments at the public meeting that spectrum is difficult to quantify in the manner requested in the proposed form, FRA modified the quarterly form so a railroad can simply identify a spectrum coverage area and select from a dropdown menu the applicable status: Not acquired/not available for use; acquired but not available for use; or acquired and available for use.
AAR asked FRA to clarify whether the section on spectrum is asking for a report about only the spectrum coverage missing and left to acquire or about all spectrum coverage. FRA clarified at the public meeting and in the soon-to-be-posted meeting minutes that a railroad should base its progress report on the information it provided in its revised PTCIP. The PTCEI Act required each railroad to identify in its revised PTCIP the calendar year(s) when spectrum will be acquired and will be available for use in each area as needed for PTC implementation, if such spectrum was
Based on AAR's request, FRA also added a comment box to the spectrum section so railroads can provide additional information or explanation.
AAR, CSX, and Metra commented that FRA should delete the row entitled “Software for Train Management and Other Applications” from the table in Section 3 because software installation is not readily quantifiable. AAR specifically commented that “PTC software is versioned repeatedly over the course of the year with each release of defect remediation and improved functionality.” Based on these concerns, FRA deleted the quantitative category for software installation and instead added a comment box for software, specifically requesting each railroad to “describe (1) the railroad's approach to installation of PTC software on its locomotive fleet, and (2) any issues the railroad is experiencing with installed versions of train management software (
With respect to the locomotive hardware installation table in Section 3, AAR commented that the “number of antennas, event recorders, displays, and other components [including GPS receivers] tells the FRA nothing relevant about how close that railroad is to adding mission-capable locomotives to its fleet.” Balancing FRA's need to monitor railroads' incremental implementation progress with the railroads' request that FRA reduce the reporting burden, FRA decided to modify the form by deleting the categories regarding antennas, GPS receivers, and secondary communications equipment. Moreover, FRA modified the row titles to clarify that a railroad should be reporting in terms of locomotives—for example, the railroad would report the quantity of locomotives with PTC displays installed, not the quantity of PTC displays installed.
The Utah Transit Authority commented that the progress report is geared only towards railroads installing the Interoperable Electronic Train Management System (I-ETMS) and, thus, it is difficult to reflect Utah Transit Authority's own progress implementing a PTC system because it states “N/A” for numerous categories, including spectrum, wayside interface units, and communication towers. FRA notes the PTCEI Act requires quantitative reporting for spectrum and these hardware categories.
The Fort Worth Transportation Authority commented the quantities of back office locations and dispatching locations installed should be only an annual, not quarterly, reporting requirement because these are large and complex installations that may take many months or years to build. More generally, BNSF and ASLRRA commented that neither back office locations nor “physical back office system equipment” (the statutory term) are possible to quantify in a meaningful way because most railroads have only one back office. Based on railroads' annual progress reports, however, FRA knows of at least one Class I railroad and one large passenger railroad that have more than one back office for PTC operations. To simplify the reporting burden, FRA has deleted the multi-faceted quantitative table regarding back office and dispatching locations and instead provided a series of more direct quantitative questions—
With respect to the Infrastructure—Wayside Installations table in Section 3, AAR commented that FRA should measure the hardware installation quantities system-wide, not by track segment, to reflect the railroad's implementation status more accurately. As requested, FRA modified this table to be system-wide, significantly reducing the reporting burden for railroads. In addition, FRA eliminated the quantitative questions regarding ground wiring and modified the row to ask only a yes/no question as in the annual progress report.
Finally, AAR commented that the “Year-to-Date Cumulative Total” is unclear because it could mean either the sum of the current year's progress or a cumulative for all prior years. To resolve the ambiguity, FRA modified the heading to instead state “Sum of Quarterly Totals” so railroads know that the column calls for the sum of the current year's progress. Also, for consistency with the annual progress report form, FRA added a “Cumulative Quantity Installed” column for the tables in Section 3.
AAR commented that FRA should add a “status” column for each row in Section 3 and eliminate the redundancy of Section 4. AAR believes the information could be better organized in one table and thus avoid the need for cross-referencing between the two tables during the review process. However, at the public meeting, AAR acknowledged the preferred modification would be for FRA to eliminate the track segment granularity from Section 3 and leave Section 4 as is. Accordingly, FRA removed the track-segment by track-segment aspect of Section 3, and did not modify Section 4.
Metra commented that, due to limited funding, it does not intend to create Geographic Information System (GIS) shapefiles to support the information request in Section 4 of the form, which stated “For all live segments, please provide GIS shapefile or corresponding data for segments put into operation.” Instead, Metra commented that it could provide the geographic information in table format. FRA has decided to eliminate this particular reporting requirement from the quarterly form. In the annual progress report, FRA intends to clarify that a railroad can provide, for track segments that are operational and complete only, either GIS shapefiles
Metra and AAR commented that the categories in the employee training section should align with the categories in 49 CFR 236.1041. Accordingly, FRA modified the employee categories in the quarterly form to correspond with the regulations, just as it did in the annual form, based on AAR's similar comment. The Fort Worth Transportation Authority also commented that railroads should have to provide employee training updates only annually, not quarterly, and BNSF commented it is difficult to accurately quantify employee training due to hiring, firing, retiring, and so forth. Although FRA acknowledges there might be a certain level of fluidity to employee training, FRA will nonetheless continue to ask for a quantitative update for employee training consistent with the railroad's revised PTCIP.
For consistency with the annual progress report form, FRA added a “Cumulative # of Employees Trained” column to the table in Section 5 and provided a comment box.
No comments were received on the interoperability section of the quarterly progress report form. However, FRA notes it modified this section to align with the revisions it made to this corresponding section in the annual progress report.
AAR commented that its member railroads estimate it will take approximately 40 hours to complete the quarterly progress report form, as opposed to the 1.5 hours that FRA estimated. FRA notes that the 1.57-hour estimate is an average for all railroads. FRA estimated that the quarterly reporting burden is 3 hours for Class I and large passenger railroads, 2 hours for Class II and medium passenger railroads, and .5 hours for Class III, terminal, and small passenger railroads. These estimates take into account that railroads have already completed and provided to FRA the Annual PTC Progress Report, which requests similar types of information as the form for the Quarterly PTC Progress Report, but with more sections. FRA maintains that the average reporting burden for the quarterly form is 1.57 hours, especially as FRA has eliminated portions of the quarterly form initially proposed on March 7, 2016. 81 FR 11878.
Both ASLRRA and the Tri-County Metropolitan Transportation District of Oregon requested clarification about whether only host railroads must submit the quarterly progress reports or whether the reporting requirement also applies to tenant railroads. FRA notes that the annual reporting the PTCEI Act mandated applies to any entity subject to 49 U.S.C. 20157(a), and the scope of this quarterly reporting is the same. A tenant railroad may coordinate with its host railroad to ensure the host railroad captures the tenant railroad's implementation progress in its progress reports.
Once OMB approves this information collection, FRA will provide the Quarterly PTC Progress Report Form to railroads in fillable PDF and Excel formats, which would be available for download on
The associated collection of information is summarized below.
Reporting Burden:
Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b), 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520, 49 U.S.C. 20157(c)(2);
Federal Railroad Administration (FRA), Department of Transportation.
Announcement of Northeast Corridor Safety Advisory Committee (NECSC) meeting.
FRA announces the sixth meeting of the NECSC, a Federal Advisory Committee mandated by section 212 of the Passenger Rail Investment and Improvement Act of 2008 (PRIIA). The NECSC is composed of stakeholders operating on the Northeast Corridor (NEC), and its purpose is to provide annual recommendations to the U.S. Secretary of Transportation. NECSC meeting topics will include the following: Maintenance-of-way fatigue, presentations on the NEC's future and NEC construction projects, Tier III passenger equipment rulemaking, the Confidential Close Call Reporting System (C
The NECSC meeting is scheduled to begin at 9:30 a.m. on Wednesday, May 25, 2016, and will adjourn by 4:30 p.m.
The NECSC meeting will be held at the National Housing Center located at 1201 15th Street NW., Washington, DC 20005. The meeting is open to the public on a first-come, first-served basis and is accessible to individuals with disabilities. Sign and oral interpretation can be made available if requested 10 calendar days before the meeting.
Mr. Larry Woolverton, RSAC Administrative Officer/Coordinator, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6212; or Mr. Robert C. Lauby, Associate Administrator for Railroad Safety and Chief Safety Officer, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6474.
The NECSC is mandated by a statutory provision in section 212 of the PRIIA (codified at 49 U.S.C. 24905(f)). The NECSC is chartered by the U.S. Secretary of Transportation, and is an official Federal Advisory Committee established in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. title 5—Appendix.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS).
Through this NOI, FRA announces its intent to jointly prepare an Environmental Impact Report (EIR) and Environmental Impact Statement (EIS) with the California High-Speed Rail Authority (Authority) for the San Francisco to San Jose Section of the California High-Speed Rail (HSR) System, Blended System Project (Blended System Project or Project). FRA invites the public and all interested parties to provide comments on the scope of the EIR/EIS, including the proposed purpose and need, the alternatives to consider, potential environmental impacts of concern, and methodologies for analysis of impacts. Through this NOI, FRA also rescinds its December 2008 NOI for the San Francisco to San Jose Section.
FRA and the Authority will develop the EIR/EIS in compliance with the California Environmental Quality Act (CEQA) and the National Environmental Policy Act of 1969 (NEPA). FRA and the Authority will hold scoping meetings and outreach activities as part of the NEPA/CEQA process. Federal cooperating agencies for the EIR/EIS are the Surface Transportation Board (STB) and the U.S. Army Corps of Engineers (USACE).
Written comments on the scope of the San Francisco to San Jose Section EIR/EIS must be provided to the Authority by June 8, 2016.
Public scoping meetings are scheduled in May 2016: FRA and the Authority will hold the scoping meetings between 5:00 p.m. and 8:00 p.m. at the following dates:
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The Authority will make scoping materials and information concerning the scoping meetings available on the Authority's Web site:
You can send written comments on the scope to Mr. Mark McLoughlin, Director of Environmental Services, Attention: San Francisco to San Jose Section EIR/EIS, California High-Speed Rail Authority, 770 L Street, Suite 1160, Sacramento, CA 95814, or via email with subject line “San Francisco to San Jose Section EIR/EIS” to:
You may provide comments orally or in writing at scoping meetings. FRA and the Authority will hold the scoping meetings between 5:00 p.m. and 8:00 p.m. at the following locations:
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Ms. Stephanie Perez, Environmental Protection Specialist, Office of Program Delivery, Federal Railroad Administration, 1200 New Jersey Avenue SE., (Mail Stop 20), Washington, DC 20590; Telephone: (202) 493-0388, email:
FRA is an operating administration of the U.S. Department of Transportation and is responsible for overseeing the safety of railroad operations, including the safety of any proposed high-speed ground transportation system. FRA is also authorized to provide, subject to appropriations, funding for high-speed and intercity passenger rail projects and is also authorized to provide loans and other financial support for railroad investments. FRA is conducting this review under NEPA because it may provide funding or financing for this project in the future. STB and USACE are Federal cooperating agencies on the EIS. STB has approval authority under
The Authority was established in 1996 and is authorized and directed by statute to undertake the planning and development of a proposed statewide HSR network fully coordinated with other public transportation services. In 2005, the Authority and FRA completed a Final Program EIR/EIS for the Proposed California HSR System (Statewide Program EIR/EIS), as the first phase of a tiered environmental review process. The Statewide Program EIR/EIS analyzed a No Project/No Action Alternative; a Modal Alternative involving expanding freeways, airports, and conventional rail systems; and a HSR alternative using electric propulsion and steel-wheel-on-steel-rail vehicles capable of operating speeds of 220 mph on fully grade separated rail alignments with state-of-the-art safety, signaling, and communication systems. The Authority certified the Statewide Program EIR under CEQA and approved the proposed HSR System, and FRA issued a Record of Decision under NEPA on the Statewide Program EIS.
In approving the Statewide Program EIR/EIS, FRA and the Authority selected the HSR Alternative for intercity travel in California between the major metropolitan centers of Sacramento and the San Francisco Bay Area in the north, through the Central Valley, to Los Angeles and San Diego in the south. The Authority and FRA also selected certain corridors/general alignments and general station locations for further study; committed to mitigation strategies and design practices; and specified further measures to guide the development of the HSR system at the site-specific project level of environmental review to avoid and minimize potential adverse environmental impacts. FRA and the Authority did not select corridors or station locations between the Central Valley and the Bay Area in 2005. Rather, they decided to prepare a second program EIR/EIS for that area.
In 2008, the Authority and FRA further evaluated alignments and station locations within the broad corridor between and including the Altamont Pass and the Pacheco Pass to connect the Bay Area and Central Valley portions of the HSR system in the Bay Area to the Central Valley High-Speed Train Program EIR/EIS. Based on that EIR/EIS, the Authority and FRA selected the Pacheco Pass—San Francisco and San Jose termini network alternative, including corridor alignments and station location options. The selected corridor alignment uses the Caltrain rail right-of-way, between San Francisco and San Jose along the San Francisco Peninsula, and the Pacheco Pass via Henry Miller Road, between San Jose and the Central Valley.
In December 2008, the Authority and FRA respectively issued a notice of preparation and notice of intent to prepare an EIR/EIS for the project-level San Francisco to San Jose Section of the proposed California HSR System. In 2009, the Authority and FRA completed project scoping and provided the public with alternatives screening documents. These alternatives screening documents were for a rail corridor based on an entirely grade separated a four-track system between San Francisco and San Jose where HSR would share tracks with Caltrain express commuter trains. Communities along the Caltrain corridor expressed concerns with this proposal because of the perceived magnitude of impacts to environmental and community resources. In response to these concerns, the Authority suspended further work on the EIR/EIS in mid-2011 to consider blending the HSR and Caltrain operations within a smaller project footprint. In November 2011, the Authority proposed blended operations for the HSR section between San Francisco and San Jose, which would still provide HSR and Caltrain service between the two cities without requiring a four-track system for the Project.
The San Francisco to San Jose Section EIR/EIS will describe the Blended System Project in detail, identify site-specific environmental impacts from construction, operation, and maintenance of the Blended System Project; identify specific mitigation measures to address those impacts; and incorporate appropriate design practices to avoid and minimize potential adverse environmental impacts. The EIR/EIS will describe the site characteristics, size, nature, and timing of the proposed action as a basis for determining whether the impacts are potentially significant and whether impacts can be avoided, minimized, or mitigated. The Authority will provide information and documents regarding this EIR/EIS on the Authority's Web site:
The San Francisco to San Jose Section EIR/EIS will tier from, and build upon, the Statewide Program EIR/EIS and the Bay Area to Central Valley HSR Program EIR/EIS consistent with Council on Environmental Quality (CEQ) regulations, (40 CFR 1508.28) and State CEQA Guidelines (14 California Code of Regulations 15168(b)).
In addition to the NEPA and CEQA process, the Authority is required by law to publish a Business Plan, updated every two years, which includes a description of service type, chronology of statewide construction, estimate of capital costs per segment, operating and maintenance costs, environmental review schedule, and discussion of public and private funding availability. The Draft 2016 Business Plan, which the Authority released in February, describes a phased implementation of the statewide HSR system. The Draft 2016 Plan prioritizes construction between San Jose and the Central Valley, but also emphasizes the importance of extending HSR service from San Francisco to San Jose as soon as possible.
The purpose of the proposed HSR system is to provide a new mode of high-speed intercity travel that would link major metropolitan areas of the state; interface with international airports, mass transit, and highways; and provide added capacity to meet increases in intercity travel demand in California in a manner sensitive to and protective of California's unique natural resources. The need for a HSR system is directly related to the expected growth in population, and increases in intercity travel demand in California over the next twenty years and beyond. With the growth in travel demand, there will be an increase in travel delays arising from the growing congestion on California's highways and at airports. In addition, there will be negative effects on the economy, quality of life, and air quality in and around California's metropolitan areas from a transportation system that will become less reliable as travel demand increases. The intercity highway system, commercial airports, and conventional passenger rail serving the intercity travel market are currently operating at or near capacity, and will require large public investments for maintenance and expansion to meet existing demand and future growth. The proposed HSR System is designed to address some of the social, economic, and environmental problems associated with transportation congestion in California.
The San Francisco to San Jose Section meets this purpose and need by:
• Connecting the San Francisco Bay Area to the rest of the statewide HSR system, including the Central Valley and Southern California;
• Incorporating HSR into the intermodal hubs at San Francisco, Millbrae and San Jose, thereby providing interfaces with airports (San
• Serving a large base of riders in the densely populated San Francisco and San Jose metropolitan areas; and
• Reaching station locations with existing and planned transit oriented development potential.
The San Francisco to San Jose Section EIR/EIS will consider a No Action or No Project Alternative and one or more HSR Alternatives for the San Francisco to San Jose corridor. The San Francisco to San Jose Section of the HSR system would connect to the San Jose to Merced Section at Diridon Station, which would extend HSR service from the San Francisco Bay Area to the Central Valley and Southern California.
The No Action Alternative (No Project or No Build) represents conditions in the San Francisco to San Jose corridor as they exist in 2016, and as they would exist in future years based on projected growth, programmed and funded improvements to the intercity transportation system, and other reasonably foreseeable projects through the implementation of Phase 1 operations in 2029, and a future year of operation in 2040. The No Action alternative takes into account the following sources of information: State Transportation Improvement Program; Regional Transportation Plans for all modes of travel; airport plans; intercity passenger rail plans; and city and county plans.
The Blended System Project would follow the Caltrain right-of-way from San Francisco to San Jose. It would utilize existing and in-progress infrastructure Caltrain developed for its electrification project, but require construction in addition to electrification. The Blended System Project is anticipated to include the following, subject to continued planning and engineering following the scoping/outreach process:
• Track improvements to support higher speeds, including upgrades of tracks, trackbeds, ties, interlockings, and possible curve straightening;
• At least one passing track, with potential alternative locations for the passing track;
• One terminal storage maintenance facility, with potential alternative locations;
• Improvements to existing bridges necessary to accommodate mixed traffic;
• Potential grade separations necessary to support blended operations; and
• Installation of quad gates at remaining grade crossings.
• High-speed rail vehicles operating over mostly the same tracks between San Francisco and San Jose;
• Speeds of up to 110 miles per hour; and
• Operations plan that would allow for up to 4 HSR vehicles per hour/per direction in the peak period.
• Raised and straightened platforms, platform screens (or other safety features) and passenger facilities at 4th & King, Millbrae and Diridon stations.
• The Authority proposes its Blended System Project will reach the TTC in San Francisco via the planned 1.3-mile extension of passenger rail track from the current terminus at the Caltrain 4th and King station.
• The Transbay Joint Powers Authority is the state lead agency for both projects, which have been the subject of separate environmental review.
• The TTC is currently under construction. The DTX is not yet under construction.
• Both projects will be addressed in the San Francisco to San Jose Section EIR/EIS.
The EIR/EIS will evaluate and document the effects of the proposed project on the physical, human, and natural environment. FRA and the Authority will continue the tiered evaluation of all potentially significant environmental, social, and economic impacts of the construction and operation of the HSR system. The San Francisco to San Jose EIR/EIS will address appropriate resource areas including: Transportation, including impacts on existing passenger and freight rail tenants; safety and security; land use and zoning; land acquisition, displacements, and relocations; cumulative and secondary impacts; cultural resource impacts, including impacts on historical and archaeological resources; parklands/recreation areas; neighborhood compatibility and environmental justice; geology and paleontology impacts; natural resource impacts including air quality, wetlands, water resources, noise and vibration, energy, wildlife and ecosystems, including endangered species, energy and hazardous materials. The EIR/EIS will also identify and evaluate measures to avoid, minimize, and mitigate adverse impacts.
The San Francisco to San Jose Section EIR/EIS will be prepared consistent with FRA's Procedures for Considering Environmental Impacts (64 FR 28545, May 26, 1999) and the CEQ's regulations implementing NEPA at 40 CFR parts 1500-1508. The San Francisco to San Jose Section EIR/EIS also will address, as necessary, other applicable statutes, regulations, and executive orders, including the Clean Air Act, Section 106 of the National Historic Preservation Act (Section 106) of 1966, Section 4(f) of the Department of Transportation Act, the Endangered Species Act, and Executive Order 12898 on Environmental Justice.
FRA funding or approval of the San Francisco to San Jose Section would be a Federal undertaking with the potential to affect historic properties. As such, it is subject to the requirements of Section 106. Consistent with the Advisory Council on Historic Preservation's (ACHP) regulations implementing Section 106, FRA intends to coordinate compliance with Section 106 of this Act with the preparation of the San Francisco to San Jose Section EIR/EIS, beginning with the identification of consulting parties in a manner consistent with the standards set out in 36 CFR 800.8. Under the Programmatic Agreement among FRA, ACHP, the California State Historic Preservation Officer, and the Authority, FRA and the Authority will conduct a phased review of effects on historic properties consistent with 36 CFR 800.4(b)(2). FRA invites the public and interested parties to provide comments on the potential effects of the proposed alternatives on historic properties within the San Francisco to San Jose Section. In
FRA encourages broad participation in the EIS process during scoping and review of the resulting environmental documents. FRA invites Native American Tribes, interested agencies, and the public at large to participate in the scoping process to ensure the EIR/EIS addresses the full range of issues related to the proposed action and reasonable alternatives, and that all significant issues are identified. FRA requests that any public agency having jurisdiction over an aspect of the Project identify the applicable permit and environmental review requirements of the agency and the scope and content of the environmental information germane to the agency's jurisdiction over the Project. Public agencies are requested to advise FRA if they anticipate taking a major action in connection with the proposed project and if they wish to participate as a cooperating agency for the San Francisco to San Jose Section EIR/EIS.
FRA and the Authority have scheduled public scoping meetings which are an important component of the scoping process for both the State and Federal environmental review. The Authority will advertise the scoping meetings described in this NOI locally and be included with any additional public notification.
Federal Transit Administration, DOT.
Notice of request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to renew the following information collection:
49 U.S.C. Section 5337, the State of Good Repair Grants Program was authorized by Moving Ahead for Progress in the 21st Century (MAP-21). It was reauthorized under the Fixing America's Surface Transportation (FAST) Act Section 3015. This program authorizes the Secretary of Transportation to make grants to designated recipients to maintain, replace, and rehabilitate high intensity fixed guideway systems and high intensity motorbus systems. Eligible recipients include state and local government authorities in urbanized areas with high intensity fixed guideway systems and/or high intensity motorbus systems operating for at least seven years. Projects are funded at 80 percent federal with a 20 percent local match requirement by statute. FTA will apportion funds to designated recipients. The designated recipients will then allocate funds as appropriate to recipients that are public entities in the urbanized areas. FTA can make grants to direct recipients after sub- allocation of funds. Recipients apply for grants electronically, and FTA collects milestone and financial status reports from designated recipients on a quarterly basis. The information submitted ensures FTA's compliance with applicable federal laws.
Comments must be submitted before July 8, 2016.
To ensure that your comments are not entered more than once into the docket, submit comments identified by the docket number by only one of the following methods:
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Mr. Eric Hu, Office of Program Management (202) 366-0870, or email:
Interested parties are invited to send comments regarding any aspect of this information collection, including: (1) The necessity and utility of the information collection for the proper performance of the functions of the FTA; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the collected information; and (4) ways to minimize the collection burden without reducing the quality of the collected information. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection.
Federal Transit Administration, DOT.
Notice of request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to renew the following information collection:
49 U.S.C. Section 5339—Bus and Bus Facilities Formula Program, was originally authorized by the Moving Ahead for Progress in the 21st Century (MAP-21). The program was reauthorized under the Fixing America's Surface Transportation (FAST) Act Section 3017. This program authorizes the Secretary of Transportation to provide funding to replace, rehabilitate and purchase buses and related equipment and to construct bus-related facilities including technological changes or innovations to modify low or no emission vehicles or facilities.
Funding is provided through formula allocations and competitive grants. Two competitive grant programs were added: 5339(b) for bus and bus facility projects and 5339(c) for bus and bus facility projects that support low and zero-emission vehicles. Eligible recipients include 5307 Direct Recipients, States and Federally Recognized Tribes. Eligible sub-recipients include those recipients that receive a grant under the formula or discretionary programs and may allocate amounts from the grant to sub-recipients that are public agencies or private nonprofit organizations engaged in public transportation.
Recipients apply for grants electronically and FTA collects milestone and financial status reports from designated recipients and states on a quarterly basis. The information submitted ensures FTA's compliance with applicable federal laws.
Comments must be submitted before July 8, 2016.
To ensure that your comments are not entered more than once into the docket, submit comments identified by the docket number by only one of the following methods:
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2.
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Samuel Snead, Office of Program Management (202) 366-1089, or email:
Interested parties are invited to send comments regarding any aspect of this information collection, including: (1) The necessity and utility of the information collection for the proper performance of the functions of the FTA; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the collected information; and (4) ways to minimize the collection burden without reducing the quality of the collected information. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection.
Department of Veterans Affairs.
Notice.
The purpose of this notice is to inform the public of the increase in the Post-9/11 GI Bill maximum tuition and fee amounts payable and the increase in the amount used to determine an individual's entitlement charge for reimbursement of a licensing, certification, or national test for the 2016-2017 academic year (August 1, 2016-July 31, 2017).
Schnell Carraway, Management and Program Analyst, Education Service (225C), Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, Telephone: (202) 461-9800. (This is not a toll-free number.)
For the 2015-2016 academic year (August 1, 2015-July 31, 2016), the Post-9/11 GI Bill allowed VA to pay the actual net cost of tuition and fees not to exceed the in-state amounts for students pursuing training at public schools: $21,084.89 for students training at private and foreign schools, $12,048.50 for students training at vocational flight schools, and $10,241.22 for students training at correspondence schools. Additionally, the entitlement charge for individuals
Sections 3313, 3315, and 3315A of title 38, United States Code (U.S.C.), direct VA to increase the maximum tuition and fee payments and entitlement-charge amounts each academic year (begins August 1st) based on the most recent percentage increase determined under 38 U.S.C. 3015(h). The percentage increase determined under 38 U.S.C. 3015(h) is effective October 1st of each year. The most recent percentage increase determined under 38 U.S.C. 3015(h) was a 4.2-percent increase, which was effective October 1, 2015.
The maximum tuition and fee payments and entitlement-charge amounts for training pursued under the Post-9/11 GI Bill beginning after July 31, 2016, and before August 1, 2017, are listed below. VA's calculations for the 2016-2017 academic year are based on the 4.2-percent increase.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert D. Snyder, Chief of Staff, Department of Veterans Affairs, approved this document on April 11, 2016, for publication.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 27, 2016.
In commenting, please refer to file code CMS-5517-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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Please allow sufficient time for mailed comments to be received before the close of the comment period.
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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, call telephone number (410) 786 7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Molly MacHarris, (410) 786-4461, for inquiries related to MIPS.
James P. Sharp, (410) 786-7388, for inquiries related to APMs.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Because of the many terms to which we refer by acronym in this proposed rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015), amended title XVIII of the Social Security Act (the Act) to repeal the Medicare sustainable growth rate and strengthen Medicare access by improving physician payments and making other improvements, to reauthorize the Children's Health Insurance Program (CHIP), and for other purposes. This rule is needed to propose policies to improve physician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in alternative payment models.
This proposed rule would establish the Merit-Based Incentive Payment System (MIPS), a new program for certain Medicare-participating practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for eligible professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs), supporting the Administration's goals of moving more fee-for-service payments into APMs that focus on better care, smarter spending, and healthier people. This proposed rule also includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations to the Secretary on physician-focused payment models (PFPMs).
In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders. We discuss these terminology changes in greater detail in the following sections of this proposed rule.
This proposed rule would sunset payment adjustments under the current PQRS, VM, and the Medicare EHR Incentive Program for EPs. Components of these three programs would be carried forward into the new MIPS program.
This proposed rule would establish a new subpart O of our regulations at 42 CFR 414.1300 to implement the new MIPS program as required by the MACRA.
In establishing MIPS, this rule would define MIPS program participants as “MIPS eligible clinicians” rather than “MIPS EPs” as that term is defined at section 1848(q)(1)(C) and used throughout section 1848(q) of the Act. MIPS eligible clinicians will include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians. The rule proposes definitions and requirements for groups. In addition to proposing definitions for MIPS eligible clinicians, the rule also proposes rules for the specific Medicare-enrolled practitioners that would be excluded from MIPS, including newly Medicare-enrolled eligible clinicians, Qualifying APM Participants (QPs), certain Partial Qualifying APM Participants (Partial QPs), and clinicians that fall under the proposed low-volume threshold.
This rule proposes MIPS performance standards and a MIPS performance period of 1 calendar year (January 1 through December 31) for all measures and activities applicable to the four performance categories. Further, we propose to use 2017 as the performance period for the 2019 payment adjustment. Therefore, the first performance period would start in 2017 for payments adjusted in 2019. This time frame is needed to allow data and claims to be submitted and data analysis to occur. In addition, it would allow for a full year of measurement and sufficient time to base adjustments on complete and accurate information.
As directed by the MACRA, this rule proposes measures, activities, reporting, and data submission standards across four performance categories: Quality, resource use, clinical practice improvement activities (CPIAs), and meaningful use of certified EHR technology (referred to in this proposed rule as “advancing care information”). Measures and activities would vary by category and include outcome measures, performance measures, and global and population-based measures. Consideration would be given to the application of measures to non-patient facing MIPS eligible clinicians.
Quality measures would be selected annually through a call for quality measures process. Selection of these measures is proposed to be based on certain criteria that align with CMS priorities, and a final list of quality measures will be published in the
Within each performance category, we propose some specific standards, including:
• Quality: For most MIPS eligible clinicians, we propose to include a minimum of six measures with at least one cross-cutting measure (for patient-facing MIPS eligible clinicians) and an outcome measure if available; if an outcome measure is not available, then the eligible clinician would report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. MIPS eligible clinicians can meet this criterion by selecting measures either individually or from a specialty-specific measure set.
• Resource Use: Continuation of two measures from the VM: Total per costs capita for all attributed beneficiaries and Medicare Spending per Beneficiaries (MSPB) with minor technical adjustments. In addition, episode-based measures, as applicable to the MIPS eligible clinician.
• CPIA: We generally encourage but are not requiring a minimum number of CPIAs.
• Advancing Care Information: Assessment based on advancing care information measures and objectives.
We propose standards for measures, scoring, and reporting for MIPS eligible clinicians across all four performance categories outlined in this section. We propose that MIPS eligible clinicians who participate in certain types of APMs will be scored using an APM scoring standard instead of the generally applicable MIPS scoring standard.
The U.S. Department of Health & Human Services' (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) is conducting studies and making recommendations on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act) and expects to issue a report to Congress by October 2016. We will closely examine the recommendations issued by ASPE and incorporate them, as feasible and appropriate, in future rulemaking.
We are proposing MIPS eligible clinicians have the flexibility to submit information individually or via a group or an APM Entity group; however, the MIPS eligible clinician would use the same identifier for all performance categories. The proposed scoring methodology has a unified approach across all performance categories, would allow MIPS eligible clinicians to know in advance what they need to do to perform well in MIPS, and eliminates the need for an “all or nothing” scoring as has been the case under some other CMS programs. The four performance category scores (quality, resource use, CPIA, and advancing care information) would be aggregated into a MIPS composite performance score (CPS). The MIPS CPS would be compared against a MIPS performance threshold. The CPS would be used to determine whether a MIPS eligible clinician receives an upward payment adjustment, no payment adjustment, or a downward payment adjustment as appropriate. Payment adjustments would be scaled for budget neutrality, as required by statute. The CPS would also be used to determine whether a MIPS eligible clinician qualifies for an additional positive adjustment factor for exceptional performance.
To ensure that MIPS results are useful and accurate, we propose a process for providing performance feedback to MIPS eligible clinicians. Beginning July 1, 2017, we propose to include information on the quality and resource use performance categories in the performance feedback. Initially, we propose to provide performance feedback on an annual basis. In future years, we may consider providing performance feedback on a more frequent basis as well as adding feedback on the performance categories of CPIA and advancing care information. We propose to make performance feedback available using a CMS designated system. Further, we propose to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians where applicable.
We propose to adopt a targeted review process under MIPS wherein a MIPS eligible clinician may request that we review the calculation of the MIPS adjustment factor and, as applicable, the calculation of the additional MIPS adjustment factor applicable to such MIPS eligible clinician for a year. We further propose a general process by which a MIPS eligible clinician could request targeted review.
We propose requirements for third-party data submission to MIPS. Specifically, qualified registries, QCDRs, health IT vendors, and CMS-approved survey vendors would have the ability to act as intermediaries on behalf of MIPS eligible clinicians and groups for submission of data to us across the quality, CPIA, and advancing care information performance categories.
We also propose a process for public reporting of MIPS information through the Physician Compare Web site. We propose public reporting of a MIPS eligible clinician's data; in that for each program year, we will post on a public Web site (for example, Physician Compare), in an easily understandable format, information regarding the performance of MIPS eligible clinicians or groups under the MIPS.
In this rule, we propose standards we would use for the purposes of the Alternative Payment Model (APM) incentive. The MACRA defines APM for the purposes of the incentive as a model under section 1115A of the Social Security Act (the Act) (excluding a health care innovation award), the Shared Savings Program under section 1899 of the Act, a demonstration under section 1866C of the Act, or a demonstration required by federal law. We propose to define the term “Other Payer APMs” to refer to arrangements in which eligible clinicians may participate through other payers. We also propose to define the term APM Entity as an entity that participates in an APM through a contract with a payer.
APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians can become QPs and earn incentive payments for participation in APMs as specified under the MACRA. This rule proposes two types of Advanced APMs: Advanced APMs and Other Payer Advanced APMs. To be an Advanced APM, an APM must meet three requirements: (1) Require participants to use certified EHR technology; (2) provide payment for covered professional services based on quality
To be an Other Payer Advanced APM, a commercial or Medicaid APM must meet three requirements similar to the CMS Advanced APM requirements: (1) Require participants to use certified EHR technology; (2) provide payment based on quality measures comparable to those used in the quality performance category of MIPS; and (3) be either a Medicaid Medical Home Model that is comparable to Medical Home Models expanded under section 1115A of the Act or bear more than a nominal amount of risk for monetary loses.
We propose that we would notify the public of which APMs will be Advanced APMs prior to each QP Performance Period, starting no later than January 1, 2017. This information will be posted on our Web site.
We propose that professional services furnished at Critical Access Hospitals (CAHs), Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) that meet certain criteria be counted towards the QP determination.
The MACRA sets a Medicare threshold for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. The Medicare Option, based on Part B payments for covered professional services or counts of patients furnished covered professional services under Part B, is applicable beginning with CY 2019. The All-Payer Combination Option, based on the Medicare Option, as well as an eligible clinician's participation in Other Payer Advanced APMs, is applicable beginning with CY 2021. For eligible clinicians to become QPs through the All-Payer Combination Option, an Advanced APM Entity or eligible clinician must submit information to us so that we can determine whether an Other Payer APM is an Other Payer Advanced APM and whether an eligible clinician meets the requisite QP threshold of participation. We propose a methodology and criteria to evaluate eligible clinicians using the All-Payer Combination Option. For purposes of evaluating Other Payer APMs, we also propose criteria for the definition of Medicaid Medical Homes and Medical Home Model.
We propose to identify individual eligible clinicians by a unique APM participant identifier using the individuals' TIN/NPI combinations, and to assess as an APM Entity group all individual eligible clinicians listed as participating in an Advanced APM Entity to determine QP status for a year. We also propose that if an individual eligible clinician who participates in multiple Advanced APM Entities does not achieve QP status through participation in any single APM Entity, we would assess the eligible clinician individually to determine QP status based on combined participation in Advanced APMs.
We propose the method that CMS would use to calculate and disburse the APM Incentive Payments to QPs. We propose specific rules for calculating the APM Incentive Payment when a QP also receives non-fee-for-service payments or payment adjustments through the Medicare EHR Incentive Program, PQRS, VM, MIPS, or other payment adjustment programs.
We propose a process for eligible clinicians to choose whether or not to be subject to the MIPS payment adjustment in the event that they are determined to be Partial QPs.
We propose that we would perform monitoring and compliance around APM Incentive Payments.
We propose a definition for Physician-Focused Payment Models (PFPMs), criteria that would be used by the PFPM Technical Advisory Committee (PTAC), the Secretary, and CMS to evaluate proposals for PFPMs, and the process by which PFPMs would be considered for testing and implementation by CMS after review by the PTAC.
We propose to require MIPS eligible clinicians, as well as EPs, eligible hospitals, and Critical Access Hospitals (CAHs) under the existing EHR Incentive Programs to make a demonstration related to the provisions concerning blocking the sharing of information under section 106(b)(2) of the MACRA and, separately, to demonstrate cooperation with authorized ONC surveillance of certified EHR technology.
Under the MACRA's requirements, MIPS would distribute payment adjustments to between approximately 687,000 and 746,000 eligible clinicians in 2019. Payment adjustments would be based on MIPS eligible clinicians' performance on specified measures and activities within the four performance categories. We estimate that MIPS payment adjustments would be approximately equally distributed between negative adjustments ($833 million) and positive adjustments ($833 million) to MIPS eligible clinicians, to ensure budget neutrality. Additionally, MIPS would distribute approximately $500 million in exceptional performance payments to MIPS eligible clinicians whose performance exceeds a specified threshold. These payment adjustments are expected to drive quality improvement in the provision of MIPS eligible clinicians' care to Medicare beneficiaries and to all patients in the health care system. However, the distribution could change based on the final population of MIPS eligible clinicians for CY 2019 and the distribution of scores under the program.
We estimate that between approximately 30,658 and 90,000 eligible clinicians would become QPs through participation in Advanced APMs, and are estimated to receive between $146 million and $429 million in APM Incentive Payments for CY 2019. As with MIPS, we expect that APM participation would drive quality improvement for clinical care provided to Medicare beneficiaries and to all patients in the health care system.
In January 2015, the Administration announced new goals for transforming Medicare by moving away from traditional fee-for-service payments in Medicare towards a payment system focused on linking physician reimbursements to quality care through APMs (
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) of 2015 (Pub. L. 114-10, enacted April 16, 2015, and hereafter referred to as the MACRA), landmark bipartisan legislation, advances a forward-looking, coordinated framework for health care providers to successfully take part in the CMS Quality Payment Program that rewards value and outcomes in one of two ways:
• Merit-Based Incentive Payment System (MIPS).
• Advanced Alternative Payment Models (Advanced APMs).
The Department is focused on three core strategies to drive continued progress and improvement, and MACRA provides new tools to that end, which build upon existing efforts, such as the CMS Quality Strategy
• Quality.
• Resource use.
• CPIA.
• Advancing care information.
Second, we are focused on improving the way care is delivered by providing clinical practice support, data and feedback reports to guide improvement and better decision-making. Allowing for stronger, real-time, easy-to-understand feedback and actionable data on eligible clinician performance on clinical quality measures (CQMs), utilization of resources and cost can lead to stronger care coordination, help facilitate and enhance team-based approaches, and support greater integration within practices, improved patient communication, a stronger focus on population health, and continuous learning and rapid-cycle improvement.
Third, we are focused on making data more available and enabling the use of certified EHR technology to support care delivery. Consistent use of certified EHR technology and clinical quality measurement in managing patient populations would help lead to substantial improvements in our health care system, by allowing clinicians to track and take care of their patients throughout the care continuum and to easily and securely access electronic health information to support care when and where it is needed.
By driving significant changes in how care is delivered and changes in the health care system to make it more responsive to patients and families, we believe the Quality Payment Programs would encourage eligible clinicians to be accountable for the health of their patient population and support interested eligible clinicians in their successful transition into APMs. To implement this vision, we propose a program that allows for stronger alignment across requirements while minimizing burden on eligible clinicians. Further, we propose a program that is meaningful, understandable and flexible with a critical focus on transparency, effective communication with stakeholders and operational feasibility. To aid in this process, we have sought feedback from the health care community through various public avenues and will seek comment through this proposed rule. As we establish policies for effective implementation of the MACRA, we are also focused on improving the health system by ensuring that our policies can scale in future years. As we drive change through this proposed rule, we will begin by laying the groundwork for expansion towards an innovative, outcome-focused, patient-centered, resource-effective health system. Through a staged approach we can develop our policies are operationally feasible and made in consideration of system capabilities and of our core strategies to drive progress and reform efforts.
Medicare payment systems have undergone significant changes since the Act established the Medicare program in 1965. Originally, Medicare was modeled on the existing health insurance marketplace (See 1965 Medicare Amendment to SSA, Pub. L. 89-97). Medicare payments to physicians and hospitals were based on the amounts that had been historically charged by physicians and hospitals for various health care services. Medicare initially paid for physicians' services using a “customary, prevailing, and reasonable” charge (CPR) payment system. (1965 Medicare Amendment to SSA, Pub. L. 89-97). Congress later changed the CPR system in part to counter increased charges to physicians, leading to rapid increases in program payments.
In 1984, Medicare changed the way it paid hospitals to a prospective payment system (Social Security Amendments of 1983, Pub. L. 98-21) that moved away from a charge-based per diem rate and introduced the Medicare Economic Index (MEI) to modify physician payment. The MEI was used to measure the annual increase in practice costs for updating payment for physicians' services.
Beginning in 1992 following the passage of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) (Pub. L. 101-239, enacted on December 19, 1989), the historical charge-based fee schedule was replaced with a fee schedule that used a Resource-Based Relative Value Scale, developed at Harvard University, which attempted to assess for each service the relative value of a physician's work effort, as well as the practice expenses and malpractice liability expenses involved.
Under OBRA 89, the resource-based Medicare PFS aimed to establish a rational basis for valuing payments for physicians' services. Therefore, under the current resource-based approach, payment for a service depends on the value of the resources involved in performing a particular service.
Following the implementation of the resource-based PFS over several years, the fee schedule has specified Medicare payments for physicians' services. Each medical, surgical and diagnostic service, described by a current procedural terminology (CPT) code is assigned relative value units (RVUs) for three resource categories: Work, practice expense, and malpractice expense. These three RVU values are summed, geographically adjusted, and multiplied by a fixed-dollar conversion factor for the payment year to determine the payment amount for each service or procedure. Over time, we have reviewed and revised the RVU values using our own methodologies and other information.
After the adoption of the resource-based PFS, further amendments to the Act have led to the imposition of spending targets for physicians' services. Initially, the spending limit was set by a Volume Performance Standard (VPS) that tied the annual update to a target that was based on historical trends in physician costs. Because of the way the adjustment was
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) replaced the VPS with the SGR formula to update the PFS each year. Under BBA, the SGR made several changes including a much more aggressive measure to control spending, tying the allowable increases in physician spending to the growth rate in real GDP per capita. In general, under the SGR formula, if cumulative expenditures from the current period going back to 1996 (the base year) were less than the cumulative spending target over that same period, the annual update was increased according to a statutory formula. However, if spending exceeded the cumulative spending target over the same period, the SGR methodology requires reductions in the fee schedule update to bring spending back in line with the targeted growth rate.
In the initial years of implementation, actual expenditures did not exceed allowed targets. But beginning in 2002, cumulative actual expenditures began to exceed allowed targets for the year, resulting in SGR-mandated reductions in the fee schedule update adjustment factor. The Congress enacted a series of laws to override these reductions. The SGR-based update adjustment factor had not been allowed to take effect since 2003 due to consistent intervention by the Congress to avert payment reductions.
Currently, payments under the Medicare PFS include several payment adjustments that increase or decrease payments to practitioners based on performance. The Tax Relief and Health Care Act of 2006 required the establishment of the PQRS that would include an incentive payment to EPs who satisfactorily report data on quality measures. The Medicare Improvements for Patients and Provider Act of 2008 (MIPPA) (Pub. L. 110-275, enacted on July 15, 2008) made the PQRS program permanent. The HITECH Act of 2009, part of the American Recovery and Reinvestment Act (ARRA), established incentive payments to EPs to promote the adoption and meaningful use of certified EHR technology. HITECH provided the statutory basis for the Medicare incentive payments made to meaningful EHR users and also established downward payment adjustments, under Medicare, beginning with calendar year 2015, for EPs that are not meaningful users of certified EHR technology for certain associated reporting periods.
The Affordable Care Act (Pub. L. 111-148) required the establishment of a value-based payment modifier that provides for differential payment to a physician or group of physicians under the Medicare PFS based upon the quality of care furnished compared to cost, that is implemented in a budget-neutral manner. Beginning in 2015, the VM applies to payments for items and services furnished by physicians in groups of 100 or more, and will apply to all physicians and certain types of non-physician practitioners in later years. The VM is being phased in and will apply to all physicians in groups and individual physicians in 2017.
The policies proposed in this rule are intended to continue to move Medicare away from a primarily volume based fee-for-service (FFS) payment system for physicians and other professionals. As described in this section of the proposed rule, for many years Medicare was primarily a FFS payment system that paid health care providers based on the volume of services they delivered, rather than the value of those services. This contributed to increased costs without incentivizing improvement in the quality of care. Over time, the Congress and CMS have taken progressive steps to move toward paying for value, as demonstrated by Medicare's long history of testing alternative payment methods.
Medicare has been testing alternative payment methods since waiver authority for Medicare demonstrations was granted through section 402 of the Social Security Amendments of 1967. Demonstrations and pilot programs, (also called “research studies”) are special projects that test improvements in Medicare coverage, payment, and quality of care (
The Affordable Care Act includes a number of provisions, for example, the Medicare Shared Savings Program, designed to improve the quality of Medicare services, support innovation and the establishment of new payment models, better align Medicare payments with health care provider costs, strengthen Medicare program integrity, and put Medicare on a firmer financial footing.
The Affordable Care Act created the Center for Medicare and Medicaid Innovation (Innovation Center). The Innovation Center was established by section 1115A of the Act (as added by section 3021 of the Affordable Care Act). The Innovation Center's mandate gives it flexibility within the parameters of section 1115A of the Act to select and test promising innovative payment and service delivery models. 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 provided to those individuals who receive Medicare, Medicaid, or CHIP benefits.
To better coordinate these models and demonstration projects and to avoid duplicative efforts and expenses, the former Office of Research, Development and Information, which oversaw statutory demonstrations and those under section 402 etc., was merged with the Innovation Center in early 2011. As a result, the Innovation Center oversees not only initiatives that are authorized under section 1115A of the Act, but also activities under several other authorities, including other provisions of the Affordable Care Act, and other laws and projects authorized by section 402 of the Social Security Amendments of 1967, as amended.
The Innovation Center's portfolio of models has attracted participation from a broad array of health care providers, states, payers, and other stakeholders, and serves Medicare, Medicaid, and CHIP beneficiaries in all 50 states, the District of Columbia, and Puerto Rico. We estimate that over 4.7 million Medicare, Medicaid, and CHIP beneficiaries are or soon will be receiving care furnished by the more than 61,000 eligible clinicians participating in APMs tested by the CMS Innovation Center.
Beyond the care improvements for these beneficiaries, Innovation Center models are affecting millions of additional Americans by engaging thousands of other health care providers, payers, and states in model tests and through quality improvement efforts across the country. Many payers other than CMS have implemented alternative payment arrangements or models, or have collaborated in
The Innovation Center works directly with other CMS components and colleagues throughout the federal government in developing and testing new payment and service delivery models. Other federal agencies with which the Innovation Center has collaborated include the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), Agency for Healthcare Research and Quality (AHRQ), Office of the National Coordinator for Health Information Technology (ONC), Administration for Community Living (ACL), Department of Housing and Urban Development (HUD), Administration for Children and Families (ACF), and the Substance Abuse and Mental Health Services Administration (SAMHSA). These collaborations help the Innovation Center effectively test new models and execute mandated demonstrations.
The MACRA's passage has led to several changes with the existing Medicare PFS, various Medicare payment programs that tie payment to value, and the testing of alternative payment models. Specifically, the MACRA's enactment consolidated aspects of certain quality reporting and performance programs into the new MIPS, including the meaningful use of certified EHR technology (section 1848(o) of the Act), the PQRS (section 1848(k) and (m) of the Act, and the VM (section 1848(p) of the Act). The following section provides an overview of existing programs and the extent of their programs before and after the MACRA.
Currently, the Medicare EHR Incentive Program has been divided into three progressive stages of meaningful use with certain specified requirements that EPs must meet in order to qualify for Medicare EHR incentive payments and avoid downward payment adjustments. Full achievement of these requirements designated an EP as a “meaningful EHR user” and made that EP eligible for incentive payments and not subject to downward payment adjustments. The MACRA's enactment altered the EHR Incentive Programs such that the existing Medicare payment adjustment for an EP under 1848(a)(7)(A) of the Act ends after CY 2018. Using certified EHR technology is included in MIPS as part of the advancing care information component of the overall performance score. Generally, the MACRA did not change hospital participation in the Medicare EHR Incentive Program or participation for EPs in the Medicaid EHR Incentive Program.
PQRS, as set forth in sections 1848(a), (k), and (m) of the Act, is a quality reporting program that provides for incentive payments (which ended in 2014) and payment adjustments (which began in 2015) to EPs and group practices based on whether they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period or to EPs and group practices based on whether they satisfactorily participate in a qualified clinical data registry (QCDR). The MACRA ends the PQRS adjustment after CY 2018 and provides for the inclusion of various aspects of PQRS in MIPS as part of the quality component of the overall performance score.
Section 1848(p) of the Act, as amended by the Affordable Care Act, required that we establish a VM that provides for differential payment under the Medicare PFS based upon the quality of care furnished compared to cost and apply it to specific physicians and groups of physicians as determined appropriate by the Secretary starting in 2015 and to all physicians by 2017. In the CY 2013 PFS final rule with comment period (77 FR 69307), we discussed the goals of the VM and also established the specific principles that should govern the implementation of the VM. The MACRA sunsets the VM, ending it after CY 2018 and establishing certain aspects of the VM as part of the resource use component of MIPS in CY 2019.
Section 101 of the MACRA amended sections 1848(d) and (f) of the Act to repeal the SGR formula for updating Medicare PFS payment rates and substituted a series of specified annual update percentages. Section 101 goes on to establish a new methodology that ties annual PFS payment adjustments to value for MIPS eligible clinicians. Section 101 also creates an incentive program to encourage participation by eligible clinicians in Advanced APMs.
Section 1848(q) of the Act, as added by section 101(c) of the MACRA, requires establishment of the MIPS, applicable beginning with payments for items and services furnished on or after January 1, 2019, under which the Secretary is required to: (1) Develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for a performance period for a year; (2) using the methodology, provide a CPS for each MIPS eligible clinician for each performance period; and (3) use the CPS of the MIPS eligible clinician for a performance period for a year to determine and apply a MIPS adjustment factor (and, as applicable, an additional MIPS adjustment factor) to the MIPS eligible clinician for the year. Under section 1848(q)(2)(A) of the Act, a MIPS eligible clinician's CPS is determined using four performance categories: (1) Quality; (2) resource use; (3) CPIA; and (4) advancing care information. Section 1848(q)(10) of the Act requires the Secretary to consult with stakeholders (through a request for information (RFI) or other appropriate means) in carrying out the MIPS, including for the identification of measures and activities for each of the four performance categories under the MIPS, the methodology to assess each MIPS eligible clinician's total performance to determine their MIPS CPS, the methodology to specify the MIPS adjustment factor for each MIPS eligible clinician for a year, and the use of QCDRs for purposes of the MIPS.
Section 1848(q)(11) of the Act, as added by section 101(c) of the MACRA, provides for technical assistance to MIPS eligible clinicians in small practices, rural areas, and practices located in geographic health professional shortage areas (HPSAs). In general, the section requires the Secretary to enter into contracts or agreements with appropriate entities (such as quality improvement organizations, regional extension centers (as described in section 3012(c) of the Public Health Service (PHS) Act), or regional health collaboratives) (such as those identified in section 1115A of the Act) to offer guidance and assistance to MIPS eligible clinicians in practices of 15 or fewer eligible clinicians. Priority is to be given to such practices located in rural areas which we propose to define at § 414.1305 to include clinicians in counties designated as Micropolitan or Non-Core Based Statistical Areas (CBSAs), using HRSA's 2014-2015 Area Health Resource File (
Section 101(e) of the MACRA encourages participation in APMs by eligible clinicians and other eligible clinicians, and promotes the development of PFPMs by creating the PTAC. Specifically, this section: (1) Creates a payment incentive that applies to eligible clinicians from 2019 through 2024 who are Qualifying APM Participants (QPs) during the respective performance years, and provides for a higher fee schedule update for eligible clinicians who are QPs for a year beginning in 2026; (2) requires the establishment of a process for stakeholders to propose PFPMs to an independent PTAC that will review, comment on, and provide recommendations to the Secretary on the proposed PFPMs; and (3) requires CMS to establish criteria for PFPMs for use by the PTAC in making comments and recommendations to the Secretary. Additionally, section 101(c)(1) of the MACRA exempts QPs from payment adjustments under MIPS.
In developing this proposed rule, in accordance with the law, we have sought feedback from stakeholders throughout the process such as in the 2016 Medicare PFS Proposed Rule; the Request for Information Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models (hereafter referred to as the MIPS and APMs RFI); listening sessions; conversations with a wide number of stakeholders; and conversations with tribes and tribal officials through CMS' Tribal Technical Advisory Group. In addition, we note that the National Indian Health Board has requested an opportunity for consultation with CMS, as well as that we coordinate its standards with the Indian Health Service. Through the MIPS and APMs RFI published in the
We appreciate the high level of interest expressed by commenters and acknowledge their valued input throughout this proposed rule, providing summaries of RFI comments in relevant sections of this rule. In general, commenters supported the passage of regulations implementing the MACRA and maintain optimism as we move from fee-for-service Medicare payment towards an enhanced focus on the quality and value of care. Public support for the MACRA focuses on the potential of a value-based program to provide enough flexibility to be applied meaningfully to physician practices and patient quality of care. Commenters cautioned us to avoid elements of prior reporting programs that have been perceived as too focused on the volume of measures reported rather than measure relevance and impact on treatment. Commenters also requested that we avoid implementing additional requirements on top of the fee-for-service system, which would increase the reporting and compliance burden for eligible clinicians. Commenters believe the underlying goal in establishing the MACRA should be to create a new program that combines a limited (yet meaningful) set of requirements with choices for health care providers on how to meet those requirements. Commenters requested that there be broad opportunities to participate in APMs and the development of new Advanced APMs, and that resources be made available to assist them in moving towards participation in APMs if they do not already participate. Commenters expressed eagerness to participate in Advanced APMs and to be a part of transforming care.
Once again, we thank stakeholders for their considered responses through various venues including comments to the MIPS and APMs RFI. We intend to continue open communication with stakeholders (including consultation with tribes and tribal officials) on an ongoing basis, and we look forward to comments on the policies proposed in this rule.
Section 1848(q) of the Act, as added by section 101(c) of the MACRA, requires establishment of the MIPS (see section I.C. of this proposed rule for additional background information). Section 101(e) of the MACRA promotes the development of, and participation in, APMs for eligible clinicians (see section I.C. of this proposed rule for additional background information). Further information will be provided in future rulemaking.
Through the MACRA amendments, we believe the Congress sets broad goals to be accomplished intended to improve care and health outcomes for every American. More specifically, our goal with the Quality Payment Program is to continue to support health care quality, efficiency, and patient safety. MIPS promotes better care, healthier people, and smarter spending by evaluating MIPS eligible clinicians using a CPS that incorporates MIPS eligible clinicians' performance on quality, resource use, clinical practice improvement activities, and advancing care information. Under the incentives for participation in Advanced APMs, our goals, described in greater detail in section II.F. of this proposed rule, are to expand the opportunities for participation in APMs, maximize participation in current and future Advanced APMs, create clear and attainable standards for incentives, promote the continued flexibility in the design of APMs, and support multi-payer initiatives across the health care market. The Quality Payment Program will encourage more MIPS eligible clinicians to participate in Advanced APMs, which link quality and value to payment. The APM Incentive Payment for eligible clinicians who qualify as QPs will only be available through Advanced APMs, but it is a powerful incentive to increase participation in those APMs. MIPS eligible clinicians participating in APMs (who do not qualify as QPs) will receive favorable scoring under certain MIPS categories.
Our strategic goals in developing the Quality Payment Program include: (1) Design a patient-centered approach to program development that leads to better, smarter, and healthier care; (2) develop a program that is meaningful, understandable, and flexible for participating clinicians; (3) design incentives that drive delivery system reform principles and participation in APMs; and (4) ensure close attention to CMS' excellence in implementation, effective communication with stakeholders and operational feasibility.
Section 101(b) of the MACRA calls for the sunsetting of payment adjustments under three existing programs for Medicare enrolled physicians and other practitioners:
• The PQRS that incentivizes EPs to report on quality measures;
• The VM that provides for budget neutral, differential payment adjustment for EPs in physician groups and solo practices based on quality of care compared to cost; and
• The Medicare EHR Incentive Program for EPs that entails meeting certain requirements for the use of certified EHR technology.
Accordingly, we propose to revise certain regulations associated with these programs. We are not proposing to delete these regulations entirely, as the final payment adjustments under these programs will not occur until the end of 2018. For PQRS, we propose to revise § 414.90(e) introductory text and § 414.90(e)(1)(ii) to continue payment adjustments through 2018.
Similarly, we are proposing to amend the regulation text at § 495.102(d) to remove references to the payment adjustment percentage for years after the 2018 payment adjustment year and add a terminal limit of the 2018 payment adjustment year.
We are not proposing changes to 42 CFR part 414 subpart N—Value-Based Payment Modifier Under the PFS (§ 414.1200-1285), at this time. These regulations are already limited to certain years.
We invite comments on these proposed regulatory changes.
a. Cooperation With Surveillance and Direct Review of Certified EHR Technology
We are proposing to require EPs, eligible hospitals, and CAHs to attest (as part of their demonstration of meaningful use under the Medicare and Medicaid EHR Incentive Programs) that they have cooperated with the surveillance of certified EHR technology under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E. Similarly, we are proposing to require such an attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM Scoring Standard, as discussed in section II.E.5.h of this proposed rule.
On October 16, 2015, ONC published the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule (“2015 Edition final rule”). The final rule made changes to the ONC Health IT Certification Program that strengthen the testing, certification, and surveillance of health IT. In addition, the final rule clarified and expanded the responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) with respect to the surveillance of certified EHR technology and other health IT certified under the ONC Health IT Certification Program, including requirements for ONC-ACBs to conduct more frequent and more rigorous surveillance of certified technology and capabilities “in the field” (80 FR 62707). The purpose of in-the-field surveillance is to provide greater assurance that health IT meets certification requirements not only in a controlled testing environment but also when used by health care providers in actual production environments (80 FR 62707).
In addition to these changes, on March 2, 2016, ONC published the ONC Health IT Certification Program: Enhanced Oversight and Accountability proposed rule, which would expand ONC's role to strengthen oversight under the ONC Health IT Certification Program by providing a means for ONC to directly review and evaluate the performance of certified health IT in certain circumstances, such as in response to potential systemic or widespread issues, or in response to problems or issues that could pose a risk to public health or safety, compromise the security or privacy of patients' health information, or give rise to other exigencies (81 FR 11055).
These efforts to strengthen surveillance and other oversight of certified health IT, including through expanded in-the-field surveillance and ONC direct review of technology and capabilities, are critical to the success of HHS programs and initiatives that require the use of certified health IT to improve health care quality and the efficient delivery of care. With respect to the use of certified EHR technology under the Medicare and Medicaid EHR Incentive Programs and the MIPS Program, effective surveillance and oversight is fundamental to providing basic confidence that such technology consistently meets applicable standards, implementation specifications, and certification criteria adopted by the Secretary when it is used by eligible clinicians, EPs, eligible hospitals, and CAHs, as well as by other persons with whom eligible clinicians, EPs, eligible hospitals, and CAHs need to exchange electronic health information to comply with program requirements. The need to ensure that technology consistently meets applicable standards, implementation specifications, and certification criteria is important both at the time it is certified and on an ongoing basis when it is implemented and used in the field by eligible clinicians, EPs, eligible hospitals, and CAHs in order to meet objectives and measures under the Medicare and Medicaid EHR Incentive Program or MIPS. Efforts to strengthen surveillance and oversight of certified EHR technology in the field will become even more important as the types and capabilities of certified EHR technology continue to evolve and with the onset of Stage 3 of the Medicare and Medicaid EHR Incentive Programs and MIPS, which include heightened requirements for sharing electronic health information with other providers and with patients using a broad range of certified EHR technology and other health IT.
For all of these reasons, the effective surveillance and oversight of certified health IT, and certified EHR technology in particular, is necessary to enable eligible clinicians, EPs, eligible hospitals, and CAHs to demonstrate that they are using certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act. Yet as ONC observed in the 2015 Edition final rule, such surveillance and oversight will not be effective unless EPs, eligible hospitals, and CAHs are actively
Accordingly, we are proposing that as part of demonstrating that it is using certified EHR technology in a meaningful manner, an eligible clinician, EP, eligible hospital, or CAH must demonstrate its cooperation with these authorized surveillance and oversight activities. We are proposing to revise the definition of a meaningful EHR user at § 495.4, as well as the attestation requirements at § 495.40(a)(2)(i)(H) and § 495.40(b)(2)(i)(H) to require EPs, eligible hospitals, and CAHs to attest their cooperation with certain authorized health IT surveillance and direct review activities, described in more detail in this section of the rule, as part of demonstrating meaningful use under the Medicare and Medicaid EHR Incentive Programs. Similarly, we are proposing to include an identical attestation requirement in the submission requirements for eligible clinicians under the advancing care information performance category proposed at § 414.1375.
We propose that eligible clinicians, EPs, eligible hospitals, and CAHs would be required to attest that they have cooperated in good faith with the surveillance and ONC direct review of their health IT certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT. Under the terms of the attestation, such cooperation would include responding in a timely manner and in good faith to requests for information (for example, telephone inquiries, written surveys) about the performance of the certified EHR technology capabilities in use by the provider in the field. The provider's cooperation would also include accommodating requests (from ONC-Authorized Certification Bodies or from ONC) for access to the provider's certified EHR technology (and data stored in such certified EHR technology) as deployed by the provider in its production environment, for the purpose of carrying out authorized surveillance or direct review, and to demonstrate capabilities and other aspects of the technology that are the focus of such efforts, to the extent that doing so would not compromise patient care or be unduly burdensome for the eligible clinician, EP, eligible hospital, or CAH.
We understand that cooperating with in-the-field surveillance may require prioritizing limited time and other resources. We note that ONC has established safeguards to minimize the burden of surveillance on eligible clinicians, EPs, eligible hospitals, and CAHs. In conducting randomized surveillance, ONC-ACBs must use consistent, objective, valid, and reliable methods to select the locations at which the surveillance will be performed (80 FR 62715). ONC-ACBs may also use appropriate sampling methodologies to minimize disruption to any individual provider or class of providers and to maximize the value and impact of surveillance activities for all providers and stakeholders (80 FR 62715). Moreover, if an ONC-ACB makes a good faith effort but is unable to complete in-the-field surveillance at a particular location, it may exclude the location and substitute a different location for surveillance (80 FR 62716).
In addition, we note that ONC has clarified, in consultation with the Office for Civil Rights, that ONC-ACBs engaging in authorized surveillance of certified EHR technology under the ONC Health IT Certification Program meet the definition of a “health oversight agency” in the HIPAA Privacy Rule (45 CFR 164.501), and as such a health care provider is permitted to disclose protected health information (PHI) (without patient authorization and without a business associate agreement) to an ONC-ACB during the limited time and as necessary for the ONC-ACB to perform the required on-site surveillance of the certified EHR technology (45 CFR 164.512(d)(1)(iii)) (80 FR 62716).
For the foregoing reasons, we believe this proposal will support the surveillance and oversight of certified health IT, as necessary to support meaningful use of CEHRT for all eligible clinicians under the MIPS program, as well as EPs, eligible hospitals and CAHs under the Medicare and Medicaid EHR Incentive Programs, while ensuring that such surveillance or review does not create unnecessary or unreasonable burdens for health care providers or patients. We request public comment on this proposal.
To prevent actions that block the exchange of information, section 106(b)(2)(A) of the MACRA amended section 1848(o)(2)(A)(ii) of the Act to require that, to be a meaningful EHR user, an EP must demonstrate that he or she has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology. Section 106(b)(2)(B) of MACRA made corresponding amendments to section 1886(n)(3)(A)(ii) of the Act for eligible hospitals and, by extension, under section 1814(l)(3) of the Act for CAHs. Sections 106(b)(2)(A) and (B) of the MACRA provide that the manner of this demonstration is to be through a process specified by the Secretary, such as the use of an attestation. Section 106(b)(2)(C) of the MACRA states that the demonstration requirements in these amendments shall apply to meaningful EHR users as of the date that is 1 year after the date of enactment, which would be April 16, 2016.
On December 16, 2014, in an explanatory statement accompanying the Consolidated and Further Continuing Appropriations Act,
Following these activities, on April 16, 2015, the MACRA was enacted, including section 106(b)(2), which amended sections 1848(o)(2)(A)(ii) and 1886(n)(3)(A)(ii) of the Act, as discussed in this section of the rule. Prior to these amendments, to be treated as a meaningful EHR user, an EP, eligible hospital, or CAH had to demonstrate to
We believe that, at a minimum, such a demonstration would need to provide substantial assurance not only that the certified EHR technology was connected in accordance with applicable standards during the relevant EHR reporting period, but that the eligible clinician, EP, eligible hospital, or CAH acted in good faith to implement and use the certified EHR technology in a manner that supported and did not interfere with the electronic exchange of health information among health care providers and with patients to improve quality and promote care coordination. Accordingly, we are proposing that such a demonstration be made through an attestation comprising three statements related to health information exchange and information blocking, which are set forth in our proposal in this rule. We are proposing to revise the definition of a meaningful EHR user at § 495.4 and the attestation requirements at § 495.40(a)(2)(i)(I) and § 495.40(b)(2)(i)(I) to provide that, for attestations submitted on or after April 16, 2016, an EP, eligible hospital, or CAH under the Medicare and Medicaid EHR Incentive Programs must attest to this three-part attestation. For the same reasons stated in this section of the rule, we are also proposing to require such an attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM Scoring Standard, as discussed in section II.E.5.h of this proposed rule. As noted in this section, the attestation we are proposing would consist of three statements related to health information exchange and information blocking. First, the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology.
Second, the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times: connected in accordance with applicable law; compliant with all standards applicable to the exchange of information, including the standards, implementation specifications, and certification criteria adopted at 45 CFR part 170; implemented in a manner that allowed for timely access by patients to their electronic health information; (including the ability to view, download, and transmit this information) and implemented in a manner that allowed for the timely, secure, and trusted bi-directional exchange of structured electronic health information with other health care providers (as defined by 42 U.S.C. 300jj(3)), including unaffiliated providers, and with disparate certified EHR technology and vendors.
Third, the eligible clinician, EP, eligible hospital, or CAH would be required to attest that it responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor's affiliation or technology vendor. We invite public comment on this proposal, including whether the foregoing statements could provide the Secretary with adequate assurances that an eligible clinician, EP, eligible hospital, or CAH has complied with the statutory requirements for information exchange. We also encourage public comment on whether there are additional facts or circumstances to which eligible clinicians, EPs, eligible hospitals, or CAHs should be required to attest, or whether there is additional information that they should be required to report.
At § 414.1305, subpart O, we are proposing definitions for the following terms:
• Additional performance threshold.
• Advanced Alternative Payment Model (Advanced APM).
• Advanced APM Entity.
• Affiliated practitioner.
• Alternative Payment Model (APM).
• APM Entity.
• APM Entity group.
• APM Incentive Payment.
• Attestation.
• Attributed beneficiary.
• Attribution-eligible beneficiary.
• Certified Electronic Health Record Technology (CEHRT).
• Clinical Practice Improvement Activity (CPIA).
• CMS-approved survey vendor.
• CMS Web Interface.
• Composite performance score (CPS).
• Covered professional services.
• Eligible clinician.
• Episode payment model.
• Estimated aggregate payment amounts.
• Group.
• Health professional shortage areas (HPSA).
• High priority measure.
• Hospital-based MIPS eligible clinician.
• Incentive payment base period.
• Low-volume threshold.
• Meaningful EHR user for MIPS.
• Measure benchmark.
• Medicaid APM.
• Medical Home Model.
• Medicaid Medical Home Model.
• Merit-Based Incentive Payment System (MIPS).
• MIPS APM.
• MIPS Payment Year.
MIPS eligible clinician.
• MIPS payment year.
• New Medicare-Enrolled MIPS eligible clinician.
• Non-patient-facing MIPS eligible clinician.
• Other Payer Advanced APM.
• Partial Qualifying APM Participant (Partial QP).
• Partial QP patient count threshold.
• Partial QP payment amount threshold.
• Participation List.
• Performance category score.
• Performance standards.
• Performance threshold.
• Qualified Clinical Data Registry (QCDR).
• Qualified registry.
• QP patient count threshold.
• QP payment amount threshold.
• QP Performance Period.
• Qualifying APM Participant (QP).
• Rural areas.
• Small practices.
• Threshold Score.
• Topped out measure.
Some of these terms are new in conjunction with MIPS and APMs, while others are used in existing CMS programs. For the new proposed terms and definitions, we note that some of
We invite public comments on all of these proposed terms and definitions, and discuss most of them in detail in relevant sections of this preamble.
We believe a successful MIPS program fully equips clinicians identified as MIPS eligible clinicians with the tools and incentives to focus on improving health care quality, efficiency, and patient safety for all their patients. Under MIPS, MIPS eligible clinicians are incentivized to engage in proven improvement measures and activities that impact patient health and safety and are relevant for their patient population. One of our strategic goals in developing the MIPS program is to advance a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is by minimizing MIPS eligible clinicians' burden. We have made an effort to focus on policies that remove as much administrative burden as possible from MIPS eligible clinicians and their practices while still providing meaningful incentives for high-quality, efficient care. In addition, we hope to balance practice diversity with flexibility to address varied MIPS eligible clinicians' practices. Examples of this flexibility include special consideration for non-patient-facing MIPS eligible clinicians, an exclusion from MIPS for eligible clinicians who do not exceed the low-volume threshold, and other proposals discussed below.
Section 1848(q)(1)(C)(i) of the Act, as added by section 101(c)(1) of the MACRA, outlines the general definition of a MIPS eligible clinician for the MIPS program. Specifically, for the first and second year for which MIPS applies to payments (and the performance period for such years) a MIPS eligible clinician is defined as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. The statute also provides flexibility to specify additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) as MIPS eligible clinicians in the third and subsequent years of MIPS. As discussed in section II.E.3. of this proposed rule, section 1848(q)(1)(C)(ii) and (v) of the Act specifies several exclusions from the definition of a MIPS eligible clinician. In addition, section 1848(q)(1)(A) of the Act requires the Secretary to permit any eligible clinician (as defined in section 1848(k)(3)(B) of the Act) who is not a MIPS eligible clinician the option to volunteer to report on applicable measures and activities under MIPS. Section 1848(q)(1)(C)(vi) of the Act clarifies that a MIPS adjustment factor (or additional MIPS adjustment factor) will not be applied to an individual who is not a MIPS eligible clinician for a year, even if such individual voluntarily reports measures under MIPS.
To implement the MIPS program we must first establish and define a MIPS eligible clinician in accordance with the statutory definition. We propose to define a MIPS eligible clinician at § 414.1305 as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. In addition, we propose that Qualifying APM Participants, Partial Qualifying APM Participants who do not report data under MIPS, low-volume threshold eligible clinicians, and new Medicare-enrolled eligible clinicians as defined at § 414.1305 would be excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act. We intend to consider using our authority under section 1848(q)(1)(C)(i)(II) of the Act to expand the definition of MIPS eligible clinician to include additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) through rulemaking in future years.
In addition, in accordance with section 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we propose to allow eligible clinicians who are not MIPS eligible clinicians as defined at proposed § 414.1305 the option to voluntarily report measures and activities for MIPS. We propose at § 414.1310(d) that those eligible clinicians who are not MIPS eligible clinicians, but who voluntarily report on applicable measures and activities specified under MIPS, would not receive an adjustment under MIPS; however, they will have the opportunity to gain experience in the MIPS program. We are particularly interested in public comment regarding the feasibility and advisability of voluntary reporting in the MIPS program for entities such as Rural Health Clinics (RHCs) and/or Federally Qualified Health Centers (FQHCs), including comments regarding the specific technical issues associated with reporting that are unique to these health care providers. We anticipate some eligible clinicians that will not be MIPS eligible clinicians during the first 2 years of MIPS, such as physical and occupational therapists, clinical social workers, and others that have been reporting quality measures under the PQRS for a number of years, will want to have the ability to continue to report and gain experience under MIPS. We request comments on these proposals.
Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in specifying measures and activities for a performance category, to give consideration to the circumstances of professional types (or subcategories of those types determined by practice characteristics) who typically furnish services that do not involve face-to-face interaction with a patient. To the extent feasible and appropriate, the Secretary may take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such non-patient-facing MIPS eligible clinicians. In carrying out these provisions, we are required to consult with non-patient-facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) of the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient-facing MIPS eligible clinicians will not have sufficient measures and activities applicable and available to report under the performance categories under MIPS. We refer readers to section II.E.6. of this proposed rule to discuss how we address performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given category.
To establish policies surrounding non-patient-facing MIPS eligible clinicians, we must first define the term “non-patient-facing.” Currently, the PQRS, VM, and Medicare EHR Incentive Program include two existing policies for considering whether an EP is providing patient-facing services. To determine, for purposes of PQRS, whether an EP had a “face-to-face” encounter with Medicare patients, we assess whether the EP billed for services under the PFS that are associated with face-to-face encounters, such as whether an EP billed general office visit codes, outpatient visits, and surgical procedures. Under PQRS, if an EP bills for at least one service under the PFS during the performance period that is associated with face-to-face encounters and reports quality measures via claims or registries, then the EP is required to report at least one “cross-cutting” measure. EPs who do not meet these criteria are not required to report a cross-cutting measure. For the purposes of PQRS, telehealth services have not historically been included in the definition of face-to-face encounters. For more information, please see the CY 2016 PFS final rule for these discussions (80 FR 71140).
In the Stage 2 final rule (77 FR 54098 through 54099), the Medicare EHR Incentive Program established a significant hardship exception from the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act for EPs that lack face-to-face interactions with patients and those who lack the need to follow-up with patients. EPs with a primary specialty of anesthesiology, pathology or radiology listed in the Provider Enrollment, Chain, and Ownership System (PECOS) as of 6 months prior to the first day of the payment adjustment year automatically receive this hardship exemption (77 FR 54100). Codes associated with these specialties include 05 Anesthesiology, 22 Pathology, 30 Diagnostic Radiology, 36 Nuclear Medicine, 94 Interventional Radiology. EPs with a different specialty are also able to request this hardship exception through the hardship application process. However, telehealth services could be counted by EPs who choose to include these services within the definition of “seen by the EP” for the purposes of calculating patient encounters with the EHR Incentive Program (77 FR 53982).
In the MIPS and APMs RFI, we sought comments on MIPS eligible clinicians that should be considered non-patient-facing MIPS eligible clinicians and the criteria we should use to identify these MIPS eligible clinicians. Commenters were split when it came to defining and identifying non-patient-facing MIPS eligible clinicians. Many took a specialty-driven approach. Commenters generally did not support use of enrollment specialty codes alone, which is the approach used by the Medicare EHR Incentive Program. Commenters indicated that these codes do not necessarily delineate between the same specialists who may or may not have patient-facing interaction. One example is cardiologists who specialize in cardiovascular imaging which is also coded as cardiology. On the other hand, as one commenter mentioned, physicians with enrollment specialty codes other than “cardiology” (for example, internal medicine) may perform cardiovascular imaging services. Therefore, using the enrollment specialty code for cardiology to identify clinicians who typically do not provide patient-facing services would be both over-inclusive and under-inclusive. Other commenters identified specialty types that they believe should be considered non-patient-facing MIPS eligible clinicians. Specific specialty types included radiologists, anesthesiologists, nuclear cardiology or nuclear medicine physicians, and pathologists. Others pointed out that certain MIPS eligible clinicians may be primarily non-patient-facing MIPS eligible clinicians even though they practice within a traditionally patient-facing specialty. The MIPS and APMs RFI comments and listening sessions with medical societies representing non-patient-facing MIPS eligible clinicians specified radiology/imaging, anesthesiology, nuclear cardiology and oncology, and pathology as inclusive of non-patient-facing MIPS eligible clinicians. Commenters noted that roles within specific types of specialties may need to be further delineated between patient-facing and non-patient-facing MIPS eligible clinicians. An illustrative list of specific types of clinicians within the non-patient-facing spectrum include:
• Pathologists who may be primarily dedicated to working with local hospitals to identify early indicators related to evolving infectious diseases;
• Radiologists who primarily provide consultative support back to a referring physician or provide image interpretation and diagnosis versus therapy;
• Nuclear medicine physicians who play an indirect role in patient care, for example as a consultant to another physician in proper dose administration; or
• Anesthesiologists who are primarily providing supervision oversight to Certified Registered Nurse Anesthetists.
Some commenters believed that MIPS eligible clinicians should be defined as non-patient-facing MIPS eligible clinicians based on whether their billing indicates they provide face-to-face services. Commenters indicated that the use of specific HCPCS codes in combination with enrollment specialty codes, may be a more appropriate way to identify MIPS eligible clinicians that have no patient interaction.
After reviewing current policies, we propose to define a non-patient-facing MIPS eligible clinicians for MIPS at § 414.1305 as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters during a performance period. We consider a patient-facing encounter as an instance in which the MIPS eligible clinician or group billed for services such as general office visits, outpatient visits, and surgical procedure codes under the PFS. We intend to publish the proposed list of patient-facing encounter codes on a CMS Web site similar to the way we currently publish the list of face-to-face encounter codes for PQRS. This proposal differs from the current PQRS policy in two ways. First, it creates a minimum threshold for the quantity of patient-facing encounters that MIPS eligible clinicians or groups would need to furnish to be considered patient-facing, rather than classifying MIPS eligible clinicians as patient-facing based on a single patient-facing encounter. Second, this proposal includes telehealth services in the definition of patient-facing encounters.
We believe that setting the non-patient-facing MIPS eligible clinician threshold for individual MIPS eligible clinician or group at 25 or fewer billed patient-facing encounters during a performance period is appropriate. We selected this threshold based on an analysis of non-patient-facing HCPCS codes billed by MIPS eligible clinicians. Using these codes and this threshold we identified approximately one quarter of MIPS eligible clinicians as non-patient-facing before MIPS exclusions, such as low-volume and newly-enrolled eligible clinician policies, were applied. The majority of clinicians enrolled in Medicare with specialties such as anesthesiology, nuclear medicine, and pathology were identified as non-patient-facing in this analysis. The addition of telemedicine to the analysis did not affect the outcome, as it created a less than 0.01 percent change in MIPS eligible clinicians categorized as non-patient-facing.
Therefore, this proposed approach allows the definition of non-patient-facing MIPS eligible clinicians, to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient-facing, as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices. This definition is also consistent with the statutory requirement that refers to professional types who typically furnish services that do not involve patient-facing interaction with a patient.
We also propose to include telehealth services in the definition of patient-facing encounters. Various MIPS eligible clinicians use telehealth services as an innovative way to deliver care to beneficiaries and we believe these services, while not furnished in-person, should be recognized as patient-facing. In addition, Medicare eligible telehealth services substitute for an in-person encounter and meet other site requirements under the PFS as defined at § 410.78.
The proposed addition of the encounter threshold for patient-facing MIPS eligible clinicians should minimize concerns that a MIPS eligible clinician could be misclassified as patient-facing as a result of providing occasional telehealth services that do not represent the bulk of their practice. Finally, this proposed definition of a non-patient-facing MIPS eligible clinician for MIPS can be consistently used throughout the MIPS program to identify those MIPS eligible clinicians for whom certain proposed requirements for patient-facing MIPS eligible clinicians (such as reporting cross-cutting measures) may not be meaningful.
We weighed several options when considering the appropriate definition of non-patient-facing MIPS eligible clinicians for MIPS; and some options were similar to those we considered in implementing the Medicare EHR Incentive Program. One option we considered was basing the non-patient-facing MIPS eligible clinician's definition on a set percentage of patient-facing encounters, such as 5 to 10 percent, that is tied to the same list of patient-facing encounter codes discussed in this section of the proposed rule. Another option we considered was the identification of non-patient-facing MIPS eligible clinicians for MIPS only by specialty, which might be a simpler approach. However, we do not consider this approach sufficient for identifying all the possible non-patient-facing MIPS eligible clinicians, as some patient-facing MIPS eligible clinicians practice in multi-specialty practices with non-patient-facing MIPS eligible clinician's practices with different specialties. We would likely have had to develop a separate process to identify non-patient-facing MIPS eligible clinicians in other specialties, whereas maintaining a single definition that is aligned across performance categories is simpler. Many comments from the MIPS and APMs RFI discouraged use of enrollment specialty alone. Additionally, we believe our proposal would allow us to more accurately identify MIPS eligible clinicians who are non-patient-facing by applying a threshold to recognize that a MIPS eligible clinician who furnishes almost exclusively non-patient-facing services should be treated as a non-patient-facing MIPS eligible clinicians despite furnishing a small number of patient-facing services. We seek comment on these alternative approaches.
In the MIPS and APMs RFI, we also requested comments on what types of measures and/or CPIAs (new or from other payment systems) we should use to assess non-patient-facing MIPS eligible clinicians' performance and how we should apply the MIPS performance categories to non-patient-facing MIPS eligible clinicians. Commenters were split on these subjects. A number of commenters stated that non-patient-facing MIPS eligible clinicians should be exempt from specific performance categories under MIPS or should be exempt from MIPS as a whole. Commenters who did not favor exemptions generally suggested that we focus on process measures and work with specialty societies to develop new, more clinically relevant measures for non-patient-facing MIPS eligible clinicians.
We took these stakeholder comments into consideration. We note that section 1848(q)(2)(C)(iv) of the Act does not grant the Secretary discretion to exempt non-patient-facing MIPS eligible clinicians from a performance category entirely, but rather to apply to the extent feasible and appropriate alternative measures or activities that fulfill the goals of the applicable performance category. However, we have placed safeguards to ensure that MIPS eligible clinicians, including non-patient facing, that do not have sufficient alternative measures that are applicable and available in a performance category are scored appropriately. We propose to apply the Secretary's authority under section 1848(q)(5)(F) of the Act to reweight such performance categories score to zero if there is no performance category score or to lower the weight of the quality performance category score if there are not at least three scored measures. Please refer to section II.E.6.b.(2)(b) in this proposed rule for details on the reweighting proposals. Accordingly, we have proposed alternative requirements for non-patient-facing MIPS eligible clinicians across this proposed rule (see sections II.E.5.b. II.E.5.e. and II.E.5.f. of this proposed rule for more details). While non-patient-facing MIPS eligible clinicians will not be exempt from any performance category under MIPS, we believe these alternative requirements fulfill the goals of the applicable performance categories and are in line with the commenters' desire to ensure that non-patient-facing MIPS eligible clinicians are not placed at an unfair disadvantage under the new program. The requirements also build on prior program components in meaningful ways and are meant to help us appropriately assess and incentivize non-patient-facing MIPS eligible clinicians. We request comments on these proposals.
Section 1848(q)(6)(E) of the Act provides that the MIPS adjustment is applied to the amount otherwise paid under Part B for the items and services furnished by a MIPS eligible clinician during a year (beginning with 2019). In the case of MIPS eligible clinicians who practice in CAHs that bill under Method I (“Method I CAHs”), the MIPS adjustment would apply to payments made for items and services billed by MIPS eligible clinicians under the PFS, but it would not apply to the facility payment to the CAH itself. In the case of MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS adjustment would apply in the same manner as for MIPS eligible clinicians who bill for items and services in Method I CAHs.
Under section 1834(g)(2) of the Act, a Method II CAH bills and is paid for facility services at 101 percent of its reasonable costs and for professional services at 115 percent of such amounts as would otherwise be paid under this part if such services were not included in outpatient critical access hospital services. In the case of MIPS eligible clinicians who practice in Method II CAHs and have assigned their billing rights to the CAHs, those professional services would constitute “covered professional services” under section 1848(k)(3)(A) of the Act because they are furnished by an eligible clinician
As noted previously in this proposed rule, section 1848(q)(6)(E) of the Act provides that the MIPS adjustment is applied to the amount otherwise paid under Part B with respect to the items and services furnished by a MIPS eligible clinician during a year. Some eligible clinician s may not receive MIPS adjustments due to their billing methodologies. If a MIPS eligible clinician furnishes items and services in an RHC and/or FQHC and the RHC and/or FQHC bills for those items and services under the RHC's or FQHC's all-inclusive payment methodology, the MIPS adjustment would not apply to the facility payment to the RHC or FQHC itself. However, if a MIPS eligible clinician furnishes other items and services in an RHC and/or FQHC and bills for those items and services under the PFS, the MIPS adjustment would apply to payments made for items and services. Accordingly, the MIPS eligible clinician would need to meet the applicable MIPS reporting requirements to avoid a downward MIPS adjustment to payments made for items and services billed by the MIPS eligible clinician under the PFS. Therefore, we propose services rendered by an eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS and the data received would not be used to assess their performance for the purpose of the MIPS adjustment. We request comments on this proposal.
Section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for purposes of assessing performance in the quality performance category. In addition, it gives the Secretary the discretion to do so for the other three performance categories. Additionally, we will assess performance either for individual MIPS eligible clinicians or for groups. As discussed in section II.E.2.b of this proposed rule, we propose to define a group at § 414.1305 as a single Taxpayer Identification Number (TIN) with two or more MIPS eligible clinicians, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicare billing rights to the TIN. Also, as outlined in section II.E.2.c. of this proposed rule, we propose to define an APM Entity group at § 414.1305 identified by a unique APM participant identifier.
To support MIPS eligible clinicians reporting to a single comprehensive and cohesive MIPS program, we need to align the technical reporting requirements from PQRS, VM, and EHR-MU into one program. This requires an appropriate MIPS eligible clinician identifier. We currently use a variety of identifiers to assess an individual eligible clinician or group under different programs. For example, under the PQRS for individual reporting, CMS uses a combination of TIN and NPI to assess eligibility and participation, where each unique TIN and NPI combination is treated as a distinct eligible clinician and is separately assessed for purposes of the program. Under the PQRS GPRO, eligibility and participation are assessed at the TIN level. Under the Medicare EHR Incentive Program, we utilize the NPI to assess eligibility and participation. And under the VM, performance and payment adjustments are assessed at the TIN level. Additionally, for APMs such as the Pioneer Accountable Care Organization (ACO) Model, we also assign a program-specific identifier (in the case of the Pioneer ACO Model, an ACO ID) to the organization(s), and associate that identifier with individual eligible clinicians who are, in turn, identified through a combination of a TIN and an NPI.
In the MIPS and APMs RFI, we sought comments on which specific identifier(s) should be used to identify a MIPS eligible clinician for purposes of determining eligibility, participation, and performance under the MIPS performance categories. In addition, we requested comments pertaining to what safeguards should be in place to ensure that MIPS eligible clinicians do not switch identifiers to avoid being considered “poor-performing” and comments on what safeguards should be in place to address any unintended consequences, if the MIPS eligible clinician identifier were a unique TIN/NPI combination, to ensure an appropriate assessment of the MIPS eligible clinician's performance. In the MIPS and APMs RFI, we sought comment on using a MIPS eligible clinician's TIN, NPI, or TIN/NPI combination as potential MIPS eligible clinician identifiers, or creating a unique MIPS eligible clinician identifier. The commenters did not demonstrate a consensus on a single best identifier.
Commenters favoring the use of the MIPS eligible clinician's TIN recommended that MIPS eligible clinicians should be associated with the TIN used for receiving payment from CMS claims. They further commented that this approach will deter MIPS eligible clinicians from “gaming” the system by switching to a higher performing group. Under this approach, commenters suggest that MIPS eligible clinicians who bill under more than one TIN can be assigned the performance and payment adjustment for the primary practice based upon majority of dollar amount of claims or encounters from the prior year.
Other commenters supported using unique TIN and NPI combinations to identify MIPS eligible clinicians. Commenters suggested many eligible clinicians are familiar with using TIN and NPI together from PQRS and other CMS programs. Commenters also noted this approach can calculate performance for multiple unique TIN/NPI combinations for those MIPS eligible clinicians who practice under more than one TIN. Commenters who supported the TIN/NPI also believe this approach enables greater accountability for individual MIPS eligible clinicians beyond what might be achieved when using TIN as an identifier and would provide a safeguard from MIPS eligible clinicians changing their identifier to avoid payment penalties.
Some commenters supported the use of only the NPI as the MIPS identifier. They believe this approach would best provide for individual accountability for quality in MIPS while minimizing potential confusion because providers do not generally change their NPI over time. Supporters of using the NPI only as the MIPS identifier also commented that this approach would be simplest for administrative purposes. These commenters also note the continuity inherent with the NPI would address the safeguard issue of providers
In the MIPS and APMs RFI, we also solicited feedback on the potential for creating a new MIPS identifier for the purposes of identifying MIPS eligible clinicians within the MIPS program. In response, many commenters indicated they would not support a new MIPS identifier. Commenters generally expressed concern that a new identifier for MIPS would only add to administrative burden, create confusion for MIPS eligible clinicians and increase reporting errors.
After reviewing the comments, we are not proposing to create a new MIPS eligible clinician identifier. However, we appreciate the various ways a MIPS eligible clinician may engage with MIPS, either individually or through a group. Therefore, we are proposing to use multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance. We also propose that the same identifier be used for all four performance categories; for example, if a group is submitting information collectively, then it must be measured collectively for all four MIPS performance categories: Quality, resource use, CPIA, and advancing care information. As discussed later in the CPS methodology section II.E.6. of this proposed rule, while we have multiple identifiers for participation and performance, we proposed to use a single identifier, TIN/NPI, for applying the payment adjustment, regardless of how the MIPS eligible clinician is assessed. Specifically, if the MIPS eligible clinician is identified for performance only using the TIN, when applying the payment adjustment we propose to use the TIN/NPI. We request comments on these proposals.
We propose to use a combination of billing TIN/NPI as the identifier to assess performance of an individual MIPS eligible clinician. Similar to PQRS, each unique TIN/NPI combination would be considered a different MIPS eligible clinician, and MIPS performance would be assessed separately for each TIN under which an individual bills. While we considered using the NPI only, we believe TIN/NPI is a better approach for MIPS. Both TIN and NPI are needed for payment purposes and using a combination of billing TIN/NPI as the MIPS eligible clinician identifier allows us to match MIPS performance and payment adjustments with the appropriate practice, particularly for MIPS eligible clinicians that bill under more than one TIN. In addition, using TIN/NPI also provides the flexibility to allow individual MIPS eligible clinician and group reporting, as the group identifiers being proposed also include TIN as part of the identifier. We recognize that TIN/NPI is not a static identifier and can change if an individual MIPS eligible clinician changes practices and/or if a group merges with another between the performance period and payment adjustment period. Section II.E.5.h. of this proposed rule describes in more detail how we propose to match performance in cases where the TIN/NPI changes. We request comments on this proposal.
We propose the following way a MIPS eligible clinician may have their performance assessed as part of a group under MIPS. We propose to use a group's billing TIN to identify a group. This approach has been used as a group identifier for both PQRS and VM. The use of the TIN would significantly reduce the participation burden that could be experienced by large groups. Additionally, the utilization of the TIN benefits large and small practices by allowing such entities to submit performance data one time for their group and develop systems to improve performance. Groups that report on quality performance measures through certain data submission methods must register in order to participate in MIPS as described in section II.E.5.b. of this proposed rule.
We are proposing to codify the definition of a group at § 414.1305 as a group that would consist of a single TIN with two or more MIPS eligible clinicians (as identified by their individual NPI) who have reassigned their billing rights to the TIN. We request comments on this proposal.
We propose the following way to identify a group to support APMs (see section II.F.5.b. of this proposed rule). To ensure we have accurately captured all of the eligible clinicians identified as participants that are participating in the APM Entity, we propose that each eligible clinician who is a participant of an APM Entity would be identified by a unique APM participant identifier. The unique APM participant identifier would be a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). For example, an APM participant identifier could be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111.
We are proposing to codify the definition of an APM Entity group at § 414.1305 as an APM Entity identified by a unique APM participant identifier. We request comments on these proposals. See section II.E.5.h. of this rule for proposed policies regarding requirements for APM Entity groups under MIPS.
Section 1848(q)(1)(C)(v) of the Act provides that in the case of a professional who first becomes a Medicare-enrolled eligible clinician during the performance period for a year (and had not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier), that the eligible clinician will not be treated as a MIPS eligible clinician until the subsequent year and performance period for that year. In addition, section 1848(q)(1)(C)(vi) of the Act clarifies that individuals who are not deemed MIPS eligible clinicians for a year will not receive a MIPS adjustment factor (or additional MIPS adjustment factor). Accordingly, we propose at § 414.1305 that a new Medicare-enrolled eligible clinician be defined as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. These eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. As discussed in section II.E.4. of this proposed rule, we are proposing that the MIPS performance period would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS adjustment is applied. For example, an eligible clinician who newly enrolls in Medicare within PECOS in 2017 would not be required to participate in MIPS in 2017, and he or she would not receive a MIPS adjustment in 2019. The same eligible clinician would be required to participate in MIPS in 2018 and would
We request comments on these proposals.
Sections 1848(q)(1)(C)(ii)(I) and (II) of the Act provide that the definition of a MIPS eligible clinician does not include, for a year, an eligible clinician who is a Qualifying APM Participant (QP) (as defined in section 1833(z)(2) of the Act) or a Partial Qualifying APM Participant (Partial QP) (as defined in section 1848(q)(1)(C)(iii) of the Act) who does not report on the applicable measures and activities that are required under MIPS. Section II.F.5. of this proposed rule provides detailed information on the determination of QPs and Partial QPs.
We propose that the definition of a MIPS eligible clinician at § 414.1310 does not include qualifying APM participants (defined at § 414.1305) and Partial QPs defined at § 414.1305 who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period. Partial QPs will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS adjustments. Please refer to the section II.F.5.c. of this proposed rule where this election is discussed in greater detail. We request comments on this proposal.
Section 1848(q)(1)(C)(ii)(III) of the Act provides that the definition of a MIPS eligible clinician does not include MIPS eligible clinicians who are below the low-volume threshold selected by the Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year. Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a low-volume threshold to apply for the purposes of this exclusion which may include one or more of the following: (1) The minimum number, as determined by the Secretary, of Part B-enrolled individuals who are treated by the MIPS eligible clinician for a particular performance period; (2) the minimum number, as determined by the Secretary, of items and services furnish to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the MIPS eligible clinician for a particular performance period.
We propose at § 414.1305 to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We believe this strategy is value-oriented as it retains as MIPS eligible clinicians those MIPS eligible clinicians who are treating relatively few beneficiaries, but engage in resource intensive specialties, or those treating many beneficiaries with relatively low-priced services. By requiring both criteria be met, we can meaningfully measure the performance and drive quality improvement across the broadest range of MIPS eligible clinician types and specialties. Conversely, it excludes MIPS eligible clinicians who do not have a substantial quantity of interactions with Medicare beneficiaries or furnish high cost services.
In developing this proposal we considered using items and services furnished to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period rather than patients but a review of the data reflected there were nominal differences between the two methods. We plan to monitor the proposed requirement and anticipate that the specific thresholds will evolve over time. We request comments on this proposal including alternative patient threshold, case thresholds, and dollar values.
As noted above, section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for the purpose of assessing performance in the quality category and give the Secretary the discretion to do so for the other performance categories. The process established for purposes of MIPS must, to the extent practicable, reflect the range of items and services furnished by the MIPS eligible clinicians in the group. We believe this means that the process established for purposes of MIPS should, to the extent practicable, encompass elements that enable MIPS eligible clinicians in a group to meet reporting requirements that reflect the range of items and services furnished by the MIPS eligible clinicians in the group. At § 414.1310(e) we propose requirements for groups. For purposes of section 1848(q)(1)(D) of the Act, at § 414.1310(e)(1) we propose the following way for individual MIPS eligible clinicians to have their performance assessed as a group: As part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN (as discussed further in section II.E.1.f. of this proposed rule).
In order to have its performance assessed as a group, at § 414.1310(e)(2) we propose a group must meet the proposed definition of a group at all times during the performance period for the MIPS payment year. Additionally, at § 414.1310(e)(3) we propose in order to have their performance assessed as a group, individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN. At § 414.1310(e)(3), we propose a group that elects to have its performance assessed as a group would be assessed as a group across all four MIPS performance categories. For example, if a group submits data for the quality performance category as a group, CMS would assess them as a group for the remaining three performance categories. We solicit public comments on the proposal regarding how groups will be assessed under MIPS.
Under the PQRS, groups are required to complete a registration process to participate in PQRS as a group. During the implementation and administration of PQRS, we received feedback from stakeholders regarding the registration process for the various methods available for data submission. Stakeholders indicated that the registration process was burdensome and confusing. Additionally, we discovered that during the registration process when groups are required to select their group submission mechanism, groups sometimes selected the option not applicable to their group, which has created issues surrounding the mismatch of data. Unreconciled data mismatching can impact the quality of data. In order to address this issue, we are proposing to eliminate a registration process for groups submitting data using third party entities. When groups
At § 414.1310(e)(5), we propose that a group must adhere to an election process established and required by CMS, as described below. We do not propose to require groups to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey for the quality performance category as described further in section II.E.5.b. of this proposed rule. For all other data submission methods, groups must work with appropriate third party entities to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission. In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, we propose that such groups must register by June 30 of the applicable 12-month performance period (that is, June 30, 2017, for performance periods occurring in 2017). For the criteria regarding group reporting applicable to the four MIPS performance categories, see section II.E.5.a. of this proposed rule.
Section 1848(q)(5)(I) of the Act establishes the use of voluntary virtual groups for certain assessment purposes. The statute requires the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect to form a virtual group with at least one other such individual MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians for a performance period of a year. As determined in statute, individual MIPS eligible clinicians and groups forming virtual groups are required to make such election prior to the start of the applicable performance period under MIPS and cannot change their election during the performance period. As discussed in section II.E.4. of this proposed rule, we are proposing that the performance period would be based on a calendar year.
As we assessed the timeline for the establishment and implementation of virtual groups and applicable election process and requirements for the first performance period under MIPS, we identified significant barriers regarding the development of a technological infrastructure required for successful implementation and the operationalization of such provisions that would negatively impact the execution of virtual groups as a conducive option for MIPS eligible clinicians or groups. The development of an electronic system before policies are finalized poses several risks, particularly relating to the impediments of completing and adequately testing the system before execution and assuring that any change in policy made during the rulemaking process are reflected in the system and operationalized accordingly. We believe that it would be exceedingly difficult to make a successful system to support the implementation of virtual groups and given these factors, such implementation would compromise not only the integrity of the system, but the intent of the policies.
Additionally, we recognize that it would be impossible for us to develop an entire infrastructure for electronic transactions pertaining to an election process, reporting of data, and performance measurement before the start of the performance period beginning on January 1, 2017. Moreover, the actual implementation timeframe would be more condensed given that the development, testing, and execution of such a system would need to be completed months in advance of the beginning of the performance period in order to provide MIPS eligible clinicians and groups with an election period.
During the implementation and ongoing functionality of other programs such as PQRS, Medicare EHR Incentive Program, and VM, we received feedback from stakeholders regarding issues they encountered when submitting reportable data for these programs. With virtual groups as a new option, we want to minimize potential issues for end-users and implement a system that encourages and enables MIPS eligible clinicians and groups to participate in a virtual group. A web-based registration process, which would simplify and streamline the process for participation, is our preferred approach. Given the aforementioned dynamics discussed in this section, implementation for the calendar year 2017 performance period is infeasible as a result of the insufficient timeframe to develop a web-based registration process. We have assessed alternative approaches for the first year only, such as an email registration process, but believe that there are limitations and potential risks for numerous errors, such as submitted information being incomplete or not in the required format. A manual verification process would cause a significant delay in verifying registration due to the lack of an automated system to ensure the accuracy of the type of information submitted that is required for registration. We believe that an email registration process could become cumbersome and a burden for groups to pursue participation in a virtual group. Implementation of a web-based registration system for calendar year 2018 would provide the necessary time to establish and implement an election process and requirements applicable to virtual groups, and enable proper system development and operations. We intend to implement virtual groups for the 2018 calendar year performance period and we intend to address all of the requirements pertaining to virtual groups in future rulemaking. We request comments on factors we should consider regarding the establishment and implementation of virtual groups.
Section 1848(q)(5)(I)(iii)(I) of the Act provides that the election process must occur prior to the performance period and may not be changed during the performance period. We propose to establish an election process that would end on June 30 of a calendar year preceding the applicable performance period. During the election process, we propose that individual MIPS eligible clinicians and groups electing to be a virtual group would be required to register in order to submit reportable data. Virtual groups would be assessed across all four MIPS performance categories. In future rulemaking, we intend to address all elements relating to the election process. We solicit public comments on this proposal. Future rulemaking will outline the criteria and requirements regarding the formation of virtual groups.
MIPS incorporates many of the requirements of several programs into a single, comprehensive program. This consolidation includes key policy goals as common themes across multiple categories such as quality improvement, patient and family engagement, and care coordination through interoperable health information exchange. However, each of these legacy programs included different eligibility requirements, reporting periods, and systems for
MIPS applies to payments for items and services furnished on or after January 1, 2019. Section 1848(q)(4) of the Act requires the Secretary to establish a performance period (or periods) for a year (beginning with 2019). Such performance period (or periods) must begin and end prior to such year and be as close as possible to such year. In addition, section 1848(q)(7) of the Act provides that, not later than 30 days prior to January 1 of the applicable year, the Secretary must make available to each MIPS eligible clinician the MIPS adjustment (and, as applicable, the additional MIPS adjustment) applicable to the MIPS eligible clinician for items and services furnished by the MIPS eligible clinician during the year.
We considered various factors when developing the policy for the MIPS performance period. Stakeholders have stated that having a performance period as close to when payments are adjusted is beneficial, even if such period would be less than a year. We have also received feedback from stakeholders that they prefer having a 1 year performance period and have further suggested that the performance period start during the calendar year. For example, having the performance period occurring from July 1 through June 30. We additionally considered operational factors, such as that a 1 year performance period may be beneficial for all four performance categories because many measures and activities cannot be reported in a shorter time frame. We also considered that data submission activities and claims for items and services furnished during the 1 year performance period (which could be used for claims- or administrative claims-based quality or resource use measures) may not be fully processed until the following year.
These circumstances will require adequate lead time to collect performance data, assess performance, and compute the MIPS adjustment so the applicable MIPS adjustment can be made available to each MIPS eligible clinician at least 30 days prior to when the payment adjustment is applied each year. For 2019, these actions will occur during 2018. In other payment systems, we have used claims that are processed within a specified time period after the end of the performance period, such as 60 or 90 days, for assessment of performance and application of the payment adjustment. For MIPS, we propose at § 414.1325(g)(2) to use claims that are processed within 90 days, if operationally feasible, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. If we determine that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we would utilize a 60-day duration.
This proposal does not affect the performance period per se, but rather the deadline by which claims for items and services furnished during the performance period need to be processed for those items and services to be included in our calculation. To the extent that claims are used for submitting data on MIPS measures and activities to us, such claims would have to be processed by no later than 90 days after the end of the applicable performance period, in order for information on the claims to be included in our calculations. As noted above, if we determine that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we will utilize a 60-day duration. As an alternative to the above proposal, we also considered using claims that are paid within 60 days after 2017, for assessment of performance and application of the MIPS payment adjustment for 2019. We are seeking comment on both approaches.
Given the need to collect and process information, we propose at § 414.1320 that for 2019 and subsequent years, the performance period under MIPS would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS adjustment is applied. For example, the performance period for the 2019 MIPS adjustment would be the full calendar year 2017, that is, January 1, 2017 through December 31, 2017. We propose to use the 2017 performance year for the 2019 payment adjustment consistent with other CMS programs. This approach allows for a full year of measurement and sufficient time to base adjustments on complete and accurate information.
For individual MIPS eligible clinicians and group practices with less than 12 months of performance data to report, such as when a MIPS eligible clinician switches practices during the performance period or when a MIPS eligible clinician may have stopped practicing for some portion of the performance period (for example, a MIPS eligible clinician who is on maternity leave or has an illness), we propose that the individual MIPS eligible clinician or group would be required to report all performance data available from the performance period. Specifically, if a MIPS eligible clinician is reporting as an individual, they would report all partial year performance data. Alternatively, if the MIPS eligible clinician is reporting with a group, then the group would report all performance data available from the performance period, including partial year performance data available for the individual MIPS eligible clinician.
Under this approach, MIPS eligible clinicians with partial year performance data could achieve a positive, neutral, or negative MIPS adjustment based on their performance data. We propose this approach in order to incentivize accountability for all performance during the performance period. Two policies will help minimize the impact of partial year data. First, MIPS eligible clinicians with volume below the low-volume threshold would be excluded from any payment adjustments. Second, MIPS eligible clinicians who report measures, yet have insufficient sample size, would not be scored on those measures and activities refer to section II.E.6. of this proposed rule for further details.
To potentially refine this proposal in future years, we seek comment on methods to identify accurately MIPS eligible clinicians with less than 12-month reporting periods, notwithstanding common and expected absences due to illness, vacation, or holiday leave. Reliable identification of these MIPS eligible clinicians will allow us to analyze the characteristics of this MIPS eligible clinicians' patient population and better understand how a reduced reporting period impacts performance.
We also seek public comment on an alternative approach for future years for assessment of individual MIPS eligible clinicians with less than 12 months of performance data in the performance year. For example, if we can identify such MIPS eligible clinician's and confirm there are data issues that led to invalid performance calculations, then we could score the MIPS eligible clinician with a CPS equal to the performance threshold, which would result in a zero payment adjustment. We note this approach would not assess a MIPS eligible clinicians' performance for partial-year performance data. We do
We also seek comment on reasonable thresholds for considering performance to be less than 12 months. For example, we expect that some MIPS eligible clinicians will take leave related to illness, vacation, and holidays. We would not anticipate applying special policies for lack of performance related to these common and expected absences assuming MIPS eligible clinicians' quality reporting includes measures with sufficient sample size to generate valid and reliable scores. We seek comment on how to account for MIPS eligible clinicians with extended leave that may affect measure sample size.
We request comments on these proposals and approaches.
Section 1848(q)(2)(A) of the Act requires the Secretary to use four performance categories in determining each MIPS eligible clinician's CPS under the MIPS: Quality; resource use; CPIA; and advancing care information. Section 1848(q)(2)(B) of the Act, subject to section 1848(q)(2)(C) of the Act, describes the measures and activities that, for purposes of the MIPS performance standards, must be specified under each performance category for a performance period.
Section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the MIPS quality performance category as the quality measures included in the annual final list of quality measures published under section 1848(q)(2)(D)(i) of the Act and the list of quality measures described in section 1848(q)(2)(D)(vi) of the Act used by QCDRs under section 1848(m)(3)(E) of the Act. Under section 1848(q)(2)(C)(i) of the Act, the Secretary must, as feasible, emphasize the application of outcome-based measures in applying section 1848(q)(2)(B)(i) of the Act. Under section 1848(q)(2)(C)(iii) of the Act, the Secretary may also use global measures, such as global outcome measures and population-based measures, for purposes of the quality performance category. Section 1848(q)(2)(B)(ii) of the Act describes the measures and activities that must be specified under the resource use performance category as the measurement of resource use for the performance period under section 1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.
Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use measures from other CMS payment systems, such as measures for inpatient hospitals, for purposes of the quality and resource use performance categories, except that the Secretary may not use measures for hospital outpatient departments, other than in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. This proposed rule seeks comment on how it might be feasible and when it might be appropriate to incorporate measures from other systems into MIPS for clinicians that work in facilities such as inpatient hospitals. For example, it may be appropriate to use such measures when other applicable measures are not available for individual MIPS eligible clinicians or when strong payment incentives are tied to measure performance, either at the facility level or with employed or affiliated MIPS eligible clinicians.
Section 1848(q)(2)(B)(iii) of the Act describes the measures and activities that must be specified under the CPIA performance category as CPIAs under subcategories specified by the Secretary for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act. Section 1848(q)(2)(C)(v)(III) of the Act defines a CPIA as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and geographic HPSAs in establishing CPIAs.
Section 1848(q)(2)(B)(iv) of the Act describes the measures and activities that must be specified under the advancing care information performance category as the requirements established for the performance period under section 1848(o)(2) for determining whether an eligible clinician is a meaningful EHR user.
As discussed in section II.E.1.b. of this proposed rule, section 1848(q)(2)(C)(iv) of the Act requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians in specifying measures and activities under the MIPS performance categories and allows the Secretary, to the extent feasible and appropriate, to take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category. In doing so, the Secretary is required to consult with non-patient facing professionals.
Section 101(b) of MACRA amends certain provisions of section 1848(k), (m), (o), and (p) of the Act to generally provide that the Secretary will carry out such provisions in accordance with section 1848(q)(1)(F) of the Act for purposes of MIPS. Section 1848(q)(1)(F) of the Act provides that, in applying a provision of section 1848(k), (m), (o), and (p) of the Act for purposes of MIPS, the Secretary must adjust the application of the provision to ensure that it is consistent with the MIPS requirements and must not apply the provision to the extent that it is duplicative with a MIPS provision.
We propose at § 414.1325(a) that individual MIPS eligible clinicians and groups would be required to submit data on measures and activities for the quality, CPIA and advancing care information performance categories. As proposed at § 414.1325(f), we do not propose any data submission requirements for the resource use performance category and for certain quality measures used to assess performance on the quality performance category and for certain activities in the CPIA performance category. For the resource use performance category, we propose that each individual MIPS eligible clinician's and group's resource use performance would be calculated using administrative claims data. As a result, individual MIPS eligible clinicians and groups would not be required to submit any additional information for the resource use performance category. In addition, we would be using administrative claims data to calculate performance on a subset of the MIPS quality measures and the CPIA performance category. For this subset of quality measures and CPIAs, MIPS eligible clinicians and groups would not be required to submit additional information. For individual clinicians and groups that are not MIPS eligible clinicians, such as physical therapists, but elect to report to MIPS, we would calculate administrative claims resource use measures and quality measures, if data is available. We are proposing multiple data
We propose at § 414.1325(d) that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending CPIA data, but a MIPS eligible clinician could not use two submission mechanisms for a single category such as submitting three quality measures via claims and three quality measures via registry. We believe the proposal to allow multiple mechanisms, while restricting the number of mechanisms per category, offers flexibility without adding undue complexity.
For individual MIPS eligible clinicians, we propose at § 414.1325(b), that an individual MIPS eligible clinician may choose to submit their quality, CPIA, and advancing care information data using qualified registry, QCDR, or EHR submission mechanisms. Furthermore, we propose at § 414.1400 that a qualified registry, health IT vendor, or QCDR could submit data on behalf of the MIPS eligible clinician for the three performance categories: Quality, CPIA, and advancing care information. As described in section II.E.9. of this proposed rule, these third party intermediaries would have to be qualified to submit for each of the performance categories. Additionally, we propose at § 414.1325(b)(4) and (5) that individual MIPS eligible clinicians may elect to report quality information via Medicare Part B claims and their CPIA and advancing care information performance category data through attestation.
For groups that are not reporting through the APM scoring standard, we propose at § 414.1325(c) that these groups may choose to submit their MIPS quality, CPIA, and advancing care information data using qualified registry, QCDR, EHR, or CMS Web Interface (for groups of 25+ MIPS eligible clinicians) submission mechanisms. Furthermore, we propose at § 414.1400 that a qualified registry, health IT vendor that obtains data from a MIPS eligible clinician's CEHRT, or QCDR could submit data on behalf of the group for the three performance categories: Quality, CPIA, and advancing care information. Additionally, groups may elect to submit their CPIA or advancing care information performance category data through attestation.
For those MIPS eligible clinicians participating in an APM that uses the APM scoring standard, we refer readers to section II.E.5.h. of this proposed rule, which describes how certain APM Entities submit data to MIPS, including separate approaches to the quality and resource use performance categories for APMs.
We propose one exception to the requirement for one reporting mechanism per category. Groups consisting of two or more eligible clinicians that elect to include CAHPS for MIPS as a quality measure must use a CMS-approved survey vendor. Their other quality information may be reported by any single one of the other proposed submission mechanisms.
While we allow MIPS eligible clinicians and groups to submit data for different performance categories via multiple submission mechanisms, we encourage MIPS eligible clinicians to submit MIPS information for the CPIA and advancing care information performance categories through the same reporting mechanism that is used for quality reporting. We believe it would reduce administrative burden and would simplify the data submission process for MIPS eligible clinicians by having a single reporting mechanism for all three performance categories for which MIPS eligible clinicians would be required to submit data: Quality, CPIA and advancing care information. However, we were concerned that not all third party entities would be able to implement the changes necessary to support reporting on all categories in the first year. We seek comments for future rulemaking on whether we should propose requiring health IT vendors, QCDRs and qualified registries to have the capability to submit data for all MIPS performance categories.
As we noted in this section of the proposed rule, we propose that MIPS eligible clinicians may report measures and activities using different submission methods across the performance categories. As we gain experience under MIPS, we anticipate that in future years it may be beneficial and reduce burden on MIPS eligible clinicians to require data for multiple performance categories to come through a single submission mechanism.
Further, we will be flexible in implementing MIPS. For example, if a MIPS eligible clinician submits data via multiple submission mechanisms (for example, registry and QCDR), we would score all the options and use the highest performance score for the eligible clinician or group as described in section II.E.6.a.(1)(b). However, we encourage eligible clinicians to report data for a given performance category using a single submission mechanism.
Finally, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the CPS methodology, to encourage MIPS eligible clinicians to report on applicable measures with respect to the quality performance category through the use of CEHRT and QCDRs. We note that this proposed rule uses the term CEHRT and certified health IT in different contexts. For an explanation of these terms and contextual use within this proposed rule, we refer readers to section II.E.5.g. of this proposed rule.
We have multiple policies to encourage the usage of QCDRs and CEHRT. In part, we are promoting the use of CEHRT by awarding bonus points in the quality scoring section for measures gathered and reported electronically via the QCDR, qualified registry, Web Interface, or CEHRT submission mechanisms (see II.E.6.b). By promoting use of CEHRT through various submission mechanisms, we believe MIPS eligible clinicians have flexibility in implementing electronic measure reporting in a manner which best suits their practice.
To encourage the use of QCDRs, we have created opportunities for QCDRs to report new and innovative quality measures. In addition, several CPIAs emphasize QCDR participation. Finally, we allow for QCDRs to report data on all MIPS performance categories that require data submission and hope this will become a viable option for MIPS eligible clinicians. We believe these flexible options will allow MIPS eligible clinicians to more easily meet the submission criteria for MIPS, which in turn will positively affect their CPS.
We request comments on these proposals.
For the submission mechanisms described in section II.E.5.a.(2) of this proposed rule, we propose a submission deadline whereby all associated data for all performance categories must be submitted. In establishing the submission deadlines, we have taken into account multiple considerations, including the type of submission mechanism, the MIPS performance period, and stakeholder input and our experiences under the submission deadlines for the PQRS, VM, and Medicare EHR Incentive Programs.
Historically, under the PQRS, VM or Medicare EHR Incentive Programs, the submission of data occurred after the close of the performance periods. Our experience has shown that allowing for the submission of data after the close of the performance period provides either the eligible clinician or the third party intermediary time to ensure the data they submit to us is valid, accurate and has undergone necessary data quality checks. Stakeholders have also stated that they would appreciate the ability to submit data to us on a more frequent basis so they can receive feedback more frequently throughout the performance period. We also note that, as described in section II.E.4. of this proposed rule, the MIPS performance period for payments adjusted in 2019 is calendar year 2017 (January 1 through December 31).
Based on the factors noted, we propose at § 414.1325(e) the data submission deadline for the qualified
We further propose that for the Medicare Part B claims submission mechanism, the submission deadline would occur during the performance period with claims required to be processed no later than 90 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, the submission deadline will occur during an eight-week period following the close of the performance period that will begin no earlier than January 1 and end no later than March 31. For example, the CMS Web Interface submission period could span an 8 week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site.
We request comments on these proposals.
The MIPS program is one piece of the broader health care infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety for all Americans. We seek to balance the sometimes competing considerations of the health system and minimize burdens on health care providers given the short timeframe available under the MACRA for implementation. Ultimately, MIPS should, in concert with other provisions of the Act, support health care that is patient-centered, evidence-based, prevention-oriented, outcome driven, efficient, and equitable.
Under MIPS, clinicians are incentivized to engage in improvement measures and activities that have a proven impact on patient health and safety and are relevant to their patient population. We envision a future state where MIPS eligible clinicians will be seamlessly using their certified health IT to leverage advanced clinical quality measurement to manage patient population with the least amount of workflow disruption and reporting burden. Ensuring clinicians are held accountable for patients' transitions across the continuum of care is imperative. For example, when a patient is discharged from an emergency department to a primary care physician office, the emergency department clinicians should have a shared incentive for a seamless transition. Clinicians may also be working with a QCDR to abstract and report quality measures to CMS and commercial payers and to track patients longitudinally over time for quality improvement.
Ideally, clinicians in the MIPS program will have accountability for quality and resource use measures that are related to one another and will be engaged in CPIAs that directly help them improve in both specialty-specific clinical practice and more holistic areas (for example, patient experience, prevention, population health). Finally, MIPS eligible clinicians will be using CEHRT and other tools which leverage interoperable standards for data capture, usage, and exchange in order to facilitate and enhance patient and family engagement, care coordination among diverse care team members, and, in continuous learning and rapid-cycle improvement leveraging advanced quality measurement and safety initiatives.
One of our goals in the MIPS program is to use a patient-centered approach to program development that will lead to better, smarter, and healthier care. Part of that goal includes meaningful measurement which we hope to achieve through:
• Measuring performance on measures that are relevant and meaningful.
• Maximizing the benefits of CEHRT.
• Flexible scoring that recognizes all of a MIPS eligible clinician's efforts above a minimum level of effort and rewards performance that goes above and beyond the norm.
• Measures that are built around real clinical workflows and data captured in the course of patient care activities.
• Measures and scoring that can discern meaningful differences in performance in each performance category and collectively between low and high performers.
Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards and, using that methodology, to provide for a CPS for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the quality performance category in determining each MIPS eligible clinician's CPS, and section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the quality performance category.
The statute does not specify the number of quality measures on which a MIPS eligible clinician must report, nor does it specify the amount or type of information that a MIPS eligible clinician must report on each quality measure. However, section 1848(q)(2)(C)(i) of the Act requires the Secretary, as feasible, to emphasize the application of outcomes-based measures.
Sections 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary to encourage the use of CEHRT and QCDRs for reporting measures under the quality performance category under the CPS methodology, but the statute does not limit the Secretary's discretion to establish other reporting mechanisms.
Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient-facing MIPS eligible clinicians and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures or activities to such clinicians.
Previously, the PQRS, which is a pay-for-reporting program, defined standards for satisfactory reporting and satisfactory participation to earn payment incentives or to avoid a payment adjustment EPs could choose from a number of reporting mechanisms and options. Based on the reporting option, the EP had to report on a certain number of measures for a certain portion of their patients. In addition, the measures had to span a set number of National Quality Strategy (NQS) domains, information related to the NQS can be found at
MIPS, in contrast to PQRS, is not a pay-for-reporting program, and we propose that it would not have a “satisfactory reporting” requirement. However, in order to develop an appropriate methodology for scoring the quality performance category, we believe that MIPS needs to define the expected data submission criteria and that the measures need to meet a data completeness standard. In this section we propose the minimum data submission criteria and data completeness standard for the MIPS quality performance category for the submission mechanisms that were proposed earlier in section II.E.5.a. The scoring methodology described in section II.E.6. of this proposed rule would adjust the quality performance category scores based on whether or not an individual MIPS eligible clinician or group met these criteria.
In the MIPS and APMs RFI, we requested feedback on numerous provisions related to data submission criteria including: How many measures should be required? Should we maintain the policy that measures cover a specified number of NQS domains? How do we apply the quality performance category to MIPS eligible clinicians that are in specialties that may not have enough measures to meet our defined criteria? Several themes emerged from the comments. Commenters expressed concern that the general PQRS satisfactory reporting requirement to report nine measures across three NQS domains is too high and forces eligible clinicians to report measures that are not relevant to their practices. The commenters requested a more meaningful set of requirements that focused on patient care, with some expressing the opinion that NQS domain requirements are arbitrary and make reporting more difficult. Some commenters asked that we align measures across payers and consider using core measure sets. Other commenters expressed the need for flexibility and different reporting options for different types of practices.
In response to the comments, and based on our desire to simplify the MIPS reporting system and make the measurement more meaningful, we are proposing MIPS quality criteria that focus on measures that are important to beneficiaries and maintain some of the flexibility from PQRS, while addressing several of the issues that concerned commenters.
• To encourage meaningful measurement, we are proposing to allow individual MIPS eligible clinicians and groups the flexibility to determine the most meaningful measures and reporting mechanisms for their practice.
• To simplify the reporting criteria, we are aligning the submission criteria for several of the reporting mechanisms.
• To reduce administrative burden and focus on measures that matter, we are lowering the expected number of the measures for several of the reporting mechanisms, yet are still requiring that certain types of measures be reported.
• To create alignment with other payers and reduce burden on MIPS eligible clinicians, we are incorporating measures that align with other national payers.
• To create a more comprehensive picture of the practice performance, we are also proposing to use all-payer data where possible.
As beneficiary health is always our top priority, we propose criteria to continue encouraging the reporting of certain measures such as outcome, appropriate use, patient safety, efficiency, care coordination, or patient experience measures. However, we are proposing to remove the requirement for measures to span across multiple domains of the NQS. We continue to believe the NQS domains to be extremely important and we encourage MIPS eligible clinicians to continue to strive to provide care that focuses on: Effective clinical care, communication, efficiency and cost reduction, person and caregiver-centered experience and outcomes, community and population health, and patient safety. While we will not require that a certain number of measures must span multiple domains, we strongly encourage MIPS eligible clinicians to select measures that cross multiple domains. In addition, we believe the MIPS program overall, with the focus on resource use, CPIAs, and advancing care information performance categories will naturally cover many elements in the NQS.
For the 2019 MIPS adjustment year, the quality performance category will account for 50 percent of the CPS, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act states the quality performance category will account for 30 percent of the CPS for MIPS. However, section 1848(q)(2)(E)(i)(I)(bb) of the Act stipulates that for the first and second years for which MIPS applies to payments, the percentage of the CPS applicable for the quality performance category will be increased so that the total percentage points of the increase equals the total number of percentage points by which the percentage applied for the resource use performance category is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of the Act requires that, for the first year for which MIPS applies to payments, not more than 10 percent of the of CPS shall be based on performance to the resource use performance category. Furthermore, section 1848(q)(2)(E)(i)(II)(bb) of the Act states that, for the second year for which MIPS applies to payments, not more than 15 percent of the CPS shall be based on performance to the resource use performance category. We propose at § 414.1330 for payment years 2019 and 2020, 50 percent and 45 percent, respectively, of the MIPS CPS will be based on performance on the quality performance category. For the third and future years, 30 percent of the MIPS CPS will be based on performance on the quality performance category.
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat any MIPS eligible clinician who fails to report on a required measure or activity as achieving the lowest potential score applicable to the measure or activity. Specifically, under our proposed scoring policies, a MIPS eligible clinician or group that reports on all required measures and activities could potentially obtain the highest score possible within the performance category, presuming they performed well on the measures and activities they reported. A MIPS eligible clinician or group who does not meet the reporting threshold would receive a zero score for the unreported items in the category (in accordance with section 1848(q)(5)(B)(i) of the Act). The MIPS eligible clinician or group could still obtain a relatively good score by performing very well on the remaining items, but a zero score would prevent the MIPS eligible clinician or group from obtaining the highest possible score.
The following are the proposed criteria for the various proposed MIPS data submission mechanisms described above in section II.E.5.a. of this
We propose at § 414.1335 that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding CMS Web Interface, and for CAHPS for MIPS survey, CMS-approved survey vendors) would be required to meet the following submission criteria. We propose that for the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C and including at least one outcome measure. If an applicable outcome measure is not available, we propose that the MIPS eligible clinician or group would be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then we propose the MIPS eligible clinician or group would be required to report on each measure that is applicable.
MIPS eligible clinicians and groups will have to select their measures from either the list of all MIPS measures in Table A or a set of specialty-specific measure set in Table E. Note that some specialty-specific measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level.
We designed the specialty-specific measure sets to address feedback we have received in the past that the quality measure selection process can be confusing. A common complaint about PQRS was that EPs were asked to review close to 300 measures to find applicable measures for their specialty. The specialty measure sets in Table E are the same measures that are within Table A, however these are sorted consistent with the American Board of Medical Specialties (ABMS) specialties. Please note that these specialty-specific measure sets are not all inclusive of every specialty or subspecialty. We request comments on the measures proposed under each of the specialty-specific measure sets. Specifically, we seek comments on whether or not the measures proposed for inclusion in the specialty-specific measure sets are appropriate for the designated specialty or sub-specialty and whether there are additional proposed measures that should be included in a particular specialty-specific measure set.
Furthermore, we note that there are some special scenarios for those MIPS eligible clinicians who select their measures from a specialty-specific measure set at either the specialty or subspecialty level (Table E). For example, some of the specialty-specific measure sets have less than six measures, in these instances MIPS eligible clinicians would report on all of the available measures including an outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures), within the set and a cross-cutting measure if they are a patient-facing MIPS eligible clinician. To illustrate, the subspecialty-level the electrophysiology cardiac specialist specialty-specific measure set only has three measures within the set, all of which are outcome measures. MIPS eligible clinicians and groups reporting on the electrophysiology cardiac specialist specialty-specific measure set would report on all three measures and since these MIPS eligible clinicians are patient-facing they must also report on a cross-cutting measure which is defined in Table C. In other scenarios, the specialty-specific measure sets may have six or more measures, in these instances MIPS eligible clinicians would report on at least six measures including at least one cross-cutting measure and at least one outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measure). Specifically, the general surgery specialty-specific measure set has eight measures within the set, including four outcome measures, three other high priority measures and one process measure. MIPS eligible clinicians and groups reporting on the general surgery specialty-specific measure set would either have the option to report on all measures within the set or could select six measures from the set and since these MIPS eligible clinicians are patient-facing one of their six measures must be a cross-cutting measure which is defined in Table C.
As noted above, the submission criteria for each specialty-specific measure set, or in the measure set defined at the subspecialty level, if applicable. Regardless of the number of measures that are contained in a specialty-specific measure set, MIPS eligible clinicians reporting on a measure set would be required to report at least one cross-cutting measure and either at least one outcome measure or, if no outcome measures are available in that specialty-specific measure set, report another high priority measure. MIPS eligible clinicians or groups that report on a specialty-specific measure set that includes more than six measures can report on as many measures as they wish as long as they meet the minimum requirement to report at least six measures, including one cross-cutting measure and one outcome measure, or if an outcome measure is not available another high priority measure. We seek comment on our proposal to allow reporting of specialty-specific measure sets to meet the submission criteria for the quality performance category, including whether it is appropriate to allow reporting of a measure set at the subspecialty level to meet such criteria, since reporting at the subspecialty level would require reporting on fewer measures. Alternatively, we seek comment on whether we should only consider reporting up to six measures at the higher overall specialty level to satisfy the submission criteria. We note that our proposal to allow reporting of specialty-specific measure sets at the subspecialty level was intended to address the fact that very specialized clinicians who may be represented by our subspecialty categories may only have one or two applicable measures. Further, we note that we will continue to work with specialty societies and other measure developers to increase the availability of applicable measures for specialists across the board.
We propose to define a high priority measure at § 414.1305 as an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measures. These measures are identified in Table A. We further note that measure types listed as an “intermediate outcome” are considered outcome measures for the purposes of scoring; see section II.E.6.
As an alternative to the above proposals, we also considered requiring individual MIPS eligible clinicians submitting via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding the CMS Web Interface and, for CAHPS for MIPS survey, CMS-approved survey vendors) to meet the following submission criteria. For the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C and one high priority measure (outcome, appropriate use, patient safety, efficiency, patient experience, and care
As discussed in section II.E.1.b. of this proposed rule, MIPS eligible clinicians who are non-patient-facing MIPS eligible clinicians would not be required to report any cross-cutting measures.
We intend to develop a validation process to review and validate a MIPS eligible clinician's or group's ability to report on at least six quality measures, or a specialty-specific measure set, with a sufficient sample size, including at least one cross-cutting measure (if the MIPS eligible clinician is patient-facing) and either an outcome measure if one is available or another high priority measure. If a MIPS eligible clinician or group had the ability to report on the minimum required measures with sufficient sample size and elects to report on fewer than the minimum required measures, then, as described in the proposed scoring algorithm in section II.E.6., the missing measures would be scored with a zero performance score.
Our proposal is a decrease from the 2016 PQRS requirement to report at least nine measures. In addition, as previously noted, we propose to no longer require reporting across multiple NQS domains. We believe these proposals are the best approach for the quality performance category because it decreases the MIPS eligible clinician's reporting burden while focusing on more meaningful types of measures.
We also note that we believe that outcome measures are more valuable than clinical process measures and are instrumental to improving the quality of care patients receive. To keep the emphasis on such measures in the statute, we plan to increase the requirements for reporting outcome measures over the next several years through future rulemaking, as more outcome measures become available. For example, we may increase the required number of outcome measures to two or three. We also believe that appropriate use, patient experience, safety, and care coordination measures are more relevant than clinical process measures for improving care of patients. Through future rulemaking, we plan to increase the requirements for reporting on these types of measures over time.
In consideration of which MIPS measures to identify as reasonably focused on appropriate use, we have selected measures which focus on minimizing overuse of services, treatments, or the related ancillary testing that may promote overuse of services and treatments. We have also included select measures of underuse of specific treatments or services that either (1) reflected overuse of alternative treatments and services that were are not evidence-based or supported by clinical guidelines; or (2) where the intent of the measure reflected overuse of alternative treatments and services that were not evidence-based or supported by clinical guidelines. We realize there are differing opinions on what constitutes appropriate use. Therefore, we are seeking comments on what specific measures of over or under use should be included as appropriate use measures.
We plan to continue developing care episode groups, patient condition groups, and patient relationship categories (and codes for such groups and categories). We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking. We also will closely examine the recommendations from HHS' Office of the Assistant Secretary for Planning and Evaluation (ASPE) study, once they are available, on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the IMPACT Act and incorporate them as feasible and appropriate through future rulemaking. In addition, we are seeking comments on ways to minimize potential gaming, for example, requiring MIPS eligible clinicians to report only on measures for which they have a sufficient sample size, to address concerns that MIPS eligible clinicians may solely report on measures that do not have a sufficient sample size to decrease the overall weight on their quality score. More information on the way we propose to score MIPS eligible clinicians in this scenario is in section II.E.6.a.2. We also seek comment on whether these proposals sufficiently encourage providers and measure developers to move away from clinical process measures and towards outcome measures and measures that reflect other NQS domains. We request comments on these proposals.
We propose at § 414.1335 the following criteria for the submission of data on quality measures by registered groups of 25 or more MIPS eligible clinicians who want to report via the CMS Web Interface. For the applicable 12-month performance period, we propose that the group would be required to report on all measures included in the CMS Web Interface completely, accurately, and timely by populating data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module/measure. If the pool of eligible assigned beneficiaries is less than 248, then the group would report on 100 percent of assigned beneficiaries. A group would be required to report on at least one measure for which there is Medicare patient data. We do not propose any modifications to this reporting process. Groups reporting via the CMS Web Interface are required to report on all of the measures in the set. Any measures not reported would be considered zero performance for that measure in our scoring algorithm.
Lastly, from our experience with using the CMS Web Interface under prior Medicare programs we are aware groups may register for this mechanism and have zero Medicare patients assigned and sampled to them. We clarify that should a group have no assigned patients, then the group, or individual MIPS eligible clinicians within the group, would need to select another mechanism to submit data to MIPS. If a group does not typically see Medicare patients for which the CMS Web Interface measures are applicable, or if the group does not have adequate billing history for Medicare patients to be used for assignment and sampling of Medicare patients into the CMS Web Interface, we advise the group to participate in the MIPS via another reporting mechanism.
As discussed in the CY 2016 PFS final rule with comment period (80 FR 71144), beginning with the 2017 PQRS payment adjustment, the PQRS aligned with the VM's beneficiary attribution methodology for purposes of assigning patients for groups that registered to participate in the PQRS Group Reporting Option (GPRO) using the CMS Web Interface (formerly referred to as the GPRO Web Interface). For certain quality and cost measures, the VM uses a two-step attribution process to associate beneficiaries with TINs during
The CAHPS for MIPS survey (formerly known as the CAHPS for PQRS survey) consists of the core CAHPS Clinician & Group Survey developed by AHRQ, plus additional survey questions to meet CMS's information and program needs. For more information on the CAHPS for MIPS survey, please see the explanation of the CAHPS for PQRS survey in the CY 2016 PFS final rule with comment period (80 FR 71142 through 71143). While we anticipate that the CAHPS for MIPS survey will closely align with the CAHPS for PQRS survey, we may explore the possibility of updating the CAHPS for MIPS survey under MIPS, specifically we may not finalize all proposed Summary Survey Measures (SSM).
We propose to allow registered groups of two or more MIPS eligible clinicians to voluntarily elect to participate in the CAHPS for MIPS survey. Specifically, we propose at § 414.1335 the following criteria for the submission of data on the CAHPS for MIPS survey by registered groups via CMS-approved survey vendor: For the applicable 12-month performance period, the group must have the CAHPS for MIPS survey reported on its behalf by a CMS-approved survey vendor. In addition, the group will need to use another submission mechanism (that is, qualified registries, QCDRs, EHR etc.) to complete their quality data submission. The CAHPS for MIPS survey would count as one cross-cutting and/or a patient experience measure, and the group would be required to submit at least five other measures through one other data submission mechanisms. A group may report any five measures within MIPS plus the CAHPS for MIPS survey to achieve the six measures threshold.
The administration of the CAHPS for MIPS survey would contain a six-month look-back period. In previous years the CAHPS for PQRS survey was administered from November to February of the reporting year. We propose to retain the same survey administration period for the CAHPS for MIPS survey. Groups that voluntarily elect to participate in the CAHPS for MIPS survey would bear the cost of contracting with a CMS-approved survey vendor to administer the CAHPS for MIPS survey on the group's behalf, just as groups do now for the CAHPS for PQRS survey.
Under current provisions of PQRS, the CAHPS for PQRS survey is required for groups of 100 or more eligible clinicians. Although we are not requiring groups to participate in the CAHPS for MIPS survey, we do still believe patient experience is important and we are therefore proposing a scoring incentive for those groups who report via the CAHPS for MIPS survey. As described in section II.E.3.d. of this proposed rule, we propose that groups electing to report the CAHPS for MIPS survey, would be required to register for the reporting of data. Because we believe patients' experiences as they interact with the health care system is important, our proposed scoring methodology would give bonus points for reporting CAHPS data (or other patient experience measures). Please refer to section II.E.6. for further details. We are interested in receiving comments on whether the CAHPS for MIPS survey should be required for groups of 100 or more MIPS eligible clinicians or whether it should be voluntary.
Currently, the CAHPS for PQRS beneficiary sample is based on Medicare claims data. Therefore, only Medicare beneficiaries can be selected to participate in the CAHPS for PQRS survey. In future years of the MIPS program, we may consider expanding the potential patient experience measures to all payers, so that Medicare and non-Medicare patients can be included in the CAHPS for MIPS survey sample. We are seeking comments on criteria that would ensure comparable samples. We seek comments on these proposals.
We want to ensure that data submitted on quality measures are complete enough to accurately assess each MIPS eligible clinician's quality performance. Section 1848(q)(5)(H) of the Act provides that analysis of the quality performance category may include quality measure data from other payers, specifically, data submitted by MIPS eligible clinicians with respect to items and services furnished to individuals who are not individuals entitled to benefits under Part A or enrolled under Part B of Medicare.
To ensure completeness for the broadest group of patients, we propose at § 414.1340 the criteria below. MIPS eligible clinicians and groups who do not meet the proposed reporting criteria noted below would fail the quality component of MIPS.
• Individual MIPS eligible clinicians or groups submitting data on quality measures using QCDRs, qualified registries, or via EHR need to report on at least 90 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for the performance period. In other words, for these submission mechanisms, we would expect to receive quality data for both Medicare and non-Medicare patients.
• Individual MIPS eligible clinicians submitting data on quality measures data using Medicare Part B claims, would report on at least 80 percent of the Medicare Part B patients seen during the performance period to which the measure applies.
• Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to report the CAHPS for MIPS survey would need to meet the data submission requirements on the sample of the Medicare Part B patients CMS provides.
We propose to include all-payer data for the QCDR, qualified registry, and EHR submission mechanisms because we believe this approach provides a more complete picture of each MIPS eligible clinicians scope of practice and provides more access to data about specialties and subspecialties not currently captured in PQRS. In addition, we propose the QCDR, qualified registry, or EHR submission must contain a minimum of one quality measure for at least one Medicare patient.
We desire all-payer data for all reporting mechanisms, yet certain reporting mechanisms are limited to Medicare Part B data. Specifically, the claims reporting mechanism relies on individual MIPS eligible clinicians attaching quality information on Medicare Part B claims; therefore only Medicare Part B patients can be reported by this mechanism. The CMS Web
The data completeness criteria we are proposing are an increase in the percentage of patients to be reported by each of the mechanisms when compared to PQRS. We believe the proposed thresholds are appropriate to ensure a more accurate assessment of a MIPS eligible clinician's performance on the quality measures and to avoid any selection bias that may exist under the current PQRS requirements. In addition, we would like to align all the reporting mechanisms as closely as possible with achievable data completeness criteria. We intend to continually assess the proposed data completeness criteria and will consider increasing these thresholds for future years of the program. We request comments on this proposal.
We are also interested in data that would indicate these data completeness criteria are inappropriate. For example, we could envision that reporting a cross-cutting measure would not always be appropriate for every telehealth service or for certain acute situations. We would not want a MIPS eligible clinician to fail reporting the measure in appropriate circumstances; therefore, we seek feedback data and circumstances where it would be appropriate to lower the data completeness criteria.
Table 3 reflects our proposed Quality Data Submission Criteria for MIPS:
Section 1848(q)(2)(C)(iv) of the Act provides that the Secretary must give consideration to the circumstances of non-patient-facing MIPS eligible clinicians and may, to the extent feasible and appropriate, take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such clinicians. In doing so, the Secretary must consult with non-patient-facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) to the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient-facing MIPS eligible clinician will not have sufficient measures and activities applicable and available to report and will not be scored on the quality performance category under MIPS. We refer readers to section II.E.6. of this proposed rule to discuss how we address performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given category.
In the MIPS and APMs RFI, we solicited feedback on how we should apply the four MIPS performance categories to non-patient-facing MIPS eligible clinicians and what types of measures and/or CPIAs (new or from other payments systems) would be appropriate for these MIPS eligible clinicians. We also engaged with seven separate organizations representing non-patient-facing MIPS eligible clinicians in the areas of anesthesiology, radiology/imaging, pathology, and nuclear medicine, specifically cardiology. Organizations we spoke with representing several specialty areas indicated that Appropriate Use Criteria (AUC) can be incorporated into the CPIA performance category by including activities related to appropriate assessments and reducing unnecessary tests and procedures. AUC are distinct from clinical guidelines and specify when it is appropriate to use a diagnostic test or procedure—thus reducing unnecessary tests and procedures. Use of AUC is an important CPIA as it fosters appropriate utilization and is increasingly used to improve quality in cardiovascular medicine, radiology, imaging, and pathology. These groups also highlighted that many non-patient-facing MIPS eligible clinicians have multiple patient safety and practice assessment measures and activities that could be included, such as activities that are tied to their participation in the Maintenance of Certification (MOC) Part IV for improving the clinician's practice. One organization expressed concern that because their quality measures are specialized, some members could be negatively affected when comparing quality scores because they did not have the option to be compared on a broader, more common set of measures. The MIPS and APMs RFI commenters noted that the emphasis should be on measures and activities that are practical, attainable, and meaningful to individual circumstances and that measurement should be as outcomes-based to the extent possible. The MIPS and APMs RFI commenters emphasized that CPIAs should be selected from a very broad array of choices and that ideally non-patient-facing MIPS eligible clinicians should help develop those activities so that they provide value and are easy to document. For more details regarding the CPIA performance category refer to section II.E.5.f. of this proposed rule. The comments from these organizations were considered in developing these proposals.
We understand that non-patient-facing MIPS eligible clinicians may have a limited number of measures on which to report. Therefore, we propose at § 414.1335 that non-patient-facing MIPS eligible clinicians would be required to meet the otherwise applicable submission criteria, but would not be required to report a cross-cutting measure.
Thus we would employ the following strategy for the quality performance criteria to accommodate non-patient-facing MIPS eligible clinicians:
• Allow non-patient-facing MIPS eligible clinicians to report on specialty-specific measure set (which may have fewer than the required six measures).
• Allow non-patient-facing MIPS eligible clinicians to report through a QCDR that can report non-MIPS measures.
• Non-patient-facing MIPS eligible clinicians would be exempt from reporting a cross-cutting measure as proposed at § 414.1340.
We request comments on these proposals.
(5) Application of Additional System Measures
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use measures used for payment systems other than for physicians, such as measures used for inpatient hospitals, for purposes of the quality and resource use performance categories. The Secretary may not, however, use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists.
In the MIPS and APMs RFI, we sought comment on how we could best use this authority. Some facility-based commenters requested a submission option that allows the MIPS eligible clinician to be scored based on the facility's measures. These commenters noted that the care they provide directly relates to and affects the facility's overall performance on quality measures and that using this score may be a more accurate reflection of the quality of care they provide than the quality measures in the PQRS or the VM program.
We will consider an option for facility-based MIPS eligible clinicians to elect to use their institution's performance rates as a proxy for the MIPS eligible clinician's quality score. We are not proposing an option for year 1 of MIPS because there are several operational considerations that must be addressed before this option can be implemented. We are requesting comment on the following issues: (1) Whether we should attribute a facility's performance to a MIPS eligible clinician for purposes of the quality and resource use performance categories and under what conditions such attribution would be appropriate and representative of the MIPS eligible clinician's performance; (2) possible criteria for attributing a facility's performance to a MIPS eligible clinician for purposes of the quality and resource use performance categories; and (3) the specific measures and settings for which we can use the facility's quality and resource use data as a proxy for the MIPS eligible clinician's quality and resource use performance categories; and (4) if attribution should be automatic or if a MIPS eligible clinician or group should elect for it to be done and choose the facilities through a registration process. We may also consider other options that would allow us to gain experience. We seek comments on these approaches.
Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary may use global measures, such as global outcome measures, and population-based measures for purposes of the quality performance category.
Under the current PQRS program and Medicare EHR Incentive Program quality measures are categorized by domains which include global and population-based measures. We identified population and community health measures as one of the quality domains related to the CMS Quality Strategy and the NQS priorities for health care quality improvement discussed in section II.E.5.c. of this proposed rule. Population-based measures are also used in the Medicare Shared Savings Program and for groups in the VM. For example, in 2015, clinicians were held accountable for a component of the Agency for Health Care Research (AHRQ) population-based, Ambulatory Care Sensitive Condition measures as part of a larger set of Prevention Quality Indicators (PQIs). Two broader composite measures of acute and chronic conditions are calculated using the respective individual measure rates for VM calculations. These PQIs assess the quality of the health care system as a whole, and especially the quality of ambulatory care, in preventing medical complications that lead to hospital admissions.
In the CY 2015 PFS final rule with comment period (79 FR 67909), Medicare Payment Advisory Commission (MedPAC) commented that we should move quality measurement for ACOs, Medicare Advantage (MA) plans, and FFS Medicare in the direction of a small set of population-based outcome measures, such as potentially preventable inpatient hospital admissions, emergency department visits, and readmissions. In the June 2014 MedPAC Report to the Congress:
In creating policy for global and population-based measures for MIPS we considered a more broad-based approach to the use of “global” and “population-based” measures in the MIPS quality performance category. After considering the above we propose to use the acute and chronic composite measures of Agency for Healthcare Research and Quality (AHRQ) Prevention Quality Indicators (PQIs) that meet a minimum sample size in the calculation of the quality measure domain for the MIPS total performance score; see Table B. Eligible clinicians will be evaluated on their performance on these measures in addition to the six required quality measures discussed previously and summarized in Table A. Based on experience in the VM program, these measures have been determined to be reliable with a minimum case size of 20. Average reliabilities for the acute and chronic measures range from 0.64 to 0.79 for groups and individual MIPS eligible clinicians. We intend to incorporate a clinical risk adjustment as soon as feasible to the PQI composites and continue to research ways to develop and use other population-based measures for the MIPS program that could be applied to greater numbers of MIPS eligible clinicians going forward. In addition to the acute and chronic composite measure, we also propose to include the all-cause hospital readmissions measure from the VM as we believe this measure also encourages care coordination. In the CY 2016 Medicare PFS final rule (80 FR 71296), we did a reliability analysis that indicates this measure is not reliable for solo clinicians or practices with fewer than 10 clinicians; therefore, we propose to limit this measure to groups with 10 or more clinicians and to maintain the current VM requirement of 200 cases. Eligible clinicians in groups with 10 or more clinicians with sufficient cases will be evaluated on their performance on this measure in addition to the six required quality measures discussed previously and summarized in Table A.
Furthermore, the proposed claims-based population measures would rely on the same two-step attribution methodology that is currently used in the VM (79 FR 67961 through 67694). The attribution focuses on the delivery of primary care services (77 FR 69320) by both primary care physicians and specialists. This attribution logic aligns with the total per capita measure and is similar to, but not exactly the same, as the assignment methodology used for the Shared Savings Program. For example, the Shared Savings Program definition of primary care services can
Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through notice and comment rulemaking, must establish an annual list of quality measures from which MIPS eligible clinicians may choose for purposes of assessment for a performance period. The annual list of quality measures must be published in the
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit a “Call for Quality Measures” each year. Specifically, the Secretary must request that eligible clinician organizations and other relevant stakeholders identify and submit quality measures to be considered for selection in the annual list of quality measures, as well as updates to the measures. Although we will accept quality measures submissions at any time, only measures submitted before June 1 of each year will be considered for inclusion in the annual list of quality measures for the performance period beginning 2 years after the measure is submitted. For example, a measure submitted prior to June 1, 2016 would be considered for the 2018 performance period. Of those quality measures submitted before June 1, we will determine which quality measures will move forward as potential measures for use in MIPS. Prior to finalizing new measures for inclusion in the MIPS program, those measures that we determine will move forward must also go through notice-and-comment rulemaking and the new proposed measures must be submitted to a peer review journal. Finally, for quality measures that have undergone substantive changes, we propose to identify measures including but not limited to measures that have had measure specification, measure title, and domain changes. Through NQF's or the measure steward's measure maintenance process, NQF-endorsed measures are sometimes updated to incorporate changes that we believe do not substantively change the intent of the measure. Examples of such changes may include updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. While we address such changes on a case-by-case basis, we generally believe these types of maintenance changes are distinct from substantive changes to measures that result in what are considered new or different measures.
In the first year of MIPS, we propose to maintain a majority of previously implemented measures in PQRS (80 FR 70885-71386) for inclusion in the annual list of quality measures. These measures can be found in the appendix at Table A: Proposed Individual Quality Measures Available for MIPS Reporting in 2017. Also included in the appendix in Table B is a list of quality measures that do not require data submission, some of which were previously implemented in the VM (80 FR 71273-71300), that we propose to include in the annual list of MIPS quality measures. These measures can be calculated from administrative claims data and do not require data submission. We are also proposing measures that were not previously finalized for implementation in the PQRS program. These measures and their draft specifications are listed in Table D. The proposed specialty-specific measure sets are listed in Table E. As we continue to develop measures and specialty-specific measure sets, we recognize that there are many MIPS eligible clinicians who see both Medicaid and Medicare patients and seek to align our measures to utilize Medicaid measures in the MIPS quality performance category. We believe that aligning Medicaid and Medicare measures is in the interest of all providers and will help drive quality improvement for our beneficiaries. For future years, we seek comment about the addition of a “Medicaid measure set” based on the CMCS Adult Core Set (
Each year, we have historically solicited a “Call for Quality Measures” from the public for possible quality measures for consideration for the PQRS. Under MIPS, we propose to continue the annual “Call for Quality Measures” as a way to engage eligible clinician organizations and other relevant stakeholders in the identification and submission of quality measures for consideration. Under section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations are professional organizations as defined by nationally recognized specialty boards of certification or equivalent certification boards. However, we do not believe there needs to be any special restrictions on the type or make-up of the organizations carrying out the process of development of quality measures. Any such restriction would limit the development of quality measures and the scope and utility of the quality measures that may be considered for endorsement. Submission of potential quality measures regardless of whether they
As previously noted, we encourage the submission of potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. However, consistent with the expectations established under PQRS, we propose to request that stakeholders apply the following considerations when submitting quality measures for possible inclusion in MIPS:
• Measures that are not duplicative of an existing or proposed measure.
• Measures that are beyond the measure concept phase of development and have started testing, at a minimum.
• Measures that include a data submission method beyond claims-based data submission.
• Measures that are outcome-based rather than clinical process measures.
• Measures that address patient safety and adverse events.
• Measures that identify appropriate use of diagnosis and therapeutics.
• Measures that address the domain for care coordination.
• Measures that address the domain for patient and caregiver experience.
• Measures that address efficiency, cost and resource use.
• Measures that address a performance gap or measurement gap.
We request comment on these proposals.
Section 1848(q)(2)(D)(iii) of the Act provides that, in selecting quality measures for inclusion in the annual final list of quality measures, the Secretary must provide that, to the extent practicable, all quality domains (as defined in section 1848(s)(1)(B) of the Act) are addressed by such measures and must ensure that the measures are selected consistent with the process for selection of measures under section 1848(k), (m), and (p)(2) of the Act.
Section 1848(s)(1)(B) of the Act defines “quality domains” as at least the following domains: clinical care, safety, care coordination, patient and caregiver experience, and population health and prevention. We believe the five domains applicable to the quality measures under MIPS are included in the NQS's six priorities as follows:
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Section 1848(q)(2)(D)(viii) of the Act provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures. Although not required to go through the pre-rulemaking process, we have found the NQF convened Measure Application Partnership's (MAP) input valuable. We propose that we may consider the MAP's recommendations as part of the comprehensive assessment of each measure considered for inclusion under MIPS. Elements we propose to consider in addition to those listed in the “Call for Quality Measures” section of this rule include a measure's fit within MIPS, if a measure fills clinical gaps, changes or updates to performance guidelines, and other program needs. Further, we will continue to explore how global and population-based measures can be expanded and plan to add additional population-based measures through future rulemaking. We request comment on these proposals.
Section 1848(q)(2)(D)(iv) of the Act, requires the Secretary to submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures. The submission must include the method for developing and selecting such measures, including clinical and other data supporting such measures. We believe this opportunity for peer review helps ensure that new measures published in the final rule are meaningful and comprehensive. We propose to use the Call for Quality Measures process as an opportunity to gather the information necessary to draft the journal articles for submission from measure developers, measure owners and measure stewards since CMS does not always develop measures for the quality programs. Information from measure developers, measure owners and measure stewards will include but is not limited to: Background, clinical evidence and data that supports the intent of the measure; recommendation for the measure that may come from a study or the United States Preventive Task Force (USPTF) recommendations; and how this measure would align with the CMS Quality Strategy. The Call for Quality Measures is a yearlong process; however, to be aligned with the regulatory process, establishing the proposed measure set for the year
Under section 1848(q)(2)(D)(v) of the Act, the final annual list of quality measures must include, as applicable, measures from under section 1848(k), (m), and (p)(2) of the Act, including quality measures among: (1) Measures endorsed by a consensus-based entity; (2) measures developed under section 1848(s) of the Act; and (3) measures submitted in response to the “Call for Quality Measures” required under section 1848(q)(2)(D)(ii) of the Act. Any measure selected for inclusion that is not endorsed by a consensus-based entity must have an evidence-based focus. Further, under section 1848(q)(2)(D)(ix), the process under section 1890A of the Act is considered optional.
Section 1848(s)(1) of the Act, as added by section 102 of the MACRA, also requires the Secretary of Health and Human Services to develop a draft plan for the development of quality measures by January 1, 2016. We solicited comments from the public on the “Draft CMS Measure Development Plan” through March 1, 2016. The final CMS Measure Development Plan must be finalized and posted on the CMS Web site by May 1, 2016.
Section 1848(q)(2)(D)(vi) of the Act provides that quality measures used by a QCDR under section 1848(m)(3)(E) of the Act are not required to be established through notice-and-comment rulemaking or published in the
Quality measures that are owned or developed by the QCDR entity and proposed by the QCDR for inclusion in MIPS but are not a part of the MIPS quality measure set are considered non-MIPS measures. If a QCDR wants to use a non-MIPS measure for inclusion in the MIPS program for reporting, we propose that these measures go through a rigorous CMS approval process during the QCDR self-nomination period. Specific details on third party entity requirements can be found in section II.E.9 of this proposed rule. The measure specifications will be reviewed and each measure will be analyzed for its scientific rigor, technical feasibility, duplication to current MIPS measures, clinical performance gaps, as evidenced by background and/or literature review, and relevance to specialty practice quality improvement. Once the measures are analyzed, the QCDR will be notified of which measures are approved for implementation. Each non-MIPS measure will be assigned a unique ID that can only be used by the QCDR that proposed it. Although non-MIPS measures are not required to be NQF-endorsed, we encourage the use of NQF-endorsed measures and measures that have been in use prior to implementation in MIPS. Lastly, we note that MIPS eligible clinicians reporting via QCDR have the option of reporting MIPS measures included in Table A in the Appendix to the extent that such measures are appropriate for the specific QCDR and have been approved by CMS. We request comment on these proposals.
Section 1848(q)(2)(D)(vii)(II) of the Act provides that any quality measure specified by the Secretary under section 1848(k) or (m) of the Act and any measure of quality of care established under section 1848(p)(2) of the Act for a performance or reporting period beginning before the first MIPS performance period (herein referred to collectively as “existing quality measures”) must be included in the annual list of MIPS quality measures unless removed by the Secretary. As discussed in section II.E.4 of this proposed rule, we are proposing that the performance period for the 2019 MIPS adjustment would be CY 2017, that is, January 1, 2017 through December 31, 2017. Therefore existing quality measures would consist of those that have been specified or established by the Secretary as part of the PQRS measure set or VM measure set for a performance or reporting period beginning before CY 2017.
Section 1848(q)(2)(D)(vii)(I) of the Act provides that existing quality measures are not required to be established through notice-and-comment rulemaking or published in the
Section 1890A of the Act, as added by section 3014(b) of the ACA, requires that the Secretary establish a pre-rulemaking process under which certain steps occur for the selection of certain categories of quality and efficiency measures, one of which is that the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) convenes multi-stakeholder groups to provide input to the Secretary on the selection of such measures. These categories are described in section 1890(b)(7)(B) of the Act and include the quality measures selected for the PQRS. In accordance with section 1890A(a)(1) of the Act, the NQF convened multi-stakeholder groups by creating the MAP. Section 1890A(a)(2) of the Act requires that the Secretary make publicly available by December 1 of each year a list of the quality and efficiency measures that the Secretary is considering under Medicare. The NQF must provide the Secretary with the MAP's input on the selection of measures by February 1 of each year. The lists of measures under consideration for selection are available at
Section 1848(q)(2)(D)(viii) of the Act provides that relevant eligible clinician organizations and other relevant stakeholders, including state and national medical societies, must be consulted in carrying out the annual list of quality measures available for MIPS assessment. Section 1848(q)(2)(D)(ii)(II) of the Act defines an eligible clinician organization as a professional organization as defined by nationally recognized specialty boards of certification or equivalent certification boards. Section 1848(q)(2)(D)(viii) of the Act further provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures.
Although MIPS quality measures are not required to go through the pre-rulemaking process under section 1890A of the Act, we have found the MAP's input valuable. The MAP process enables us to consult with relevant eligible professional organizations and other stakeholders, including state and national medical societies in finalizing the annual list of quality measures. In addition to the MAP's input this year, we also received input from the Core Measure Collaborative, specifically the America's Health Insurance Plans (AHIP), on core quality measure sets. The Core Measure Collaborative was organized by CMS in coordination with AHIP in 2014. This stakeholder workgroup has developed several condition-specific core measure sets to help align reporting requirements for private and public health insurance providers. Sixteen of the newly proposed measures under MIPS were recommended by the Core Measure Collaborative.
Under PQRS we realized the value in requiring EPs to report a cross-cutting measure and have proposed to continue the use of cross-cutting measures under MIPS. The cross-cutting measures help focus our efforts on population health improvement and they also allow for meaningful comparisons between MIPS eligible clinicians. Under MIPS, we are proposing fewer cross-cutting measures than those available under PQRS for 2016 reporting; however, we believe the list contains measures for which all patient-facing MIPS eligible clinicians should be able to report, as the measures proposed include commonplace health improvement activities such as checking blood pressure and medication management. We have eliminated some measures for which the reporting MIPS eligible clinician may not actually be providing the care, but are just reporting another MIPS eligible clinician's performance result. An example of this would be a MIPS eligible clinician who never manages a diabetic patient's glucose, yet previously could have reported a measure about hemoglobin A1c based on an encounter. This type of reporting will likely not help improve or confirm the quality of care the MIPS eligible clinician provides to his or her patients. Although there are fewer proposed cross-cutting measures under MIPS, in previous years some measures were too specialized and could not be reported on by all MIPS eligible clinicians. The proposed cross-cutting measures under MIPS are more broadly applicable and can be reported on by most specialties. The proposed MIPS cross-cutting measure set will be available on the CMS Web site. Non-patient-facing MIPS eligible clinicians do not have a cross-cutting measure requirement. The cross-cutting measures that were available under PQRS for 2016 reporting that are not being proposed as cross-cutting measures for 2017 reporting are:
• PQRS #001 (Diabetes: Hemoglobin A1c Poor Control).
• PQRS #046 (Medication Reconciliation Post Discharge).
• PQRS #110 (Preventive Care and Screening: Influenza Immunization).
• PQRS #111 (Pneumonia Vaccination Status for Older Adults).
• PQRS #112 (Breast Cancer Screening).
• PQRS #131 (Pain Assessment and Follow-Up).
• PQRS #134 (Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan).
• PQRS #154 (Falls: Risk Assessment).
• PQRS #155 (Falls: Plan of Care).
• PQRS #182 (Functional Outcome Assessment).
• PQRS #240 (Childhood Immunization Status).
• PQRS #318 (Falls: Screening for Fall Risk).
• PQRS #400 (One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk).
While we are proposing to remove the above listed measures from the cross-cutting measure set, these measures are being proposed to be available as individual quality measures available for MIPS reporting, some of which have proposed substantive changes. The proposed MIPS cross-cutting measure set can be found in Table C of the appendix of this proposed rule and will be available on the CMS Web site.
Measuring resource use is an integral part of measuring value. We envision the measures in the MIPS resource use performance category would provide MIPS eligible clinicians with the information they need to provide appropriate care to their patients and enhance health outcomes. In implementing the resource use performance category, we propose to start with existing condition and episode-based measures, and the total per capita costs for all attributed beneficiaries measure (total per capita cost measure). All resource use measures would be adjusted for geographic payment rate adjustments and beneficiary risk factors. In addition, a specialty adjustment would be applied to the total per capita cost measure. As detailed in section II.E.6.a.3 of this proposed rule, all of the measures attributed to a MIPS eligible clinician or group would be weighted equally within the resource use performance category, and there would be no minimum number of measures required to receive a score under the resource use performance category. We plan to draw on standards for measure reliability, patient attribution, risk adjustment, and payment standardization from the Physician Value-based Payment Modifier (Value Modifier or VM) as well as the Physician Feedback Program, as we believe many of the same measurement principles for cost measurement in the VM are applicable for measurement in the resource use performance category in MIPS.
All measures used under the resource use performance category would be derived from Medicare administrative claims data and as a result, participation would not require use of a data submission mechanism.
We plan to continue developing care episode groups, patient condition groups, and patient relationship categories (and codes for such groups and categories). We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking. We also will closely examine the recommendations from the HHS' Office of the Assistant Secretary for Planning and Evaluation (ASPE) study, when they are available, on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the IMPACT Act and incorporate them as feasible and appropriate through future rulemaking, under section 1848(q)(1)(G) of the Act.
Section 1848(q)(2)(A)(ii) of the Act establishes “resource use” as a performance category under the MIPS. Section 1848(q)(2)(B)(ii) of the Act describes the measures of the resource use performance category as the measurement of resource use for a MIPS performance period under section1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.
As discussed in section II.E.5.e.(1)(c) of this proposed rule, we previously established in rulemaking a value-based
Section 1848(r) of the Act specifies a series of steps and activities for the Secretary to undertake to involve the physician, practitioner, and other stakeholder communities in enhancing the infrastructure for resource use measurement, including for purposes of MIPS and APMs. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups. That section provides for care episode and patient condition groups to account for a target of an estimated one-half of expenditures under Parts A and B (with this target increasing over time as appropriate). We are required to take into account several factors when establishing these groups. For care episode groups, we must consider the patient's clinical problems at the time items and services are furnished during an episode of care, such as clinical conditions or diagnoses, whether or not inpatient hospitalization occurs, the principal procedures or services furnished, and other factors determined appropriate by the Secretary. For patient condition groups, we must consider the patient's clinical history at the time of a medical visit, such as the patient's combination of chronic conditions, current health status, and recent significant history (such as hospitalization and major surgery during a previous period), and other factors determined appropriate. We are required to post on the CMS Web site a draft list of care episode and patient condition groups and codes for solicitation of input from stakeholders, and subsequently post on the Web site an operational list of such groups and codes. As required by section 1848(r)(2)(H) of the Act, not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.
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. These categories shall include different relationships of the clinician to the patient and reflect various types of responsibility for and frequency of furnishing care. We are required to post on the CMS Web site a draft list of patient relationship categories and codes for solicitation of input from stakeholders, and subsequently post on the Web site an operational list of such categories and codes. As required by section 1848(r)(3)(F) of the Act, not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.
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).
Under section 1848(r)(5) of the Act, to evaluate the resources used to treat patients, the Secretary shall, as determined appropriate, use the codes reported on claims under section 1848(r)(4) of the Act to attribute patients to one or more physicians and applicable practitioners and as a basis to compare similar patients, and conduct an analysis of resource use. In measuring such resource use, the Secretary shall use per patient total allowed charges for all services under Parts A and B (and, if the Secretary determines appropriate, Part D) and may use other measures of allowed charges and measures of utilization of items and services. The Secretary shall seek comments through one or more mechanisms (other than notice and comment rulemaking) from stakeholders regarding the resource use methodology established under section 1848(r)(5) of the Act.
On October 15, 2015, as required by section 1848(r)(2)(B) of the Act, we posted on the CMS Web site for public comment a list of the episode groups developed under section 1848(n)(9)(A) of the Act with a summary of the background and context to solicit stakeholder input as required by section 1848(r)(2)(C) of the Act. That posting is available at
Currently, the physician value-based payment modifier established under section 1848(p) of the Act utilizes six cost measures (see 42 CFR 414.1235): (1) A total per capita costs for all-attributed beneficiaries measure (which we will refer to as the total per capita cost measure); (2) a total per capita costs for all attributed beneficiaries with chronic obstructive pulmonary disease (COPD) measure; (3) a total per capita costs for all attributed beneficiaries with congestive heart failure (CHF) measure; (4) a total per capita costs for all attributed beneficiaries with coronary artery disease (CAD) measure; (5) a total per capita costs for all attributed beneficiaries with diabetes mellitus (DM) measure; and (6) a Medicare Spending Per Beneficiary (MSPB) measure.
Total per capita costs include payments under both Part A and Part B, but do not include Medicare payments under Part D for drug expenses. All cost measures for the VM are attributed at the physician group and solo practice level using the Medicare-enrolled billing TIN under a two-step attribution methodology. They are risk-adjusted and payment-standardized, and the expected cost is adjusted for the TIN's specialty composition. We refer readers to our discussions of these total per capita cost measures (76 FR 73433 through 73434, 77 FR 69315 through 69316), MSPB measure (78 FR 74774 through 74780, 80 FR 71295 through 71296), payment standardization methodology (77 FR 69316 through 69317
The total per capita cost measures use a two-step attribution methodology that is similar, but not exactly the same, as the assignment methodology used for the Shared Savings Program. The attribution focuses on the delivery of primary care services (77 FR 69320) by both primary care clinicians and specialists. The MSPB measure has a different attribution methodology. It is attributed to the TIN that provides the plurality of Medicare Part B claims (as measured by allowable charges) during the index inpatient hospitalization. We refer readers to the discussion of our attribution methodologies (77 FR 69318 through 69320, 79 FR 67960 through 67964) in prior rulemaking for the VM.
These total per capita cost measures include payments for a calendar year and have been reported to TINs for several years through the Quality and Resource Use Reports (QRURs), which are issued as part of the Physician Feedback Program under section 1848(n) of the Act. The total per capita cost measures have been used in the calculation of the VM payment adjustments beginning with the 2015 payment adjustment period and the MSPB measure has been used in the calculation of the VM payment adjustments beginning with the 2016 payment adjustment period. More information about the current attribution methodology for these measures is available in the “Fact Sheet for Attribution in the Value-Based Payment Modifier Program” document available at
In the MIPS and APMs RFI (80 FR 59102 through 59113), we solicited feedback on the resource use performance category. Commenters directed our attention towards the “2015 Value-Based Payment Modifier Program Experience Report” (document available at
As required by section 1848(q)(5)(E)(i)(II)(bb) of the Act, the resource use performance category shall make up no more than 10 percent of the CPS for the first MIPS payment year (CY 2019) and not more than 15 percent of the CPS the second MIPS payment year (CY 2020). Therefore, we propose at § 414.1350 that the resource use performance category would make up 10 percent of the CPS for the first MIPS payment year (CY 2019) and 15 percent of the CPS for the second MIPS payment year (CY 2020). As required by section 1848(q)(5)(E)(i)(II)(aa) of the Act and proposed at § 414.1350, starting with the third MIPS payment year and for each MIPS payment year thereafter, the resource use performance category would make up 30 percent of the CPS.
As discussed above in section II.E.5.a. of this proposed rule, performance in the resource use performance category would be assessed using measures based on administrative Medicare claims data. At this time, we are not proposing any additional data submissions for the resource use performance category. As such, MIPS eligible clinicians and groups would be assessed based on resource use for Medicare patients only and only for patients that are attributed to them. MIPS eligible clinicians or groups that do not have enough attributed cases to meet or exceed the case minimums proposed in sections II.E.5.e.(3)(a)(ii) and II.E.5.e.(3)(b)(ii) would not be measured on resource use. For more discussion of MIPS eligible clinicians and groups without a resource use performance category score, please refer to II.E.6.a.(3)(d) and II.E.6.b.
For purposes of assessing performance of MIPS eligible clinicians on the resource use performance category, we propose at § 414.1350 to specify resource use measures for a performance period. For the CY 2017 MIPS performance period, we propose to utilize the total per capita cost measure, the MSPB measure, and several episode-based measures discussed in section II.E.5.e.3.b. of this proposed rule for the resource use performance category. The total per capita costs measure and the MSPB measure are described above in section II.E.5.e.(1)(c) of this proposed rule.
We propose including the total per capita cost measure as it is a global measure of all Part A and Part B resource use during the performance period and inclusive of the four condition specific measures under the VM (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus) for which performance tends to be correlated and its inclusion was supported by commenters on the MIPS and APMs RFI (80 FR 59102 through 59113). We also anticipate that MIPS eligible clinicians are familiar with the total per capita cost measure as the measure has been in the VM since 2015
We propose to adopt the MSPB measure because by the beginning of the initial MIPS performance period in 2017, we believe most MIPS eligible clinicians will be familiar with the measure in the VM or its variant under the Hospital Value Based Purchasing program. However, we propose two technical changes to the MSPB measure calculations for purposes of its adoption in MIPS which are discussed in the reliability section II.E.5.e.3.a.ii. of this proposed rule.
We propose to use the same methodologies for payment standardization, and risk adjustment for these measures for the resource use performance category as are defined for the VM. For more details on the previously adopted payment standardization methodology see 77 FR 69316 through 69317. For more details on the previously adopted risk adjustment methodology see 77 FR 69317 through 69318.
We are not proposing to include the VM total per capita cost measures for the four condition-specific groups (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus). Instead, we are generally proposing to assess performance as part of the episode-based measures proposed under section II.E.5.e.3.b. of this proposed rule. This shift is in response to feedback received as part of the MIPS and APMs RFI (80 FR 59102 through 59113). In the MIPS and APMs RFI, commenters stated that they do not believe the existing condition-based measures under the VM are relevant to their practice and expressed support for episode-based measures under MIPS.
In the VM, all cost measures are attributed to a TIN. In MIPS, however, we are proposing to evaluate performance at the individual and group levels. Please refer to section II.E.5.e.(3)(c) of this proposed rule, for our proposals to address attribution differences for individuals and groups. For purposes of this section, we will use the general term MIPS eligible clinicians to indicate attribution for individuals or groups.
For the MSPB measure, we propose to use attribution logic that is similar to what is used in the VM. MIPS eligible clinicians with the plurality of claims (as measured by allowable charges) for Medicare Part B services, rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the applicable performance period would be assigned the episode. The only difference from the VM attribution methodology would be that the MSPB measure would be assigned differently for individuals than for groups. For the total per capita cost measure, we propose to use a two-step attribution methodology that is similar to the methodology used in the 2017 and 2018 VM. We also propose to have the same two-step attribution process for the claims-based population measures in the quality performance category (section II.E.5.b.6.), CMS Web Interface measures, and CAHPS for MIPS. However, we also propose to make some modifications to the primary care services definition that is used in the attribution methodology to align with policies adopted under the Shared Savings Program.
The VM currently defines primary care services as the set of services identified by the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99340, 99341 through 99350, the welcome to Medicare visit (G0402), and the annual wellness visits (G0438 and G0439). We propose to update this set to include new care coordination codes that have been implemented in the Medicare Physician Fee Schedule: Transitional care management (TCM) codes (CPT codes 99495 and 99496) and the chronic care management (CCM) code (CPT code 99490). These services were added to the primary care service definition used by the Shared Saving Program in June 2015 (80 FR 32746 through 32748). We believe that these care coordination codes would also be appropriate for assigning services in the MIPS.
In the CY 2016 PFS final rule, the Shared Saving Program also finalized another modification to the primary care service definition: To exclude nursing visits that occur in a skilled nursing facility (SNF) (80 FR 71271 through 71272). Patients in SNFs (POS 31) are generally shorter stay patients who are receiving continued acute medical care and rehabilitative services. While their care may be coordinated during their time in the SNF, they are then transitioned back to the community. Patients in a SNF (POS 31) require more frequent practitioner visits—often from 1 to 3 times a week. In contrast, patients in nursing facilities (NFs) (POS 32) are almost always permanent residents and generally receive their primary care services in the facility for the duration of their life. Patients in the NF (POS 32) are usually seen every 30 to 60 days unless medical necessity dictates otherwise. We believe that it would be appropriate to follow a similar policy in MIPS; therefore, we propose to exclude services billed under CPT codes 99304 through 99318 when the claim includes the POS 31 modifier from the definition of primary care services.
We believe that making these two modifications would help align the primary care service definition between MIPS and Shared Savings Program and would improve the results from the 2-step attribution process.
We note, however, that while we are aligning the definition for primary care services, the 2-step attribution for MIPS would be different than the one used for the Shared Saving Program. We believe there are valid reasons to have differences between MIPS and the Shared Savings Program attribution. For example, as discussed in CY 2015 PFS final rule (79 FR 67960 through 67962), we eliminated the primary care service pre-step that is statutorily required for the Shared Savings Program from the VM. We noted that without the pre-step, the beneficiary attribution method would more appropriately reflect the multiple ways in which primary care services are provided, which are not limited to physician groups. As MIPS eligible clinicians include more than physicians, we continue to believe it is appropriate to exclude the pre-step.
In addition, in the 2015 Shared Saving Program final rule, we finalized a policy for the Shared Savings Program that we did not extend to the VM 2-step attribution: to exclude select specialties (such as several surgical specialties) from the second attribution step (80 FR 32749 through 32754). We do not believe it is appropriate to restrict specialties from the second attribution step for MIPS. If such a policy were adopted under MIPS, then all specialists on the exclusion list, unless they were part of a multispecialty group, would automatically be excluded from measurement on the total per capita cost measure, as well as on the claims-based population measures which rely on the same 2-step attribution. While we do not believe that many MIPS eligible clinicians or clinician groups with these specialties would be attributed enough cases to meet or exceed the case minimum, we believe that an automatic exclusion could remove some MIPS eligible clinicians and groups that should be measured for resource use.
We request comments on these proposed changes.
Additionally, we seek to ensure that MIPS eligible clinicians and groups are measured reliably; therefore, we intend to use the 0.4 reliability threshold currently applied to measures under the
To ensure sufficient measure reliability for the resource use performance category in MIPS, we also propose at § 414.1380(b)(2)(ii) to use the minimum of 20 cases for the total per capita cost measure, the same case minimum that is being used for the VM. An analysis in the CY 2016 PFS final rule (80 FR 71282) confirms that this measure has high average reliability for solo practitioners (0.74) as well as for groups with more than 10 professionals (0.80).
In the CY 2016 PFS final rule, we finalized a policy that increases the minimum cases for the MSPB measure from 20 to 125 cases (80 FR 71295 through 71296) due to reliability concerns with the measure including the specialty adjustment. That said, we recognize that a case size increase of this nature also may limit the ability of MIPS eligible clinicians to be scored on MSPB, and have been evaluating alternative measure calculation strategies for potential inclusion under MIPS that better balance participation, accuracy, and reliability. As a result of this, we are proposing two modifications to the MSPB measure.
The first technical change we are proposing is to remove the specialty-adjustment from the MSPB measure's calculation. As currently reported on the QRURs, the MSPB measure is risk adjusted to ensure that these comparisons account for case-mix differences between practitioners' patient populations and the national average. It is unclear that the current additional adjustment for physician specialty improves the accounting for case-mix differences for acute care patients, and thus, may not be needed.
The second technical change we propose is to modify the cost ratio used within the MSPB equation to evaluate the difference between observed and expected episode cost at the episode level before comparing the two at the individual or group level. In other words, rather than summing all of the observed costs and dividing by the sum of all the expected costs, we would take the observed to expected cost ratio for each MSPB episode assigned to the MIPS eligible clinician or group and take the average of the assigned ratios. As we did previously, we would take the average for the MIPS eligible clinician or group and multiply it by the average of observed costs across all episodes nationally.
Our analysis, which is based on all Medicare Part A and B claims data for beneficiaries discharged from an acute inpatient hospital between January 1, 2013 and December 1, 2013, indicates that these two changes would improve the MSPB measure's ability to calculate costs and the accuracy with which it can be used to make clinician-level performance comparisons. We also believe that these changes would help ensure the MSPB measure can be applied to a greater number of MIPS eligible clinicians while still maintaining its status as a reliable measure. More specifically, our analysis indicates that after making these changes to the MSPB measure's calculations, the MSPB measure meets the desired 0.4 reliability threshold used in the VM for over 88 percent of all TINs with a 20 case minimum, including solo practitioners. While this percentage is lower than our current policy for the VM (where virtually all TINs with 125 or more episodes have moderate reliability), setting the case minimum at 20 allows for an increase in participation in the MSPB measure. Therefore, we propose at § 414.1380(b)(2)(ii) to use a minimum of 20 cases for the MSPB measure. As noted previously, we consider expanded participation of MIPS eligible clinicians, particularly individual reporters, to be of great import for the purposes of transitioning to MIPS and believe that this justifies a slight decrease of the percentage of TINs meeting the reliability threshold.
We welcome public comment on these proposals.
As noted in the previous section, we are proposing to calculate several episode-based measures for inclusion in the resource use performance category. Groups have received feedback on their performance on episode-based measures through the Supplemental Quality and Resource Use Report (sQRUR), which are issued as part of the Physician Feedback Program under section 1848(n) of the Act; however, these measures have not been used for payment adjustments through the VM. Several stakeholders expressed in the MIPS and APMs RFI the desire to transition to episode-based measures and away from the general total per capita measures used in the VM. Therefore, in lieu of using the total per capita cost measures for populations with specific conditions that are used for the VM, we are proposing episode-based measures for a variety of conditions and procedures that are high cost, have high variability in resource use, or are for high impact conditions. In addition, as these measures are payment standardized and risk adjusted, we believe they meet the statutory requirements for appropriate measures of cost as defined in section 1848(p)(3) of the Act because the methodology eliminates the effects of geographic adjustments in payment rates and takes into account risk factors.
We also reiterate that while we transition to using episode-based measures for payment adjustments, we will continue to engage stakeholders through the process specified in section 1848(r)(2) of the Act to refine and improve the episodes moving forward.
As noted earlier, we have provided performance information on episode-based measures to MIPS eligible clinicians through the Supplemental Quality and Resource Use Reports (sQRURs), which are released in the Fall. The sQRURs provide groups and solo practitioners with information to evaluate their resource utilization on conditions and procedures that are costly and prevalent in the Medicare FFS population. To accomplish this goal, various episodes are defined and attributed to one or more groups or solo practitioners most responsible for the patient's care. The episode-based measures include Medicare Part A and Part B payments for services determined to be related to the triggering condition or procedure. The payments included are standardized to remove the effect of differences in geographic adjustments in payment rates and incentive payment programs and they are risk adjusted for the clinical condition of beneficiaries. Although the sQRURs provide detailed information on these care episodes, the calculations are not used to determine a TIN's VM payment adjustment and are only used to provide feedback.
We propose to include in the resource use performance category several clinical condition and treatment episode-based measures that have been reported in the sQRUR or were included in the list of the episode groups developed under section 1848(n)(9)(A)
The measures listed in Table 4 were developed under section 1848(n)(9)(A) of the Act, which required the Secretary to develop an episode grouper that combines separate but clinically related items and services into an episode of care for an individual, as appropriate, and provide reports on utilization to physicians (episode grouping Method A). The proposed measures accommodate both chronic and acute procedure episodes. The measures are also specifically designed to accommodate episodes that are initiated by physician claims, and section 1848(r)(4) of the Act requires claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, to include (as determined appropriate by the Secretary) the applicable codes established for care episode groups, patient condition groups, and patient relationship categories. The episodes and logic have undergone detailed and rigorous evaluation by an independent evaluation contractor and CMS also reviewed for clinical validity.
Attribution and reliability for the measures are discussed later in this section. Information about how the measures are constructed can be found at
Table 5 shows a second set of proposed measures that were developed to complement previous CMS efforts and to provide additional episode types to report in the supplemental QRURs. These measures represent acute conditions and procedures that are costly and prevalent in the Medicare FFS population. These measures examine services independently, regardless of other episodes a patient may be experiencing, and episodes do not interact with each other (episode grouping Method B).
Some of the episode types listed in Table 5 have subtypes that provide additional clinical detail and improve the actionability of data reported on these episode types, as well as comparability to expected costs. All episode types were developed with clinical input and complement the existing MSPB measure currently used in the VM. In addition, all episode types were reported in 2014 sQRURs.
Information about how the measures are constructed can be found at
While we are proposing the measures listed in Tables 4 and 5 for the resource use performance category, we are uncertain as to how many of these measures we will ultimately include in the final rule. As these measures have never been used for payment purposes, we may choose to specify a subset of these measures in the final rule. We request public comment on which of the measures listed in Tables 4 and 5 to include in the final rule. In addition to considering public comments, we intend to consider the number of MIPS eligible clinicians able to be measured, the episode's impact on Medicare Part A and Part B spending, and whether the measure has been reported through sQRUR. In addition, while we do not believe specialty adjustment is necessary for the episode-based measures, we will continue to explore this further given the diversity of episodes. We seek comment on whether we should specialty adjust the episode-based measures.
For the episode-based measures listed in Tables 4 and 5, we propose to use the attribution logic used in the 2014 sQRUR (full description available at
Acute condition episodes would be attributed to all MIPS eligible clinicians that bill at least 30 percent of inpatient evaluation and management (IP E&M) visits during the initial treatment, or “trigger event,” that opened the episode. E&M visits during the episode's trigger event represent services directly related to the management of the beneficiary's acute condition episode. MIPS eligible clinicians that bill at least 30 percent of IP E&M visits are therefore likely to have been responsible for the oversight of care for the beneficiary during the episode. It is possible for more than one MIPS eligible clinician to be attributed a single episode using this rule. If an acute condition episode has no IP E&M claims during the episode, then that episode is not attributed to any MIPS eligible clinician.
Procedural episodes would be attributed to all MIPS eligible clinicians that bill a Medicare Part B claim with a trigger code during the trigger event of the episode. For inpatient procedural episodes, the trigger event is defined as the IP stay that triggered the episode plus the day before the admission to the IP hospital. For outpatient procedural episodes constructed using Method A, the trigger event is defined as the day of the triggering claim plus the day before and two days after the trigger date. For outpatient procedural episodes constructed using Method B, the trigger event is defined as only the day of the triggering claim. Any Medicare Part B claim or line during the trigger event with the episode's triggering procedure code is used for attribution. If more than one MIPS eligible clinician bills a triggering claim during the trigger event, the episode is attributed to each of the MIPS eligible clinicians. If co-surgeons bill the triggering claim, the episode is attributed to each MIPS eligible clinician. If only an assistant surgeon bills the triggering claim, the episode is attributed to the assistant surgeon or group. If an episode does not have a concurrent Part B claim with a trigger code for the episode, then that episode is not attributed to any MIPS eligible clinician.
To ensure moderate reliability, we propose at § 414.1380(b)(2)(ii) to use the minimum of 20 cases for all episode-based measures listed in Tables 4 and 5. We propose to not include any measures that do not have average moderate reliability (at least 0.4) at 20 episodes.
In the VM and sQRUR, all resource use measurement was attributed at the solo practitioner and group level, as identified by TIN. In MIPS, however, we are proposing to evaluate performance at the individual and group levels. For MIPS eligible clinicians whose performance is being assessed individually across the other MIPS performance categories, we propose to attribute resource use measures using TIN/NPI rather than TIN. Attribution at the TIN/NPI level allows individual MIPS eligible clinicians, as identified by their TIN/NPI, to be measured based on cases that are specific to their practice, rather than being measured on all the cases attributed to the group TIN. For MIPS eligible clinicians that choose to have their performance assessed as a group across the other MIPS performance categories, we propose to attribute resource use measures at the TIN level (the group TIN under which they report). The logic for attribution would be similar whether attributing to the TIN/NPI level or the TIN level. As an alternative proposal, we seek comment on whether MIPS eligible clinicians that choose to have their performance assessed as a group should first be attributed at the individual TIN/NPI level and then have all cases assigned to the individual TIN/NPIs attributed to the group under which they bill. This alternative would apply one consistent methodology to both groups and individuals, compared to having a methodology that assigns cases using TIN/NPI for assessment at the individual level and another that assigns cases using only TIN for assessment at the group level. For example, the general attribution logic for MSPB is to assign the MSPB measure based on the plurality of claims (as measured by allowable charges) for Medicare Part B services rendered during an inpatient hospitalization that is an index admission for the MSPB measure. Our proposed approach would determine “plurality of claims” separately for individuals and groups. For individuals, we would assign the MSPB measure using the “plurality of claims” by TIN/NPI, but for groups we would determine the “plurality of claims” by TIN. The alternative proposal, in contrast, would determine the “plurality of claims” by TIN/NPI for both groups and individuals. However, for individuals, only the MSPB measure attributed to the TIN/NPI would be evaluated, while for groups the MSPB measure attributed to any TIN/NPI billing under the TIN would be evaluated.
We request comment on this proposal and alternative considered.
Section 101(c) of the MACRA added section 1848(q)(2)(C)(iv) to the Act, which requires the Secretary to give consideration to the circumstances of professional types who typically furnish services without patient facing interaction (non-patient-facing) when determining the application of measures and activities. In addition, this section allows the Secretary to apply alternative measures or activities to non-patient facing MIPS eligible clinicians that fulfill the goals of a performance category. Section 101(c) of the MACRA also added section 1848(q)(5)(F) to the Act, which allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of eligible clinician involved.
For the 2017 MIPS performance period, we are not proposing any alternative measures for non-patient facing MIPS eligible clinicians or groups. This means that non-patient facing MIPS eligible clinicians or groups may not be attributed any resource use measures that are generally attributed to clinicians who have patient facing encounters with patients. We therefore anticipate that, similar to MIPS eligible clinicians or groups that do not meet the required case minimum for any resource use measures, many non-patient facing MIPS eligible clinicians may not have sufficient measures and activities available to report and would not be scored on the resource use performance category under MIPS. We refer readers to section II.E.6.b.2. of this proposed rule where we discuss how we would address performance category weighting for MIPS eligible clinicians or groups who do not receive a performance category score for a given performance category. We also intend to work with non-patient facing MIPS eligible clinicians and specialty societies to propose alternative resource use measures for non-patient facing MIPS eligible clinicians and groups under MIPS in future years. Lastly, we seek comment on how best to incorporate appropriate alternative resource use measures for all MIPS eligible clinician types, including non-patient facing MIPS eligible clinicians.
Section 1848(q)(2)(C)(ii) of the Act, as added by section 101(c) of MACRA
We intend to align any facility-based MIPS measure decision across the quality and resource use performance categories to ensure consistent policies for MIPS in future years. We refer readers back to section II.E.5.b.5. of this proposed rule, which discusses our strategy and solicits comments related to this provision.
In the future, we intend to consider how best to incorporate Part D costs into the resource use performance category, as described in section 1848(q)(2)(B)(ii) of the Act. We seek public comments on how we should incorporate those costs under MIPS for future years. We also intend to continue developing and refining episode groups for purposes of resource use performance category measure calculations.
The CPIA performance category focuses on one of our MIPS strategic goals, to use a patient-centered approach to program development that leads to better, smarter, and healthier care. We believe improving the health of all Americans can be accomplished by developing incentives and policies that drive improved patient health outcomes. CPIAs emphasize activities that have a proven association with improved health outcomes. The CPIA performance category also focuses on another MIPS strategic goal which is to use design incentives that drive movement toward delivery system reform principles and APMs. Another MIPS strategic goal we are striving to achieve is to establish policies that can be scaled in future years as the bar for improvement rises. Under the CPIA performance category we are proposing baseline requirements that will continue to have more stringent requirements in future years, and lay the groundwork for expansion towards continuous improvement over time.
Section 1848(q)(2)(C)(v)(III) of the Act defines a CPIA as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery, and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to specify CPIAs under subcategories for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act, and in doing so to give consideration to the circumstances of small practices (consisting of 15 or fewer clinicians), and practices located in rural areas and geographic health professional shortage areas (HPSAs).
Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient-facing MIPS eligible clinicians or groups and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures and activities to such MIPS eligible clinicians and groups.
Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a request for information (RFI) to solicit recommendations from stakeholders to identify CPIAs and specify criteria for such CPIAs, and provides that the Secretary may contract with entities to assist in identifying activities, specifying criteria for the activities, and determining whether MIPS eligible clinicians or groups meet the criteria set. In the MIPS and APMs RFI, we requested recommendations to identify activities and specify criteria for activities. In addition, we requested details on how data should be submitted, the number of activities, how performance should be measured, and what considerations should be made for small and/or rural practices. There were two overarching themes from the comments that we received. First, the majority of the comments indicated that all subcategories should be weighted equally and that MIPS eligible clinicians or groups should be allowed to select from whichever subcategories are most applicable to them during the performance period. Second, commenters supported inclusion of a diverse set of activities that are meaningful for individual MIPS eligible clinicians or groups. We have reviewed all of the comments that we received and have taken these recommendations into consideration while developing the proposed CPIA policies.
Section 1848(q)(5)(E)(i)(III) of the Act specifies that the CPIA performance category will account for 15 percent of the CPS, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Therefore, we propose at § 414.1355, that the CPIA performance category will account for 15 percent of the CPS.
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician or group that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period must be given the highest potential score for the CPIA performance category for the performance period. For a further description of APMs that have a certified patient centered-medical home designation, we refer readers to section II.E.5.h.
A patient-centered medical home will be recognized if it is a nationally recognized accredited patient-centered medical home, a Medicaid Medical Home Model, or a Medical Home Model. The NCQA Patient-Centered Specialty Recognition will also be recognized, which qualifies as a comparable specialty practice. Nationally recognized accredited patient-centered medical homes are recognized if they are accredited by: (1) The Accreditation Association for Ambulatory Health Care; (2) the National Committee for Quality Assurance (NCQA) PCMH recognition; (3) The Joint Commission Designation; or (4) the Utilization Review Accreditation Commission (URAC).
Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible clinicians or groups who are participating in an APM (as defined in section 1833(z)(3)(C) of the Act) for a performance period must earn at least one half of the highest potential score for the CPIA performance category for the performance period. For further description of CPIA and the APM scoring standard for MIPS, we refer readers to section II.E.5.h. For all other MIPS eligible clinicians or groups, this section applies and we also refer readers to the scoring requirements for MIPS eligible clinicians and groups in section II.E.6. of this proposed rule.
Section 1848(q)(5)(C)(iii) of the Act provides that a MIPS eligible clinician or group must not be a MIPS eligible clinician or group required to perform activities in each CPIA subcategory or participate in an APM to achieve the highest potential score for the CPIA performance category.
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat a MIPS eligible clinician or group that fails to report on an applicable measure or activity that is required to be reported, they will receive the lowest potential score applicable to the measure or activity.
For the purpose of submitting under the CPIA performance category, we proposed in section II.E.5.a. of this proposed rule to allow for submission of data for the CPIA performance category using the qualified registry, EHR, QCDR, CMS Web Interface and attestation data submission mechanisms. If technically feasible, we will use administrative claims data to supplement the CPIA submission. Regardless of the data submission method, all MIPS eligible clinicians or groups must select activities from the CPIA Inventory provided in Table H of the Appendices. We believe the proposed data submission methods will allow for greater access and ease in submitting data, as well as consistency throughout the MIPS program.
In addition, we propose at § 414.1360, that for the first year only, all MIPS eligible clinicians or groups, or third party entities such as health IT vendors, QCDRs and qualified registries that submit on behalf of a MIPS eligible clinician or group, must designate a yes/no response for activities on the CPIA Inventory. In the case where a MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, the MIPS eligible clinician or group will certify all CPIAs have been performed and the health IT vendor, QCDR, or qualified registry will submit on their behalf. An agreement between a MIPS eligible clinician or group and a health IT vendor, QCDR, or qualified registry for data submission for CPIA as well as other performance data submitted outside of the CPIA performance category could be contained in a single agreement, minimizing the burden on the MIPS eligible clinician or group. See section II.E.9 for additional details.
We propose to use the administrative claims method, if technically feasible, only to supplement CPIA submissions. For example, if technically feasible, MIPS eligible clinicians or groups, using the telehealth modifier GT, could get automatic credit for this activity. We request comments on these proposals.
While we considered both equal and differentially weighted scoring in this performance category, the statute requires a differentially weighted scoring model by requiring 100 percent of the potential score in the CPIA performance category for patient-centered medical home participants, and a minimum 50 percent score for APM participants. For additional activities in this category, we propose at § 414.1380 a differentially weighted model for the CPIA performance category with two categories: Medium and high. The justification for these two weights is to provide flexible scoring due to the undefined nature of activities (that is, CPIA standards are not nationally recognized and there is no entity for CPIA that serves the same function as the National Quality Forum does for quality measures). CPIAs are weighted as high based on alignment with CMS national priorities and programs such as the Quality Innovation Network-Quality Improvement Organization (QIN/QIO) or the Comprehensive Primary Care Initiative which recognizes specific activities related to expanded access and integrated behavioral health as important. Programs that require performance of multiple activities such as participation in the Transforming Clinical Practice Initiative, seeing new and follow-up Medicaid patients in a timely manner in the provider's State Medicaid Program, or an activity identified as a public health priority (such as emphasis on anticoagulation management or utilization of prescription drug monitoring programs) were weighted as high.
The statute references patient-centered medical homes as achieving the highest score for the MIPS program. MIPS eligible clinicians or groups may use that to guide them in the criteria or factors that should be taken into consideration to determine whether to weight an activity medium or high on comments for this proposal. We request comments on this proposal, including criteria or factors we should take into consideration to determine whether to weight an activity medium or high.
We propose at § 414.1380 to set the CPIA submission criteria under MIPS, in order to achieve the highest potential score of 100 percent, at three high-weighted CPIAs (20 points each) or six medium-weighted CPIAs (10 points each), or some combination of high and medium-weighted CPIAs to achieve a total of 60 points for MIPS eligible clinicians participating as individuals or as groups (refer to Table H of the Appendices for CPIAs and weights). MIPS eligible clinicians or groups that select less than the designated number of CPIAs will receive partial credit based on the weighting of the CPIA selected. To achieve a 50 percent score, one high-weighted and one medium-weighted CPIA or three medium-weighted CPIAs are required for these MIPS eligible clinicians or groups.
Exceptions to the above apply for: MIPS small groups (consisting of 15 or fewer clinicians), MIPS eligible clinicians and groups located in rural areas, MIPS eligible clinicians and groups that are located in geographic HPSAs, non-patient-facing MIPS eligible clinicians or groups or MIPS eligible clinicians, or groups that participate in an APM and/or a patient-centered medical home submitting in MIPS.
For MIPS eligible clinicians and groups that are small, located in rural areas or geographic HPSAs, or non-patient-facing MIPS eligible clinicians or groups, in order to achieve the highest score of 100 percent, two CPIAs are required (either medium or high).
MIPS eligible clinicians or groups that participate in APMs are considered eligible to participate under the CPIA performance category unless they are participating in an Advanced APM and they have met the Qualifying APM Participant (QP) thresholds or are Partial QPs that elect not to report information. A MIPS eligible clinician or group that is participating in an APM and participating under the CPIA performance category will receive 50 percent of the total CPIA score (30 points) just through their APM participation. These are MIPS eligible clinicians or groups that CMS identifies as participating in APMs for MIPS and may participate under the CPIA performance category. To achieve 100 percent of the total CPIA score, MIPS eligible clinicians or groups will need to identify that they participate in an alternative payment model (30 points) and also select additional CPIAs for an additional 30 points to reach the 60 point CPIA highest score.
For further description of MIPS eligible clinicians or groups that are required to report to MIPS under the APM scoring standard and their CPIA scoring requirements, we refer readers to section II.E.5.h. For all other MIPS eligible clinicians or groups participating in APMs that would report to MIPS, this section applies and we also refer readers to the scoring requirements for these MIPS eligible clinicians or groups in section II.E.6.
Since we cannot measure variable performance within a single CPIA, we propose at § 414.1380 to compare the CPIA points associated with the reported activities against the highest number of points that are achievable under the CPIA performance category which is 60 points. We propose that the highest potential score of 100 percent can be achieved by selecting a number of activities that will add up to 60 points. MIPS eligible clinicians and groups, including those that are participating as an APM, and all those that select activities under the CPIA performance category can achieve the highest potential score of 60 points by selecting activities that are equal to the 60-point maximum. We refer readers to scoring section II.E.6 for additional rationale for using 60 points for the first year.
If a MIPS eligible clinician or group reports only one CPIA, we will score that activity accordingly, as 10 points for a medium-level activity or 20 points for a high-level activity. If a MIPS eligible clinician or group reports no CPIAs, then the MIPS eligible clinician or group would receive a zero score for the CPIA performance category. We believe this proposal allows us to capture variation in the total CPIAs reported.
In addition, we believe these are reasonable criteria for MIPS eligible clinicians or groups to accomplish within the first year for three reasons: (1) In response to several stakeholder MIPS and APMs RFI comments, we are not recommending a minimum number of hours for performance of an activity; (2) we are offering a broad list of activities from which MIPS eligible clinicians or groups may select; and (3) also in response to MIPS and APMs RFI comments, we are proposing that an activity must be performed for at least 90 days during the performance period for CPIA credit. We intend to reassess this requirement threshold in future years. We do not believe it is appropriate to require a determined number of activities within a specific subcategory at this time. This proposal aligns with the requirements in section 1848(q)(2)(C)(iii) of the Act that states MIPS eligible clinicians or groups are not required to perform activities in each subcategory.
Lastly, we recognize that working with a QCDR could allow a MIPS eligible clinician or group to meet the measure and activity criteria for multiple CPIAs. For the first year of MIPS, there are several CPIAs in the inventory that incorporate QCDR participation. Each activity must be selected and achieved separately for the first year of MIPS. A MIPS eligible clinician or group cannot receive credit for multiple activities just by selecting one activity that includes participation in a QCDR. As the CPIA inventory expands over time we are interested in receiving comments on what restrictions, if any, should be placed around CPIA measures and activities that incorporate QCDR participation.
We propose § 414.1360 that MIPS eligible clinicians or groups must perform CPIAs for at least 90 days during the performance period for CPIA credit. We understand there are some activities that are ongoing whereas others may be episodic. We considered setting the threshold for the minimum time required for performing an activity to longer periods up to a full calendar year. However, after researching several organizations we believe a minimum of 90 days is a reasonable amount of time. Two illustrative examples of organizations that used 90 days as a window for reviewing clinical practice improvements include practice improvement activities undertaken by anesthesiologists, as detailed in a study describing anesthesiologists' practice improvements as part of the Maintenance of Certification in Anesthesiology Program requiring a 90-day report back period,
Additional clarification for how some activities meet the 90-day rule or if additional time is required are reflected in the description of that activity in Table H of the Appendices. In addition we propose that activities, where applicable, may be continuing (that is, could have started prior to the performance period and are continuing) or be adopted in the performance period as long as an activity is being performed for at least 90 days during the performance period.
We anticipate in future years that extended CPIA time periods will be needed for certain activities. We will monitor the time period requirement to asses if allowing for extended time requirements may enhance the value associated with generating more effective outcomes, or conversely, the extended time may reveal that more time has little or no value added for certain activities when associated with desired outcomes. We request comments on this proposal.
We understand that non-patient-facing MIPS eligible clinicians and groups may have a limited number of measures and activities to report. Therefore, we propose at § 414.1360 allowing non-patient-facing MIPS eligible clinicians and groups to report on a minimum of one activity to achieve partial credit or two activities to achieve full credit to meet the CPIA submission criteria. These non-patient-facing MIPS eligible clinicians and groups receive
We anticipate the number of activities for non-patient-facing MIPS eligible clinicians or groups will increase in future years as we gather more data on the feasibility of performing CPIAs. As part of the process for identifying activities, we consulted with several organizations that represent a cross-section of non-patient-facing MIPS eligible clinicians and groups. An illustrative example of those consulted with include organizations that represent cardiologists involved in nuclear medicine, nephrologists who serve only in a consulting role to other providers, or pathologists who, while they typically function as a team, have different members that perform different roles within their specialty that are primarily non-patient-facing.
In the course of those discussions these organizations identified CPIAs they believed would be applicable. Comments on activities appropriate for non-patient-facing MIPS eligible clinicians or groups are reflected in the proposed CPIA Inventory across multiple subcategories. For example, several of these organizations suggested consideration for Appropriate Use Criteria (AUC). As a result, we have incorporated AUC into some of the activities. We encourage MIPS eligible clinicians or groups who are already required to use AUC (for example, for advanced imaging) to report a CPIA other than one related to appropriate use. Another example, under Patient Safety and Practice Assessment, is the implementation of an antibiotic stewardship program that measures the appropriate use of antibiotics for several different conditions (Upper Respiratory Infection (URI) treatment in children, diagnosis of pharyngitis, bronchitis treatment in adults) according to clinical guidelines for diagnostics and therapeutics. In addition, we request comments on what activities would be appropriate for non-patient-facing MIPS eligible clinicians or groups to add to the CPIA Inventory in the future. We request comments on this proposal.
As noted previously in this proposed rule, section 1848(q)(2)(B)(iii) of the Act requires the Secretary, in establishing CPIAs, to give consideration to small practices (15 or fewer clinicians) and practices located in rural areas (proposed definition at § 414.1305) and in geographic based HPSAs as designated under section 332(a)(1)(A) of the Public Health Service Act. In the MIPS and APMs RFI, we requested comments on how CPIAs should be applied to MIPS eligible clinicians or groups in small practices, in rural areas, and geographic HPSAs: If a lower performance requirement threshold or different measures should be established that will better allow those MIPS eligible clinicians or groups to perform well in this performance category, what methods should be leveraged to appropriately identify these practices, and what best practices should be considered to develop flexible and adaptable CPIAs based on the needs of the community and its population.
We engaged high performing organizations, including several rural health clinics with 15 or fewer clinicians that are designated as geographic HPSAs, to provide feedback on relevant QIN/QIO activities based on their specific circumstances. Some examples provided include participation in implementation of self-management programs such as for diabetes, and early use of telemedicine, as in the one case for a top performing multi-specialty rural practice that covers 20,000 people over a 25,000-mile radius in a rural area of North Dakota. Comments on activities appropriate for MIPS eligible clinicians or groups located in rural areas or practices that are designated as geographic HPSAs are reflected in the proposed CPIA Inventory across multiple subcategories.
Based on the review of comments and listening sessions, we propose at § 414.1360 to accommodate small practices and practices located in rural areas, or geographic HPSAs for the CPIA performance category by allowing MIPS eligible clinicians or groups to submit a minimum of one activity to achieve partial credit or two activities to achieve full credit. These MIPS eligible clinicians or groups receive partial or full credit for submitting two activities of any type of weighting (for example, two medium activities will qualify for full credit). We anticipate the requirement on the number of activities for small practices and practices located in rural areas, or practices in geographic HPSAs will increase in future years as we gather more data on the feasibility of small practices and practices located in rural areas and practices located in geographic HPSAs to perform CPIAs. Therefore, we request comments on what activities would be appropriate for these practices for the CPIA Inventory in future years. We request comments on this proposal.
Section 1848(q)(2)(B)(iii) of the Act provides that the CPIA performance category must include at least the subcategories listed below. The statute also provides the Secretary discretion to specify additional subcategories for the CPIA performance category, which have also been included below.
• Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.
• Population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR.
• Care coordination, such as timely communication of test results, timely exchange of clinical information to patients and other MIPS eligible clinicians or groups, and use of remote monitoring or telehealth.
• Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision-making mechanisms.
• Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.
• Participation in an APM, as defined in section 1833(z)(3)(C) of the Act.
In the MIPS and APMs RFI, we requested recommendations on the inclusion of the following five potential new subcategories:
• Promoting Health Equity and Continuity, including (a) serving Medicaid beneficiaries, including individuals dually eligible for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries, (c) participating in the network of plans in the Federally Facilitated Marketplace or state exchanges, and (d) maintaining adequate equipment and other accommodations (for example, wheelchair access, accessible exam tables, lifts, scales, etc.) to provide comprehensive care for patients with disabilities.
• Social and Community Involvement, such as measuring
• Achieving Health Equity, as its own performance category or as a multiplier where the achievement of high quality in traditional areas is rewarded at a more favorable rate for MIPS eligible clinicians or groups that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs.
• Emergency preparedness and response, such as measuring MIPS eligible clinician or group participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty military MIPS eligible clinician or group activities, and measuring MIPS eligible clinician or group volunteer participation in domestic or international humanitarian medical relief work.
• Integration of primary care and behavioral health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; or cross-training of MIPS eligible clinicians or groups participating in integrated care. This subcategory also includes integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.
We recognize that quality improvement is a critical aspect of improving the health of individuals and the health care delivery system overall. We also recognize that this will be the first time MIPS eligible clinicians or groups will be measured on the quality improvement work on a national scale. We have approached the CPIA performance category with these principles in mind along with the overarching principle for the MIPS program that we are building a process that will have increasingly more stringent requirements over time.
Therefore, for the first year of MIPS, we propose at § 414.1365 that the CPIA performance category include the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. In addition, we propose at § 414.1365 adding the following subcategories: “Achieving Health Equity”, “Integrated Behavioral and Mental Health”, and “Emergency Preparedness and Response.” In response to multiple MIPS and APMs RFI comments requesting the inclusion of “Achieving Health Equity,” we are proposing to include this subcategory because: (1) It is important and may require targeted effort to achieve and so should be recognized when accomplished; (2) supports our national priorities and programs, such as Reducing Health Disparities; and (3) encourages “use of plans, strategies, and practices that consider the social determinants that may contribute to poor health outcomes.” (CMS, Quality Innovation Network Quality Improvement Organization Scope of Work: Excellence in Operations and Quality Improvement, 2014).
Similarly, MIPS and APMs RFI comments strongly supported the inclusion of the subcategory of “Integrated Behavioral and Mental Health”, citing that “statistics show 50 percent of all behavioral health disorders are being treated by primary care and behavioral health integration.” Additionally, according to MIPS and APMs RFI comments, behavioral health integration with primary care is already being implemented in numerous locations throughout the country. The third additional subcategory we propose to include is “Emergency Preparedness and Response,” based on MIPS and APMs RFI comments that encouraged us to consider this subcategory to help ensure that practices remain open during disaster and emergency situations and support emergency response teams as needed. Additionally, commenters were able to provide a sufficient number of recommended activities (that is, more than one) that could be included in the CPIA Inventory in all of these proposed subcategories and the subcategories included under section 1848(q)(2)(B)(iii) of the Act.
We also seek public comments on two additional subcategories for future consideration:
• Promoting Health Equity and Continuity, including (a) serving Medicaid beneficiaries, including individuals dually eligible for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries, (c) participating in the network of plans in the Federally Facilitated Marketplace or state exchanges, and (d) maintaining adequate equipment and other accommodations (for example, wheelchair access, accessible exam tables, lifts, scales, etc.) to provide comprehensive care for patients with disabilities; and
• Social and Community Involvement, such as measuring completed referrals to community and social services or evidence of partnerships and collaboration with community and social services.
For these two subcategories, we are requesting activities that can demonstrate some improvement over time and go beyond current practice expectations. For example, maintaining existing medical equipment would not qualify for a CPIA, but implementing some improved clinical workflow processes that reduce wait times for patients with disabilities or improve coordination of care including activities that regularly provide additional assistance to find other care needed for patients with disabilities, would be some examples of activities that could show improvement in clinical practice over time.
We request comments on these proposals.
To implement the MIPS program, we are required to create an inventory of CPIAs. Consistent with our MIPS strategic goals, we believe it is important to create a broad list of activities that can be used by multiple practice types to demonstrate CPIAs and activities that may lend themselves to being measured for improvement in future years.
We took several steps to ensure the initial CPIA Inventory is inclusive of activities in line with the statutory intent. We had numerous interviews with highly performing organizations of all sizes, conducted an environmental scan to identify existing models, activities, or measures that met all or part of the CPIA category, including the patient centered medical homes, the Transforming Clinical Practice Initiative (TCPI), Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys, and AHRQ's Patient Safety Organizations. In addition, we reviewed the CY 2016 PFS final rule with comment period (80 FR 70886) and the comments received in response to the MIPS and APMs RFI regarding the CPIA performance category. The CPIA Inventory was compiled as a result of the stakeholder input, an environmental scan, MIPS and MIPS and APMs RFI comments, and subsequent working sessions with AHRQ and ONC and additional communications with CDC, SAMHSA and HRSA.
Based on the above discussions we established guidelines for CPIA inclusion based on one or more of the following criteria (in any order):
• Relevance to an existing CPIA subcategory (or a proposed new subcategory);
• Importance of an activity toward achieving improved beneficiary health outcome;
• Importance of an activity that could lead to improvement in practice to reduce health care disparities;
• Aligned with patient-centered medical homes;
• Representative of activities that multiple MIPS eligible clinicians or groups could perform (for example, primary care, specialty care);
• Feasible to implement, recognizing importance in minimizing burden, especially for small (15 or fewer clinicians) practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;
• CMS is able to validate the activity; or
• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes.
Activities that overlap with other performance categories were excluded unless there was a strong policy rationale to include it in the CPIA Inventory. We propose to use the CPIA Inventory for the first year of MIPS, as provided in Table H of the Appendices. For further description of how MIPS eligible clinicians or groups will be designated to submit to MIPS for CPIA, we refer readers to section II.E.6.h. For all other MIPS eligible clinicians or groups participating in APMs that would report to MIPS, this section applies and we also refer readers to the scoring requirements for these MIPS eligible clinicians or groups in section II.E.5. of this proposed rule.
We request comments on the inventory and welcome suggestions for CPIAs for future years as well.
From our experience under the PQRS, VM, and Medicare EHR Incentive programs we have discovered that many providers have errors within their data sets, as well as issues understanding the data that corresponds to their selected quality measures. To help better understand the current processes and limitations, we propose to conduct a study on CPIAs and measurement to examine clinical quality workflows and data capture using a simpler approach to quality measures. The study will allow a limited number of selected MIPS eligible clinicians and groups to receive full credit (60 points) for the CPIA category.
The lessons learned in this study on practice improvement and measurement may or may not influence changes to future MIPS data submission requirements. The goals of the study are to see whether there will be improved outcomes, reduced burden in reporting, and enhancements in clinical care by selected MIPS eligible clinicians desiring:
• A more data driven approach to quality measurement.
• Measure selection unconstrained with a CEHRT program or system.
• Improving data quality submitted to CMS.
• Enabling CMS get data more frequently and provide feedback more often.
Eligible clinicians and groups in the CMS study on practice improvement and measurement will receive full credit for the CPIA category of MIPS after successfully electing, participating and submitting data to CMS. Based on feedback and surveys from MIPS eligible clinicians, study measurement data will be made available to CMS throughout the study on at least a quarterly basis unless the MIPS eligible clinician or group agrees to submit data on a more frequent basis. Participants will be required to attend a monthly focus group to share lessons learned along with providing survey feedback to monitor effectiveness. The focus group will also include providing visual displays of data, workflows, and best practices to be shared amongst the participants to obtain feedback and make further improvements. The monthly focus groups will be used to learn from the practices on how to be more agile as we test new ways of measure recording and workflow.
For the 2017 performance period, the participating MIPS eligible clinicians or groups would submit their data and workflows for a minimum of three MIPS clinical quality measures that are relevant and prioritized by their practice. One of the measures must be an outcome measure, and one must be a patient experience measure. The participating MIPS eligible clinicians could elect to report on more measures as this would provide more options from which to select in subsequent years for purposes of measuring improvement.
If MIPS eligible clinicians or groups calculate the measures working with a QCDR, qualified registry, or CMS-approved third party intermediary, CMS will use the same data validation process described in section II.E.8.e. CMS will only collect the numerator and denominator for the measures selected for the overall population, all patients/all payers. This will enable the practices to build the measures based on what is important for their area of practice while increasing the quality of care.
In future years, participating MIPS eligible clinicians or groups would select three of the measures for which they have baseline data from the 2017 performance period to compare against later performance years. Participants electing to continue in future years will be afforded the opportunity opt-in or opt-out following the successful submission of data to CMS. The first opportunity to continue in the study will be at the end of the 2017 performance period. Eligible clinicians who elect to join the study but fail to participate and/or fail to successfully submit the data required will be removed from the study. Unsuccessful study participants will then be subject to the full requirements for the CPIA category.
Participation will be open to a limited number of MIPS eligible clinicians in rural settings and non-rural settings. A rural area is defined at § 414.1305 and a non-rural area would be any MIPS eligible clinicians or groups not included as part of the rural definition. This test will be open to include up to 10 non-rural individual MIPS eligible clinicians or groups of less than three non-rural MIPS eligible clinician's, 10 rural individual MIPS eligible clinicians or groups of less than three rural MIPS eligible clinician's, 10 groups of three to eight MIPS eligible clinicians, five groups of nine to twenty MIPS eligible clinicians, three groups of twenty-one to one hundred MIPS eligible clinicians, two groups of greater than 100 MIPS eligible clinicians, and two specialist groups of MIPS eligible clinicians. Eligible clinicians and groups will need to sign up from January 1, 2017, to January 31, 2017. The sign up process will utilize this web-based interface—
We request comment on the study and welcome suggestions on future study topics.
We propose, for future years of, MIPS, to consider the addition of a new subcategory or activity to the CPIA
• The new subcategory represents an area that could highlight improved beneficiary health outcomes, patient engagement and safety based on evidence.
• The new subcategory has a designated number of activities that meet the criteria for a CPIA activity and cannot be classified under the existing subcategories.
• Newly identified subcategories would contribute to improvement in patient care practices or improvement in performance on quality measures and resource use performance categories.
In future years, MIPS eligible clinicians or groups will have an opportunity to nominate additional subcategories, along with activities associated with each of those subcategories that are based on criteria specified for these activities, as discussed above.
We request comments on this proposal.
We plan to develop a call for measures and activities process for future years of MIPS, where MIPS eligible clinicians or groups and other relevant stakeholders may recommend activities for potential inclusion in the CPIA Inventory. As part of the process, MIPS eligible clinicians or groups would be able to nominate additional activities that we could consider adding to the CPIA Inventory. The MIPS eligible clinician or group or relevant stakeholder would be able to provide an explanation of how the activity meets all the criteria we have identified. This nomination and acceptance process would, to the best extent possible, parallel the annual call for measures process already conducted by CMS for quality measures. The final CPIA Inventory for the performance year would be published in accordance with the overall MIPS rulemaking timeline and program. In addition, in future years we anticipate developing a process and establishing criteria to remove or add new activities to CPIA.
Additionally, prospective activities that are submitted through a QCDR could also be included as part of a beta-test process that may be instrumental for future years to determine whether that activity should be included in the CPIA Inventory based on specific criteria noted above. MIPS eligible clinicians or groups and groups that use QCDRs to capture data associated with an activity, for example the frequency in administering depression screening and a follow-up plan, may be asked to voluntarily submit that same data in year 2 to begin identifying a baseline for improvement for subsequent year analysis. This is not intended to require any MIPS eligible clinician or group to submit CPIAs only via QCDR from one year to the next or to require the same activity from one year to the next. Participation in doing so, however, can help to identify how activities can contribute to improve outcomes. This data submission process will be considered part of a beta-test to: (1) Determine if the activity is being regularly conducted and effectively executed and (2) if the activity warrants continued inclusion on the CPIA Inventory. The data will help capture baseline information to begin measuring improvement and inform the Secretary of the likelihood that the activity would result in improved outcomes. If an activity is submitted and reported by a QCDR, it would be reviewed by CMS for final inclusion in the CPIA Inventory the following year, even if these activities are not submitted through the future call for measures and activities process. We intend, in future performance years, to begin measuring CPIA data points for all eligible clinicians and to award scores based on performance and improvement. We solicit comment on how best to collect such CPIA data and factor it into future scoring under MIPS.
We request comments on this approach and on any other considerations we should take into account when developing this type of approach for future rulemaking.
In future years, we expect to learn more about CPIAs and how the inclusion of additional measures and activities captured by QCDRs could enhance the ability of MIPS eligible clinicians or groups to capture and report on more meaningful activities. This is especially true for specialty groups. In the future, we may propose use of QCDRs for identification and acceptance of additional measures and activities which is in alignment with section 1848(q)(1)(E) of the Act which encourages the use of QCDRs, as well as under section 1848(q)(2)(B)(iii)(II) of the Act related to the population management subcategory. We recognize, through the MIPS and APMs RFI comments and interviews with organizations that represent non-patient-facing MIPS eligible clinicians or groups and specialty groups that QCDRs may provide for a more diverse set of measures and activities under CPIA than are possible to list under the current CPIA Inventory. This diverse set of measures and activities, which we can validate, affords specialty practices additional opportunity to report on more meaningful activities in future years. QCDRs may also provide the opportunity for longer-term data collection processes which will be needed for future year submission on improvement, in addition to achievement. Use of QCDRs also supports ongoing performance feedback and allows for implementation of continuous process improvements. We believe that for future years, QCDRs will be allowed to define specific CPIAs for specialty and non-patient-facing MIPS eligible clinicians or groups through the already-established QCDR approval process for measures and activities. We request comments on this approach.
The American Recovery and Reinvestment Act of 2009 (ARRA), which included the Health Information Technology for Economic and Clinical Health Act (HITECH Act), amended Titles XVIII and XIX of the Act to authorize incentive payments and Medicare payment adjustments for EPs to promote the adoption and meaningful use of certified EHR technology (CEHRT). Section 1848(o) of the Act provides the statutory basis for the Medicare incentive payments made to meaningful EHR users. Section 1848(a)(7) of the Act also establishes downward payment adjustments, beginning with calendar year (CY) 2015, for EPs who are not meaningful users of certified EHR technology for certain associated EHR reporting periods. (For a more detailed explanation of the statutory basis for the Medicare and Medicaid EHR Incentive Programs, see the July 28, 2010 Stage 1 final rule titled, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule” (75 FR 44316 through 44317).)
A primary policy goal of the EHR Incentive Program is to encourage and promote the adoption and use of certified EHR technology among Medicare and Medicaid health care providers to help drive the industry as a whole toward the use of certified EHR technology. As described in the final rule titled “Medicare and Medicaid
Section 1848(q)(2)(A) of the Act, as added by section 101(c) of the MACRA, includes the meaningful use of certified EHR technology as a performance category under the MIPS, referred to in this proposed rule as the advancing care information performance category, which will be reported by MIPS eligible clinicians as part of the overall MIPS program. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories shall be used in determining the MIPS CPS for each MIPS eligible clinician. In general, MIPS eligible clinicians will be evaluated under all four of the MIPS performance categories, including the advancing care information performance category. This includes MIPS eligible clinicians who were not previously eligible for the EHR Incentive Program incentive payments under section 1848(o) of the Act or subject to the EHR Incentive Program payment adjustments under section 1848(a)(7) of the Act, such as physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and hospital-based EPs (as defined in section 1848(o)(1)(C)(ii) of the Act). Understanding that these MIPS eligible clinicians may not have prior experience with certified EHR technology and the objectives and measures under the EHR Incentive Program, we have proposed a scoring methodology within the advancing care information performance category that provides flexibility for MIPS eligible clinicians from early adoption of certified EHR technology through advanced use of health IT. We note that in section II.e.5.g.8.a of this proposed rule, we have also proposed to reweight the advancing care information performance category to zero in the MIPS composite performance score for certain hospital-based and other MIPS eligible clinicians where the measures proposed for this performance category may not be available or applicable to these types of MIPS eligible clinicians.
In implementing MIPS, we intend to develop the requirements for the advancing care Information performance category to continue supporting the foundational objectives of the HITECH Act, and to encourage continued progress on key uses such as health information exchange and patient engagement. These more challenging objectives are essential to leveraging certified EHR technology to improve care coordination and they represent the greatest potential for improvement and for significant impact on delivery system reform in the context of MIPS quality reporting.
In developing the requirements and structure for the advancing care information performance category, we considered several approaches for establishing a framework that would naturally integrate with the other MIPS performance categories. We considered historical performance on the EHR Incentive Program objectives and measures, feedback received through public comment, and the long term goals for delivery system reform and quality improvement strategies.
One approach we considered would be to maintain the current structure of the Medicare EHR Incentive Program and award full points for the advancing care information performance category for meeting all of the objectives and measures finalized in the 2015 EHR Incentive Programs final rule, and award zero points for failing to meet all of these requirements. This method would be consistent with the current EHR Incentive Program and is based on objectives and measures already established in rulemaking. However, we considered and dismissed this approach as it would not allow flexibility for MIPS eligible clinicians and would not allow CMS to effectively measure performance for MIPS eligible clinicians in the advancing care information performance category who have taken incremental steps toward the use of certified EHR technology, or to recognize exceptional performance for MIPS eligible clinicians who have excelled in any one area. This is particularly important as many MIPS eligible clinicians may not have had past experience relevant to the advancing care information performance category and use of EHR technology because they were not previously eligible to participate in the Medicare EHR Incentive Program. This approach also does not allow for differentiation among the objectives and measures that have high adoption and those where there is potential for continued advancement and growth.
We subsequently considered several methods which would allow for more flexibility and provide CMS the opportunity to recognize partial or exceptional performance among MIPS eligible clinicians for the measures under the advancing care information performance category. We decided to design a framework that would allow for flexibility and multiple paths to achievement under this category while recognizing MIPS eligible clinicians' efforts at all levels. Part of this framework requires moving away from the concept of requiring a single threshold for a measure, and instead incentivizes continuous improvement, and recognizes onboarding efforts among late adopters and MIPS eligible clinicians facing continued challenges in full implementation of certified EHR technology in their practice.
In defining the advancing care information performance category for the MIPS, we considered stakeholder feedback and lessons learned from our experience with the Medicare EHR Incentive Program. Specifically, we considered feedback from the Stage 1 (75 FR 44313) and Stage 2 (77 FR 53967) EHR Incentive Program rules, and the 2015 EHR Incentive Programs final rule (80 FR 62769), as well as comments received from the MIPS and APMs RFI (80 FR 59102). We have learned from this feedback that clinicians desire flexibility to focus on health IT implementation that is right for their practice. We have also learned that updating software, training staff and changing practice workflows to accommodate new technology can take time, and that clinicians need time and flexibility to focus on the health IT activities that are most relevant to their patient population. Clinicians also desire consistent timelines and reporting requirements in order to simplify and streamline the reporting process. Recognizing this, we have worked to align the advancing care information performance category with the other MIPS performance categories, which would streamline reporting requirements, timelines and measures in an effort to reduce burden on MIPS eligible clinicians.
The implementation of the advancing care information performance category is an important opportunity to increase clinician and patient engagement, improve the use of health IT to achieve better patient outcomes, and continue to meet the vision of enhancing the use of certified EHR technology as defined under the HITECH Act. As discussed later in this section, we are proposing in section II.E.5.g.6.a. new flexibility in how we would assess MIPS eligible clinician performance for the advancing care information performance category. We propose to emphasize performance in the objectives and measures that are the most critical and would lead to the most improvement in the use of health IT and health care quality. We intend to promote innovation so that technology can be interconnected easily and securely, and data can be accessed and directed where and when it is needed to support patient care. These objectives include Patient Electronic Access, Coordination of Care Through Patient Engagement and Health Information Exchange, which are essential to leveraging certified EHR technology to improve care. At the same time, we propose to eliminate reporting on objectives and measures in which the vast majority of clinicians already achieve high performance—which would reduce burden, encourage greater participation and direct MIPS eligible clinicians' attention to higher-impact measures. Our proposal balances program participation with rewarding performance on high-impact objectives and measures, which we believe would make the overall program stronger and further the goals of the HITECH Act.
Section 1848(o)(2)(A) of the Act requires that the Secretary seek to improve the use of electronic health records and health care quality over time by requiring more stringent measures of meaningful use. In implementing MIPS and the advancing care information performance category, we seek to improve and encourage the use of certified EHR technology over time by adopting a new, more flexible scoring methodology, as discussed in section II.E.5.g.6. of this proposed rule, that would more effectively allow MIPS eligible clinicians to reach the goals of the HITECH Act, and would allow MIPS eligible clinicians to use EHR technology in a manner more relevant to their practice. This new, more flexible scoring methodology puts a greater focus on Patient Electronic Access, Coordination of Care Through Patient Engagement, and Health Information Exchange—objectives we believe are essential to leveraging certified EHR technology to improve care by engaging patients and furthering interoperability. This methodology would also de-emphasize objectives in which clinicians have historically achieved high performance with median performance rates of over 90 percent for the last 2 years. We believe shifting focus away from these objectives would reduce burden, encourage greater participation, and direct attention to other objectives and measures which require more attention. Through this flexibility, MIPS eligible clinicians would be incentivized to focus on those aspects of certified EHR technology that are most relevant to their practice, which we believe would lead to improvements in health care quality.
We also seek to increase the adoption and use of certified EHR technology by incorporating such technology into the other MIPS performance categories. For example, in section II.6.a.2.f. of this proposed rule, we are proposing to incentivize electronic reporting by awarding a bonus point for submitting quality measure data using certified EHR technology. Additionally, in section II.E.5.f. of this proposed rule, we have aligned some of the activities under the CPIA performance category such as Care Coordination, Beneficiary Engagement and Achieving Health Equity with a focus on enhancing the use of certified EHR technology. We believe this approach would strengthen the adoption and use of EHR systems and program participation consistent with the provisions of section 1848(o)(2)(A) of the Act.
We note that the increased flexibility and removal of previously established thresholds for reporting, as proposed in this section of this proposed rule, may appear to be a lower standard than what previously existed in the Medicare EHR Incentive Program. In reality, this restructuring of program requirements is geared toward increasing participation and EHR adoption. We believe this is the most effective way to encourage the adoption of certified EHR technology, and introduce new MIPS eligible clinicians to the use of EHR technology and health IT overall.
We will continue to review and evaluate MIPS eligible clinician performance in the advancing care information performance category, and will consider evolutions in health IT over time as it relates to this performance category. Based on our ongoing evaluation, we expect to adopt changes to the scoring methodology for the advancing care information performance category to ensure the efficacy of the program and to ensure increased value for MIPS eligible clinicians, as well as to adopt more stringent measures of meaningful use as required by section 1848(o)(2)(A) of the Act.
Potential changes may include establishing benchmarks for MIPS eligible clinician performance on the advancing care information performance category measures, and using these benchmarks as a baseline or threshold for future reporting. This may include scoring for performance improvement over time and the potential to reevaluate the efficacy of measures based on these analyses. For example, in future years we may use a MIPS eligible clinician's prior performance on the advancing care information performance category measures as comparison for the subsequent year's performance category score, or compare a MIPS eligible clinician's performance category score to peer groups to measure their improvement and determine a performance category score based on improvement over those benchmarks or peer group comparisons. This type of approach would drive continuous improvement over time through the adoption of more stringent performance standards for the advancing care information performance category measures.
We are committed to continual review, improvement and increased stringency of the advancing care information performance category measures as directed under section 1848(o)(2)(A) of the Act both for the purposes of ensuring program efficacy as well as ensuring value for the MIPS eligible clinicians reporting the advancing care information performance category measures. We seek comment on further methods to increase the stringency of the advancing care information performance category measures in the future.
We additionally seek comment on the concept of a holistic approach to health IT—one that we believe is similar to the concept of outcome measures in the quality performance category in the sense that MIPS eligible clinicians could potentially be measured more directly on how the use of health IT contributes to the overall health of their patients. Under this concept, MIPS eligible clinicians would be able to track certain use cases or patient outcomes to tie patient health outcomes with the use of health IT.
We believe this approach would allow us to directly link health IT adoption and use to patient outcomes, moving
Section 1848(o)(2)(A)(iii) of the Act requires the reporting of clinical quality measures (CQMs) using certified EHR technology. Section 1848(q)(5)(B)(ii)(II) provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall, with respect to a performance period for a year, for which a MIPS eligible clinician reports applicable measures under the quality performance category through the use of certified EHR technology, treat the MIPS eligible clinician as satisfying the CQMs reporting requirement under section 1848(o)(2)(A)(iii) of the Act for such year. We note that in the context and overall structure of MIPS, the quality performance category allows for a greater focus on patient-centered measurement, and multiple pathways for MIPS eligible clinicians to report their quality measure data. Therefore, we are not proposing separate requirements for clinical quality measure reporting within the advancing care information performance category and instead would require submission of quality data for measures specified for the quality performance category, in which we encourage reporting of CQMs with data captured in certified EHR technology. We refer readers to section II.E.5.a of this proposed rule for discussion of reporting of CQMs with data captured in certified EHR technology under the quality performance category.
In the Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 proposed rule, we proposed to eliminate the 90-day EHR reporting period beginning in 2017 for EPs who had not previously demonstrated meaningful use, with a limited exception for the Medicaid EHR Incentive Program (80 FR 16739-16740, 16774-16775). We received many comments from respondents stating their preference for maintaining the 90-day EHR reporting period to allow first time participants to avoid payment adjustments. In addition, commenters indicated that the 90-day time period reduced administrative burden and allowed for needed time to adapt their EHRs to ensure they could achieve program objectives. As a result, we did not finalize our proposal and established a 90-day EHR reporting period for all EPs in 2015 and for new participants in 2016, as well as a 90-day EHR reporting period for new participants in 2015, 2016, and 2017 with regard to the payment adjustments (80 FR 62777-62779; 62904-62906).
Moving forward, the implementation of MIPS creates a critical opportunity to align performance periods to ensure that quality, CPIA, resource use, and the advancing care information performance categories are all measured and scored based on the same period of time. We believe this would lower reporting burden, focus clinician quality improvement efforts and align administrative actions so that clinicians can use common systems and reporting pathways.
Under MIPS, we propose to align the performance period for the advancing care information performance category to the proposed MIPS performance period of one full calendar year. Thus, the performance period for the advancing care information performance category would be the same as the performance periods for the other performance categories as indicated in section II.E.4. We note that there would not be a separate 90-day performance period for the advancing care information performance category. Under this proposal, MIPS eligible clinicians would need to submit data based on performance period starting January 1, 2017, and ending December 31, 2017 for the first year of MIPS. We recognize that stakeholders may still have concerns related to a full year performance period. We note that, as discussed in section II.E.4. of this proposed rule, MIPS eligible clinicians that only have data for a portion of the year can still submit data, be assessed and be scored for the advancing care information performance category. Under the proposal, MIPS eligible clinicians would need to possess certified EHR technology and report on the objectives and measures (without meeting any thresholds) during the calendar year performance period to achieve the advancing care information category base score. We note that MIPS eligible clinicians would be required to submit all of the data they have available for the performance period, even if the time period they have data for is less than one full calendar year.
We believe this proposal would reduce reporting burden and streamline requirements so that MIPS eligible clinicians and third party intermediaries, such as registries and QCDRs, would have a common timeline for data submission to all performance categories. We refer readers to section II.E.4. of this proposed rule for discussion of the performance period for MIPS and solicit feedback on our proposal.
The use of certified health IT continues to be an important component of care delivery for clinicians. Certified health IT that advances patient engagement, interoperability, and privacy and security are key to care coordination, and a critical component in improving health outcomes.
We anticipate that as certified health IT and related standards continue to evolve to support health information exchange, care coordination (for example, referral management), and other capabilities, we will consider updates to the certified health IT requirements for MIPS. We continue to work with the Office of the National Coordinator for Health IT to identify certified health IT that would aid clinicians in MIPS.
Throughout this proposed rule, we use the terms “certified health IT” and “certified EHR technology”. These terms refer to health information technologies and systems that are certified to various standards and functions under the ONC Health IT Certification Program. In general, the full range of potential technologies, functions, standards, and systems for which ONC has established certification criteria are referred to as “certified health IT” (See the 2015 Edition Health IT Certification Criteria final rule (80 FR 62604)). In contrast, the term “certified EHR technology” is a statutory and regulatory term that defines the technology that MIPS eligible clinicians
It is important to note that certified EHR technology is a part of the larger category of certified health IT. Therefore when discussing certified health IT in a broad and general manner; such a discussion includes both the functions included in certified EHR technology and other additional potential functions and criteria. In other words, certified EHR technology is a subset of the broader definition of certified health IT.
“Certified health IT” is used in two different ways within this proposed rule. The first is stated as “certified health IT” to identify where the text is referencing a broad range of technology that is included in the ONC Health IT Certification Program. The second use is where the term “a certified Health IT Module” identifies a technology or function used independently from the clinicians' EHR. An example of this second use of the term includes the certified functions leveraged by Health Information Exchange organizations, QCDRs, and public health agencies to support actions like information exchange, quality measurement, and data submission. These individual functions may also be a part of the certified EHR technology definition and may connect with the EHR, but are in these cases used independently from the clinicians' EHR systems.
ONC and CMS worked closely to identify the set of certified health IT that are part of the certified EHR technology definitions proposed in this rule. For example, ONC's 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications (80 FR 62602 through 62759) hereinafter referred to as “2015 Edition final rule”, defines the technological requirements for health IT systems used by EHR Incentive Program participants. In this proposed rule, we are proposing to adopt a definition of certified EHR technology at § 414.1305 for MIPS eligible clinicians that is based on the definition that applies in the EHR Incentive Programs under 42 CFR 495.4.
In the 2015 EHR Incentive Programs final rule (80 FR 62873) we outlined the requirements for EPs using certified EHR technology in 2017 as it relates to the objectives and measures they select to report. We propose at § 414.1375 similar requirements for the use of certified EHR technology in relation to the selection of objectives and measures under the MIPS advancing care information performance category.
For 2017, the first MIPS performance period, MIPS eligible clinicians would be able to use EHR technology certified to either the 2014 or 2015 Edition certification criteria as follows:
• A MIPS eligible clinician who only has technology certified to the 2015 Edition may choose to report: (1) On the objectives and measures specified for the advancing care information performance category in section II.E.5.g.7 of this proposed rule, which correlate to Stage 3 requirements; or (2) on the alternate objectives and measures specified for the advancing care information performance category in section II.E.5.g.7 of this proposed rule, which correlate to modified Stage 2 requirements.
• A MIPS eligible clinician who has technology certified to a combination of 2015 Edition and 2014 Edition may choose to report: (1) On the objectives and measures specified for the advancing care information performance category in section II.E.5.g.7 of this proposed rule, which correlate to Stage 3; or (2) on the alternate objectives and measures specified for the advancing care information performance category as described in section II.E.5.g.7 of this proposed rule, which correlate to modified Stage 2, if they have the appropriate mix of technologies to support each measure selected.
• A MIPS eligible clinician who only has technology certified to the 2014 Edition would not be able to report on any of the measures specified for the advancing care information performance category described in section II.E.5.g.7 of this proposed rule that correlate to a Stage 3 measure that requires the support of technology certified to the 2015 Edition. These MIPS eligible clinicians would be required to report on the alternate objectives and measures specified for the advancing care information performance category as described in section II.E.5.g.7. of this proposed rule, which correlate to modified Stage 2 objectives and measures.
Beginning with the performance period in 2018, MIPS eligible clinicians:
• Must only use technology certified to the 2015 Edition to meet the objectives and measures specified for the advancing care information performance category in section II.E.5.g.7. of this proposed rule, which correlate to Stage 3.
We welcome comments on this proposal, which is intended to maintain consistency across MIPS, the Medicare EHR Incentive Program and the Medicaid EHR Incentive Program.
Finally, we propose to define at § 414.1305 a meaningful EHR user under MIPS as a MIPS eligible clinician who possesses certified EHR technology, uses the functionality of certified EHR technology, and reports on applicable objectives and measures specified for the advancing care information performance category for a performance period in the form and manner specified by CMS.
We invite comments on our proposals.
Under the Medicare EHR Incentive Program, EPs attest to the numerators and denominators for certain objectives and measures, through a CMS web portal. For the purpose of reporting advancing care information performance category objectives and measures under the MIPS, we propose at § 414.1325 to allow for MIPS eligible clinicians to submit advancing care information performance category data through qualified registry, EHR, QCDR, attestation and CMS Web Interface submission methods. Regardless of data submission method, all MIPS eligible clinicians must follow the reporting requirements for the objectives and measures to meet the requirements of the advancing care information performance category.
We note that under this proposal, 2017 would be the first year that EHRs (through the QRDA submission method), QCDRs and qualified registries would be able to submit EHR Incentive Program objectives and measures (as adopted for the advancing care information performance category) to CMS, and the first time this data would be reported through the CMS Web Interface. We recognize that some Health IT vendors, QCDRs and qualified registries may not be able to conduct this type of data submission for the 2017 performance period given that the development efforts associated with this data submission capability. However, we are including these data submission mechanisms in 2017 to support early adopters and to signal our longer-term commitment to working with organizations that are agile, effective and can create less burdensome data submission mechanisms for MIPS eligible clinicians. We believe the proposed data submission methods could reduce reporting burden by synchronizing reporting requirements and data submission, and systems, allow for greater access and ease in submitting data throughout the MIPS program. We note that specific details about the form and manner for data submission will be addressed by CMS in the future.
Under the Medicare EHR Incentive Program, CMS adopted a reporting mechanism for EPs that are part of a group to attest using one common form, or batch reporting process. Under that batch reporting process CMS assessed the individual performance of the EPs that made up the group, not the group as a whole, to determine whether those EPs meaningfully used certified EHR technology.
The structure of the MIPS and our desire to achieve alignment across the MIPS performance categories appropriately necessitates the ability to assess the performance of MIPS eligible clinicians at the group level for all MIPS performance categories. We believe MIPS eligible clinicians should be able to submit data as a group, and be assessed at the group level, for all of the MIPS performance categories, including the advancing care information performance category. For this reason, we are proposing a group reporting mechanism for individual MIPS eligible clinicians to have their performance assessed as a group for all performance categories in section II.E.1.e. of this proposed rule, consistent with section 1848(q)(1)(D)(i)(I) & (II) of the Act.
Under this option, we are proposing that performance on advancing care information performance category objectives and measures would be assessed and reported at the group level, as opposed to the individual MIPS eligible clinician level. We note that the data submission criteria would be the same when submitted at the group-level as if submitted at the individual-level, but the data submitted would be aggregated for all MIPS eligible clinicians within the group practice. We believe this approach to data submission better reflects the team dynamics of groups, and would reduce the overall reporting burden for MIPS eligible clinicians that practice in groups, incentivize practice-wide approaches to data submission, and provide enterprise-level continuous improvements strategies for submitting data to the advancing care information performance category. Please see section II.E.1.e. of this proposed rule for more discussion of how to participate as a group under MIPS.
Section 1848(q)(5)(E)(i)(IV) of the Act, as added by section 101(c) of the MACRA, states that 25 percent of the MIPS CPS shall be based on performance for the advancing care information performance category. Therefore, we propose at § 414.1375 that performance in the advancing care information performance category will comprise 25 percent of a MIPS eligible clinician's CPS for payment year 2019 and each year thereafter. We received many comments in the MIPS and APMs RFI from stakeholders regarding the importance of flexible scoring for the advancing care information performance category and provisions for multiple performance pathways. We agree that this is the best approach moving forward with the adoption and use of certified EHR technology as it becomes part of a single coordinated program under the MIPS. For the reasons described here and previously in this preamble, we are proposing a methodology which balances the goals of incentivizing participation and reporting while recognizing exceptional performance by awarding points through a performance score. In this methodology, we are proposing at § 414.1380(b)(4) that the score for the advancing care information performance category would be comprised of a score for participation and reporting, hereinafter referred to as the “base score,” and a score for performance at varying levels above the base score requirements, hereinafter referred to as the “performance score”.
To earn points toward the base score, a MIPS eligible clinician must report the numerator and denominator of certain measures specified for the advancing care information performance category (see measure specifications in section II.E.5.g.7 of this proposed rule), which are based on the measures adopted by the EHR Incentive Programs for Stage 3 in the 2015 EHR Incentive Programs Final Rule, to account for 50 percent (out of a total 100 percent) of the advancing care information performance category score. For measures that include a percentage-based threshold for Stage 3 of the EHR Incentive Program, we would not require those thresholds to be met for purposes of the advancing care information performance category under MIPS, but would instead require MIPS eligible clinicians to report the numerator (of at least one) and denominator (or a yes/no statement for applicable measures, which would be submitted together with data for the other measures) for each measure being reported. We note that for any measure requiring a yes/no statement, only a yes statement would qualify for credit under the base score. Under the proposal, the base score of the advancing care information performance category would incorporate the objective and measures adopted by the EHR Incentive Programs with an emphasis on privacy and security. We are proposing two variations of a scoring methodology for the base score, a primary and an alternate proposal, which are outlined below. Both proposals would require the MIPS eligible clinician to meet the requirement to protect patient health information created or maintained by certified EHR technology to earn any score within the advancing care information performance category; failure to do so would result in a base score of zero, a performance score of zero (discussed in section II.E.5.g of this proposed rule), and an advancing care information performance category score of zero.
The primary proposal at section II.E.5.g.6.b.ii. of this proposed rule would require a MIPS eligible clinician to report the numerator (of at least one) and denominator or yes/no statement (only a yes statement would qualify for credit under the base score) for a subset of measures adopted by the EHR Incentive Program for EPs in the 2015 EHR Incentive Programs Final Rule. In an effort to streamline and simplify the reporting requirements under the MIPS, and reduce reporting burden on MIPS eligible clinicians, two objectives (Clinical Decision Support and Computerized Provider Order Entry) and their associated measures would not be required for reporting the advancing care information performance category. Given the consistently high performance on these two objectives in the EHR Incentive Program with EPs accomplishing a median score of over 90 percent for the last 3 years, we believe these objectives and measures are no longer an effective measure of EHR performance and use. In addition, we do not believe these objectives and associated measures contribute to the goals of patient engagement and interoperability, and thus believe these objectives can be removed in an effort to reduce reporting burden without negatively impacting the goals of the advancing care information performance category. We note that the removed objectives and associated measures would still be required as part of ONC's functionality standards for certified EHR technology, however, MIPS eligible clinicians would not be required to report the numerator and denominator or yes/no statement for those measures. In the 2015 EHR Incentive Programs Final Rule we also established that, for measures that were removed, the technology requirements would still be a part of the definition of certified EHR
The alternate proposal at section II.E.5.g.6.b.iii. of this proposed rule would require a MIPS eligible clinician to report the numerator (of at least one) and denominator or yes/no statement (only a yes statement would qualify for credit under the base score) for all objectives and measures adopted for Stage 3 in the 2015 EHR Incentive Programs Final Rule to earn the base score portion of the advancing care information performance category, which would include reporting a yes/no statement for Clinical Decision Support and a numerator and denominator for Computerized Provider Order Entry objectives. We include these objectives in the alternate proposal as MIPS eligible clinicians may feel the continued measurement of these objectives is valuable to the continued use of EHR technology as this would maintain the previously established objectives under the EHR Incentive Program.
We believe both proposed approaches to the base score are consistent with the statutory requirements and previously established certified EHR technology requirements as we transition to MIPS. We also believe both approaches, in conjunction with the advancing care information performance score, recognize the need for greater flexibility in scoring CEHRT use across different clinician types and practice settings by allowing MIPS eligible clinicians to focus on the objectives and measures most applicable to their practice.
In the 2015 EHR Incentive Programs Final Rule (80 FR 62832), we finalized the Protect Patient Health Information objective and its associated measure for Stage 3, which requires EPs to protect electronic protected health information (ePHI) created or maintained by the certified EHR technology through the implementation of appropriate technical, administrative, and physical safeguards. As privacy and security is of paramount importance and applicable across all objectives, the Protect Patient Health Information objective and measure would be an overarching requirement for the base score under both the primary proposal and alternate proposal, and therefore would be an overarching requirement for the advancing care information performance category. We propose that a MIPS eligible clinician must meet this objective and measure in order to earn any score within the advancing care information performance category. Failure to do so would result in a base score of zero under either the primary proposal or alternate proposal outlined below, as well as a performance score of zero (discussed in section II.E.5.g. of this proposed rule) and an advancing care information performance category score of zero.
In the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871), we finalized certain objectives and measures EPs would report to demonstrate meaningful use of certified EHR technology for Stage 3. Under our proposal for the base score of the advancing care information performance category, MIPS eligible clinicians would be required to submit the numerator (of at least one) and denominator, or yes/no statement as appropriate (only a yes statement would qualify for credit under the base score), for each measure within a subset of objectives (Electronic Prescribing, Patient Electronic Access to Health Information, Care of Coordination Through Patient Engagement, Health Information Exchange, and Public Health and Clinical Data Registry Reporting) adopted in the 2015 EHR Incentive Programs Final Rule for Stage 3 as outlined in Table 6 to account for the base score of 50 percent of the advancing care information performance category score. Successfully submitting a numerator and denominator or yes/no statement for each measure of each objective would earn a base score of 50 percent for the advancing care information performance category. Failure to meet the submission criteria (numerator/denominator or yes/no statement as applicable) and measure specifications (as defined in section II.E.5.g.7. of this proposed rule) for any measure in any of the objectives would result in a score of zero for the advancing care information performance category base score, a performance score of zero (discussed in section II.E.5.g. of this proposed rule) and an advancing care information performance category score of zero.
For the Public Health and Clinical Data Registry Reporting objective there is no numerator and denominator to measure; rather, the measure is a “yes/no” statement of whether the MIPS eligible clinician has completed the measure, noting that only a yes statement would qualify for credit under the base score. Therefore we are proposing that MIPS eligible clinicians would include a yes/no statement in lieu of the numerator/denominator statement within their submission for the advancing care information performance category for the Public Health and Clinical Data Registry Reporting objective. We further propose that, to earn points in the base score, a MIPS eligible clinician would only need to complete submission on the Immunization Registry Reporting measure of this objective. Completing any additional measures under this objective would earn one additional bonus point in the advancing care information performance category score. For further information on this proposed objective, we direct readers to section II.E.5.g.7. of this proposed rule.
Under our alternate proposal for the base score of the advancing care information performance category, a MIPS eligible clinician would be required to submit the numerator (of at least one) and denominator, or yes/no statement as appropriate, for each measure, for all objectives and measures for Stage 3 in the 2015 EHR Incentives Program Final Rule (80 FR 62829-62871) as outlined in Table 7. Successfully submitting a numerator and denominator for each measure of each objective would earn a base score of 50 percent for the advancing care information performance category. Failure to meet the submission requirements, or measure specifications for any measure in any of the objectives would result in a score of zero for the advancing care information performance category base score, a performance score of zero (discussed in Section II.E.5.g.), and an advancing care information performance category score of zero.
We propose the same approach in the alternate proposal for the Public Health and Clinical Data Registry Reporting objective as for the primary proposal outlined above. We direct readers to section II.E.5.g.7. for further details on the individual objectives and measures.
In the 2015 EHR Incentive Programs final rule (80 FR 62772), we streamlined reporting for EPs by adopting a single set of objectives and measures for EPs regardless of their prior stage of participation. This was the first step in synchronizing the objectives and eliminating the separate stages of meaningful use in the EHR Incentive Program. In doing so, we also sought to provide some flexibility and to allow adequate time for EPs to move toward the more advanced use of EHR technology. This flexibility included alternate exclusions and specifications for EPs scheduled to demonstrate Stage 1 in 2015 and 2016 (80 FR 62788) and allowed clinicians to select either the Modified Stage 2 Objectives or the Stage 3 Objectives in 2017 (80 FR 62772) with all EPs moving to the Stage 3 Objectives in 2018. We note that in section II.E.5.g. of this proposed rule, we proposed the requirements for MIPS eligible clinicians using various editions of certified EHR technology in 2017 as it relates to the objectives and measures they select to report.
In connection with that proposal, and in an effort not to unfairly burden MIPS eligible clinicians who are still utilizing EHR technology certified to the 2014 Edition certification criteria in 2017, we propose at § 414.1380(b)(4) modified primary and alternate proposals for the base score for those MIPS eligible clinicians utilizing EHR technology certified to the 2014 Edition. We note that these modified proposals are the same as the primary and alternate proposals outlined above in regard to scoring and data submission, but vary in the measures required under the Coordination of Care Through Patient Engagement and Health Information Exchange objectives as demonstrated in Table 8.
This approach allows MIPS eligible clinicians to continue moving toward advanced use of certified EHR technology in 2018, but allows for flexibility in the implementation of upgraded technology and in the selection of measures for reporting in 2017.
We invite comments on our proposal.
In addition to the base score, which includes submitting each of the objectives and measures in order to achieve 50 percent of the possible points within the advancing care information performance category, we propose to allow multiple paths to achieve a score greater than the 50 percentage base score. The performance score is based on the priority goals established by CMS to focus on leveraging certified EHR technology to support the coordination of care. A MIPS eligible clinician would earn additional points above the base score for performance in the objectives and measures for Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange. These measures have a focus on patient engagement, electronic access and information exchange, which promote healthy behaviors by patients and lay the ground work for interoperability. These measures also have significant opportunity for improvement among eligible clinicians and the industry as a whole based on adoption and performance data. We believe this approach for achievement above a base score in the advancing care information performance category would provide MIPS eligible clinicians a flexible and realistic incentive towards the adoption and use of certified EHR technology.
We are proposing at § 414.1380(b)(4) that, for the performance score, the eight associated measures under these three objectives would each be assigned a total of 10 possible points. For each measure, a MIPS eligible clinician may earn up to 10 percent of their performance score based on their performance rate for the given measure. For example, a performance rate of 95 percent on a given measure would earn 9.5 percentage points of the performance score for the advancing care information performance category. This scoring approach is consistent with the performance score approach outlined for other MIPS categories in this proposed rule. Table 9 provides an example of the proposed performance score methodology.
We note that in this methodology, a MIPS eligible clinician has the potential to earn a performance score of up to 80 percent, which, in combination with the base score would be greater than the total possible 100 percent for the advancing care information performance category. This methodology allows flexibility for MIPS eligible clinicians to focus on measures which are most relevant to their practice to achieve the maximum performance category score, while deemphasizing concentration in other measures which are not relevant to their practice.
This proposed methodology recognizes the importance of promoting health IT adoption and standards and the use of certified EHR technology to support quality improvement, interoperability, and patient engagement. We invite comments on our proposal.
To determine the MIPS eligible clinician's overall advancing care information performance category score, we propose to use the sum of the base score, performance score, and the potential Public Health and Clinical Data Registry Reporting bonus point. We note that if the sum of the MIPS eligible profession's base score (50 percent) and performance score (out of a possible 80 percent) with the Public Health and Clinical Data Registry Reporting bonus point are greater than 100 percent, we would apply an advancing care information performance category score of 100 percent. For example, if the MIPS eligible clinician earned the base score of 50 percent, a performance score of 60 percent and the bonus point for Public Health and Clinical Data Registry Reporting for a total of 111 percent, the MIPS eligible clinician's overall advancing care information performance category score would be 100 percent. The total percentage score (out of 100) for the advancing care information performance category would then be applied to the 25 points allocated for the advancing care information performance category and incorporated into the MIPS CPS, as described in section II.E.6. of this proposed rule. Table 10 provides an example of the calculation of the advancing care information performance category score based on these proposals.
Section 1848(q)(5)(E)(ii) of the Act, as added by section 101(c) of the MACRA, provides that in any year in which the Secretary estimates that the proportion of EPs (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the MIPS CPS, but not below 15 percent, and increase the weightings of the other performance categories such that the total percentage points of the increase equals the total percentage points of the reduction. We note section 1848(o)(5) of the Act defines an EP as a physician, as defined in section 1861(r) of the Act. For purposes of applying section 1848(q)(5)(E)(ii) of the Act, we propose to estimate the proportion of physicians as defined in section 1861(r) who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of at least 75 percent under our proposed scoring methodology for the advancing care information performance category for a performance period. This would require the MIPS eligible clinician to earn the advancing care information base score of 50 percent, and an advancing care information performance score of at least 25 percent (or 24 percent plus the Public Health and Clinical Data Registry Reporting bonus point) for an overall performance category score of 75 percent for the advancing care information performance category. We are alternatively proposing to estimate the proportion of physicians as defined in section 1861(r) who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of 50 percent (which would only require the MIPS eligible clinician to earn the advancing care information base score) under our proposed scoring methodology for the advancing care information performance category for a performance period, and we seek comments on both of these proposed thresholds.
We propose to base this estimation on data from the relevant performance period, if we have sufficient data available from that period. For example, if feasible, we would consider whether to reduce the applicable percentage weight of the advancing care information performance category in the MIPS CPS for the 2019 MIPS payment year based on an estimation using the data from the 2017 performance period. We note that in section II.E.5.g.8. of this proposed rule, we have proposed to reweight the advancing care information performance category to zero for certain hospital-based physicians and other physicians. These physicians meet the definition of MIPS eligible clinicians, but would not be included in the estimation because the advancing care information performance category would be weighted at zero for them. We note that any adjustments of the performance category weights specified in section 1848(q)(5)(E) of the Act based on this policy would be established in future notice and comment rulemaking.
We invite comments on our proposals.
We propose the objectives and measures for the advancing care information performance category of MIPS as outlined in this section of the proposed rule. We note that these objectives and measures have been adapted from the Stage 3 objectives and measures as finalized in the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871), however, we have not proposed to maintain the previously established thresholds for MIPS. Any additional changes to the objectives and measures are outlined in this section of the proposed rule. For a more detailed discussion of the Stage 3 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871).
• Denominator: Number of prescriptions written for drugs requiring a prescription in order to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription in order to be dispensed during the performance period.
• Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using certified EHR technology.
For this objective, we note that the 2015 EHR Incentive Program final rule included a discussion of controlled substances in the context of the Stage 3 objective and measure (80 FR 62834), which we understand from stakeholders has caused confusion. We are therefore proposing for both MIPS and for the EHR Incentive Programs that health care providers would continue to have the option to include or not include controlled substances that can be electronically prescribed in the denominator. This means that health care providers may choose to include controlled substances in the definition of “permissible prescriptions” at their discretion where feasible and allowable by law in the jurisdiction where they provide care. The health care provider may also choose not to include controlled substances in the definition of “permissible prescriptions” even if such electronic prescriptions are feasible and allowable by law in the jurisdiction where they provide care.
• Denominator: Number of medication orders created by the MIPS eligible clinician during the performance period.
• Numerator: The number of orders in the denominator recorded using CPOE.
• Denominator: Number of laboratory orders created by the MIPS eligible clinician during the performance period.
• Numerator: The number of orders in the denominator recorded using CPOE.
• Denominator: Number of diagnostic imaging orders created by the MIPS eligible clinician during the performance period.
• Numerator: The number of orders in the denominator recorded using CPOE.
• Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator (or patient authorized representative) who are provided timely access to health information to view online, download, and transmit to a third party and to access using an application of their choice that is configured meet the technical specifications of the API in the MIPS eligible clinician's certified EHR technology.
• Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator who were provided electronic access to patient-specific educational resources using clinically relevant information identified from certified EHR technology during the performance period.
• Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information during the performance period and the number of unique patients (or their authorized representatives) in the denominator who have accessed their health information through the use of an API during the performance period.
• Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator for whom a secure electronic message is sent to the patient (or patient-authorized representative) or in response to a secure message sent by the patient (or patient-authorized representative), during the performance period.
• Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator for whom data from non-clinical settings, which may include patient-generated health data, is captured through the certified EHR technology into the patient record during the performance period.
• Denominator: Number of transitions of care and referrals during the performance period for which the MIPS eligible clinician was the transferring or referring clinician.
• Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using certified EHR technology and exchanged electronically.
• Denominator: Number of patient encounters during the performance period for which a MIPS eligible clinician was the receiving party of a transition or referral or has never before encountered the patient and for which an electronic summary of care record is available.
• Numerator: Number of patient encounters in the denominator where an electronic summary of care record received is incorporated by the clinician into the certified EHR technology.
• Denominator: Number of transitions of care or referrals during the performance period for which the MIPS eligible clinician was the recipient of the transition or referral or has never before encountered the patient.
• Numerator: The number of transitions of care or referrals in the denominator where the following three clinical information reconciliations were performed: Medication list, medication allergy list, and current problem list.
We propose the Modified Stage 2 objectives and measures for the advancing care information performance category of MIPS as outlined in this section of the proposed rule. We note that these objectives and measures have been adapted from the Modified Stage 2 objectives and measures as finalized in the 2015 EHR Incentive Programs Final Rule (80 FR 62793—62825), however, we have not proposed to maintain the previously established thresholds for MIPS. Any additional changes to the objectives and measures are outlined in this section of the proposed rule. For a more detailed discussion of the Modified Stage 2 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs Final Rule (80 FR 62793—62825).
ePrescribing Measure: At least one permissible prescription written by the MIPS eligible clinician is queried for a drug formulary and transmitted electronically using certified EHR technology.
• Denominator: Number of prescriptions written for drugs requiring a prescription in order to be dispensed other than controlled substances during the performance period; or number of prescriptions written for drugs requiring a prescription in order to be dispensed during the performance period.
• Numerator: The number of prescriptions in the denominator generated, queried for a drug formulary, and transmitted electronically using certified EHR technology.
• Denominator: Number of medication orders created by the MIPS eligible clinician during the performance period.
• Numerator: The number of orders in the denominator recorded using CPOE.
• Denominator: Number of laboratory orders created by the MIPS eligible clinician during the performance period.
• Numerator: The number of orders in the denominator recorded using CPOE.
• Denominator: Number of diagnostic imaging orders created by the MIPS eligible clinician during the performance period.
• Numerator: The number of orders in the denominator recorded using CPOE.
• Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator (or patient authorized representative) who are provided timely access to health information to view online, download, and transmit to a third party.
• Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of unique patients (or their authorized representatives) in the denominator who have viewed online, downloaded, or transmitted to a third party the patient's health information during the performance period.
• Denominator: The number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator who were provided access to patient-specific educational resources using clinically relevant information identified from certified EHR technology during the performance period.
• Denominator: Number of unique patients seen by the MIPS eligible clinician during the performance period.
• Numerator: The number of patients in the denominator for whom a secure electronic message is sent to the patient (or patient-authorized representative) or in response to a secure message sent by the patient (or patient-authorized representative), during the performance period.
• Denominator: Number of transitions of care and referrals during the performance period for which the EP was the transferring or referring health care provider.
• Numerator: The number of transitions of care and referrals in the denominator where a summary of care record was created using certified EHR technology and exchanged electronically.
• Denominator: Number of transitions of care or referrals during the performance period for which the MIPS eligible clinician was the recipient of the transition or referral or has never before encountered the patient.
• Numerator: The number of transitions of care or referrals in the denominator where the following three clinical information reconciliations were performed: Medication list, medication allergy list, and current problem list.
We invite comments on our proposal.
In the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871) we outlined certain exclusions from the objectives and measures of meaningful use for EPs who perform low numbers of a particular action or activity for a given measure (for example, an EP who writes fewer than 100 permissible prescriptions during the EHR reporting period would be granted an exclusion for the Electronic Prescribing measure) or for EPs who had no office visits during the EHR reporting period. Moving forward, we believe that the proposed MIPS exclusion criteria as outlined in section II.E.3. of this proposed rule, and advancing care information performance category scoring methodology together accomplish the same end as the previously established exclusions for the majority of the advancing care information measures. By excluding from MIPS those clinicians who do not exceed the low-volume threshold (proposed in section II.E.3.c. as MIPS eligible clinicians who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provide care for 100 or fewer Part B-enrolled Medicare beneficiaries), we believe exclusions for most of the individual advancing care information measures are no longer necessary. The additional flexibility afforded by the proposed advancing care information performance category scoring methodology eliminates required thresholds for measures and allows MIPS eligible clinicians to focus on, and therefore report higher numbers for, measures that are more relevant to their practice.
We note that EPs who write less than 100 permissible prescriptions during the EHR reporting period are allowed an exclusion for the Electronic Prescribing measure under the EHR Incentive Program (80 FR 62834), which we do not propose for MIPS. We note that the Electronic Prescribing objective would not be part of the performance score under our proposals, and thus MIPS eligible clinicians who write very low numbers of permissible prescriptions would not be at a disadvantage in relation to other MIPS eligible clinicians when seeking to achieve a maximum advancing care information performance category score. For the purposes of the base score, we are proposing that those MIPS eligible clinicians who write fewer than 100 permissible prescriptions in a performance period may elect to report their numerator and denominator (if they have at least one permissible prescription for the numerator), or they may report a null value. This is consistent with prior policy which allowed flexibility for clinicians in similar circumstances to choose an alternate exclusion (80 FR 62789).
In addition, in the 2015 EHR Incentive Programs final rule, we adopted a set of exclusions for the Immunization Registry Reporting measure under the Public Health and Clinical Data Registry Reporting objective (80 FR 62870). We recognize that some types of clinicians do not administer immunizations, and are therefore proposing to maintain the previously established exclusions for the Immunization Registry Reporting measure. We are therefore proposing that these MIPS eligible clinicians may elect to report their yes/no statement if applicable, or they may report a null value (if the previously established exclusions apply) for purposes of reporting the base score.
We note that we are not proposing to maintain any of the other exclusions established under the EHR Incentive Program, however, we are seeking comment on whether other exclusions should be considered under the advancing care information performance category under the MIPS.
As discussed previously in this proposed rule, section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment at the end of CY 2018. Section 1848(a)(7) of the Act includes certain statutory exceptions to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. Specifically, section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under section 1848(a)(7)(A) of the Act. In addition, section 1848(a)(7)(B) of the Act provides that the Secretary may exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The MACRA did not maintain these statutory
Section 1848(q)(5)(F) of the Act provides, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable to each type of MIPS eligible clinician, and for each measure and activity specified for each such category based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician.
We believe that under our proposals for the advancing care information performance category of the MIPS, there may not be sufficient measures that are applicable and available to certain types of MIPS eligible clinicians as outlined in this section of this proposed rule, some of whom may have qualified for a statutory exception to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. For the reasons stated below, we propose to assign a weight of zero to the advancing care information performance category for purposes of calculating a MIPS CPS for these MIPS eligible clinicians. We refer readers to section II.E.6. of this proposed rule for more information regarding how the quality, resource use and CPIA performance categories would be reweighted.
Section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. We defined a hospital-based EP for the EHR Incentive Program under § 495.4 as an EP who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an inpatient hospital or emergency room setting in the year preceding the payment year, or in the case of a payment adjustment year, in either of the 2 years before the year preceding such payment adjustment year. Under this definition, EPs that have 90 percent or more of payments for covered professional services associated with claims with Place of Service Codes 21 (inpatient hospital) or 23 (emergency department) are considered hospital-based (75 FR 44442).
We believe there may not be sufficient measures applicable and available to hospital-based MIPS eligible clinicians under our proposals for the advancing care information performance category of MIPS.
Hospital-based MIPS eligible clinicians may not have control over the decisions that the hospital makes regarding the use of health IT and certified EHR technology. These MIPS eligible clinicians therefore may have no control over the type of certified EHR technology available, the way that the technology is implemented and used, or whether the hospital continually invests in the technology to ensure it is compliant with ONC certification criteria. In addition, some of the specific advancing care information performance category measures, such as the Patient Access measure under the Patient Electronic Access objective requires that patients have access to view, download and transmit their health information from the EHR which is made available by the health care provider, in this case the hospital. Thus the measure is more attributable and applicable to the hospital and not to the MIPS eligible clinician, as the hospital controls the availability of the EHR technology. Further, the requirement under the Protect Patient Health Information objective to conduct a security risk analysis, would rely on the actions of the hospital, rather than the actions of the MIPS eligible clinician, as the hospital controls the access and availability and secure implementation of the EHR technology. In this case, the measure is again more attributable and applicable to the hospital than to the MIPS eligible clinician. Further, certain specialists (such as pathologists, radiologists and anesthesiologists) who often practice in a hospital setting and may be hospital-based MIPS eligible clinicians often lack face-to-face interaction with patients, and thus may not have sufficient measures applicable and available to them under our proposals. For example, hospital-based MIPS eligible clinicians who lack face-to-face patient interaction may not have patients for which they could transfer or create an electronic summary of care record.
In addition, we note that eligible hospitals and CAHs are subject to meaningful use requirements under sections 1886(b)(3)(B) and (n) and 1814(l) of the Act, respectively, which were not affected by the enactment of the MACRA. Eligible hospitals and CAHs are required to report on objectives and measures of meaningful use under the EHR Incentive Program, as outlined in the 2015 EHR Incentive Programs Final Rule. We note the objectives and measures of the EHR Incentive Programs for eligible hospitals and CAHs are specific to these facilities, and are more applicable and better represent the EHR technology available in these settings.
For these reasons, we propose to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category for hospital-based MIPS eligible clinicians. We propose to define a “hospital-based MIPS eligible clinician” at § 414.1305 as a MIPS eligible clinician who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an inpatient hospital or emergency room setting in the year preceding the performance period, otherwise stated as the year three years preceding the MIPS payment year. For example, under this proposal, hospital-based determinations would be made for the 2019 MIPS payment year based on covered professional services furnished in 2016. We also propose, consistent with the EHR Incentive Program, that CMS would determine which MIPS eligible clinicians qualify as “hospital-based” for a MIPS payment year. We invite comments on these proposals.
In addition, we are seeking comment on how the advancing care information performance category could be applied to hospital-based MIPS eligible clinicians in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.
We are also seeking comment on whether the previously established 90 percent threshold of payments for covered professional services associated with claims with Place of Service (POS) Codes 21 (inpatient hospital) or 23 (emergency department) is appropriate, or whether we should consider lowering this threshold to account for hospital-based MIPS eligible clinicians who bill more than 10 percent of claims with a POS other than 21 or 23. Although we have proposed a threshold of 90 percent, we are considering whether a lower threshold would be more appropriate for hospital-based MIPS eligible clinicians. In particular, we are interested in what factors should be applied to determine the threshold for hospital-based MIPS eligible clinicians. We will continue to evaluate the data to determine whether there are certain thresholds which naturally define a hospital-based MIPS eligible clinician.
Section 1848(a)(7)(B) of the Act provides that the Secretary may exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship. In the Stage 2 Final Rule (77 FR 54097-54100), we defined certain categories of significant hardships that may prevent an EP from meeting the requirements of being a meaningful EHR user. These categories include:
• Insufficient Internet Connectivity (as specified in 42 CFR 495.102(d)(4)(i)).
• Extreme and Uncontrollable Circumstances (as specified in 42 CFR 495.102(d)(4)(iii)).
• Lack of Control over the Availability of certified EHR technology (as specified in 42 CFR 495.102(d)(4)(iv)(A)).
• Lack of Face-to-Face Patient Interaction (as specified in 42 CFR 495.102(d)(4)(iv)(B)).
We believe that under our proposals for the advancing care information performance category, there may not be sufficient measures applicable and available to MIPS eligible clinicians within the categories above. For these MIPS eligible clinicians, we propose to rely on section 1848(q)(5)(F) of the Act to re-weight the advancing care information performance category to zero.
Sufficient internet access is fundamental to many of the measures proposed for the advancing care information performance category. For example, the ePrescribing measure requires sufficient access to the Internet to transmit prescriptions electronically, and the Secure Messaging measure requires sufficient Internet access to receive and respond to patient messages. These measures may not be applicable to MIPS eligible clinicians who practice in areas with insufficient internet access. We propose to require MIPS eligible clinicians to demonstrate insufficient internet access through an application process in order to be considered for a reweighting of the advancing care information performance category. The application would have to demonstrate that the MIPS eligible clinicians lacked sufficient internet access, during the performance period, and that there were insurmountable barriers to obtaining such infrastructure, such as a high cost of extending the internet infrastructure to their facility.
Extreme and uncontrollable circumstances, such as a natural disaster in which an EHR or practice building are destroyed, can happen at any time and are outside a MIPS eligible clinician's control. If a MIPS eligible clinician's certified EHR technology is unavailable as a result of such circumstances, the measures specified for the advancing care information performance category may not be available for the MIPS eligible clinician to report. We propose that these MIPS eligible clinicians submit an application to include the circumstances by which the EHR technology was unavailable, and for what period of time it was unavailable, to be considered for reweighting of their advancing care information performance category.
In the Stage 2 Final Rule (77 FR 54100) we discussed EPs who practice at multiple locations, and may not have the ability to impact their practices' health IT decisions. We noted the case of surgeons using ambulatory surgery centers or a physician treating patients in a nursing home who does not have any other vested interest in the facility, and may have no influence or control over the health IT decisions of that facility. If MIPS eligible clinicians lack control over the EHR technology in their practice locations, then the measures specified for the advancing care information performance category may not be available to them for reporting. To be considered for a reweighting of the advancing care information performance category, we propose that these MIPS eligible clinicians would need to submit an application demonstrating that a majority (50 percent or more) of their outpatient encounters occur in locations where they have no control over the health IT decisions of the facility, and request their advancing care information performance category score be reweighted to zero. We note that in such cases, the MIPS eligible clinician must have no control over the availability of certified EHR technology. Control does not imply final decision-making authority. For example, we would generally view MIPS eligible clinicians practicing in a large group as having control over the availability of certified EHR technology, because they can influence the group's purchase of certified EHR technology, they may reassign their claims to the group, they may have a partnership/ownership stake in the group, or any payment adjustment would affect the group's earnings and the entire impact of the adjustment would not be borne by the individual MIPS eligible clinician. These MIPS eligible clinicians can influence the availability of certified EHR technology and the group's earnings are directly affected by the payment adjustment. Thus, such MIPS eligible clinicians would not, as a general rule, be viewed as lacking control over the availability of certified EHR technology and would not be eligible for their advancing care information performance category to be reweighted based on their membership in a group practice that has not adopted certified EHR technology.
In the Stage 2 Final Rule (77 FR 54099), we noted the challenges faced by EPs who lack face-to-face interaction with patients (EPs that are non-patient facing), or lack the need to provide follow-up care with patients. Many of the measures proposed under the advancing care information performance category require face-to-face interaction with patients, including all eight of the measures that make up the three performance score objectives (Patient Electronic Access, Coordination of Care Through Patient Engagement and Health Information Exchange). Because these proposed measures rely so heavily on face-to-face patient interactions, we do not believe there would be sufficient measures applicable to non-patient-facing MIPS eligible clinicians under the advancing care information performance category. We propose to automatically reweight the advancing care information performance category to zero for a MIPS eligible clinician who is classified as a non-patient facing MIPS eligible clinician (based on the number of patient-facing encounters billed during a performance period) without requiring an application to be submitted by the MIPS eligible clinician. We refer readers to section II.E.1.b. of this proposed rule for further discussion of non-patient facing MIPS eligible clinicians. We are seeking comment on how the advancing care information performance category could be applied to non-patient facing MIPS eligible clinicians in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.
We propose that all applications for reweighting the advancing care information performance category be submitted by the MIPS eligible clinician or designated group representative in the form and manner specified by CMS. We propose that all applications may be submitted on a rolling basis, but must be received by CMS no later than the close of the submission period for the relevant performance period, or a later date specified by CMS. For example, for the 2017 performance period, applications
We invite comments on our proposals.
The definition of a MIPS EP under section 1848(q)(1)(C) of the Act includes certain non-physician practitioners, including Nurse Practitioners (NPs), Physicians Assistants (PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical Nurse Specialists (CNSs)). CRNAs and CNSs are not eligible for the incentive payments under Medicare or Medicaid for the adoption and meaningful use of certified EHR technology (sections 1848(o) and 1903(t) of the Act, respectively) or subject to the meaningful use payment adjustment under Medicare (section 1848(a)(7)(A) of the Act), and thus they may have little to no experience with the adoption or use of certified EHR technology. Similarly, NPs and PAs may also lack experience with the adoption or use of certified EHR technology, as they are not subject to the payment adjustment under section 1848(a)(7)(A) of the Act. We further note that only 19,281 NPs and only 1,379 PAs have attested to the Medicaid EHR Incentive Program. Nurse practitioners are eligible for the Medicaid incentive payments under section 1903(t) of the Act, as are PAs practicing in a Federally Qualified Health Center (FQHC) or a rural health clinic (RHC) that is led by a PA, if they meet patient volume requirements and other eligibility criteria.
Because many of these non-physician clinicians are not eligible to participate in the Medicare and/or Medicaid EHR Incentive Program, we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under our proposals for the advancing care information performance category. The low numbers of NPs and PAs who have attested for the Medicaid incentive payments may indicate that EHR Incentive Program measures required to earn the incentive are not applicable or available, and thus would not be applicable or available under the advancing care information performance category. For these reasons, we propose to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We would assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the advancing care information performance category. We encourage all NPs, PAs, CRNAs, and CNSs to report on these measures to the extent they are applicable and available, however, we understand that some NPs, PAs, CRNAs, and CNSs may choose to accept a weight of zero for this performance category if they are unable to fully report the advancing care information measures. We believe this approach is appropriate for the first MIPS performance period based on the payment consequences associated with reporting, the fact that many of these types of MIPS eligible clinicians may lack experience with EHR use, and our current uncertainty as to whether we have proposed sufficient measures that are applicable and available to these types of MIPS eligible clinicians. We note that we would use the first MIPS performance period to further evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category and would consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians.
We invite comments on our proposal. We are additionally seeking comment on how the advancing care information performance category could be applied to NPs, PAs, CRNAs, and CNSs in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.
In the 2015 EHR Incentive Programs Final Rule we adopted an alternate method for demonstrating meaningful use for certain Medicaid EPs that would be available beginning in 2016, for EPs attesting for an EHR reporting period in 2015 (80 FR 62900). Medicaid EPs who previously received an incentive payment under the Medicaid EHR Incentive Program, but failed to meet the eligibility requirements for the program in subsequent years, are permitted to attest using the CMS Registration and Attestation system for the purpose of avoiding the Medicare payment adjustment (80 FR 62900). However, as discussed previously in this proposed rule, section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment for Medicare EHR Incentive Program EPs at the end of CY 2018. This means that after the CY 2018 payment adjustment year, there will no longer be a separate Medicare EHR Incentive Program for EPs, and therefore Medicaid EPs who may have used this alternate method for demonstrating meaningful use cannot potentially be subject to a payment adjustment under the Medicare EHR Incentive Program at that time. Accordingly, there will no longer be a need for this alternate method of demonstrating meaningful use after the CY 2018 payment adjustment year.
Similarly, beginning in 2014, states were required to collect, upload and submit attestation data for Medicaid EPs for the purposes of demonstrating meaningful use to avoid the Medicare payment adjustment (80 FR 62915). This form of reporting will also no longer need to continue with the sunset of the meaningful use payment adjustment for Medicare EHR Incentive Program EPs at the end of CY 2018. Accordingly, we are proposing to amend the reporting requirement described at 42 CFR 495.316(g) by adding an ending date such that after the CY 2018 payment adjustment year states would no longer be required to report on meaningful EHR users.
We note that the Medicaid EHR Incentive Program for EPs was not impacted by the MACRA and the requirement under section 1848(q) of the Act to establish the MIPS program. In this rule, we do not propose any changes to the objectives and measures previously established in rulemaking for the Medicaid EHR Incentive Program, and thus EPs participating in that program must continue to report on the objectives and measures under the guidelines and regulations of that program.
Accordingly, reporting on the measures specified for the advancing care information performance category under MIPS cannot be used as a demonstration of meaningful use for the Medicaid EHR Incentive Programs. Similarly, a demonstration of meaningful use in the Medicaid EHR Incentive Programs cannot be used for purposes of reporting under MIPS.
Therefore, MIPS eligible clinicians who are also participating in the Medicaid EHR Incentive Programs must report their data for the advancing care information performance category through the submission methods established for MIPS in order to earn a score for the advancing care information performance category under MIPS and must separately demonstrate meaningful use in their state's Medicaid EHR Incentive Program in order to earn a
Under section 1848(q)(1)(C)(ii) of the Act, as added by section 101(c)(1) of the MACRA and discussed above in section II.E.3.b. of this proposed rule, Qualifying APM Participants (QPs) are not MIPS eligible clinicians and are thus excluded from MIPS payment adjustments. Partial Qualifying APM Participants (Partial QPs) are also not MIPS eligible clinicians unless they opt to report and be scored under MIPS. All other eligible clinicians participating in APMs are MIPS eligible clinicians and subject to MIPS requirements, including reporting requirements and payment adjustments. However, most current APMs already assess their participants on cost and quality of care and require engagement in certain care improvement activities.
We propose at § 414.1370 to establish a scoring standard for MIPS eligible clinicians participating in certain types of APMs in order to reduce participant reporting burden by eliminating the need for such APM eligible clinicians to submit data for both MIPS and their respective APMs. For purposes of this APM scoring standard, we propose to consider a participant in an APM to be an entity participating in an APM under an agreement with CMS that may either include eligible clinicians or be an eligible clinician and that is directly tied to beneficiary attribution, quality measurement or cost/utilization measurement under the APM. In accordance with section 1848(q)(1)(D)(i) of the Act, we propose to assess the performance of a group of MIPS eligible clinicians in an APM Entity that participates in certain types of APMs based on their collective performance as an APM Entity group, as defined at § 414.1305.
In addition to reducing reporting burden, we seek to ensure that eligible clinicians in APM Entity groups are not assessed in multiple ways on the same performance activities. For instance, performance on the generally applicable resource use measures under MIPS could contribute to upward or downward adjustments to payments under MIPS in a way that is not aligned with the strategy in an ACO initiative for reducing total Medicare costs for a specified population of beneficiaries attributed through the unique ACO initiative's attribution methodology. Depending on the terms of the particular APM, we believe similar misalignments could be common between the MIPS quality and resource use performance categories and the evaluation of quality and resource use in APMs. We believe requiring eligible clinicians in APM Entity groups to submit data, be scored on measures, and be subject to payment adjustments that are not aligned between MIPS and an APM could potentially undermine the validity of testing or performance evaluation under the APM. We also believe imposition of these requirements would result in reporting activity that provides little or no added value to the assessment of eligible clinicians, and could confuse eligible clinicians as to which CMS incentives should take priority over others in designing and implementing care activities.
We are proposing to use the APM scoring standard for MIPS eligible clinicians in APM Entity groups participating in certain APMs that meet the criteria listed below (and are identified as “MIPS APMs” on the CMS Web site). In this section of the rule, we define the proposed criteria for MIPS APMs, the APM scoring standard, the performance period for APM Entity groups, the proposed MIPS scoring methodology for APM Entity groups, and other information related to the APM scoring standard.
We propose at § 414.1370 to specify that the APM scoring standard under MIPS would only be applicable to certain eligible clinicians participating in MIPS APMs, which we propose to define as APMs (as defined in section II.F.4. of this preamble) that meet the following criteria: (1) APM Entities participate in the APM under an agreement with CMS; (2) the APM Entities include one or more MIPS eligible clinicians on a Participation List; and (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures. We understand that under some APMs the APM Entity may enter into agreements with clinicians or entities that have supporting or ancillary roles to the APM Entity's performance under the APM, but are not participating under the APM Entity and therefore are not on a Participation List. We would not consider eligible clinicians under such arrangements to be participants for purposes of the APM Entity group to which the APM scoring standard would apply. We understand that this policy would not accommodate certain APMs pursuant to statute or our regulations rather than under an agreement with CMS. We seek comments on how the APM scoring standard should apply to those APMs as well.
The criteria for the identification of MIPS APMs are independent of the criteria for Advanced APM determinations discussed in section II.F.3. of this proposed rule, so a MIPS APM may or may not also be an Advanced APM. As such, it would be possible that an APM meets all three proposed criteria to be a MIPS APM, but does not meet the Advanced APM criteria listed in section II.F.4. Conversely, it would be possible, that an Advanced APM does not meet the criteria listed above because it does not include MIPS eligible clinicians as participants.
The APM scoring standard would not apply to MIPS eligible clinicians involved in APMs that include only facilities as participants (such as the Comprehensive Care for Joint Replacement Model). APMs that do not base payment on cost/utilization and quality measures (such as the Accountable Health Communities Model) would also not meet the proposed criteria for the APM scoring standard. Instead, MIPS eligible clinicians participating in these APMs would need to meet the generally applicable MIPS data submission requirements for the MIPS performance period, and their performance would be assessed using the generally applicable MIPS standards, either as individual eligible clinicians or as a group under MIPS.
As discussed above, the APM scoring standard described in this proposed rule would require MIPS eligible clinicians to report certain data under MIPS regardless of whether they ultimately become QPs or Partial QPs through their participation in Advanced APMs. Although QPs (and Partial QPs who elect not to participate in MIPS) would be excluded from MIPS payment adjustments, we believe it is necessary, for the operational and administrative reasons discussed in section II.F.5.d., to treat these eligible clinicians as MIPS eligible clinicians unless and until the QP or Partial QP determination is made. We believe the proposed APM scoring standard would help to alleviate certain duplicative, unnecessary, or competing data submission requirements for MIPS eligible clinicians participating in MIPS
We invite public comment on alternative MIPS data submission and scoring methods. Specifically, if, during a future performance period, we are able to make QP determinations before MIPS reporting must occur, we seek to attain the least amount of required MIPS data submission while avoiding unnecessary operational complexity.
We propose that the performance period for MIPS eligible clinicians participating in MIPS APMs would match the generally applicable performance period for MIPS proposed in section II.E.4 of this preamble. We propose this policy would apply to all MIPS eligible clinicians participating in MIPS APMs (those that meet the criteria specified in section II.E.5.h.1. of this proposed rule) except for a new MIPS APM for which the first APM performance period begins after the start of the corresponding MIPS performance period. In this instance, the participating MIPS eligible clinicians in the new MIPS APM would submit data to MIPS in the first MIPS performance period for the APM either as individual MIPS eligible clinicians or as a group using one of the MIPS data submission mechanisms for all four performance categories, and report to CMS using the APM scoring standard for subsequent MIPS performance period(s). Additionally, we anticipate that there might be MIPS APMs that would not be able to use the APM scoring standard (even though they met the criteria for the APM scoring standard and were treated as a MIPS APMs in the prior MIPS performance period) in their last year of operation because of technical or resource issues. For example, a MIPS APM in its final year may end earlier than the end of the MIPS performance period (proposed to be December 31). CMS might not have continuing resources dedicated or available to continue to support the MIPS APM activities under the APM scoring standard if the MIPS APM ends during the MIPS performance period. Therefore, if we determine it is not feasible for the MIPS eligible clinicians participating in the APM Entity to report to MIPS using this APM scoring standard in an APM's last year of operation, the MIPS eligible clinicians in the MIPS APM would need to submit data to MIPS either as individual MIPS eligible clinicians or as a group using one of the MIPS data submission mechanisms for the applicable performance period. We propose the eligible clinicians in the MIPS APM would be made aware of this decision in advance of the relevant MIPS performance period.
We believe that establishing an APM scoring standard under MIPS would allow APM Entities and their participating eligible clinicians to focus on the goals and objectives of the APM to improve quality and lower costs of care while avoiding duplicative reporting that would occur as a result of having to submit data to MIPS separately. The APM scoring standard we propose is similar to group assessment under MIPS as described in section II.E.3.d. of this proposed rule, but would differ in one or more of the following ways: (1) Depending on the terms and conditions of the MIPS APM, an APM Entity could be comprised of a sole MIPS eligible clinician (for example, a physician practice with only one eligible clinician could be considered an APM Entity); (2) the APM Entity could include more than one unique TIN, as long as the MIPS eligible clinicians are identified as participants in the APM by their unique APM participant identifiers; (3) the composition of the APM Entity group could include APM participant identifiers with TIN/NPI combinations such that some MIPS eligible clinicians in a TIN are APM participants and other MIPS eligible clinicians in that same TIN are not APM participants. In contrast, assessment as a group under MIPS requires a group to be comprised of at least two MIPS eligible clinicians who have assigned their billing rights to a TIN. It also requires that all MIPS eligible clinicians in the group to use the same TIN.
In addition to the APM Entity group composition being potentially different than that of a group as generally defined under MIPS, we propose for the APM scoring standard that we will generate a MIPS CPS by aggregating all scores for MIPS eligible clinicians in the APM Entity that is participating in the MIPS APM to the level of the APM Entity. We believe that aggregating the MIPS performance category scores at the level of the APM Entity is more meaningful to, and appropriate for, these MIPS eligible clinicians because they have elected to participate in an APM and collectively focus on care transformation activities to improve the quality of care.
Further, we propose below that, depending on the type of MIPS APM, the weights associated with performance categories may be different than the generally applicable weights for MIPS eligible clinicians. The weights assigned to the MIPS performance categories under the APM scoring standard for MIPS eligible clinicians who are participating in a MIPS APM may be different from the performance category weights for MIPs eligible clinicians not participating in a MIPS APM for the same performance period. For example, we propose below that under the APM scoring standard, the weight for the resource use performance category will be zero. We also propose that for certain MIPS APMs, the weight for the quality performance category will be zero for the 2019 payment year. Where the weight for the performance category is zero, neither the APM Entity nor the MIPS eligible clinicians in the MIPS APM would need to report data in these categories, and we would redistribute the weights for the quality and resource use performance categories to the CPIA and advancing care information performance categories to maintain a CPS of 100 percent.
In order to implement certain elements of the APM scoring standard, we would need to use the Shared Savings Program (section 1899 of the Act) and CMS Innovation Center (section 1115A of the Act) authorities to waive specific statutory provisions related to MIPS reporting and scoring. Section 1899(f) of the Act authorizes waivers of title XVIII requirements as may be necessary to carry out the Shared Savings Program, and section 1115A(d)(1) of Act authorizes waivers of title XVIII requirements as may be necessary solely for purposes of testing models under section 1115A of the Act. In each section below in which we propose scoring methodologies and waivers to enable the proposed approaches, we describe how the use of waivers is necessary under the respective waiver authority standards. The underlying purpose of APMs is for CMS to pay for care in ways that are unique from fee-for-service payment and to test new ways of measuring and assessing performance. If the data submission requirements and associated adjustments under MIPS are not aligned
We note that for at least the first performance year, we do not anticipate that any APMs not authorized under sections 1115A or 1899 of the Act would meet the criteria to be MIPS APMs. In the event that we do anticipate other Federal demonstrations will become MIPS APMs, we will address MIPS scoring for participating eligible clinicians in future rulemaking.
To ensure we have accurately captured performance data for all of the MIPS eligible clinicians that are participating in an APM, we would establish and maintain an APM participant database that will include all of the MIPS eligible clinicians who are part of the APM Entity. We would establish this database to track participation in all APMs, in addition to specifically tracking participation in MIPS APMs and Advanced APMs. We propose that each APM Entity be identified in the MIPS program by a unique APM Entity identifier. We also propose in section II.E.2.b. that the unique APM participant identifier for a MIPS eligible clinician would be a combination of four identifiers including: (1) APM identifier (established for the APM by CMS; for example, XXXXXX); (2) APM Entity identifier (established for the APM by CMS; for example, AA00001111); (3) the eligible clinician's billing TIN (for example, XXXXXXXXX); and (4) NPI (for example, 1111111111). For example, this APM participant identifier for the MIPS eligible clinician in this case would be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111. The use of the APM participant identifier will allow CMS to identify all MIPS eligible clinicians participating in an APM Entity, including instances when the MIPS eligible clinicians use a billing TIN that is shared with MIPS eligible clinicians who are not participating in the APM Entity. We would plan to communicate to each APM Entity the MIPS eligible clinicians who are included in the APM Entity group in advance of the applicable MIPS data submission deadline for the MIPS performance period.
Under the Shared Savings Program, each ACO is formed by a collection of Medicare-enrolled TINs (ACO participants). Pursuant to our regulation at 42 CFR 425.118, all Medicare enrolled individuals and entities that have reassigned their rights to receive Medicare payment to the TIN of the ACO participant must agree to participate in the ACO and comply with the requirements of the Shared Savings Program. Because all providers and suppliers that bill through the TIN of an ACO participant are required to agree to participate in the ACO, all MIPS eligible clinicians that bill through the TIN of an ACO participant are considered to be participating in the ACO. For purposes of the APM scoring standard, the ACO would be the APM Entity. The Shared Savings Program has established criteria for determining the list of eligible clinicians participating under the ACO, and we would use the same criteria for determining the list of MIPS eligible clinicians included in the APM Entity group for purposes of the APM scoring standard.
We recognize that there may be scenarios in which MIPS eligible clinicians may change TINs, use more than one TIN for billing Medicare, change their APM participation status, and/or change other practice affiliations during a performance period. Therefore, we propose that only those MIPS eligible clinicians who are listed as participants in the APM Entity in a MIPS APM on December 31 (the last day of the proposed performance period) would be considered part of the APM Entity group for purposes of the APM scoring standard. Consequently, MIPS eligible clinicians who are not listed as participants of an APM Entity in a MIPS APM at the end of the performance period would need to submit data to MIPS through one of the MIPS data submission mechanisms and would have their performance assessed either as individual MIPS eligible clinicians or as a group for all four performance categories. For example, a MIPS eligible clinician who participates in the APM Entity on January 1, 2017 and leaves the APM Entity on June 15, 2017 would need to submit data to MIPS using one of the MIPS data submission mechanisms and would have their performance assessed either as individual MIPS eligible clinicians or as a group. This approach for defining the applicable group of MIPS eligible clinicians is consistent with our proposal for identifying eligible clinician groups for purposes of QP determinations outlined in section II.F.5.b. of this proposed rule; the group of eligible clinicians CMS uses for purposes of a QP determination would be the same as that used for the APM scoring standard. This would be an annual process for each MIPS performance period. We propose to calculate one MIPS CPS for each APM Entity group, and that MIPS CPS would be applied to all MIPS eligible clinicians in the group. As previously explained in section II.E.7. of this proposed rule, the MIPS payment adjustment would be applied at the TIN/NPI level for each of the MIPS eligible clinicians in the APM Entity group.
The APM Entity group used for purposes of the APM scoring standard would be the same APM Entity group used for QP determinations under section II.F.5 of this proposed rule, except in the instances of APMs that do not meet the criteria to be MIPS APMs, as discussed in section II.E.5.h.(1) of this proposed rule. Examples of APMs that would not meet criteria to be MIPS APMs are those that do not have MIPS eligible clinicians as participants under the APM, or do not tie payment to cost/utilization and quality measures. We propose that the APM scoring standard would not apply to MIPS eligible clinicians participating in APMs that are not MIPS APMs. MIPS eligible clinicians who participate in an APM that is not a MIPS APM, would submit data to MIPS and have their performance assessed either as an individual MIPS eligible clinician or group as described in section II.E.2. of this proposed rule. Some APMs may involve certain types of MIPS eligible clinicians that are affiliated with an APM Entity but not included in the APM Entity group because they are not participants of the APM Entity. We propose that even if the APM meets the criteria to be a MIPS APM, MIPS eligible clinicians who are not included in the list of participants would not be considered part of the APM Entity group for purposes of the APM scoring standard. For instance, MIPS eligible clinicians in the Comprehensive Care for Joint Replacement Model might be involved in the APM through a business arrangement with the APM Entity (the inpatient hospital) but are not directly tied to beneficiary attribution, quality measurement, or care improvement activities under the APM. Additionally, we propose that if a MIPS eligible clinician participates in an APM Entity during the MIPS performance period but is no longer a participant in the APM Entity group on the last day of the
As mentioned previously, section 1848(q)(3)(A) of the Act requires the Secretary to establish performance standards for the measures and activities under the following performance categories: (1) Quality; (2) resource use; (3) clinical practice improvement activities; and (4) advancing care information. We propose at § 414.1370 to calculate one CPS that is applied to the billing TIN/NPI combination of each MIPS eligible clinician in the APM Entity group. Therefore, each APM Entity group (for example, the MIPS eligible clinicians in a Shared Savings Program ACO or an Oncology Care Model practice) would receive a score for each of the four performance categories according to the proposals described in this section of the proposed rule, and we would calculate one CPS for the group. The APM Entity group score would be applied to each MIPS eligible clinician in the group, and subsequently used to develop the MIPS payment adjustment that is applicable for each MIPS eligible clinician in the group. Thus the APM Entity group score and the participating MIPS eligible clinician score are the same. For example, in the Shared Savings Program, the MIPS eligible clinicians in each ACO would be an APM Entity group. That group would receive a single CPS that would be applied to each of its participating MIPS eligible clinicians. Similarly, in the Oncology Care Model, the MIPS eligible clinicians in each oncology practice would be an APM Entity group. That group would receive a single CPS that would be applied to each of the MIPS eligible clinicians in the group. We note that this APM Entity group CPS is not used to evaluate eligible clinicians or the APM Entity for purposes of incentives within the APM, shared savings payments, or other potential payments under the APM, and we currently do not foresee APMs that would use the CPS for purposes of evaluation within the APM. Rather the APM Entity group CPS would be used only for the purposes of the APM scoring standard under MIPS for the first MIPS performance period. As proposed in this rule, all MIPS eligible clinicians listed as participating in the APM Entity on the last day of the performance period would be part of the APM Entity group and thus receive the same CPS. It should be noted that although we propose that the APM scoring standard only applies to participants in MIPS APMs, MIPS eligible clinicians that participate in an APM (including but not limited to a MIPS APM) and submit either individual or group level data to MIPS may earn a minimum score of 50 percent of the highest potential CPIA performance category score as long as such MIPS eligible clinicians are on the list of participants for an APM and are identifiable by the APM participant identifier.
Several commenters on the MIPS and APMs RFI suggested, and we generally agree, that MIPS eligible clinicians who collaborate under an APM Entity to accomplish the APM's goals should be treated as a group under MIPS and receive the same CPS. Furthermore, we want to avoid situations in which different MIPS eligible clinicians in the same APM Entity group receive different MIPS scores. APM Entities have a goal of collective success under the terms of the APM, so having a variety of differing MIPS adjustments for eligible clinicians within that collective unit would undermine the intent behind the APM to test a departure from a purely fee-for-service system based on independent clinician activity. Lastly, we believe that measurement of the performance for MIPS at the APM Entity level for eligible clinicians participating in MIPS APMs will result in more statistically valid performance scores for these eligible clinicians because the scores are aggregated to represent a larger group of MIPS eligible clinicians.
We propose, for the first MIPS performance period, a specific scoring and reporting approach for the MIPS eligible clinicians participating in MIPS APMs, which would include the Shared Savings Program, the Next Generation ACO Model, and other APMs that meet the criteria proposed above for a MIPS APM. Specifically, we propose that APM quality measure data submitted through the CMS Web Interface by ACOs participating in the Shared Savings Program and the Next Generation ACO Model would be used to evaluate performance for the MIPS quality performance category. We believe this is appropriate because all MIPS eligible clinicians that use the CMS Web Interface as their quality measure submission mechanism,
Beginning with the first MIPS performance period all Shared Savings Program ACOs would submit their quality measures to MIPS using the CMS Web Interface through the same process that they use to report to the Shared Savings Program and be scored as they normally would under Shared Savings Program rules. Shared Savings Program ACOs have used the CMS Web Interface for submitting their quality measures since the program's inception, making this a familiar data submission process. We also propose that the Shared Savings Program ACO quality measure data that is submitted through the CMS Web Interface will be submitted only once but will be used for two purposes. The Shared Savings Program quality measure data reported to the CMS Web Interface would be used by CMS to calculate the MIPS quality performance category score at the APM Entity group (ACO) level. The Shared Savings Program quality performance data that is not submitted to the CMS Web Interface, for example the CAHPS survey and other claims measures would not be included in the MIPS APM quality performance category score. We believe this will reduce the reporting burden for Shared Savings Program MIPS eligible clinicians by requiring quality measure data to be submitted only once and used for both programs. The MIPS quality
We believe that no waivers are necessary here because the quality measures submitted via the CMS Web Interface under the Shared Savings Program are also MIPS quality measures and will be scored under MIPS performance standards. In the event that Shared Savings Program quality measures depart from MIPS measures in the future, we will address such changes including whether further waivers are necessary at such a time in future rulemaking.
We propose that for the first MIPS performance period, we will not assess MIPS eligible clinicians participating in the Shared Savings Program (the MIPS APM) under the resource use performance category. We propose this approach because: (1) Eligible clinicians participating in the Shared Savings Program are already subject to cost and utilization performance assessments under the APM; (2) the Shared Savings Program measures resource use in terms of an objective, absolute total cost of care expenditure benchmark for a population of attributed beneficiaries, and participating ACOs may share savings and/or losses based on that standard, whereas the MIPS resource use measures are relative measures such that clinicians are graded relative to their peers, and therefore different than assessing total cost of care for a population of attributed beneficiaries; and (3) the beneficiary attribution methodologies for measuring resource use under the Shared Savings Program and MIPS differ, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many TINs comprise an ACO. We believe that with an APM Entity's finite resource for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through an APM must take priority to ensure that the goals and program evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across Shared Savings Program and MIPS assessments—due to the differences in attribution, the inclusion in MIPS of episode-based measures that do not reflect the total cost of care, and the objective versus relative assessment factors listed above—creates uncertainty for eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the Shared Savings Program.
For example, Shared Savings Program ACOs are held accountable for expenditure benchmarks that reflect the total Medicare Parts A and B spending for their assigned beneficiaries, whereas many of the proposed MIPS resource use measures focus on spending for particular episodes of care or clinical conditions. For the reasons stated above, we consider it a programmatic necessity that the Shared Savings Program has the ability to structure its own measurement and payment for performance on total cost of care independent from other incentive programs such as the resource use performance category under MIPS. Thus, we propose to reduce the MIPS resource use performance category weight to zero for all MIPS eligible clinicians in APM Entities participating in the Shared Savings Program. Accordingly, under section 1899(f) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Shared Savings Program—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the resource use performance category. With the proposed reduction of the resource use performance category weight to zero, we believe it would be unnecessary specify and use resource use measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1899(f) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Shared Savings Program—the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, resource use measures in calculating the MIPS CPS for such MIPS eligible clinicians.
Given the proposal to waive requirements under section 1848(q)(5)(E)(i)(II) of the Act in order to reduce the weight of the resource use performance category to zero, we must subsequently specify how that weight would be redistributed among the remaining performance categories in order to maintain a total weight of 100 percent. We propose to redistribute the resource use performance category weight to both the CPIA and advancing care information performance categories as specified in Table 12. The MIPS resource use performance category is proposed to have a weight of 10 percent for the first performance period. Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories, and its weight is scheduled to be reduced from 50 to 30 percent over time, we propose to evenly redistribute the 10 percent resource use performance category weight to the CPIA and advancing care information performance categories so that the distribution does not change the relative weight of the quality performance category in the opposite direction of its future state. The redistributed resource use performance category weight of 10 percent would result in a 5 percentage point increase (from 15 to 20 percent) for the CPIA performance category and a 5 percentage point increase (from 25 to 30 percent) for the advancing care information performance category. We invite comments on the proposed weights and specifically, whether we should increase the MIPS quality performance category weight.
We understand that as the MIPS resource use performance category evolves over time, there might be greater potential for alignment and less potential duplication or conflict with MIPS resource use measurement for MIPS eligible clinicians participating in APMs such as the Shared Savings Program. We will continue to monitor and consider how we might incorporate an assessment in the MIPS resource use performance category into the APM scoring standard for MIPS eligible clinicians participating in the Shared Savings Program. We also understand that reducing the resource use performance category weight to zero and redistributing the weight to the CPIA and advancing care information performance categories could, to the extent that CPIA and advancing care information scores are higher than the scores these MIPS eligible clinicians would have received under resource use, result in higher average scores for MIPS eligible clinicians participating in the Shared Savings Program. We seek comment on the possibility of assigning a neutral score to the Shared Savings Program APM Entity groups for the resource use performance category to moderate MIPS composite performance scores for APM Entities participating in the Shared Savings Program. We also generally seek comment on our proposed policy, and on whether and how we should incorporate the resource use performance category into the APM scoring standard under MIPS for eligible
We propose that MIPS eligible clinicians participating in the Shared Savings Program would submit data for the MIPS CPIA and advancing care information performance categories through their respective ACO participant billing TINs independent of the Shared Savings Program ACO. Pursuant to section 1848(q)(5)(C)(ii) of the Act, all ACO participant group billing TINs would receive a minimum of one half of the highest possible score for the CPIA performance category. Additionally, pursuant to section 1848(q)(5)(C)(i) of the Act, any ACO participant TIN that is determined to be a patient-centered medical home or comparable specialty practice will receive the highest potential score for the CPIA performance category. The scores from all of the ACO participant billing TINs would be averaged to a weighted mean MIPS APM Entity group level score. We propose to use a weighted mean in computing the overall CPIA and advancing care information quality performance category score in order to account for difference in the size of each TIN and to allow each TIN to contribute to the overall score based on its size. Then all MIPS eligible clinicians in the APM Entity group, as identified by their APM participant identifiers, would receive that APM Entity score. The weights used for each ACO participant billing TIN would be the number of MIPS eligible clinicians in that TIN. Because all providers and suppliers that bill through the TIN of an ACO participant are required to agree to participate in the ACO, all MIPS eligible clinicians that bill through the TIN of an ACO participant are considered to be participating in the ACO. Any Shared Savings Program ACO participant billing TIN that does not submit data for the MIPS CPIA and/or advancing care information performance categories would contribute a score of zero for each performance category for which it does not report; and that score would be incorporated into the resulting weighted average score for the Shared Savings Program ACO. All MIPS eligible clinicians in the ACO (the APM Entity group) would receive the same score that is calculated at the ACO level (the APM Entity).
In this example, each eligible clinician participating in the APM Entity (Shared Savings Program ACO) would receive a CPIA performance category score of 78.5 and an advancing care information performance category score of 85. We recognize that the Shared Savings Program eligible clinicians participate as a complete TIN because all of the eligible clinicians that have reassigned their Medicare billing rights to the TIN of an ACO participant must agree to participate in the Shared Savings Program. This is different from other APMs, which may include APM Entity groups with eligible clinicians who share a billing TIN with other eligible clinicians who do not participate in the APM Entity. We seek comment on a possible alternative approach in which CPIA and advancing care information performance category scores would be applied to all MIPS eligible clinicians at the individual billing TIN level, as opposed to aggregated to the ACO level, for Shared Savings Program participants. If MIPS APM scores were applied to each TIN in an ACO at the TIN level, we would also likely need to permit those TINs to make the Partial QP election, as discussed elsewhere in this proposed rule, at the TIN level. We propose that under the APM scoring standard, the ACO-level APM Entity group score would be applied to each participating MIPS eligible clinician to determine the MIPS payment adjustment. We believe calculating the score at the APM Entity level mirrors the way APM participants are assessed for their shared savings and other incentive payments in the APM, but we understand there may be reasons why a group TIN, particularly one that believes it would achieve a higher score than the weighted average APM Entity level score, would prefer to be scored in the CPIA and advancing care information performance categories at the level of the group billing TIN rather than the ACO (APM Entity level). Therefore, we seek comment as to whether Shared Savings Program ACO eligible clinicians should be scored at the ACO level or the group billing TIN level for the CPIA and advancing care information performance categories. In
Beginning with the first MIPS performance period, all Next Generation ACO Model ACOs would submit their ACO quality measures to MIPS using the CMS Web Interface through the same process that they use to report to the Next Generation ACO Model and be scored as they normally would under Next Generation ACO Model rules. Next Generation ACO Model ACOs will have used the CMS Web Interface for submitting their quality measures since the model's inception and would most likely continue to use the CMS Web Interface as the submission method in future years. We also propose that the Next Generation ACO Model quality measure data that is submitted through the CMS Web Interface will be submitted only once but will be used for two purposes. The Next Generation ACO Model quality measure data reported to the CMS Web Interface would be used by CMS to calculate the MIPS APM quality performance score. The MIPS quality performance category requirements and performance benchmarks for reporting quality measures via the CMS Web Interface would be used to determine the MIPS quality performance category score at the ACO level for the APM Entity group. The Next Generation ACO Model quality performance data that is not submitted to the CMS Web Interface, for example the CAHPS survey and other claims measures would not be included in the MIPS APM quality performance score. The MIPS APM quality performance category score would be calculated using only quality measure data submitted through the CMS Web Interface, while the quality reporting requirements and performance benchmarks calculated by the Next
We believe that no waivers are necessary here because the quality measures submitted via the CMS Web Interface under the Next Generation ACO Model are MIPS quality measures and will be scored under MIPS performance standards. In the event that Next Generation ACO Model quality measures depart from MIPS measures in the future, we will address such changes, including whether further waivers are necessary, at such a time in future rulemaking.
We propose that for the first MIPS performance period, we will not assess MIPS eligible clinicians in the Next Generation ACO Model participating in the MIPS APM under the resource use performance category. We propose this approach because: (1) MIPS eligible clinicians participating in the Next Generation ACO Model are already subject to cost and utilization performance assessments under the APM; (2) the Next Generation ACO Model measures resource use in terms of an objective, absolute total cost of care expenditure benchmark for a population of attributed beneficiaries, and participating ACOs may share savings and/or losses based on that standard, whereas the MIPS resource use measures are relative measures such that clinicians are graded relative to their peers and therefore different than assessing total cost of care for a population of attributed beneficiaries; and (3) the beneficiary attribution methodologies for measuring resource use under the Next Generation ACO Model and MIPS differ, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many eligible clinicians comprise an ACO. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through the Next Generation ACO Model must take priority to ensure that the goals and model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across the Next Generation ACO Model and MIPS assessments—due to the differences in attribution, the inclusion in MIPS of episode-based measures that do not reflect the total cost of care, and the objective versus relative assessment factors listed above—creates uncertainty for eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the Next Generation ACO Model. For example, Next Generation ACOs are held accountable for expenditure benchmarks that reflect the total Medicare Parts A and B spending for their attributed beneficiaries, whereas many of the proposed MIPS resource use measures focus on spending for particular episodes of care or clinical conditions. For all the reasons stated above, we propose to reduce the MIPS resource use performance category weight to zero for all MIPS eligible clinicians participating in the Next Generation ACO Model. Accordingly, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the resource use performance category. With the proposed reduction of the resource use performance category weight to zero, we believe it would be unnecessary to specify and use resource use measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in the Next Generation ACO Model—the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, resource use measures in calculating the MIPS CPS for such eligible clinicians.
Given the proposal to waive requirements under section 1848(q)(5)(E) of the Act in order to reduce the weight of the resource use performance category to zero, we must subsequently specify how that weight would be redistributed among the remaining performance categories in order to maintain a total weight of 100 percent. We propose to redistribute the resource use performance category weight to both the CPIA and advancing care information performance categories as specified in Table 13. The MIPS resource use performance category is proposed to have a weight of 10 percent. Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories and its weight is scheduled to be reduced from 50 to 30 percent over time, we propose to evenly redistribute the 10 percent resource use weight to the CPIA and advancing care information performance categories so that the distribution does not change the relative weight of the quality performance category in the opposite direction of its future state. The redistributed resource use performance category weight of 10 percent would result in a 5 percentage point increase (from 15 to 20 percent) for the CPIA performance category and a 5 percentage point increase (from 25 to 30 percent) for the advancing care information performance category. We invite comments on the proposed redistributed weights and specifically on whether we should also increase the MIPS quality performance category weight.
We understand that as the MIPS resource use performance category evolves over time, there might be greater potential for alignment and less potential duplication or conflict with MIPS resource use measurement for MIPS eligible clinicians participating in MIPS APMs such as the Next Generation ACO Model. We will continue to monitor and consider how we might incorporate an assessment in the MIPS resource use performance category into the APM scoring standard for the Next Generation ACO Model. We also understand that reducing the resource use weight to zero and redistributing the weight to the CPIA and advancing care information performance categories could, to the extent that CPIA and advancing care information scores are higher than the scores MIPS eligible clinicians would have received under resource use, result in higher average scores for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO Model. We seek comment on the possible alternative of assigning a neutral score to APM Entity groups (ACOs) participating in the Next Generation ACO model for the resource use performance category in order to moderate APM Entity scores. We also generally seek comment on our proposed policy, and on whether and how we should incorporate the resource use performance category into the APM scoring standard for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO model for future years.
We propose that all MIPS eligible clinicians participating in the Next Generation ACO Model would submit data for the CPIA and advancing care information performance categories. Eligible clinicians in the Next Generation ACO Model may belong to a billing TIN that includes non-participating APM eligible clinicians. Therefore for both CPIA and the advancing care information performance category, we propose that these MIPS eligible clinicians would submit individual level data to MIPS and not group level data.
For both the CPIA and advancing care information performance categories, the scores from all of the individual MIPS eligible clinicians in the APM Entity group would be aggregated to the APM Entity level and averaged for a mean score. Any individual MIPS eligible clinicians that do not report the CPIA or advancing care information performance category would contribute a score of zero for that performance category in the calculation of the APM Entity score. All MIPS eligible clinicians in the APM Entity group would receive the same APM Entity score.
As noted above, because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories, we propose to evenly redistribute the 10 percent resource use performance category weight to the CPIA and advancing care information performance categories. Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible clinicians who are in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period shall be given the highest potential score for the CPIA performance category. Accordingly, a MIPS eligible clinician participating in an APM Entity that meets the definition of a patient-centered medical home or comparable specialty practice, as discussed in section II.E.5.f. of this proposed rule, will receive the highest potential score. Additionally, section 1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for CPIA.
For the APM scoring standard for the first MIPS performance period, we propose to weight the CPIA and advancing care information performance categories for the Next Generation ACO Model in the same way that we propose to weight those categories for the Shared Savings Program: 20 percent and 30 percent for CPIA and advancing care information, respectively. We seek comment on our proposals for reporting and scoring the CPIA and advancing care information performance categories under the APM scoring standard. In particular, we seek comment on the appropriate weight distributions in the first year.
In Table 13, we provide a summary of the proposed MIPS data submission and scoring under the APM scoring standard for MIPS eligible clinicians participating in a Next Generation ACO.
For MIPS APMs other than the Shared Savings Program and the Next Generation ACO Model, we propose that eligible clinicians or APM Entities would submit APM quality measures under their respective MIPS APM as usual, and those eligible clinicians or APM Entities would not also be required to submit quality information under MIPS. Current MIPS APMs have requirements regarding the number of quality measures, measure specifications, as well as the measure reporting method(s) and frequency of reporting, and have an established mechanism for submission of these measures to CMS. We believe there are operational considerations and constraints that would prevent us from being able to use the quality measure data from some MIPS APMs for the purpose of satisfying the MIPS data submission requirements for the quality performance category in the first performance period. For example, some current APMs use a quality measure data collection system or vehicle that is separate and distinct from the MIPS systems. We do not believe there is sufficient time to adequately implement changes to the current APM quality measure data collection timelines and infrastructure to conduct a smooth hand-off to the MIPS system that would enable use of APM quality measure data to satisfy the MIPS quality performance category requirements in the first MIPS performance period. As we have noted, we are concerned about subjecting MIPS eligible clinicians who participate in MIPS APMs to multiple performance assessments—under MIPS and under the APMs—that are not necessarily aligned and that could potentially undermine the validity of testing or performance evaluation under the APM. As stated previously, our goal is to reduce MIPS eligible clinician reporting burden by not requiring APM participants to report quality data twice to CMS, and to avoid misaligned performance incentives. Therefore, we propose that, for the first MIPS performance period only, for MIPS eligible clinicians participating in APM Entity groups in MIPS APMs (other than the Shared Savings Program or the Next Generation ACO Model), we would reduce the weight for the quality performance category to zero. We believe it is necessary to do this because CMS requires additional time to make adjustments in systems and processes related to the submission and collection of APM quality measures in order to align APM quality measures with the MIPS, and ensure APM quality measure data can be submitted in a time and in a manner sufficient for use in assessing quality performance under MIPS and under the APM. Additionally, due to the implementation of a new program that does not account for non-MIPS
We anticipate that beginning in the second MIPS performance period, the APM quality measure data submitted during the MIPS performance period to us would be used to derive a MIPs quality performance score for APM Entities in all APMs that meet criteria for application of the APM scoring standard. We anticipate that it may be necessary to propose policies and waivers of different requirements of the statute—such as one for section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality measures in the quality performance category score—through future rulemaking. We expect that by the second MIPS performance period we will have had sufficient time to resolve operational constraints related to use of separate quality measure systems and adjust quality measure data submission timelines. Therefore, beginning with the second MIPS performance period, we anticipate that through use of the waiver authority under section 1115A(d)(1) of the Act, the quality measure data for APM Entities for which the APM scoring standard applies would be used for calculation of a MIPS quality performance score in a manner specified in future rulemaking. We seek comment on this transitional approach to use APM quality measures for the MIPS quality performance category for purposes of the APM scoring standard under MIPS in future years.
For the first MIPS performance period, we propose that, for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO, to reduce the weight of the resource use performance category to zero. We propose this approach because: (1) APM Entity groups are already subject to cost and utilization performance assessments under MIPS APMs; (2) MIPS APMs usually measure resource use in terms of total cost of care, which is a broader accountability standard inherently encompasses the purpose of the claims-based measures that have relatively narrow clinical scopes, and MIPS APMs that do not measure resource use in terms of total cost of care may depart entirely from MIPS measures; and (3) the beneficiary attribution methodologies differ for measuring resource use under APMs and MIPS, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many eligible clinicians comprise an APM Entity. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through an APM must take priority to ensure that the goals and model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across APM and MIPS assessments creates uncertainty for MIPs eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of an APM. Accordingly, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the resource use performance category.
With the proposed reduction of the resource use performance category weight to zero, we believe it would be unnecessary to specify and use resource use measures in determining the MIPS CPS for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we propose to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirements under section under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, resource use measures in calculating the MIPS CPS for such eligible clinicians.
Given the proposal to waive requirements of section 1848(q) of the Act to reduce the weight of the quality and resource use performance categories to zero, we must subsequently specify how those weights would be redistributed among the remaining CPIA and advancing care information categories in order to maintain a total weight of 100 percent. We propose to redistribute the quality and the resource use performance category weights as specified in Table 14.
We understand that as the resource use performance category evolves, the rationale we discussed earlier for establishing a weight of zero for this performance category might not be applicable in future years. We seek comment on whether and how we should incorporate the resource use performance category into the APM scoring standard under MIPS. We also understand that reducing the quality and resource use performance category weight to zero and redistributing the weight to the CPIA and advancing care information performance categories could, to the extent that CPIA and advancing care information scores are higher than the scores MIPS eligible clinicians would have received under resource use, result in higher average scores for MIPs eligible clinicians in
We propose that all MIPS eligible clinicians participating in a MIPS APM other than the Shared Savings Program or the Next Generation ACO would submit data for the CPIA and Advancing Care Information performance categories. We propose that these MIPS eligible clinicians would submit data for both the CPIA and advancing care information performance categories as individual MIPS eligible clinicians. MIPS eligible clinicians in these other APMs may belong to a billing TIN that includes MIPs eligible clinicians that do not participate in the APM. Therefore for both CPIA and the advancing care information performance category, we propose that these MIPS eligible clinicians submit individual level data to MIPS and not group level data.
For both the CPIA and advancing care information performance categories, the scores from all of the individual MIPS eligible clinicians in the APM Entity group would be aggregated to the APM Entity level and averaged for a mean score. Any individual MIPS eligible clinicians that do not submit data for the CPIA or advancing care information performance category would contribute a score of zero for that performance category in the calculation of the APM Entity score. All MIPS eligible clinicians in the APM Entity group would receive the same APM Entity group score.
Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible clinicians who are in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period shall be given the highest potential score for the CPIA performance category. Accordingly, a MIPS eligible clinician in an APM Entity group that meets the definition of a patient-centered medical home or comparable specialty practice, as discussed in section II.E.5.f. of this proposed rule, will receive the highest potential score. Additionally, section 1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for CPIA. We acknowledge that using this increased weight for CPIA may make it easier in the first performance period to attain a higher MIPS score. We do not have historical data to assess the range of scores under CPIA because this is the first time such activities are being assessed in such a manner.
With respect to the advancing care information performance category, we believe that MIPS eligible clinicians participating in MIPS APMs would be using certified health IT and other health information technology to coordinate care and deliver better care to their patients. Most MIPS APMs encourage participants to use health IT to perform population management, monitor their own quality improvement activities and, better coordinate care for their patients in a way that aligns with the goals of the advancing care information performance category. We want to ensure that where we propose reductions in weights for other MIPS performance categories, such weights are appropriately redistributed to the advancing care information performance category.
Therefore, for the first MIPS performance period, we propose that the weights for the CPIA and advancing care information performance categories would be 25 percent and 75 percent, respectively. We seek comment on our proposals for reporting and scoring the CPIA and advancing care information performance categories under the APM scoring standard. In particular, we seek comment on the appropriate weight distributions in the first year and subsequent years when we anticipate incorporating assessment in the quality performance category for all MIPS eligible clinicians participating in MIPS APMs.
Table 14 shows the performance category scoring and weights for other APMs for which the APM scoring standard applies.
Presently, CMS requires MIPS APMs to either use the CMS Web Interface or another data submission mechanism for submitting data on the quality measures for purposes of the APM. We are not currently proposing to change the method used by APM Entities to submit their data on quality measures to CMS for purposes of MIPS. Therefore, we expect that APM Entities like the Shared Savings Program ACOs would continue to submit their data on quality measures using the CMS Web Interface data submission mechanism. Similarly, participants in the Comprehensive ESRD Care (CEC) Initiative would continue to submit their quality measures to CMS using the Quality Measures Assessment Tool (QMAT) for purposes of the CEC quality performance assessment under the APM. All eligible clinicians in APM Entities participating in MIPS APMs would be required to use one of the proposed MIPS data submission mechanisms to submit data for the CPIA and advancing care information performance categories.
For the first MIPS performance feedback specified under section 1848(q)(12) of the Act to be published by July 1, 2017, we propose that all MIPS eligible clinicians participating in MIPS APMs would receive the same historical information prepared for all MIPS eligible clinicians except the report would indicate that the historical information provided to such MIPS eligible clinicians is for informational purposes only. MIPS eligible clinicians participating in APMs have been evaluated for performance only under the APM. Thus, historical information may not be representative of the scores that these MIPS eligible clinicians would receive under MIPS.
For MIPS eligible clinicians participating in MIPS APMs, we propose that the MIPS performance feedback would consist only of the scores applicable to the APM Entity group for the specific MIPS performance period. For example, the MIPS eligible clinicians participating in the Shared Savings Program and Next Generation ACO Model would receive performance feedback for the quality, CPIA, and advancing care information performance categories for the 2017 performance period. Because these MIPS eligible clinicians would not be assessed for the resource use performance category, information on MIPS performance scores for the resource use performance category would not be applicable to these MIPS eligible clinicians.
We also propose that, for the Shared Savings Program the performance feedback would be available to the eligible clinicians participating in the Shared Savings Program at the group billing TIN level. For the Next Generation ACO Model we propose that the performance feedback would be available to all MIPS eligible clinicians participating in the MIPS APM Entity.
We propose that in the first MIPS performance period, the MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model would receive performance feedback for the CPIA and advancing care information only, as they would not be assessed under the quality or resource use performance categories. The information such as MIPS measure score comparisons for the quality and resource use performance categories would not be applicable to these MIPS eligible clinicians because no such comparative data would exist. We propose the performance feedback for all other MIPS eligible clinicians participating in APMs would be available for each MIPS eligible clinician that submitted MIPS data for these performance categories under their respective APM Entities. We invite comment on these proposals.
By incentivizing quality and value for all eligible clinicians, MIPS creates a new mechanism for calculating eligible clinician payments. To implement this vision, we propose a scoring methodology that allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians. Further, we propose a scoring methodology that is meaningful, understandable and flexible for all MIPS eligible clinicians. Our proposed methodology allows for multiple pathways to success with flexibility for the variety of practice types and reporting options. First, we have proposed multiple ways that MIPS eligible clinicians may submit data to MIPS for the quality performance category. Second, we generally do not propose “all-or-nothing” reporting requirements for MIPS. Third, bonus points would be available for reporting high priority measures and electronic reporting of quality data. Recognizing that MIPS is a new program, we also outline proposals which we believe are operationally feasible for us to implement in the first year, while maintaining our longer-term vision, as well as Congress' vision.
Section 1848(q) of the Act requires the Secretary to: (1) Develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for a performance period for a year; (2) using the methodology, provide a composite performance score for each MIPS eligible clinician for each performance period; and (3) use the CPS of the MIPS eligible clinician for a performance period to determine and apply a MIPS adjustment factor (and, as applicable, an additional MIPS adjustment factor) to the MIPS eligible clinician for the MIPS payment year. Section II.E.5 of this rule proposes the measures and activities for each of the four MIPS performance categories: Quality, resource use, CPIA, and advancing care information. This section proposes the performance standards for the measures and activities for each of the four performance categories under section 1848(q)(3) of the Act, the methodology for determining a score for each of the four performance categories (referred to as a “performance category score”), and the methodology for determining a CPS under section 1848(q)(5) of the Act based on the scores determined for each of the four performance categories. The performance category score is defined at § 414.1305 as the assessment of each MIPS eligible clinician's performance on the applicable measures and activities for a performance category for a performance period based on the performance standards for those measures and activities. Section II.E.7. includes proposals for determining the MIPS adjustments factors based on the CPS.
As noted in section II.E.2., we propose to use multiple identifiers to allow MIPS eligible clinicians to be measured as individuals, or collectively as part of a group or an APM Entity group (an
APM Entity group reporting and scoring for MIPS eligible clinicians participating in MIPS APMs are described in section II.E.5.h. of this proposed rule. All eligible clinicians that participate in APMs are considered MIPS eligible clinicians unless and until they are determined to be either QPs or Partial QPs who elect not to report under MIPS, and excluded from MIPS. For the APM scoring standard to apply to a MIPS eligible clinician, the eligible clinician must be listed as a participant in the APM Entity that participates in a MIPS APM as of December 31 of the performance period, as described in section II.E.5.h. CMS will publish a list of MIPS APMs on the CMS Web site in advance of the performance period.
MIPS eligible clinicians who participate in APMs that are not MIPS APMs would report to MIPS as an individual MIPS eligible clinician or group. Unless otherwise specified, the proposals in this section II.E.6 that relate to reporting and scoring of measures and activities do not affect the APM scoring standard.
Our rationale for our scoring methodology is grounded in the understanding that the MIPS scoring system is a complex system with numerous moving parts. Thus, we believe it is necessary to set up key parameters around scoring, including requiring MIPS eligible clinicians to report at the individual or group level across all performance categories and generally to submit information for a performance category using a single submission mechanism. Too many different permutations would create additional complexities that could create confusion amongst MIPS eligible clinicians as to what is and is not allowed.
The detailed policies for scoring the four performance categories are described in this section II.E.6.a. of this rule. However, as the four performance categories collectively create a single MIPS CPS, there are some cross-cutting policies that we propose to apply to multiple performance categories.
Section 1848(q)(3)(A) of the Act requires the Secretary to establish performance standards for the measures and activities in the four MIPS performance categories. Section 1848(q)(3)(B) of the Act requires the Secretary, in establishing performance standards for measures and activities for the four MIPS performance categories, to consider historical performance standards, improvement, and the opportunity for continued improvement. We propose to define the term, performance standards, at § 414.1305 as the level of performance and methodology that the MIPS eligible clinician is assessed on for a MIPS performance period at the measures and activities level for all MIPS performance categories. We define the term, MIPS payment year at § 414.1305 as the calendar year in which MIPS payment adjustments are be applied. Performance standards for each performance category are proposed in more detail later in this section, II.E.6. MIPS eligible clinicians would know the actual performance standards in advance of the performance period, when possible. Further, each performance category is unified under the principle that MIPS eligible clinicians would know, in advance of the performance period, the methodology for determining the performance standards and the methodology that would be used to score their performance. Table 16 summarizes the performance standards, which are proposed in more detail in section II.E.6.a.
Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for applicable measures and activities in each performance category applicable to the MIPS eligible clinician for a performance period. While MIPS has four different performance categories, we propose a unified scoring system that enables MIPS eligible clinicians, beneficiaries, and stakeholders to understand what is required for a strong performance in MIPS while being consistent with statutory requirements. We sought to keep the scoring as simple as possible, while providing flexibility for the variety of practice types and reporting options. We would incorporate the following characteristics into the proposed scoring methodologies for each of the four MIPS performance categories:
• For the quality and resource use performance categories, all measures would be converted to a 10-point scoring system which provides a framework to universally compare different types of measures across different types of MIPS eligible clinicians. A similar point framework has been successfully implemented in several other CMS quality programs including the Hospital Value-Based Purchasing Program (HVBP).
• The measure and activity performance standards would be published, where feasible, before the performance period begins, so that MIPS eligible clinicians can track their performance during the performance period. This transparency would make the information more actionable to MIPS eligible clinicians.
• Unlike the PQRS or the EHR Incentive Program, we generally would not include “all-or-nothing” reporting requirements for MIPS. The methodology would score measures and activities that meet certain standards defined in section II.E.5 and this section. However, section 1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring methodology, MIPS eligible clinicians who fail to report on an applicable measure or activity that is required to be reported shall be treated as receiving the lowest possible score for the measure or activity. Therefore, MIPS eligible clinicians that fail to report specific measures or activities would receive zero points for each required measure or activity that they do not submit to MIPS.
• The scoring system would ensure sufficient reliability and validity, by only scoring the measures that meet certain standards (such as required case minimum). The standards are described later in this section.
• The scoring proposals provide incentives for MIPS eligible clinicians to invest and focus on certain measures and activities that meet high priority policy goals such as improving beneficiary health, improving care coordination through health information exchange, or encouraging APM Entity participation.
• Performance at any level would receive points towards the performance category scores.
For the first year of MIPS, there are some minor differences in the proposed performance category scoring methodologies to account for differences in the maturity of the data collection systems and the measures and activities; however, we anticipate that the scoring in future years would continue to align and simplify. We request comment on the characteristics of the proposed unified scoring system.
We also propose at § 414.1325 that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending CPIA data, but a MIPS eligible clinician could not use two submission mechanisms for a single performance category, such as submitting three quality measures via claims and three quality measures via registry. We do intend to allow flexibility, for example, in rare
In carrying out MIPS, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act. In addition, section 1848(q)(5)(B)(ii) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall encourage MIPS eligible clinicians to report on applicable measures under the quality performance category through the use of CEHRT and QCDRs. To encourage the use of QCDRs, we have created opportunities for QCDRs to report new and innovative quality measures. In addition, several CPIAs emphasize QCDR participation. Finally, we propose under section II.E.5.a. for QCDRs to be able to submit data on all MIPS performance categories. We believe these flexible options would allow MIPS eligible clinicians to meet the submission criteria for MIPS in a low burden manner, which in turn may positively affect their CPS.
In addition, section 1848(q)(5)(D) of the Act lays out the requirements for incorporating performance improvement into the MIPS scoring methodology beginning with the second MIPS performance period, if data sufficient to measure improvement is available. Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may be weighted higher than improvement. Stated generally, we consider achievement to mean how a MIPS eligible clinician performs compared to other MIPS eligible clinicians for each applicable measure and activity in a performance category, and improvement to mean how a MIPS eligible clinician performs compared to the MIPS eligible clinician's own previous performance on measures and activities in a performance category. Improvement would not be scored for the first year of MIPS, but we seek comment on how best to incorporate improvement scoring for all performance categories.
In other Medicare quality programs, such as the HVBP, we have adopted a baseline period that occurs prior to the performance period for a program year to measure improvement and to establish performance standards. We view the MIPS Program as necessitating a similar baseline period for the quality performance category. We intend to establish a baseline period for each performance period for a MIPS payment year to measure improvement for the quality performance category and to enable us to calculate performance standards that we can establish and announce prior to the performance period. As with the HVBP, we intend to adopt baseline periods that are as close as possible in duration to the performance period specified for a MIPS payment year. In addition, evaluating performance compared to a baseline period may enable other payers to incorporate MIPS benchmarks into their programs. For each MIPS payment year, we propose at § 414.1380 that the baseline period would be two years prior to the performance period for the MIPS payment year. Therefore, for the first MIPS payment year (CY 2019 payment adjustments), for the quality performance category, we propose that the baseline period would be calendar year 2015 which is 2 years prior to the proposed calendar year 2017 performance period. As discussed in section II.E.6.a.2.a. we propose to use performance in the baseline period to set benchmarks for the quality performance category, with the exception of new measures for which we would set the benchmarks using performance in the performance period. For the resource use performance category, we propose to set the benchmarks using performance in the performance period and not the baseline period, as discussed in section II.E.6.a.3. For the resource use performance category, we also have included an alternative proposal to set the benchmarks using performance in the baseline period. We define the term “measure benchmark” for the quality and resource use performance categories at § 414.1305 as the level of performance that the MIPS eligible clinician will be assessed on for a performance period at the measures level.
In section II.E.5.b.3, we proposed multiple ways that MIPS eligible clinicians may submit data for the quality performance category to MIPS; however, we propose that the scoring methodology would be consistent regardless of how the data is submitted. In summary, we propose at § 414.1380(b)(1) to assign 1-10 points to each measure based on how a MIPS eligible clinician's performance compares to benchmarks. Measures must have the required case minimum to be scored. If a MIPS eligible clinician fails to submit a measure required under the quality performance category criteria, then the MIPS eligible clinician would receive zero points for that measure. MIPS eligible clinicians would not receive zero points if the required measure is submitted (meeting the data completeness criteria as defined in section II.E.5.b.3.b.) but is unable to be scored for any of the reasons listed in this section II.E.6.a.2., such as not meeting the required case minimum or a measure lacks a benchmark). For example, if a MIPS eligible clinician reports a measure that meets the requirements specified in section II.E.5.b., but that measure does not meet the required case minimum criteria or lacks a benchmark, then the measure would not be scored under the MIPS quality performance category, whereas a MIPS eligible clinician that did not report this measure would have the measure scored as a zero. We describe in section II.E.6a.2.d. examples of how points would be allocated and how to compute the overall quality performance category score under these scenarios. Bonus points would be available for reporting high priority measures, defined as outcome, appropriate use, efficiency, care coordination, patient safety, and patient experience measures.
As discussed in section II.E.6.a.2.g., the quality performance category score would be the sum of all the points assigned for the scored measures required for the quality performance category plus the bonus points (subject to the cap) divided by the sum of total possible points. Since MIPS eligible clinicians would be generally required to submit six measures or six measures from a specialty measure set and we would also score MIPS eligible clinicians on up to three population-based measures calculated from administrative claims data as discussed in section II.5.b.6, the total possible points for the quality performance category would be 90 points (6 submitted measures × 10 points + 3 population-based measures × 10 points = 90). However, for eligible groups reporting via CMS Web Interface, the total possible points for the quality performance category would be 210 points (17 measures × 10 points + 3 population-based measures × 10 points = 200), subject to CMS Web Interface reporting criteria. Further, the total possible points for small groups of less than 10 would be 80 points (6 submitted measures × 10 points + 2 population-based measures × 10 points = 80) because under our proposals the all-cause hospital readmissions measure
In section II.E.6.b, we discuss how we would score MIPS eligible clinicians who do not have any scored measures in the quality performance category. The details of the proposed scoring methodology for the quality performance category are described below.
For the quality performance category, we propose at § 414.1380(b)(1) that the performance standard is measure-specific benchmarks. Benchmarks would be determined based on performance on measures in the baseline period. For quality performance category measures for which there are baseline period data, we would calculate an array of measure benchmarks based on performance during the baseline period, breaking baseline period measure performance into deciles. Then, a MIPS eligible clinician's actual measure performance during the performance period would be evaluated to determine the number of points that should be assigned based on where the actual measure performance falls within these baseline period benchmarks. If a measure does not have baseline period information, (for example, new measures) or if the measure specifications for the baseline period differ substantially from the performance period (for example, when the measure requirements change due to updated clinical guidelines), then we would determine the array of benchmarks based on performance on the measure in the performance period, breaking the actual performance on the measure into deciles. In addition, we propose to create separate benchmarks for submission mechanisms that do not have comparable measure specifications. For example, several electronic clinical quality measures have specifications that are different than the corresponding measure from registries. We propose to develop separate benchmarks for EHR submission options, claims submission options, Qualified Clinical Data Registries (QCDRs) and qualified registries submission options.
For CMS Web Interface reporting, we propose to use the benchmarks from the Shared Savings Program as described at
As an alternative approach, we considered creating CMS Web Interface specific benchmarks for MIPS. This alternative would be restricted to CMS Web Interface reporters and would not include other MIPS data submission methods, which are currently used to create the Shared Saving Program benchmarks. This alternative would also apply the topped out cluster approach if any measures are topped out. While we see benefit in having CMS Web Interface methodology match the other MIPS benchmarks, we are also concerned about the Shared Saving Program and the Next Generation ACO Model participants having conflicting benchmark data. We request comments on building CMS Web Interface specific benchmarks.
All MIPS eligible clinicians, regardless of whether they report as an individual or group, and regardless of specialty, that submit data using the same submission mechanism would be included in the same benchmark. We propose to unify the calculation of the benchmark by using the same approach as the VM of weighting the performance rate of each MIPS eligible clinician and group submitting data on the quality measure by the number of beneficiaries used to calculate the performance rate so that group performance is weighted appropriately (77 FR 69321-69322). We would also include APM Entity submissions in the benchmark but would not score APM Entities using this methodology. For APM scoring, we refer to section II.E.5.h.
To ensure that we have robust benchmarks, we propose that each benchmark must have a minimum of 20 MIPS eligible clinicians who reported the measure meeting the data completeness requirement defined in section II.E.5.b.3, as well as meeting the required case minimum criteria for scoring that is defined later in this section. We selected a minimum of 20 because, as discussed below, our benchmarking methodology relies on assigning points based on decile distributions with decimals. A decile distribution requires at least 10 observations. We doubled the requirement to 20 so that we would be able to assign decimal point values and minimize cliffs between deciles. We did not want to increase the benchmark sample size requirement due to concerns that an increase could limit the number of measures with benchmarks.
We also propose that MIPS eligible clinicians who report measures with a performance rate of 0 percent would not be included in the benchmarks. In our initial analysis, we identified some measures that had a large cluster of eligible clinicians with a 0 percent performance rate. We are concerned that the 0 percent performance rate represents clinicians who are not actively engaging in that measurement activity. For example, it could be clinicians reporting the measures that are programmed into their EHR and that are submitted unintentionally, rather than measures the eligible clinician has actively selected for quality improvement. We do not want to inappropriately skew the distribution. We seek comment on whether or not to include 0 percent performance in the benchmark.
We propose at § 414.1380(b)(1)(i) to base the benchmarks on performance in the baseline period when possible, and to publish the numerical benchmarks when possible, prior to the start of the performance period. In those cases where we do not have comparable data from the baseline period, we propose to use information from the performance period to establish benchmarks. While the benchmark methodology would be established in a final rule in advance of the performance period, the actual numerical benchmarks would not be published until after the performance period for quality measures that do not
We considered not scoring measures that either are new to the MIPS program or do not have a historical benchmark based on performance in the baseline period. This policy would be consistent with the VM policy in which we do not score measures that have no benchmark (77 FR 69322). However, we are concerned that such a policy could stifle reporting on innovative new measures because it would take several years for the measure to be incorporated into the performance category score. We also believe that any issues related to reporting a new measure would not disproportionately affect the relative performance between MIPS eligible clinicians.
We also considered a variation on the scoring methodology that would provide a floor for a new MIPS measure. Under this variation, if a MIPS eligible clinician reports a new measure under the quality performance category, the MIPS eligible clinician would not score lower than 3 points for that measure. This would encourage reporting on new measures, but also prevent MIPS eligible clinicians from receiving the lowest scores for a new measure, while still measuring variable performance. Finally, we also considered lowering the weight of a new measure, so that new measures would contribute relatively less to the score compared to other measures. In the end, we are not proposing these alternatives we considered, because we want to encourage adoption and measured performance of new measures, however, we do request comment on these alternatives, including comments on what the lowest score should be for MIPS eligible clinicians who report a new measure under the quality performance category and protections against potential gaming related to reporting of new measures only. We also seek comments on alternative methodologies for scoring new measures under the quality performance category, which would assure equity in scoring between the methodology for measures for which there is baseline period data and for new measures which do not have baseline period data available.
Finally, we want to clarify that some PQRS reporting mechanisms have limited experience with all-payer data. For example, under PQRS, all-payer data was permitted only when reporting via registries for measure groups; reporting via registries for individual measures was restricted to Medicare only. Under MIPS however, we intend to have more robust data submissions, as described in section II.E.5.b.3. We recognize that comparing all-payer performance to a benchmark that is built, in part, on Medicare data is a limitation and would monitor the benchmarks to see if we need to develop separate benchmarks. This data issue would resolve in a year or two, as new MIPS data becomes the historical benchmark data in future years.
We propose at § 414.1380(b)(1)(x) to establish benchmarks using a percentile distribution, separated by decile categories, because it translates measure-specific score distributions into a uniform distribution of MIPS eligible clinicians based on actual performance values. For each set of benchmarks, we propose to calculate the decile breaks for measure performance and assign points for a measure based on which benchmark decile range the MIPS eligible clinician's performance rate on the measure falls between. For example, MIPS eligible clinicians in the top decile would receive 10 points for the measure, and MIPS eligible clinicians in the next lower decile would receive points ranging from 9 to 9.9. We propose to assign partial points to prevent performance cliffs for MIPS eligible clinicians near the decile breaks. The partial points would be assigned based on the percentile distribution.
Table 17 illustrates an example of using decile points along with partial points to assign achievement points for a sample quality measure. The methodology in this example could apply to measures where the benchmark is based on the baseline period or for new measures where the benchmark is based on the performance period.
In the example above, a MIPS eligible clinician with a measure performance rate of 41 percent would receive 6.0 points based on the benchmark. MIPS eligible clinicians with measure performance rates of 85 percent or above would receive 10 points because they were in the top benchmark decile. We believe that MIPS eligible clinicians within the top decile in performance would warrant receiving the maximum number of points. This is a similar concept to the HVBP “benchmark” level. We note that 85 percent is solely illustrative. Any MIPS eligible clinician who reports some level of performance would receive a minimum of one point for reporting if the measure has the required case minimum, assuming the measure has a benchmark.
In Table 17 we described our scoring approach, using deciles. We do not propose to base scoring on decile distributions for the same measure
Using 2014 PQRS quality reported data measures, we modeled the proposed benchmark methodology and identified that approximately half of the measures proposed under the quality performance category are topped out. Several measures have a median score of 100 percent, which makes it difficult to assess relative performance needed for the quality performance category score.
However, we do not believe it would be appropriate to remove topped out measures at this time. As not all MIPS eligible clinicians would be required to report these measures under our proposals for the quality performance category in section II.E.5.b. it would be difficult to determine whether a measure is truly topped out or if only excellent performers are choosing to report the measure. We also believe removing such a large volume of measures would make it difficult for some specialties to have enough applicable measures to report. At the same time, we do not believe that the highest values on topped out measures convey the same meaning of relative quality performance as the highest values for measures that are not topped out. In other words, we do not believe that eligible clinicians electing to report topped out process measures should be able to receive the same maximum score as eligible clinicians electing to report preferred measures, such as outcome measures.
Therefore, we propose to modify the benchmark methodology for topped out measures. Rather than assigning up to 10 points per measure, we propose to limit the maximum number of points a topped out measure can achieve based on how clustered the scores are. We propose to identify clusters within topped out measures and would assign all MIPS eligible clinicians within the cluster the same value, which would be the number of points available at the midpoint of the cluster. That is, we would take the midpoint of the highest and lowest scores that would pertain if the measure was not topped out and the values were not clustered. We would only apply this methodology for benchmarks based on the baseline period. When we develop the benchmarks, we would identify the clusters and state the points that would be assigned when the measure performance rate is in a cluster. We would notify MIPS eligible clinicians when those benchmarks are published with regard to which measures are topped out.
Table 18 illustrates this hypothetical example. In developing the benchmark, we identified that the top five deciles (50 percent of eligible clinicians reporting the measure) of MIPS eligible clinicians are clustered at 100 percent. We would identify the middle of that cluster (in this example, the top 25 percent or the middle of the eighth decile) and then assign all MIPS eligible clinicians with performance rates in the cluster the same number of points for the measure. The decile points for the hypothetical topped out measure in Table 18 shows that the maximum a MIPS eligible clinician can receive for the topped out measure is 8.5 points in this example.
We propose this approach because we want to encourage MIPS eligible clinicians not to report topped out measures, but to instead choose other measures that are more meaningful. We also seek feedback on alternative ways and an alternative scoring methodology to address topped out measures so that topped out measures do not disproportionately affect a MIPS eligible clinician's quality performance category score. Other alternatives could include placing a limit on the number of topped out measures MIPS eligible clinicians may submit or reducing the weight of topped out measures. We also considered whether we should apply a flat percentage in building the benchmarks, similar to the Shared Savings Program, where MIPS eligible clinicians are scored on their percentage of their performance rate and not on a decile distribution and request comment on how to apply such a methodology without providing an incentive to report topped out measures. Under the Shared Savings Program, 42 CFR 425.502, there are circumstances when benchmarks are set using flat percentages. For some measures, benchmarks are set using flat percentages when the 60th percentile was equal to or greater than 80.00 percent, effective beginning with the 2014 reporting year (78 FR 74759-74763). For other measures benchmarks are set using flat percentages when the 90th percentile was equal to or greater than 95.00 percent, effective beginning in 2015 (79 FR 67925). Flat percentages
We seek to ensure that MIPS eligible clinicians are measured reliably; therefore, we propose at § 414.1380(b)(1)(v) to use for the quality performance category measures the case minimum requirements for the quality measures used in the 2018 VM (see § 414.1265): 20 cases for all quality measures, with the exception of the all-cause hospital readmissions measure, which has a minimum of 200 cases. We refer readers to Table 46 of the CY 2016 PFS final rule (80 FR 71282) which summarized our analysis of the reliability of certain claims-based measures used for the 2016 VM payment adjustment. MIPS eligible clinicians that report measures with fewer than 20 cases (and the measure meets the data completeness criteria) would receive recognition for submitting the measure, but the measure would not be included for MIPS quality performance category scoring. Since the all-cause hospital readmissions measure does not meet the threshold for what we consider to be moderate reliability for solo practitioners and groups of less than ten MIPS eligible clinicians for purposes of the VM (see Table 46 of the CY 2016 PFS final rule, referenced above), for consistency, we propose to not include the all-cause hospital readmissions measure in the calculation of the quality performance category for MIPS eligible clinicians who individually report, as well as solo practitioners or groups of two to nine MIPS eligible clinicians.
We also propose that if we identify issues or circumstances that would impact the reliability or validity of a measure score, we would also exclude those measures from scoring. For example, if we discover that there was an unforeseen data collection issue that would affect the integrity of the measure information, we would not want to include that measure in the quality performance category score. If a measure is excluded, we would recognize that the measure had been submitted and would not disadvantage the MIPS eligible clinicians by assigning them zero points for a non-reported measure. In this instance, if the MIPS eligible clinician, as a solo practitioner, scored 10 out of 10 on each of the remaining five measures submitted, and the two population-based measures applicable to solo practitioners, the MIPS eligible clinician would receive a perfect score in the quality performance category (5 measures × 10 points) + (2 population-based measures × 10 points) or 70 out of 70 possible points.
Section II.E.5.b. of this proposed rule outlines our proposed quality performance category criteria for the different reporting mechanisms. The criteria vary by reporting mechanism, but generally we propose to include a minimum of six measures with at least one cross-cutting measure (for patient facing MIPS eligible clinicians) (Table C) and an outcome measure if available. If an outcome measure is not available, then the eligible clinician would report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. MIPS eligible clinicians and groups would have to select their measures from either the list of all MIPS Measures in Table A or a set of specialty specific measures in Table E.
We note that there are some special scenarios for those MIPS eligible clinicians who select their measures from the Specialty Sets (Table E) as discussed in section II.E.5.b.
For groups using the CMS Web Interface and MIPS APMs, we propose to have different quality performance category criteria described in sections II.E.5.b. and II.E.5.h. Additionally, as described in section II.E.5.b. we also propose to score MIPS eligible clinicians on up to three population-based measures.
Previously in PQRS, EPs had to meet all the criteria or be subject to a negative payment adjustment. We heard from numerous commenters a desire to move away from “all-or-nothing” scoring. Therefore, in MIPS, we propose that MIPS eligible clinicians receive credit for measures that they report, regardless of whether or not the MIPS eligible clinician meets the quality performance category submission criteria. Section 1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring methodology, MIPS eligible clinicians who fail to report on an applicable measure or activity that is required to be reported shall be treated as receiving the lowest possible score for the measure or activity; therefore, for any MIPS eligible clinician who does not report a measure required to satisfy the quality performance category submission criteria, we propose that the MIPS eligible clinician would receive zero points for that measure. For example, a MIPS eligible clinician who is able to report on six measures, yet reports on four measures, would receive two “zero” scores for the missing measures. In another example, a patient facing MIPS eligible clinician reports more than six measures, but does not elect to report a cross-cutting measure and an outcome measure, or if one is not available, another high priority measure. The MIPS eligible clinician in that scenario would receive at least two “zero” scores for not reporting measures required by the quality performance category criteria.
However, MIPS eligible clinicians who report a measure that does not meet the required case minimum would not be scored on the measure but would also not receive a “zero” score. For example, a MIPS eligible clinician who submits six measures as part of a group with 10 or more clinicians, one of which does not meet the required case minimum, would be scored on the five remaining measures and the three population-based measures based on administrative claims data. If the MIPS eligible clinician scored 10 out of 10 on each of these measures, the MIPS eligible clinician would receive a perfect score in the quality performance category (5 measures × 10 points) + (3 population-based measures × 10 points) or 80 out of 80 possible points.
We also note that if MIPS eligible clinicians are able to submit measures that can be scored, we want to discourage them from continuing to submit the same measures year-after-year that cannot be scored due to not meeting the required case minimum. Rather, to the fullest extent possible, MIPS eligible clinicians should select measures that would have a required case minimum. We seek comment on any safeguards we should implement in future years to minimize any gaming attempts. For example, if the measures that a MIPS eligible clinician submits for a performance period are not able to be scored due to not meeting the required case minimum, we seek comment on whether we should require these MIPS eligible clinicians to submit different measures with sufficient cases for the next performance period (to the
MIPS eligible clinicians who report a measure where there is no benchmark due to less than 20 MIPS eligible clinicians reporting on the measure would not be scored on the measure but would also not receive a “zero” score. Instead, these MIPS eligible clinicians would be scored according to the following example: A MIPS eligible clinician who submits six measures through a group of 10 or more clinicians, with one measure lacking a benchmark, would be scored on the five remaining measures and the three population-based measures based on administrative claims data. If the MIPS eligible clinician scored 10 out of 10 on each of these measures, the MIPS eligible clinician would receive a perfect score in the quality performance category (5 measures × 10 points) + (3 population-based measures × 10 points) or 80 out of 80 possible points.
We intend to develop a validation process to review and validate a MIPS eligible clinician's inability to report on the quality performance requirements as proposed in section II.E.5.b. We anticipate that this process would function similar to the Measure Applicability Validity (MAV) process that occurred under PQRS, with a few exceptions. First, the MAV process under PQRS was a secondary process after an EP was determined to not be a satisfactory reporter. Under MIPS, we intend to build the process into our overall scoring approach to reduce confusion and burden on MIPS eligible clinicians by having a separate process. Second, as the requirements under PQRS are different than those proposed under MIPS, the process must be updated to account for different measures and different quality performance requirements. More information on the MAV process under PQRS can be found at
Consistent with other CMS value-based payment programs, we propose that MIPS scoring policies would emphasize and focus on high priority measures that impact beneficiaries. These high priority measures are defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures; see Tables A-D for these measures. We propose these measures as high priority measures given their critical importance to our goals of meaningful measurement and our measure development plan. We note that many of these measures are grounded in NQS domains. For patient safety, efficiency, patient experience and care coordination measures, we refer to the measures within the respective NQS domains and measure types. For outcomes measures, we include both outcomes measures and intermediate outcomes measures. For appropriate use measures, we have noted which measures fall within this category in Tables A-D and provided criteria for how we identified these measures in section II.E.5.b. For non-MIPS measures reported through QCDRs, we propose to classify which measures are high priority during the measure review process.
We are proposing scoring adjustments to create incentives for MIPS eligible clinicians to submit certain high priority measures and to allow these measures to have more impact on the total quality performance category score.
We propose to create an incentive for MIPS eligible clinicians to voluntarily report additional high priority measures. We propose to provide two bonus points for each outcome and patient experience measure and one bonus point for other high priority measures reported in addition to the one high priority measure (an outcome measure, but if one is not available, then another high priority measure) that would already be required under the proposed quality performance category criteria. For example, if a MIPS eligible clinician submitted two outcome measures, and two patient safety measures, the MIPS eligible clinician would receive two bonus points for the second outcome measure reported and two bonus points for the two patient safety measures. The MIPS eligible clinician would not receive any bonus points for the first outcome measure submitted since that is a required measure. We selected two bonus points for outcome measures given the statutory requirements under section 1848(q)(2)(C)(i) of the Act to emphasize outcome measures. We selected two bonus points for patient experience measures given the importance of patient experience measures to our measurement goals. We selected one bonus point for all other high priority measures given our measurement goals around each of those areas of measurement. We believe the number of bonus points provides extra credit for submitting the measure, yet would not mask poor performance on the measure. For example, a MIPS eligible clinician with poor outcomes receives only two points for performance for a particular high priority measure. The bonus points would increase the MIPS eligible clinician's points to three (or four if the measure is an outcome measure or patient experience measure), but that amount is far less than the ten points a top performer would receive. We note that population-based measures would not receive bonus points.
We note that a MIPS eligible clinician who submits a high priority measure but had a performance rate of 0 percent would not receive any bonus points. Eligible clinicians would only receive bonus points if the performance rate is greater than zero. Bonus points are also available for measures that are not scored (not included in the top 6 measures for the quality performance category score) as long as the measure has the required case minimum and data completeness. We believe these qualities would allow us to include the measure in future benchmark development.
For groups submitting data through the CMS Web Interface, including MIPS APMs that report through the CMS Web Interface, groups are required to submit a set of predetermined measures and groups are unable to submit additional measures. For that submission mechanism, we propose to apply bonus points based on the finalized set of measures. We would assign two bonus points for each outcome measure (after the first required outcome measure) and for each patient experience measure. We would also have one additional bonus point for each other high priority measure (patient safety, efficiency, appropriate use, care coordination). We believe MIPS eligible clinicians or groups should have the ability to receive bonus points for reporting high priority measures through all submission mechanisms, including the CMS Web Interface. In the final rule, we will publish how many bonus points the CMS Web Interface measure set would have available based on the final list of measures.
We propose to cap the bonus points for the high priority measures (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures) at 5 percent of the denominator of the quality performance category score. Tables 19 and 20 illustrate examples of how to calculate the bonus cap. We also propose an alternative approach of capping bonus points for high priority measures at 10 percent of the denominator of the quality performance category score. Our rationale for the 5
Section 1848(q)(5)(B)(ii) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall: (I) Encourage MIPS eligible clinicians to report on applicable measures under the quality performance category through the use of CEHRT and QCDRs; and (II) with respect to a performance period for a year, for which a MIPS eligible clinician reports applicable measures under the quality performance category through the use of CEHRT, treat the MIPS eligible clinician as satisfying the clinical quality measures reporting requirement under section 1848(o)(2)(A)(iii) of the Act for such year. To encourage the use of CEHRT for quality improvement and reporting on measures under the quality performance category, we are proposing a scoring incentive to MIPS eligible clinicians who use their CEHRT systems to capture and report quality information.
We propose to allow one bonus point under the quality performance category score, up to a maximum of 5 percent of the denominator of the quality performance category score if:
• The MIPS eligible clinician uses CEHRT to record the measure's demographic and clinical data elements in conformance to the standards relevant for the measure and submission pathway, including but not necessarily limited to the standards included in the CEHRT definition proposed in 414.1305;
• The MIPS eligible clinician exports and transmits measure data electronically to a third party using relevant standards or directly to CMS using a submission method as defined at § 414.1325; and
• The third party intermediary (for example, a QCDR) uses automated software to aggregate measure data, calculate measures, perform any filtering of measurement data, and submit the data electronically to CMS using a submission method as defined at § 414.1325.
These requirements are referred to as “end-to-end electronic reporting.”
We note that this bonus would be in addition to the high priority bonus. MIPS eligible clinicians would be eligible for both this bonus option and the high priority bonus option with separate bonus caps for each option. We also propose an alternative approach of capping bonus points for this option at 10 percent of the denominator of the quality performance category score. Our rationale for the 5 percent cap is that we do not want to mask poor performance by allowing a MIPS eligible clinician to perform poorly on a measure but still obtain a high quality performance category score by submitting numerous measures in order to obtain bonus points; however, we are also concerned that 5 percent may not be enough incentive to encourage end-to-end electronic reporting. We seek comment on the appropriate threshold for this bonus cap. We propose the CEHRT bonus would be available to all submission mechanisms except claims submissions. This incentive would also be available for MIPS APMs reporting through the CMS Web Interface. Specifically, MIPS eligible clinicians who report via qualified registries, QCDRs, EHR submission mechanisms, and CMS Web Interface may receive one bonus point for each reported measure with a cap as described. We do not propose to allow this option for claims submission, because there is no mechanism for MIPS eligible clinicians to identify the information was pulled using an EHR.
This approach supports and encourages innovative approaches to measurement using the full array of standards ONC adopts, and the data elements MIPS eligible clinicians capture and exchange, to support patient care. Thus, approaches where a qualified registry or QCDR obtains data from a MIPS eligible clinician's CEHRT using any of the wide range of ONC-adopted standards and then uses automated electronic systems to perform aggregation, calculation, filtering, and reporting would qualify each such measure for the CEHRT bonus point. In addition, measures submitted using the EHR submission mechanism or the EHR submission mechanism through a third party would also qualify for the CEHRT bonus.
We request comment on this proposed approach.
The next two subsections provide a detailed description of how the quality performance category score would be calculated under our proposals.
To calculate the quality performance category score, we propose at § 414.1380(b)(1)(xv) to sum the weighted points assigned for the measures required by the quality performance category criteria plus the bonus points and divide by the weighted sum of total possible points.
If a MIPS eligible clinician elects to report more than the minimum number of measures to meet the MIPS quality performance category criteria, then we would only include the scores for the measures with the highest number of assigned points. For example, if a patient facing MIPS eligible clinician's quality submission criteria is to report six measures with at least one cross-cutting measure and a high priority measure, and the MIPS eligible clinician reports eight process measures (three using CEHRT), one cross-cutting measure, and one outcome measure, then we propose to use the four process measures with the highest number of assigned points, plus the cross-cutting measure and the outcome measure, in addition to the two population-based measures (the all-cause readmission measure would not apply to an MIPS eligible clinician reporting individually), to calculate the quality performance category score. Allowing MIPS eligible clinicians to report additional measures without including them in the scoring allows MIPS eligible clinicians to become familiar with new measures and gain experience with those measures. It also provides the foundation for the MIPS eligible clinician to receive credit for improvement on those measures in future years.
If a MIPS eligible clinician has met the quality performance category submission criteria for reporting quality information, but does not have any scored measures as discussed in section II.E.6.b.2., then a quality performance category score would not be calculated. Refer to section II.E.6.a.2.d. for details on how we propose to address scenarios where a quality performance category score is not calculated for a MIPS eligible clinician.
The following example illustrates a sample scoring methodology. In this scenario, a MIPS eligible clinician submits individually via registry three process measures, one outcome measure, and one other high priority measure. Two of the process measures and one outcome measure qualify for
The total possible points for the eligible clinician is 70 points. The eligible clinician has 48.2 points based on performance. The eligible clinician also qualifies for one bonus point for reporting an additional high priority patient safety measure and three bonus points for end-to-end electronic reporting of quality measures. The bonus points for high priority measures and CEHRT reporting are both under two separate caps which is 5 percent of 70 possible points or 3.5 points per bonus category). The quality performance category score for this MIPS eligible clinician is (48.2 points + 4 bonus points = 52.2)/70 total possible points = 74.6 percent. The quality performance category score would be capped at 100 percent.
The following example in Table 20 illustrates how to calculate the bonus cap for the high priority measure bonus and the CEHRT bonus. In the scenario below, the MIPS eligible clinician has submitted six measures and would also be scored on two of the three population-based measures. The MIPS eligible clinician below successfully submitted five quality measures using end-to-end electronic reporting, and therefore, qualifies for the CEHRT bonus of one point for each of those measures. In addition to CEHRT bonus points, the MIPS eligible clinician reported outcome measures for high priority bonus points. The MIPS eligible clinician reported two outcome measures and receives two bonus points for the second outcome measure, given that no bonus points are given for the first required measure. However, both bonus categories are over the cap (which is 5 percent of 80 possible points or four points per bonus category). The quality performance category score for this MIPS eligible clinician is 68.8 (60.8 + 4 CEHRT bonus points after the cap + 4
We request comment on our proposals to calculate the quality performance category score.
CMS Web Interface reporters have different quality performance category submission criteria; therefore, we propose to modify our scoring logic slightly to accommodate this submission mechanism. CMS Web Interface users report on the entire set of measures specified for that mechanism. Therefore, rather than scoring the top six reported measures, we propose to score all measures. If a group does not meet the reporting requirements for one of the measures, then the group would receive zero points for that measure. We note that since groups reporting through the Web Interface are required to report on all measures, and since some of those measures are “high priority,” these groups would always have some bonus points for the quality performance category score if all the measures are reported. That is, the group would either report on less than all web interface measures, in which case the group would receive zeros for unreported measures, or the group would report on all measures, in which case the group would automatically be eligible for bonus points. The other proposals for scoring discussed in section II.E.6.a.2.g.i., including bonus points, would still apply for CMS Web Interface. We request comment on this proposal.
Section 1848(q)(3)(B) of the Act requires the Secretary, in establishing performance standards for measures and activities for the MIPS performance categories, to consider: Historical performance standards; improvement; and the opportunity for continued improvement. In addition, under section 1848(q)(5)(D) of the Act, beginning with the second year of the MIPS, if data sufficient to measure improvement are available, the CPS methodology shall take into account improvement of the MIPS eligible clinician in calculating the performance score for the quality and resource use performance categories and may take into account improvement for the CPIA and advancing care information performance categories.
We are soliciting public comments on potential ways to incorporate improvement into the scoring methodology moving forward. We are especially interested in feedback on the following three options, with the assumption that eligible clinicians would report the same measures year-to-year (where possible). We are also interested in feedback on how to score improvement given that a MIPS eligible clinician can change measures and submission mechanisms from year-to-year. In addition, a MIPS eligible clinician can elect to report as an individual or a member of a group and that election can vary from year to year. Finally, we seek feedback on whether to score improvement where MIPS eligible clinicians do not have the required case minimum for measures to be scored.
As we described in section II.E.6.a.1. of this rule, we proposed to align scoring across the MIPS performance categories. For the resource use performance category, we propose to score the resource use measures similarly to the quality performance category. Specifically, we propose at § 414.1380(b)(2) to assign one to ten points to each measure based on a MIPS eligible clinician's performance compared to a benchmark. However, we note that for the resource use performance category (unlike the quality performance category), the benchmark is based on the performance period, rather than the baseline period. The details of the scoring for resource use measures are described below.
For the resource use performance category, we propose at § 414.1380(b)(2) that the performance standard is measure-specific benchmarks. We would calculate an array of measure benchmarks based on performance. Then, a MIPS eligible clinician's actual measure performance during the performance period would be evaluated to determine the number of points that should be assigned based on where the actual measure performance falls within these benchmarks.
We propose at § 414.1380(b)(2) to create benchmarks for the resource use measures based on the performance period. Changes in payment policies, including changes in relative value units, and changes that affect how hospitals, clinicians and other health care providers are paid under Medicare Parts A and B, can make it challenging to compare resource use in a performance period with a historical baseline period. In addition, for HVBP and VM, we use the performance period to establish the benchmarks for scoring HVBP's efficiency measures and VM's cost measures (80 FR 49562, 80 FR 71280). If we use the performance period, we would publish the benchmark methodology in a final rule, but would not be able to publish the actual numerical benchmarks in advance of the performance period. We believe that it is important for MIPS eligible clinicians to know in advance how they might be scored and can track their performance so we would continue to provide performance feedback with information on the MIPS eligible clinician's relative performance.
We considered an alternative to base the resource use performance category measure benchmarks on the baseline period proposed in section II.E.6.a.1.c., rather than the performance period. This option would further align the resource use performance category benchmark methodology with the quality performance category benchmark methodology. This option would also allow us to publish the numerical benchmarks before the performance period ends; however, we believe the benefits of earlier published benchmarks are more limited for resource use measures. MIPS eligible clinicians would not be able to track their daily progress because they would not have all the necessary information to determine the attribution, price standardization, and otherwise adjust the measures. We believe the relative performance that we provide through
We propose to create a single set of benchmarks for each measure specified for the resource use performance category. All MIPS eligible clinicians that are attributed sufficient cases for the measure would be included in the same benchmark. In addition, we would require a minimum of 20 MIPS eligible clinicians or groups to be attributed the case minimum in order to develop the benchmark. If a measure does not have enough eligible clinicians or groups that are attributed enough cases to create a benchmark, then we would not include that measure in the scoring for the resource use performance category.
We request comment on the proposal to establish resource use measure benchmarks based on the performance period as well as the alternative proposal.
For each set of benchmarks, we propose to calculate the decile breaks based on measure performance during the performance period and assign points for a measure based on which benchmark decile range the MIPS eligible clinician's performance on the measure is between. We propose that for resource use measures, lower costs represent better performance. In other words, MIPS eligible clinicians in the top decile would have the lowest resource use. We propose to use a methodology generally consistent with the methodology proposed for the quality performance category. We refer readers to Tables 21 and 22 for details on assigning points based on decile distribution. We request comments on the methodology for assigning points based on performance period deciles for the resource use performance category and solicit comments on alternative methodologies for assigning points for performance under this performance category for future rulemaking.
Table 21 illustrates an example of using decile points along with partial points to assign achievement points for a sample resource use measure.
We seek to ensure that MIPS eligible clinicians are measured reliably; therefore, we proposed in section II.E.5.e.3. to establish a 20 case minimum for each resource use measure. We note that this would include the Medicare Spending Per Beneficiary (MSPB) measure. In the CY 2016 PFS final rule, we finalized a policy that increases the required case minimum for MSPB from 20 to 125 cases (80 FR 71295-71296). However, due to the proposed changes to the MSPB measure, discussed in section II.E.5.e.(3)(a)., we believe we can appropriately use a required case minimum of 20 for the revised MSPB measure. Refer to section II.E.5.e.(3) for our rationale for this proposal.
To calculate the resource use performance category score, we propose at § 414.1380(b)(2)(iii) to average all the scores of all the resource use measures attributed to the MIPS eligible clinician. All measures in the resource use performance category as described in section II.E.5.e would be weighted equally. If a MIPS eligible clinician has only one resource use measure with a required case minimum to be scored, we would score that measure accordingly, and the MIPS eligible clinician's resource use performance category score would consist of the score for that one measure. We note that MIPS eligible clinicians cannot receive a zero score for any resource use measure for failure to submit the measure since none of the resource use performance category measures are submitted by MIPS eligible clinicians. Rather, these measures are attributed to MIPS eligible clinicians through claims data. However, if a MIPS eligible clinician is not attributed any resource use measures (for example, because the case minimum requirements have not been met for any measure or there is not a sufficient number of MIPS eligible clinicians to create a benchmark for any measure), then a resource use performance category score would not be calculated. Refer to section II.E.6.b for details on how we propose to address scenarios where a performance category score is not calculated for a MIPS eligible clinician. MIPS eligible clinicians would receive performance feedback as
Table 22 illustrates a sample scoring methodology for a limited set of measures. A MIPS eligible clinician is attributed resource use measures as described above and receives a score for measures where the eligible clinician has a sufficient number of cases attributed.
The MIPS eligible clinician described in Table 22 did not have the required case minimum for Measure 4 (Episode 2), and therefore is not scored on this measure. Similarly, the MIPS eligible clinician was not attributed any cases for Measure 5 (Episode 3) and was not scored on the measure. Measures that do not meet the required case minimum are not used for scoring.
In the example above, making the assumption that all measures listed have a median performance falling between the fifth and sixth deciles and would provide a score of six points, the MIPS eligible clinician with a value above the median would receive a score lower than six points. For example, Measure 1 has a performance of $15,000 which is higher than the median performance of $13,000, therefore the number of points assigned (4.0) is lower than six points.
Based on the resource use measures available for scoring, the MIPS eligible clinician is scored against the total number of points available. The resource use performance category score for this eligible clinician is (22.3 performance points/40 possible points) = 55.8 percent.
Unlike the quality performance category score, we are not proposing bonus points as part of the resource use performance category score.
Section 1848(q)(5)(C) of the Act outlines specific scoring rules for the CPIA performance category. Section 1848(q)(5)(C)(i) of the Act provides that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home or comparable specialty practice with respect to a performance period shall receive the highest potential score for the CPIA performance category for such period. Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible clinicians participating in an APM with respect to a performance period shall earn a minimum score of one-half of the highest potential score for the CPIA performance category for such period. We refer readers to section II.E.5.h of this preamble for a description of the APM scoring standard. Section 1848(q)(5)(C)(iii) of the Act states that MIPS eligible clinicians are not required to perform activities in each subcategory or participate in an APM in order to receive the highest possible score for the CPIA performance category. Based on these criteria, we propose a scoring methodology that assigns points for the CPIA performance category (based on patient-centered medical home participation and the CPIAs reported by the MIPS eligible clinician). A MIPS eligible clinician's performance would be evaluated by comparing the reported CPIAs to the highest possible score.
CPIA is a new performance category that has not been implemented in our previous programs. Therefore, in year 1, we cannot assess how well the MIPS eligible clinician has performed on the activity against data from a baseline year. We can only assess whether the MIPS eligible clinician has participated sufficiently to receive credit in the CPIA performance category. Therefore, we propose at § 414.1380(b)(3) to assign points for each reported activity within two categories: Medium-weighted and high-weighted activities. Medium-weighted activities are worth 10 points. High-weighted activities are worth 20 points. Table 23 lists all of the proposed CPIAs that are high-weighted. All other activities not listed as high-weighted activities would be considered medium activities. Table H in the Appendices provides the CPIA Inventory of all activities, both medium-weighted and high-weighted. Consistent with our unified scoring system principles, MIPS eligible clinicians would know in advance how many potential points they could receive for each CPIA.
Activities are proposed to be weighted as high based on the extent to which they align with activities that support the patient-centered model home, since that is the standard under section 1848(q)(5)(C)(i) of the Act for achieving the highest potential score for the CPIA performance category, as well as with CMS priorities for transforming clinical practice. Additionally, activities that require performance of multiple actions, such as participation in the
We also considered an approach of equal weighting for all CPIAs. We seek comment on a multi-tier weighting approach such as low, medium and high activity categories for future years of MIPS.
Although there is variability in the level that each MIPS eligible clinician would perform a CPIA, we currently do not have a standard way of measuring that variability. In future years, we plan to capture data to begin to develop a baseline for measuring CPIA improvement. Because we cannot measure variable performance within a CPIA, we propose at § 414.1380(b)(3)(v) to compare the points associated with the reported activities against the highest potential score. We propose the highest potential score to be 60 points for the CY 2017 performance period given the following rationale.
Based on discussions with several high performing organizations, we believe that MIPS eligible clinicians would be able to report on as many as six activities of medium weight. Examples of these organizations include one that led a major redesign of patient workflow after Hurricane Katrina, implementing clinical practice improvements to ensure patients receive faster treatment in the event of future disasters, ranked nationally in 6 adult specialties and high-performing in 6
We also believe that a top performing small practice (consisting of 15 or fewer professionals) or practice in a rural or health professional shortage area, or a non-patient facing MIPS eligible clinician would be able to report on at least two activities. In consideration of special circumstances for these small practices, as well as practices located in rural areas and in Health Professional Shortage Areas (HPSAs) or non-patient facing MIPS eligible clinicians, we propose that the weight for any activity selected would be 30 points. For any MIPS eligible clinician, the maximum total points achievable in this performance category is 60 points. Based on the above rationale, we believe it is reasonable to expect all MIPS eligible clinicians to be able to report CPIAs, and as such, a MIPS eligible clinician reporting no CPIA would receive a zero score for the CPIA performance category. We believe this proposal allows us to capture variation in reporting the CPIA performance category.
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, with respect to a performance period must be given the highest potential score for the CPIA performance category for the performance period. We propose that patient-centered medical home practices are those that have received accreditation from any of the following four nationally recognized accreditation organizations (the Accreditation Association for Ambulatory Health Care, the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Commission (URAC));
Section II.E.5.f. of this rule outlines the policy for certified patient-centered medical homes. The organizations identified above maintain a list of certified patient-centered medical homes, including the Medicaid Medical Home and Medical Home Models, that would be used to determine whether a MIPS eligible clinician qualifies for the highest potential score for the CPIA performance category because the MIPS eligible clinician is in a certified patient-centered medical home. NCQA maintains a list of practices that have received the Patient-Centered Specialty Recognition which would be used to determine whether a MIPS eligible clinician qualifies for the highest potential score for the CPIA performance category because the MIPS eligible clinician is in a comparable specialty practice.
We propose at § 414.1380(b)(3) that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home, including a Medicaid Medical Home or Medical Home Model, or comparable specialty practice in accordance with those proposals would receive the highest potential score (in accordance with section 1848(q)(5)(C)(i) of the Act) of 60 points for the CPIA performance category.
(1) Section II.E.5.f. of this rule presents the CMS Study on CPIA and Measurement. Given the burden for participants completing the year-long study and the value of collectively examining innovation and practice activities to improve clinical quality data submissions and further reduce time requirements for eligible clinicians and groups to report, we propose that MIPS eligible clinicians and groups that successfully participate and submit data to fulfill study requirements would receive the highest potential score of 60 points for the CPIA performance category.
To determine the CPIA performance category score, we propose to sum the points for all of the MIPS eligible clinician's reported activities and divide by the proposed CPIA performance category highest potential score of 60. A perfect score would be 60 points divided by 60 possible points, which equals 100 percent. If MIPS eligible clinicians have more than 60 CPIA points, then we propose to cap the resulting CPIA performance category score at 100 percent.
Table 24 illustrates a sample scoring methodology for the CPIA performance category. The MIPS eligible clinician below was not an APM participant and does not immediately earn the minimum score of one-half of the highest potential score or 30 points that are available for APM participation. The MIPS eligible clinician below completed two high-weighted activities worth 20 points each and two medium-weighted activities for 10 points each in order to receive the maximum 60 points available in the performance category for a CPIA performance category score of 100 percent.
Alternatively, the MIPS eligible clinician could have selected three high-weighted activities for 20 points each, six medium-weighted activities for ten points each, or some combination to reach 60 points. The score however is capped at 100 percent (60/60). This means that a MIPS eligible clinician who selects four high-weight activities (80 possible points) would still be given a score of 100 percent (60/60).
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and in geographic health professional shortage areas (HPSAs) (as designated under section 332(a)(1)(A) of the Public Health Service Act) in defining activities. Section 1848(q)(2)(C)(iv) of the Act also requires the Secretary to give consideration to non-patient-facing MIPS eligible clinicians. Further, section 1848(q)(F)(5) of the Act allows the Secretary to assign different scoring weights for measures, activities, and performance categories, if there are not sufficient measures and activities applicable and available to each type of eligible clinician.
For MIPS eligible clinicians and groups that are small practices (consisting of 15 or fewer professionals), practices located in rural areas, practices located in geographic HPSAs, or non-patient facing MIPS eligible clinicians or non-patient facing MIPS eligible clinician groups, we propose alternative scoring requirements for the CPIA performance category. The rationale for this alternative scoring is grounded in the resource constraints these MIPS eligible clinicians face which was further discovered during listening sessions with small, rural and geographic HPSAs and medical societies for non-patient facing MIPS eligible clinicians and groups. We believe that while non-patient facing MIPS eligible clinicians and non-patient facing groups could select activities from some sub-categories (such as care coordination and patient safety), for other sub-categories (such as beneficiary engagement and population management) non-patient facing MIPS eligible clinicians and groups will need to consider novel practice activities that are within their scope and can improve beneficiary care. We will continue to work with non-patient facing MIPS eligible clinician professional organizations to further develop activities relevant for these clinicians in future years. Our rationale for small practices and practices located in rural areas and in HPSAs is grounded in the resource constraints that these MIPS eligible clinicians face. This rationale is especially compelling given that each activity requires at least 90 days and may not necessarily be conducted in parallel, with time allocated to pre-planning and post-planning, which would impact the practice's limited resources.
All MIPS eligible clinicians would be allowed to self-identify as part of an APM, a patient-centered medical home or comparable specialty practice, a Medicaid Medical Home or Medical Home Model, a non-patient facing professional, a small practice (consisting of 15 or fewer professionals), a practice located in a rural area, or a practice in a geographic HPSA or any combination thereof as applicable during attestation following the performance period. We refer readers to
We would validate these self-identifications as appropriate. We propose that the following scoring would apply to MIPS eligible clinicians who are a non-patient facing professional, a small practice (consisting of 15 or fewer professionals), a practice located in a rural area, or practice in a geographic HPSA or any combination thereof:
• Reporting of one medium-weighted or high-weighted activity would result in 50 percent of the highest potential score.
• Reporting of two medium-weighted or high-weighted activities would result in 100 percent of the highest potential score.
In future years, we may adjust the weighting of activities at the MIPS eligible clinician level based on initial patterns of CPIA reporting. For example, if a MIPS eligible clinician reports on the same medium-weighted activity over several performance periods, in a subsequent year that MIPS eligible clinician may not be allowed to continue to select that same activity. This is because the intent of the CPIA performance category is to demonstrate improvement over time and not just demonstrate same benefit from year to year. For example, continuing to provide expanded practice access does not demonstrate improvement over time. Further, should the weighting of activities change in future years, we may also adjust the CPIA performance category point target accordingly. We request comment on our proposed approach to score the CPIA performance category. We also seek comment on alternative methodologies for the CPIA performance category. We seek to assure equity in scoring MIPS eligible clinicians while still considering activity variation, impact and burden.
We refer readers to section II.E.5.g.6. for our proposed methodology for scoring the advancing care information performance category. We reiterate that this methodology has many of the features of the unified scoring system described above. Specifically, we are moving away from the “all-or-nothing” scoring approach of the Medicare EHR Incentive Program. In addition, MIPS
In the advancing care information performance category, we propose to score for both participation and performance. We refer to these scoring methods as the “base score” and the “performance score”.
To earn points toward the base score, a MIPS eligible clinician or group must report the numerator and denominator (or yes/no statement as applicable) for certain measures adopted by the EHR Incentive Programs in the 2015 EHR Incentive Programs Final Rule to achieve 50 percent of the total advancing care information performance category score. For measures that previously included a percentage-based threshold, we are not requiring MIPS eligible clinicians or groups to meet those thresholds. Instead we propose to require eligible clinicians and groups to report the numerator (of at least one) and denominator (or a yes/no statement for applicable measures) for each measure being reported.
For the base score, MIPS eligible clinicians or groups must meet Objective 1: Protect Patient Health Information and its associated measure in 2015 EHR Incentive Programs Final Rule. Additionally, eligible clinicians would be required to report the numerator and denominator, or a yes/no statement as appropriate, for each measure for Electronic Prescribing, Patient Electronic Access to Health Information, Coordination of Care Through Patient Engagement, Health Information Exchange, and Public Health and Clinical Data Registry Reporting— as adopted in the 2015 EHR Incentive Programs Final Rule. Failure to meet any of the objectives would result in a base score of zero and an advancing care information performance category score of zero.
For the Public Health and Clinical Data Registry Reporting objective, an eligible clinician or group is only required to report on the Immunization Registry Reporting measure. Completing any additional measures under the objective would earn one additional bonus point after calculation of the performance score.
The performance score is then determined in addition to the base score. The performance score methodology would implement a decile scale for the application of additional points based on performance in the objectives and measures for Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange. There are eight associated measures under these three objectives; each has a maximum of ten percentage points available. The total available performance score would be 80 percent which is, in combination with the base score of 50 percent, greater than the total possible performance category score of 100 percent. We have taken this approach in order to provide flexibility toward achieving the maximum score in the advancing care information performance category—however, a MIPS eligible clinician or group's score is capped at 100 percent.
This summary only represents the primary advancing care information performance category scoring proposal. For full details on the advancing care information performance category scoring and an explanation of alternatives considered, as well as accommodation for eligible clinicians planning to report Modified Stage 2 or use 2014 Edition CEHRT in 2017 please refer to II.E.5.g.4.
Section II.E.6.a. of this rule describes our proposed methodology for assessing and scoring MIPS eligible clinician performance for each of the four performance categories. In this section, we propose the methodology to determine the CPS based on the scores for each of the four performance categories. We define at § 414.1305 the CPS as a composite assessment (using a scoring scale of 0 to 100) for each MIPS eligible clinician for a specific performance period determined using the methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards with respect to the applicable measures and activities for each applicable performance category. The CPS is the sum of the products of each performance category score and each performance category's assigned weight multiplied by 100.
Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards with respect to the applicable measures and activities with respect to each performance category applicable to such clinician for a performance period, and using the methodology, provide for a CPS (using a scoring scale of 0 to 100) for each MIPS eligible clinician for the performance period. Additionally, sections 1848(q)(5)(E) and (F) of the Act address the weights for each of the performance categories in the CPS.
To create a CPS from 0-100 based on the individual performance category scores, we propose to multiply the score for each performance category by the assigned weight for the performance category. We provide in Table 25 the weights for each performance category for the 2019, 2020 and 2021 MIPS payment years. The resulting weighted performance category scores would be summed to create a single CPS. As described in section II.E.2 of this preamble, we propose that the identifier for MIPS performance would be the same for all four performance categories, and therefore, the methodology to calculate a CPS would be the same for both individual and group performance.
The following equation summarizes the proposed CPS calculation at § 414.1380(c):
CPS = [(quality performance category score × quality performance category weight) + (resource use performance category score × resource use performance category weight) + (CPIA performance category score × CPIA performance category weight) + (advancing care information performance category score × advancing care information performance category weight)] × 100.
Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, that section provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals' health status and other risk factors, assess appropriate adjustments to quality measures, resource use measures and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, CPSs, scores for performance categories or scores for measures or activities under the MIPS. In doing this, the Secretary is required to take into account the relevant studies conducted and recommendations made in reports under section 2(d) of the Improving Medicare Post-Acute Transformation (IMPACT) Act of 2014 and, as appropriate, other information, including information collected before completion of such studies and recommendations. HHS' Office of the Assistant Secretary for Planning and Evaluation (ASPE) is conducting studies and making recommendations on the issue of risk adjustment for socioeconomic status on quality measures and resource use as required by section 2(d) of the IMPACT Act and
We invite public comments on this proposal.
Section 1848(q)(5)(E)(i) of the Act specifies weights for the performance categories included in the MIPS CPS: In general, 30 percent for the quality performance category, 30 percent for the resource use performance category, 25 percent for the advancing care information performance category, and 15 percent for the CPIA performance category. However, that section also specifies different weightings for the quality and resource use performance categories for the first and second years for which the MIPS applies to payments. Section 1848(q)(5)(E)(i)(II)(bb) of the Act specifies that for year 1, not more than 10 percent of the CPS will be based on the resource use performance category and for year 2, not more than 15 percent will be based on resource use performance category. Under section 1848(q)(5)(E)(i)(I)(bb) of the Act, the weight of the quality performance category for each of the first two years will increase by the difference of 30 percent minus the weight specified for the resource use performance category for the year.
In previous sections of this rule, we have proposed the performance category weights for the first MIPS payment year of 2019. In section II.E.5.e.2., we propose to set the resource use performance category weight at 10 percent for the 2019 payment year and 15 percent for the 2020 payment year. Correspondingly, in section II.E.5.b.2., we propose to set the quality performance category weight to 50 percent for the 2019 payment year and 45 percent for the 2020 payment. The quality performance category weight proposal is based on the 30 percent required by statute for the quality performance category plus 30 percent minus the weight of the resource use performance category, as required by section 1848(q)(5)(E)(i)(I)(bb) of the Act. As specified in section 1848(q)(5)(E)(i) of the Act, the weights for the other performance categories are 25 percent for the advancing care information performance category; and 15 percent for the CPIA performance category. Section 1848(q)(5)(E)(ii) of the Act provides that in any year in which the Secretary estimates that the proportion of eligible professionals (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under in section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the CPS, but not below 15 percent, and adjust the weighting of the other performance categories. We refer readers to our proposals concerning section 1848(q)(5)(E)(ii) of the Act in section II.E.5.g.(6)(e).
Table 25 summarizes the weights specified for each performance category under section 1848(q)(5)(E)(i) of the Act and in accordance with our proposals.
Under section 1848(q)(5)(F) of the Act, if there are not sufficient measures and activities applicable and available to each type of eligible clinician involved, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable and for each measure and activity based on the extent to which the measure or activity is applicable and available to the type of eligible clinician involved.
In section II.E.6.a and section II.E.5.g.8., we describe scenarios where certain MIPS eligible clinicians might not receive a performance category score in the quality, resource use, or advancing care information performance categories. We propose that in such scenarios we would use the authority under section 1848(q)(5)(F) of the Act to assign a weight of zero to the performance category and redistribute the weight for that performance category or categories as described in the next section.
For the quality and resource use performance categories, we believe having sufficient measures applicable
For the quality performance category, we anticipate that most MIPS eligible clinicians would select the measures most relevant to their practice and that in most cases, the measures they select would meet the required case minimum. We plan to monitor measure selection trends under the performance category and will revise this policy if it appears MIPS eligible clinicians are reporting measures that are not relevant to their practice or measures that do not meet the required case minimum. In the resource use performance category, we believe MIPS eligible clinicians who are not attributed enough cases to be reliably measured should not be scored for the performance category. We have proposed to include many resource use measures that we believe are sufficiently developed and ready for evaluating resource use by MIPS eligible clinicians; however, if a MIPS eligible clinician is not attributed any (or very few) cases for the measure, then we do not believe the MIPS eligible clinician should be measured on performance.
We refer readers to section II.E.5.g.8. of this proposed rule for a detailed discussion of the scenarios in which a MIPS eligible clinician may not have sufficient measures applicable and available under the advancing care information performance category. For the CPIA performance category, however, we envision that all MIPS eligible clinicians would have sufficient activities applicable and available and do not propose any scenario where a MIPS eligible clinician would not receive a CPIA performance category score.
In addition to scenarios where a MIPS eligible clinician would have no scored measures for a performance category, we believe there may be scenarios in which a MIPS eligible clinician would have too few scored measures under the quality performance category for us to reliably calculate a performance category score that is worth half the weight of the CPS for the 2019 MIPS payment year. We propose that if a MIPS eligible clinician has fewer than three scored quality measures (either submitted measures or measures calculated from administrative claims data) for a performance period, we would consider the MIPS eligible clinician not to have a sufficient number of measures applicable and available for the 2019 MIPS payment year quality performance category weight and would therefore lower the weight of the quality performance category. In this situation, the MIPS eligible clinician has a quality performance category score, but has data for only one or two scored measures, which is not a sufficient number of measures for the quality performance category because the quality performance category would constitute half of the CPS for the 2019 MIPS payment year. In addition, as described in the next section, for MIPS eligible clinicians that are not scored on the resource use or advancing care information performance category, we propose to increase the weight of the quality performance category. For these reasons, we believe that for the first year of MIPS, the quality performance category requires a sufficient number of measures to justify its weight in the CPS. We will reconsider this policy in future years as the weights for the performance categories change. We may consider implementing a similar policy for the resource use performance category for future years, but not for the first year of MIPS based upon the lower weighting of the resource use performance category.
In section II.E.5.b., we are proposing for the quality performance category, generally, that MIPS eligible clinicians submit a minimum of six measures for scoring in MIPS. In addition, we propose to include up to three population-based measures derived from claims data. As described in section II.E.6.a.2., a MIPS eligible clinician may submit a measure that is not scored, either because the measure did not meet the required case minimum to be reliably measured or because fewer than 20 MIPS eligible clinicians with sufficient volume submitted a measure through a similar reporting mechanism and a benchmark could not be created for the performance or baseline period. We reiterate that a measure that is not scored due to not meeting the required case minimum or lack of a measure benchmark, is different than a required measure that is not reported. Any required measure that is not reported or reported with in a way that does not meet the data completeness requirements would receive a score of zero points and would be considered a scored measure.
We are concerned that if a large percentage of the expected measures are not able to be scored due to not meeting the required case minimums or a missing benchmark, then just one or two measures would contribute disproportionately to the CPS because the quality performance category score is worth 30 to 50 percent (depending on the year) of the CPS under section 1848(q)(5)(E)(i) of the Act. We do not believe a score for one or two quality measures can capture all the elements of quality performance during a performance period. We believe the lack of a sufficient number of measures for scoring limits the value of quality performance measurement toward the CPS. Therefore, we propose that if a MIPS eligible clinician has only two scored measures (including both submitted measures and measures derived from administrative claims data) to reduce the weight of the quality performance category by one-fifth (for example, from 50 percent to 40 percent in year 1) and redistribute the weight (for example, 10 percent in year 1) proportionately to the other performance categories for which the MIPS eligible clinician did receive a performance category score. If a MIPS eligible clinician has only one scored quality measure, then we propose to reduce the weight of the quality performance category by two-fifths (for example, from 50 percent to 30 percent in year 1) and redistribute the weight (for example, 20 percent in year 1) proportionately to the other performance categories for which the MIPS eligible clinician did receive a performance category score. Lowering the weight of the quality performance category would be consistent with the relatively low percentage of expected quality measures that are able to be scored.
We request comment on these proposals to identify MIPS eligible clinicians without sufficient measures and activities applicable and available
We propose at § 414.1380(c)(3) to reweight the performance categories for MIPS eligible clinicians when there are not sufficient measures and activities applicable and available to them. We propose to reweight the performance categories in the following situations.
If the MIPS eligible clinician does not receive a resource use or advancing care information performance category score, and has at least three scored measures (either submitted measures or those calculated from administrative claims) in the quality performance category, then we propose to reassign the weights of the performance categories without a score to the quality performance category. We believe this policy is appropriate for several reasons. First, section 1848(q)(5)(E)(i)(I)(bb) of the Act redistributes weight from the resource use performance category to the quality performance category in the first two years of MIPS. This proposal is consistent with that redistribution logic. In addition, MIPS eligible clinicians have experience reporting quality measures through the PQRS program and measurement in this performance category is more mature. Finally, for the 2019 MIPS payment year, quality performance would be worth at least half of the CPS. By requiring the MIPS eligible clinician to have at least three scored quality measures, we believe the quality performance category would be robust enough to support more weight reassigned to it than other performance categories. We may revisit this policy in future years as the weight for the resource use performance category increases and the weight for the quality performance category decreases.
We also propose an alternative that does not reassign all the weight to the quality performance category, but rather reassigns the weight proportionately to each of the other performance categories for which the MIPS eligible clinician has received a performance category score.
We request public comments on the proposal to reassign the weights to the quality performance category, as well as the alternate proposal to redistribute proportionately to other performance categories.
If the MIPS eligible clinicians have fewer than three scored measures in the quality performance category score, then we propose to reassign the weights for the performance categories without scores proportionately to the other performance categories for which the MIPS eligible clinician has received a performance category score. We request comment on this proposal.
Finally, because the CPS is a composite score, we believe the intention of section 1848(q)(5) of the Act is for MIPS eligible clinicians to be scored based on multiple performance categories. Basing a CPS on a single performance category, even a robust and familiar performance category like quality, would frustrate that intent. In our proposals, CPIA is the only performance category which would always have a performance category score. We are particularly concerned about the possibility that a MIPS eligible clinician might, for the reasons discussed above, not have sufficient measures applicable and available for the quality, resource use, and advancing care information performance categories, and would only receive a score for the CPIA performance category. The CPIA performance category is based on activities that are reported by attestation, not on measured performance. In addition, because CPIA is not as mature as the other performance categories, each of which include certain aspects of existing CMS programs, we are unsure how much variation we will have in the CPIA performance category. We do not think it would be equitable to allow MIPS eligible clinicians that attest to receive the maximum points for that performance category and then base the CPS solely on the CPIA performance category. Such a scenario may result in higher CPS and payment adjustment factors for some MIPS eligible clinicians based solely on the CPIA performance category, while other MIPS eligible clinicians are measured based on their performance under the other performance categories. Therefore, we propose that if a MIPS eligible clinician receives a score for only one performance category, we would assign the MIPS eligible clinician a CPS that is equal to the performance threshold described in section II.E.5., which means the eligible clinician would receive a MIPS adjustment factor of 0 percent for the year. We anticipate this proposal would affect very few MIPS eligible clinicians in year 1 and even fewer in future years as more eligible clinicians are able to report on and receive scores for more of the performance categories.
We welcome public comment on this proposal.
As we describe in section II.E.2 of this preamble, we propose to allow MIPS eligible clinicians to measure performance as an individual, as a group defined by TIN, or as an APM Entity group using the APM scoring standard, yet for purposes of the application of the MIPS adjustment factors to payments in accordance with section 1848(q)(6)(E) of the Act (referred to as the payment adjustment), we are proposing to use a single identifier, TIN/NPI, for all MIPS eligible clinicians, regardless of whether the TIN/NPI was measured as an individual, group or APM Entity group. In other words, a TIN/NPI may receive a CPS based on individual, group, or APM Entity group performance, but the payment adjustment would be applied at the TIN/NPI level.
We are proposing to use the single identifier, TIN/NPI, for the payment adjustment for a few reasons. First, the final eligibility status of some clinicians would not be known until after the performance period ends. For example, the calculations to determine which clinicians would be excluded from MIPS, such as identifying clinicians that are QPs or are below the low-volume threshold, occur after the performance period ends. Using TIN/NPI would allow us to correctly identify which TIN/NPIs are still MIPS eligible clinicians after the exclusion criteria have been applied.
Second, the identifiers for measurement are not mutually exclusive and using TIN/NPI to apply the payment adjustment would allow us to resolve any inconsistencies that arise from the measurement identifiers. For example, a TIN may have 40 percent of its eligible clinicians participating in a MIPS APM and the remaining 60 percent are not participating in any APM. The TIN elects to submit performance information for all the eligible clinicians in the TIN, including those that are participating in the MIPS APM, so that it can ensure all of its eligible clinicians are being measured in MIPS. We cannot simply use the APM
Because we are proposing to use only TIN/NPI to apply the MIPS payment adjustments and because there is a gap between the performance period and the MIPS payment year, we believe we should assign the historical CPS to each TIN/NPI that is subject to MIPS for the payment year.
In general, we propose to use the CPS associated with the TIN/NPI combination in the performance period. For groups submitting data using the TIN identifier, we propose to apply the group CPS to all the TIN/NPI combinations that bill under that TIN during the performance period. For individual MIPS eligible clinicians submitting data using TIN/NPI, we propose to use the CPS associated with the TIN/NPI that is used during the performance period. For eligible clinicians in MIPS APMs, we propose to assign the APM Entity group's CPS to all the APM Entity Participant Identifiers that are associated with the APM Entity on December 31 of the performance period. We refer readers to section II.E.5.h for more information about the process to identify participating APM Entities. For eligible clinicians that participate in APMs for which the APM scoring standard does not apply, we propose to assign a CPS using either the individual or group data submission assignments described above.
In the case where a MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, there would be no corresponding historical performance information or CPS for the new TIN/NPI. Because we want to connect actual performance to the individual MIPS eligible clinician as often as possible, in cases where there is no CPS associated with a TIN/NPI from the performance period, we propose to use the NPI's performance for the TIN(s) the NPI was billing under during the performance period. If the MIPS eligible clinician has only one CPS associated with the NPI from the performance period, then we propose to use that CPS. For example, if a MIPS eligible clinician worked in one practice (TIN A) in the performance period, but is working at a new practice (TIN B) during the payment year, then we would use the CPS for the old practice (TIN A/NPI) to apply the MIPS payment adjustment for the NPI in the new practice (TIN B/NPI). This proposal most closely links the MIPS eligible clinician's performance during the performance period to the payment adjustment. It also ensures that MIPS eligible clinicians who qualify for a positive payment adjustment are able to keep it, even if they change practices. For those who have a negative payment adjustment, this proposal also ensures MIPS eligible clinicians are still accountable for their performance.
In scenarios where the MIPS eligible clinician billed under more than one TIN during the performance period, and the MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, we propose to use a weighted average CPS based on total allowed charges associated with the NPI from the performance period. This proposal would provide a CPS that is based on all the services the NPI billed to Medicare during the performance period. Table 26 presents an example of how this proposed approach would work. In this example, a MIPS eligible clinician (NPI) was assigned a CPS for two unique TIN/NPI combinations from the performance period (TIN A/NPI and TIN B/NPI). In the MIPS payment year, the eligible clinician is now billing for Medicare services under a third TIN/NPI combination without a previously calculated CPS (TIN C/NPI). In this case, the eligible clinician's MIPS adjustment for payments made to TIN C/NPI would be based on a weighted average of CPSs for TIN A/NPI and TIN B/NPI.
If an NPI did not have any allowed charges in the performance period, then the clinician would not be included in MIPS due to the low-volume exclusion.
We also propose an alternative proposal where in lieu of taking the
We request comment on the proposal to use the CPSs associated with the TIN(s) the NPI was billing under during the performance period when the TIN/NPI does not have a CPS from the performance period. We also request comment on our proposal to use a weighted average, and the alternative proposal to select the highest CPS from the performance period.
We also considered, but are not proposing, a policy to have the performance follow the group (TIN) rather than the individual (NPI). In other words, the MIPS eligible clinician's performance would be based on the historical performance of the new TIN that the MIPS eligible clinician moved to after the performance period, even though the MIPS eligible clinician was not part of this group during the performance period. This policy is consistent with the policy for the VM and would create incentives for MIPS eligible clinicians to move to higher performing practices (77 FR 69308). We also believe this policy would provide a lower burden for practice administrators as all MIPS eligible clinicians in the TIN would have the same payment adjustment. On the other hand, having performance follow the TIN creates some challenges. We are concerned that MIPS eligible clinicians who earned a positive adjustment based on their performance during the performance period would not retain the positive adjustment if the new TIN had a lower CPS. Finally, we believe that having performance follow the TIN could create some unanticipated issues with budget neutrality if high-performing TINs expand. For all of these reasons, we are not proposing to have performance follow the TIN, but rather have performance follow the NPI; however, we seek comment on this option.
In some cases, a TIN/NPI could have more than one CPS associated with it from the performance period, if the eligible clinician submitted duplicative data sets. In this situation, the MIPS eligible clinician has not changed practices, rather for example, a MIPS eligible clinician has a CPS for an APM Entity and a CPS for a group TIN. If a MIPS eligible clinician has multiple CPSs, we propose a multi-pronged approach to select the CPS that would be used to determine the MIPS payment adjustment. First, we propose that if a MIPS eligible clinician is a participant in MIPS APM, then the APM Entity CPS would be used instead of any other CPS (such as a group TIN CPS or individual CPS). We propose that if a MIPS eligible clinician has more than one APM Entity CPS for the same TIN (by participating in multiple MIPS APMs), we would apply the highest APM Entity CPS to the eligible clinician. Second, if a MIPS eligible clinician reports as a group and as an individual, we would calculate a CPS for the group and individual identifier and use the highest CPS for the TIN/NPI. We request comment on this proposed approach.
Section 1848(q)(6)(A) of the Act requires the Secretary to specify a MIPS adjustment factor for each MIPS eligible clinician for a year determined by comparing the CPS of the MIPS eligible clinician for such year to the performance threshold established under paragraph (D)(i) for such year, in a manner such that the adjustment factors specified for a year result in differential payments. Section 1848(q)(6)(A)(iii) of the Act provides that MIPS eligible clinicians with CPS at or above the performance threshold receive a zero or positive adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a CPS at the performance threshold and an adjustment factor of the applicable percent is assigned for a CPS of 100. Section 1848(q)(6)(A)(iv) of the Act provides that MIPS eligible clinicians with CPS below the performance threshold receive a negative payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a CPS at the performance threshold and an adjustment factor of the negative of the applicable percent is assigned for a CPS of 0; further, MIPS eligible clinicians with CPS that are equal to or greater than zero, but not greater than one-fourth of the performance threshold, receive a negative payment adjustment factor that is equal to the negative of the applicable percent.
Section 1848(q)(6)(B) of the Act defines the applicable percent for each year as follows: (i) For 2019, 4 percent; (ii) for 2020, 5 percent; (iii) for 2021, 7 percent; and (iv) for 2022 and subsequent years, 9 percent.
Section 1848(q)(6)(C) of the Act provides for an additional positive MIPS adjustment factor for exceptional performance, for each of the years 2019 through 2024, for each MIPS eligible clinician with a CPS for a year at or above the additional performance threshold under paragraph (D)(ii) for such year. The additional MIPS adjustment factor shall be in the form of a percent and determined in a manner such that eligible clinicians having higher CPS above the additional performance threshold receive higher additional MIPS adjustment factors.
Under section 1848(q)(6)(D)(i) of the Act, for each year of the MIPS, the Secretary shall compute a performance threshold with respect to which the CPS of MIPS eligible clinicians are compared for purposes of determining the MIPS adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, which may be reassessed every three years) of the CPS for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act outlines a special rule for the initial two years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS adjustment factors under paragraph (A) and an additional performance threshold for purposes of determining the additional MIPS adjustment factors under paragraph (C), each of which shall be based on a period prior to the performance periods and take into account data available with respect to performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary.
We define the term performance threshold at § 414.1305, as the level of performance that is established for a performance period at the CPS level. CPSs above the performance threshold receive a positive MIPS adjustment factor and CPSs below the performance threshold receive a negative MIPS adjustment factor. CPSs that are equal to or greater than 0, but not greater than one-fourth of the performance threshold receive the maximum negative MIPS adjustment factor for the MIPS payment year. CPSs at the performance threshold
To establish the performance threshold for the 2019 MIPS payment year, we propose to model 2014 and 2015 Part B allowed charges, 2014 and 2015 PQRS data submissions, 2014 and 2015 QRUR and sQRUR feedback data, and 2014 and 2015 Medicare and Medicaid EHR Incentive Program data to inform where the performance threshold should be. We would use this data to estimate the impact of the quality and resource use scoring proposals. We would also use the EHR Incentive Program information to estimate which MIPS eligible clinicians are likely to receive points for the advancing care information performance category. Because of the lack of historical data for the CPIA performance category, we would apply some sensitivity analyses to help inform where the performance threshold should be.
For the 2019 MIPS payment year, we propose to set the performance threshold at a level where approximately half of the eligible clinicians would be below the performance threshold and half would be above the performance threshold, which we believe is consistent with the intent of section 1848(q)(6)(D)(i) of the Act which requires the performance threshold in year 3 and beyond to be equal to the mean or median of CPS from a prior period. We also considered other policy options when setting the performance threshold. For example, we considered setting the performance threshold so that the scaling factor (which is described in section II.E.7.b) is 1.0. We could set the performance threshold based on policy goals to ensure a minimum number of points are earned before an eligible clinician is able to receive a positive adjustment factor and potentially an additional adjustment factor for exceptional performance. We seek comment on the policy options for setting the performance threshold.
We would determine the performance threshold in accordance with the methodology established in the final rule. We intend to publish the performance threshold on the CMS Web site prior to the performance period.
In addition to the performance threshold, section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS, an additional performance threshold for purposes of determining the additional positive MIPS adjustment factors for exceptional performance under paragraph (C). For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold: (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible CPS above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score that is equal to the 25th percentile of the actual CPS for MIPS eligible clinicians with CPS at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act.
We define at § 414.1305 the additional performance threshold as an additional level of performance, in addition to the performance threshold, for a performance period at the CPS level at or above which a MIPS eligible clinician may receive an additional positive MIPS adjustment factor. For each year of the MIPS, we will compute an additional performance threshold for purposes of determining the additional MIPS adjustment factors under section 1848(q)(6)(C) of the Act. We propose at § 414.1405(e) the following methods for computing the additional performance threshold: the threshold shall be equal to the 25th percentile of the range of possible CPS above the performance threshold; or it shall be equal to the 25th percentile of the actual CPS for MIPS eligible clinicians with CPS at or above the performance threshold with respect to the prior period used to determine the performance threshold.
As discussed above, section 1848(q)(6)(D)(iii) of the Act outlines a special rule for establishing the additional performance threshold for the initial two years of MIPS. Because 2019 is the first MIPS payment year, we do not have any actual CPS for MIPS eligible clinicians to use for purposes of defining an additional performance threshold under the methodology proposed above. Therefore, we propose to establish the additional performance threshold at the 25th percentile of the range of possible CPS above the performance threshold. For example, if the performance threshold is 60, then the range of possible CPS above the performance threshold would be 61-100. The 25th percentile of those possible values is 70. We intend to publish the exceptional performance threshold with the performance threshold prior to the performance period.
Section 1848(q)(6)(F)(i) of the Act provides, with respect to positive MIPS adjustment factors for eligible clinicians whose CPS is above the performance threshold under paragraph (D)(i) for such year, the Secretary shall increase or decrease such adjustment factors by a scaling factor (not to exceed 3.0) in order to ensure that the budget neutrality requirement of clause (ii) is met. Stated generally, budget neutrality as required by section 1848(q)(6)(F)(ii) of the Act means the estimated increase in the aggregate allowed charges resulting from the application of positive MIPS adjustment factors under paragraph (A) (after application of the scaling factor) is equal to the estimated decrease in the aggregate allowed charges resulting from the application of negative MIPS adjustment factors under paragraph (A). Under section 1848(q)(6)(F)(iii) of the Act, budget neutrality requirements shall not apply if all MIPS eligible clinicians receive CPS for a year that are below the performance threshold under paragraph (D)(i) for such year, or if the maximum scaling factor (3.0) is applied for a year.
Section 1848(q)(6)(C) of the Act requires, for each of the years 2019 through 2024, the Secretary to specify an additional positive MIPS adjustment factor for each MIPS eligible clinician whose CPS for a year is at or above the additional performance threshold established under paragraph (D)(ii) for that year. This additional adjustment factor is required to take the form of a percentage and to be determined by the Secretary such that MIPS eligible clinicians with higher CPS above the additional performance threshold receive higher additional MIPS adjustment factors. Section 1848(q)(6)(F)(iv)(I) of the Act provides, in specifying the additional adjustment factors under paragraph (C) for each applicable MIPS eligible clinician for a year, the Secretary shall ensure that the estimated aggregate increase in payments under Part B resulting from the application of such additional adjustment factors shall be equal to $500,000,000 for each year beginning with 2019 and ending with 2024. We refer to the $500,000,000 increase in payments as aggregate incentive payments. Section 1848(q)(6)(F)(iv)(II) of the Act provides that the additional adjustment factor for each applicable MIPS eligible clinician shall not exceed 10 percent, which may result in an aggregate increase in payments that is less than $500,000,000 as described in subclause (I).
To be consistent with the MIPS adjustment factors under section 1848(q)(6)(A) of the Act, we propose to
Section 1848(q)(6)(E) of the Act provides that for items and services furnished by a MIPS eligible clinician during a year (beginning with 2019), the amount otherwise paid under Part B with respect to such items and services and MIPS eligible clinician for such year, shall be multiplied by 1 plus the sum of the MIPS adjustment factor determined under paragraph (A) divided by 100, and as applicable, the additional MIPS adjustment factor determined under paragraph (C) divided by 100. We would apply the adjustment factors in accordance with section 1848(q)(6)(E) of the Act.
We request comment on our proposals.
Figure A provides an example of how various CPS would be converted to an adjustment factor and potentially an additional adjustment factor, using the statutory formula. In this example, the performance threshold is 60. The applicable percentage is 4 percent for 2019. The adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest negative applicable percentage (negative 4 percent for 2019), and 100 being the highest positive applicable percentage. However, there are two modifications to this linear sliding scale. First, there is an exception for a CPS between 0 and
For the performance threshold of 60, the additional performance threshold for exceptional performance is 70. A CPS of 70 would have an additional adjustment factor of 0.5 percent, and the amount of the additional adjustment factor would increase to 10 percent times a scaling factor that is greater than 0 and less than or equal to 1.0. In Figure A, the scaling factor for the additional adjustment factor is 0.32. Therefore, MIPS eligible clinicians with a CPS of 100 would have an additional adjustment of 3.2 percent (10 percent × 0.32). The total adjustment for a MIPS eligible clinician with a CPS equal to 100 would be 1 + 0.055 + 0.032 = 1.087, for a total positive adjustment of 8.7 percent.
The adjustment factor for CPS values above the performance threshold is illustrative. For MIPS eligible clinicians with a CPS of 100, the adjustment factor would be 4 percent times a scaling factor greater than 0 and less than or equal to 3.0. The scaling factor is intended to ensure budget neutrality, but cannot be higher than 3.0. The additional adjustment factor is also illustrative. The additional adjustment factor starts at 0.5 percent and cannot exceed 10 percent.
The final MIPS payment adjustments would be determined by the distribution of CPS across MIPS eligible clinicians and the performance threshold. More MIPS eligible clinicians above the performance threshold means the scaling factors would decrease because more MIPS eligible clinicians receive a positive adjustment. More MIPS eligible clinicians below the performance threshold means the scaling factors would increase because more MIPS eligible clinicians would have negative adjustments and relatively fewer MIPS eligible clinicians receive positive adjustments.
We request comment on our proposals.
Through the MIPS and APMs RFI, we solicited comment on various questions related to performance feedback under section 1848(q)(12) of the Act, such as what type of information should be contained in the performance feedback data, how often the feedback should be made available, and who should be able to access the data. Several commenters stated that it would be beneficial if the performance feedback under MIPS contained all the data that contributes to an EP's CPS and any MIPS adjustment. Further, several commenters suggested that performance feedback allow for interactive use of the data. Commenters supported frequent availability of such data and many noted that a minimum of quarterly feedback data would be preferred. Commenters also noted that access to PQRS Feedback Reports currently was a challenge and some suggested that the EPs should be able to control who can access the feedback reports.
Under section 1848(q)(12)(A)(i) of the Act, as added by section 101(c)(1) of the MACRA, we are at a minimum required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and resource use performance categories beginning July 1, 2017, and we have discretion to provide such feedback regarding the CPIA and advancing care information performance categories.
Beginning July 1, 2017, we propose to include information on the quality and resource use performance categories in the performance feedback. Within these performance categories, we propose to use fields similar (that is, quality and resource use) to those currently available in the Quality and Resource Use Reports (QRURs). Since the QRURs already provide information on quality and resource use we believe this is a good starting point for the data fields to be included in the performance feedback. Additional information on the current QRURs can be found at
The first performance feedback is due on July 1, 2017. As this is prior to us having received any MIPS data, we propose to initially provide feedback to MIPS eligible clinicians who are participating in MIPS using historical data set(s), as available and applicable. For example, these historical data set(s) could be a baseline report, using data based off performance that occurred in CY 2015 or CY 2016 for applicable and available quality and resource use data. In the event that 2017 is the first MIPS performance period (as proposed in section II.E.4. of this rule), we would not anticipate receiving the first set of
In future years and as the program evolves, we intend to seek comment on the template, including but not limited to the data fields, for performance feedback. While section 1848(q)(12)(A)(i) of the Act only requires us to provide performance feedback for the quality and resource use performance categories, we understand that the CPIA and advancing care information performance categories are important MIPS data. Commenters to the MIPS and APMs RFI noted that CMS should consult with stakeholders to ensure this performance feedback is useful before this data is provided to MIPS eligible clinicians. Therefore, we may consider including feedback on the performance categories of CPIA and advancing care information in future years. Further, before we consider adding CPIA and advancing care information data to the performance feedback we would like to engage in stakeholder outreach to understand what data fields might be helpful and usable to MIPS eligible clinicians. Regarding the MIPS CPS, this is something we are targeting to provide annually as part of the performance feedback as the program evolves. As technically feasible, we are also planning to provide data fields such as the CPS and each of the four performance categories in future performance feedback once MIPS data becomes available. In addition, we plan to explore the possibility of including the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) in future performance feedback. We seek comment on the frequency with which this performance feedback should be provided, considerations for including CPIA and advancing care information, and data fields that should be included in the performance feedback as this program evolves.
We proposed in section II.E.5.h.(15) of this rule that MIPS eligible clinicians who participate in APM Entities would receive performance feedback, as technically feasible.
Under section 1848(q)(12)(A)(ii) of the Act, the Secretary may use one or more mechanisms to make performance feedback available, which may include use of a web-based portal or other mechanisms determined appropriate by the Secretary. For the quality performance category, described in section 1848(q)(2)(A)(i) of the Act, the feedback shall, to the extent an eligible clinician chooses to participate in a data registry for purposes of MIPS (including registries under sections 1848(k) and (m)) of the Act, be provided based on performance on quality measures reported through the use of such registries. With respect to any other performance category (that is, resource use, CPIA, or advancing care information), the Secretary shall encourage provision of feedback through qualified clinical data registries (QCDRs) as described in sections 1848(m)(3)(E) of the Act.
We understand that the PQRS and VM programs have employed various communication strategies to notify health care providers of the availability of their PQRS Feedback Reports and QRURs, respectively, through the CMS portal. However, many health care providers are still unaware of these reports and/or have difficulty accessing their reports in the portal. Further, we are aware that some health care providers perceive the current reports as complex and often difficult to understand; while others find the QRURs, and the drill down data included in them on the Medicare beneficiaries they serve, very useful. We are continuing to work with stakeholders to improve the usability of these reports. As we transition to MIPS, we are committed to ensuring that eligible clinicians are able to access their performance feedback, and that the data are easy to understand while providing information that will help drive quality improvement. We propose to initially make performance feedback available using a CMS designated system, such as a web-based portal; if technically feasible perhaps an interactive dashboard. As further discussed in section II.E.7.e. of this proposed rule, we also propose to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians, where applicable. At this time, we believe that these additional mechanisms will only be able to provide information on the quality performance category for MIPS in regard to performance feedback.
We plan to coordinate with third party intermediaries such as health IT vendors and QCDRs as MIPS evolves to enable additional feedback to be sent on the resource use, advancing care information and CPIA performance categories. We seek comment on this for future rulemaking.
Comments received through the MIPS and APMs RFI noted issues associated with access to the current Feedback Reports for PQRS. Specifically, comments were received noting issues with Enterprise Identity Management (EIDM) and access to the portal to view PQRS Feedback Reports. Commenters also noted the need for a mechanism to be put in place to notify EPs when their PQRS Feedback Report is available. We propose to use the information contained in the provider or supplier's Medicare enrollment records, and stored in the Provider Enrollment, Chain, and Ownership System (PECOS), as the system of records for eligible clinicians' contact information that should be used when the MIPS performance feedback is available. It is therefore critical that eligible clinicians ensure that their Medicare enrollment records (especially in regard to phone and email contact information) are updated, meaning current, on a consistent basis in PECOS. If more than one email address is listed, then the email address that should be used for communication should be designated. We also intend to provide education and outreach on how to access performance feedback. We seek comment on additional means that could be used to notify or contact MIPS eligible clinicians and groups when their performance feedback is available.
Under section 1848(q)(12)(A)(iii) of the Act, for purposes of providing performance feedback, the Secretary may use data, for a MIPS eligible clinician, from periods prior to the
As stated under section 1848(q)(12)(A)(iv) of the Act, feedback made available under section 1848(q)(12)(A) of the Act shall be exempt from disclosure under 5 U.S.C. 552 (the Freedom of Information Act).
Section 1848(q)(12)(A)(v) of the Act, states that the Secretary may use the mechanisms established under section 1848(q)(12)(A)(ii) of the Act to receive information from professionals. This allows for expanded use of the feedback mechanism to not only provide feedback on performance to eligible clinicians, but to also receive information from professionals.
We intend to explore the possibility of adding this feature to the CMS designated system, such as a portal, in future years under MIPS. This feature could be a mechanism where eligible clinicians can send their feedback (that is, if they are experiencing issues accessing their data, technical questions about their data, etc.) to CMS. We appreciate that eligible clinicians may have questions regarding the information contained in their performance feedback. In order to assist eligible clinicians, we intend to establish resources, such as a helpdesk or offer technical assistance, to help address questions with the goal of linking these resource features to the CMS designated system, such as a portal.
Additionally, we seek comment on the types of information eligible clinicians would like to send to CMS via this mechanism.
Section 1848(q)(12)(B)(i) of the Act, states that beginning July 1, 2018, the Secretary shall make available to MIPS eligible clinicians information about the items and services for which payment is made under Title 18 that are furnished to individuals who are patients of MIPS eligible clinicians by other suppliers and providers of services. This information may be made available through mechanisms determined appropriate by the Secretary, such as the proposed CMS designated system that would also provide performance feedback. Section 1848(q)(12)(B)(ii) of the Act specifies that the type of information provided may include the name of such providers, the types of items and services furnished, and the dates items and services were furnished. Historical data regarding the total, and components of, allowed charges (and other figures as determined appropriate by the Secretary) may also be provided. We seek comment on the type of information MIPS eligible clinicians would find useful and the preferred mechanisms to provide such information, as well as, arrangements that should be in place regarding this data (that is, eligible clinicians sharing data). We also seek comment as to whether additional information regarding beneficiaries attributed to a MIPS eligible clinician under the resource use performance category or information about which MIPS eligible clinician(s) beneficiaries to whom a given MIPS eligible clinician provides services were attributed would be useful feedback in regards to quality improvement efforts.
The performance feedback under section 1848(q)(12)(A) of the Act is meant to be meaningful and usable to eligible clinicians. In an effort to ensure these data are tailored to the needs of eligible clinicians, we solicited comment through the MIPS and APMs RFI and received numerous comments regarding overall format of the performance feedback template. Suggestions were made on what this feedback should include for MIPS. We intend to collaborate with stakeholders outside of notice-and-comment rulemaking on how the performance feedback should look for MIPS; as well as, what data elements would be useful for eligible clinicians. We seek comment on the fields that should be included in the performance feedback template for MIPS eligible clinicians.
Section 1848(q)(7) of the Act requires that under the MIPS, the Secretary shall, not later than 30 days prior to January 1 of the year involved, make available to MIPS eligible clinicians the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) applicable to the eligible clinician for items and services furnished by the professional for such year. The Secretary may include such information in the confidential feedback under section 1848(q)(12) of the Act.
If technically feasible, we propose to include the MIPS adjustment factor (and, as applicable, the additional MIPS adjustment factor) in the performance feedback for eligible clinicians provided under section 1848(q)(12)(A) of the Act. If it is not technically feasible to provide this information in the performance feedback, we propose to make it available through another mechanism as determined appropriate by the Secretary (such as a portal or a CMS designated Web site) and seek comment on mechanisms that might be appropriate. The first announcement will be available no later than December 1, 2018 to meet statutory requirements. We request comment on these proposals.
Section 1848(q)(13)(A) of the Act requires the establishment of a process under which a MIPS eligible clinician may seek an informal review of the calculation of the MIPS adjustment factor (or factors) applicable to such MIPS eligible clinician for a year.
We recognize that a principled approach to requesting and conducting a targeted review is required under the MACRA in order to minimize burdens on MIPS eligible clinicians and ensure transparency under MIPS. We also believe it is important to retain the flexibility to modify MIPS eligible clinicians' CPS or payment adjustment based on the results of targeted review. This will lend confidence to the determination of the CPS and payment adjustments, as well as, providing finality for the MIPS eligible clinician after the targeted review is completed. It will also minimize the need for claims reprocessing. We are proposing an approach below that outlines the factors that we would use to determine if a targeted review may be conducted. In keeping with the statutory direction that this process be “informal,” we have attempted to minimize the associated burden on the MIPS eligible clinician to the extent possible.
In accordance with section 1848(q)(13)(A) of the Act, we propose at § 414.1385 to adopt a targeted review process under MIPS wherein a MIPS eligible clinician may request that we review the calculation of the MIPS adjustment factor under section 1848(q)(6)(A) of the Act and, as applicable, the calculation of the additional MIPS adjustment factor
• The MIPS eligible clinician believes that measures or activities submitted to CMS during the submission period and used in the calculations of the CPS and determination of the adjustment factors have calculation errors or data quality issues. These submissions could be with or without the assistance of a third party intermediary; or
• The MIPS eligible clinician believes that there are certain errors made by CMS, such as performance category scores were wrongly assigned to the MIPS eligible clinician (for example, the MIPS eligible clinician should have been subject to the low-volume threshold exclusion and should not have received a performance category score).
We believe that a fair targeted review request process requires accessibility to all MIPS eligible clinicians within a reasonable period of time and provides electronic and telephonic communication for questions regarding the targeted review process, as well as for the actual request for review and receipt of the decision on that request. The targeted review process will use the same help desk support mechanism as is provided for MIPS as a whole.
We further propose at § 414.1385 to adopt the following general process for targeted reviews under section 1848(q)(13)(A):
• A MIPS eligible clinician electing to request a targeted review may submit their request within 60 days (or a longer period specified by us) after the close of the data submission period. All requests for targeted review must be submitted by July 31 after the close of the data submission period or by a later date that we specify in guidance.
• We will provide a response with our decision on whether or not a targeted review is warranted. If a targeted review is warranted, the timeline for completing that review may be dependent on the number of reviews requested (for example, multiple reviews versus a single review by one MIPS eligible clinician) and general nature of the review.
• As this process is informal and the statute does not require a formal appeals process, we will not include a hearing process. The MIPS eligible clinician may submit additional information to assist in their targeted review at the time of request. If we or our contractors request additional information from the MIPS eligible clinician, the supporting information must be received from the MIPS eligible clinician by us or our contractors within 10 calendar days of the request. Non-responsiveness to the request for additional information will result in the closure of that targeted review request, although another review request may be submitted if the targeted review submission deadline has not passed.
• Since this is an informal review process and given the limitations on review under section 1848(q)(13)(B) of the Act, decisions based on the targeted review will be final, and there will be no further review or appeal.
If a request for targeted review is approved, the outcome of such review may vary. For example, we may determine that the clinician should have been excluded from MIPS, re-distribute the weights of certain performance categories within the CPS (for example, if a performance category should have been weighted at zero), or recalculate a performance category score in accordance with the scoring methodology for the affected category, if technically feasible.
We request comments on these proposals.
Section 1848(q)(13)(B) of the Act, as added by section 101(c)(1) of the MACRA, provides there shall be no administrative or judicial review under sections 1869 and 1878 of the Act, or otherwise of the following:
• The methodology used to determine the amount of the MIPS adjustment factor and the amount of the additional MIPS adjustment factor and the determination of such amounts;
• The establishment of the performance standards and the performance period;
• The identification of measures and activities specified for a MIPS performance category and information made public or posted on our Physician Compare Web site; and
• The methodology developed that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.
We propose at § 414.1385 to implement these provisions as written in the statute.
We would reject any requests for targeted review under section 1848(q)(13)(A) of the Act that focus on the areas precluded from review under section 1848(q)(13)(B) of the Act. We request comments on this proposal.
Our experience with the PQRS, VM and Medicare EHR Incentive Programs, has demonstrated the value of data validation and auditing as an important part of program integrity, which is necessary to ensure valid, reliable data. The current voluntary data validation process for PQRS and the audit process for the Medicare EHR Incentive Program are multi-step processes. We communicate the types of data elements that may be included for data validation across multiple Web sites and our documents. This includes defining specific data that may be abstracted from the certified EHR technology, as well as other documented records.
As we begin the MIPS, our strategy is to combine our past program integrity processes of the data validation process used in PQRS, and the auditing process used in the Medicare EHR Incentive Program into one set of requirements for MIPS eligible clinicians and groups, which we refer to as “data validation and auditing.” Based on our need for valid and reliable data on which to base a MIPS eligible clinician's or group's payment, we propose certain requirements for MIPS eligible clinicians and groups submitting data for the 2017 performance period (see section II.E.4) under MIPS. Further, we propose at § 414.1390 to selectively audit MIPS eligible clinicians on a yearly basis, and that if a MIPS eligible clinician or group is selected for audit, the MIPS eligible clinician or group would be required to do the following in accordance with applicable law:
• Comply with data sharing requests, providing all data as requested by us or our designated entity. All data must be shared with CMS or our designated entity within 10 business days or an alternate time frame that is agreed to by CMS and the MIPS eligible clinician or group. Data would be submitted via email, facsimile, or an electronic method via a secure Web site maintained by CMS.
• Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives and activities. Primary source documentation also may include verification of records for Medicare and
We propose that we would monitor MIPS eligible clinicians and groups on an ongoing basis for data validation, auditing, program integrity issues and instances of non-compliance with MIPS requirements. If a MIPS eligible clinician or group is found to have submitted inaccurate data for MIPS, we propose that we would reopen, revise, and recoup any resulting overpayments in accordance with the rules set forth at § 405.980 (re-opening rules), § 450.982 and § 450.984 (revising rules); and § 405.370 and § 405.373 (recoupment rules). It is important to note that at § 405.980(b)(3) there is an exception whereby we have the authority to re-open at any time for fraud or similar fault. If we re-open the initial determination we must revise it, and send out a notice of the revised determination under § 450.982. We also propose that we would recoup any payments from the MIPS eligible clinician by the amount of any debts owed to us by the MIPS eligible clinician and likewise, we would recoup any payments from the group by the amount of any debts owed to us by the group. We also note that we would need to limit each such data validation and audit request to the minimum data necessary to conduct validation.
We propose all MIPS eligible clinicians and groups that submit data to CMS electronically must attest to the accuracy and completeness to the best of their knowledge of any data submitted to us. This attestation will occur prior to any electronic data submissions, via a Web site maintained by CMS.
We request comments on these proposals.
One of our strategic goals in developing MIPS includes developing a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is through flexible reporting options to accommodate different practices and make measurement meaningful. We believe this goal can be accomplished by allowing MIPS eligible clinicians the flexibility of using third party intermediaries to collect or submit data on their behalf. Specifically, qualified registries, QCDRs, health IT vendors that obtain data from an eligible clinician's certified EHR technology, and CMS-approved survey vendors as discussed in the following proposed policies. In this section, we are specifying the requirements that must be met to become a third party intermediary.
In the PQRS program, quality measures data may be collected or submitted by third party vendors on behalf of an individual EP or group by: (1) A registry; (2) a QCDR; or (3) an EHR vendor that obtains data from an EP's certified EHR technology; or (4) a CMS-approved survey vendor. We propose at § 414.1400(a)(1) that MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician or group by: (1) A qualified registry; (2) a QCDR; (3) a health IT vendor; or (4) a CMS-approved survey vendor. Furthermore, we propose at § 414.1400(a)(3) that third party intermediaries must meet all the requirements designated by CMS as a condition of their qualification or approval to participate in MIPS as a third party intermediary. As proposed at § 414.1400(a)(3)(ii), all submitted data must be submitted in the form and manner specified by CMS.
In the MIPS and APMs RFI, we solicited feedback on how we should address data integrity, testing and standards, and review and qualification processes for QCDRs. Subsequently, we also met with several organizations that were either a QCDR or are in the process of becoming a QCDR. Commenters agreed that data quality is a critical issue for QCDRs. To address some of the data quality concerns, some commenters suggested having processes in place in advance of reporting that could mitigate data errors. For example, this could include a process to reconcile TIN and NPI combinations. Several commenters also suggested limiting submission mechanisms to one submission mechanism per performance category to the extent possible. Commenters generally agreed that QCDRs should be required to submit data using uniform submission standards, with several suggesting the use of the Quality Reporting Document Architecture (QRDA) standard, which certified EHR technology is required to support.
Most commenters noted that uniform standards would ease participation by MIPS eligible clinicians and reduce barriers to entry. Others noted that we should work with ONC and the standards development organization Health Level Seven (HL7) to improve the QRDA standard for current submissions, and that in the future, we should prepare to support emerging standards such as Fast Healthcare Interoperability Resources. Commenters also noted that use of QRDA will align CMS requirements and ONC certification requirements as ONC's 2015 Edition Certification requires that all health information technology (IT) modules used for the submission of CQM data must at least be certified to the QRDA standard. Requiring QCDRs to use QRDA could help reduce vendor interface costs for MIPS eligible clinicians already using certified EHR technology and who desire to participate in registry reporting. Commenters also directed our attention towards the 2015 Edition Certification for additional information on improved test methods and to address historic issues and inaccuracies observed with past calculation and reporting of quality and performance data. With regard to testing, commenters were divided about whether we should require QCDR-specific testing. Several noted that certified EHR technology that support QCDRs have been tested already and that onerous testing may discourage participation. Commenters in favor of testing recommended a degree of flexibility in the early years of the program. Suggestions for testing included the use of comprehensive specifications and accurate testing tools far enough in advance of the performance period to allow developers and implementers to conduct robust testing. These specifications could be included in an Implementation Guide. Opportunities for early testing, using sample data was also emphasized. Commenters did express concern on the amount of time needed for troubleshooting and fixing errors early enough in the testing process such as format, content, and measure accuracy. Commenters suggested several ways we might implement testing, recommending that we:
• Test the accuracy, completeness, and reliability of measure calculations for specific, individual measures.
• Test the feasibility of data collection requirements.
• Pilot new CQMs before release; establish a regular schedule of CQM revisions, and ensure adequate time is allowed for implementation of the revisions.
• Align the ONC Health IT Certification program and CMS testing requirements for data submission.
• Expand the test data sets used by the Cypress Testing Tool. More information on the Cypress Testing Tool is available at:
There was a strong consensus that MIPS eligible clinicians should not be penalized for signing up with an entity that purported to offer reliable services but then was unable to accurately submit data to us. Several commenters suggested that entities that do not meet
Commenters had mixed responses regarding how to resolve inaccurate data submission problems when time did not allow for continued review. Commenters felt we should use a “trust but validate” methodology, allowing the QCDR to recalculate the performance rate or authorizing us to do so, but also that we should have validation processes in place as well once the recalculation of the performance rate occurs. Ultimately, we would need to be able to calculate all rates based on a submitted numerator and denominator. Commenters suggested that MIPS eligible clinicians should be assessed an average score or a “pass” for the MIPS quality performance category if data problems cannot be resolved in a timely manner or at the least not be penalized due to data errors outside their control. One commenter suggested use of a Data Quality Management (DQM) program for MIPS eligible clinicians that includes early data qualification evaluation processes to take advantage of feedback and assessments with thresholds for acceptance of data. MIPS eligible clinicians who demonstrate effort toward achieving high quality data submissions but were not able to meet the threshold should be chaperoned to that target and provided with guidance.
Commenters were also divided about our review and qualification of QCDRs to ensure our form and manner requirements are met. Several commenters were concerned with a CMS process in addition to an ONC certification process and recommended we work with ONC to align their certification to address our requirements for QCDRs. Commenters suggested that we also develop more robust implementation guides, and enhance our submission engine validation tool (SEVT).
Section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the CPS methodology, to encourage MIPS eligible clinicians to report on applicable measures with respect to the quality performance category through the use of certified EHR technology and QCDRs. Section 1848(q)(2)(B)(iii)(II) of the Act requires that the CPIA subcategories specified by the Secretary include population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR. Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the provision of performance feedback through QCDRs.
Section 1848(m)(3)(E)(i) of the Act requires the Secretary to establish requirements for an entity to be considered a QCDR, which must include a requirement that the entity provide the Secretary with such information, at such times, and in such manner, as the Secretary determines necessary to carry out section 1848(m) of the Act. Section 1848(m)(3)(E)(iv) of the Act requires the Secretary to consult with interested parties in carrying out section 1848(m)(3)(E) of the Act.
Currently, the QCDR reporting mechanism provides a method to satisfy PQRS requirements based on satisfactory participation. We propose that entities interested in becoming a QCDR for MIPS go through a qualification process. This includes the QCDR meeting the definition of a QCDR, self-nomination requirements, and the requirements of a QCDR, including the deadlines listed below. This qualification process allows us to ensure that the entity has the capability to successfully report MIPS eligible clinicians' data to us and allows for review and approval of the QCDR's proposed non-MIPS quality measures. We intend to compile and post a list of entities that we “qualify” to submit data to us as a QCDR for purposes of MIPS on a Web site maintained by CMS.
Section 1848(q)(1)(E) of the Act encourages the use of QCDRs in carrying out the MIPS. Although section 1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to encourage MIPS eligible clinicians to use QCDRs to report on applicable measures with respect to the quality performance category and section 1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the provision of performance feedback through QCDRs, the statute does not specifically address usage of QCDRs for the other MIPS performance categories. Although we could limit the usage of QCDRs to assessing the quality performance category under MIPS and providing performance feedback, we believe it would be less burdensome for MIPS eligible clinicians if we expand the QCDRs capabilities. By allowing QCDRs to report on the quality, advancing care information, and CPIA performance categories we would alleviate the need for individual MIPS eligible clinicians and groups to use a separate mechanism to report data for these performance categories. It is important to note that no data will need to be reported for the resource use performance category since these measures are administrative claims-based. Therefore, we are proposing at § 414.1400(a)(2) to expand QCDRs' capabilities by allowing QCDRs to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
(i) Quality;
(ii) CPIA; or
(iii) Advancing care information, if the MIPS eligible clinician or group is using certified EHR technology.
We believe this approach would permit a single QCDR to report on the quality, advancing care information, and CPIA performance category requirements for MIPS and should mitigate the risks, costs, and burden of MIPS eligible clinicians having to report multiple times to meet the requirements of MIPS.
We propose to define a QCDR at § 414.1305 as a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical and/or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. Examples of the types of entities that may qualify as QCDRs include, but are not limited to, regional collaboratives and specialty societies using a commercially available software platform, as appropriate.
We propose at § 414.1400(c) the establishment of a QCDR entity is required as follows: for an entity to become qualified for a given performance period as a QCDR, the entity must be in existence as of January 1 of the performance period for which the entity seeks to become a QCDR (for example, January 1, 2017, to be eligible to participate for purposes of performance periods beginning in 2017). The QCDR must have at least 25 participants by January 1 of the performance period. These participants do not need to be using the QCDR to report MIPS data to us; rather, they need to be submitting data to the QCDR for quality improvement.
For the 2017 performance period we propose at § 414.1400(b) a self-nomination period from November 15, 2016 until January 15, 2017. For future years of the program, starting with the 2018 performance period, we propose to establish the self-nomination period from September 1 of the prior year until November 1 of the prior year. Entities that desire to qualify as a QCDR for the purposes of MIPS for a given performance period would need to self-nominate for that year and provide all information requested by CMS at the time of self-nomination. Having qualified as a QCDR in a prior year does not automatically qualify the entity to participate in MIPS as a QCDR in subsequent performance periods. For example, a QCDR may choose not to continue participation in the program in future years, or the QCDR may be precluded from participation in a future year due to multiple data or submission errors as noted below. Finally, QCDRs may want to update or change the measures or services or performance categories they intend to provide. As such, CMS believes an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.
We propose to require other information (described below) of QCDRs at the time of self-nomination. If an entity becomes qualified as a QCDR, they will need to sign a statement confirming this information is correct prior to listing it on their Web site. Once we post the QCDR on our Web site, including the services offered by the QCDR, we will require the QCDR to support these services/measures for its clients as a condition of the entity's qualification as a QCDR for purposes of MIPS. Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year.
We propose that a QCDR must provide the following information to us at the time of self-nomination to ensure that QCDR data is valid:
• Organization Name (Specify Sponsoring Organization name and software vendor name if the two are different. For example, a specialty society in collaboration with a software vendor).
• MIPS performance categories (that is, categories for which the entity is self-nominating. For example, quality, advancing care information, and/or CPIA).
• Performance Period.
• Vendor Type (for example, qualified clinical data registry).
• Provide the method(s) by which the entity obtains data from its customers for each performance category for which it is approved: Claims, web-based tool, practice management system, certified EHR technology, other (please explain). If a combination of methods (Claims, web-based tool, Practice Management System, certified EHR technology, and/or other) is utilized, the entity should state which method(s) it utilizes to collect data (for example, performance numerator and denominator).
• Indicate the method the entity will use to verify the accuracy of each TIN/NPI it is intending to submit (for example, National Plan and Provider Enumeration System (NPPES), CMS claims, tax documentation).
• Describe the method that the entity will use to accurately calculate performance rates for quality measures based on the appropriate measure type and specification. For composite measures or measures with multiple performance rates, the entity must provide us with the methodology the entity uses to calculate these composite measures and measures with multiple performance rates. The entity should be able to report to us a calculated composite measure rate if applicable.
• Describe the method that the entity will use to accurately calculate performance data for CPIA and advancing care information based on the appropriate parameters or activities.
• Describe the process that the entity will use for completion of a randomized audit of a subset of data prior to the submission to us (for all performance categories the QCDR is submitting data on, that is, quality, CPIA, and advancing care information, as applicable). Periodic examinations may be completed to compare patient record data with submitted data and/or ensure MIPS quality measures or other performance category (CPIA, advancing care information) activities were accurately reported and performance calculated based on the appropriate measure specifications (that is, accuracy of numerator, denominator, and exclusion criteria) or performance category requirements.
• Provide information on the entity's process for data validation for both individual MIPS eligible clinicians and groups within a data validation plan. For example, for individuals it is encouraged that 3 percent of the TIN/NPIs submitted to us by the QCDR be sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 TIN/NPIs. For each TIN/NPI sampled, it is encouraged that 25 percent of the TIN/NPI's patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
• Provide the results of the executed data validation plan by May 31 of the year following the performance period. If the results indicate the QCDR's validation reveals inaccuracy or low compliance provide to CMS an improvement plan. Failure to implement improvements may result in the QCDR being placed in a probationary status or disqualification from future participation.
• For non-MIPS quality measures, if the measure is risk-adjusted, the QCDR is required to provide details to CMS on their risk adjustment methodology (risk adjustment variables, and applicable calculation formula) at the time of the QCDR's self-nomination. The QCDR must submit the risk adjusted results to CMS when submitting a risk-adjusted measure on behalf of the QCDR's MIPS eligible clinicians for the performance period.
In addition, we propose that a QCDR must perform the following functions:
• For measures under the quality performance category and as proposed at § 414.1400(a)(4)(i), if the data is derived from certified EHR technology, the QCDR must be able to indicate this data source.
• QCDRs must provide complete quality measure specifications including data elements to us for non-MIPS quality measures intended for reporting from certified EHR technology.
• QCDRs must provide a plan to risk adjust (if appropriate for the measure) the non-MIPS quality measures data for which it collects and intends to transmit to us and must submit the risk-adjusted results (not the non-risk adjusted rates), to CMS. The risk adjustment methodology (formula and variables) must be integrated with the complete quality measure specifications. Specifically, for risk-adjusted non-MIPS quality measures, a QCDR is required to provide details to CMS on their risk adjustment methodology. The data elements used for risk adjustment may vary by measure and measure type. The risk adjustment methodology, including the risk adjustment variables, must be posted along with the measure's specifications on the QCDR's Web site. CMS believes risk-adjustment for certain outcomes measures is important to account for the differences in the complexities of care provided to
• QCDRs submitting MIPS quality measures that are risk-adjusted (and have the risk-adjusted variables and methodology listed in the measure specifications) must submit the risk-adjusted measure results to CMS when submitting the data for these measures.
• Submit quality, advancing care information, or CPIA data and results to us in the applicable MIPS performance categories for which the QCDR is providing data.
• A QCDR must have in place mechanisms for the transparency of data elements and specifications, risk models, and measures. That is, we expect that the non-MIPS measures and their data elements (that is, specifications) comprising these measures be listed on the QCDR's Web site unless the measure is a MIPS measure, in which case the specifications will be posted by us.
• Submit to us data on measures, activities, and objectives for all patients, not just Medicare patients.
• Provide timely feedback, at least 6 times a year, on all of the MIPS performance categories that the QCDR will report to us. That is, if the QCDR will be reporting on data for the CPIA, advancing care information, or quality performance category, all results as of the feedback report date should be included in the information sent back to the MIPS eligible clinician. The feedback should be given to the individual MIPS eligible clinician or group (if participating as a group) at the individual participant level or group level, as applicable, for which the QCDR reports. The QCDR is only required to provide feedback based on the MIPS eligible clinician's data that is available at the time the feedback report is generated.
• Possess benchmarking capacity (for non-MIPS quality measures) that compares the quality of care a MIPS eligible clinician provides with other MIPS eligible clinicians performing the same quality measures. For non-MIPS measures the QCDR must provide us, if available, data from years prior (for example, 2015 data for the 2017 MIPS performance period) before the start of the performance period. In addition, the QCDR must provide us, if available, with the entire distribution of the measure's performance broken down by deciles. As an alternative to supplying this information to us, the QCDR may post this information on their Web site prior to the start of the performance period, to the extent permitted by applicable privacy laws.
• QCDRs must comply with any request by us to review the data submitted by the QCDR for purposes of MIPS in accordance with applicable law. Specifically, data requested would be limited to the minimum necessary for us to carry out, for example, health care operations or health oversight activities.
• Mandatory participation in ongoing support conference calls hosted by us (approximately one call per month), including an in-person QCDR kick-off meeting (if held) at our headquarters in Baltimore, MD. More than one unexcused absence could result in the QCDR being precluded from participation in the program for that year. If a QCDR is precluded from participation in MIPS, the individual MIPS eligible clinician or group would need to find another QCDR or utilize another data submission mechanism to submit their MIPS data.
• Agree that data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent of the total number of MIPS eligible clinicians submitted by the QCDR may result in notations on our qualified QCDR posting of low data quality and would place the QCDR on probation (if they decide to self-nominate for the next program year). If the QCDR does not reduce their data error rate below 3 percent in the subsequent year, they would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians submitted by the QCDR may lead to the disqualification of the QCDR from participation in the following year's program. As we gain additional experience with QCDRs, we intend to revisit and enhance these thresholds in future years.
• Be able to submit results for at least six quality measures including one cross-cutting measure and one outcome measure. If an outcome measure is not available, be able to submit results for at least one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If no outcome measure is available, then the QCDR must provide a justification for not including an outcome measure.
• QCDRs may request to report on up to 30 quality measures not in the annual list of MIPS quality measures. Full specifications will need to be provided to us at the time of self-nomination. CMS will review the quality measures and determine if they are appropriate for QCDR reporting.
• Enter into and maintain with its participating clinicians an appropriate Business Associate agreement that provides for the QCDR's receipt of patient-specific data from an individual MIPS eligible clinician or group, as well as the QCDR's disclosure of quality measure results and numerator and denominator data and/or patient specific data on Medicare and non-Medicare beneficiaries on behalf of MIPS eligible clinicians and groups.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the QCDR, has authorized the QCDR to submit quality measure results, CPIA measure and activity results, advancing care information objective results and numerator and denominator data and/or patient-specific data on Medicare and non-Medicare beneficiaries to CMS for the purpose of MIPS participation. This documentation must be obtained at the time the MIPS eligible clinician or group signs up with the QCDR to submit MIPS data to the QCDR and must meet the requirements of any applicable laws, regulations, and contractual business associate agreements. Groups participating in MIPS via a QCDR may have their group's duly authorized representative grant permission to the QCDR to submit their data to us. If submitting as a group, each individual MIPS eligible clinician does not need to grant their individual permission to the QCDR to submit their data to us.
• Not be owned and managed by an individual locally owned single specialty group (for example, single specialty practices with only one practice location or solo practitioner practices are prohibited from self-nominating to become a qualified QCDR).
• Be able to separate out and report on all payers including Medicare Part B FFS patients and non-Medicare patients.
• Provide the measure numbers for the MIPS quality measures on which the QCDR is reporting.
• Provide the measure title for the MIPS quality measures and CPIAs (if applicable) on which the QCDR is reporting.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (performance numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Comply with a CMS-specified secure method for data submission, such as submitting the QCDR's data in an XML file.
• Sign a document verifying the QCDR's name, contact information, cost for MIPS eligible clinicians or groups to use the QCDR, services provided, and the measures and specialty-specific measure sets the QCDR intends to report. Once posted, on the QCDR's or CMS Web site, the QCDR will need to support the measures/measure sets confirmed by the QCDR. Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year.
• Must provide attestation statements during the data submission period that all of the data (quality measures, CPIAs, and advancing care information measures and objectives, if applicable) and results are accurate and complete.
• For purposes of distributing feedback reports to MIPS eligible clinicians, collect a MIPS eligible clinician's email addresses and have documentation from the MIPS eligible clinician authorizing the release of his or her email address.
• Be able to calculate and submit measure-level reporting rates or, upon request, the data elements needed to calculate the reporting and performance rates by TIN/NPI and/or TIN.
• Be able to calculate and submit, by TIN/NPI and/or TIN, a performance rate (that is the percentage of a defined population who receive a particular process of care or achieves a particular outcome based on a calculation of the measures' numerator and denominator specifications) for each measure on which the TIN/NPI and/or TIN reports or, upon request the Medicare beneficiary data elements needed to calculate the performance rates.
• Provide the performance period start date the QCDR will cover.
• Provide the performance period end date the QCDR will cover.
• Report the number of reported instances, performance not met, meaning the quality actions was not performed for no valid reason as defined by the measure specification.
• For data validation purposes, provide information on the entity's sampling methodology. For example, it is encouraged that 3 percent of the MIPS eligible clinicians be sampled with a minimum sample of 10 MIPS eligible clinicians or a maximum sample of 50 MIPS eligible clinicians. For each MIPS eligible clinicians sampled, it is encouraged that 25 percent of the MIPS eligible clinicians' patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
• Submit all of the measures (MIPS measures and non-MIPS measures) including specifications for the non-MIPS measures to CMS on a designated Web page. The measures must address a gap in care. Outcome or other high priority types of measures are preferred. Simple documentation or “check box” measures are discouraged.
A QCDR must provide specifications for each measure, activity, or objective the QCDR intends to submit to CMS. We propose at § 414.1400(f) the QCDR must provide the following information:
• Provide descriptions and narrative specifications for, each measure activity, or objective for which it will submit to us by no later than January 15 of the applicable performance period for which the QCDR wishes to submit quality measures or other performance category (CPIA and advancing care information) data. In future years, starting with the 2018 performance period, those specifications must be provided to us by no later than November 1 prior to the applicable performance period for which the QCDR wishes to submit quality measures or other performance category (CPIA and advancing care information) data.
• For non-MIPS quality measures, the quality measure specifications must include: Name/title of measures, NQF number (if NQF-endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. The narrative specifications provided must be similar to the narrative specifications we provide in our measures list. CMS will consider all non-MIPS measures submitted by the QCDR but the measures must address a gap in care and outcome or other high priority measures are preferred. Documentation or “check box” measures are discouraged. Measures that have very high performance rates already or address extremely rare gaps in care (thereby allowing for little or no quality distinction between MIPS eligible clinicians) are also unlikely to be approved for inclusion.
• For MIPS measures, the QCDR only needs to submit the MIPS measure numbers and/or the specialty-specific measure sets (if applicable).
• The QCDR must publicly post the measure specifications (no later than 15 days following our approval of these measure specifications) for each non-MIPS quality measure it intends to submit for MIPS. The QCDR may use any public format it prefers. Immediately following posting of the measures specification information, the QCDR must provide CMS with the link to where this information is posted. CMS will then post this information when it provides its list of QCDRs for the year.
To clarify the definition of a non-MIPS quality measures for purposes of QCDRs submitting data for the MIPS quality performance category, we propose at § 414.1400(e) to consider the following types of quality measures to be non-MIPS quality measures:
• A measure that is not contained in the annual list of MIPS quality measures for the applicable performance period.
• A measure that may be in the annual list of MIPS quality measures but has substantive differences in the manner it is submitted by the QCDR. For example, if a MIPS quality measure is only reportable via the CMS Web Interface and a QCDR wishes to report this quality measure on behalf of its MIPS eligible clinicians, the quality measure would be considered a non-MIPS quality measure. This is because we would have only extracted the data collected from this quality measure using the CMS Web Interface, in which we utilize a claims-based assignment and sampling methodology to inform the groups on which patients they are to report, and the reporting of this quality measure would require changes to the way that the quality measure is calculated and reported to us via a QCDR instead of through the CMS Web Interface. Therefore, due to the substantive changes needed to report this quality measure via a QCDR, this CMS Web Interface quality measure would be considered a non-MIPS quality measure. CMS would not be able to directly compare MIPS eligible clinicians submitting the quality measure using the CMS Web Interface to those submitting the quality measure using the QCDR. Thus, this would be considered a non-MIPS quality measure.
• In addition, the CAHPS for MIPS survey currently could be submitted only using a CMS-approved survey vendor. Although the CAHPS for MIPS survey is proposed for inclusion in the MIPS measure set, we consider the changes that will need to be made available for reporting by individual
In the CY 2016 PFS final rule (80 FR 71136 through 71138) we finalized our proposal to allow collaboration of entities to become a QCDR based on our experience with the qualifying entities wishing to become QCDRs for performance periods. We received feedback from organizations who expressed concern that the entity wishing to become a QCDR may not meet the requirements of a QCDR solely on its own. We believe this policy supporting entity collaboration should be continued under MIPS. Therefore, we are proposing at § 414.1400 that an entity that may not meet the requirements of a QCDR solely on its own but could do so in conjunction with another entity, would be eligible for qualification through collaboration with another entity.
We propose to allow that an entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR provided the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR (for example, September 1, 2016, to be eligible to participate for purposes of the 2017 performance period). Entities that have a mere verbal, non-written agreement to work together to become a QCDR by September 1 the year prior to the year for which the entity seeks to become a QCDR would not fulfill this proposed requirement. We request comments on these proposals.
Currently, EHR-based systems are required to be considered certified EHR technology for multiple CMS quality programs. The Office of the National Coordinator for Health Information Technology (ONC) certification process has established standards and other criteria for structured data that EHRs must use. We propose to maintain this standard and require EHR-based data submission (whether transmitted directly from the EHR or from a data intermediary) to be certified EHR technology to submit quality measures, advancing care information, and CPIA data for MIPS. In addition, we propose at § 414.1400(a)(4) that health IT vendors that obtain data from a MIPS eligible clinician's certified EHR technology, like other third party intermediaries, would have to meet all requirements designated by CMS as a condition of their qualification or approval to participate in MIPS as a third party intermediary. This includes submitting data in the form and manner specified by CMS as proposed at § 414.1400(a)(4)(ii). We anticipate that for the initial years of MIPS the form and manner requirements will be similar to what was used in the PQRS program however, at a minimum these will be modified to address the four performance categories under MIPS and MIPS data calculation needs. As we gain experience under MIPS we anticipate that these form and manner requirements may change in future years to ease reporting burden. Historical form and manner requirements under the PQRS program are available here:
Although section 1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to encourage MIPS eligible clinicians to report on applicable measures using EHR technology with respect to the quality performance category, the statute does not specifically address allowing a third party intermediary—such as a health IT vendor to submit on a MIPS eligible clinician's behalf for the other performance categories. Although we could limit the usage of health IT vendors assessing the quality performance category under MIPS, we believe it would be less burdensome for MIPS eligible clinicians if we expand the health IT vendors' capabilities. By allowing health IT vendors to report on the quality, advancing care information, and CPIA performance categories we would alleviate the need for individual MIPS eligible clinicians and groups to use a separate mechanism to report data for these performance categories. Our intention is to encourage health IT vendors to design systems to be able to accept new types of EHR data (for example, CPIA and advancing care information) from MIPS eligible clinicians and groups—this would be in addition to the quality measure data that we already can accept. Therefore, we are proposing at § 414.1400(a)(2) to expand health IT vendors' capabilities by allowing health IT vendors to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
(i) Quality;
(ii) CPIA; or
(iii) Advancing care information.
As proposed at § 414.1400(a)(1), health IT vendors submitting data on behalf of a MIPS eligible clinician or group would be required to obtain data from the MIPS eligible clinician's certified EHR technology. We believe this approach would permit a single health IT vendor to report on quality, advancing care information, and CPIA performance category requirements for MIPS and should mitigate the risks, costs, and burden of MIPS eligible clinicians having to report multiple times to meet the requirements of MIPS.
We further propose that health IT vendors must be able to do the following:
• For measures, activities, and objectives under the quality, advancing care information, and CPIA performance categories, and as proposed at § 414.1400(a)(4)(i); if the data is derived from certified EHR technology, the health IT vendor must be able to indicate this data source.
• Either transmit data from the certified EHR technology or through a data intermediary in the CMS-specified form and manner, or have the ability for the individual MIPS eligible clinician and group to be able to submit data directly from their certified EHR technology, in the CMS-specified form and manner.
For MIPS eligible clinicians who choose to electronically submit quality, advancing care information, and CPIA data extracted from their certified EHR technology to an intermediary, the
We propose to define a qualified registry at § 414.1305 as a medical registry, a maintenance of certification program operated by a specialty body of the American Board of Medical Specialties or other data intermediary that, with respect to a particular performance period, has self-nominated and successfully completed a vetting process (as specified by CMS) to demonstrate its compliance with the MIPS qualification requirements specified by CMS for that performance period. The registry must have the requisite legal authority to submit MIPS data (as specified by CMS) on behalf of a MIPS eligible clinician or group to CMS. In addition, we are proposing at § 414.1400(a)(2) to expand a qualified registry's capabilities by allowing qualified registries to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
(i) Quality;
(ii) CPIA; or
(iii) Advancing care information, if the MIPS eligible clinician or group is using certified EHR technology.
We propose at § 414.1400(h) that in order for an entity to become qualified for a given performance period as a qualified registry, the entity must be in existence as of January 1 of the performance period for which the entity seeks to become a qualified registry (for example, January 1, 2017, to be eligible to participate for purposes of performance periods beginning in 2017). The qualified registry must have at least 25 participants by January 1 of the performance period. These participants do not necessarily need to be using the qualified registry to report MIPS data to us; rather, they need to be submitting data to the qualified registry for quality improvement. We also propose a qualified registry must provide attestation statements from the qualified registry/MIPS eligible clinicians during the data submission period that all of the data (quality measures, CPIAs, and advancing care information measures and objectives, if applicable) and results are accurate and complete.
For the 2017 performance period, we propose at § 414.1400(g) a self-nomination period from November 15, 2016 until January 15, 2017. For future years of the program, starting with the 2018 performance period, we propose to establish the self-nomination period from September 1 of the prior year until November 1 of the year in which the qualified registry seeks to be qualified. Entities that desire to qualify as a qualified registry for purposes of MIPS for a given performance period would need to provide all requested information to CMS at the time of self-nomination and would need to self-nominate for that performance period. Having qualified as a qualified registry does not automatically qualify the entity to participate in subsequent MIPS performance periods. For example, a qualified registry may choose not to continue participation in the program in future years, OR the qualified registry may be precluded from participation in a future year, due to multiple data or submission errors as noted below. As such, CMS believes an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.
We propose to require further information (described below) of qualified registries at the time of self-nomination. If an entity becomes qualified as a qualified registry, they will need to sign a statement confirming this information is correct prior to us listing their qualifications on their Web site. Once we post the qualified registry on our Web site, including the services offered by the qualified registry, we will require the qualified registry to support these services/measures for its clients as a condition of the entity's qualification as a qualified registry for purposes of MIPS. Failure to do so will preclude the qualified registry from participation in MIPS in the subsequent performance year.
We propose that a qualified registry must provide the following information to us at the time of self-nomination:
• Organization Name (Specify Sponsoring Organization name and software vendor name if the two are different. For example, a specialty society in collaboration with a software vendor).
• MIPS performance categories (that is, categories for which the entity is self-nominating to report. For example, quality measures, advancing care information, and/or CPIA).
• Performance Period.
• Vendor Type (for example, qualified registry).
• Provide the method(s) by which the entity obtains data from its customers for each performance category for which it is approved: Claims; web-based tool; practice management system; certified EHR technology; other (please explain). If a combination of methods (Claims, web-based tool, Practice Management System, certified EHR technology, and/or other) is utilized, please state which method(s) the entity utilizes to collect data (performance numerator and denominator).
• Indicate the method the entity will use to verify the accuracy of each TIN/NPI and/or TIN it is intending to submit (for example; National Plan and Provider Enumeration System (NPPES), CMS claims, tax documentation).
• Describe the method the entity will use to accurately calculate performance rates for quality measures based on the appropriate measure type and specification. For composite measures or measures with multiple performance rates, the entity must provide us with the methodology the entity uses to calculate these composite measures and measures with multiple performance rates. The entity should be able to report to us a calculated composite measure rate, if applicable.
• Describe the method that the entity will use to accurately calculate performance data for CPIA and advancing care information performance categories based on the appropriate parameters or activities.
• Describe the process that the entity will use for completion of a randomized audit of a subset of data prior to the submission to us (for all performance categories the qualified registry is submitting data on; that is, quality, CPIA, and advancing care information, as applicable). Periodic examinations may be completed to compare patient record data with submitted data and/or ensure MIPS quality measures or other performance category (CPIA and advancing care information) activities, measures, or objectives were accurately reported and performance calculated based on the appropriate measure specifications (that is, accuracy of numerator, denominator, and exclusion criteria) or performance category requirements.
• Provide information on the entity's process for data validation for both individual MIPS eligible clinicians and groups within a data validation plan. For example, for individuals, it is encouraged that 3 percent of the MIPS eligible clinicians submitted to CMS by the qualified registry be sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 MIPS eligible clinicians. For each MIPS eligible clinician sampled, it is encouraged that 25 percent of the MIPS eligible clinicians' patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
• Provide the results of the executed data validation plan by May 31st of the year following the performance period. If the results indicate the qualified registry's validation reveals inaccuracy or low compliance provide to us an improvement plan. Failure to implement improvements may result in the qualified registry being placed in a probationary status or disqualification from future participation.
Further, we propose that a qualified registry must perform the following functions:
• For measures, activities, and objectives under the quality, advancing care information, and CPIA performance categories and as proposed at § 414.1400(a)(4)(i); if the data is derived from certified EHR technology, the qualified registry must be able to indicate this data source.
• A qualified registry submitting MIPS quality measures that are risk-adjusted (and have the risk-adjusted variables and methodology listed in the measure specifications) must submit the risk-adjusted measure results to CMS when submitting the data for these measures.
• Submit to us, quality measures and activities data on all patients, not just Medicare patients.
• Submit quality measures, advancing care information, or CPIA performance categories data and results to us in the applicable MIPS performance categories for which the qualified registry is providing data.
• Provide timely feedback, at least 4 times a year, on all of the MIPS performance categories that the qualified registry will report to us. That is, if the qualified registry will be reporting on data for the CPIA, advancing care information, or quality performance category, all results as of the feedback report date should be included in the information sent to the MIPS eligible clinician. The feedback should be given to the individual MIPS eligible clinician or group (if participating as a group) at the individual participant level or group level, as applicable, for which the qualified registry reports. The qualified registry is only required to provide feedback based on the MIPS eligible clinician's data that is available at the time the feedback report is generated.
• A qualified registry must comply with any request by us to review the data submitted by the qualified registry for purposes of MIPS in accordance with applicable law. Specifically, data requested would be limited to the minimum necessary for us to carry out, for example, health care operations or health oversight activities.
• Mandatory participation in ongoing support conference calls hosted by us (approximately one call per month), including an in-person qualified registry kick-off meeting (if held) at our headquarters in Baltimore, MD. More than one unexcused absence could result in the qualified registry being precluded from participation in the program for that year. If a qualified registry is precluded from participation in MIPS, the individual MIPS eligible clinician or group would need to find another entity to submit their MIPS data.
• Agree that data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent of the total number of MIPS eligible clinicians submitted by the qualified registry may result in notations on our qualified registry posting of low data quality and would place the qualified registry on probation (if they decide to self-nominate for the next program year). If the qualified registry does not reduce their data error rate below 3 percent in the subsequent year, they would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians submitted by the qualified registry may lead to the disqualification of the qualified registry from participation in the following year's program. As we gain additional experience with qualified registries, we intend to revisit and enhance these thresholds in future years.
• Be able to report at least six quality measures including one cross-cutting measure and one outcome measure. If an outcome measure is not available, be able to report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures).
• Enter into and maintain with its participating clinicians an appropriate Business Associate agreement that provides for the qualified registry's receipt of patient-specific data from an individual MIPS eligible clinician or group, as well as the qualified registry's disclosure of quality measure results and numerator and denominator data and/or patient specific data on Medicare and non-Medicare beneficiaries on behalf of MIPS eligible clinicians or group.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the qualified registry, has authorized the qualified registry to submit quality measure results, CPIA measure and activity results, advancing care information objective results and numerator and denominator data and/or patient-specific data on Medicare and non-Medicare beneficiaries to us for the purpose of MIPS participation. This documentation must be obtained at the time the MIPS eligible clinician or group signs up with the qualified registry to submit MIPS data to the qualified registry and must meet any applicable laws, regulations, and contractual business associate agreements. Groups participating in MIPS via a qualified registry may have their group's duly authorized representative grant permission to the qualified registry to submit their data to us. If submitting as a group each individual MIPS eligible clinician does not need to grant their individual permission to the qualified registry to submit their data to us.
• Not be owned and managed by an individual locally-owned single specialty group (for example, single specialty practices with only one practice location or solo practitioner practices are prohibited from self-nominating to become a MIPS qualified registry).
• Be able to separate out and report on all payers, including Medicare Part B FFS patients and non-Medicare patients.
• Provide the measure numbers for the MIPS quality measures on which the qualified registry is reporting.
• Provide the measure title (and specialty-specific measure set title, if applicable) for the MIPS quality measures and CPIAs (if applicable) on which the qualified registry is reporting.
• Indicate if the qualified registry will be reporting the advancing care information component measures and objectives.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (performance numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Comply with a CMS-specified secure method for data submission, such as submitting the qualified registry's data in an XML file.
• Sign a document verifying the qualified registry's name, contact information, cost for MIPS eligible clinicians or groups to use the qualified registry, services provided, and the specialty-specific measure sets the qualified registry intends to report. Once posted on the qualified registry's CMS Web site, the qualified registry will need to support the measures/measure sets confirmed by the qualified registry. Failure to do so will may preclude the qualified registry from participation in MIPS in the subsequent year.
• Must provide attestation statements during the data submission period that all of the data (quality measures, CPIAs, and advancing care information measures and objectives, if applicable) and results are accurate and complete.
• For purposes of distributing feedback reports to MIPS eligible clinicians, collect a MIPS eligible clinician's email address(es) and have documentation from the MIPS eligible clinician authorizing the release of his or her email address.
• Be able to calculate and submit measure-level reporting rates or, upon request, the data elements needed to calculate the reporting and performance rates by TIN/NPI and/or TIN.
• Be able to calculate and submit, by TIN/NPI and/or TIN, a performance rate (that is the percentage of a defined population who receive a particular process of care or achieves a particular outcome based on a calculation of the measures' numerator and denominator specifications) for each measure on which the TIN/NPI and/or TIN reports or, upon request the Medicare and non-Medicare level data elements needed to calculate the performance rates.
• Provide the performance period start date the qualified registry will cover.
• Provide the performance period end date the qualified registry will cover.
• Report the number of instances in which the applicable submission criteria were not met, for example, the quality measure was not reported and a performance exclusion did not apply.
• For data validation purposes, provide information on the entity's sampling methodology. For example, if is encouraged that 3 percent of the MIPS eligible clinicians be sampled with a minimum sample of 10 MIPS eligible clinicians or a maximum sample of 50 MIPS eligible clinicians. For each MIPS eligible clinician sampled, it is encouraged that 25 percent of the MIPS eligible clinicians' patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
We request comments on these proposals.
As discussed in the section II.E.5.b. we propose to allow groups to report CAHPS for MIPS survey measures. We propose the data collected on the CAHPS for MIPS survey measures would be transmitted to us via a CMS-approved survey vendor.
For purposes of MIPS, we propose to define a CMS-approved survey vendor at § 414.1305 as a survey vendor that is approved by CMS for a particular performance period to administer the CAHPS for MIPS survey and transmit survey measures data to CMS. We propose at § 414.1400(i) that vendors are required to undergo the CMS approval process for each year in which the survey vendor seeks to transmit survey measures data to CMS. We anticipate retaining the same policies and procedures we currently follow for a CMS-approved survey vendor for PQRS and apply them to a MIPS CMS-approved survey vendor. We propose the following requirements for a CMS-approved survey vendor for the CAHPS for MIPS survey. A CMS-approved survey vendor for CAHPS for MIPS must:
(1) Comply with and complete the Vendor Participation Form—We anticipate retaining the same application process and Vendor Participation Form that was required for the CAHPS for PQRS survey. Please refer to
• Meet all of the Minimum Survey Vendor Business Requirements at the time of the submission of the Vendor Participation Form; and
• Complete the Vendor Participation Form.
(2) Comply with the Minimum Survey Vendor Business Requirements—We anticipate retaining the same minimum survey business requirements that were required for the CAHPS for PQRS survey. Please refer to
• Relevant organization and survey experience.
• Survey capability and capacity.
• Adherence to quality assurance guidelines and participation in quality assurance activities.
• Documentation requirements.
• Adhere to all protocols and specifications, and agree to participate in training sessions.
Specifically, to obtain our approval, we propose that survey vendors would be required to undergo training, meet our standards on how to administer the survey, and submit a quality assurance plan. We would provide the identified survey vendor with an appropriate sample frame of beneficiaries from each group that has contracted with the survey vendor and elected to participate in the CAHPS for MIPS survey. The survey vendor would also be required to administer the survey according to established protocols to ensure valid and reliable results. More information on quality assurance and protocols can be reviewed at
We propose at § 414.1400(k) a process for placing third party intermediaries on probation and for disqualifying such entities for failure to meet certain standards established by CMS. Specifically, we propose that if at any time we determine that a third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) has not met all of the applicable requirements for qualification, we may place the third party intermediary on probation for the current performance period and/or the following performance period, as applicable.
In addition, we propose CMS requires a corrective action plan from the third party intermediary to address any deficiencies or issues and prevent them from recurring. We propose the corrective action plan must be received and accepted by CMS within 14 days of the CMS notification to the third party intermediary of the deficiencies or probation. Failure to comply with this would lead to disqualification from MIPS for the subsequent performance period.
We propose probation to mean that, for the applicable performance period, the third party intermediary would not be allowed to miss any meetings or deadlines and would need to submit a corrective action plan for remediation or correction of deficiencies identified that resulted in the probation.
In addition, we propose that if the third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, CMS would annotate on the CMS qualified posting that the third party intermediary furnished data of poor quality and would place the entity on probation for the subsequent MIPS performance period with the opportunity to go on probation for a year to correct their deficiencies.
Further, we propose if the third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS for one additional performance year. After two years on probation, the third party intermediary would be disqualified for the subsequent performance year. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians or groups submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation for the following performance period. In placing the third party intermediary on probation; we would notify the third party intermediary of the identified issues, at the time of discovery of such issues.
Finally, we propose if the third party intermediary does not submit an acceptable corrective action plan within 14 days of notification of the deficiencies and correct the deficiencies within 30 days or before the submission deadline—whichever is sooner, we may disqualify the third party intermediary from participating in MIPS for the current performance period and/or the following performance period, as applicable. We request comments on these proposals.
We propose at § 414.1400(j) that any third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) must comply with certain auditing requirements as a condition of their qualification or approval to participate in MIPS as a third party intermediary. Specifically, we propose the entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information will include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email. Further, we propose the entity must retain all data submitted to CMS for MIPS for a minimum of 10 years. We request comments on this proposal.
This section contains the proposed approach for publicly reporting on Physician Compare for the MIPS, APM, and other information as required by the MACRA.
Physician Compare draws its operating authority from section 10331(a)(1) of the Affordable Care Act. As required, by January 1, 2011, we developed a Physician Compare Internet Web site with information on physicians enrolled in the Medicare program under section 1866(j) of the Act, as well as information on other EPs who participate in the PQRS under section 1848 of the Act. More information on Physician Compare can be accessed on the Physician Compare Initiative Web site at
The first phase of Physician Compare was launched on December 30, 2010 (
Consistent with section 10331(a)(2) of the Affordable Care Act, Physician Compare also phased in public reporting of information on physician performance that provides comparable information on quality and patient experience measures for reporting periods beginning January 1, 2012. To the extent that scientifically sound measures are developed and are available, Physician Compare is required to include, to the extent practicable, the following types of measures for public reporting: Measures collected under PQRS and an assessment of efficiency, patient health outcomes, and patient experience, as specified. The first set of quality measures were publicly reported on Physician Compare in February 2014. Currently, Physician Compare publicly reports 14 group practice level measures
As finalized in the CY 2015 and CY 2016 PFS final rules (79 FR 67547 and 80 FR 70885) Physician Compare will expand public reporting over the next several years. This expansion includes publicly reporting both individual EP and group practice level QCDR measures starting with 2015 individual EP measures to be publicly reported on Physician Compare in late 2016, and expanding to group practice QCDR measures in late 2017 (80 FR 71125), which is consistent with section 101(d)(1)(B) of the MACRA.
Section 1848(q)(9)(A) and (D) of the Act facilitates the continuation of the phased approach to public reporting by requiring the Secretary to make available on the Physician Compare Web site, in an easily understandable format, individual MIPS eligible clinician and groups performance information, including:
• The MIPS eligible clinician's CPS;
• The MIPS eligible clinician's performance under each MIPS performance category (quality, resource use, CPIA and advancing care information);
• Names of eligible clinician's in Advanced APMs and, to the extent feasible, the names of such Advanced APMs and the performance of such models; and
• Periodically post aggregate information on the MIPS, including the range of composite scores for all MIPS eligible clinician's and the range of the performance of all MIPS eligible clinician's with respect to each performance category.
Section 1848(q)(9)(B) of the Act also requires that this information indicate, where appropriate, that publicized information may not be representative of the eligible clinician's entire patient population, the variety of services furnished by the eligible clinician, or the health conditions of individuals treated. In order to ensure the information mandated under section 1848(q)(9) of the Act are publicly reported, the information must be in compliance with the existing mandate and regulations previously established under section 10331(a)(2) and 10331(b) of the Affordable Care Act. As required under section 10331(a)(2) of the Affordable Care Act, all measure data included on Physician Compare must be comparable. In addition, section 10331(b) of the Affordable Care Act requires that we include, to the extent practicable, processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary. In addition to the Affordable Care Act informed public reporting standards—statistically valid and reliable data, that are accurate and comparable—existing regulation notes that all the data must also prove through consumer testing to resonate with and be accurately interpreted by consumers in order to be included on Physician Compare profile pages. Together, we refer to these conditions as the Physician Compare public reporting standards (80 FR 71118-20). Section 10331(d) of the Affordable Care Act also requires us to consider input from multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A of the Act. We also continue to receive general input from stakeholders on Physician Compare through a variety of means, including rulemaking and different forms of stakeholder outreach (for example, Town Hall meetings, Open Door Forums, webinars, education and outreach, Technical Expert Panels, etc.).
In addition, section 1848(q)(9)(C) of the Act requires the Secretary to provide an opportunity for MIPS eligible clinicians to review the information that will be publicly reported prior to such information being made public. This is generally consistent with section 10331(a)(2) of the Affordable Care Act and current regulations that established a 30-day preview period for all measurement performance data that will allow physicians and other EPs to view their data as it will appear on the Web site in advance of publication on Physician Compare (80 FR 71120). Section 1848(q)(9)(C) of the Act also requires that MIPS eligible clinicians be able to submit corrections for the information to be made public. We propose that this extension of the current Physician Compare 30-day preview period will be implemented starting with data from the 2017 MIPS performance period. We propose a 30-day preview period in advance of the publication of any data on Physician Compare. We will coordinate efforts between Physician Compare and the four components of MIPS in terms of data review and appeal and any relevant data resubmission or correction. All data available for public reporting—measure rates, scores, and/or attestations—will be available for review and correction during the targeted review process (see section II.E.8.c. of this proposed rule). The process will begin at least 30 days in advance of the publication of new data. Data under appeal and review will not be publicly reported until the review is complete. All corrected measure rates, scores, and/or attestations submitted will be available for public reporting. The technical details of the process will be communicated directly to affected MIPS eligible clinicians and groups and detailed outside of rulemaking.
As with the current process, the details will be made public on the Physician Compare Initiative page on cms.gov and communicated through Physician Compare and other CMS listservs.
In addition, section 1848(q)(9)(D) of the Act requires that aggregate information on the MIPS be periodically posted on the Physician Compare Web site; including the range of composite scores for all MIPS eligible clinicians and the range of performance for all MIPS eligible clinicians with respect to each performance category.
Lastly, section 104 of the MACRA requires the Secretary to make publicly available, on an annual basis (beginning with 2015), in an easily understandable format, information with respect to physicians and other eligible clinician's on items and services furnished to Medicare beneficiaries, and to include, at a minimum:
• Information on the number of services furnished under Part B, which may include information on the most frequent services furnished or groupings of services;
• Information on submitted charges and payments for Part B services; and
• A unique identifier for the physician or other eligible clinician that is available to the public, such as an NPI.
The information would further be required to be made searchable by at least specialty or type of physician or other eligible clinician; characteristics of the services furnished (such as, volume or groupings of services); and the location of the physician or other eligible clinician.
Therefore, at § 414.1395(a) we propose public reporting of an eligible clinician's MIPS data; in that for each program year, we would post on a public Web site, in an easily understandable format, information regarding the performance of MIPS eligible clinicians or groups under the MIPS.
Furthermore, in accordance with section 104(e) of the MACRA, we finalized in the CY 2016 PFS final rule
We believe section 10331 of the Affordable Care Act supports our overarching goals of the MACRA by providing consumers with quality information that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, section 1848(q)(9) of the Act, and section 104(e) of the MACRA, we plan to continue to publicly report performance information on Physician Compare. As a result, we propose inclusion of the following information on Physician Compare.
As noted, section 1848(q)(9)(A) and (D) of the Act requires that we publicly report on Physician Compare the composite score for each MIPS eligible clinician, performance of each MIPS eligible clinician for each performance category, and periodically post aggregate information on the MIPS, including the range of composite scores for all MIPS eligible clinicians and the range of performance of all the MIPS eligible clinicians for each performance category. We propose that these data, to the extent that they meet the previously established public reporting standards, will be added to Physician Compare for each MIPS eligible clinician or group, either on the profile pages or in the downloadable database, as technically feasible. Statistical testing and consumer testing, as well as consultation of the Physician Compare Technical Expert Panel (TEP), will determine how and where these data are reported on Physician Compare. We request comments on these proposals.
In addition, we seek comment on the advisability and technical feasibility of including data voluntarily reported by EPs and groups that are not subject to MIPS payment adjustments, such as those practicing through RHC, FQHCs, etc., on Physician Compare. Any regulatory changes would be made through separate notice-and-comment rulemaking.
The quality performance category is discussed in detail in section II.E.5.b. of this proposed rule. Consistent with the current policy that makes all current PQRS measures available for public reporting, we now propose to make all measures under the MIPS quality performance category (see section II.E.5.b. of this proposed rule) available for public reporting on Physician Compare. This includes all available measures reported via all available submission methods, and applies to both MIPS eligible clinicians and groups.
Also consistent with current policy, although all measures will be available for public reporting not all measures will be made available on the consumer-facing Web site profile pages. As explained in the CY 2016 PFS final rule (80 FR 71120), providing too much information can overwhelm consumers and lead to poor decision making. Therefore, we propose that all measures in the quality performance category that meet the public reporting standards would be included in the downloadable database, as technically feasible. We also propose that a subset of these measures would be publicly reported on the Web site's profile pages, as technically feasible. Statistical testing and consumer testing will determine how and where measures are reported on Physician Compare. In addition, we do not publicly report first year measures, meaning new measures that have been in use for less than 1 year, regardless of submission methods. After a measure's first year in use, we will evaluate the measure to see if and when the measure is suitable for pubic reporting (80 FR 71118).
Currently, there is a minimum sample size requirement of 20 patients for performance data to be included on the Web site. As part of the MIPS and APMs RFI we asked for comment on moving away from this requirement and moving to a reliability threshold for public reporting. In general, commenters supported a minimum reliability threshold. As a result, we are now proposing to institute a minimum reliability threshold for public reporting on Physician Compare.
The reliability of a measure refers to the extent to which the variation in measure is due to variation in quality of care as opposed to random variation due to sampling. Statistically, reliability depends on performance variation for a measure across entities, the random variation in performance for a measure within an entity's panel of attributed beneficiaries, and the number of beneficiaries attributed to the entity. High reliability for a measure suggests that comparisons of relative performance across entities, in this case groups or eligible clinicians, are likely to be stable and consistent, and that the performance of one entity on the quality measure can confidently be distinguished from another. Conducting analysis to determine reliability of the data collected will allow us to calculate the minimum reliability threshold for those data. Once an appropriate minimum reliability threshold is determined, the reporting of reporters' performance rates for a given measure can be restricted to only those meeting the minimum reliability threshold.
We propose to also include the total number of patients reported on per measure in the downloadable database to facilitate transparency and more accurate understanding and use of the data. We request comments on these proposals.
We also are seeking comment on the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the quality performance category. Any regulatory changes would be made in separate notice-and-comment rulemaking.
The resource use performance category is detailed in section II.E.5.e. of this proposed rule. We propose to make all measures under the MIPS resource use performance category (see section II.E.5.e. of this proposed rule) available for public reporting on Physician Compare. This includes all available measures reported via all available submission methods, and applies to both MIPS eligible clinicians and groups.
We have found that resource use data do not resonate with consumers and can instead lead to significant misinterpretation and misunderstanding. Therefore, we propose to include a sub-set of resource use measures, that meet the aforementioned public reporting standards, on Physician Compare, either
We also are seeking comment on the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the resource use performance category. Any regulatory changes would be made in separate notice-and-comment rulemaking.
The CPIA performance category is detailed in section II.E.5.f. of this proposed rule. We propose to make all activities under the MIPS CPIA performance category (see section II.E.5.f. of this proposed rule) available for public reporting on Physician Compare. This includes all available CPIAs reported via all available submission methods, and applies to both MIPS eligible clinicians and groups.
We propose to include a subset of CPIA data that meet the aforementioned public reporting standards, on Physician Compare, either on the profile pages or in the downloadable database, if technically feasible. For those eligible clinicians that successfully meet the CPIA performance category requirements this may be posted on Physician Compare as an indicator. The CPIA performance category is a new field of data for Physician Compare so concept and consumer testing will be needed to ensure these data are understood by consumers. Therefore, statistical testing and consumer testing will determine how and where CPIAs are reported on Physician Compare. In addition, since we do not publicly report first year measures, we are also applying this policy to CPIA, meaning new CPIAs that have been in use for less than 1 year, regardless of submission methods. After a CPIA's first year in use, we will evaluate the activity to see if and when the activity is suitable for pubic reporting (80 FR 71118). We request comments on these proposals.
We also are seeking comment on the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the CPIA performance category. Any regulatory changes would be made in separate notice-and-comment rulemaking.
Since the beginning of the EHR Incentive Programs in 2011, participant performance data has been publically available in the form of public use files on the CMS Web site. In the 2015 EHR Incentive Programs final rule, we addressed comments requesting that CMS not only continue this practice but also include a wider range of information on participation and performance. In that rule, we stated our intent to publish the performance and participation data on Stage 3 objectives and measures of meaningful use in alignment with quality programs which utilize publicly available performance data such as Physician Compare (80 FR 62901). At this time there is only a green check mark on Physician Compare profile pages to indicate that an EP successfully participated in the current Medicare EHR Incentive Program for EPs.
As MIPS will now include advancing care information as one of the four MIPS performance categories, we are proposing to include more information on eligible clinician's performance on the objectives and measures of meaningful use on Physician Compare. An important consideration is that to meet the aforementioned public reporting standards, the data added to Physician Compare must resonate with the average Medicare consumer and their caregivers. Consumer testing to date has shown that people with Medicare value the use of certified EHR technology and see EHR use as something that if used well can improve the quality of their care. In addition, we believe the inclusion of indicators for providers who achieve high performance in key care coordination and patient engagement activities provide significant value for consumers.
We are therefore proposing to include an indicator for any eligible clinician or group who successfully meets the advancing care information performance category, as detailed in section II.E.5.g. of this proposed rule, as technically feasible on Physician Compare. Also as technically feasible, we are proposing to include additional indicators, including but not limited to, identifying if the eligible clinician or group scores high performance in patient access, care coordination and patient engagement, or health information exchange; as further specified in section II.E.5.g. of this proposed rule. To reiterate, any advancing care information objectives or measures must meet the public reporting standards to be posted on Physician Compare, either on the profile pages or in the downloadable database. This includes all available objectives or measures reported via all available submission methods, and applies to both MIPS eligible clinicians and groups. Statistical testing and consumer testing will determine how and where objectives and measures are reported on Physician Compare. In addition, we do not publicly report first year measures, meaning new measures that have been in use for reporting for less than 1 year, regardless of submission methods. After a measure's first year in use, we will evaluate the measure to see if and when the measure is suitable for pubic reporting (80 FR 71118). We request comment on these proposals.
We also are seeking comment on potentially including an indicator to show low performance in the advancing care information performance category, as well as, the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the advancing care information performance category. Additionally, we would need to perform consumer testing and evaluate the feasibility of potentially including an indicator to show low performance in the advancing care information performance category to ensure this is understood by consumers. Any regulatory changes would be made in separate notice-and-comment rulemaking.
As discussed above, we previously finalized to begin to include utilization data in the Physician Compare downloadable database in late 2016 using the most currently available data (80 FR 71130) to meet section 104(e) of the MACRA. As there are thousands of Healthcare Common Procedure Coding System (HCPCS) codes in use, not all available data will be included. The specific HCPCS codes included will be determined based on analysis of the available data, focusing on the most used codes. The goal will be to include counts that can facilitate a greater understanding and more in-depth analysis of the other measure and performance data being made available. We propose to continue to include utilization data in the Physician Compare downloadable database. We request comment on this.
As discussed above, section 1848(q)(9)(A)(ii) of the Act requires us to publicly report names of eligible
At the outset, APMs will be very new concepts for consumers. Testing shows that at this time, ACOs are not a familiar concept to the average Medicare consumer. It is very easy for consumers to misunderstand an ACO as just a type of group. We expect at least the same lack of familiarity when introducing the broader concept of APM, of which ACOs comprise only one type. In these early years, indicating who participated in APMs and testing language to accurately explain that to consumers provides useful and valuable information as we continue to evolve Physician Compare. As we come to understand how to best explain this concept to consumers, we can continue to assess how to most fully integrate these data on the Web site. We request comment on these proposals.
Section 1833(z) of the Act, as added by section 101(e)(2) of the MACRA, requires that an incentive payment be made to Qualifying APM Participants (QPs) for participation in eligible alternative payment models (referred to as Advanced APMs). Key statutory elements of the incentives for participation in Advanced APMs under the Quality Payment Program addressed in this proposed rule include:
• Beginning in 2019, if an eligible clinician participates in a certain type of APM (an Advanced APM), they may become a QP. Eligible clinicians who are QPs are excluded from the MIPS.
• For years from 2019 through 2024, QPs receive a lump sum incentive payment equal to 5 percent of their prior year's payments for Part B covered professional services, and beginning in 2026, QPs receive a higher update under the PFS than non-QPs.
• For 2019 and 2020, eligible clinicians may become QPs only through participation in Advanced APMs.
• For 2021 and later, eligible clinicians may become QPs through a combination of participation in Advanced APMs and APMs with other payers (Other Payer Advanced APMs).
• This section of the rule proposes the definitions, requirements, procedures, and thresholds of participation that will govern this program.
Several core policy principles are derived from both the MACRA law and the Department's broad vision for better care, smarter spending, and healthier people. These principles drive many of our decisions in developing the overall framework for making APM Incentive Payments to QPs and for approaching interactions between MIPS and APMs found in this proposed rule. In addition to increasing the quality and efficiency of care delivered in the Medicare program and across the health system, these principles include the following seven goals:
• To the greatest extent possible, continue to build a portfolio of APMs that collectively allows participation for a broad range of physicians and other practitioners. We believe finding better ways to deliver care across settings and specialties can lead to improved health outcomes and more efficient health care spending. Doing this requires active CMS engagement with stakeholders, as well as input from those stakeholders to refine ideas in ways that meet statutory and delivery system reform goals.
• Design the program such that the APM Incentive Payment is attainable by increasing numbers of practitioners over time, yet remains reserved for those eligible clinicians participating in organizations that are truly engaged in care transformation. We believe the structure of the law is clear in that the APM Incentive Payments are earned through participation in APMs that are designed to be challenging and involve rigorous care improvement activities. In general, we believe eligible clinicians that receive incentives should be those who: Take on financial risk for potential losses under an APM; are accountable for performance based on meaningful quality metrics; and use certified EHR technology.
• Maximize participation in both Advanced APMs and other APMs. Although we want to maintain high standards for eligible clinicians to earn the APM Incentive Payment, we also want to enable and encourage high levels of participation in a broad range of APMs, including those that are not Advanced APMs. We believe participation in any APM offers eligible clinicians and beneficiaries significant benefits.
• Create policies that allow for flexibility in future innovative Advanced APMs. We do not want to constrain the robust development of new Advanced APMs by framing standards only in terms of today's APMs but rather in ways that allow many avenues for meeting the Advanced APM criteria.
• Support multi-payer models and participation in innovative models in Medicaid and commercial markets in order to promote high quality and efficient care across the health care market.
• Recognize that the APM Incentive Payment added by the MACRA primarily incentivizes participation in Advanced APMs that involve covered professional services under Medicare Part B. We believe the new provisions of section 1833(z) of the Act distinguish between participation in Advanced APMs that involve Medicare Part B covered professional services and participation in Other Payer Advanced APMs, which could include those sponsored by Medicare Advantage organizations. The Quality Payment Program has the potential to influence a wide range of payment arrangements, such as those under Medicare Advantage, but there is a clear distinction between Medicare Part B and all other payers in how calculations are performed for QP determinations and the APM Incentive Payment. Through the all-payer route to the APM Incentive Payment, we hope to encourage cooperation across payers and create demand for arrangements that, like Advanced APMs, meaningfully incorporate financial risk, quality measure performance, and use of certified EHR technology as strategies for improving care outcomes.
• Minimize burden on organizations and professionals. Between APM participation and MIPS reporting, we hope to coordinate administrative processes, minimize overall reporting burden, and make transitioning between being a QP and being subject to MIPS as seamless as possible.
• We do not intend to create additional performance assessments or audits beyond those specified under an APM. Rather, we believe the process for determining whether an eligible clinician receives the APM Incentive Payment should focus on the relative degree of participation by eligible clinicians in Advanced APMs, not on their performance within the APM. The Quality Payment Program does not alter how each particular APM measures and rewards success within its design. Rather, it rewards a substantial degree of participation in certain APMs.
The incentives for Advanced APM participation established by MACRA includes several sets of related requirements that must be met. Three distinct roles play important parts in the program structure: (1) The Advanced Alternative Payment Model (Advanced APM), which is a health care payment and/or delivery model that includes payment arrangements and other design elements as part of a particular approach to care improvement; (2) the Advanced APM Entity, which is the entity participating in the Advanced APM and which meets criteria established under section 1833(z) of the Act; and (3) the eligible clinician, who is the individual physician or practitioner, or group of physicians or practitioners, who is a participant of the Advanced APM Entity and may be determined to be a QP.
In this rule we are proposing a series of steps that result in the determination of certain eligible clinicians as QPs for a particular year (the payment year). QPs would receive the APM Incentive Payment as specified in section 1833(z) of the Act for each of the years they qualify from 2019 through 2024, and the differential update incentive in section 1848(d)(20) of the Act for each of the years they qualify beginning in 2026. Per section 1833(z)(1)(A) of the Act, the APM Incentive Payment that an eligible clinician receives as a QP for a year between 2019 and 2024 is a lump sum payment equal to 5 percent of the QP's estimated aggregate payments for Medicare Part B covered professional services (services paid under or based on the Medicare PFS) for the prior year. Eligible clinicians who are QPs for a year are also excluded from MIPS for that year. In addition, beginning in 2026, QPs receive a higher Medicare PFS update (the “qualifying APM conversion factor”) than non-QPs. This QP determination is made for one calendar year at a time.
The proposed steps that would result in a QP determination can be summarized as follows: (1) We determine whether the design of an APM meets three specified criteria for it to be deemed an Advanced APM; (2) an entity (the Advanced APM Entity) with a group of individual eligible clinicians participates in the Advanced APM; (3) we determine whether, during a performance period (the QP Performance Period), the eligible clinicians in the Advanced APM Entity collectively have at least a specified percentage of their aggregate Medicare Part B payments for covered professional services, or patients who received covered professional services, through the Advanced APM; (4) all of the eligible clinicians in the Advanced APM Entity are designated QPs for the payment year associated with that QP Performance Period. Those QPs would receive the 5 percent lump-sum APM Incentive Payments mentioned above for the payment year. This QP determination process would occur each year following the QP Performance Period, with the first payment year being 2019. In section II.F.5.a, we propose that the QP Performance Period will be the calendar year 2 years prior to the payment year.
Under the MACRA, for payment years 2019 and 2020, QP determinations must be based only on payments or patients under Medicare Part B (the Medicare payment threshold option, which we refer to as the “Medicare Option”). Beginning in payment year 2021—which according to our proposal would be based on 2019 calendar year data—there would be an additional option for eligible clinicians to become QPs through a combination of their participation in Advanced APMs and similar payment arrangements with other payers (Other Payer Advanced APMs). This option is the combination all-payer and Medicare payment threshold option, which we refer to as the “All-Payer Combination Option.” An eligible clinician need only meet the threshold for one of the options to be a QP for a year. Thus, an Advanced APM Entity may be able to compensate for a relatively low level of Advanced APM participation with participation in Other Payer Advanced APMs such as those with State Medicaid programs and commercial payers. Figure B illustrates the stages of determinations that result in QP determinations.
The proposed Quality Payment Program relies on a set of interrelated defined terms. The bases for some core terms are set forth at sections 1833(z)(3) and 1848(q)(1)(C)(iii) of the Act, and others we will propose to define in this proposed rule.
We use the statutory text as a foundation to develop definitions for other key terms used in this proposed rule. The terms cover three primary topics: (1) The different types of APMs and their participating individuals and entities; (2) the timing, process and thresholds for determining QPs and partial qualifying APM participants (Partial QPs); and (3) the payment of the 5 percent lump sum incentive to QPs.
As discussed in sections II.D and II.F.3 of this proposed rule, we are proposing definitions for the following APM-specific terms at § 414.1302 of new subpart O:
• Affiliated Practitioner.
• APM Entity.
• APM Incentive Payment.
• Attributed beneficiary.
• Attribution-eligible beneficiary.
• Alternative Payment Model (APM).
• Advanced Alternative Payment Model (Advanced APM).
• Advanced APM Entity.
• Episode payment model.
• Incentive Payment Base Period.
• Medicaid APM.
• Medicaid Medical Home Model.
• Medical Home Model.
• Other Payer APM.
• Other Payer Advanced APM.
• Partial Qualifying APM Participant (Partial QP).
• Partial QP Patient Count Threshold.
• Partial QP Payment Amount Threshold.
• Qualifying APM Participant (QP).
• QP Patient Count Threshold.
• QP Payment Amount Threshold.
• QP Performance Period.
• Threshold Score.
To organize the terms, we have proposed the term “Advanced APM” for those APMs defined by section 1833(z)(3)(C) of the Act that meet the criteria under section 1833(z)(3)(D) of the Act. The MACRA uses the term “Eligible APM” in the heading for section 1833(z) of the Act, in section 1848(q)(9)(A)(ii) of the Act, and indirectly defines it at section 1833(z)(3)(D) of the Act as the APMs in which “eligible alternative payment entities” participate. We have decided to use the term “Advanced” in lieu of “Eligible,” and rather than referring indirectly, as is done in section 1833(z)(3)(D)(i) of the Act, to the APM in which an eligible alternative payment entity participates, we believe it is essential to the understanding of this proposed rule to be able to identify and propose requirements directly for an Advanced APM.
Similarly, we propose to use the term “Advanced APM Entity” instead of “alternative payment entity” because it highlights the connected but different roles of the Advanced APM (for example, a CMS Innovation Center ACO model meeting specified criteria) and the Advanced APM Entity (for example, a specific ACO participating in that ACO model). We also believe that it is important to the clarity of this proposed rule to define “APM Entity” in addition to “Advanced APM Entity” so that we can easily distinguish between the two under both MIPS and the APM incentives. We propose that an APM Entity would be any participating entity in an APM, whereas we propose that an Advanced APM Entity would be one that participates in an APM that CMS has in fact determined to be an Advanced APM.
We also propose to define the terms “Medical Home Model” and “Medicaid Medical Home Model” as subsets of APMs and Other Payer APMs, respectively. The MACRA provides no definition for the term “medical homes” but makes it an instrumental piece of the law under sections 1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB), 1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act.
We note that medical homes would be the APM Entities in an APM, not the APM itself. The requirements in the MACRA and in this proposed rule actually relate to the disposition of the APM, not the participating medical homes. For instance, as described in section II.F.4.b.(6) of this preamble, section 1115A(c) of the Act relates to the expansion of models (APMs), not the participants (APM Entities) of such models. APM participants are not expanded under section 1115A(c) of the Act. Therefore, we discuss medical homes in terms of the Medical Home Model, which is the concept to which the MACRA and this proposed rule actually refer. Although the definitions are identical but for their payer context, we distinguish Medicaid Medical Home Models because there are specific requirements for them under the determination of Other Payer Advanced APMs as described in section II.F.7.b.(3) of this preamble.
We propose that a Medical Home Model must have the following elements at a minimum:
• Model participants include primary care practices or multispecialty practices that include primary care physician and practitioners and offer primary care services.
• Empanelment of each patient to a primary clinician.
In addition to these elements, we propose that a Medical Home Model must have at least four of the following elements:
• Planned coordination of chronic and preventive care.
• Patient access and continuity of care.
• Risk-stratified care management.
• Coordination of care across the medical neighborhood.
• Patient and caregiver engagement.
• Shared decision-making.
• Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings, population-based payments).
The two required elements are consistent with the fundamental characteristics of medical homes in the various incarnations and accreditation standards across the health care market. Therefore, we believe that an APM cannot be a Medical Home Model unless it has a primary care focus with an explicit relationship between patients and their practitioners. To determine that an APM has a primary care focus, we propose that the Medical Home Model would have to have involve specific design elements related to Eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant. We solicit comments on whether this proposal for determining that an APM has a primary care focus is sufficiently specified.
We believe the optional elements should be present in Medical Home Models, but individually, each is less definitive of a characteristic than the two required elements. We also want to adhere to our principle of enabling future flexibility of APM design. Extensive rigid Medical Home Model criteria would not serve the purpose of promoting the development of new and potentially better ways of managing patient care through primary care.
We seek comment on these elements and which of the elements should be required as opposed to optional. Our proposed definition of Medicaid Medical Home Model is identical to Medical Home Model, except that it specifically describes a payment arrangement operated by a State under title XIX. It is important to separate the terms because Medicaid Medical Home Models have distinct implications in the Other Payer Advanced APM determination and the QP determination under the All-Payer Combination Option.
We believe that these proposed terms and definitions are sufficient to clearly implement the Quality Payment Program. For example, these terms cover all steps of the incentive payment process, from participation in Advanced APMs to QP determinations and payment of incentives. We are aware that this is a complex program and that we are proposing a significant number of terms. We believe that using more distinctive terms is preferable to using fewer terms that could overlap and convey different meanings in different contexts. For instance, Partial QP Patient Count Threshold is a highly specific term, but we believe that it is necessary in context because there are differences between QPs and Partial QPs, and there are differences between the payment amount and patient count thresholds used to determine whether an Eligible clinician becomes a QP or a Partial QP.
We seek comment on these terms, including how we have defined the term, the relationship between terms, any additional terms that we should formally define to clarify the explanation and implementation of this program, and potential conflicts with other terms used by CMS in similar contexts. We also seek comment on the naming of the terms and whether there are ways to name or describe their relationships to one another that make the definitions more distinct and easier to understand. For instance, we would like to know if commenters believe there are more intuitive or efficient terms than those proposed that would still adhere to the statutory language and the intended purposes of the terms. In particular, we would consider options for a framework of definitions that might more intuitively distinguish between APMs and Other Payer APMs and between APMs and Advanced APMs.
We also seek comment on alternative terms or definitions that are both useful in the calculations described in § 414.1430, § 414.1435, § 414.1440, and § 414.1445 of the proposed rule and easily understood by stakeholders.
The purpose of this section is to define and outline the proposed criteria for Advanced APMs, APMs through which eligible clinicians would have the opportunity to become QPs as specified in section 1833(z)(3)(C) and (D) of the Act. Other Payer Advanced APMs, types of alternative payment arrangements related to the All-Payer Combination Option, are addressed below in section II.F.7 of this preamble.
First, an Advanced APM must, by statute, meet certain requirements, and we propose details for these requirements within this section. First, the broad category of APMs is defined at section 1833(z)(3)(C) of the Act, which states that an APM is any of the following: (i) A model under section 1115A (other than a health care innovation award); (ii) the Shared Savings Program under section 1899; (iii) a demonstration under section 1866C; or (iv) a demonstration required by Federal law.
We believe it necessary to propose additional clarification around the requirements as defined in section 1833(z)(3)(C)(iv) of the Act given the broad scope of programs and demonstrations required by federal legislation that are administered by the Department. We propose that in order to be an APM as a “demonstration
Second, to be considered an Advanced APM, an APM must meet all three of the following criteria, as required under section 1833(z)(3)(D) of the Act. The criteria are:
• The APM must require participants to use certified EHR technology;
• The APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS;
• The APM must either require that participating APM Entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 1115A(c) of the Act. For a discussion of our proposals for Medical Home Models under this criterion, see section II.F.4.b.(6) of this preamble.
We propose that an APM Entity is the participating entity in an APM that is primarily responsible for the cost and quality of care provided to beneficiaries under the terms of a direct agreement with CMS. The term “eligible alternative payment entity” (which we refer to as an “Advanced APM Entity”) is defined under section 1833(z)(3)(D) of the Act. An Advanced APM Entity is an APM Entity that participates in an Advanced APM that, through terms of a Participation Agreement with CMS or through Federal law or regulation, meets the criteria proposed in this rule. In section II.E.2 of this proposed rule, we propose that each unit—APM, APM Entity, and eligible clinician—would be clearly identified in CMS systems by a unique combination of APM identifier/APM Entity identifier/TIN/NPI to be considered for possible determination as an Advanced APM, Advanced APM Entity, or QP, respectively.
In some cases, APMs offer multiple options or tracks with variations in the level of financial risk, or multiple tracks designed for different types of organizations, and we propose to assess the eligibility of each such track or option within the APM independently. For instance, the Medicare Shared Savings Program (Shared Savings Program) has three distinct tracks, the Comprehensive ESRD Care Initiative (CEC) consists of one track for large dialysis organizations and another track for non-large dialysis organizations, and the Next Generation ACO Model has two risk arrangement options that feature different levels of financial risk.
Significant distinctions between the design of different tracks or options may mean that some tracks or options within an APM would meet the proposed Advanced APM criteria while other tracks or options would not. For example, APM Entities may have the option to assume two-sided risk (meaning that they bear a portion of the losses when spending exceeds expectations and share in the savings when spending is below expectations) or one-sided risk (meaning that they share in the savings when spending is below expectations, but do not bear a portion of the losses when spending exceeds expectations) under an APM. If the one-sided risk track does not meet the standard for financial risk as discussed in section II.F.4.b.(3) of this preamble, APM Entities in this track would not be Advanced APM Entities, whereas those in the two-sided risk track could be Advanced APM Entities. In these instances, we propose that we would distinguish that the APM is only an Advanced APM for specific options or tracks.
All entities participating in Advanced APMs are Advanced APM Entities, and distinguishing between the model and the participating entities allows us to directly identify and discuss the requirements unique to each. This approach to identifying Advanced APMs and Advanced APM Entities is also consistent with our proposal for determining QPs, described in section II.F.5 of this preamble, at the Advanced APM Entity level. We believe that because the Advanced APM Entity is the main participant in an Advanced APM, it should therefore be the operative unit by which QP determinations are made.
We propose that an eligible clinician's QP status for a given payment year would be based on a collective evaluation of a group consisting of all eligible clinicians participating in an Advanced APM Entity. All eligible clinicians in an Advanced APM Entity would be identified as participants according to their APM participant identifiers in CMS systems as described in section II.E.2 of this preamble. To attain QP status, we propose that an eligible clinician would have to be listed on December 31 of the QP Performance Period as part of an Advanced APM Entity that, through the collective calculation of all its eligible clinicians, meets the QP Payment Amount Threshold or the QP Patient Count Threshold, both of which are described in section II.F.5 of this preamble. The form and collection of this list is part of the APM's design. For example, an ACO in the Shared Savings Program is comprised of a list of participating Medicare-enrolled TINs (ACO participants) that includes all eligible clinicians, as identified by their NPIs, who bill through those TINs. The group of eligible clinician TIN/NPI combinations determined as of December 31 at the end of each performance year, consistent with the proposals above, would be used to make a QP determination that would apply to all eligible clinicians on the list.
Only eligible clinicians in Advanced APM Entities during the QP Performance Period would have the potential to become QPs and to qualify for the APM Incentive Payment. If the eligible clinicians in the Advanced APM Entity collectively meet the QP Payment Amount Threshold, QP Patient Count Threshold, Partial QP Payment Amount Threshold, or Partial QP Patient Count Threshold criteria as described in section II.F.5 of this preamble, we propose that all of those eligible clinicians in the group defined by the Advanced APM Entity would receive the QP status for the relevant payment year. For example, in the event that a track in the Shared Savings Program is determined to be an Advanced APM and the eligible clinicians in an ACO participating in that track (the Advanced APM Entity) collectively meet the QP threshold criteria, all of the eligible clinicians (as identified by their TIN/NPI combinations) in the ACO would become QPs.
In sections II.F.5 and II.F.8 of the proposed rule, we propose that such QP status would apply to the individual eligible clinician's NPI across all of the TINs to which he or she reassigned the right to receive Medicare payment, not solely to the billing TIN affiliated with the Advanced APM Entity. We believe that this approach is consistent with the statute and prevents situations in which an eligible clinician may be excluded from MIPS for part of his or her practice but still subject to MIPS with respect to another part of his or her practice.
Table 27 illustrates how hypothetical APM designs could intersect with proposed MACRA definitions.
In order to determine Advanced APMs and achieve transparency for the Quality Payment Program, we propose to establish a process by which we identify and notify the public of the APMs (including specific APM tracks or options) that would be considered Advanced APMs for a QP Performance Period. We would post this notification to the CMS Web site prior to the beginning of the first QP Performance Period and update the information on a rolling basis according to the proposals below. We believe that making this information available in an accessible format is important for stakeholders to understand how CMS applies the Advanced APM criteria to existing APMs, and to be informed as early as possible about whether an APM they are considering joining is an Advanced APM. Similar to our stated principles earlier in this preamble, we believe that participation in APMs that are not Advanced APMs would continue to offer significant opportunities to eligible clinicians who are not immediately able or prepared to take on the additional risk and requirements of Advanced APMs.
To determine Advanced APMs, we propose two phases of determination and notice. First, we propose to release an initial set of Advanced APM determinations no later than January 1, 2017, for APMs that will be operating during the first QP Performance Period. Second, for new APMs that are announced after January 1, 2017, CMS would include its Advanced APM determination in conjunction with the first public notice of the model, such as the Request for Applications (RFA) or proposed rule. We propose that determinations of Advanced APMs would be posted on the CMS Web site and updated on an ad hoc basis to the extent feasible, but no less frequently than annually, as new APMs become available and others end or change. Both the initial and ad hoc notifications would contain descriptions of whether each track or option within an APM would result in different Advanced APM statuses. We believe that this proposal incorporates both the interest in immediate dissemination of Advanced APM determinations for the existing APM portfolio following finalization of this rule and the structure for making the Advanced APM status a regular part of the development and release of new APMs in the future.
We seek comment on the proposals for both the initial and ad hoc notices of Advanced APM determinations. In particular, we seek comments on optimal times, locations, formats, and other methods of notice of Advanced APM determinations to promote clarity and consistency around which APMs are considered Advanced APMs for a particular QP Performance Period.
In addition to identifying Advanced APMs, we propose that we would identify Other Payer Advanced APMs. The Other Payer Advanced APM identification process would go into effect starting in the third QP Performance Period (applicable for payment year 2021) and would align with the availability of the All-Payer Combination Option for QP determinations. We propose that Other Payer Advanced APM determinations and associated notice would rely on information submitted by APM Entities and eligible clinicians as described in section II.F.7.d of this preamble and would operate in conjunction with the QP determination process under the All-Payer Combination Option as described in section II.F.7 of this preamble. If the information needed by CMS to make a determination for the Other Payer Advanced APM is not submitted in the manner and by the deadlines set by CMS through subregulatory guidance, we would not assess that Other Payer APM as explained under section II.F.7 of this preamble.
Under MACRA, for an APM to be an Advanced APM it must meet the criteria set forth in sections 1833(z)(3)(C) and (D) of the Act and discussed below. An Advanced APM must be an APM that:
• Requires its participants to use certified EHR technology (CEHRT), as described in section II.F.4.b.(1) of this preamble;
• Provides for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS, as described in II.F.4.b(2); and
• EITHER (a) requires its participating Advanced APM Entities to bear financial risk for monetary losses that are in excess of a nominal amount, as described in section II.F.4.b(3) of this preamble, or (b) is a Medical Home Model expanded under section 1115A(c) of the Act, as described in section II.F.4.b(4) of this preamble.
These requirements as set forth in the statute and proposed in this section must be met through the design of the APM. Whether an APM is an Advanced APM depends solely upon how the APM is designed, rather than on assessments of participant performance within the APM. Some stakeholders have suggested that actual performance (for example, on clinical quality measures or on whether the Advanced APM Entity generates savings) be
For example, an APM that ties payments to performance on quality measures comparable to those under MIPS may be an Advanced APM regardless of an Advanced APM Entity's actual performance on those quality measures. If an Advanced APM Entity fails to meet quality performance standards under the Advanced APM, it would face consequences within the Advanced APM, such as financial penalties, loss of access to data or certain waivers, or termination of its participation agreement. The termination scenario would have the downstream effect of terminating Advanced APM Entity status and the eligible clinicians' potential eligibility for the APM Incentive Payment because the entity would no longer be participating in the Advanced APM. As another example, an Advanced APM Entity that bears more than nominal financial risk for monetary losses in accordance with the standards set forth in section II.F.4.b.(3) of this preamble would be an Advanced APM Entity regardless of whether it actually earns shared savings or generates shared losses under the Advanced APM. This would work similarly for an Other Payer Advanced APM.
We do not intend to add additional performance assessments on top of existing Advanced APM standards. As stated in the discussion of policy principles at the beginning of section II.F.1 of this preamble, the proposed QP determination process assesses the relative degree of participation of the Advanced APM Entity and eligible clinician in Advanced APMs, not their performance success as assessed under the APM. The Quality Payment Program would not alter how each particular APM measures and rewards success within its design. Rather, the Quality Payment Program rewards a substantial degree of participation in certain APMs.
The first criterion an APM must meet to be considered an Advanced APM is that it requires participants in such model to use certified EHR technology (as defined in section 1848(o)(4) of the Act), as specified in section 1833(z)(3)(D)(i)(I) of the Act. Furthermore, to be considered an Other Payer Advanced APM, as described under sections 1833(z)(2)(B)(iii)(II)(bb) and 1833(z)(2)(C)(iii)(II)(bb) of the Act, payments must be made under arrangements in which certified EHR technology is used. Although the statutory requirement is phrased slightly differently for Advanced APMs and Other Payer Advanced APMs, we believe that there is value in keeping the two standards as similar as possible. We received a number of comments on the MIPS and APMs RFI regarding the definition and use of CEHRT by APMs. A number of commenters recommended that CMS use the same CEHRT definition for APMs that is used for the MIPS program to reduce confusion among participants in these programs and to align the program requirements. Some commenters suggested we should not require additional CEHRT requirements for APMs, while others indicated that current health IT is not adequate to support practice transformation efforts to perform as a patient centered medical home. Other commenters indicated the focus should not be on the technology used, but rather the design and purpose of the APM. A few commenters indicated there was a need to develop certified health IT for specialty eligible clinicians. Additionally, psychologists, plastic surgeons, radiologists, and other specialists commented that they did not want to be left out of APMs because they did not have certified health IT meeting the CEHRT definition now or may not use CEHRT for the same functions as other eligible clinicians.
After consideration of these comments, we propose to adopt for Advanced APMs and Other Payer Advanced APMs, the definition of CEHRT that is proposed for MIPS and the APM incentive under § 414.1305. In the 2015 EHR Incentive Programs final rule (80 FR 62872 through 62873), we established the definition of CEHRT for EHR technology that must be used by Eligible Professionals to meet the meaningful use objectives and measures in specific years. In this proposed rule, we are proposing to adopt the specifications from within the current definition of CEHRT in this regulation at § 414.1305 for eligible clinicians participating in MIPS or in APMs. This definition is similar to the definition that applies to eligible hospitals, CAHs, and eligible professionals (EPs) in the EHR Incentive Programs. The definition includes the certification criteria for a wide range of standards for use in capturing patient health information like vital signs, medications and medication allergies, problem list, and lab results among other data elements including the common clinical data set (CCDS). It also includes the certification criteria and standards for functions related to information exchange, patient engagement, quality reporting, and protecting the privacy of electronic protected health information. For further information on the certification criteria see the 2015 Edition Certification Criteria final rule (80 FR 62602 through 62759) and for example Table 8: “Common Clinical Data Set” (80 FR 62696).
This approach aligns the APM health IT certification requirements for Advanced APMs with those used by MIPS eligible clinicians. We understand this proposed CEHRT definition may include some EHR functionality used by MIPS eligible clinicians which may be less relevant for an APM participant, and likewise APM participants may use additional functions that are not required for MIPS participation. However, we observe that APM participants often work in the same office space, group, entity, or organization with eligible clinicians that are not APM participants. At times they might share common resources, such as the same EHR system. Using the same CEHRT definition for both MIPS and Advanced APMs would allow Eligible clinicians to continue to use shared EHR systems and give eligible clinicians flexibility of participation as a MIPS eligible clinician or an eligible clinician in an Advanced APM without needing to change or upgrade EHR systems. Although updates to the certified health IT for APM participants, MIPS participants, or both may be necessary in future years, we believe that aligning the APM and MIPS definition for CEHRT is appropriate at this time.
We seek comment on the proposed definition of CEHRT for Advanced APMs and Other Payer Advanced APMs and whether the definition should be the same for both.
The statute does not specify the number of eligible clinicians who must use CEHRT or how CEHRT must be used in an Advanced APM. We believe CMS has discretion to define the ways in which an Advanced APM uses CEHRT. In accordance with section 1833(z)(3)(D)(i)(I) of the Act, we propose that an Advanced APM must require at least 50 percent of eligible clinicians who are enrolled in Medicare (or each hospital if hospitals are the APM participants) to use the certified health IT functions outlined in the proposed
We believe there are a few reasons why having a lower threshold requirement for the use of CEHRT by the eligible clinicians participating in an APM Entity in the first year is appropriate. First, we want to ensure that APMs have sufficient time to alter their terms and conditions to meet this standard. We also acknowledge that eligible clinicians will be expected to upgrade from technology certified to the 2014 Edition to technology certified to the 2015 Edition for use in 2018, and some eligible clinicians who have not yet adopted CEHRT may wish to delay acquiring CEHRT products until a 2015 Edition certified product is available.
Although these are important considerations for the first year of the program, we believe that APMs should expect their APM Entities to meet a higher standard for the use of certified EHR technology in future years. We note that several APMs that are likely to meet the other criteria to be an Advanced APM have already demonstrated higher rates of achievement of meaningful use under the EHR Incentive Program that exceed the requirements under the APM. For instance, an analysis of 2014 performance year quality reporting data under the SSP showed that an average of 86 percent of primary care physicians met meaningful use requirements in 2014 (See
Stakeholders should keep in mind that this CEHRT requirement would be based on the requirements that an APM places on its participating APM Entities. In determining whether an APM meets this criterion, CMS does not propose to assess the level of use of each APM Entity or individual eligible clinician participating in the APM but rather whether the APM requirements meet the standard set forth in this proposed rule.
We invite comment on whether the proposed thresholds for use of CEHRT for APM Entities that are not hospitals (50 percent for the first QP Performance Period (proposed 2017) and 75 percent for the second QP Performance Period (proposed 2018) and later are appropriate, or if we should consider additional options such as a higher or lower percentage in 2018, or an additional incremental increase for 2019. We also invite comment on whether we should consider higher thresholds for APMs that target eligible clinician populations with higher-than-average adoption of certified health IT, such as eligible clinicians in patient-centered medical homes. Finally, we invite comment on whether we should explore ways to set lower thresholds for those APMs targeting eligible clinician populations that may have lower average adoption of certified health IT, such as specialty-focused APMs.
We also propose an alternative criterion for determining whether an APM meets the CEHRT requirement, exclusively applicable for the Shared Savings Program. We believe this method is appropriate for the Shared Savings Program because although the Shared Savings Program requires ACOs to encourage and promote the use of enabling technologies (such as EHRs) to coordinate care for assigned beneficiaries, the Shared Savings Program does not require a specific level of CEHRT use for participation in the program. Instead, the Shared Savings Program includes an assessment of EHR use as part of the quality performance standard which directly impacts the amount of shared savings/losses generated by the Shared Savings Program ACO. We believe it is important to incentivize ever-increasing level of CEHRT use. However, in contrast to CMS APMs under section 1115A of the Act, CMS would have to undertake significant rulemaking to adopt an eligibility standard for the Shared Savings Program that is consistent with the proposed criterion for other CMS APMs. Following such rulemaking, we would have to collect additional information from each existing and applying ACO outside the routine application process in the weeks prior to the start of the 2017 performance year which we believe could introduce uncertainty and burden for CMS, ACOs, and participating EPs. Moreover, we believe that the proposed alternative criterion builds on established Shared Savings Program rules and incentives that directly tie the level of CEHRT use to the ACO's financial reward which in turn has the effect of directly incentivizing ever-increasing levels of CEHRT use among EPs. We believe that the proposed alternative criterion for the Shared Savings Program is consistent with the goals of the APM incentive and reduces burden and uncertainty for the Shared Savings Program participants. Therefore, because most other APMs can accommodate a new CEHRT use requirement for eligible clinicians without modifying our regulations, we are restricting this method to the Shared Savings Program. We propose that this alternative would allow the Shared Savings Program to meet the criterion if it holds APM Entities accountable for their eligible clinicians' use of CEHRT by applying a financial penalty or reward based on the degree of CEHRT use (such as the percentage of eligible clinicians that use CEHRT or the engagement in care coordination or other activities using CEHRT). One of the quality measures used in the Shared Savings Program's quality performance standard assesses the degree to which certain eligible clinicians in the ACO successfully meet the requirements of the EHR Incentive program, which requires the use of CEHRT by certain eligible clinicians in the ACO. Successful reporting of the measure for a performance year gives the ACO points toward its overall quality score, which in turn affects the amount of shared savings or shared losses an ACO could earn or be liable for, respectively. Because of this, ACOs in the Shared Savings Program actively promote and
In addition to these proposals, we are interested in what other health IT functionalities APM participants might need to effectively provide care to their patients and how the use of interoperable health IT can strengthen and encourage higher quality patient care and more effective care coordination across all APMs. Recent research and input from experts, practitioners, and the public (See
We look forward to receiving comments as to whether new health IT standards and certification criteria may be needed to ensure that participants in APMs have access to interoperable health IT products and services necessary for effective care coordination, population health management, and patient engagement. We will work with the Office of the National Coordinator (ONC) to explore opportunities for certified health IT capabilities reflected in the CEHRT definition to evolve in ways that meet the needs of participants in APMs while supporting eligible clinicians in MIPS to fulfill the EHR performance category under MIPS.
We believe that all patients, families, and healthcare professionals should have consistent and timely access to health information in a standardized format that can be securely exchanged between these parties (See HHS August 2013 Statement, “Principles and Strategies for Accelerating Health Information Exchange”). The secure, appropriate exchange of health information can help health care professionals improve quality of care through more robust care coordination, and improve the efficiency of care through access to patient information across settings. Interoperability is a key priority for the healthcare industry. HHS recently received pledges from companies that provide 90 percent of the electronic health records used by hospitals nationwide, as well as the top five largest health care systems in the country, to: help consumers easily and securely access their electronic health information; help clinicians share individuals' health information for care with other clinicians and their patients whenever permitted by law and not block electronic health information; and implement federally recognized, national interoperability standards, policies, guidance, and practices for electronic health information.
A growing number of organizations across the country are now focused on facilitating health information exchanges (HIEs) among healthcare professionals at the national, state, and community levels. According to one figure, there were 267 organizations providing HIE services operating in the U.S. in 2014 (see
We seek comment on how requirements for the use of CEHRT within APMs could evolve to support expanded participation in organizations supporting HIEs. For instance, should CMS consider expanding in future rulemaking the CEHRT criterion for Advanced APMs to include recognition of participation with an organization providing HIE services? Would this option be likely to spur further interest among entities in partnering with organizations that provide HIE services? Should these organizations be required to adhere to specific standards that promote interoperability across health information systems? How could a potential future governance mechanism for HIE (that is, establishing a common set of standards, services, policies, and practices) be incorporated into requirements for APMs? We seek comment on these and any other issues related to advancing participation in HIEs though the use of CEHRT in APMs.
The second criterion for a APM to be an Advanced APM is that it provides for payment for covered professional services based on quality measures comparable to measures under the performance category described in section 1848(q)(2)(B)(i) of the Act, which is the MIPS quality performance category. We interpret this criterion to require the APM to incorporate quality measure results as a factor when determining payment to participants under the terms of the APM.
Our proposed policy for this criterion is informed by our proposed policy for the MIPS quality performance category. For more information on quality measures under the MIPS quality performance category, please see section II.E.3.b of this preamble of this preamble, in which CMS proposes eligible clinicians will select quality measures from the MIPS measures list in section II.E.3 of this preamble for the first performance year of MIPS. We will publish a list of quality measures annually, through notice and comment rulemaking, from which MIPS eligible clinicians may choose measures for assessment under the MIPS quality performance category. The measures included in the annual list of MIPS measures must adhere to specific criteria that include the following: (1) Measures must have an evidence-based focus if the measures are not endorsed by a consensus-based entity as described in section 1848(q)(2)(D)(v) of the Act; and (2) new measures and the method for developing and selecting such measures, including clinical and other data supporting such measures, must be submitted to a specialty-appropriate, peer-reviewed journal prior to inclusion of the measure in MIPS as described in section 1848(q)(2)(D)(iv) of the Act.
The statute also establishes priorities for both the quality domains of measures to be developed and the types of measures to be prioritized in the measure development plan, which are located, respectively at sections 1848(s)(1)(B) and (D) of the Act. The priority measure types include outcome, patient experience, care coordination, and measures of appropriate use of services such as measures of overuse.
We are considering a number of ways to implement the Advanced APM requirement to base payment on measures comparable to those in MIPS, as well as how to define which measures would reflect the statutory
In exploring these options we decided that while they all have merit, we are concerned they may be overly restrictive for the variety of APMs, many of which are designed to have the flexibility to test new ways of paying for and delivering care. We want to ensure that APMs have the latitude to base payment on quality measures that meet the goals of the model and assess the quality of care provided to the population of patients that the APM participants are serving. It is important to note that many APMs include some common measures that are proposed for inclusion in MIPS. For example, many of the quality measures used in the Shared Savings Program and the Next Generation ACO Model that are submitted to CMS through the CMS web interface, are also proposed for inclusion in MIPS.
However, APMs that focus on patients with specific clinical conditions, such as end-stage renal disease or patients undergoing specific surgical procedures, would have valid reasons for including different quality measures than those that target more general populations. Similarly, some models may focus on specialist eligible clinicians for whom there may be only a small number of valid and relevant quality measures. Lastly, we cannot predict the specific care goals and payment designs of future physician-focused payment models and other APMs. Consequently, we do not want to impose measure requirements that may prevent CMS from including quality measures that may be better suited to the specific aims of new innovative APMs.
We received a number of comments on the MIPS and APMs RFI on the use of MIPS-comparable quality measures by an Advanced APM. A commenter suggested CMS include high-value performance measures to assess and improve the quality of care that are clinically important, evidence-based, transparent, feasible, valid and reliable, actionable, and rigorously audited to ensure accuracy. Other commenters indicated APMs should not be required to have the same reporting requirements as is required under the quality reporting performance category for MIPS because each APM is designed differently and may be developed with a specific specialty or condition in mind, so broad reporting requirements would not be relevant. Commenters also indicated the need for measures that could be used across APMs and MIPs to reduce the eligible clinician's reporting burden when switching from one program to the other.
After consideration of the comments and the options above, we recognize the need to propose a measure framework for comparable measures that reflects a few key principles. For the Advanced APM measures to be comparable to MIPS measures, the measures should have an evidence-based focus and as appropriate, target the same priorities, (for example, clinical outcomes, use and overuse). However, as each APM Entity is different, there needs to be the flexibility to determine which measures are most appropriate for use in their respective APM for the purpose of linking those measures to payment under the model. We agree that measures that could be used in both MIPS and APMs is beneficial to eligible clinicians who may switch from one program to the other, but we also do not want to restrict APMs from including new innovative measures that may not be included in MIPS initially, or until later years of the program.
We also note that under the MACRA and in this proposal, not all quality measures under which an APM is assessed are required to be “comparable” and not all payments under the APM must be based on comparable measures. However, at least some payments must be tied to measures comparable to MIPS, regardless of whether those comparable measures are the only ones the APM uses. Under this proposal, APMs retain sufficient freedom to innovate in paying for services and measuring quality. For instance, an APM may have incentive payments related to quality, total cost of care, participation in learning activities, and adoption of health IT. The existence of all of the payments associated with non-quality aspects does not preclude the APM from meeting this Advanced APM criterion. In other words, this criterion only sets standards for payments tied to quality measurement, not other methods of payment. Conversely, an APM may, as current models at the CMS Innovation Center currently do, test new quality measures that do not fall into the MIPS-comparable standard. So long as the APM meets the requirements set forth in this criterion, there is no additional prescription for how the APM tests additional measures that may or may not meet the standards under this criterion. Therefore, we propose that the quality measures on which the Advanced APM bases payment must include at least one of the following types of measures provided that they have an evidence-based focus and are reliable and valid:
(1) Any of the quality measures included on the proposed annual list of MIPS quality measures;
(2) Quality measures that are endorsed by a consensus-based entity;
(3) Quality measures developed under section 1848(s) of the Act;
(4) Quality measures submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(5) Any other quality measures that CMS determines to have an evidence-based focus and be reliable and valid.
We believe that quality measures that are endorsed by the National Quality Forum would meet these criteria. We also propose to establish an Innovation Center quality measure review process for those measures that are not NQF-endorsed or included on the final MIPS measure list to assess if the quality measures have an evidence-based focus, and are reliable and valid. For example, the Comprehensive ESRD Care Model includes NQF #0226 Influenza Immunization for the ESRD Population which is not a measure included for reporting in MIPS but meets the proposed criteria for MIPS-comparable quality measures. We believe under the proposed categories above MIPS-comparable quality measures may include measures that are fully developed after being tested in an APM and found to be reliable and valid. Similarly, we believe that MIPS-comparable quality measures may include QCDR measures provided that the QCDR measures used by the Advanced APM for payment have an evidence-based focus and are reliable and valid.
The statute identifies outcome measures as a priority measure type and we want to encourage the use of outcome measures for quality performance assessment in APMs. Therefore, we propose that in addition to the general comparable quality measure requirements proposed in this section, an Advanced APM must include at least one outcome measure if an appropriate measure (that is, the measure addresses the specific patient
We believe that this framework would provide the flexibility needed to ensure APM quality performance metrics meet the APM's goals. We invite comments on whether measures to be considered comparable to MIPS should all be reliable and valid and have an evidenced-based focus.
The third criterion that a APM must meet to be an Advanced APM is that it must either be a Medical Home Model expanded under section 1115A(c) of the Act as described below, or the APM Entities under the APM must bear financial risk for monetary losses under such APM that are in excess of a nominal amount. We will refer to the latter criterion as the “financial risk criterion.” The proposed correlating financial risk criterion for Other Payer Advanced APMs is described in section II.F.7 of this preamble with the requirements for consideration under the All-Payer Combination Option that is applicable in payment years 2021 and later.
The proposed financial risk criterion for Advanced APMs would apply to the design of the APM financial risk arrangement between CMS and the participating APM Entity. If the structure of the arrangement meets the proposed financial risk requirements, then this criterion would be met. This proposal would not impose any additional performance criteria related to bearing financial risk. For example, eligible clinicians under the Advanced APM Entity would not need to bear financial risk under the APM so long as the APM Entity bears that risk. Furthermore, an APM Entity would not need to actually achieve savings or other metrics for success under the APM in order for the APM to meet this criterion.
This discussion is broken into two main topics: (1) What it means for an APM Entity to bear financial risk for monetary losses under a APM; and (2) what levels of risk CMS would consider to be in excess of a nominal amount. In developing our proposed policies we prioritized keeping these standards consistent across different types of APMs, including Other Payer Advanced APMs as described in section II.F.7.b.(6) of this preamble. We believe that keeping these standards consistent to the extent possible would make it easier for stakeholders, APM Entities, and eligible clinicians to understand the type of financial risk required in order for an APM to be an Advanced APM. However, we do propose to specify small variations in the requirements in order to accord with the differing characteristics of certain types of APMs.
In particular, we propose specific standards that would apply for Medical Home Models. We believe that, given the unique financial risk and nominal amount standards we are proposing for Medical Home Models in this section below, it would be appropriate to impose size and composition limits for the Medical Home Models to which the unique standards would apply in order to ensure that the focus is on organizations with a limited capacity for bearing the same magnitude of financial risk as larger APM Entities do. We propose that beginning in the second QP Performance Period (proposed to be 2018), the Medical Home Model financial risk standard and nominal amount standard, described in section II.F.4.b.(4) of this preamble, would only apply to APM Entities that participate in Medical Home Models and that have 50 or fewer eligible clinicians in the organization through which the APM Entity is owned and operated. Thus, in a Medical Home Model that is an Advanced APM, the proposed Medical Home Model financial risk and nominal amount standards would only apply to those APM Entities owned and operated by organizations with 50 or fewer eligible clinicians. We believe it is appropriate to use eligible clinicians, rather than physicians, when setting this threshold as the number of eligible clinicians both reflects organizational resources and capacity and also may fluctuate widely around a specific number of physicians. We also believe that this size threshold of 50 eligible clinicians is appropriate because organizations of that size have demonstrated the capacity and interest in taking on higher levels of two-sided risk either by themselves or by joining with other organizations. In the event that a Medical Home Model happens to meet the generally applicable financial risk and nominal amount standards, this organizational size limitation would be moot.
Measuring organizational size based on the size of the “parent organization” differs from measuring it based on the size of the APM Entity. Collecting accurate information on the number of eligible clinicians affiliated with a parent organization will require additional, but we believe achievable, reporting by APM Entities. We believe that size of the organization is generally a better indication of risk-bearing capacity than APM Entity size. For instance, an APM Entity may be very small if it represents one practice site, but that practice site may be one of many affiliated with a health system or independent physician association of substantial size. We believe that the proposed limits on the types and sizes of entities that can be Advanced APM Entities under Medical Home Models will encourage larger organizations to move into Advanced APMs with greater levels of risk than the smaller levels that could enable Medical Home Models to become Advanced APMs. This is consistent with our goals that the incentives for Advanced APM participation should reward commitment to challenging models. However, we do not intend to imply that participation in Medical Home Models is necessarily inappropriate for larger organizations. We recognize that Medical Home Models differ from other APMs, such as ACO initiatives, because Medical Home Models focus on improving primary care through much more targeted and intensive interventions than those commonly found in other APMs. We hope to encourage participation in Medical Home Models for all organizations that can derive value from their designs, not just those that are too small to join ACO initiatives and other higher risk APMs.
We propose implementing this size limitation for Advanced APMs that are Medical Home Models beginning in the second year of the Quality Payment Program (proposed QP Performance Period 2018) because we understand that applications for many APMs will be due to CMS before this rule will be finalized, precluding APM Entities from having time to substantially adjust their APM participation strategies for the 2017 QP Performance Period. We propose that CMS would make a determination of whether an APM Entity meets the size limitation prospectively before a QP Performance Period, and that the determinations would not subsequently change based on changes in organizational size during or after the QP Performance Period (although changes in organizational size would, as applicable, affect determinations for subsequent QP Performance Periods). We want all organizations to have the greatest amount of knowledge possible about their APM participation options prior to
We seek comment on this proposal, particularly with regard to the use of the count of eligible clinicians in the parent organization of the APM Entity as the metric of organizational size for Medical Home Models, and whether setting the limit at 50 for the number of eligible clinicians in the organization would constitute a reasonable threshold to distinguish between organizations that we could expect to have the financial capability to join APMs, such as ACO initiatives, that have two-sided risk. We also seek comment on an alternative option to establish the size limitation based on the number of eligible clinicians in the Medical Home Model, rather than on number of eligible clinicians in the APM Entity's organization. Under this alternative option, we would modify the Medical Home Model definition so that an APM could only be considered a Medical Home Model if no more than 10 percent of eligible clinicians (or, alternatively, 10 percent of APM Entities) in the APM are part of parent organizations with more than 50 eligible clinicians. If this element of the Medical Home Model definition were met (along with all other Medical Home Model elements), all APM Entities participating in the APM would be considered medical homes regardless of their size. Conversely, if more than 10 percent of eligible clinicians (or alternatively, 10 percent APM Entities) participating in the APM are part of parent organizations with more than 50 eligible clinicians, the entire APM would not be a Medical Home Model, and, in the event that the APM does not meet the generally applicable Advanced APM financial risk criterion, none of the participating APM Entities would be Advanced APM Entities.
In this section, we propose a generally applicable financial risk standard for Advanced APMs and a unique standard that would apply only for Advanced APMs that are identified as Medical Home Models.
First, we propose that the generally applicable financial risk standard for Advanced APMs would be that an APM must include provisions that, if actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified performance period, CMS can:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians; or
• Require the APM Entity to owe payment(s) to CMS.
The proposed financial risk standard for Advanced APMs reflects our interpretation of the statutory requirement that Advanced APM Entities must bear financial risk for monetary losses to encompass “losses” that could be incurred through either direct repayments to CMS or reductions in payments for services. The former would cover two-sided risk arrangements such as shared savings initiatives in which an Advanced APM Entity may receive shared savings or be liable for shared losses. The latter would cover a range of alternative methods for linking performance to payment, such as payment withholds subject to successful performance, or discounts in payment rates retrospectively applied at reconciliation similar to those in many episode-based bundled payment models. We note that the proposed generally applicable financial risk standard would not include reductions in bonus payments—such as shared savings payment incentives that vary based on quality performance—whereas, as described below, the Medical Home Model financial risk standard could be satisfied by such reductions in bonus payments if appropriate conditions are met. As such, except when the Medical Home Model standard applies, one-sided risk arrangements would not meet this financial risk criterion.
We believe that statute supports a financial risk criterion that should be met only by those APMs that are most focused on challenging organizations, physicians, and practitioners to assume financial risk and provide high-value care. Our proposal reflects our belief that more and more APMs will meet this high bar over time. In response to the MIPS and APMs RFI, many stakeholders commented that business risk should be sufficient to meet this financial risk criterion to be an Advanced APM. We also considered whether the substantial time and money commitments required by participation in certain APMs would be sufficient to meet this financial risk criterion. However, we believe that financial risk for monetary losses under an APM must be tied to performance under the model as opposed to indirect losses related to financial investments APM Entities may make. The amount of financial investment made by APM Entities may vary widely and may also be difficult to quantify, resulting in uncertainty regarding whether an APM Entity had exceeded the nominal amount required by statute. In addition to the difficulty in creating an objective and enforceable standard for determining whether an entity's business risk associated with the Advanced APM exceeds a nominal amount, we strongly believe that the statutory scheme under section 1833(z) of the Act recognizes that not all APMs will meet this criterion. We do not intend for our proposal to diminish the substantial time and money commitments in which APM Entities invest in order to become successful participants. We welcome comments on how we could potentially create an objective and meaningful financial risk criterion that would define financial risk for monetary losses based on performance under the APM differently.
Second, we propose to adopt a slightly different financial risk standard for Medical Home Models. For a Medical Home Model to be an Advanced APM, it must include provisions that potentially:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians;
• Require the APM Entity to owe payment(s) to CMS; or
• Lose the right to all or part of an otherwise guaranteed payment or payments, if either:
• Actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified performance period; or
• APM Entity performance on specified performance measures does not meet or exceed expected performance on such measures for a specified performance period.
With regard to the proposed financial risk standard for Medical Home Models, we believe that the Medical Home Model is a unique type of APM that is treated differently under both the MIPS and APM programs. For example, under the MIPS clinical practice improvement activity performance category, as described in section II.E.3.f of this preamble of this proposed rule, eligible clinicians participating in medical homes receive an automatic 100 percent score, whereas eligible clinicians participating in other APM Entities receive a minimum of a 50 percent score. Additionally, both Medical Home Models and Medicaid Medical Homes Models are distinct from other APMs in
We therefore believe that the unique characteristics of Medical Home Models warrant the application of a financial risk standard that reflects these differences in order to provide incentives for participation in the most advanced financial risk arrangements available to medical homes practitioners.
The proposed financial risk standard for Medical Home Models is similar to the generally applicable Advanced APM standard in its first three conditions. The difference is in the inclusion of the fourth condition for the proposed financial risk standard for Medical Home Models, which would allow a performance-based forfeiture of part of all of a payment under an APM to be considered a monetary loss. For example, a Medical Home Model would meet this standard if it conditions the payment of some or all of a regular care management fee to APM Entities upon meeting specified performance standards. Because the APM does not require any direct payment or repayment to CMS, a medical home penalized in such a manner would not necessarily be in a weaker financial position than it had been prior to the decreased payment; however, it would be in a comparatively worse position in the future than it otherwise would have been had it met performance standards. We believe that this financial risk standard respects the unique challenges of medical homes in bearing risk for losses while maintaining a more rigorous standard than business risk.
We seek comment on the proposed standards set forth for both Advanced APM Medical Home Models and for all other APMs. We would consider any comments on alternative standards suggested by the public that could achieve our stated goals and the statutory requirements. We also seek comment on types of financial risk arrangements that may not be clearly captured in this proposal.
If the APM risk arrangement meets the proposed financial risk standard, we would then consider whether the amount of the risk is in excess of a nominal amount in order for this Advanced APM criterion to be met. We believe the statutory requirement that an APM Entity bear risk under an APM in excess of a nominal amount (which we will term the “nominal amount standard”) relates to a particular quantitative risk value at which CMS would consider the risk arrangement to involve potential losses of more than a nominal amount. Similar to the financial risk portion of this assessment, we propose to adopt a generally applicable nominal amount standard for Advanced APMs and a unique nominal amount standard for Medical Home Models. Under the generally applicable nominal amount standard, the total risk percentages are of the APM Entity benchmark or, in the case of episode payment models, the target price, which is the amount of Medicare expenditures (which can vary as to the involvement of Parts A and B depending on the APM) above which an APM Entity owes losses and below which an APM Entity earns savings. In the case of Medical Home Models, the risk percentages for Medical Home Models are based on Medicare Parts A and B revenue. As an alternative, we considered assessing total risk under the generally applicable nominal amount standard (for APM other than episode payment models) in relation to the APM Entity's Parts A and B revenue instead of in relation to the APM benchmark. We note that the ratio between entity revenue and the expenditures reflected in an APM's benchmark may vary across different types of entities, such as when the APM benchmark is based on total cost of care. However, we are not proposing the alternative of basing the generally applicable standard on Parts A and B revenue because that policy would prevent a general determination that an APM meets such standards. Instead, it would require case-by-case determinations at the APM Entity level that could change from year to year. We are also concerned that assessing total risk based on an APM Entity's revenue instead of the APM benchmark would set meaningfully different standards for different types of entities regarding the extent to which they must be held financially responsible if expenditures exceed the benchmark. In general, we believe we should apply a common standard to all types of entities. That being said, we understand that setting the total risk standard too high could create challenges for smaller organizations for which a total cost of care benchmark represents more risk in relation to revenue than it does for larger organizations.
In general, we believe that the meaning of “nominal” is, as plain language implies, minimal in magnitude. However, in the context of financial risk arrangements, we do not believe it to be a mere formality. For instance, we do not believe the law was intended to consider one dollar of risk to be more than nominal. That would create an arbitrary distinction between an APM that has only upside reward potential and one that has the same upside reward potential with a fractional and relatively meaningless downside risk. Therefore, in arriving at the proposed values, we sought amounts that would be meaningful for the entity but not excessive. As reference points to anchor the proposed values, we used the percentage amounts of MIPS adjustments in the MACRA and surveyed current APM risk arrangements, including those in Tracks 2 and 3 of the Shared Savings Program, the Pioneer ACO Model, and the Bundled Payments for Care Improvement (BPCI) Initiative. We consider the potential losses and marginal risk rates of those initiatives to be optimal in that they have been vetted through the APM development process and determined to be the appropriate amount of risk for each initiative such that, in the context of the APM, it is anticipated that the amount of risk
Except for risk arrangements described under section II.F.4.b.(4) of this preamble, we propose to measure three dimensions of risk described in this section to determine whether an APM meets the nominal amount standard: (a) Marginal risk, which is a common component of risk arrangements—particularly those that involve shared savings—that refers to the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity would be liable under the APM; (b) minimum loss rate (MLR), which is a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk; and (c) total potential risk, which refers to the maximum potential payment for which an APM Entity could be liable under the APM. Except for risk arrangements described under section II.F.4.b.(3) of this preamble, we propose that for a APM to meet the nominal amount standard the specific level of marginal risk must be at least 30 percent of losses in excess of expected expenditures, and a minimum loss rate, to the extent applicable, must be no greater than 4 percent of expected expenditures, and total potential risk must be at least 4 percent of expected expenditures. As described in greater detail in section II.F.7 of this preamble, the proposed Other Payer Advanced APM nominal risk standard parallels the standard described here for Advanced APMs. In general, we define expected expenditures to be the level of expenditures reflected in the APM benchmark. However, for episode payment models, we defined expected expenditures to be the level of expenditures reflected in the target price.
To determine whether an APM satisfies the marginal risk portion of the nominal risk standard, we would examine the payment required under the APM as a percentage of the amount by which actual expenditures exceeded expected expenditures. We propose that we would require that this percentage exceed the required marginal risk percentage regardless of the amount by which actual expenditures exceeded expected expenditures. APM arrangements with less than 30 percent marginal risk would not meet the nominal risk standard. We believe that meaningful risk arrangements can be designed with marginal risk rates of greater than 30 percent. Any marginal risk below 30 percent creates scenarios in which the total risk could be very high, but the average or likely risk for an APM Entity would actually be very low. We also propose that the payment required by the APM could be smaller when actual expenditures exceed expected expenditures by enough to trigger a payment greater than or equal to the total risk amount required under the nominal risk standard (as specified in Table 28). This is essentially an exception to the marginal risk requirement so that the standard does not effectively require APMs to incorporate total risk greater than the amount required by the total risk portion of the standard.
An example of marginal risk is the sharing rate in the Shared Savings Program. For instance, an ACO in Track 2 or Track 3 of the Shared Savings Program that has a sharing rate, or marginal risk, of 50 percent and exceeds its benchmark (expected expenditures) by $1 million would be liable for $500,000 of those losses. The inclusion of a marginal risk standard is intended to focus on maintaining a more than nominal level of average or likely risk under an Advanced APM. For instance, a APM with a large (for example, 20 percent of benchmark) total potential risk could have a very small (for example, 10 percent) sharing rate as its marginal risk, which substantially mitigates the amount of loss the APM Entity would reasonably expect to incur. We believe that including marginal risk in the Advanced APM financial risk criterion clarifies for APM Entities and eligible clinicians the type of risk they must bear should they pursue becoming QPs. Focusing on marginal risk in the proposed criterion for Other Payer Advanced APMs in section II.F.7.b.(6) of this preamble additionally acts as a guard against gaming through strategic development of risk arrangements with very low marginal risk.
We propose a maximum allowable “minimum loss rate” (MLR) of 4 percent in which the payment required by the APM could be smaller than the nominal amount standard would otherwise require when actual expenditures exceed expected expenditures by less than 4 percent; this exception accommodates APMs that include zero risk with respect to small losses but otherwise satisfy the marginal risk standard. If actual expenditures exceed expected expenditures by an amount exceeding the MLR, then all excess expenditures (including excess expenditures within the MLR) would be subject to the marginal risk requirements. For example, ACOs participating in performance-based risk arrangements under Tracks 2 and 3 of the Shared Savings Program are permitted to choose their own minimum savings rate (MSR) and MLR as long as they are symmetrical. If losses do not exceed the chosen MLR, the ACO is not held responsible for losses. If the ACO has a very large MLR, there may be little to no risk with respect to losses below a certain percentage of the benchmark. Therefore, we believe that proposing a maximum allowable MLR is appropriate. We recognize that there may be instances where an APM can satisfy the marginal risk portion of the nominal risk standard even with a high MLR. Therefore, we also propose a process through which CMS could determine that a risk arrangement with an MLR higher than 4 percent could meet the nominal amount standard, provided that the other portions of the nominal risk standard are met. In determining whether such an exception would be appropriate, CMS would consider: (1) Whether the size of the attributed patient population is small; (2) whether the relative magnitude of expenditures assessed under the APM is particularly small; and (3) in the case of a test of limited size and scope, whether the difference between actual expenditures and expected expenditures would not be statistically significant even when actual expenditures are 4 percent above expected expenditures. We note that CMS would grant such exceptions rarely, and CMS would expect APMs considered for such exceptions to demonstrate that a sufficient number of APM Entities are likely to incur losses in excess of the higher MLR. In other words, the potential for financial losses based on statistically significant expenditures in excess of the benchmark must remain meaningful for participants.
To determine whether an APM satisfies the total risk portion of the nominal risk standard, we would identify the maximum potential payment an APM Entity could be required to make as a percentage of expected expenditures under the APM. If that percentage exceeded the required
In evaluating both the total and marginal risk portions of the nominal amount standard, we would not include any payments the APM Entity or its eligible clinicians would make to CMS under the APM if actual expenditures exactly matched expected expenditures. In other words, payments made to CMS outside the risk arrangement related to expenditures would not count toward the nominal risk standard. This requirement ensures that perfunctory or pre-determined payments do not supersede incentives for improving efficiency. For example, an APM that simply requires an APM Entity to make a payment equal to 5 percent of the APM benchmark at the end of the year, regardless of actual expenditure performance, would not satisfy the nominal amount standard.
We believe that this approach to measuring the amount of risk flexibly accommodates a wide variety of risk structures, including APMs in which marginal risk varies with the amount of losses. For example, an APM could have a sharing rate of 75 percent for expenditure amounts that exceed the benchmark by up to 2 percent and a sharing rate of 50 percent for expenditure amounts that exceed the benchmark by 2 percent or more. Because the smallest sharing rate is 50 percent, the marginal risk rate exceeds 30 percent at all levels of expenditures, so the model satisfies the marginal risk portion of the nominal amount standard. Because this hypothetical APM does not have MLR or stop loss provisions, it satisfies the total risk and MLR portions of the nominal amount standard.
In particular, the financial risk an Advanced APM Entity would bear under an Advanced APM need not take a shared savings structure in which the financial risk increases smoothly based on the amount by which an Advanced APM Entity's actual expenditures exceed expected expenditures. An example of a risk arrangement being based on shared savings is Tracks 2 and 3 of the Shared Savings Program, where the greater the losses in relation to the expenditure benchmark, the greater the potential amount of shared losses an ACO would be required to repay CMS. On the other hand, an Advanced APM could require APM Entities to pay a penalty based on expenditure targets, regardless of the degree to which the APM Entity actually exceeded those expenditure targets, provided that the payments are otherwise structured in a way that satisfies both the marginal and total risk requirements under the nominal amount standard.
We seek comment on appropriate levels for the allowable minimum loss rate and the parameters we should consider when determining whether a risk arrangement should warrant an exception from the minimum loss rate portion of the nominal amount standard.
Table 28 summarizes the generally applicable nominal amount standard. Tables 29 and 30 provide examples of types of risk arrangements that would and would not meet the financial risk criterion. The examples are divided between shared savings-style arrangements in which marginal risk is a component and non-shared savings arrangements.
Figures C and D illustrate types of payment arrangements would meet the nominal amount standard. Figure C represents the minimum nominal amount standard, so any APM in which the risk for required payments would be on or above the line would satisfy the nominal amount standard. Figure D represents an example of a risk arrangement that would exceed the nominal amount standard.
We seek comment on the Advanced APM nominal amount standard. In particular, we seek comment on whether the Advanced APM benchmark or the Advanced APM Entity revenue is a more appropriate basis for assessing total risk and on the proposed amounts of total potential risk, marginal risk, and maximum allowable minimum loss rate. In particular, we seek comment on whether 30 percent is a sufficient level of marginal risk to be considered “more than nominal.” We also seek comment on whether CMS could adopt a meaningful standard that only includes total and marginal risk without the minimum loss rate component. Finally, we seek comment on a tiered nominal risk structure in which different levels of marginal risk could be paired with different levels of total risk.
In commenting on possible alternatives, we encourage commenters to refer to the policy principles articulated in section II.F.1 and to consider the extent to which their proposed alternatives would be more or less consistent with those principles.
We propose that for Medical Home Models, the total annual amount that an Advanced APM Entity potentially owes CMS or foregoes under the Medical Home Model must be at least the following amounts in a given performance year:
• In 2017, 2.5 percent of the APM Entity's total Medicare Parts A and B revenue;
• In 2018, 3 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2019, 4 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2020 and later, 5 percent of the APM Entity's total Medicare Parts A and B revenue.
We believe the statute's explicit discussion of medical homes gives us unique latitude to separately set financial risk and nominal amount standards for Medical Home Models that fall below an amount we consider sufficient to be “more than nominal” in the context of other types of APMs. We also believe that the meaning of the term “nominal” depends on the situation in which it is applied, so we believe it is appropriate to consider the characteristics of the medical home class of APM Entities in setting the nominal amount standard for Medical Home Models. As we noted in discussing the financial risk standard, few medical homes have had experience with financial risk, and many would be financially unable to provide sufficient care or even remain a viable business in the event of substantial disruptions in revenue. As such, we believe we should base the nominal amount standard on the APM Entity's total Medicare Parts A and B revenues and also not include a potentially excessive level of risk for such entities in the first year of the program. Thus, our proposal sets forth a gradually increasing but achievable long-term amount of risk that would apply in subsequent years. In general, we believe that this scheme allows Medical Home Models to craft incentive designs that allow medical homes to succeed through care transformation and the provision of high-value care while not threatening the ability of small practices to function.
Some benchmarks are based on total cost of care, and, as discussed with respect to the generally applicable nominal amount standard, we generally believe that the APM benchmark or target price is the appropriate basis for evaluating the nominal amount standard. However, we note that, for a small practice, the benchmark can be an amount that is significantly greater than the practice's revenue from all payment sources. Thus, basing the Medical Home Model nominal amount standard on percentage of risk in relation to a total cost of care benchmark would mean that certain types of entities would be required to bear greater total risk in relation to their revenues than other entities, which we believe would be undesirable in light of the special characteristics of Medical Home Models. On the other hand, most APMs base risk on the benchmark instead of revenue, and using revenue as the basis for determining the nominal risk standard could cause the APM Entity's eligibility to vary from year to year based on changes in an APM entity's revenue despite the core risk arrangement remaining unchanged.
For the Medical Home Model nominal amount standard, we seek additional comment on the length of the proposed multi-year “ramp up period” and the magnitude of the total risk amounts during such a period. We also seek comment on the potential addition of a marginal risk amount to the extent applicable and on whether the Advanced APM benchmark or Advanced APM Entity revenue is the most appropriate standard for measuring total risk.
In commenting on possible alternatives, we encourage commenters to refer to the policy principles articulated in section II.F.1 and to consider the extent to which their proposed alternatives would be more or less consistent with those principles.
We propose that full capitation risk arrangements would meet the Advanced APM financial risk criterion. We propose that, for purposes of this rulemaking, a capitation risk arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made to an APM Entity for all items and services furnished to a population of beneficiaries, and no settlement is performed for the purpose of reconciling or sharing losses incurred or savings earned by the APM Entity. We also would like to reiterate that—in line with statute—Medicare Advantage and other private plans paid to act as insurers on the Medicare program's behalf are not Advanced APMs.
We believe that capitation risk arrangements, as defined here, involve full risk for the population of beneficiaries covered by the arrangement, recognizing that it might require no services whatsoever or could require exponentially more services than were expected in calculating the capitation rate. The APM Entity bears the full downside and upside risk in this regard. Thus, we believe capitation arrangements inherently require an APM Entity to bear financial risk for monetary losses in excess of a nominal amount. We propose that, where payment is made to participating entities in a APM using a capitation risk arrangement, the APM and participating entities would meet the criterion under section 1833(z)(3)(D)(ii)(I) of the Act.
In implementing this proposed policy, it is important to distinguish capitation as a risk arrangement from capitation as only a cash flow mechanism. A capitation risk arrangement adheres to
We seek comment on our proposal for acceptance of capitation risk arrangements and on our proposed definition of a capitation risk arrangement. We also seek comment on other types of arrangements that may be suitable for such treatment for purposes of this financial risk criterion. Finally, we seek comment on potential limits or qualifications to the capitation standard in order to prevent potential abuse or incentives that are not consistent with the provision of high value care.
Section 1833(z)(3)(D)(ii)(II) of the Act states that an Advanced APM must either meet the financial risk criterion or be a Medical Home Model expanded under section 1115A(c) of the Act. We will refer to the latter criterion as the expanded Medical Home Model criterion. We propose that a Medical Home Model that has been expanded under section 1115A(c) of the Act would meet the expanded Medical Home Model criterion and thus would not need to meet the Advanced APM financial risk criterion as described above. Under this this proposal, an APM would have to both be determined to be a Medical Home Model as defined in this rulemaking and in fact be expanded using the authority under section 1115A(c) of the Act. Such expansion is contingent upon whether, for an APM tested under section 1115A(b) of the Act:
• The Secretary determines that such expansions is expected to reduce spending under the applicable title without reducing the quality of care; or improve the quality of patient care without increasing spending;
• CMS' Chief Actuary certifies that such expansion would reduce (or would not result in any increase in) net program spending under the applicable titles; and
• The Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals. In determining which models or demonstration projects to expand under the preceding sentence, the Secretary shall focus on models and demonstration projects that improve the quality of patient care and reduce spending.
We note that the expanded Medical Home Model criterion cannot met unless a Medical Home Model has been expanded under section 1115A(c). Merely satisfying expansion criteria would not be sufficient to meet this Advanced APM criterion. This expanded Medical Home Model criterion is directly related to a similar criterion addressed in this proposed rule for Medicaid Medical Home Models, which addresses how such APMs can meet the Other Payer Advanced APM financial risk criterion by having criteria comparable to an expanded Medical Home Model. We request comments on the proposed requirements for this and all proposed Advanced APM criteria.
Using the Advanced APM criteria proposed in sections II.F.4.b.1-6 of this preamble, we have identified the current APMs that we anticipate would be Advanced APMs for the first QP Performance Period. We note that since no CMS Medical Home APMs have been expanded under section 1115A(c) of the Act, we have not included this criterion in the table.
The information presented in Table 32 is based on the preliminary application of proposed Advanced APM criteria in this preamble and does not preclude any changes to the list based on: (1) Any changes made to the proposed criteria in the publication of the final rule in response to public comments; (2) any modifications to the design of current APMs; or (3) any new APMs announced between publication of this proposed rule and the beginning of the first QP Performance Period. Consistent with our proposal in section II.F.4.a, we propose to post an official determination of which APMs would meet the final Advanced APM criteria prior to the beginning of the first QP Performance Period and update that list in accordingly.
We note that the Comprehensive Care for Joint Replacement (CJR) model does not meet the Advanced APM criteria proposed in sections II.F.4.b.1-6 of this preamble. We seek comment on how we might change the design of CJR through future rulemaking to make it an Advanced APM, and we seek comment on how to include eligible clinicians in CJR for purposes of the QP determination as described in section II.F.5.
The QP determination process is specified under section 1833(z)(2) of the Act, in which QPs are defined as those eligible clinicians who meet the specified threshold(s).
In this section, we propose a process for determining which eligible clinicians would be QPs or Partial QPs for a given payment year through their participation in Advanced APMs during a corresponding QP Performance Period. Per sections 1833(z)(2) and 1848(q)(1)(C)(ii)(I) and (II) of the Act, an eligible clinician would become a QP or Partial QP for a payment year if they are determined at the end of the performance period to be eligible clinicians in an Advanced APM Entity that collectively meets the threshold values for participation in an Advanced APM during the corresponding QP Performance Period, and starting in 2021, the threshold values for participation in an Other Payer Advanced APMs as proposed here. Each year, CMS would determine whether an eligible clinician achieved the threshold to become a QP or Partial QP during the corresponding QP Performance Period. CMS would make this assessment independent of QP or Partial QP determinations made in previous years and accounting for Advanced APMs that begin or end on timeframes that do not align precisely with the QP Performance Period. The following would apply to an eligible clinician whom CMS determines to be a QP for a particular year:
• For payment years 2019-2024, the QP will receive a lump sum payment equal to 5 percent of the estimated aggregate payment amounts for Medicare Part B covered professional services for the prior year, as described in section II.F.8 of this preamble;
• The QP will be excluded from MIPS payment adjustments, as described in section II.E.3 of this preamble; and
• For payment years 2026 and later, payment rates under the Medicare physician fee schedule for services furnished by the eligible clinician will be updated by the 0.75 percent qualifying APM conversion factor as specified in sections 1848(d)(1)(A) and (d)(20) of the Act.
Through the APM Entity group determination described in section II.F.5.b of this preamble, CMS would identify eligible clinicians who do not meet the QP threshold but reach the Partial QP threshold for a year to be Partial QPs. Partial QPs would not be eligible for the 5 percent APM Incentive Payment for years from 2019 through 2024 or, beginning for 2026, the qualifying APM conversion factor. However, as described below, Partial QPs would have an opportunity to decide whether they wish to be subject to a MIPS payment adjustment, which could be positive or negative.
The statute requires that we use two options to determine whether an eligible clinician is a QP or Partial QPs for a payment year—one is the Medicare Option and, beginning in 2021, the other is the All-Payer Combination Option. While these are the terms based on statutory language that we have chosen to use for the purposes of describing the process by which we can calculate an eligible clinician's Threshold Score, we note that the use of the word “option” does not imply that an eligible clinician will have the ability to choose between the two. We further outline in this section our proposed process by which we will assess eligible clinicians under both options (beginning in 2021) to the extent that sufficient data is submitted to CMS.
The Medicare Option, described in this section, focuses on participation in Advanced APMs, and CMS would make determinations under this option based on Medicare Part B covered professional services attributable to services furnished through an Advanced APM Entity. The Medicare Option is the only option available for QP determinations during the first two years of this
The QP and Partial QP Thresholds under the Medicare Option are shown in Tables 33 and 35. The QP and Partial QP Threshold values under the All-Payer Combination Option are shown in Tables 34 and 36. CMS will determine an eligible clinician's QP status for a payment year by calculating an eligible clinician's Threshold Score, and comparing the eligible clinician's Threshold Score (either based on payment amounts or patient counts) to the relevant QP Threshold or Partial QP Threshold. In addition, we discuss our proposal to make QP determinations at a group level based on an entire Advanced APM Entity in section II.F.5.b of this preamble.
According to section 1833(z)(2)(D) of the Act, the Secretary may base the determination of whether an eligible clinician is a QP or a Partial QP by using counts of patients in lieu of using payment amounts and using the same or similar percentage criteria as those used for the payment amount method, as the Secretary determines is appropriate. For QP and Partial QP determinations using patient count calculations, we propose to use the percentage values displayed in Tables 35 and 36. The purpose of the proposed design of the Medicare patient count method is to make QP status determinations accessible to entities and individuals who are clearly and significantly engaged in delivering value-based care through participation in Advanced APMs. We also propose that when determining whether to use the payment amounts or patient counts method to calculate the QP threshold status, CMS will use both methods in tandem for each Advanced APM Entity group of eligible clinicians. We further propose that after QP and Partial QP threshold calculations have been completed, we will use the QP threshold method that is more favorable to the Advanced APM Entity group of eligible clinicians.
By performing preliminary analyses using our proposed QP determination methodologies with historical APM data, we found that the proposed QP and Partial QP Patient Count Thresholds are similar in magnitude and trajectory to those specified in the statute for the payment-based calculations. Due to varying attribution and organizational characteristics, we anticipate that using our proposed thresholds, the method—payment amount or patient count—that results in the most favorable QP status will likely vary across different Advanced APMs and Advanced APM Entities. We believe that each eligible clinician should have every opportunity to reach the QP threshold for each year, and do not intend to limit this opportunity by preemptively selecting one method over another.
We seek comment on the proposed QP Patient Count Threshold and Partial QP Patient Count Threshold percentage values for both the Medicare Option and the All-Payer Combination Option, on our proposal to calculate the Threshold Score under the payment amount and patient count methods simultaneously, and on our proposal to use the method that is most favorable to the Advanced APM Entity group of eligible clinicians.
We propose that, beginning with payment year 2021, CMS will conduct the QP determination sequentially so that the Medicare Option is applied before the All-Payer Combination Option. We propose to apply the All-Payer Combination Option only to an Advanced APM Entity group of eligible clinicians or eligible clinicians who do not meet either the QP Payment Amount or Patient Count Threshold under the Medicare Option but who do meet the lower Medicare threshold for the All-Payer Combination Option. This process is illustrated in Figures E and F, which show that the first assessment is whether the Medicare QP Threshold has been met under either the Medicare Option or the All-Payer Combination Option.
Because the Medicare Option (either based on payment amounts or patient counts) is also part of the All-Payer Combination Option, and because all eligible clinicians must reach at least a minimum Medicare Threshold Score through Advanced APMs to be QPs, we believe that this sequential approach streamlines the analytic and operational requirements to make QP determinations under the All-Payer Combination Option. Figure E illustrates the proposed process for making QP determinations under the Medicare Option for 2019 and 2020. Figure F illustrates the process proposed for making QP determinations under both the Medicare and All-Payer Combination Options for payment years 2021-2024. Figure G provides an example of the proposed process for making QP determinations in payment years 2023-2024. Figures E, F, and G only discuss the payment amount method, but a similar process would apply for the patient count method.
According to section 1833(z)(2) of the Act, we are required to determine QP and Partial QP status based on payment amounts (or patient counts) during the most recent period for which data are available (which may be less than a year). We propose that the QP Performance Period is the full calendar year that aligns with the MIPS performance period (for instance, 2017 would be the QP Performance Period for the 2019 payment year). We believe that having a QP Performance Period parallel with the proposed MIPS performance period offers will reduce operational complexity and gives CMS the opportunity to clearly communicate an eligible clinician's status in this program throughout the process. We also believe that having a QP Performance Period that concludes one year and one day before the payment year enables CMS to provide all eligible clinicians participating in Advanced APMs the best opportunity to monitor their performance through the Advanced APM and make the most informed decisions regarding their decision whether to not to be subject to MIPS in the event that they become a Partial QP. We seek comment on this proposal and any alternative QP Performance Period timeframes that would both enable meaningful QP assessment and ensure operational alignment with MIPS.
The statute consistently refers to an eligible clinician throughout section 1833(z) of the Act and clearly identifies that the QP determinations are to be made for an eligible clinician. In section 1833(z)(3)(B) of the Act, the definition of an eligible clinician includes a group of such professionals. We received several comments to our MIPS and APMs RFI recommending that CMS make QP determinations at a group level and indicating a preference for entity cohesion over a highly precise analysis for individual eligible clinicians. Commenters stated a number of reasons why they recommended that QP determinations should be made at the group level. These reasons included promoting administrative simplicity, the need to foster collaboration among group members (instead of promoting barriers), and the fact that while many beneficiaries are attributed to an APM Entity based on the services rendered by one eligible clinician, many of the eligible clinicians participating in the APM Entity may play a role in the actual diagnosis, treatment, and management of many beneficiaries in the APM Entity population. Each of these individual eligible clinicians could potentially view themselves as being instrumental in providing quality care to the beneficiary that is in line with the objectives of the APM, regardless of whether their individual services are counted towards APM-specific attribution methods. A few commenters indicated that the Advanced APM Entities themselves should determine whether individual eligible clinicians meet the annual threshold to become a QP.
An Advanced APM Entity faces the risks and rewards of participation in an Advanced APM as a single unit, and is responsible for performance metrics that are aggregated to the level of that entity. This policy is also based on the premise that positive change occurs when entire organizations commit to participating in an Advanced APM and focusing on its cost and quality goals as a whole. It also mitigates situations in which individual eligible clinicians who practice together in an Advanced APM Entity receive different QP determinations and thus are treated differently for purposes of APM Incentive Payments, MIPS payment adjustments, and eventually, differential fee schedule updates under the PFS. We believe that such discrepancies could potentially lead to confusion and lack of cohesion among eligible clinicians and Advanced APM Entities and place additional burdens on eligible clinicians and organizations to track these differences. Additionally, we wish to avoid any additional burden, confusion, and operational difficulties for both eligible clinicians and CMS that would result from allowing eligible clinicians or Advanced APM Entities to elect whether to be assessed at the Advanced APM Entity level. We believe that a simple, overarching rule is preferable to adding extra variables to the already complex processes under this program.
We understand that, as with any group assessment, there will be some situations in which individual Threshold Scores would differ from group Threshold Scores if assessed separately. This could lead to some eligible clinicians becoming QPs when they would not have met the QP Threshold individually (a “free-rider” scenario) or, conversely, some eligible clinicians not becoming QPs within an Advanced APM Entity when they might have qualified individually (a dilution scenario). We believe that through the methodology we propose for QP determination in this proposed rule, the magnitude of such discrepancies will be relatively small compared to the value of maintaining Advanced APM Entity cohesion.
We propose, except in the specific situations discussed below in this section, to make the QP determination at a group level. As a result, the QP determination for the group would apply to all the individual eligible Clinicians who are identified as part of an Advanced APM Entity. If that eligible Clinician group's collective Threshold Score meets the relevant QP threshold, all eligible Clinicians in that group would receive the same QP determination for the relevant year. The QP determination calculations described in this proposed rule would be aggregated using data for all eligible clinicians participating in the Advanced APM Entity during the QP Performance Period.
In some cases, the list of eligible clinicians who will be grouped together for purposes of the QP determination may include eligible clinicians who have relationships with the Advanced APM Entity but no relationship with each other. We believe this is appropriate for purposes of the QP determination because it support the Advanced APM Entity as the coordinator of its participating eligible clinicians to contribute to its success and promotes eligible clinician coordination when appropriate to further the success of the Advanced APM Entity.
We propose that the group of eligible clinicians would consist of all the eligible clinicians identified as participants in an Advanced APM Entity during the QP Performance Period on a Participation List provided to CMS, with one exception for Advanced APMs whose participants are not eligible clinicians. We propose to define participant for the purposes of participation in an APM as an entity participating in an APM under an agreement with CMS or statute or regulation that may either include eligible clinicians or be an eligible clinician and that is directly tied to beneficiary attribution, quality measurement or cost measurement under the APM. This definition encapsulates those entities and eligible clinicians under an APM who have roles of central importance to performance under the APM. We propose that the Participation List for each Advanced APM Entity would be compiled from CMS-maintained lists that will be used to identify each eligible clinician by a unique TIN/NPI combination attached to the identifier of the Advanced APM Entity. Therefore, an eligible clinician must be officially identified using an Advanced APM Entity's Participation List to be part of the QP determination for that group.
In APMs, the APM Entity that has an agreement with CMS or is identified as such under statute or regulation is considered a participant in the APM. Some APMs have eligible clinicians under the APM Entity who are also under our definition considered participants in the Advanced APM Entity. For example, in an APM like the Comprehensive Primary Care Initiative with physician group practices as participants, the APM Entity, the Practice, may have a Participation List it provides to CMS that can be used to identify each eligible clinician participant participating in the APM through that APM Entity by a unique TIN/NPI combination attached to the identifier of the APM Entity. As stated above, we propose to include of all the eligible clinicians identified using a Participation List as participants in an Advanced APM Entity during the QP Performance Period for purposes of the QP determination.
In certain APMs, a Participation List may not include any eligible clinicians. For example, in an APM where all APM Entities are hospitals, the APM Entity will not have eligible clinicians identified by a unique TIN/NPI combination attached to the identifier of the Advanced APM Entity on a
Where there is a Participation List that can be used to identify eligible clinicians, we propose that it automatically be the list that is considered for the QP Determination. Where there is no Participation List that can be used to identify eligible clinicians, but there is another list of eligible clinicians who have a contractual relationship with the Advanced APM Entity based at least in part on supporting the Advanced APM Entity's quality or cost goals under the Advanced APM (Affiliated Practitioners), we propose to use the list of those eligible clinicians, the Affiliated Practitioner List, for purposes of the QP determination. Where there is both a Participation List and an Affiliated Practitioner List that can be used to identify eligible clinicians under an Advanced APM, we propose only to use the Participation List for purposes of the QP determination. We seek comment on whether to limit the proposed policy to use an Affiliated Practitioner List for the QP Determination to the Medicare payment threshold option, as it may be less likely that Affiliated Practitioners support the Advanced APM Entity as a group in Other Payer Advanced APMs than eligible clinicians on a Participation List.
This proposed policy was developed to capture the group or groups of eligible clinicians who are the most closely associated with the performance of the Advanced APM Entity under an Advanced APM and to recognize their role in supporting the Advanced APM Entity. We believe this policy appropriately considers those eligible clinicians who have the most central role or roles in supporting the Advanced APM Entity's performance under an Advanced APM to be the eligible clinician group for purposes of the QP determination. We believe this policy provides for flexibility in the design of Advanced APMs while providing the APM Incentive Payment to those eligible clinicians who are the most engaged in the Advanced APM. We believe this will promote more robust engagement by eligible clinicians in Advanced APMs, and appropriately incentivize participation in Advanced APMs where eligible clinicians have a less direct relationship with the Advanced APM Entity than eligible clinicians who are on a Participation List. We also believe that although the relationship an Affiliated Practitioner has with an Advanced APM Entity is less direct than an eligible clinician on a Practitioner List, the contractual relationship the Affiliated Practitioner has with the Advanced APM Entity is sufficient for an Affiliated Practitioner can become a QP based on their support of the Advanced APM Entity.
We seek comment on our proposals for defining the eligible clinician group for QP determinations, particularly our proposals to define the eligible clinician group for QP determination as the Participation List, and the exception for Advanced APMs in which there are no eligible clinicians on the Participation List but there are eligible clinicians on an Affiliated Practitioner List. Because there may be Advanced APMs in the future that have multiple lists of Affiliated Practitioners, we plan to propose a policy for such situations in future rulemaking, and we seek comment on approaches for grouping those separate lists for purposes of the QP determination.
We propose that we will identify the eligible clinician group for each Advanced APM Entity at a specified point in time for each QP Performance Period. We propose that this point in time assessment will occur on December 31st of each QP Performance Period. We believe that taking a “snapshot” of the participant list on the last day of the proposed QP Performance Period provides the best opportunity to comprehensively assess the eligible clinicians' active participation in an Advanced APM throughout an entire QP Performance Period. Under this proposal, we would use the eligible clinicians identified using the Participant List as the group of eligible clinicians who would be assessed together for the purposes of QP determination. We considered taking the “snapshot” at an earlier point in the QP Performance Period, but we felt that because certain APMs allow for changes in participation (either adding or dropping participants from the APM Entity) during the calendar year, an earlier “snapshot” date would not be the most accurate reflection of active eligible clinician participation in a APM throughout the QP Performance Period. We believe that these proposals maintain cohesiveness for eligible clinicians and Advanced APM Entities and maintain consistency with the participation structure of Advanced APMs.
We seek comment on our proposal to assess each Participation List for each Advanced APM Entity at a specified point in time during the QP Performance Period. We also seek comment on the proposed date of the Participant List assessment, and whether this date should be earlier in the QP Performance Period or should instead be a range of time.
We propose one exception to making QP determinations at the group level. Some eligible clinicians may participate in multiple Advanced APMs. For instance, an eligible clinician could participate in an ACO under the Shared Saving Program and an episode payment model with another entity, both of which have been determined to be Advanced APM Entities. In such a case, we propose the following:
• Consistent with the general policy proposed above, if one or more of the Advanced APM Entities in which the eligible clinician participates meets the QP threshold, the eligible clinician becomes a QP.
• If none of the Advanced APM Entities in which the eligible clinician participates meet the QP threshold, CMS proposes to assess the eligible clinician individually, using combined information for services associated with that individual's NPI and furnished through all such eligible clinician's Advanced APM Entities during the QP Performance Period. CMS will adjust to assure that services are not double-counted (for example, a surgeon participating in a bundled payments model, in which some of the procedures are performed on patients affiliated with an ACO that the surgeon is also a part of, would only have payments or patients from those procedures count once towards the QP determination).
We believe that this proposal maintains the general simplicity of the Advanced APM Entity-level QP determination while acknowledging individual eligible clinicians who are participating in multiple advanced initiatives that support CMS goals. This also complements the policy described under the All-Payer Combination Option for QP determinations in which an eligible clinician may submit information on participation in Other Payer Advanced APMs in order to be assessed as an individual under that option in the event that the APM Entity or Entities in which the eligible
We seek comment on the proposal to make most QP determinations at the Advanced APM Entity level and our proposals for exceptions to that policy. In particular, we seek comment on the merits of making all determinations at the individual eligible clinician level versus through some alternative grouping methodology. We also seek comment on our proposal to assess an eligible clinician who participates in multiple Advanced APM Entities, and any other potential exceptions to the proposed general policy to make QP determinations at the Advanced APM level.
Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the definition of MIPS eligible clinician an eligible clinician who is a Partial QP for a year. However, under section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a Partial QP for a year and reports on applicable measures and activities as required under the MIPS is considered to be a MIPS eligible clinician for the year. To carry out these provisions, we propose to require that each Advanced APM Entity must make an election each year on behalf of all of its identified participating eligible clinicians on whether to report under MIPS in the event that the eligible clinicians participating in the Advanced APM Entity are determined as a group to be Partial QPs for a year. We propose that the Advanced APM Entity could change its election for a year at any time during the QP Performance Period, but the election would become permanent at the close of the QP Performance Period. We believe that this is consistent with our proposed general policy to make QP determinations at the Advanced APM Entity level; and with related MIPS policies described in section II.E.3.h of this preamble, under which we propose that each APM Entity would be considered a group for purposes of MIPS reporting. Therefore, we believe that the decision of whether to report and subsequently be subject to MIPS adjustments should also be made at the group level. We seek comment on whether the Advanced APM Entity or each individual eligible clinician should make the Partial QP MIPS reporting election.
As discussed in section II.E.3.h. of this preamble, we recognize that the Shared Savings Program eligible clinicians participate as a complete TIN such that all of the eligible clinician participants in the participant billing TIN participate in the Shared Savings Program. Therefore, we also seek comment on an alternative approach for Shared Savings Program APM Entities in which each individual billing TIN participating in the APM Entity would make the Partial QP election on behalf of its individual eligible clinicians and that election would be applied to all eligible clinicians in that individual billing TIN, as opposed to having the APM Entity (ACO) make the Partial QP election. We would only undertake this alternative paired with determining MIPS CPS for each TIN within an APM Entity (ACO) at the TIN level, an alternative discussed under the APM scoring standard elsewhere in this proposed rule.
Our proposal that Partial QPs may choose whether to report to MIPS has two additional interactions with other proposed policies. First, because we have proposed unique MIPS scoring policies for MIPS eligible clinicians participating in certain APMs, the election by the APM Entity not to report under MIPS is in effect a decision to tell CMS not to score the information submitted by the APM Entity under MIPS. Under our proposal, that decision would be made at the APM Entity level. APM Entities and eligible clinicians would continue to report to their respective APMs as required under the terms of their participation agreements with CMS.
Second, given the proposed timeframe for QP determinations under section II.F.5.a, our proposed treatment of claims run-out, claims adjustments, supplemental service payments, and alternative payment methods for purposes of QP determination (further detailed in section II.F.8 of this preamble), and the and subsequent notification of QP determinations proposed under section II.F.5.d of this preamble, eligible clinicians who become Partial QPs would not receive notification of this status until after the proposed timeframe for the MIPS reporting period will have closed. We do not believe that it would be in the best interest of APM Entities and eligible clinicians, nor would it be operationally feasible, to have APM Entities wait to make a Partial QP election to be included in MIPS until after the close of the MIPS reporting period. Although the information necessary for MIPS reporting would already be prepared in the CMS systems by the time the Partial QP determination is made, a prospective election by the Advanced APM Entity to not be scored under MIPS and receive a MIPS payment adjustment would signal us to not transfer information from our reporting system to the MIPS scoring system in the event of a Partial QP determination, and that any submitted information is not to be used for purposes of a MIPS assessment or payment adjustment. Thus, by choosing not to report under MIPS, those Advanced APM Entities and eligible clinicians determined to be Partial QPs would be exempted from the MIPS payment adjustment for that year. We seek comment on the timing and process for Advanced APM entities to elect whether to be subject to MIPS in the event of a Partial QP determination.
We propose to notify both Advanced APM Entities and their participating eligible clinicians of their QP and Partial QP status as soon as CMS has made the determination and performed all necessary validation of the results. Given the proposed timeframe for QP determinations under section II.F.5.a of this preamble and our proposed treatment of claims run-out (further detailed in section II.F.8 of this preamble), we do not anticipate that this notification could be made before the summer of the subsequent year. We propose that this notification would be made directly to the Advanced APM Entity and eligible clinician, and made in combination with a general public notice on the CMS Web site that such determinations have been completed for the applicable QP Performance Period. We propose that this notification would also contain other necessary and useful information, such as what actions, if any, an Advanced APM Entity or eligible clinician may or should take with respect to MIPS. We believe that this is the most efficient method for dissemination of this information to all QPs, Partial QPs, and MIPS eligible clinicians.
We seek comment on our proposals to make the QP and Partial QP status notifications. We also seek comment on an alternative approach for Shared Savings Program ACOs in which we would separately notify each billing TIN participating in the ACO. We seek comment on other methods and media for the notification of QP and Partial QP status. We also seek comment on the content of such notifications so that they may be as clear and useful as possible.
Under the Medicare Option, we propose to calculate a Threshold Score for an Advanced APM Entity—or eligible clinician in the cases of an exception described in section II.F.5.b of this preamble—based on participation in an Advanced APM by analyzing claims for Medicare Part B covered professional services. Under the alternative calculation using patient counts in lieu of payments (patient count method), we propose to similarly calculate a Threshold Score for the Advanced APM Entity based on patient attribution as described below. Under either the payment amount or patient count method, only Medicare Part B covered professional services under the physician fee schedule will count toward the numerator and denominator of the Threshold Score calculation.
Section 1833(z)(2)(A), (B)(i) and (C)(i) of the Act describes the QP determination using the Medicare payment method as follows: A QP is an eligible clinician whose payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an Advanced APM Entity. Section 1833(z)(2)(D) of the Act describes the basis for the patient count method.
In section II.F.3 of this preamble, we propose two definitions that would apply specifically for the purposes of QP determination: Attributed beneficiary and attribution-eligible beneficiary. Each term describes a particular relationship between an Advanced APM Entity and the beneficiaries for whose cost and quality of care the participating eligible clinicians are held accountable. These terms are the foundation for how we propose to count services furnished through an Advanced APM Entity.
In section II.F.3 of this preamble, we propose that “attributed beneficiary” be defined as a beneficiary attributed to the Advanced APM Entity on the latest available list of attributed beneficiaries during the QP Performance Period based on each APM's respective attribution rules. There are some natural advantages to using this term for the purposes of QP determination because it is consistent with how many APMs—including the Shared Savings Program (assigned beneficiaries), Next Generation ACO Model (aligned beneficiaries
In most episode payment models, such as the CJR Model, attribution is defined by the beneficiaries who trigger the defined episode of care under the model, often by presenting with a specific condition at the location of a participating APM Entity. In many attribution-based APMs, such as ACO initiatives or the Comprehensive Primary Care Initiative, CMS attributes beneficiaries to APM Entities through claims-based algorithms that identify the APM Entity with the plurality of evaluation and management visits for a beneficiary. In addition, most APMs do not allow beneficiaries to be attributed to more than one APM Entity. This means that the greater the APM Entity density in a market, the lower the attributed population for a given APM Entity will be as a percent of its total beneficiaries. We seek comment on the proposed methodology for defining the attributed beneficiary population, including comment on alternative methods for capturing the most meaningful cohort of attributed beneficiaries.
Under these plurality-based approaches, typically only 30-50 percent of an Advanced APM Entity's total population of beneficiaries for whom its eligible clinicians furnish services are actually attributed to the Advanced APM Entity for a performance period. These percentages reflect a combination of CMS' design decisions, beneficiaries' underlying care patterns, and the fact that beneficiaries in Medicare FFS retain freedom of choice to select clinicians. These percentages reflect conditions that are not entirely under the control of the APM Entity or its eligible clinicians. Thus, we recognize that because Advanced APMs have different attribution methodologies, using the specific Advanced APM attributed beneficiary as the definition may create a standard that advantages or disadvantages participation in certain Advanced APMs relative to others simply based on the specific attribution policies.
The unintended consequence would be that greater APM participation in a given market could make it impossible for many highly engaged Advanced APM Entities to reach a 50 percent or 75 percent QP Payment Amount Threshold. The result could be that an ACO functioning under arrangements with significant financial risk, (for example, in the Next Generation ACO Model or Track 3 of the Shared Savings Program), would still not meet the QP threshold, particularly in later years of the program under higher thresholds. We believe this would undercut our stated CMS goal of broadly increasing participation in advanced APMs, and we have attempted to compensate for these differences with how we propose to define the terms attributed beneficiary and attribution-eligible beneficiary for the purposes of making QP determinations.
Consistent with our proposed definition of attributed beneficiary, our proposed definition for an attribution-eligible beneficiary would allow us to be
(1) Is not enrolled in Medicare Advantage or a Medicare cost plan.
(2) Does not have Medicare as a secondary payer.
(3) Is enrolled in both Medicare Parts A and B.
(4) Is at least 18 years of age.
(5) Is a United States resident.
(6) Has a minimum of one claim for evaluation and management services by an eligible clinician or group of eligible clinicians within an APM Entity for any period during the QP Performance Period.
An attribution-eligible beneficiary may or may not be an attributed beneficiary. Attributed beneficiaries are a subset of attribution-eligible beneficiaries. Much like the term “attributed beneficiary,” the term attribution-eligible beneficiary is generally consistent with the attribution methodologies used in most current APMs—such as the Shared Savings Program and the Next Generation ACO Model—to identify the beneficiaries who could potentially be attributed to an APM Entity. Although the factors we are proposing for the definition of an attribution-eligible beneficiary in this context would only apply for the purposes of QP determinations, and would not change APM-specific methodologies, we believe that the factors in the proposed definition are representative of the methodologies most current APMs use to perform attribution. Therefore, we believe it would serve as a practical common set to apply in QP threshold calculations.
The purpose of using the attribution-eligible construct is to ensure that the denominator of QP determination calculations described in this section only includes payments for services furnished to patients who could potentially be attributed to an Advanced APM Entity under the Advanced APM, and thus could also appear in the numerator of the QP determination calculations. We believe that including amounts in the denominator that could not possibly be included in the numerator would be arbitrarily punitive toward certain Advanced APM Entities that furnish services to a substantial population of non-attribution-eligible beneficiaries.
We note that specialty-focused or disease-specific APMs may have attribution methodologies that are not based on evaluation and management services. Therefore, we anticipate needing targeted exceptions, especially related to the sixth factor of the definition of attribution-eligible beneficiary, for such APMs so that the attributed beneficiary population is truly a subset of the attribution-eligible population. Such exceptions would be made either through rulemaking or using available waiver authority and would be announced when the APM is announced.
For example, under the CEC Model, one criterion, among others, to be an aligned beneficiary requires that the beneficiary receive maintenance dialysis services. In the event that the CEC Model were determined to be an Advanced APM, we would consider attribution-eligible beneficiaries for the APM Entities participating in the CEC Model to be beneficiaries that meet the first five criteria outlined above and that have had at least one maintenance dialysis service billed through the Advanced APM Entity during the QP Performance Period. We would make this exception for the CEC Model to ensure that the denominator of QP determination calculations described in this section only includes payments for services furnished to patients who could potentially be attributed to an Advanced APM Entity under the Advanced APM.
Although the availability of such exceptions, as outlined above, would create multiple standards, we believe this slightly more complex approach is more appropriate and equitable because it is consistent with the design of APMs. An alternative approach could be to have a simple standard that includes in the denominator all beneficiaries who are furnished any Medicare Part B covered professional service by eligible clinicians participating the Advanced APM Entity.
We seek comment on the proposed general definition of attribution-eligible beneficiary. We further seek comment on our proposal to use of APM-specific standards as necessary to fulfill our expressed goals for specialty- or disease-focused APMs that may use alternative attribution methodologies.
We propose to use the attributed beneficiaries on Advanced APM attribution lists generated by each Advanced APM in making QP determinations. We also propose that the attributed beneficiary list would be taken from the Advanced APM's latest available list at the end of the QP Performance Period prior to making the QP determinations. For episode payment models, attributed beneficiaries would be those beneficiaries who trigger episodes of care under the terms of the APM.
We believe that this approach to attribution lists maintains consistency with the panel of beneficiaries for whom Advanced APM Entities are responsible under their respective Advanced APMs during the QP Performance Period. Therefore, we believe that such lists would be appropriate for use in QP determinations. Advanced APM Entities are already accustomed to providing care for the panel of beneficiaries represented by their APM Entity specific list. We believe that our proposal to link attribution for QP determination to Advanced APM attribution lists further strengthens the goals of the Advanced APMs in which these Advanced APM Entities participate. By using the same beneficiary population for QP determination purposes, Advanced APM Entities may continue focusing on the care they furnish to the same panel of attributed beneficiaries, instead of shifting focus and changing practice patterns to reach a QP threshold. As stated in our principles in section II.F.1 of this preamble, we intend for the QP determination process to seamlessly reward participation in the most advanced APMs, not to create a new set of performance standards distinct from the goals of APMs.
We seek comment on our proposal for determining which beneficiaries are considered attributed to an Advanced APM Entity for a QP Performance Period.
This section describes our proposal for calculating a Threshold Score for the eligible clinician group in an Advanced APM Entity—or individual eligible clinician in the exception situations under section II.F. 6 of this preamble—using the payment amount method, which would then be compared to the relevant QP Payment Amount Threshold and Partial QP Payment Amount Threshold to determine if the eligible clinician meets the QP status for a payment year.
For the payment amount method, section 1833(z)(2)(A), (B)(i) and (C)(i) of the Act requires that we use payments for Medicare Part B covered professional services to make QP determinations.
We propose to use all available Medicare Part B claims information generated during the QP Performance Period. Additionally, we propose that CMS will treat claims run-out, claims adjustments, supplemental service payments, and alternative payment methods in the same manner for purposes of calculating both the Threshold Score and for determining the APM Incentive Payment amount. We further detail our proposals to account for claims run-out, claims adjustments, non-claims-based payments, and alternative payment methods in section II.F.8 of this preamble.
We believe it is appropriate to maintain consistency across the QP determination and the incentive payment calculation in order to support internal CMS operational consistencies. It also ensures that any unique payment mechanisms within an Advanced APM do not affect the opportunity for an eligible clinician to reach the QP threshold.
We seek comment on whether the claims methodology we use under the Medicare payment method should align with the proposed claims methodology for purposes of calculating the estimated aggregate payment amount for the APM Incentive Payment.
In general, our proposed method for deriving a Threshold Score for an Advanced APM Entity is to divide the value described under paragraph (a) below by the value described under paragraph (b) below. This calculation would result in a percent value that CMS would compare to the QP Payment Amount Threshold and the Partial QP Payment Amount Threshold to determine the QP status for all eligible clinicians in the Advanced APM Entity for the payment year.
We propose that the numerator for this calculation would be the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attributed beneficiaries during the QP Performance Period.
We believe that this method is the most logical reading of the statute and is reflective of the population of beneficiaries for whom an Advanced APM Entity is responsible for cost and quality. Therefore, we believe that counting payments for covered professional services furnished to attributed beneficiaries is the most suitable metric for payments that are attributable to services furnished “through” an Advanced APM Entity. In episode payment models, because a beneficiary is considered attributed during the course of an episode, the payments included in the numerator for this calculation are those for Medicare Part B covered professional services furnished to an attributed beneficiary by eligible clinicians in the Advanced APM Entity during the course of an episode.
One program integrity concern is that an Advanced APM Entity might meet the higher QP Payment Amount Threshold in later years by providing substantially disproportionate amounts of care for attributed beneficiaries relative to all others. However, because of the financial risk an Advanced APM Entity bears, which is usually based on expenditures, we believe that the relatively large potential loss under the Advanced APM would outweigh the advantage of any overutilization geared toward abusing Threshold Score calculations.
We seek comment on any alternative numerators we could use for purposes of the Medicare payment method that meaningfully meet statutory requirements, are understandable, and operationally feasible.
We propose that the denominator in the Medicare payment method would be the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attribution-eligible beneficiaries during the QP Performance Period. We propose that when the QP determination is made at the eligible clinician level as described in section II.F.5 of this preamble, the denominator will be the total of all payments for Medicare Part B covered professional services furnished to attribution-eligible beneficiaries by the eligible clinician. In episode payment models, the payments included in the denominator for this calculation are those for Medicare Part B covered professional services furnished to any attribution-eligible beneficiary by eligible clinicians in the Advanced APM Entity. This includes all such services to all attribution-eligible beneficiaries whether or not such services occur during the course of an episode under the Advanced APM.
We believe that this denominator represents a meaningful alignment with the way in which current APMs perform attribution. Including payment for services furnished only to attribution-eligible beneficiaries standardizes the denominator to ensure fairness across types of eligible clinicians and geographic regions. By using the attribution-eligible population, the denominator will not penalize entities for furnishing services to beneficiaries who could not possibly be in the numerator through attribution under an Advanced APM. For example, an ACO's eligible clinicians may furnish services to a large population of beneficiaries with Medicare as a secondary payer. Those beneficiaries may not be eligible for attribution to the ACO, and could never be included in the numerator. Therefore, we believe that this methodology focuses on factors for which Advanced APM Entities have some control rather than those for which they may have no control or that disadvantage certain organizational structures or types of APMs. We seek comment on alternative methods that are consistent with the statutory language.
Similar to the Medicare payment method, this section describes our proposal for calculating a Threshold Score for the eligible clinicians participating in an Advanced APM Entity—or eligible clinician in situations under section II.F.6 of this preamble—using the Medicare patient count method, which would then be compared against the relevant QP Patient Count Threshold and Partial QP Patient Count Threshold to determine the QP status of an eligible clinician for the year. Given our authority under section 1833(z)(2)(D) of the Act to use patient counts in lieu of payments “as the Secretary determines appropriate,” we are interpreting the patient count method to offer a more flexible alternative to the payment method. As previously mentioned, the purpose of the proposed design of the Medicare patient count method is to make QP status determinations accessible to entities and individuals who are clearly and significantly engaged in delivering value-based care through participation in Advanced APMs.
We propose that when counting the number of beneficiaries under this
This is a distinct issue from the question of whether CMS pays shared savings to APM Entities more than once for a given beneficiary. Such payment overlap issues are handled separately through CMS' operational rules governing APM initiative overlaps that address double payments, and are not affected by decisions regarding QP Threshold Score calculations discussed in this regulation.
We propose that CMS will not count any beneficiary more than once for any single Advanced APM Entity. In other words, for each Advanced APM Entity, CMS will count each unique beneficiary no more than one time in the numerator and one time in the denominator.
We believe that counting beneficiaries this way retains integrity of the Threshold Scores by preventing double counting of beneficiaries within an Advanced APM Entity while recognizing the reality that beneficiaries often have relationships with eligible clinicians in different organizations. We seek comment on our proposal for counting beneficiaries.
To be consistent with the Medicare payment method, we propose that beneficiary counts would be based on any beneficiary for whom the eligible clinicians within an Advanced APM Entity receive payments for Part B covered professional services, even if an Advanced APM bases its attribution and/or financial risk on both Parts A and B. We propose that for this Threshold Score calculation, we would use any and all available Part B claims information generated during the QP Performance Period.
We propose that the Threshold Score would be calculated under the Medicare patient count method as a percent, by dividing the value described under paragraph (a) below by the value described under paragraph (b) below. We include the formula and examples in the summary equation below.
We propose that the numerator would be the number of unique attributed beneficiaries to whom eligible clinicians in the Advanced APM Entity furnish Medicare Part B covered professional services during the QP Performance Period. For episode payment models, this would include the number of attributed beneficiaries furnished Medicare Part B covered professional services by eligible clinicians in the Advanced APM Entity during the course of an episode under the Advanced APM.
We propose that the denominator would be the number of attribution-eligible beneficiaries to whom eligible clinicians in the Advanced APM Entity furnish covered professional services during the QP Performance Period. For episode payment models, this would include the number of attribution-eligible beneficiaries furnished Medicare Part B covered professional services by eligible clinicians in the Advanced APM Entity group at any point during the QP Performance Period, irrespective of whether such services occur during the course of an episode.
The proposed Medicare patient score method Threshold Score calculation can be summarized with the following equations.
For episode payment models, the equation is:
In general, we believe that through consistency with the payment amount method this approach balances our interests of relative simplicity and having a meaningful standard that recognizes the common aspects of attribution and accountability under Advanced APMs. Similar to the payment amount method, the patient count method represents a proportion of the patients for whom an Advanced APM Entity is accountable under the Advanced APM with respect to all patients who could potentially be attributed to the Advanced APM Entity under the Advanced APM. We believe that it important from any equity perspective to not include patients in the denominator if there is no possibility—based on Advanced APM attribution methodologies—that such individuals could be included in the numerator. We note that although we believe this method to be a fair assessment of the degree of participation in an Advanced APM, our preliminary analyses indicate that many Advanced APM Entities would still miss high thresholds set for later years of the Quality Payment Program.
We seek comment on alternative approaches to the patient count method that would achieve our goal of a simple and meaningful Threshold Score calculation.
We propose that if the same Advanced APM Entity participates in multiple Advanced APMs and if at least one of those Advanced APMs is an episode payment model, that we would add the number of unique beneficiaries in the numerator of the episode payment model Advanced APM Entity to the numerator(s) for non-episode payment models in which the Advanced APM Entity participates. For example, if an Advanced APM Entity is an ACO in Track 3 of the Shared Savings Program and also in the OCM, (both of which are hypothetically considered to be Advanced APMs for purposes of this example), we would add the entity's unique attributed beneficiaries in OCM to the numerator for its Shared Savings Program Track 3 Threshold Score calculation. We propose that for purposes of this proposal, Advanced APM Entities would be considered the same if CMS determines, that the eligible clinician participant lists are the same or substantially similar, or if the Advanced APM Entity participating in one Advanced APM is the same as, or is a subset of, the other.
The purpose of this proposal is to allow the logical combination of activities under multiple Advanced APMs where appropriate. We believe that the purpose of the incentives for Advanced APM participation is to capture the degree of Advanced APM participation generally, not simply the degree of participation within a single Advanced APM. Where relevant and operationally feasible, we want this program to encourage participation in multiple Advanced APMs. The counterfactual where we would not account for a single Advanced APM Entity's participation in multiple Advanced APMs could be seen as punitive. For instance, an Advanced APM Entity could serve the vast majority of its beneficiaries through several Advanced APMs, but unless that participation is aggregated, the entity could end up with several lower Threshold Scores that are below the QP Patient Count Threshold and not indicative of its broader participation.
We understand the difficulty associated with determining whether two Advanced APM Entities are in fact the same organization. It is highly unlikely that their participant lists will be exactly the same. Therefore, we seek comment on how best to make a determination of substantial similarity, which includes, for example, matching organizational information, aligning TINs, and comparing participant lists. We also seek comment on percentages of participant list or TIN similarity that would be sufficient for APM Entities to be considered under this policy.
CMS may apply one or both of two different methods—using payment amounts or patient counts—to arrive at an eligible clinician's Threshold Score. CMS will compare the Threshold Score against the relevant QP Threshold or Partial QP Threshold to determine an eligible clinician's QP status for the year.
We propose that CMS would calculate Threshold Scores for eligible clinicians in an Advanced APM Entity under both the payment amount and patient count methods for each QP Performance Period. We also propose that CMS would assign QP status using the more advantageous of the Advanced APM Entity's two scores.
We believe that both the payment amount and patient count methods should be considered in order to produce Threshold Scores. As the two calculations differ there may be cases in which Threshold Scores vary enough that different QP determinations could result depending on which is used. In such an event, we do not believe that prioritizing the Threshold Score using one calculation over the other would yield an appropriate, non-arbitrary result. By using the greater of the Threshold Scores achieved, we hope to promote simplicity in QP determinations and to maximize the number of eligible clinicians that attain QP status each year. We seek comment on the use of the payment and patient count methods for the Medicare Option.
We propose that professional services billed by CAHs under section 1834(g)(2)(B) of the Act (Method II CAH professional services) would count towards the QP determination threshold calculations for both the Medicare payment and patient count methods in both the numerator and the denominator, as applicable. We believe these services would constitute “covered professional services” under section 1848(k)(3) of the Act because they are furnished by an eligible clinician and payment is based on the Medicare PFS. This policy is consistent with our treatment of payments for Method II CAH professional services for purposes of the EHR Incentive Program and PQRS adjustments under sections 1848(a)(7) and (8) of the Act, respectively. Under section 1848(a)(7) and (8) of the Act, the PQRS and EHR Incentive Program adjustments are applied to payments for covered professional services furnished by an eligible clinician in a Method II CAH.
CAHs were established under the Balanced Budget Act (BBA) of 1997 as a separate provider type with a distinct set of Medicare Conditions of Participation and their own payment methodology. CAHs are not subject to the Medicare Inpatient Prospective Payment System (IPPS) or the Medicare Outpatient Prospective Payment System (OPPS). Instead, CAHs are generally paid based on 101 percent of reasonable costs for inpatient services and are paid for outpatient services under one of two methods: The Standard Payment method outlined in section 1834(g)(1) of the Act (Method I), or the Optional Payment Method outlined in section 1834(g)(2) of the Act (Method II). A CAH is paid under Method I unless it elects to be paid under Method II.
Under Method I, for cost reporting periods beginning on or after January 1, 2004, payments to CAHs are made for outpatient CAH facility services at 101 percent of reasonable costs. Physicians and practitioners receive payment for professional services under the Medicare PFS. A CAH may elect Method II billing, under which the CAH bills Medicare for both facility services and professional services furnished to its outpatients by a physician or practitioner who has reassigned his or her billing rights to the CAH. Even if a CAH makes this election, each physician or practitioner who furnishes professional services to CAH outpatients can choose to either: (1) Reassign his or her billing rights to the CAH, agree to be included under the Method II billing, attest in writing that he or she will not bill Medicare for professional services furnished in the CAH outpatient department, and receive payment from the CAH for the professional services; or (2) elect to file claims for his or her professional services with Medicare for standard payment under the Medicare PFS.
As of January 1, 2004, payment for a physician's professional services provided at a CAH billing under Method II is 115 percent of the allowable amount, after applicable deductions, under the Medicare PFS. For a non-physician practitioner's professional services, the payment amount is 115 percent of the amount that otherwise
RHCs and FQHCs are facilities that furnish services that are typically furnished in an outpatient clinic setting. They are located in areas that have been designated as HPSAs, and meet other requirements.
Under section 1833(a)(3) of the Act, RHCs are paid an all-inclusive rate (AIR) based on reasonable costs, subject under section 1833(f) of the Act to a maximum payment per visit that is established by Congress and updated annually based on the percentage change in the Medicare Economic Index (MEI) and subject to annual reconciliation. The per-visit limit does not apply to RHCs determined to be an integral and subordinate part of a hospital with fewer than 50 beds. Laboratory tests (excluding venipuncture) and technical components of RHC services are paid separately. The RHC payment limit per visit for CY 2016 is $81.32, effective January 1, 2016, through December 31, 2016.
The FQHC Medicare benefit was added when section 1861(aa) of the Act was amended by section 4161 of the Omnibus Budget Reconciliation Act of 1990. FQHCs are paid according to the FQHC PPS set out under section 1834(o) of the Act, in which Medicare pays a national encounter based rate per beneficiary per day, with some adjustments based on where and by whom the services are furnished. The unadjusted 2016 PPS rate is $160.60.
We propose that professional services furnished at RHCs and FQHCs that participate in ACOs, and are reimbursed under the RHC AIR or FQHC PPS (respectively), be counted towards the QP determination calculations under the patient count method but not under the payment amount method.
In certain Medicare ACO APMs, RHC and FQHC services can be counted for purposes of attributing beneficiaries to an ACO. Therefore, we propose to include beneficiaries attributed to an Advanced APM Entity in full or in part because of services furnished by RHCs or FQHCs in the patient counts used for QP determination calculations.
As previously stated, section 1833(z)(2)(D) of the Act permits us to use patient counts in lieu of payments when determining whether an eligible clinician is a QP “as the Secretary determines appropriate.” Our proposal to include the professional services furnished by eligible clinicians at RHCs and FQHCs in the QP threshold calculations for the patient count method is essential to assure consistency with this program and existing APM attribution methodologies. An Advanced APM Entity is responsible for the cost and quality of care for all beneficiaries attributed to an APM Entity, including all professional services furnished to such beneficiaries, regardless of whether or not attribution was based on services furnished by an eligible clinician or by an RHC or FQHC. We believe such beneficiaries are clearly served through the Advanced APM Entity, and it would be potentially confusing to eligible clinicians and Advanced APM Entities to track this distinction strictly for purposes of QP determination. We also believe that it would be unduly burdensome and impractical for CMS to develop and maintain a separate list of beneficiaries aligned to each Advanced APM Entity from the full list of beneficiaries for whom an Advanced APM Entity is responsible under an Advanced APM.
Because professional services furnished by eligible clinicians at RHCs and FQHCs are not reimbursed under, or based on, the Medicare PFS, professional services furnished in these settings do not constitute “covered professional services” under section 1848(k)(3)(A) of the Act. In the Medicare Payment Amount Method, where payments for specified covered professional services are summed, only payments for covered professional services can be included.
We believe that our proposal will continue to encourage the development of APMs that span rural and/or underserved areas. We seek comment on this proposal.
Beginning in 2021, in addition to the Medicare Option, eligible clinicians may also become QPs through the All-Payer Combination Option, described under section 1833(z)(2)(B)(ii) and (C)(ii) of the Act as the Combination All-Payer and Medicare Payment Threshold Option. Thus, there will be two avenues for eligible clinicians to become QPs—the Medicare Option and the All-Payer Combination Option—and an eligible clinician need only meet the QP threshold under one of them to be a QP for the payment year. The All-Payer Combination Option provides an incentive for eligible clinicians to participate in arrangements with non-Medicare payers that have payment designs similar to those in Advanced APMs. The All-Payer Combination Option uses both the methods described in the Medicare Option and methods that calculate payments for all services from all payers, with certain exceptions, that are attributable to participation in both Advanced APMs and Other Payer Advanced APMs.
Although the statutory QP threshold for an eligible clinician to be a QP (the QP Payment Amount Threshold) under the Medicare Option increases from 25 percent in 2019 and 2020 under section 1833(z)(2)(A) of the Act, to 50 percent in 2021 and 2022 under section 1833(z)(2)(B)(i) of the Act, to 75 percent beginning in 2023 under section 1833(z)(2)(C)(i) of the Act, the All-Payer Combination Option allows eligible clinicians with lower levels of participation in Advanced APMs to become QPs through sufficient participation in Other Payer Advanced APMs with payers such as State Medicaid programs and commercial payers, including Medicare Advantage plans. Similar to Medicare payment amount and patient count methods the statute also allows, under section 1833(z)(2)(D) of the Act, the QP determination to be based on payment amount or on counts of patients in lieu of payments using the same or similar percentage criteria. These QP thresholds are presented in Tables 38 and 39, and the process is shown in Figures J and K. The process shown in H and I will be similar for the patient count threshold, although only the process for the payment amount threshold is displayed. CMS may reassess the QP Patient Count Thresholds in future years based on the experience gained from eligible clinician Threshold Scores during the first years of operations. In summary, eligible clinicians may become QPs if the following steps occur as described below in the associated sections: (1) The eligible clinician submits to CMS sufficient information on all relevant payment arrangements with other payers; (2) CMS determines that an Other Payer APM is an Other Payer Advanced APM; (3) the eligible clinician meets the relevant QP thresholds by having sufficient payments or patients attributed to a combination of participation in Advanced APMs and Other Payer Advanced APMs.
Sections 1833(z)(2)(B)(ii) and (C)(ii) of the Act describe the payment amount method for making the QP determination under the All-Payer Combination Option. For purposes of making a QP determination under this
A payment arrangement with a non-Medicare payer (Other Payer APM) can become an Other Payer Advanced APM if the arrangement meets three criteria:
• Certified Electronic Health Record technology (CEHRT) is used;
• Quality measures comparable to measures under the MIPS quality performance category apply; and
• The APM Entity either: (1) Bears more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures; or (2) for beneficiaries under title XIX, is a medical home in a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act.
Other Payer APMs include payment arrangements under any payer other than traditional Medicare. Medicare Advantage and other Medicare-funded private plans are categorized as a payer other than traditional Medicare for these purposes. In this section, we explain how the three criteria are applied to determine whether arrangements are Other Payer Advanced APMs.
We propose to define a Medicaid APM as a payment arrangement under title XIX that meets the criteria to be an Other Payer Advanced APM as proposed in this section. States can choose from different authorities in title XIX when implementing new payment models. We believe this proposal would provide some flexibility for States but align the core requirements for Medicaid APMs with the broader Advanced APM and Other Payer Advanced APM criteria. Otherwise, we intend to generally defer to states in their design of payment arrangements.
We propose that a Medicaid Medical Home Model is a Medical Home Model that is operated under a State title XIX program instead of under section 1115A of the Act. Section 1833(z) of the Act mentions medical homes and what we have termed Medicaid Medical Homes (those with respect to beneficiaries under title XIX) several times, but does not define the terms. In addition, Medicaid Medical Home is not defined in title XIX or in Medicaid laws or regulations. Therefore, we need to define the terms because of their importance in the Quality Payment Program.
We propose that a Medicaid Medical Home Model must have the following elements at a minimum:
• Model participants include primary care practices or multispecialty practices that include primary care physician and practitioners and offer primary care services, and
• Empanelment of each patient to a primary clinician.
In addition to these elements, we propose that a Medicaid Medical Home Model must have at least four of the following elements:
• Planned chronic and preventive care.
• Patient access and continuity.
• Risk-stratified care management.
• Coordination of care across the medical neighborhood.
• Patient and caregiver engagement.
• Shared decision-making.
• Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings, population-based payments).
This definition of Medicaid Medical Home Model applies only for the purposes of the Quality Payment Program, and could be defined differently for other purposes. To define these terms, we reviewed existing and past Medical Home Models CMS developed under section 1115A of the Act, including the Comprehensive Primary Care Initiative (CPC). In addition, we reviewed a variety of other sources including several from the National Committee for Quality Assurance, the Joint Principles of the Patient-Centered Medical Home (a joint statement by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association), and the Agency for Healthcare Research and Quality. Our proposed definition of Medicaid Medical Home Model uses common elements from these sources. We believe that using a common set of elements ensures general comparability between Medical Home Models and Medicaid Medical Home Models while maintaining flexibility for the States under title XIX. In response to the MIPS and APMs RFI, some commenters suggested that we should require a specific method or accreditation process for recognizing Medicaid Medical Home Models, while others asked us not to use such an approach. We will not mandate a specific method or accreditation process. We believe that such a policy would provide limited additional benefit while unnecessarily restricting state innovation. However, we believe it likely that accredited models, such as those certified by the National Committee on Quality Assurance may also meet these proposed criteria. Medicaid Medical Home Models can be Other Payer Advanced APMs if they meet the criteria set forth in this section.
We seek comment on the definitions of Medicaid APMs and Medicaid Medical Homes Models.
To be an Other Payer Advanced APM, as described under section 1833(z)(2)(B)(iii)(II)(bb) and (z)(2)(C)(iii)(II)(bb) of the Act, payments must be made under arrangements in which certified EHR technology is used. This is slightly different than the requirement for Advanced APMs that “requires participants in such model to use certified EHR technology (as defined in section 1848(o)(4) of the Act),” as specified in section 1833(z)(3)(D)(i)(I) of the Act. Although the statutory requirements are phrased slightly differently, we believe that there is value in keeping the two standards—for Advanced APMs and Other Payer Advanced APMs—as similar as possible.
We propose that Other Payer APMs would meet this Other Payer Advanced APM criterion under sections 1833(z)(2)(B)(iii)(II)(bb) and (z)(2)(C)(iii)(II)(bb) of the Act by requiring participants to use CEHRT as defined for MIPS and APMs under § 414.1305. This approach is consistent with the approach for Advanced APMs as described in section II.F.4.b.(1) of this preamble. In the 2015 EHR Incentive Programs final rule (80 FR 62872 through 62873), we established the definition of CEHRT for EHR technology that must be used by eligible clinicians to meet the meaningful use objectives and measures in specific years. In this proposed rule, we are proposing to adopt the specifications from within the current definition of CEHRT in our regulation at § 414.1305 for eligible clinicians participating in MIPS or in APMs. This definition is identical to the definition for use by eligible hospitals and CAHs and Medicaid eligible clinicians in the EHR Incentive Programs.
In accordance with section 1833(z)(2)(C)(iii)(II) of the Act, we
We seek comment on the proposed definition of CEHRT for Advanced APMs and Other Payer Advanced APMs and whether they should be the same for both. We seek comment on the proposed method for Other Payer APMs to meet the CEHRT use criterion.
Another of the criteria to be considered an Other Payer Advanced APM, as described in sections 1833(z)(2)(B)(ii)(II)(aa) and (C)(iii)(II)(aa) of the Act, are quality measures comparable to those under MIPS quality performance category apply under the Other Payer APM. Under the MACRA and in this proposal, not all quality measures in an APM are required to be “comparable” and not all payments under the APM must be based on comparable measures. This approach is similar to the requirement for Advanced APMs as described in section II.F.4.b.(2) of this preamble. Under this proposal, Other Payer APMs retain sufficient freedom to innovate in paying for services and measuring quality. For instance, an Other Payer APM may have incentive payments related to quality, total cost of care, participation in learning activities, and adoption of health IT. The existence of all of the payments associated with non-quality aspects does not preclude the Other Payer APM from meeting this Other Payer Advanced APM criterion. In other words, this criterion only sets standards for payments tied to quality measurement, not other methods of payment. Conversely, an Other Payer APM may test new quality measures that do not fall into the MIPS-comparable standard. So long as the Other Payer APM meets the requirements set forth in this criterion, there is no additional prescription for how the Other Payer APM tests additional measures that may or may not meet the standards under this criterion. Therefore, we propose that the quality measures on which the Other Payer Advanced APM bases payment must include at least one of the following types of measures provided that they have an evidence-based focus and are reliable and valid as described in section II.F.4.b.(2) of this preamble:
(1) Any of the quality measures included on the proposed annual list of MIPS quality measures;
(2) Quality measures that are endorsed by a consensus-based entity;
(3) Quality measures developed under section 1848(s) of the Act;
(4) Quality measures submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(5) Any other quality measures that CMS determines to have an evidence-based focus and are reliable and valid.
We want to encourage the use of outcome measures for quality performance assessment in Other Payer APMs. As we did for APMs in section II.F.4.b.(2) of this preamble, we propose that in addition to the general comparable quality measure requirement proposed in this section, an Other Payer Advanced APM must include at least one outcome measure if an appropriate measure (that is, the measure addresses the specific patient population and is specified for the APM participant setting) is available on the MIPS list of measures for that specific QP Performance Period.
We believe that this framework will provide other payers the flexibility needed to ensure that their quality performance metrics meet their unique goals. We seek comment on this proposed criterion.
As described in sections 1833(z)(2)(B)(iii)(II)(cc) and (C)(iii)(II)(cc) of the Act, the third criterion that an Other Payer APM must meet to be an Other Payer Advanced APM is that under the arrangement, the APM Entity must either bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures or the Other Payer APM be a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act, as described in paragraph (d) below.
The financial risk standard under this criterion is similar to that proposed for the Advanced APM criterion. For purposes of determining whether the Other Payer APM is an Other Payer Advanced APM, this proposal does not impose any additional performance criteria, such as actual achievement of savings, on APM Entities in other payer arrangements. As with all the proposed Advanced APM criteria, this requirement pertains to the payment arrangement structure, not of the performance of the participants within the payment arrangement.
This section is broken into two main parts: (1) What it means for an Advanced APM Entity to bear financial risk if actual aggregate expenditures exceed expected aggregate expenditures under an Other Payer Advanced APM; and (2) what amounts of risk are considered to be more than nominal.
We prioritized keeping the standards consistent across different types of APMs, including Advanced APMs as described in section II.F.4.b.(3) of this preamble.
We propose a generally applicable standard for Other Payer Advanced APMs and a slightly different standard for Medicaid Medical Home Models. We want to be consistent with and comparable to the Advanced APM financial risk standard within the limits of the statutory text.
We propose that the generally applicable financial risk standard for Other Payer Advanced APMs would be that a payment arrangement must, if APM Entity actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians; or
• Require direct payments by the APM Entity to the payer.
We believe this financial risk criterion best distinguishes most Other Payer APMs from those that are focused on challenging physicians and practitioners to assume risk and provide high value care. We expect that an increasing proportion Other Payer APMs will meet that bar over time. This proposal is based on the statutory requirement that the APM Entity bear risk if aggregate actual expenditures exceed aggregate expected expenditures under the model, and is consistent with our proposal for the corresponding criterion proposed for Advanced APMs. Through the MIPS and APM RFI, many stakeholders commented that business risk should be sufficient to meet this Advanced APM criterion. We do not intend for our proposal to minimize the substantial time and financial commitments that APM Entities invest to become successful APM participants. We note that there is also difficulty in creating an
We propose that for a Medicaid Medical Home Model to be an Other Payer Advanced APM if the APM Entity's actual aggregate expenditures exceed expected aggregate expenditures, the APM must:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians;
• Require direct payment by the APM Entity to the payer; or
• Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
For instance, a Medicaid Medical Home Model would meet our proposed financial risk criterion if it conditions the payment of some or all of a regular care management fee to medical home APM Entities upon expenditure performance in relation to a benchmark. Because the arrangement would require no direct payment as a consequence for failure to meet expenditure standards, such a medical home would not necessarily be worse off than it had been prior to the decreased payment. However, it would be worse off in the future than it otherwise would have been had it met expenditure standards. Similarly, a Medicaid Medical Home Model that offers expenditure and quality performance payments in addition to payment withholds that can be earned back for meeting minimum requirements would also meet this criterion. Consistent with the treatment of Medical Home Models under the statute, this proposal acknowledges the unique challenges of medical homes in bearing risk for losses while maintaining a more rigorous standard than mere business risk.
We believe that because Medicaid Medical Home Models are unique types of Medicaid APMs and because they are identified and treated differently by the statute under the Quality Payment Program, it is appropriate to establish a unique standard for bearing financial risk that reflects these differences and remains consistent with the statutory scheme, which is to provide incentives for participation by eligible clinicians in advanced APMs.
Similar to Medical Home Model standards for Advanced APMs in II.F.4.b.(3), we believe that it would be appropriate to impose size and composition limits for Medicaid Medical Home Models to ensure that the focus is on organizations with a limited capacity for bearing the same magnitude of financial risk as larger APM Entities do. We propose that this limit would only apply to APM Entities that participate in Medicaid Medical Home Models and that have 50 or fewer eligible clinicians in the organization through which the APM Entity is owned and operated. Thus, in a Medicaid Medical Home Model that is an Other-Payer Advanced APM, only those APM Entities that are part of a parent organization with 50 or fewer eligible clinicians would be Advanced APM Entities. We believe it is appropriate to use eligible clinicians, rather than physicians, when setting this threshold as the number of eligible clinicians both reflects organizational resources and capacity and also may differ substantially across organizations with the same number of physicians.
We also believe that this size threshold of 50 eligible clinicians is appropriate as organizations of that size have demonstrated the capacity and interest in taking on risk, and organizations may also join together to take on risk collectively, for example, in an ACO. In the event that a Medicaid Medical Home Model happens to have criteria that meet the Advanced APM financial risk criterion that is generally applicable to all Other Payer APMs, this organizational size limitation would be moot.
There are several unique aspects of Medicaid Medical Home Models, which statute specifically singles out for unique treatment, and their participating APM Entities (medical homes) that support the need for a separate standard to assess financial risk if actual expenditures exceed expected expenditures. Medical homes are generally more limited in their ability to bear financial risk than other Entities because they tend to be smaller and predominantly include primary care practitioners, whose revenues are a smaller fraction of the beneficiaries' total cost of care than those of other eligible clinicians. Moreover, Medicaid medical homes serve low income populations and those with significant health disparities; due to the method of payment for care for these populations, Medicaid medical home practices often have relatively low revenues. Lastly, Medicaid Medical Home Models to date have not required participants to bear substantial downside risk, and including such a requirement under this program would create a significant challenge for medical homes to serve their patients.
We seek comment on the proposed financial risk standard set forth for Medicaid Medical Home Models and on alternative standards that would be consistent with the statute and could achieve our stated goals. We also seek comment on types of financial risk arrangements that may not be clearly captured in this proposal.
When an Other Payer APM risk arrangement meets the proposed financial risk standard, we would then consider whether the risk is of a more than nominal amount such that it meets this nominal risk standard. Similar to the financial risk portion of this assessment, we propose to adopt a generally applicable nominal amount standard for Other Payer Advanced APMs and a unique nominal amount standard for Medicaid Medical Home Models.
We propose to measure three dimensions of risk to determine whether a model meets the nominal amount standard: (a) Marginal risk, which is a common component of risk arrangements—particularly those that involve shared savings—that refers to the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity would be liable under an Other Payer APM; (b) minimum loss rate (MLR), which is a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk; and (c) total potential risk, which refers to the maximum potential payment for which an APM Entity could be liable under an Other Payer APM. An example of marginal risk within an Other Payer APM could be set up in a manner similar to the Shared Savings Program, where an ACO that has a sharing rate, or marginal rate, of 50 percent and exceeds its benchmark (expected expenditures) by $1 million would be liable for $500,000 of those losses. The marginal risk could also vary with the amount of losses.
When assessing whether an Other Payer APM meets the marginal and total risk portions of the nominal risk standard, we would use the same approach we proposed to use with respect to APMs. Specifically, to determine whether an Other Payer APM
To determine whether an Other Payer APM satisfies the marginal risk portion of the nominal risk standard, we would examine the payment required under the Other Payer APM as a percentage of the amount by which actual expenditures exceeded expected expenditures. We propose that we would require that this percentage exceed the required marginal risk percentage regardless of the amount by which actual expenditures exceeded expected expenditures, with two exceptions.
First, we propose a maximum allowable “minimum loss rate” (MLR) of 4 percent in which the payment required by the Other Payer APM could be smaller than the nominal amount standard would otherwise require when actual expenditures exceed expected expenditures by less than 4 percent; this exception accommodates Other Payer APMs that include zero risk with respect to small losses but otherwise satisfy the marginal risk standard. We also propose a process through which CMS could determine that a risk arrangement with an MLR higher than 4 percent could meet the nominal amount standard, provided that the other portions of the nominal risk standard are met. In determining whether such an exception would be appropriate, CMS would consider: (1) Whether the size of the attributed patient population is small; (2) whether the relative magnitude of expenditures assessed under the Other Payer APM is particularly small; and (3) in the case of test of limited size and scope, whether the difference between actual expenditures and expected expenditures would not be statistically significant even when actual expenditures are 4 percent above expected expenditures. We note that CMS would grant such exceptions rarely, and CMS would expect APMs considered for such exceptions to demonstrate that a sufficient number of APM Entities are likely to incur losses in excess of the higher MLR. In other words, the potential for financial losses based on statistically significant expenditures in excess of the benchmark remains meaningful for participants.
Second, we propose that the payment required by the Other Payer APM could be smaller when actual expenditures exceed expected expenditures by enough to trigger a payment greater than or equal to the total risk amount required under the nominal amount standard (as specified in Table 40). This exception ensures that the marginal risk requirement does not effectively require Other Payer APMs to incorporate total risk greater than the amount required by the total risk portion of the standard in order to become Other Payer Advanced APMs.
In evaluating both the total and marginal risk portions of the nominal amount standard, we would not include any payments the APM Entity or its participating providers would make to the other payer if actual expenditures exactly matched expected expenditures. In other words, payments made to the other payer outside the risk arrangement related to expenditures would not count toward the nominal risk standard. This requirement ensures that perfunctory or pre-determined payments do not supersede incentives for improving efficiency. For example, an Other Payer APM that simply requires an APM Entity to make a payment equal to 5 percent of the Other Payer APM benchmark at the end of the year, regardless of actual expenditure performance, would not satisfy the nominal amount standard.
Finally, like the Advanced APM criterion described in section II.F.4.b.(4) of this preamble, the amounts described in this section need not take a shared savings structure in which financial risk increases smoothly based on the amount by which an Other Payer Advanced APM Entity's actual expenditures exceed expected expenditures. The risk arrangement must be tied to expenditures, but the amount of that risk does not have to be directly proportional to expenditures. For instance, an APM Entity could be required to pay the payer a flat amount or an amount tied to the number of attributed beneficiaries in the case of exceeding an expenditure benchmark, provided that these amounts are otherwise structured in a way that satisfies the nominal amount standard.
Except for risk arrangements described under the Medicaid Medical Home Standard in paragraph (ii) below, we propose that for an Other Payer APM to meet the nominal amount standard the specific level of marginal risk must be at least 30 percent of losses in excess of the expected expenditures and total potential risk must be at least four percent of the expected expenditures.
Other Payer APM arrangements with less than 30 percent marginal risk would not meet the nominal amount standard. We believe that meaningful risk arrangements can be designed with marginal risk rates of greater than 30 percent. Any marginal risk below 30 percent creates scenarios in which the total risk could be very high, but the average or likely risk for an Other Payer APM Entity would actually be very low.
Table 40 summarizes the generally applicable nominal amount standard.
In establishing the proposed criteria for Other Payer Advanced APMs, we are keeping the approach to nominal risk as consistent as possible with the approach for the proposed Advanced APM criteria as described in section II.F.4.b.(4) of this preamble. The statute specifies that the Other Payer Advanced APM Entity must bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures. We believe it is important, to the extent possible and consistent with the statute, to adopt consistent financial risk standards with the Advanced APM
For Medicaid APMs we propose the same standard as for Other Payer APMs. However, we recognize that Medicaid practitioners may be less able to bear substantial financial risk because they are generally reimbursed at lower payment rates, and they serve low-income populations and those with significant health disparities. Therefore, we seek comment and supporting evidence on whether the proposal offered identifies the appropriate amounts of nominal risk for Medicaid APMs.
For Medicaid Medical Home Models, we propose that the minimum total annual amount that an APM Entity must potentially owe or forego to be considered an Other Payer Advanced APM must be at least:
• In 2019, 4 percent of the APM Entity's total revenue under the payer.
• In 2020 and later, 5 percent of the APM Entity's total revenue under the payer.
We believe that because few Medicaid Medical Homes have experience with financial risk, and because they tend to be smaller in size than other APM Entities, we should not include a potentially excessive nominal amount for such entities in the first year of the program. We have also taken into account that the MACRA explicitly highlights Medical Home Models, generally, for special treatment under the Quality Payment Program. We have less information on Medicaid Medical Home Models and their performance to date compared to our information on Medical Home Models. Medicaid Medical Home Models are still developing, and we believe the introduction of a nominal amount standard that is not currently widely represented in the marketplace should be approached in a measured manner. We therefore believe that the unique characteristics of Medicaid Medical Home Models warrant the application of a nominal amount standard that reflects these differences, and statute provides us with the flexibility to make such a distinction.
We seek comment on all of the proposed nominal amount standards. We also seek comment on the potential inclusion of a marginal risk amount in the standard and the extent to which it is applicable.
We propose that full capitation risk arrangements would meet this Other Payer Advanced APM financial risk criterion. We propose that for purposes of this rulemaking, a capitation risk arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made to an APM Entity for services furnished to a population of beneficiaries, and no settlement is performed for the purpose of reconciling or sharing losses incurred or savings earned by the APM Entity. Our rationale for this policy is the same as the rationale on capitation for Advanced APMs described in section II.F.4.b.(3) of this preamble. As such, we reiterate that capitation should not simply be a cash flow mechanism. We also reiterate that capitation arrangements qualifying under the financial risk standard must be structured to directly hold the provider—or the entity to which the provider has assigned their billing—accountable.
We seek comment on our proposal for categorical definition of Other Payer APM capitation risk arrangements as meeting the financial risk criterion for Other Payer Advanced APMs, and on our proposed definition of a capitation risk arrangement. We also seek comment on other types of arrangements that may be suitable for such treatment for purposes of this financial risk criterion.
In accordance with sections 1833(z)(2)(B)(iii)(II)(cc)(BB) and (C)(iii)(II)(cc)(BB) of the Act, we propose that Medicaid Medical Home Models that meet criteria comparable to a Medical Home Model expanded under section 1115A(c) of the Act would meet the Other Payer Advanced APM financial risk criterion. We propose that CMS will specify in subsequent rulemaking the criteria of any Medical Home Model that is expanded under section 1115A(c) of the Act that will be used for purposes of making this comparability assessment. We believe that the expanded Medical Home Model criteria can only be used for comparison when a Medical Home Model is, in fact, expanded as described in section II.F.4.b.(6) of this preamble, not merely by satisfying the expansion criteria under section 1115A(c) of the Act. If no such Medical Home Model has actually been expanded under section 1115A(c) of the Act, we would not have any criteria for comparison. In the absence of any expanded Medical Home Model to which we could draw comparisons, Medicaid Medical Home Models must meet the financial risk criterion through the other provisions (the financial risk and nominal amount standards) in order to be an Other Payer Advanced APM. We seek comment on how to determine the criteria of an expanded Medical Home Model that could be used for comparison, and on how similar the Medicaid Medical Home Model criteria must be to the expanded Medical Home Model criteria in order to be considered “comparable.”
We received multiple comments on the MIPS and APMs RFI requesting that participation in Medicare Advantage be credited as participation in Advanced APMs. We recognize that many eligible clinicians participating in Medicare Advantage may offer high-value care to Medicare beneficiaries enrolled in such plans.
With respect to the APM Incentive Payment, section 1833(z)(1)(A) of the Act clearly states that the APM Incentive Payment is based on payments for Part B for covered professional services (which are made under the Medicare Physician Fee Schedule) and which do not include payments for services furnished to Medicare Advantage enrollees. For QP determination calculations, we believe it is important to note that APMs may involve Medicare Advantage plans and payers other than Medicare. Under the All-Payer Combination Option for QP determinations, eligible clinicians and Advanced APM Entities can meet the QP threshold based in part on payment amounts or patients counts associated with Medicare Advantage plans and other payers, provided that such arrangements meet the criteria to be considered Other Payer Advanced APMs. However, under sections 1833(z)(2)(A), (2)(B)(i), and (3)(B)(i) of the Act, such Medicare Advantage and other payer payments cannot be included in the QP determination calculations under the Medicare Option, which requires that we only consider payment amounts or patient counts for Medicare Part B covered professional services. Regardless of which option—Medicare or All-Payer Combination—is used to determine that an eligible clinician is a QP for a year, the APM Incentive Payment calculation will only be based upon payments for Medicare Part B covered professional services, which does not include payments for
We recognize that Medicare Advantage contracts can include financial risk as well as quality performance standards and certified EHR and other health IT requirements that support high-value care. We propose to evaluate payment arrangements between eligible clinicians, APMs Entities and MA plans as Other Payer APMs and according to the proposed Other Payer Advanced APM criteria. In the assessment of MA plans with respect to the Other Payer Advanced APM criteria, it is important to note that the requirements refer to aspects of the payment arrangement between the MA plan and the participating APM Entity, and this includes the criterion for bearing more than a nominal amount of financial risk. To qualify as an Other Payer Advanced APM, there must be a financial risk component. We would not consider an arrangement where the MA plan meets the CEHRT and quality measures criteria outlined in this proposed rule, but pays the APM Entity on a fee-for-service basis, to be an Other Payer Advanced APM because there is no risk connected to actual cost of care exceeding projected cost of care. Because this arrangement would not be an Other Payer Advanced APM, it would not be assessed for the purposes of determining QPs. In addition, the financial relationship between CMS and the MA plan—even if the relationship is part of a APM—is not relevant to this assessment because there would not be a direct payment arrangement between CMS and the APM Entities or eligible clinicians.
We also received comments on the MIPS and APMs RFI expressing concern that the distribution of APM Incentive Payments could disadvantage Medicare Advantage plans relative to Medicare FFS by changing payment rates for health plans in a given area based on the aggregate APM incentive amounts paid to eligible clinicians in that area. APM Incentive Payments will be lump-sum payments made under Medicare Part B, but outside of the claims payment system. Medicare Advantage rates are set through a separate process, and payment policies for 2019 will be addressed in the Advance Notice and Rate Announcement for that program.
We propose that APM Entities and/or eligible clinicians must submit certain information for CMS to assess whether other payer arrangements meet the Other Payer Advanced APM criteria and to calculate Threshold Scores a QP determination under the All-Payer Combination Option. For CMS to make QP determinations at the individual eligible clinician level in the specified exception cases described in section II.F.5 and II.F.6 of this preamble, either the Advanced APM Entity or the eligible clinician may submit this information with respect to the individual eligible clinician. If we do not receive sufficient information to complete our evaluation of the other payer arrangement and perform the QP threshold calculation, we would not evaluate the eligible clinicians under the All-Payer Combination Option.
We propose that submissions by APM Entities and/or eligible clinicians must include at least sufficient information for CMS to determine whether the payment arrangement meets the Other Payer Advanced APM criteria described in this section. To make the QP determination using the All-Payer Combination Option, submissions must include specific payment and patient numbers for each payer from whom the eligible clinician has received payments during the QP Performance Period, in order to calculate the Advanced APM Entity eligible clinician group's or individual eligible clinician's Threshold Score. We propose that—by a date and in a manner specified by CMS—the following data must be submitted to CMS for consideration under the All-Payer Combination Option: (1) The payment amounts and/or number of patients furnished any service through each Other Payer Advanced APM for each payer; and (2) the sum of their total payment amounts and/or number of patients furnished any service from each payer.
CMS will ask each payer to attest to the accuracy of all submitted information including the reported payment and patient data. Contracts may be subject to audit by CMS. We propose that if a payer does not attest to the accuracy of the reported payment and patient data, these data will not be assessed under the All-Payer Combination Option. However, we recognize that such a requirement leaves eligible clinicians dependent on a payer over which they may have limited control. We therefore seek comment on alternatives to requiring payer attestation, such as addressing the scope and intensity of audits to verify the submitted data. For Advanced APM Entities and eligible clinicians participating in Medicaid, CMS will initiate a review and determine in advance of the QP determination period the existence of Medicaid Medical Home Models and Medicaid APMs based on information obtained from state Medicaid agencies and other authorities, such as professional organizations or research entities. We seek comment regarding how such a review and determination could be conducted.
Detailed guidance on implementing data collection for Calculation of the All-Payer Combination Option Threshold Score will be issued prior to 2019.
CMS may apply one or both of two different methods—using payment amounts or patient counts—to arrive at an eligible clinician's Threshold Score. CMS will compare the Threshold Score against the relevant QP Threshold or Partial QP Threshold to determine an eligible clinician's QP status for the year.
We propose that CMS would calculate Threshold Scores for eligible clinicians in an Advanced APM Entity under both the payment amount and patient count methods for each QP Performance Period. We also propose that CMS would assign QP status using the more advantageous of the Advanced APM Entity's two scores.
We believe that both the payment amount and patient count methods should be considered in order to produce Threshold Scores. As the two calculations differ there may be cases in which Threshold Scores vary enough that different QP determinations could result depending on which is used. In such an event, we do not believe that prioritizing the Threshold Score using one calculation over the other would yield an appropriate, non-arbitrary result. By using the greater of the Threshold Scores achieved, we hope to promote simplicity in QP determinations and to maximize the number of eligible clinicians that attain QP status each year. We seek comment on the use of the payment and patient count methods for the All-Payer Combination Option.
Section 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act specifies that the calculation under the All-Payer
The statue excludes payments made:
• By the Secretary of Defense for the costs of Department of Defense health care programs;
• By the Secretary of Veterans Affairs for the costs of Department of Veterans Affairs health care programs; and
• Under Title XIX in a state in which no Medicaid Medical Home Model or APM is available under the state plan.
We propose that title XIX payments or patients would be excluded in the numerator and denominator for the QP determination unless: (1) A state has at least one Medicaid Medical Home Model or Medicaid APM in operation that is determined to be an Other Payer Advanced APM; and (2) the relevant Advanced APM Entity is eligible to participate in at least one of such Other Payer Advanced APMs during the QP Performance Period, regardless of whether the Advanced APM Entity actually participates in such Other Payer Advanced APMs. This will apply to both the payment amount and patient count methods. We believe this Medicaid exclusion avoids penalizing eligible clinicians who do not have the possibility of participation in an Other Payer Advanced APM under Medicaid. We believe that failing to exclude such payments and/or patients would unduly disadvantage potential QPs by inflating denominators based on circumstances beyond their control. For example, if a state's Medicaid Medical Home Model is determined to be an Other Payer Advanced APM and is operated on a statewide basis, Medicaid payments will be included in the denominator for all eligible clinicians in that state assessed under the All-Payer Combination Option. However, if the state operates such an Other Payer Advanced APM at a sub-state level, and eligible clinicians who do not practice in the geographic area where the Medicaid Medical Home Model is available are not eligible to participate, Medicaid payments would not be included in such eligible clinicians' QP calculations. We will more fully develop the approach to identify Medicaid Medical Home Models and Medicaid APMs, as well as eligible clinician eligibility to participate in them, through subsequent rulemaking.
We seek comment on our proposals to determine exclusions and on how we could account for eligible clinician participation in Medicaid APM or Medicaid Medical Home Models, such as pilots where participation may be intentionally limited by the state.
We propose to calculate an All-Payer Combination Option Threshold Score for eligible clinicians in an Advanced APM Entity using the payment amount method, which would then be compared to the relevant QP Payment Amount Threshold and Partial QP Payment Amount Threshold to make a QP determination.
We propose to calculate the All-Payer Threshold Score for eligible clinicians in an Advanced APM Entity (or an eligible clinician that participates in multiple APMs, as this exception is discussed above) by dividing the value described under paragraph (ii) by the value described under paragraph (iii). This calculation would result in a percent value Threshold Score that CMS would compare to the QP Payment Amount Threshold and the Partial QP Payment Amount Threshold to determine the QP status of the eligible clinicians for the payment year. The calculations occur in two steps because there is a Medicare QP Threshold and an All-Payer QP Threshold. The formula for determining the payment Threshold Score is: Threshold Score = A/B, where:
We propose that the numerator would be the aggregate of all payments from all other payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM Entity's eligible clinicians—or the eligible clinician in the event of an individual eligible clinician assessment—under the terms of all Other Payer Advanced APMs during the QP Performance Period. For example, if a beneficiary is attributed to an ACO and sees a clinician outside that ACO, payments made to the non-ACO clinician would not count towards this numerator, even if the ACO is an Other Payer Advanced APM. Medicare Part B covered professional services will be calculated under the All-Payer Combination Option in the same manner as it is for the Medicare Option.
We propose that the denominator would be the aggregate of all payments from all other payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM Entity's eligible clinicians—or the eligible clinician in the event of an individual eligible clinician assessment—during the QP Performance Period. The portion of this amount that relates to Medicare Part B covered professional services will be calculated under the All-Payer Combination Option in the same manner as it is for the Medicare Option.
In this example, an Advanced APM Entity participates in a Medicare ACO initiative, a commercial ACO arrangement, and a Medicaid APM. Each of the APMs is determined to be an Advanced APM. In the QP Performance Period for payment year 2021 (proposed in this proposed rule to be 2019), the Advanced APM Entity receives the following payments:
In Table 41, the Advanced APM Entity meets the minimum Medicare threshold (30% >25%). However, it falls short of the QP Payment Amount Threshold (43% <50%). In this case, the Advanced APM Entity would meet the Partial QP Payment Amount Threshold (43% >40%).
Another Advanced APM Entity in the same year receives the following payments:
In Table 42, the Advanced APM Entity meets the minimum Medicare threshold (40% >25%). It also exceeds the QP Payment Amount Threshold (61% >50%). In this case, the eligible clinicians in the Advanced APM Entity would become QPs.
We seek comment on the payment amount method described in this proposal and any potential alternative approaches.
We propose to calculate a Threshold Score for the eligible clinician group in an Advanced APM Entity—or eligible clinician in the exception situations under sections II.F.5 and II.F.6 of this preamble—using the patient count method, which would then be compared against the relevant QP Patient Count Threshold and Partial QP Patient Count Threshold to determine the QP status of an eligible clinician for the year based on the higher of the two values.
We propose that the Threshold Score calculation for the patient count method would include patients for whom the eligible clinicians in an Advanced APM Entity furnish services and receive payment under the terms of an Other Payer Advanced APM, with certain exceptions as outlined in the previous section. This calculation would result in a percent value Threshold Score that CMS would compare to the QP Patient Count Threshold and the Partial QP Patient Count Threshold to determine the eligible clinicians' QP status for the payment year. The calculations occur in two steps as there is a Medicare Threshold requirement and an All-Payer Threshold requirement. The formula for determining the patient count Threshold Score is:
First, we propose that, like the Medicare Option, the patient count method under the All-Payer Combination Option would only count unique patients, with multiple eligible clinicians able to count the same patient. Similarly, we propose to count a single patient, where appropriate, in the numerator and denominator for multiple different Advanced APM Entities when counting the number of beneficiaries under this method section II.F.6 of this preamble. We also propose that CMS will not count any patient more than once for any single Advanced APM Entity. In other words, for each Advanced APM Entity, CMS will count each unique patient one time in the numerator, and one time in the denominator.
We believe that counting patients this way maintains integrity by preventing double counting of patients within an Advanced APM Entity while recognizing the reality that patients often have relationships with eligible clinicians in different organizations. We hope to avoid distorting patient counts for such overlap situations, especially in Advanced APM Entity-dense markets.
We seek comment on our proposal for counting patients and on alternative methods for counting beneficiary overlaps across Advanced APM Entities.
We propose that the numerator would be the number of unique patients to whom eligible clinicians in the Advanced APM Entity furnish services that are included in the measures of
We propose that the denominator would be the number of unique patients to whom eligible clinicians in the Advanced APM Entity furnish services under all non-excluded payers during the QP Performance Period.
In the QP Performance Period for payment year 2021 (proposed to be 2019 under this proposed rule) the Advanced APM entity experienced the following patient counts:
In Table 43, the Advanced APM Entity meets the minimum Medicare threshold (30% >20%). However, it falls short of the QP Patient Count Threshold (30% <35%). In this case, the Advanced APM Entity would meet the Partial QP Patient Count Threshold (30% >25%).
Another Advanced APM Entity in the same year experienced the following patient counts:
In Table 44, the Advanced APM Entity meets the minimum Medicare threshold (40% > 20%). It also exceeds the minimum QP Patient Count Threshold (61% > 35%). In this case, the eligible clinicians in the Advanced APM Entity would become QPs.
We seek comment on the patient count method described above and any potential alternative approaches.
Under sections 1833(z)(2)(B)(ii)(III) and (C)(ii)(III), an eligible clinician can only become a QP using the All-Payer Combination Option by providing the Secretary such information as is necessary for the Secretary to determine whether an Other Payer APM is an Other Payer Advanced APM and to determine the eligible clinician's Threshold Score under section II.F.7.c of this preamble. To be considered under the All-Payer Combination Option we propose that APM Entities or individual eligible clinicians must submit by a date and in a manner determined by CMS: (1) Payment arrangement information necessary to assess whether each Other Payer APM is an Other Payer Advanced APM, including information on financial risk arrangements, use of certified EHR technology, and payment tied to quality measures; and (2) for each Other Payer APM, the amounts of revenues for services furnished through the arrangement, the total revenues from the payer, the numbers of patients furnished any service through the arrangement (that is, patients for whom the eligible clinician is at risk if actual expenditures exceed projected expenditures), and the total numbers of patients furnished any service through the payer. CMS would then assess the characteristics of the Other Payer APMs to determine if they are Other Payer Advanced APMs and would notify the APM Entities and/or eligible clinicians of the Other Payer Advanced APM determinations based on their submissions. We propose further, that an Other Payer Advanced APM is required to have an outcome measure. If an Other Payer Advanced APM has no outcome measure, the Advanced APM Entity must attest that there is no applicable outcome measure on the MIPs list. CMS intends to establish specific requirements regarding the timing and manner of submission of such information through future rulemaking.
At this time, we seek comment from stakeholders on the specific types of payment arrangement information that would be necessary to assess whether an
We seek comment on the possibility of receiving information on Other Payer APMs and their participants directly from other payers in order to minimize reporting burden for APM Entities and eligible clinicians. We seek comment on the extent to which collecting voluntary submissions of data from other payers could reduce burden and increase program integrity through more accurate determinations of QP status based on payment or patient threshold calculations for Other Payer Advanced APMs. Likewise, we seek comment on the extent to which such data collection is operationally feasible or could infringe upon other payers' interests in maintaining the confidentiality of their business practices.
In addition, we propose to make early Other Payer Advanced APM determinations on other payer arrangements if sufficient information is submitted at least 60 days before the beginning of a QP Performance Period. This would allow CMS to offer eligible clinicians advance notice of their prospects of achieving QP status in the event they are assessed under the All-Payer Combination Option. This early determination would be considered final for the QP Performance Period based on the Other Payer APM information submitted. If new information is submitted based on a change in the Other Payer APM during the QP Performance Period, the initial determination could be subject to review and revision. We also propose that, to the extent permitted by federal law, CMS would maintain confidentiality of certain information that the Advanced APM Entities and/or eligible clinicians submit regarding Other Payer Advanced APM status in order to avoid dissemination of potentially sensitive contractual information or trade secrets. We propose that, unlike our proposal for Advanced APM determinations, the Other Payer Advanced APM determinations would be made available directly to participating APM Entities and eligible clinicians rather than through public notice, and we would explain how and within what timeframes such notifications will occur in subregulatory guidance. CMS may consider publicly releasing information on Other Payer Advanced APMs on the CMS Web site with general and/or aggregate information on the payers involved and the scopes of such agreements.
We seek comment on the proposed timing and method of feedback to Advanced APM Entities and eligible clinicians regarding the status of Other Payer Advanced APMs for which they have submitted information and on the proposed early determination process and the ability of Advanced APM Entities and eligible clinicians to submit sufficient information prior to the beginning of a QP Performance Period. We also seek comment on the types of information that contain potentially sensitive information.
The information submitted to determine whether an eligible clinician is a QP under the All-Payer Combination Option may be subject to audit, and eligible clinicians and Advanced APM Entities will be required to maintain copies of any supporting documentation. If an audit reveals a material discrepancy in the information submitted to CMS, and such discrepancy affected the eligible clinician's QP status, the APM Incentive Payment may be recouped. Providing false information may reflect a false claim subject to investigation and prosecution. We may provide further details on the audit and recoupment process under the All-Payer Combination Option in future rulemaking.
The APM Incentive Payment is specified under section 1833(z)(1) of the Act.
This section describes our proposal for calculating the amount of the APM Incentive Payment and accounts for the specific scenarios outlined under sections 1833(z)(1)(A)(i) and 1833(z)(1)(A)(ii) of the Act. This section also describes the process by which CMS proposes to disburse these APM Incentive Payments to QPs.
In accordance with section 1833(z)(1)(A) of the Act, CMS will make an APM Incentive Payment for a year to eligible clinicians that achieve QP status for the year during years 2019 through 2024. In accordance with the statute, we propose that this APM Incentive Payment shall be equal to 5 percent of the estimated aggregate amounts paid for Medicare Part B covered professional services furnished by the eligible clinician from the preceding year across all billing TINs associated with the QP's NPI.
The incentive payment base period is the range of dates that will be used to calculate the estimated aggregate payment amounts for the year preceding the QP payment year that will serve as the basis for the incentive payment. Section 1833(z)(1)(A) of the Act states that in calculating the amount that is equal to 5 percent of the estimated aggregate payment amounts for Medicare Part B covered professional services under this part for the preceding year, the payment amount for the preceding year may be an estimation for the full preceding year based on a period of such preceding year that is less than the full year. We believe this provision gives CMS flexibility in determining the incentive payment base period. We propose to use the full calendar year prior to the payment year as the incentive payment base period from which to calculate the estimated aggregated payment amounts.
When determining the time period for the incentive payment base period, we considered using a partial calendar year and a completion factor to forecast and account for the remainder of claims that would be billed during the remainder of the calendar year. However, there are instances where eligible clinician practice patterns change during a given period of time. For example, an eligible clinician may begin practicing, retire, change practice locations, or switch between full-time and part-time; or there could be seasonal fluctuations in an eligible clinician's practice. Given the possible variability in billings and payments over a calendar year, we believe an incentive payment base period of less than one year would produce a less accurate estimated aggregated payment amount and could potentially disadvantage some eligible clinicians based on the circumstances of their practice in a given year.
Using a complete calendar year of claims would allow for the most accurate representation of the covered professional services delivered by each eligible clinician, which we believe outweighs a modest potential delay in making the APM Incentive Payment. We seek comment on our proposal to use the entire preceding calendar year as the incentive payment base period.
Section 1833(z)(1)(A) of the Act directs CMS to make the APM Incentive Payment in a lump sum on an annual basis “as soon as practicable.” We believe that, in implementing this provision, it is important to balance the desire for accuracy in the data used to calculate the APM Incentive Payment with the desire to expedite the payments so that the APM Incentive Payments are made in an appropriate and timely manner.
We propose to calculate the APM Incentive Payment based on data available 3 months after the end of the incentive payment base period in order to allow time for claims to be processed. For example, for the 2019 payment year, we would capture claims submitted with dates of service from January 1, 2018 through December 31, 2018 and processing dates of January 1, 2018 through March 31, 2019. We believe that 3 months of claims run-out is sufficient to conduct the APM Incentive Payment calculations in an accurate and timely manner. This methodology is consistent with the claims run-out timeframes used for reconciliation payments in several current APMs, such as the Shared Savings Program, the Pioneer and Next Generation ACO Models, and CEC. We seek comment on the potential use of a completion factor. We note that several current APMs apply the 3 month claims run-out in conjunction with a completion factor. However, where a completion factor may be appropriate for payments based on claims submitted by groups of providers and suppliers that may be billing under multiple TINs, we believe that with payments based on individual eligible clinician claims, categorical variability in claims completion across type of eligible clinicians would cause inequitable results.
We recognize that by pulling claims 3 months after the end of the performance year to conduct reconciliation, we would not have a complete claims run-out, especially for the later months of the year. We considered instead proposing a 6 month of claims run-out. On average, 99.3 percent of Medicare claims are processed within 3 months after the end of a calendar year, and 99.8 percent of claims are processed within 6 months after the end of a calendar year. We concluded that the benefit of making the incentive payments 3 months earlier outweighed the benefit of an additional 3 months of processed claims, since the difference in claims completion is extremely small. We also believe that our proposal provides an additional incentive for timely submission of claims at the end of the year because claims for services furnished during the incentive payment base period that are not submitted and processed within this 3 month run-out would not be considered in the incentive payment amount calculations.
We also considered our regulations at § 424.44 and the Medicare Claims Processing Manual (Pub. L. 100-04), Chapter 1, Section 70, stating that Medicare claims can be submitted no later than one calendar year from the date of service. We considered waiting for the full claims run-out 12 months after the end of the performance year, but were concerned that this approach would significantly delay the timing of the incentive payments and possibly dilute their effect as a reward for eligible clinician decisions to participate in APMs. We also believe that such a significant delay would not be consistent with the statutory intent of making payments as soon as practicable.
In summary, for the incentive payment base period we propose to use a complete calendar year of claims with 3 months of claims run-out from the end of the calendar year. We believe our proposed approach balances our goals of providing incentive payments in a reasonable timeframe while being able to account for the vast majority (on average, 99.3 percent of claims for) covered professional services. Given these parameters, we estimate that incentive payments could be made approximately 6 months after the end of the incentive payment base period, or roughly mid-way through the payment year. However, we propose that the APM Incentive Payment would be made no later than one year from end of the incentive payment base period. We do not propose to set a specific deadline mid-way during the payment year because we believe doing so could pose operational risks in the event that 6 months is impracticable in a given year for reasons that CMS cannot predict. We seek comment on our proposed timing of the incentive payment base period.
Part B covered professional services under the Medicare PFS are currently subject to several statutory provisions that are geared towards improving quality and efficiency in service delivery. Eligible clinicians are subject to payment adjustments under: The Medicare EHR Incentive Program for Eligible Professionals (MU), the PQRS, and the VM. Beginning in 2019, the MIPS adjustment, as described in section II.E.5, will replace payment adjustments under the MU, PQRS, and VM for all MIPS eligible clinicians. These special payment provisions directly adjust the payment amount that eligible clinicians receive under the PFS. In contrast, we consider the APM Incentive Payment to be separate from, and, as indicated under section 1833(z)(1)(A) of the Act, in addition to the amount of payments made for covered professional services under the Medicare PFS.
We propose to exclude the MIPS, VM, MU and PQRS payment adjustments when calculating the estimated aggregate payment amount for covered professional services upon which to base the APM Incentive Payment amount. For example, a QP who receives an upward fee adjustment during 2018 in VM would not see that adjustment reflected in the estimated aggregate payment amount for covered professional services used to calculate his or her APM Incentive Payment in 2019. Similarly, a QP who receives a downward fee adjustment during 2018 in VM would not see that amount reflected in the aggregate payment amount for the APM Incentive Payment.
We believe this proposed policy is most consistent with the specification in section 1833(z)(1)(A) of the Act that the APM Incentive Payment is based on the estimated aggregate payment amounts for “such” covered professional services for the preceding year, which refers to the Part B covered professional services furnished by the particular eligible clinician.
While we considered the alternative of including these performance-related payment adjustments in calculating the APM Incentive Payment, we are concerned that such a policy would create incentives that are not aligned with the intent of the APM Incentive Payment. As previously stated in our policy principles, we believe that the APM Incentive Payment is best viewed as a complementary reward for eligible clinicians that have a substantial degree of participation in the most advanced APMs and deliver high-value care, not an evaluation of their performance within the APM or in another statutorily required performance-based payment adjustment.
For example, the incentive payment base period for the 2019 payment year will be 2018, and any QP in payment year 2019 may have quality payment adjustments from the PQRS, MU, and VM payment provisions, which affect the amount of incentive payment for that year, in the incentive payment base period. The PQRS, MU, and VM payment adjustments will sunset at the end of 2018. In addition, in 2020 and
We also proposed in section II.F.6.b.(1) to account for payment adjustments in the QP determination process in the same manner as when calculating the amount of the APM Incentive Payment. If we were to include statutory payment adjustments when determining QP status, there could be situations where an eligible clinician could become a QP because of a positive payment adjustment amount, or conversely, there could be situations where an eligible clinician would not meet the QP threshold because of a negative payment adjustment. We believe that our proposal to not include payment adjustments when determining QP status for a year, or when calculating the amount of the APM Incentive Payment, allows CMS to assess all eligible clinicians on the same merits throughout the entire QP determination and APM Incentive Calculation process. We do not believe the intent of the statute was to enhance or negate an eligible clinician's opportunity to become a QP in a given performance year, or to enhance or negate the amount of APM Incentive Payment a QP receives, based on factors that are extraneous to APM participation.
We seek comment on this proposed approach to coordinating the various Medicare Physician Fee Schedule payment adjustments when calculating the amount of the APM Incentive Payment.
We recognize that many APMs use incentives and financial arrangements that differ from usual fee schedule payments. Section 1833(z)(1)(A)(i) of the Act requires us to establish policies for payments that are made to an Advanced APM Entity rather than directly to the QP. Section 1833(z)(1)(A)(ii) of the Act requires us to establish policies for when payment is made on a basis other than fee-for-service. For the purposes of this proposed regulation, we place such payments into three categories: Financial risk payments, supplemental service payments, and cash flow mechanisms.
Financial risk payments are non-claims-based payments, based on performance in an APM when an APM Entity assumes responsibility for the cost of a beneficiary's care, whether it be for an entire performance year, or for a shorter duration of time, such as over the course of a defined episode of care. We note that in the context of categorizing these types of payments as “financial risk payments,” we refer to payments that may be based on the cost of a beneficiary's care and do not necessarily limit these payments to financial arrangements that would require an APM Entity to accept downside risk. For instance, we would consider the shared savings payments to ACOs in all tracks of the Shared Savings Program to be financial risk payments. We would also consider net payment reconciliation amounts from CMS to an Awardee (or vice versa) under the BPCI Initiative, and reconciliation payments from CMS to a participant hospital or repayment amounts from a participant hospital to CMS under the CJR model to be examples of financial risk payments.
We propose to exclude financial risk payments such as shared savings payments or net reconciliation payments, when calculating the estimated aggregate payment amount. Financial risk payments are not for specific Medicare Part B covered professional services; rather they are for performance in an APM. Therefore, we believe their inclusion in the estimated aggregate payment amount would be inconsistent with the statutory language and our stated policy principles. In addition, the difficulty of disaggregating payments to individual QPs and the lagged timing of some financial risk payments creates significant policy and operational barriers that we do not believe are in line with our objective of making APM Incentive Payments in a timely manner.
Supplemental service payments are Medicare Part B payments for longitudinal management of a beneficiary's health, or for services that are within the scope of medical and other health services under Medicare Part B that are not separately reimbursed through the physician fee schedule. Often these are per-beneficiary per-month (PBPM) payments that are made for care management services or separately billable services that share the goal of improving quality of care overall, enabling investments in care improvement, and reducing Medicare expenditures for services that could be avoided through care coordination. For example, the OCM makes a per beneficiary Monthly Enhanced Oncology Services (MEOS) payment to practices for care management and coordination during episodes of care initiated by chemotherapy treatment.
We propose to determine on a case-by-case basis whether certain supplemental service payments are in lieu of covered services that are reimbursed under the PFS. In cases where payments are for covered services that are in lieu of services reimbursed under the PFS, those payments would be considered covered professional services and would be included in the APM Incentive Payment amounts. We propose to include a supplemental service payment in calculation of the APM Incentive Payment amount if it meets all of the following 4 criteria:
(1) Payment is for services that constitute physician services authorized under section 1832(a) of the Act and defined under section 1861(s) of the Act.
(2) Payment is made for only Part B services under the first criterion above, that is, payment is not for a mix of Part A and Part B services.
(3) Payment is directly attributable to services furnished to an individual beneficiary.
(4) Payment is directly attributable to an eligible clinician.
Table 45 provides an example of how a limited number of supplemental service payments in currently operating or recently announced APMs would be considered with respect to our proposed criteria. We further propose to establish a process by which we notify the public of the supplemental service payments in all APMs and identify the supplemental service payments that meet our proposed criteria and would be included in the APM Incentive Payment calculations. Similar to our proposal to announce Advanced APM determinations, we propose to post an initial list of supplemental service payments that would be included in our APM Incentive Payment calculations on the CMS Web site. As new APMs are announced, CMS would include its determination of whether an APM related supplemental service payment would be included in our APM Incentive Payment calculations, if applicable, in conjunction with the first public notice of the APM. We propose to update the list of supplemental service payments that would be included in our APM Incentive Payment calculations on an ad hoc basis, but no less frequently than on an annual basis.
We seek comment on this proposed approach to include certain supplemental service payments when calculating the basis for the amount of the APM Incentive Payment.
Cash flow mechanisms involve changes in the method of payments for services furnished by providers and suppliers participating in an APM Entity. In themselves, cash flow mechanisms do not change the overall amount of payments. Rather, they change cash flow by providing a different method of payment for services. An example of a cash flow mechanism is the population-based payment (PBP) available in the Pioneer ACO Model and the Next Generation ACO Model. PBP provides ACOs with a monthly lump sum payment in exchange for a percentage reduction in Medicare fee-for-service payments to certain ACO providers and suppliers.
For expenditures affected by cash flow mechanisms, we propose to calculate the estimated aggregate payment amount using the payment amounts that would have occurred for Part B covered professional services if the cash flow mechanism had not been in place. For example, for QPs in an ACO receiving PBP with a 50 percent reduction in fee-for-service payments, we would use the amount that would have been paid for Part B covered professional services in the absence of the 50 percent reduction. Cash flow mechanisms represent a potential reallocation of dollars between eligible clinicians and entities for specific purposes related to care improvement. We do not believe that the presence of certain cash flow mechanisms should impact the APM Incentive Payment amount, and we do not intend for the APM Incentive Payment to influence the use or attractiveness of cash flow mechanisms in current and future APMs.
We recognize that new payment methods and financial arrangements may be developed that do not fit into these categories as described. For instance, in the recently announced CPC + Model, the supplemental service payments (that is, the CMFs) would meet all of our proposed criteria to be included in the APM Incentive Payment calculations. The CMFs are for Medicare Part B covered professional services, and the CMF payments will only cover Medicare Part B covered professional services. The CMF amounts will be risk adjusted based on each individual beneficiary's HCC risk scores; therefore these payments will be attributable to individual beneficiaries. Additionally, the attribution method in the CPC + Model uses a combination of the TIN/Individual NPI/Practice Address when attributing an individual beneficiary to a CPC Practice site. However, the CMF payments for attributed beneficiaries are aggregate payments is made to each CPC Practice Site. We recognize that throughout the course of a QP Performance Period more than one NPI may furnish covered professional services to an attributed beneficiary. If that occurs, more than one NPI could potentially receive the corresponding CMF for that eligible beneficiary. We do not believe it would be appropriate to count the same CMF for more than one NPI. Therefore, (assuming that the CPC + Model is deemed an Advanced APM and the APM Entity group achieves the QP threshold for a QP Performance Period), we could split the CMF amounts equally between the multiple NPIs, or we could develop a method to “assign” the NPI for which the CMFs would be counted in their APM Incentive Payment calculation based on the plurality of visits with that beneficiary.
We seek comment on the methods that CMS could use to allocate the supplemental service payments to individual NPIs in these types of scenarios in which payment for a supplemental service payment is made in the aggregate to an APM Entity.
We also recognize that payment methods and financial arrangements may evolve over time and would need to be addressed in future rulemaking. CMS seeks comment on the proposals for accounting for risk-based payments, supplemental service payments, and cash flow mechanisms when calculating the amount of APM Incentive Payment.
Section 1833(z)(1)(D) of the Act specifies that CMS shall not include certain existing Medicare incentive payments in the calculation of the APM Incentive Payment. This includes payments made under section 1833 of the Act (subsections (m), (x), and (y)). Section 1833(m) of the Act describes the HPSA Physician Bonus Program. The HPSA Physician Bonus Program provides bonus payments to physicians for physicians' services furnished in geographic areas that are designated as of December 31 of the prior year by the HRSA as HPSAs under section 332 (a)(1)(A) of the PHS Act. The HPSA bonus payment is 10 percent of the Medicare Part B payment amount for the service; and this bonus is paid as a quarterly lump sum payment.
Subsection (x) describes the Primary Care Incentive Payment (PCIP) program. The PCIP payment amount was 10 percent of the payment amount for Medicare Part B primary care services furnished by primary care practitioners for whom primary care services accounted for at least 60 percent of their allowed fee-for-service charges in a prior qualification period. For purposes of the PCIP program, primary care practitioners were defined as those physicians with certain Medicare specialty codes and certain types of non-physician practitioners. The PCIP payment was made on a quarterly basis. This bonus payment expired under the statute on December 31, 2015.
Subsection (y) describes the HPSA Surgical Incentive Payment (HSIP). For major surgical procedures furnished by physicians with a primary specialty designation of “general surgeon” in HPSAs (under section 332(a)(1)(A) of the PHS Act), physicians received an additional 10 percent bonus payment in addition to the amount of payment that would otherwise be made. This additional payment was combined with any other HPSA payment outlined in 1833 of the Act, subsection (m), and was paid on a quarterly basis. This bonus payment expired under the statute on December 31, 2015.
Section 1833(z)(1)(D) of the Act also directs CMS not to include APM Incentive Payments when calculating payments made under section 1833 (subsections (m), (x), and (y)) of the Act. CMS considers the APM Incentive Payment to be separate from the incentive payments as previously discussed in this section and has established procedures to ensure that the APM Incentive Payment will not be included when calculating the amount of incentive payments made under section 1833 (subsections (m), (x), and (y)) of the Act.
Section 1833(z)(1)(C) states that the amount of the APM Incentive Payment shall not be taken into account for purposes of determining actual expenditures under an APM and for purposes of determining or rebasing any benchmarks used under the APM. As a lump sum payment, the APM Incentive Payments will be made outside of the Medicare claims processing system. Current APMs, such as the Medicare ACO initiatives and the CJR model, have established procedures for ensuring that lump sum payments from other APMs are accounted for when they do their APM reconciliations and rebasing calculations. We anticipate that each APM will have in place a procedure to avoid counting APM Incentive Payments toward determining actual expenditures or rebasing any benchmarks under the APM.
Eligible clinicians who furnish services at Critical Access Hospitals (CAHs) that have elected to be paid for outpatient services under section 1834(g)(2)(B) of the Act (Method II) will be eligible to become QPs and receive the APM Incentive Payment if they are part of an Advanced APM Entity. As stated in section II.F.6.d.(1) of this proposed rule, professional services furnished at a Method II CAH are considered “covered professional services” because they are furnished by an eligible clinician and payment is based on the Medicare Physician Fee Schedule. Therefore, the APM Incentive Payment would be based on the amounts paid for those services attributed to the eligible clinician, as identified using the attending NPI included on a submitted claim, in the same manner as all other covered professional services.
For an eligible clinician who becomes a QP based on covered professional services furnished at a Method II CAH, we propose that the APM Incentive Payment would be made to the CAH TIN that is affiliated with the Advanced APM Entity. This proposal is consistent with how CMS proposes to make the APM Incentive Payment to eligible clinicians who practice at locations other than Method II CAHs. We seek comment on this proposal.
As explained in section II.F.6.d.(2) of this preamble, payment for services furnished by eligible clinicians in RHCs and FQHCs is not reimbursed under or based on the PFS. Therefore, professional services furnished in those settings would not constitute covered professional services under section 1848(k)(3)(A) of the Act and would not be considered part of the amount upon which the APM Incentive Payment is based. For eligible clinicians that practice in RHCs or FQHCs, this does not preclude the inclusion of payment amounts for covered professional services furnished by those eligible clinicians in other settings. This only excludes payments made for RHC and FQHC services furnished by the eligible clinicians. For example, an eligible clinician may practice at both an FQHC and with a separate physician group practice that receives payment under the PFS. If the eligible clinician becomes a QP under the methodologies described in II.F.6, whether based on their participation in an Advanced APM Entity that includes the FQHC as outlined in section II.F.6.d.(2) or based on their participation in an Advanced APM Entity that includes the separate physician group practice, or both, only the eligible clinician's payments for covered professional services at the separate physician group practice setting would form the basis amount for the APM Incentive Payment.
The APM Incentive Payment, as described in this section, will be made to QPs who are identified by their unique TIN/NPI combination as participants in an Advanced APM Entity on a CMS maintained list.
We received a number of comments on the MIPS and APMs RFI regarding the process by which we should make the APM Incentive Payment. One commenter suggested that we give QPs the opportunity to select where they want the APM Incentive Payment to be sent, while another suggested that we send payments directly to the individual eligible clinician. A number of commenters recommended that CMS make the APM Incentive Payments directly to the Advanced APM Entity. Additionally, some commenters noted that making payments directly to the Advanced APM Entity would allow Advanced APM Entities to fairly and accurately allocate incentive payments
After consideration of these comments, we propose that for eligible clinicians that are QPs, CMS would make the APM Incentive Payment to the TIN that is affiliated with the Advanced APM Entity through which the eligible clinician met the threshold during the QP performance period. For both individual eligible clinicians and group practices, CMS uses the TIN as the billing unit. Earlier in this section, we proposed that the APM Incentive Payment would be calculated across all billing TINs associated with an NPI. Medicare has the ability to track all unique TIN/NPI combinations associated with an individual NPI, including which TINs are affiliated with an Advanced APM entity. We considered making separate payments for each TIN/NPI combination associated with the individual eligible clinician's APM Incentive Payment, similar to the current PQRS incentive payment program. Under the current PQRS incentive payment program, incentive payments are paid to the holder of the TIN, aggregating individual incentive payments for groups that bill under one TIN. For eligible clinicians who submit claims under multiple TINs, CMS groups claims by TIN for payment purposes and any incentive payments earned are paid to that specific TIN. As a result, an eligible clinician with multiple TINs who qualifies for the PQRS incentive payment under more than one TIN would receive a separate PQRS incentive payment associated with each TIN.
However, we believe that making the APM Incentive Payments to the TIN associated with the Advanced APM Entity during the QP Performance Period would be most consistent with section 1833(z) of the Act to incentivize participation in Advanced APMs. Rewarding TINs that are not involved in an Advanced APM for the activity of their constituent NPIs through separate entities seems to be antithetical to the objective of the APM Incentive Payment. We also believe that making the APM Incentive Payments to the TIN associated with the Advanced APM Entity during the QP Performance Period is most consistent with section 1833(z) of the Act with regards to making the APM Incentive Payments to eligible clinicians who become QPs. We also hope to promote simplicity and foster QP awareness of the recipient of the APM Incentive Payment that is based on their activity within APMs. We also believe that making multiple separate payments would increase complexity for both CMS and eligible clinicians.
Additionally, we proposed in section II.F.5 of this preamble, that in order to be a QP, an eligible clinician would need to be identified using a CMS maintained participation list of eligible clinicians for the Advanced APM entity. This proposal would allow CMS to track the APM Entity/TIN/NPI identifiers for each individual eligible clinician, and we believe that this information will allow CMS to determine which of the QP's TINs should receive the APM Incentive Payment.
We recognize that there may be scenarios in which an individual eligible clinician may change his or her affiliation between the QP Performance Period and the payment year such that the eligible clinician no longer practices at the TIN affiliated with the Advanced APM Entity. In this instance, we propose to make the APM Incentive Payment to the TIN provided on the eligible clinician's CMS-588 EFT Application. This proposal is consistent with the process that CMS has used to make incentive payments under other programs, such as the PCIP program.
We seek comment on our proposal to make the APM Incentive Payments to the TIN affiliated with the Advanced APM Entity through which an individual eligible clinician becomes a QP during the QP Performance Period and our proposal to make the APM Incentive Payment when an eligible clinician no longer practice at the TIN affiliated with the Advanced APM Entity. We also seek comment on alternative options that maintain the goals of equity and simplicity, and of using the APM Incentive Payment to encourage and reward participation in Advanced APMs.
As discussed in the exceptions section II.F.5 of this preamble, we recognize that there may be instances where none of the Advanced APM Entities with which an individual eligible clinician participates meets the QP threshold. In this instance, we have proposed to assess the eligible clinician individually, using services furnished through all Advanced APM Entities during the QP Performance Period. When we make the QP determination at the individual eligible clinician level, we propose to split the APM Incentive Payment amount proportionally across all of the QP's TINs associated with Advanced APM Entities. For example, if an eligible clinician is a QP who participates in two APMs (APM 1 and APM 2), and has 75 percent of his or her payments (or patients) used to make the QP determination through APM 1 and 25 percent of his or her payments (or patients) used to make the QP determination APM 2, we would make 75 percent of the APM Incentive Payment to the TIN affiliated with APM 1, and 25 percent of the APM Incentive Payment to the TIN affiliated with APM 2. We believe that splitting the APM Incentive Payment in this way is most consistent with section 1833(z) of the Act, as well as our goal to encourage participation in APMs. We also believe that splitting the incentive payment in this way appropriately recognizes the several activities of the individual eligible clinician toward achieving the QP threshold.
CMS seeks comment on the proposal to split the APM Incentive Payment among the QP's TINs associated with Advanced APM Entities in instances where the QP determination is made at the individual eligible clinician level. We also welcome comments regarding to which TIN(s) payments should be made in the cases where the QP changes TIN affiliations between the QP Performance Period and the payments of the APM Incentive Payment.
We anticipate that the notification of the APM Incentive Payment amount will not occur at the same time as the notification of QP status, but will occur later in the year to allow for accurate calculation and validation of the incentive payment amount. We propose to send notification to both Advanced APM Entities and their individual participating QPs of their APM Incentive Payment amount as soon as CMS has calculated the amount of the APM Incentive Payment and performed all necessary validation of the results. Following our proposed method to notify eligible clinicians of their QP status, as discussed in section II.F.5 of this preamble, we propose that the APM Incentive Payment amount notification would be made directly to QPs in combination with a general public notice that such calculations have been completed for the year. For the direct QP notification, CMS intends to include the amount of APM Incentive Payment and the TIN to which the incentive payments will be made. In the case that a QP determination is made at the individual eligible clinician level, and the incentive payment is split across multiple TINS, CMS intends to identify which TINs we will make the incentive payment, and include the amount of APM Incentive Payment that will be
We seek comment on other methods for the notification of APM Incentive Payment amount. We also seek comment on the content of such notifications so that they may be as clear and useful as possible.
In an effort to accurately award the APM Incentive Payment and preserve the integrity of the Medicare program, we propose that CMS will monitor Advanced APM Entities and eligible clinicians on an ongoing basis for non-compliance with the conditions of participation for Medicare and the terms of the relevant Advanced APMs in which they participate during the QP Performance Period. This will include vetting of applicants to Advanced APMs to determine whether they are in compliance with the conditions of participation of Medicare and ongoing, periodic assessments of Advanced APM Entities and eligible clinicians by APMs in conjunction with the CMS Center for Program Integrity and other relevant federal government departments and agencies. These actions are currently taking place for APMs and will continue in the future as stated in the proposed rule.
We propose that if an Advanced APM terminates an Advanced APM Entity or eligible clinician during the QP Performance Period for program integrity reasons, or if the Advanced APM Entity or eligible clinician is out of compliance with program requirements, CMS may reduce or deny the APM Incentive Payment to such eligible clinicians. In addition, if the APM Incentive Payment is paid during the QP Performance Period and the Advanced APM Entity or eligible clinician is later terminated due to a program integrity matter arising during the QP Performance Period, CMS may recoup all or a portion of the amount of the payment from the entity to which CMS made the payment.
We also propose that CMS will reopen and recoup any payments that were made in error in accordance with procedures similar to those set forth at §§ 405.980 and 405.370
As discussed in section II.F.7.b.(7) of the preamble, we propose that APM Entities and/or eligible clinicians must submit certain information for CMS to assess whether other payer arrangements meet the Other Payer Advanced APM criteria and to calculate the Threshold Score for a QP determination under the All-Payer Combination Option. We also propose that Advanced APM Entities and eligible clinicians must maintain copies of all records related to the All-Payer Combination Option for at least ten years and must provide the government with access to these records for auditing and inspection purposes. If an audit reveals that the information submitted is inaccurate, CMS may recoup the APM Incentive Payment. We note that nothing in this proposed rule limits or restricts the authority of the Office of the Inspector General.
We seek comment on our monitoring and program integrity proposals.
Section 101(e)(1) of the MACRA entitled, “Increasing the Transparency of Physician-Focused Payment Models,” adds a new section 1868(c) to the Act. In general, this section establishes an innovative process for individuals and stakeholder entities (stakeholders) to propose physician-focused payment models (PFPMs) to the Physician-Focused Payment Model Technical Advisory Committee (PTAC). A copy of the PTAC's charter, established by the Secretary on January 5, 2016, is available at
Section 1868(c)(2)(A) of the Act requires the Secretary to establish, through notice and comment rulemaking following an RFI, criteria for PFPMs (PFPM criteria), including models for specialist physicians, that could be used by the PTAC in making comments and recommendations on PFPMs. We issued the MIPS and APMs RFI requesting stakeholder input on PFPMs on October 1, 2015, and propose PFPM criteria in this rule, section II.F.10.c. of this proposed rule.
Section 1868(c)(2)(B) of the Act specifies that stakeholders may submit proposals to the PTAC on an ongoing basis for PFPMs that they believe meet the PFPM criteria established by the Secretary. We recognize this statutory directive, but do not propose to define “ongoing basis” because we believe that the process for submitting proposals to the PTAC should be determined by the PTAC.
Section 1868(c)(2)(C) of the Act requires the PTAC to review stakeholders' proposed PFPMs, prepare comments and recommendations regarding whether such PFPMS meet the PFPM criteria established by the Secretary, and submit those comments and recommendations to the Secretary.
The PTAC, established under section 1868(c)(1)(A) of the Act, is an independent committee comprised of 11 members. As required under section 1868(c)(1)(B) of the Act, the initial appointments to the PTAC were made by the Comptroller General of the United States on October 9, 2015. The terms of the first appointed members of the PTAC are intended to be staggered, with the first set of appointments for terms of 1, 2, or 3 years. After the initial appointments, all subsequent appointments would be for terms of 3 years. PTAC members who were among the initial appointments may be reappointed for subsequent 3-year terms. There are no limitations for how many terms a PTAC member may serve. No end date for the PTAC is specified. Section 1868(c)(1)(B)(ii) and (iii) of the Act state that no more than 5 members of the PTAC shall be providers of services or suppliers, or representatives of providers of services or suppliers, and no member of the PTAC shall be an employee of the federal government. We received responses to the MIPS and APMs RFI recommending that CMS ensure that the PTAC is made up of varying ratios of professionals from particular backgrounds. We appreciate these responses; however, section 1868(c) of the Act specifies that the Comptroller General of the United States is to appoint members of the PTAC. Therefore, CMS does not have the authority to appoint members of the PTAC.
Section 1868(c)(2)(D) of the Act requires the Secretary to review the PTAC's comments and recommendations on proposed PFPMs and to post “a detailed response” to those comments and recommendations on the CMS Web site. We received comments on the MIPS and APMs RFI requesting that we review PFPM proposals from stakeholders before they are submitted to the PTAC. We also received comments on the MIPS and APMs RFI requesting that the PTAC review PFPM proposals under development by stakeholders before they are formally submitted to the PTAC. Section 1868(c) of the Act does not require either the PTAC or the Secretary to evaluate proposed PFPMs prior to their submission to the PTAC,
We also received responses to the MIPS and APMs RFI recommending that all proposed PFPMs that the PTAC recommends to the Secretary should be tested by us. Without being able to predict the volume, quality, or appropriateness of the PFPMs that the PTAC would recommend, we are not in a position to propose a commitment to test all such models. Section 1868(c) of the Act does not require us to test models that are recommended by the PTAC and given a favorable response by the Secretary. However, this does not imply that we would not give serious consideration to proposed PFPMs recommended by the PTAC. The PTAC serves an important advisory role in the implementation of APMs, but there are additional considerations that must be made by the Secretary beyond what is provided by the PTAC, such as competing priorities and available resources. We believe that this flexibility is important because the Secretary, and CMS through its delegated authority to test APMs, must retain the ability to make final decisions on which models to test and when, based on multiple factors including those that the Innovation Center currently uses to determine which payment models to test as described in section II.F.10.d. of this proposed rule.
While we would consider these factors separately from the PTAC's review process, the decision to test a model recommended by the PTAC would not require a second application process to us as speculated by some commenters on the MIPS and APMs RFI; we would review the proposal submitted to the PTAC along with comments from the PTAC, and any other resources we believe would be useful. Proposed PFPMs that the PTAC recommends to the Secretary but that are not immediately tested by us may be considered for testing at a later time. We would continue to test PFPMs that are developed within CMS.
We received multiple responses to the MIPS and APMs RFI recommending that we establish deadlines for the PTAC's comments and recommendations on proposed PFPMs, the Secretary's response to the PTAC's comments and recommendations, and our testing of PFPMs. We do not propose to set deadlines for these tasks through regulations. We believe that setting a deadline for the PTAC's comments and recommendations would interfere with the PTAC's freedom to govern itself and develop its own process and timeline for reviewing proposed PFPMs. We wish to preserve the PTAC's independence and to give it the freedom to determine how and when it would review proposed PFPMs without rulemaking.
We believe that setting a deadline through rulemaking for the Secretary's review of the PTAC's comments and recommendations, publication of a response to them, and our potential testing of a proposed PFPM submitted to the PTAC is inappropriate because these tasks would take varying amounts of time depending on factors that we cannot predict. Proposed PFPMs may be submitted to the PTAC on “an ongoing basis” in accordance with section 1868(c)(2)(B) of the Act, and given that there may be variation in the number and frequency of proposals, setting a deadline would be difficult. We do not believe we can effectively set deadlines because we do not know how many PFPM proposals the PTAC would receive. The Secretary would need varying lengths of time to review, comment on, and respond to PFPM proposals depending on the volume and nature of each proposal.
We do not believe it would be reasonable to require us to adhere to a deadline in deciding whether to test a particular proposed PFPM. It is important for us to retain the flexibility to test models when it believes that it is the right time to do so, taking into account the other models it is currently testing, any potential design changes to the proposed PFPM, interactions with other our policies, and resource allocation. APMs generally take 18 months for us to develop, although the period of development may vary in length significantly, making a deadline difficult to establish.
We received comments on the MIPS and APMs RFI suggesting that that any proposed PFPM approved by the PTAC should be available immediately for participant enrollment, and that participant enrollment should continue on an ongoing basis. We believe that setting deadlines for testing proposed PFPMs that we decide to test would be inappropriate. Entities need time to complete applications for voluntary models and we need time to review applications and prepare participation agreements for entities to sign. Entities need time to review these participation agreements and to begin planning for implementation of the model. To maintain rigorous evaluation of model outcomes, we also need time to build the necessary model infrastructure for such functions as quality measurement, financial calculations, and payment disbursements, and to coordinate with other payers if they are included in the model's design.
We believe that proposed PFPMs that meet all of the proposed criteria may need less time to go through the development process; however, we cannot guarantee that the development process would be shortened, or estimate by how much it would be shortened. These processes depend on the nature of the PFPM's design and any attempt to impose a deadline on them would not benefit stakeholders because it would not allow us to tailor its review and development process to the needs of the proposed PFPM.
Section 1868(c) of the Act does not define the term “physician-focused payment model” (PFPM). In § 414.1465, we are proposing to add the following definition of PFPM: An Alternative Payment Model wherein Medicare is a payer, which includes physician group practices (PGPs) or individual physicians as APM Entities and targets the quality and costs of physician services. We propose to require a PFPM to target physician services. To address physician services, proposed PFPMs may address such elements as physician behavior or clinical decision-making. APM Entities may be individual eligible clinicians, physician group practices (PGPs), or other entities, depending on the payment model's design. Therefore a PFPM must focus on physician services and contain either individual physicians or PGPs as APM Entities, although it may also include facilities or other practitioner types.
We propose to require that PFPMs be designed to be tested as APMs with Medicare as a payer. Other Payer APMs would therefore not be PFPMs. We believe this is an appropriate standard for PFPMs because the Secretary is interested in reviewing comments and recommendations from the PTAC on models that may be tested with Medicare as a payer and because this provision is in section 1868 of the Act, and title XVIII of the Act governs Medicare. A PFPM may include other payers in addition to Medicare under the proposed definition. We believe this definition is appropriate because it
We received many responses to the MIPS and APMs RFI regarding the proposed definition of PFPMs. These recommendations ranged from broadening the definition to include any payment model that alters payment for particular programs or populations to restricting the definition to specialist physicians only. We also received responses to the MIPS and APMs RFI recommending the definition of PFPM be broadened to include other care providers in the definition, such as nurses. We did not accept these suggestions because we believe that a payment model that does not specifically include individual physicians or PGPs would not appropriately be termed physician-focused. While we agree that there is merit in allowing other practitioners and facilities to be included in proposed PFPMs, we do not agree that changing the definition to explicitly include additional care providers or broadening the definition such that physicians or PGPs might not be included would satisfy the statutory directives under section 1868(c) of the Act that promote the development of PFPMs. Defining PFPM to allow the inclusion of other entities and additional targets gives stakeholders more flexibility in their proposals and may lead to models that promote broader participation in PFPMs, greater potential for care redesign, and greater potential for cost reduction.
We do not propose to limit a PFPM to exclusively targeting physicians and physician services because we believe that stakeholders should be able to propose payment models that include additional types of entities, as well as additional services. We do not propose to define PFPM as a payment model that exclusively addresses Medicare FFS payments. A proposed PFPM may also include other payers in addition to Medicare, including Medicaid, Medicare Advantage, CHIP, and private payers, which may promote broader participation in PFPMs and greater potential for cost reduction. If tested as an APM, a PFPM that includes payers in addition to Medicare would include an Other Payer APM as part of its design in addition to an APM.
Section 1868(c) of the Act does not require PFPMs to meet the criteria to be an Advanced APM for purposes of the incentives for participation in Advanced APMs under section 1833(z) of the Act, and we do not propose to define PFPMs solely as Advanced APMs. Stakeholders may therefore propose either Advanced APMs or other PFPMs that might lead to better care for patients, better health for our communities, and lower health care spending. We received responses to the MIPS and APMs RFI recommending that all proposed PFPMs selected for testing by us should be Advanced APMs without needing to meet the additional criteria for Advanced APMs. Section 1833(z)(3)(C) and (D) of the Act makes a clear distinction between APMs and Advanced APMs and we do not believe the statutory requirements for Advanced APMs can or should be waived for proposed PFPMs.
We recognize that both stakeholders and the PTAC may want to discuss in their proposals, comments, and recommendations, respectively, whether a proposed PFPM would be an Advanced APM. Therefore, we recommend that stakeholders provide information in their proposal about whether their proposed PFPM might be an Advanced APM as described in section II.F.4 of this proposed rule.
Section 1868(c)(2)(A) of the Act requires the Secretary to establish PFPM criteria for PFPMs, including models for specialist physicians, not later than November 1, 2016. The PFPM criteria would be used by the PTAC to make comments and recommendations on proposed PFPMs to the Secretary. The proposed PFPM criteria are listed in section II.F.10.c.(1) of this rule, and at proposed § 414.1465(b). We have designed these criteria so that they are broad enough to encompass all physician specialties and provide stakeholders with flexibility in designing PFPMs.
We propose PFPM criteria organized into three categories that are consistent with the Administration's strategic goals for achieving better care, smarter spending and healthier people: Payment incentives; care delivery; and information availability. First, we propose a category of criteria that promote payment incentives for higher-value care, including paying for value over volume and providing resources and flexibility necessary for practitioners to deliver high-quality health care.
To address paying for value over volume, we propose a criterion that PFPMs should provide incentives to practitioners to deliver high-quality health care. We believe that the correct incentives are necessary to drive change to improve quality of care. To address this criterion, the PTAC may request or stakeholders may wish to provide information about specific incentives in the proposed PFPM and how they are expected to incentivize quality, or information about any adjustments to payments to APM Entities based on quality performance. Similarly, we believe that it is important for a PFPM to provide sufficient flexibility for practitioners to deliver high-quality care. Flexibility relates to operational feasibility, the PFPM's ability to adapt to accommodate clinical differences in patient subgroups, and the APM Entity's ability to respond to changes in healthcare. To address this criterion, the PTAC may request or stakeholders may wish to provide information about how feasible it would be for APM Entities in the PFPM to deliver high-quality care as defined by the PFPM, and how the model design facilitates and encourages delivery of high-value care with respect to the dynamic and evolving nature of healthcare. In addition, the PTAC may request or stakeholders may wish to provide information about how the proposed PFPM can adapt to accommodate clinical differences in patient subgroups, and how it can adapt to account for changing technology, including new drug therapies.
This category of criteria also aligns with the Innovation Center's statutory authority under section 1115A of the Act to test models aimed to improve care, reduce cost, or achieve both of these goals, by proposing a criterion that assesses to what extent a PFPM proposal is expected to achieve these goals. To address this criterion, the PTAC may request or stakeholders may wish to provide information about specific quality measures included in the PFPM's design, including any prior validation of those measures, and whether any of those measures are patient reported outcome measures or measurements of beneficiary experience of care. We believe estimates of any cost reduction under the PFPM to the most precise extent possible would also be useful in addressing this criterion.
We propose a criterion that the PFPM proposal must pay APM Entities under a payment methodology that furthers the PFPM Criteria. The payment methodology must address how it is different from current Medicare payment methodologies, and why the payment methodology cannot be tested under current payment methodologies. We believe it is necessary for PFPM proposals to contain such a payment methodology because the PTAC is tasked with reviewing payment models and therefore cannot evaluate a proposal
We also propose to include in the first category a criterion that the PFPM must either aim to solve an issue in payment policy not addressed in the CMS APM portfolio at the time it is proposed or include in its design APM Entities who have had limited opportunities to participate in APMs. We believe this criterion would promote participation in APMs by broadening and expanding our portfolio of APMs in areas such as geographic location, specialty, condition, and illness, without overly limiting proposed PFPMs. We believe that because proposed PFPMs may satisfy this criterion by either addressing a new issue or including a new specialty, the criterion is sufficiently broad to allow stakeholders to submit many proposed PFPMs that could expand the CMS APM portfolio. Physicians and practitioners whose opportunities to participate in other PFPMs with us have been limited to date include, for example, those who have not been able to apply for any other PFPM because one has not been designed that would include physicians and practitioners of their specialty. We propose that a proposed PFPM that includes multiple specialties may meet the PFPM criteria where a minimum of one of the specialties in the proposed PFPM is not currently being addressed by another APM. We believe this reflects the intent of section 1868(c)(2)(A)(i) of the Act which specifically directs the Secretary to establish PFPM criteria, including models for specialist physicians.
We also propose a criterion that a PFPM proposal must have evaluable goals for the impact of cost and quality under the PFPM. To make the decision to expand an APM under section 1115A(c) of the Act, the Secretary must evaluate the model's success. This standard informed our proposed criterion not only because it would be important for any APMs that are tested under section 1115A(c) of the Act, but also because it is necessary for measuring the success of any APM that it be evaluable. It is the evaluation of an APM that tells us whether the APM is successful in reducing cost or improving quality. We believe that the more detailed the information regarding how the impact of a proposed PFPM would be evaluated, the easier it would be for the PTAC to evaluate the impact of the proposed PFPM in terms of potential expansion, as well as in terms of incentivizing high quality care and reducing costs. To address this criterion, the PTAC may request or stakeholders may wish to provide information about potential approaches for evaluation including evaluation study design, comparison groups, key outcome measures, the level of precision the evaluation may reach, and the extent that the impact of each element of the PFPM can be evaluated.
Second, we propose a category of criteria that address care delivery improvements that promote better care. Here we propose criteria to address integration and care coordination, patient choice, and patient safety. To address these criteria, the PTAC may request or stakeholders may wish to provide information about how the payment model would affect access to care for Medicare beneficiaries, including an explanation of how the payment model would not reduce benefits for Medicare beneficiaries, limit coverage for beneficiaries, how the payment model would affect disparities among Medicare beneficiaries by race, ethnicity, gender, disability, and geography, and what measures may be used to measure the provision of necessary care and monitor for any potential stinting of care. The PTAC may also request or stakeholders may wish to provide information about how patient choice is preserved under the model by accommodating individual differences in patient characteristics, conditions, and health-related preferences while furthering population health outcomes.
Third, we propose a category of criteria that address information enhancements that improve the availability of information to guide decision-making. We believe that information enhancements, particularly through use of technology are important to improving Medicare payment policy and delivering better care. Here we propose a criterion for encouraging use of health information technology. In addition, we recommend that stakeholders include information about any information enhancements that encourage transparency concerning cost and quality of care to patients and other stakeholders. To address these criteria, the PTAC may request or stakeholders may wish to provide information about how the payment model could increase transparency, or how the payment model could incorporate certified EHR technology.
In carrying out its review of PFPM proposals, the PTAC shall assess whether the PFPM meets the following criteria for PFPMs sought by the Secretary. The Secretary seeks PFPMs that:
(1) Incentives: Pay for higher-value care.
• Value over volume: Provide incentives to practitioners to deliver high-quality health care.
• Flexibility: Provide the flexibility needed for practitioners to deliver high-quality health care.
• Quality and Cost: Are anticipated to improve health care quality at no additional cost, maintain health care quality while decreasing cost, or both improve health care quality and decrease cost.
• Payment methodology: Pays APM Entities with a payment methodology designed to achieve the goals of the PFPM Criteria. Addresses in detail
• Scope: Aim to either directly address an issue in payment policy that broadens and expands the CMS APM portfolio or include APM entities whose opportunities to participate in APMs have been limited.
• Ability to be evaluated: Have evaluable goals for quality of care, cost, and any other goals of the Physician-focused Payment Model.
(2) Care delivery improvements: Promote better care coordination, protect patient safety, and encourage patient engagement.
• Integration and Care Coordination: Encourage greater integration and care coordination among practitioners and across settings where multiple practitioners or settings are relevant to delivering care to the population treated under the Physician-Focused Payment Model.
• Patient Choice: Encourage greater attention to the health of the population served while also supporting the unique needs and preferences of individual patients.
• Patient Safety: Aim to maintain or improve standards of patient safety.
(3) Information Enhancements: Improving the availability of information to guide decision-making.
• Health Information Technology: encourage use of health information technology to inform care.
In order to facilitate and potentially expedite the consideration of models for our testing following PTAC review and recommendation, we suggest “supplemental information elements” stakeholders may include in their PFPM proposals to assist our review. We do not propose to require these elements as PFPM criteria and defer to the PTAC on how it may approach requesting any supplemental information beyond that required to meet the PFPM criteria.
Section 1115A of the Act authorizes the Innovation Center to test innovative payment and service delivery models. We have an established process by which it routinely assesses proposals for new models. Many factors are typically used in the selection of models to be tested, and can be viewed on the Innovation Center Web site at
These factors address a variety of details in an APM's design. Examining these factors helps us to answer important questions that inform its decision whether to test a payment model. They provide necessary insight about how a potential APM would fit within our current CMS APM portfolio, including information such as the scope of its impact, likelihood of success, how many practitioners and beneficiaries it would impact, whether those potential outcomes merit the required investments and opportunity costs, and whether the impact of the payment model can be measured to determine if it should be expanded. We believe that to the extent stakeholders develop PFPM proposals that address the factors used by us in evaluating payment model designs, they would increase the probability that PTAC recommendations would be positive and might lead us to test the proposed PFPMs.
We considered each factor currently used by us when we developed the suggested supplemental information elements for PFPM submission. We balanced the burden these expectations would place on stakeholders in developing their proposed PFPMs with the value this information would provide to the PTAC in its review of the proposed PFPMs and to us in our decision whether or not to test a proposed PFPM. We acknowledge that the factors used by us may change in the future and we believe that the PFPM criteria we have proposed are sufficiently broad and relevant to our evaluation of the testing of models that they would align with any future changes in our factors. While we believe that the more detail concerning these factors the stakeholder can provide the more it would facilitate our review, we have determined that certain factors are of particular importance.
We also chose not to include certain of these factors, including the size of investment required and waiver authority, in the suggested supplemental information elements because we believe the burden to evaluate how these factors apply to potential APMs should be on us, not stakeholders. For example, we received responses to the RFI both in favor of, and opposed to requiring information about whether, if the proposed PFPM cannot be implemented under existing law, we have the authority to waive any laws or regulations for purposes of testing the payment model. We decided it would be inappropriate to require stakeholders to speculate as to the scope of our waiver authority in their proposals. We and other components of HHS are responsible for interpreting the relevant laws and regulations, and for designing and issuing any potential waivers. We also decided not to include as a supplemental information element the size of investment for proposed PFPMs because we do not believe stakeholders would have the necessary information about our operational costs to include in a PFPM proposal.
There are three pieces of information we consider fundamental to evaluating new models. First, the anticipated size and scope of a proposed PFPM is essential. For example, any proposed PFPM should describe the estimated number of Medicare beneficiaries that would be affected by the model, the number and scope of eligible clinicians expected to participate, including eligible clinician specialty(s), the potential geographic location(s) included in the model, the defined period of performance or clinical episode(s) of care in the model, and the number and quality of services that would be affected by the model. A definition of the target population and any criteria for including or excluding patients from the model would also be useful in addressing the scope of the PFPM. We believe this information is vital to evaluating a proposed PFPM. Second, we also consider an estimate of the burden in terms of morbidity and mortality on a population to be relevant in describing the scope of physician services addressed by the model. For example, stakeholders could provide estimates of morbidity and mortality from peer-reviewed publications and analyses of health care data such as Medicare or Medicaid data. Third, we believe an explanation of how a proposed model would be attractive to participate in and feasible to implement for potential APM Entities from a financial perspective is necessary for us to evaluate a proposed model.
To summarize, the following specific supplemental information elements are considered essential:
• A description of the anticipated size and scope of the model in terms of eligible clinicians, beneficiaries, and services.
• A description of the burden of disease, illness or disability on the target patient population.
• An assessment of the financial opportunity for APM Entities, including a business case for how their participation in the model could be more beneficial to them than participation in traditional fee-for-service Medicare.
In addition, we recommend that proposed PFPMs submitted to the PTAC include information about whether the stakeholder or individual submitting the proposal believes it would meet the criteria to be an Advanced APM, discussed in section II.F.4. of this proposed rule. This information would allow us to evaluate whether the proposed PFPM would provide eligible clinicians with an opportunity to become QPs for purposes of the incentives for participation in Advanced APMs. We are interested in receiving proposed PFPMs from stakeholders that would be Advanced APMs and we received comments on the RFI stating that stakeholders would like this opportunity as well. As discussed in section II.F.10.b. of this proposed rule, we do not believe that it is necessary to limit stakeholders' proposed PFPMs to only those that would be Advanced APMs, but believe that it is useful for proposed PFPMs to state whether, if tested by us, they would be Advanced APMs.
We received multiple responses to the MIPS and APMs RFI recommending that the Secretary include specialty-specific criteria to be used by the PTAC. We appreciate the interest from multiple specialties and encourage them to submit proposed PFPMs for review by the PTAC, but do not believe that we should limit proposed PFPMs by adding specialty-specific criteria.
We received multiple comments suggesting prioritization of certain patient groups, physician specialties, diseases, and other issues. We believe that the aim of section 1868(c) of the Act to promote development of PFPMs is best satisfied by not prioritizing certain specialties or issues over others in the PFPM criteria. However, the PTAC may decide to prioritize specific patient groups, specialties, or issues in its comments and recommendations.
We received several responses to the MIPS and APMs RFI recommending that types of physicians and practitioners that have had the opportunity to participate in previous APMs should not be excluded from future proposals for PFPMs because current or previous APMs are not exhaustive of all possible APMs for any given specialty or issue. We agree with this recommendation, so long as the proposed PFPM instead aims to solve an issue in payment policy that broadens and expands the CMS APM portfolio at the time it is tested as stated in section II.F.10.c. of this proposed rule. We believe this best serves our goal of expanding and diversifying our portfolio of APMs. We believe that concurrently implementing multiple PFPMs that attempt to solve the same clinical or payment issue may not be the most efficient use of limited resources, and may complicate the evaluations of some or all of the relevant models. However, we would consider a proposed PFPM that focuses on an issue addressed in a model that we are no longer testing, even if that prior model was unsuccessful.
We also received responses to the MIPS and APMs RFI recommending that we should consider proposals that modify or extend the testing of existing models. We do not believe that the PTAC is the proper forum for considering modifications or extensions of current models. We also note that our legal authority to modify or extend existing models is contingent on other criteria that are unrelated to the criteria for proposed PFPMs. Stakeholders who wish to discuss changes to models that we are currently testing may discuss them with us directly, outside of the PTAC review process.
We received many comments suggesting payment for high-value services that we do not currently (or separately) reimburse as examples of potential PFPMs. These types of changes are an important part of moving toward value-based delivery system reform, but adding payment for specific services without any other change does not constitute a sufficient departure from current payment methodologies to meet our proposed PFPM criteria or to be considered an APM, and could be better achieved outside of the PTAC process. We do however welcome these suggestions within the context of broader model proposals.
We received responses to the MIPS and APMs RFI recommending that in addition to criteria about how the proposed PFPM would either fit in to or replace the existing Medicare payment system, there should also be criteria to identify specific barriers to care improvement that exist in the current payment system. We believe that information about how the proposed PFPM changes or fits into existing payment systems is essential to understanding how the proposed PFPM operates. We believe information about existing barriers to improving care and reducing costs and how the proposed PFPM addresses those barriers is also important. Therefore, we encourage stakeholders to include this information in their proposals although we do not propose to require it.
We received many responses to the MIPS and APMs RFI recommending that the PFPM criteria include specific quality measures and guidelines, such as those set by the Core Quality Measures Collaborative. We do not believe it would be appropriate to limit proposed PFPMs to include specific quality measures. We encourage stakeholders to propose quality measures that are tailored to their particular proposed PFPM. We also received responses to the MIPS and APMs RFI recommending we should not include criteria requiring information on the impact that the proposed PFPM would have on quality of care. We understand that the full scope of the potential impact a proposed PFPM may have on quality of care and cost reduction might not be known at the time of submission. However, we believe proposed PFPMs should provide realistic assessments and estimates of the impacts, as well as information to justify these estimates. Commentators also voiced opinions about the utilization of Clinical Data Registries managed by specialty societies or other groups. We believe that this information, if applicable, should be included in the PFPM proposal as an aspect of CEHRT use.
Finally, we received many responses to the MIPS and APMs RFI offering proposed PFPMs that we should implement. We appreciate the interest in PFPMs and encourage these commenters to submit their proposed PFPMs to the PTAC.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).
To derive wage estimates, we used data from the U.S. Bureau of Labor Statistics' May 2014 National Occupational Employment and Wage Estimates and the December 2015 Employer Costs for Employee Compensation. In this regard, Table 46 presents the mean hourly wage, the cost of fringe benefits and overhead, and the adjusted hourly wages for Billing and Posting Clerks, Computer Systems Analysts, and Physicians. We are adjusting our employee hourly wage estimates by a factor of 100 percent to reflect current HHS department-wide guidance on estimating the cost of time spent by employees of regulated entities. These are necessarily rough adjustments, 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 these are reasonable estimation methods. In addition, in order to calculate the costs to beneficiaries for their time, we have used Bureau of Labor Statistics (BLS) estimates for Civilian, all occupations. We have not adjusted these costs for fringe benefits and overhead because only the direct wage costs represent the “opportunity cost” to beneficiaries themselves for time spent in health care settings.
Because the entities permitted to submit MIPS data on behalf of eligible clinicians will vary based on APM participation and the type of data, Table 47 presents a framework for understanding the entities facing the burden of MIPS data submission. As shown in the first row of Table 47, eligible clinicians that are not in APMs will submit data either as individuals or groups to the quality, advancing care information, and CPIA performance categories.
For APMs, the entities submitting data on behalf of model participants will vary across categories of data and APM Model. When APM Entities submit quality data to fulfill the requirements of their APMs, the burden will be ascribed to their APMs, and will not contribute to the MIPS data submission burden.
This section discusses the information collection requirements for the eligible clinicians who are not APM participants because burden for APM Entities' submission of quality data to fulfill the requirements of their APMs will not be ascribed to MIPS.
We assume that the number of MIPS eligible clinicians who will submit through claims mechanisms (299,169), Qualified Registry or QCDR-mechanisms (214,590), certified EHR technology mechanisms (77,241), and as groups through CMS Web Interface (112,467) will be the same as the numbers submitting data through those mechanisms under the 2014 PQRS.
For MIPS eligible clinicians or groups, the burden associated with the requirements of the MIPS quality performance category is the time and effort associated with MIPS eligible clinicians identifying applicable quality measures for which they can report the necessary information, collecting the necessary information, and reporting the information needed to submit the MIPS eligible clinician's measures. We believe it is difficult to quantify the burden accurately because MIPS eligible clinicians and groups may have different processes for integrating quality reporting into their practices' work flows. Moreover, the time needed for an MIPS eligible clinician to review the quality measures and other information, select measures applicable to his or her patients and the services he or she furnishes to them, and incorporate the use of quality data codes into the office work flows is expected to vary, along with the number of measures that are potentially applicable to a given professional's practice.
For MIPS eligible clinicians and groups, we estimate a total of 6 hours as the amount of time needed for an MIPS eligible clinician's billing clerk to review the quality measures list, review the various submission options, select the most appropriate submission option, identify the applicable measures or specialty measure sets for which they can report the necessary information, review the measure specifications for the selected measures or measures groups, and incorporate submission of the selected measures or specialty measure sets into the office work flows. The measures list contains the measure title and brief summary information for the MIPS eligible clinician's billing clerk to review. The 6 hour estimate for the billing clerk is comprised of reviewing the performance criteria (up to 2 hours) and reviewing measure specifications (up to 4 hours). Assuming the MIPS eligible clinician has received no training from his/her specialty society, we estimate it will take an MIPS eligible clinician's billing clerk up to 2 hours to review this list, review the submission method, and select a submission method and measures on which to report. If an MIPS eligible clinician has received training, then we believe this would take less time. We believe 4 hours is a reasonable estimate for an MIPS eligible clinician's billing clerk to review the measure specifications of measures they select to report and to develop a mechanism for incorporating submission of the selected measures or into the office work flows. Further, we estimate that it will take a physician up to 1 hour to review MIPS quality performance category measure specifications for each MIPS eligible clinician.
We believe the burden associated with actually submitting the quality measures will vary depending on the submission method selected by the MIPS eligible clinician. As such, we break down the burden estimates by MIPS eligible clinicians and groups according to the submission method used. The revised quality performance requirements and burden estimates will be submitted along with all other ICRs listed below under a new OMB control number (0938-NEW).
We anticipate the claims submission process for MIPS will be operationally similar as it was under the PQRS. MIPS eligible clinicians must gather the required information, select the appropriate quality data codes (QDCs), and include the appropriate QDCs on the claims they submit for payment. MIPS eligible clinicians will collect QDCs as additional (optional) line items on the CMS-1500 claim form or the electronic equivalent HIPAA transaction 837-P, approved by OMB under control number 0938-0999. This rule does not revise either of those forms. We note that the claims submission option is only available to individual MIPS eligible clinicians and is not available for groups.
The total estimated burden will vary along with the volume of claims on which the quality data is reported. Based on our experience with the PQRS, we estimate that the burden for submission of quality data will range from 7.22 hours to 17.8 hours per MIPS eligible clinician. The wide range of estimates for the time required for a MIPS eligible clinician to submit quality measures via claims reflects the wide variation in complexity of submission across different clinician quality measures. As shown in Table 48 we also estimate that the cost of quality data submission will range from $18.47 (.22 hours × $83.96) to $906.77 (10.8 hours × $83.96). The total estimated annual cost per MIPS eligible clinician ranges from the minimum burden estimate of $406.13 to a maximum burden estimate of $1,294.43. The burden will involve becoming familiar with MIPS data submission requirements. Therefore, we believe that the start-up cost for a MIPS eligible clinician's billing clerk to report measures data may be calculated as: 6 hours × $34.20/hour = $205.20, and the start-up cost for a physician to review quality performance category measure specifications to be calculated as 1 hour × $182.46/hour = $182.46. Therefore, total annual burden cost is estimated to range from a minimum burden estimate of $121,501,865 (299,169 × $406.13) to a maximum burden estimate of $387,252,730 (299,169 × $1294.43).
Based on the assumptions discussed above, Table 48 summarizes the range of total annual burden associated with MIPS eligible clinicians using the claims submission mechanism.
For qualified registry and QCDR submissions, we estimate an additional time burden for MIPS eligible clinicians and groups to become familiar with MIPS submission requirements and, in some cases, new specialty measure sets. Therefore, we believe that the start-up cost for a MIPS eligible clinician's billing clerk to report measures data may be calculated as: 6 hours × $34.20/hour = $205.20, and the start-up cost for a physician to review quality performance category measure specifications to be calculated as 1 hour × $182.46/hour = $182.46. These start-up costs pertain to the specific quality submission methods below, and hence appear in the burden estimate table.
Little, if any, additional data will need to be reported to the qualified registry or QCDR solely for purposes of participation in MIPS. However, MIPS eligible clinicians and groups will need to authorize or instruct the qualified registry or QCDR to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf. We estimate that the time and effort associated with this will be approximately 5 minutes (0.083 hours) per MIPs eligible clinician for a total burden cost of $6.97, at a computer systems analyst's labor rate. Hence, we estimated 10.083 burden hours per MIPS eligible clinician, with annual total burden hours of 2,163,711 (10.083 burden hours × 214,590 MIPS eligible clinicians). The total estimated annual cost per MIPS eligible clinician is estimated to be approximately $646.51. Therefore, total annual burden cost is estimated to be $138,734,298 (214,590 × $646.51). Based on these burden requirements and the number of eligible clinicians historically using the Qualified Registry and QCDR
Based on our experience with the PQRS, we estimate that the time needed to perform all the steps necessary for MIPS eligible clinicians to report quality performance measures includes the time to prepare for participating in quality performance category submissions for MIPS (calculated at 6 hours plus 1 hour of physician time for reviewing specifications), and an additional 3 hours for data submission through an EHR.
For EHR submission, the MIPS eligible clinician or group must review the quality measures on which we will be accepting MIPS data extracted from EHRs, select the appropriate quality measures, extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. To submit data to CMS directly from their EHRs, MIPS eligible clinicians must have access to a CMS-specified identity management system which we believe takes less than 1 hour to obtain. Once an MIPS eligible clinician has an account for this CMS-specified identity management system, he or she will need to extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. We estimate that obtaining a CMS-specified identity management system will require 1 hour per MIPS eligible clinician cost of $83.96 (1 × $83.96), and that submitting a test data file to CMS will also require 1 hour for a per MIPS eligible clinician for a cost of $83.96. With respect to submitting the actual data file for the respective reporting period, we believe that this will take an MIPS eligible clinician or group no more than 2 hours for a per MIPS eligible clinician cost of submission of $167.92 (2 × $83.96). The burden will involve becoming familiar with MIPS submission. In addition, we believe that the start-up cost for a MIPS eligible clinician's billing clerk to report measures data may be calculated as: 6 hours × $34.20/hour = $205.20, and the start-up cost for a physician to review quality performance category measure specifications to be calculated as 1 hour × $182.46/hour = $182.46. Hence, we estimated 11 burden hours per MIPS eligible clinician, with annual total burden hours of 849,651 (11 burden hours × 77,241 MIPS eligible clinicians). The total estimated annual cost per MIPS eligible clinician is estimated to be $723.50. Therefore, total annual burden cost is estimated to be $55,883,864 (77,241 × $723.50).
Based on these burden requirements and the number of eligible clinicians historically using the EHR submission mechanism, we have calculated a burden estimate for quality performance category reporting for this submission mechanism:
We estimate that 112,467 MIPS eligible clinicians submitting as 300 groups will participate in MIPS using the CMS Web Interface in the 2017 Performance Period. Groups interested in participating in the MIPS using the CMS Web Interface must complete a registration process. However, since a group using the CMS Web Interface would not need to determine which measures to report under MIPS, we believe that the registration process is handled by the group's administrative staff. We estimate that the registration process for groups under MIPS involves approximately 1 hour per group. We assume that the group staff involved in the group registration process has an average labor cost of $34.20 per hour. Therefore, assuming the total burden hours per group associated with the group registration process is 1 hour, we estimate the total cost to a group associated with the group registration process to be approximately $34.20 ($34.20 per hour × 1 hour per group).
The burden associated with the group submission requirements under the CMS Web Interface is the time and effort associated with the group submitting the quality measures data. For physician groups, this would be the time associated with the physician group completing the CMS Web Interface. We estimate that, on average, it will take each group 79 hours to submit quality measures data via the CMS Web Interface at a cost of $83.96 per hour, for a total cost of $6,6632.84 (79 × $83.96). We also estimate that a physician for each group will need to spend 1 hour per year to review quality performance measure specifications, for a total cost of $182.46. As mentioned above, we estimate it will take 1 hour for a group to register to submit through the CMS Web Interface, for a total of cost of $34.20 (1 × $34.20). Therefore, the total estimated annual cost per group is estimated to be approximately $6,632.84. The total annual burden hours are estimated to be 24,300 (300 eligible groups × 81 annual hours), and the total annual burden cost is estimated to be $2,052,850 (300 × $6,849.50).
Based on the assumptions discussed above we have calculated the following burden estimate for groups submitting to MIPS with the CMS Web Interface.
For CY 2015, 98 qualified registries and 49 QCDRs were qualified to report quality measures data to CMS for purposes of the PQRS.
Please note that the self-nomination statement is an online form that entities will use to provide information on their business. The self-nomination statement will be available at
In addition to completing a self-nomination statement, qualified registries and QCDRs will need to perform various other functions, such as meet with CMS officials when additional information is needed. In addition, QCDRs must benchmark and calculate their measure results. We note, however, that many of these capabilities may already be performed by QCDRs for purposes other than to submit data to CMS for MIPS. The time it takes to perform these functions may vary depending on the sophistication of the entity, but we estimate that a qualified registry or QCDR will spend an additional 9 hours performing various other functions related to being a MIPS qualified registry or QCDR.
We estimate that the staff involved in the qualified registry or QCDR self-nomination process will mainly be Computer Systems Analysts or the equivalent, at an average labor cost of $83.96/hour. Therefore, assuming the total burden hours per qualified registry or QCDR associated with the self-nomination process is 10 hours, the annual burden hours is 1,500 (150 QCDRs × 10 hours). We estimate that the total cost to a qualified registry or QCDR associated with the self-nomination process will be approximately $839.60 ($83.96 per hour × 10 hours per qualified registry). We also estimate that 150 new qualified registries or QCDRs will go through the self-nomination
The burden associated with the qualified registry and QCDR submission requirements in MIPS will be the time and effort associated with the qualified registry calculating quality measures results from the data submitted to the qualified registry or QCDR by its participants and submitting the quality measures results, the numerator and denominator data on quality measures, and the advancing care information performance category and CPIA data to CMS on behalf of their participants. We expect that the time needed for a qualified registry or QCDR to review the quality measures and other information, calculate the measures results, and submit the measures results and numerator and denominator data on the quality measures and the advancing care information performance category and CPIA data on their participants' behalf will vary along with the number of MIPS eligible clinicians submitting data to the qualified registry or QCDR and the number of applicable measures. However, we believe that qualified registries and QCDRs already perform many of these activities for their participants. Therefore, there may not necessarily be an additional burden on a particular qualified registry or QCDR associated with calculating the measure results and submitting the measures results and numerator and denominator data on the quality measures to CMS on behalf of their MIPS participants. Whether there is any additional burden to the qualified registry or QCDR as a result of the qualified registry's or QCDR's participation in MIPS will depend on the number of measures that the qualified registry or QCDR intends to report to CMS and how similar the qualified registry's measures are to CMS' MIPS quality measures.
Based on the assumptions previously discussed, we provide an estimate of total annual burden hours and total annual cost burden associated with a qualified registry or QCDR self-nominating to be considered “qualified” for the purpose of submitting quality measures results and numerator and denominator data on MIPS eligible clinicians.
Under MIPS, a CMS contractor will conduct a data validation survey in order to identify and address problems with data handling, data accuracy, and incorrect payments for the MIPS Program. Because the data that will be submitted by, or on behalf of, MIPS eligible clinicians to the MIPS Program will be used to calculate payment adjustments, it is critical that this data be accurate. Additionally, the data will be used to generate Feedback Reports for MIPS eligible clinicians and groups and, in some cases, is posted publicly on the CMS Web site, further supporting the need for accurate and complete data. The CMS data validation contractor will conduct surveys of Groups, Registries, Qualified Clinical Data Registries (QCDRs), EHR Vendors, and MIPS eligible clinicians in support of evaluating the data submitted for MIPS. The MIPS Data Validation survey will be similar to the PQRS Data Validation Survey. The PQRS Data Validation Survey uses a series of approximately thirty questions, arranged by category, to gather information about data handling practices, training, and quality assurance, as well as the challenges that stakeholders faced in participating in the PQRS program. Under MIPS, the survey's topics will be expanded beyond validation of quality measures to include CPIA and potentially advancing care information performance category data.
The MIPS Data Validation Survey for Performance Year 2017 will be conducted in late 2018 for data reported in early 2018. Because the MIPS verification process is still under development, the precise sample size for respondents has not yet been determined. We anticipate that at most 500 entities would be contacted for MIPS data verification for Performance Year 2017. Based on the most recent year of the PQRS data validation survey, we will assume that the response rate will be 86 percent. Hence, we estimated the total number of respondents for Performance Year 1 will be 430 (500 entities contacted × 86 percent response rate).
We estimate the total annual burden for the ongoing MIPS data validation will be up to 750 hours each performance year (500 responses × 1.5 hours), and the data validation will be conducted at a clerk's labor rate of $34.20 per hour for a total burden cost of $25,650 ($34.20 × 1.5).
Under MIPS, groups may elect to report on the CAHPS for MIPS Survey by contracting for survey administration with a CMS approved vendor. At this point, we do not believe that the groups that elect to report on CAHPS for MIPS will experience additional burden because CAHPS will cover one of their six Quality performance category measures. Beneficiaries will experience burden under the CAHPS survey; and because the survey will be similar to the CAHPS for PQRS survey, we are assuming that the burden per beneficiary will be the same.
The usual practice in estimating the burden on public respondents to surveys such as CAHPS is to assume that respondent time is valued, on average, at civilian wage rates. As previously explained, the BLS data show the average hourly wage for civilians in all occupations to be $23.06. Although most Medicare beneficiaries are retired, we believe that their time value is unlikely to depart significantly from prior earnings expense, and have used the average hourly wage to compute the dollar cost estimate for these burden hours.
Under the first performance year of MIPS, we assume the number of groups that elect to report on the CAHPS for MIPS survey will be the same as 2014, when the CAHPS for PQRS survey was used. Table 54 shows the estimated annualized burden for beneficiaries to participate in the CAHPS for MIPS survey. We assume that all 300 groups submitting via the CMS Web Interface will elect to use the CAHPS for MIPS Survey. Based on historical information on the numbers of CAHPS for PQRS respondents, we assume that an average of 287 beneficiaries will respond per group. The CAHPS Survey for MIPS will be administered to approximately 86,100 beneficiaries per year (300 groups × an average of 287 beneficiaries per group responding). The survey contains 83 items and is estimated to require an average administration time of 18.4 minutes in English (at a pace of 4.5 items per minute) and 22 minutes in Spanish (assuming 20 percent more words in the Spanish translation), for an average response time of 20.24 minutes or 0.337 hours. These burden and pace estimates are based on CMS's experience with surveys of similar length that were fielded with Medicare beneficiaries. As indicated below, the annual total burden hours are estimated to be 29,106 hours (86,100 respondents × .337 burden hours per respondent to report).
Advancing care information performance category data will not be submitted separately by MIPS eligible clinicians in most cases as was required under the Medicare EHR Incentive Program. MIPS eligible clinicians and clinician groups will submit this data using the same submission mechanism, or a similar submission mechanism they have selected for the other MIPS performance categories. For the purpose of submission advancing care information performance category objectives and measures under the MIPS, we have proposed in section II.E.1.f. of this proposed rule to allow for MIPS eligible clinicians to submit advancing care information performance category data through qualified registry, EHR, QCDR, and CMS Web Interface submission methods. Also, we have streamlined the submission requirements for advancing care information as part of the MIPS program. Compared to the reporting requirements in the 2015 Medicare EHR Incentive Program Final Rule, two objectives and their associated measures (Clinical Decision Support and
As noted above in Section B, a variety of entities will report advancing care information performance category data on behalf of clinicians. Based on historical data and 2015 Medicare EHR Incentive Program attestation, we estimate that approximately 436,500 clinicians not participating in APMs would submit advancing care information performance category data to MIPS.
Requirements for submitting clinical practice improvement activities are new, and we do not have historical data which is directly relevant. As noted in section III.B, a variety of entities will report advancing care information performance category data on behalf of eligible clinicians. For eligible clinicians who are not part of APMs, we assume that the number of eligible clinicians submitting as part of a group will be approximately the same as the number of eligible clinicians submitting PQRS data through the GPRO Web Interface in 2014. We estimate that that there could be as many as 595,100 MIPS eligible clinicians submitting CPIA category data as individuals, which is equal to the number of eligible clinicians using the claims, QCDR or qualified registry, or EHR submission mechanisms under the 2014 PQRS.
The resource use performance category relies on administrative claims data. For claims-based submitting, the Medicare Parts A and B claims submission process is used to collect data on resource measures from MIPS eligible clinicians. MIPS eligible clinicians are not asked to provide any documentation by CD or hardcopy. Therefore, we do not anticipate any new or additional submitting for MIPS eligible clinicians as a result of this performance category within MIPS.
Section II.E.5.h. of this preamble discusses the MIPS-related submission requirements for participants in the Shared Savings Program and certain APMs. APM Entities participating in Advanced APMs will face an additional submission requirement under MIPS related to Partial Qualifying APM Participant (QP) elections. A representative from each APM Entity will log into the MIPS portal to indicate whether eligible clinicians would wish to participate in MIPS if the eligible clinicians participating in the APM Entity are later deemed to be Partial QPs. We estimate it will take each APM Entity representative 15 minutes to make this election, and an additional 15 minutes to register for the MIPS Portal. We estimate that 543 APM Entities will make this election on the MIPS Portal, for a total burden estimate of 272 hours (543 × .5). At a computer systems analyst's hourly labor cost, the total burden cost is estimated to be $22,795 (272 × $83.96).
The total gross burden estimate includes the total burden of recordkeeping and data submission under MIPS. Table 60 provides an estimate of the total annual burden of MIPS of 12,493,654 hours and a total annual burden cost of $1,327,177,683. Some of the information collection burden under MIPS does not represent an additional burden to the public, but replaces information collection burden that existed under two of its predecessor programs, the PQRS and the Medicare EHR Incentive Program. The estimated total existing burden approved for information collections related to PQRS and the Medicare EHR Incentive Program (for EPs) was 9,969,514 hours for a total annual burden cost of $1,199,257,029. The net burden estimate reflects only the incremental burden associated with this rule, and excludes the burden of existing recordkeeping and data submission under the PQRS, the Medicare EHR Incentive Program, CAHPS for PQRS, and PQRS Data Validation.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS's Web site 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
ICR-related comments are due July 8, 2016.
Because of the large number of public comments we normally receive on
This proposed rule is necessary to make payment and policy changes under the Medicare PFS and to make statutorily-required changes under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The MACRA's enactment consolidated certain aspects of physician quality reporting and performance programs into the new Merit-Based Incentive Payment System, including using certified EHR technology (Section 1848(o) of the Act), the PQRS (Section 1848(k) and (m) of the Act), and the value-based payment modifier (Section 1848(p) of the Act). These programs have been developed and most recently implemented by CMS as the Medicare EHR Incentive Program (80 FR 62761), the PQRS (80 FR 71135), and the VM (80 FR 71273). The MACRA's enactment altered the Medicare EHR Incentive Program such that the existing Medicare payment adjustment for EPs under section 1848(a)(7)(A) of the Act will end in CY 2018. Similarly, MACRA ends the separate PQRS Program in CY 2018 and provides for the inclusion of various aspects of PQRS in MIPS, and sunsets the VM program, ending it in CY 2018 and establishing certain aspects of the VM as a component of MIPS in CY 2019. Finally, the MACRA introduces incentive payment to eligible clinicians who become Qualifying APM Participants (QPs) through participation in Advanced APMs.
This consolidated program for physicians and other eligible clinicians represents a new approach to the delivery of health care in this care setting aimed at reducing burden on Medicare-enrolled eligible clinicians, improving population health, lowering growth in overall health care costs, and providing clear incentives for the provision of the best quality care for Medicare beneficiaries. MIPS provides payment adjustments for eligible clinicians for providing value-driven health care services to their patients, and APMs offer a variety of opportunities that substantially alter the methods of payment for health care and enable clinicians to make fundamental changes to their day-to-day operations to improve the quality and reduce the cost of health care.
We have 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 Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 14-04), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). 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 below in this section, that the PFS provisions included in this proposed rule will redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100
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.
There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Approximately 95 percent of practitioners, other providers and suppliers are considered to be small entities, based upon the SBA standards. As shown later in this analysis, however, potential losses to these practitioners under the MIPS program are a small percentage of their total Medicare Part B PFS revenue—4 percent in the first year—though rising to as high as 9 percent in subsequent years. On average, practitioners' Medicare billings are only about 22 percent of total revenue,
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 are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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 2016, that threshold is approximately $146 million. This proposed rule would impose no mandates on state, local, or tribal governments or on the private sector because participation in Medicare is voluntary and because physicians and other professionals have multiple options as to how they will participate under MIPS and discretion over their performance. Moreover, HHS interprets UMRA as applying only to “unfunded” mandates. We do not interpret Medicare payment rules as being “unfunded mandates,” but simply as conditions for the receipt of payments from the Federal government for providing services that meet Federal standards. This interpretation applies whether the facilities or providers are private, state, local, or tribal.
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. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
We have 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 proposing to implement a variety of changes to our regulations, payments, or payment policies to implement 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 101 of the, (1) repeals the Sustainable Growth Rate formula for physician payments in Medicare, and (2) requires that we establish a Merit-based Incentive Payment System for eligible clinician under which the Secretary must use an eligible clinician's composite performance score (CPS) to determine and apply a MIPS adjustment factor to the professional for a year.
Repealing the Sustainable Growth Rate formula eliminated significant and immediate problems with Medicare's physician fee schedule payments, including implausible payment reductions (such as the 21.2 percent decrease that was scheduled for April 1, 2015). The Office of the Actuary estimated that avoiding those payment reductions results in a budgetary cost of $150.5 billion for fiscal years 2015 through 2025 compared to the prior-law baseline. However, that cost is partially offset by other MACRA provisions that are estimated to have a net reduction in Federal expenditures of $47.7 billion.
As required by the MACRA, overall payment rates for services for which payment is made under the PFS would remain at the 2019 level through 2025, but starting in 2019, the amounts paid to individual eligible clinicians would be subject to adjustment through one of two mechanisms, depending on whether the eligible clinician meets the threshold for participation in Advanced APMs to be considered a Qualifying APM Participant (QP) or Partial QP, or is instead evaluated under MIPS.
For APMs, from 2019 through 2024, eligible clinicians receiving a substantial portion of their revenue through Advanced APMs and meeting other applicable requirements to become QPs would receive a lump-sum payment after each year equal to 5 percent of their Medicare covered professional services for services reimbursed according to the PFS in the preceding year. The APM Incentive Payment is separate from, and in addition to, the reimbursement for services furnished by an eligible clinician during that year. Eligible clinicians who become QPs would not receive a MIPS performance adjustment under the PFS. Eligible clinicians who do not become QPs, but meet a slightly lower threshold, would be deemed Partial QPs for that year, and may elect to report to and be scored under MIPS. In QP Performance Period 2017, we define Partial QPs to be Advanced APM participants that have at least 20 percent but less than 25 percent, of their Medicare Part B payments for covered professional services through an Advanced APM Entity, or at least 10 percent, but less than 20 percent, of their Medicare patients served through an Advanced APM Entity. If the Partial QP elects to be scored under MIPS, they would be subject to all MIPS requirements and would receive a MIPS payment adjustment. This adjustment may be positive or negative. If an eligible clinician does not meet either of those standards, the eligible clinician would be subject to MIPS and would report to MIPS and receive the corresponding MIPS payment adjustment.
Beginning in 2026, payment rates for eligible clinicians who achieve QP status for a year would be increased each year by 0.75 percent, while payment rates for eligible clinicians who do not achieve QP status would be increased each year by 0.25 percent. MIPS eligible clinicians would receive positive, neutral, or negative adjustments to their PFS payments in a payment year based on performance during a prior performance period. Although the legislation establishes overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the initial payment year (2019) in detail. After 2019, while overall payment levels will be partially bounded, we have also acknowledged in the preamble that the Department will revise its quality and other payment measures and overall payment thresholds and other parameters as eligible clinicians' behavior changes.
As discussed further in the preamble to this proposed rule, we are proposing requirements for MIPS that may result in the exclusion of certain eligible clinicians for various reasons. For example, MACRA requires us to exclude eligible clinicians from MIPS participation if they are QPs, or if they are a type of eligible clinician whose specialty is excluded from MIPS for the 2019 and 2020 MIPS payment years. Additionally, we are proposing above to exclude low volume eligible clinicians, or those with less than $10,000 in allowable claims and fewer than 100 Medicare patients.
We estimated the number of physicians and other professionals that would be excluded from MIPS due to their being QPs using data from APM entities that existed in 2014. First, we identified APM entities that participated in APMs that have similar design characteristics to those proposed for Advanced APMs in section II.F.4.b. of this proposed rule. In 2014, those models included the Pioneer Accountable Care Organization (ACO) Model (which is scheduled to end in 2016), Comprehensive ESRD Care (CEC) (which began in 2015, but used historical data from 2014), and Comprehensive Primary Care Initiative (CPC). Further, we assigned Shared Savings Program ACOs that existed in 2014 their 2016 track assignments because several ACOs have since transitioned to higher risk tracks. Next, we analyzed 2014 claims data to identify the APM Entities within each of those APMs to determine which of those APM Entities met the criteria for having at least 25 percent of their beneficiaries or allowable charges through the APM Entity.
Using those procedures, we arrived at a lower bound estimate that approximately 30,658 physicians and other professionals would become QPs, representing an estimated total incentive payment amount of approximately $146,000,000. However, we expect that the number of QPs may be significantly higher than the estimate based on 2014 data. CMS has continued to introduce new APMs since 2014, and intends to continue to introduce more APMs in future years. We base this expectation on prior experience with increased enrollment in current models and targets for new models that are expected to be adopted in the future. Additionally, CMS anticipates increased participation in currently existing APMs. Our upper bound estimate of QPs, based on the same estimating procedures, is 90,000 and the corresponding estimated total incentive payment is $429,000,000. In this regard, it is longstanding HHS policy not to attempt to predict the effects of future rulemakings, in order to maximize future Secretarial discretion over whether, and if so how, payment or other rules would be changed.
To estimate the number of physicians and other professionals ineligible or excluded due to the proposed low-volume exclusion, ineligible specialties, and newly-enrolled eligible clinicians, we began with a sample of clinicians participating in Medicare B in 2014.
We have estimated the effects of these various exclusions in Table 61.
We have also estimated the number of clinicians
Based on the estimates of excluded providers in Table 61, we estimate that between approximately 687,000 and 746,000 clinicians will be assigned a CPS score in MIPS Year 1.
According to National Health Expenditure data,
We used 2014 VM, PQRS, and other available data to model the scoring provisions described in this regulation. First, we arithmetically calculated a hypothetical CPS for each eligible clinician. Then, we implemented an exchange function based on the provisions of this proposed rule to translate the hypothetical CPS into a negative payment adjustment or positive payment adjustment. This entailed modifying parameters of the exchange function iteratively in order to achieve distributions in payment adjustments that meet requirements related to budget neutrality and aggregate exceptional performance payment amounts. However, because of the lack of historical data for the proposed advancing care information and CPIA measures, this version of the model does not estimate scores for the advancing care information and CPIA performance categories. Based on 2015 Medicare EHR Incentive Program data, we estimate that approximately 226,514 Medicare attesters would receive a 90 percent score in the advancing care information performance category and thereby receive an estimated 23 more points to their CPS, and that 209,000 eligible clinicians receiving a negative adjustment for 2016 would receive an advancing care information performance category score of 0. We also estimate that approximately 412,678 clinicians are non-eligible provider types, and therefore, would not be measured on the advancing care information performance category. Hence we estimate the CPS using only quality and resource use performance category scores, but recognize the scores would adjust by the advancing care information characteristic estimates described above. The model also set a hypothetical performance threshold, and estimated a MIPS payment adjustment associated with each CPS.
The costs for implementation and complying with the advancing care information performance category requirements could potentially lead to higher operational expenses for MIPS eligible clinicians. However, we believe that the combination of payment adjustments and long-term overall gains in efficiency will likely offset the initial expenditures. Additionally, because we are proposing above to reweight the advancing care information performance category scores for eligible clinicians that were exempt from the Medicare EHR Incentive Program or received hardship exemptions, these proposals would not impose additional requirements for EHR adoption during the first MIPS performance period. Health IT vendor may face additional costs in the first year of MIPS if they choose to develop additional capabilities in their systems in order to submit advancing care information and CPIA performance category data on behalf of eligible clinicians.
Additionally, we believe a majority of MIPS eligible clinicians who are able to report the advancing care information performance category of MIPS have already adopted an EHR during Stage 1 and 2 of the prior Medicare EHR Incentive Program. As we have stated with respect to the Medicare EHR Incentive Program, we believe that future retrospective studies on the costs to implement an EHR and the return on investment (ROI) will demonstrate efficiency improvements that offset the actual costs incurred by eligible clinicians participating in MIPS and specifically in the advancing care information performance category, but we are unable to quantify those costs and benefits at this time.
At present, evidence on EHR benefits in either improving quality of care or reducing health care costs is mixed. This is not surprising since the adoption of EHR as a fully functioning part of medical practice is still in its infancy. Even physician offices and hospitals that can meet Medicare EHR Incentive Program standards have not necessarily fully implemented all the functionality of their systems or fully exploited the diagnostic, prescribing, and coordination of care capabilities that these systems promise. Moreover, many of the most important benefits of EHR depend on interoperability among systems and this functionality is still lacking in many EHR systems. A recent RAND report prepared for the ONC reviewed 236 recent studies that related the use of health IT to quality, safety, and efficacy in ambulatory and non-ambulatory care settings and found that—
A majority of studies that evaluated the effects of health IT on healthcare quality, safety, and efficiency reported findings that were at least partially positive. These studies evaluated several forms of health IT: metrics of satisfaction, care process, and cost and health outcomes across many different care settings. The relationship between health IT and [health care] efficiency is complex and remains poorly documented or understood, particularly in terms of healthcare costs, which are highly dependent upon the care delivery and financial context in which the technology is implemented.
Similarly, the costs for implementation and complying with the CPIA performance category requirements could potentially lead to higher expenses for MIPS eligible clinicians. Costs per full-time equivalent primary care clinician for CPIA will vary across practices, including for some activities or patient-centered medical home practices, in incremental costs per encounter, and in estimated costs per member per month. Costs may vary based on panel size and location of practice among other variables. For example, Magill (2015), conducted a study of PCMH in two states.
Payment impacts in this proposed rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual eligible clinician could vary from the average and would depend on the mix of services that the eligible clinician furnishes. The average percentage change in total revenues would be less than the impact displayed here because eligible clinicians generally furnish services to both Medicare and non-Medicare patients. In addition, eligible clinicians may receive substantial Medicare revenues for services under other Medicare payment systems that would not be affected by MIPS adjustment factors.
Table 63 shows the estimated 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 eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Table 63. We conducted sensitivity analyses with low, high, and midpoint estimates, and we believe the midpoint estimate represents our best projection of the effects of the MIPS program on Medicare charges. As noted above, given the limitations on the data used for this simulation, differences between specialties are attributable to different performance levels on the quality and resource use performance category measures available from historical PQRS and VM data. Our midpoint estimate, with a performance threshold set at 50, follows as Table 63.
Based on National Health Expenditure data,
There are a number of changes in this proposed rule that would have an effect on beneficiaries. In general, we believe that the proposed changes will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries.
More broadly, we expect that over time both the overall MIPS program and increasing participation in APMs will increasingly result in improved quality of care, resulting in lower morbidity and mortality, and in reduced spending, as physicians respond to the incentives offered by MIPS and APMs and adjust their clinical practices in order to maximize their performance on specified quality measures and activities. The various shared savings initiatives already operating have had modest success but have demonstrated that all three outcomes are possible. For example, in August of 2015, we issued 2014 quality and financial performance results showing that Medicare ACOs continue to improve the quality of care for Medicare beneficiaries while generating financial savings.
Results from the first year of the CPC Initiative indicate that it has generated nearly enough savings in Medicare health care expenditures to offset care management fees paid by CMS.
• The primary sources of the savings were reduced rates of hospital admissions and emergency department visits.
• The bulk of the savings was generated by patients in the highest-risk quartile, but favorable results were also seen in other patients.
• Over 90 percent of practices successfully met all first-year transformation requirements.
• The expenditure impact estimates differ across the seven regions.
• Additional time and data are needed to assess impact on care quality.
These results should be interpreted cautiously as effects are emerging earlier than anticipated, and additional research is needed to assess how the initiative affects cost and quality of care beyond the first year. Because the effects of the CPC Initiative are likely to be larger in subsequent years, these early results suggest it is likely the model will eventually break-even or generate savings.
Basing reimbursement in part on performance metrics is still an evolving art and, as discussed throughout this preamble, there are multiple variables and as yet no definitive answers as to what combinations of measures, benchmarks, and other variables will achieve the best results over time. Accordingly, we are unable at this time to provide specific dollar estimates of these benefits and cost reductions.
The MIPS program is aimed at Medicare FFS physicians and other professionals paid under the PFS. These physicians and other professionals are almost all engaged in serving patients covered by other payers as well. Because Medicare covers only about one person in seven (though a considerably higher share of total healthcare spending, since older persons incur far higher expenses on average than younger persons), for most of those services that will be subject to MIPS payment adjustments, Medicare provides only a fraction of practice revenues. Moreover, it is unlikely that many insurance payers will adopt MIPS or MIPS-like payment models in the short run. Hence, MIPS incentives are necessarily attenuated. On the other hand, changing practices for one group of patients will possibly lead to changes for other patients (for example, EHR systems are almost always used for all patients served by a physician). Physicians and other professionals may find it simpler and more efficient to adopt clinical practice improvements for all patients, regardless of payer, in response to MACRA's incentives, through the use of both MIPS measures and activities and alternative payment models. Furthermore, since MACRA eventually rewards participation in APMs beyond those in Medicare, other payers may start to develop more models in which clinicians and patients can participate. Hence, there are likely to be beneficial effects on a far broader range of patients in the health care system than simply Medicare patients, and we believe those effects would include improved health care quality and lower costs over time. However, we have no basis at this time for quantifying such effects.
We note that large proportions of the Medicare and Medicaid programs are already delivered through capitated insurance payments to HMOs, PPOs, and related organizations. The Medicare Advantage program and related State programs therefore already have substantial incentives to improve quality and reduce costs. MIPS does not affect provider payments under those programs directly, which have their own reimbursement mechanisms for physicians and other professionals. In many but not all cases, those insurance carriers do use incentive mechanisms that are similar in purpose and design to the kinds of APMs that we expect will arise under the new payment adjustments. We would not expect major near-term changes in HMO and PPO payment arrangements, or performance, from any MIPS or APM spillover effects. Regardless, we have no
There are other potentially affected provider entities, including hospitals, skilled nursing facilities, Critical Access Hospitals (largely small rural hospitals), and providers serving unique populations, such as providers of tribal health care services. In none of these cases do we believe that MIPS would have significant effects on substantial numbers of providers. But to the extent that MIPS and increasing participation in APMs over time succeed in improving quality and reducing costs, there may be some beneficial effects not only on patients but also on some providers.
As noted previously in this section of the preamble, and as discussed in this subsection, we have concluded that financial effects on either directly or indirectly affected small entities, including rural hospitals, will be minimal. We welcome comments on these conclusions.
This proposed rule contains a range of policies, including many provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies where discretion has been exercised, presents our rationale for our proposed policies and, where relevant, analyzes alternatives that we considered. While it is hard to single out any one alternative for public comment, we particularly call attention to the performance threshold and the level at which it is set for scoring purposes under MIPS.
As described above, pursuant to section 1848(q)(6)(D)(i) of the Act, for each year of the MIPS, the Secretary shall compute a performance threshold with respect to which the CPSs of MIPS eligible clinicians are compared for purposes of determining the MIPS adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, which may be reassessed every 3 years) of the CPSs for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act outlines a special rule for the initial 2 years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS adjustment factors under paragraph (A) and an additional performance threshold for purposes of determining the additional MIPS adjustment factors under paragraph (C), each of which shall be based on a period prior to the performance periods and take into account data available with respect to performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary.
Depending on where the threshold is set within those parameters, the proportions and distributions of MIPS eligible clinicians receiving payment reductions versus positive payment adjustments can change dramatically from our estimates. For example, in Table 63, we estimated (based on available data) that 40.0 percent of Colon/Rectal Surgery specialists will receive a negative payment adjustment under MIPS. Setting the performance threshold at a lower level would enable more Colon/Rectal Surgery specialists to avoid negative adjustments and potentially qualify for more positive adjustments. Conversely, we estimated above that 59.2 percent of Interventional Radiology specialists would receive a positive adjustment under the current proposal. Setting the performance threshold at a higher level would result in fewer Interventional Radiology specialists qualifying for positive adjustments, and potentially more of them receiving negative adjustments. But any payment changes resulting from changes to the performance threshold policy will depend primarily on changes to practices and other responses from MIPS eligible clinicians.
We request comment on these alternatives, on all previous estimates of effects, and on any other issues or options that might improve the substantive effects of this proposed rule, or our estimates of those effects. We are particularly interested in comments on any aspects of this proposed rule that might inadvertently or unintentionally create adverse effects on the delivery of high quality and high value health care, and on options that might reduce such effects.
We would like to note several limitations to the analyses that estimated eligible clinicians' eligibility, negative payment adjustments, and positive payment adjustments based for the first MIPS performance period (2017) based on 2014 data described above:
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Due the limitations above, there is considerable uncertainty around our estimates that is difficult to quantify in detail.
As required by OMB Circular A-4 (available at
We have not attempted to quantify the benefits of this rule because of the many uncertainties as to both provider behaviors and resulting effects on patient health and cost reductions. For example, the applicable percentage for MIPS incentives changes over time, increasing from 4 percent in 2019 to 9 percent in 2022 and subsequent years, and we are unable to estimate precisely how physicians will respond to the increasing incentives. As noted above, in CY 2019, we estimate that we will distribute approximately $833 million in payment adjustments on a budget-
Further, the addition of new APMs and participants over time will affect the pool of MIPS eligible clinicians, and for those that are MIPS eligible clinicians, may change their relative performance. The $500 million available for exceptional performance and the 5 percent incentive for QPs are only available from 2019 through 2024. Beginning in 2026, QPs will receive a higher conversion factor than non-QPs. However, we are unable to estimate the number of QPs in those years, as we cannot project the number or types of Advanced APMs that will be made available in those years through future CMS initiatives proposed and implemented in those years, nor the number of QPs for those models.
The percentage of the CPS attributable to each performance category will change over time, and we will incorporate improvement scoring in future years. The CPIA category represents an entirely new category for measuring eligible clinicians' performance. We may also propose policy changes in future years as we continue implementing MIPS and as eligible clinicians accumulate experience with the new system. Moreover, there are interactions between the MIPS and APM incentive programs and other shared savings and incentive programs that we cannot model or project. Nonetheless, even if ultimate savings and health benefits represent only low fractions of current experience, benefits are likely to be substantial in overall magnitude.
The table that follows includes our estimate for MIPS payment adjustments ($833 million), the exceptional performance payments under MIPS ($500 million), and payments to QPs (using the lower bound estimate described in the preceding analysis, $146 million). However, of these three elements, only the budget-neutral MIPS payment adjustments are shown as estimated decreases.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, 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. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(a)
(1) Section 1833(z)—Incentive Payments for Participation in Eligible Alternative Payment Models.
(2) Section 1848(a)—Payment Based on Fee Schedule.
(3) Section 1848(k)—Quality Reporting System.
(4) Section 1848(q)—Merit-Based Incentive Payment System.
(b)
(1) The circumstances under which eligible clinicians are not considered MIPS eligible clinicians with respect to a year.
(2) How individual MIPS eligible clinicians can have their performance assessed as a group.
(3) The data submission methods and data submission criteria for each of the MIPS performance categories.
(4) Methods for calculating a performance category score for each of the MIPS performance categories.
(5) Methods for calculating a MIPS composite performance score and applying the MIPS payment adjustment to MIPS eligible clinicians.
(6) The elements an APM must require of its participants to be designated an “Advanced APM.”
(7) Methods for how eligible clinicians and entities participating in Advanced APMs can meet the participation thresholds to become Qualifying APM Participants (QPs) and Partial QPs.
(8) Methods and processes for counting participation in certain other payer arrangements (Other Payer Advanced APMs) in making QP and Partial QP determinations.
(9) Methods for calculating and paying the APM Incentive Payment to QPs.
(10) Evaluation of stakeholder submissions of Physician-Focused Payment Models (PFPMs).
As used in this section, unless otherwise indicated—
(1) A model under section 1115A of the Act (other than a health care innovation award).
(2) The shared savings program under section 1899 of the Act.
(3) A demonstration under section 1866C of the Act.
(4) A demonstration required by Federal law.
(1) Is not enrolled in Medicare Advantage or a Medicare cost plan,
(2) Does not have Medicare as a secondary payer,
(3) Is enrolled in both Medicare Parts A and B,
(4) Is at least 18 years of age,
(5) Is a United States resident, and
(6) Has a minimum of one claim for evaluation and management services furnished by an eligible clinician in the APM Entity group for any period during the QP Performance Period. For APMs that CMS determines to be focused on specific specialties or conditions or to have an attribution methodology that is not based on evaluation and management services, CMS uses a comparable standard related to the APM-specific attribution methodology for identifying beneficiaries as potential candidates for attribution.
(1) For any calendar year before 2018, EHR technology (which could include
(i) The 2014 Edition Base EHR definition (as defined at 45 CFR 170.102) and that has been certified to the certification criteria that are necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category, including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) for all certification criteria that support a meaningful use objective with a percentage-based measure.
(ii) Certification to—
(A) The following certification criteria:
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(B) Clinical quality measures at—
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(C) Privacy and security at—
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(D) The certification criteria that are necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category, including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2) for all certification criteria that support a meaningful use objective with a percentage-based measure.
(iii) The definition for 2018 and subsequent years specified in paragraph (2) of this definition.
(2) For 2018 and subsequent years, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets the 2015 Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to the 2015 Edition health IT certification criteria—
(i) At 45 CFR 170.315(a)(12) (family health history) and 45 CFR 170.315(e)(3) (patient health information capture); and
(ii) Necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category including the following:
(A) The applicable measure calculation certification criterion at 45 CFR 170.315(g)(1) or (2) for all certification criteria that support a meaningful use objective with a percentage-based measure.
(B) Clinical quality measure certification criteria that support the calculation and reporting of clinical quality measures at 45 CFR 170.315(c)(2) and (c)(3)(i) and (ii) and optionally (c)(4), and can be electronically accepted by CMS.
(1) A physician.
(2) A practitioner described in section 1842(b)(18)(C) of the Act.
(3) A physical or occupational therapist or a qualified speech-language pathologist.
(4) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act).
(1) The APM's participants include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services. For the purposes of this provision, primary care focus means involving specific design elements related to eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant;
(2) Empanelment of each patient to a primary clinician; and
(3) At least four of the following:
(i) Planned coordination of chronic and preventive care.
(ii) Patient access and continuity of care.
(iii) Risk-stratified care management.
(iv) Coordination of care across the medical neighborhood.
(v) Patient and caregiver engagement.
(vi) Shared decision-making.
(vii) Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings or population-based payments).
(1) The Other Payer APM's participants include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services. For the purposes of this provision, primary care focus means involving specific design elements related to eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant.;
(2) Empanelment of each patient to a primary clinician; and
(3) At least four of the following:
(i) Planned chronic and preventive care.
(ii) Patient access and continuity.
(iii) Risk-stratified care management.
(iv) Coordination of care across the medical neighborhood.
(v) Patient and caregiver engagement.
(vi) Shared decision-making.
(vii) Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings or population-based payments).
(1) A physician as defined in section 1861(r) of the Act.
(2) A physician assistant, a nurse practitioner, and clinical nurse specialist as such terms are defined in section 1861(aa)(5) of the Act.
(3) A certified registered nurse anesthetist as defined in section 1861(bb)(2) of the Act.
(4) A group that includes such clinicians.
(a) Except as specified in paragraph (b) of this section, MIPS applies to payments for items and services furnished by MIPS eligible clinicians on or after January 1, 2019.
(b)
(i) Is a Qualifying APM Participant as defined at § 414.1305;
(ii) Is a Partial Qualifying APM Participant (as defined at § 414.1305) for the most recent period for which data are available and who, for the performance period for the year, elects to not have measures and activities reported that are otherwise required to be reported by such professional under the MIPS; or
(iii) For the performance period with respect to a year, does not exceed the low-volume threshold as defined at § 414.1305.
(2) [Reserved]
(c)
(d) In no case will a MIPS adjustment factor (or additional MIPS adjustment factor) apply to the items and services furnished by individuals who are not MIPS eligible clinicians, including the MIPS eligible clinicians described in paragraphs (b) and (c) of this section.
(e)
(i) As part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN.
(ii) [Reserved]
(2) A group must meet the definition of a group at all times during the performance period for the MIPS payment year in order to have its performance assessed as a group.
(3) Individuals MIPS eligible clinicians within a group must aggregate their performance data across the TIN.
(4) A group that elects to have its performance assessed as a group will be assessed as a group across all four MIPS performance categories.
(5) A group must adhere to an election process established and required by CMS.
For purposes of this subpart, the performance period for the year is the calendar year (January 1 through December 31) 2 years prior to the year in which the payment adjustment applies.
(a)
(b)
(1) A qualified registry for the quality, CPIA, or advancing care information performance categories;
(2) The EHR submission mechanism (which includes submission of data by health IT vendors on behalf of MIPS eligible clinicians) for the quality, CPIA,
(3) A QCDR for the quality, CPIA, or advancing care information performance categories;
(4) Medicare Part B claims for the quality performance category; or
(5) Attestation for the CPIA and advancing care information performance categories.
(c)
(1) A qualified registry for the quality, CPIA, or advancing care information performance categories;
(2) The EHR submission mechanism (which includes the submission of data by health IT vendors on behalf of groups) for the quality, CPIA, or advancing care information performance categories;
(3) A QCDR for the quality, CPIA, or advancing care information performance categories;
(4) A CMS Web Interface (for groups comprised of at least 25 MIPS eligible clinicians) for the quality, CPIA, and advancing care information performance categories;
(5) Attestation for the CPIA and advancing care information performance categories; or
(6) A CMS-approved survey vendor for groups that elect to include the CAHPS for MIPS survey as a quality measure. Groups that elect to include the CAHPS for MIPS survey as a quality measure must select one of the above data submission mechanisms to submit their other quality information.
(d)
(e)
(f)
(g)
(1) For the qualified registry, QCDR, EHR, and attestation submission mechanisms shall be March 31 following the close of the performance period.
(2) For Medicare Part B claims, shall be on claims with dates of service during the performance period that must be processed no later than 90 days following the close of the performance period.
(3) For the CMS Web Interface, shall be an eight-week period following the close of the performance period. The period shall begin no earlier than January 1 and end no later than March 31.
(a) For purposes of assessing performance of MIPS eligible clinicians on the quality performance category, CMS will use:
(1) Quality measures included in the MIPS final list of quality measures.
(2) Quality measures used by QCDRs.
(b) Subject to CMS's authority to reweight performance category weights under section 1848(q)(5)(F) of the Act, performance in the quality performance category will comprise:
(1) 50 percent of a MIPS eligible clinician's composite performance score for 2019.
(2) 45 percent of a MIPS eligible clinician's composite performance score for 2020.
(3) 30 percent of a MIPS eligible clinician's composite performance score for each year thereafter.
(a)
(1)
(i) Submit data on at least six measures including one cross-cutting measure and at least one outcome measure. If an applicable outcome measure is not available, report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If fewer than six measures apply to the MIPS eligible clinician or group, report on each measure that is applicable.
(ii) Subject to paragraph (a)(1)(i) of this section, MIPS eligible clinicians and groups can either select their measures from the complete MIPS final measure list or a subset of that list, MIPS specialty-specific measure sets, as designated by CMS.
(2)
(i) For a group of 25 or more MIPS eligible clinicians, report on all measures included in the CMS Web Interface. The group must report on the first 248 consecutively ranked beneficiaries in the sample for each measure/module.
(ii) If the sample of eligible assigned beneficiaries is less than 248, then the group must report on 100 percent of assigned beneficiaries. In some instances, the sampling methodology will not be able to assign at least 248 patients on which a group may report, particularly those groups on the smaller end of the range of 25-99 MIPS eligible clinicians.
(3)
(A) The CAHPS for MIPS survey counts for one measure towards the MIPS quality performance category and also fulfills the requirement to report at least one cross-cutting measure (and in the absence of an applicable outcome measure, the requirement to report at least one high priority measure as a patient experience measure).
(B) Groups that elect this reporting mechanism must select an additional group data submission mechanism in order to meet the data submission criteria for the MIPS quality performance category.
(ii) [Reserved]
(b)
(a) MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or
(b) MIPS eligible clinicians submitting quality measures data using Medicare Part B claims, must submit data on at least 80 percent of the applicable Medicare Part B patients.
(c) Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to submit the CAHPS for MIPS survey must meet the data submission requirement on the sample of the Medicare Part B patients CMS provides.
(a) For purposes of assessing performance of MIPS eligible clinicians on the resource use performance category, CMS specifies resource use measures for a performance period.
(b) Subject to CMS's authority to reweight performance category weights under section 1848(q)(5)(F) of the Act, performance in the resource use performance category comprises:
(1) 10 percent of a MIPS eligible clinician's composite performance score for MIPS payment year 2019.
(2) 15 percent of a MIPS eligible clinician's composite performance score for MIPS payment year 2020.
(3) 30 percent of a MIPS eligible clinician's composite performance score for each year thereafter.
(a) For purposes of assessing performance of MIPS eligible clinicians on the CPIA performance category, CMS specifies an inventory of measures and activities for a performance period.
(b) Subject to CMS's authority to reweight performance category weights under section 1848(q)(5)(F) of the Act, performance in the CPIA performance category comprises:
(1) 15 percent of an MIPS eligible clinician's composite performance score for MIPS payment year 2019 and for each year thereafter.
(2) [Reserved]
(c) The CPIA inventory shall include one or more of the following criteria (in any order):
(1) Relevant to an existing CPIA subcategory (or a proposed new subcategory).
(2) Importance of activity toward achieving improved beneficiary health outcome.
(3) Importance of activity that could lead to improvement in practice to reduce healthcare disparities.
(4) Aligned with patient-centered medical home.
(5) Representative of activities that multiple providers could perform (for example, primary care, specialty care).
(6) Feasible to implement, recognizing importance in minimizing provider burden, especially for small (consisting of 15 or fewer clinicians), practices located in rural areas, and geographic HPSAs designated by HRSA.
(7) CMS is able to be validate the activity; or
(8) Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes.
(d) For purposes of assessing performance of MIPS eligible clinicians on the CPIAs performance category, CMS uses activities included in the CPIA Inventory described in paragraph (c) of this section.
(a) MIPS eligible clinicians must submit data on MIPS CPIAs in one of the following manners:
(1) Via administrative claims (if technically feasible), qualified registry, EHR submission mechanisms, QCDR, CMS Web Interface or Attestation. For activities that are performed for at least 90-days during the performance period, MIPS eligible clinicians must—
(i) Submit a yes/no response for activities within the CPIA Inventory.
(ii) [Reserved]
(2) [Reserved]
(b) [Reserved]
(a) MIPS eligible clinicians select subcategories from the following:
(1) Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.
(2) Population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR.
(3) Care coordination, such as timely communication of test results, timely exchange of clinical information to patients or other providers, and use of remote monitoring or telehealth.
(4) Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision-making mechanisms.
(5) Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.
(6) Participation in an APM, as defined in section 1833(z)(3)(C) of the Act.
(7) Achieving health equity, as its own category or as a multiplier where the achievement of high quality in traditional areas is rewarded at a more favorable rate for MIPS eligible clinicians that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs.
(8) Emergency preparedness and response, such as measuring MIPS eligible clinician participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty military MIPS eligible clinician activities, and measuring MIPS eligible clinician volunteer participation in domestic or international humanitarian medical relief work.
(9) Integrated behavioral and mental health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; cross-training of MIPS eligible clinicians, and integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.
(b) [Reserved]
(a)
(b)
(1) APM Entities participate in the APM under an agreement with CMS;
(2) The participating APM Entities include one or more MIPS eligible clinicians on a Participation List;
(3) The APM bases payment on cost/utilization and quality measures; and
(4) The APM does not have the following characteristics:
(i)
(ii)
(c)
(d)
(1) APM identifier (established for the APM by CMS; for example, XXXXXX);
(2) APM Entity identifier (established for the APM by CMS; for example, AA00001111);
(3) Medicare-enrolled billing TIN (for example, XXXXXXXXX); and
(4) Eligible clinician NPI (for example, 1111111111).
(e)
(2) The APM scoring standard only applies to the eligible clinicians identified on the Participation List for an APM Entity group.
(3) CMS communicates to each APM Entity the list of eligible clinicians included in the APM Entity group as soon as practicable following the end of each calendar year.
(4) The MIPS composite performance score calculated for the APM Entity group is applied to each eligible clinician in the APM Entity group.
(5) The MIPS payment adjustment is applied at the TIN/NPI level for each of the eligible clinicians in the APM Entity group.
(f)
(ii)
(2)
(3)
(ii) For APM Entity groups in MIPS APMs other than the Shared Savings Program, each MIPS eligible clinician in the APM Entity submits data on the CPIA performance category according to the CPIA data submission criteria at § 414.1360. The MIPS eligible clinicians within the APM Entity will have their performance on the CPIA performance category assessed as individual MIPS eligible clinicians. The APM Entity group CPIA performance category score is the mean of the individual scores for each MIPS eligible clinician in the APM Entity group.
(4)
(ii) For APM Entity groups in MIPS APMs other than the Shared Savings Program, each MIPS eligible clinician in the APM Entity submits data on the advancing care information performance category according to the criteria at § 414.1375(b). The MIPS eligible clinicians within the APM Entity will have their performance on the advancing care information performance category assessed as individual MIPS eligible clinicians. The APM Entity group advancing care information performance category score is the mean of the individual scores for each eligible clinician in the APM Entity group.
(g)
(1)
(ii) MIPS APMs that do not submit quality data through the CMS Web Interface: 0 percent.
(2)
(3)
(ii) MIPS APMs that do not submit quality data through the CMS Web Interface: 25 percent.
(4)
(ii) MIPS APMs that do not submit quality data through the CMS Web Interface: 75 percent.
(a)
(b)
(1) Use CEHRT as defined at § 414.1305 for the MIPS performance period;
(2)
(i) Report the numerator and denominator for all measures; or
(ii) Report the number and denominator for all applicable and available measures and a null value for any measure that:
(A) Is not applicable and available for the MIPS eligible clinician; and
(B) Includes a null value as an acceptable result in the measure specification.
(3)
(ii)
(A) Did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of CEHRT.
(B) Implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the CEHRT was, at all relevant times—
(
(
(
(
(c)
(a)
(1) Measures and activities in the four performance categories are scored against performance standards.
(i) For the quality and resource use performance categories, measures are scored between zero and 10 points against performance standards that we refer to as measure benchmarks. Bonus points are available for the quality performance category for both reporting specific types of measures and using CEHRT systems to capture and report quality measures.
(ii) For the CPIA performance category, each CPIA is worth a certain number of points. The points for each reported activity is summed and compared against the highest potential score.
(iii) For the advancing care information performance category, performance is the sum of a base score and performance score.
(A) Base score: Achieved by meeting the Protect Patient Health Information measure and reporting the numerator (of at least one) and denominator or yes/no statement as appropriate (only a yes statement would qualify for credit under the base score) for each required measure.
(B) Performance score: Decile scale for additional achievement on selected measures above their base score requirement.
(2) MIPS eligible clinicians meeting applicable data completeness criteria receive credit for applicable measures and activities.
(3) All performance levels receive points provided that data meet the required case minimum, data completeness and sufficient benchmark for the quality and resource use performance categories.
(4) The baseline period is 2 years prior to the performance period for the MIPS payment year.
(b)
(1)
(i) Measure benchmarks are based on historical performance for the measure based on a baseline period and each benchmark must have a minimum of 20 MIPS eligible clinicians who reported the measure meeting the data completeness requirement and minimum case size criteria.
(ii)
(A) CMS Web Interface submission uses benchmarks from the corresponding reporting year of the Shared Savings Program.
(B) [Reserved]
(iii) Separate benchmarks are used for the following submission mechanisms:
(A) EHR submission options;
(B) Administrative claims submission options;
(C) QCDR and qualified registry submission options;
(D) CMS Web Interface submission options;
(E) Claims submission options.
(iv) Minimum case requirements for quality measures are 20 cases, unless a measure is subject to an exception.
(v)
(vi) MIPS eligible clinicians failing to report a measure expected under this category receive zero points for that measure.
(vii) MIPS eligible clinicians do not receive zero points if the expected measure is submitted (meeting the data completeness criteria) but is unable to be scored because it does not meet the required case minimum or if the measure does not have a measure benchmark.
(viii) Measures that are not able to be scored would not be included for the MIPS quality performance category scoring.
(ix) MIPS eligible clinicians are scored using a percentile distribution, separated by decile categories.
(x) For each set of benchmarks, CMS calculates the decile breaks for measure performance and assigns points based on which benchmark decile range the MIPS eligible clinician's measure rate is between.
(xi) CMS assigns partial points based on the percentile distribution.
(xii) MIPS eligible clinicians are required to submit measures consistent with § 414.1335.
(xiii) Bonus points are available for measures determined to be high priority measures when two or more high priority measures are reported.
(A) Bonus points are not available for the first reported high priority measure which is required to be reported. To qualify for bonus points, each measure must be reported with sufficient case volume to meet the required case minimum and does not have a zero percent performance rate, regardless of whether it is included in the calculation of the quality performance category score.
(B) Outcome and patient experience measures receive two bonus points.
(C) Other high priority measures receive one bonus point.
(D) Bonus points for high priority measures cannot exceed 5 percent of the total possible points.
(xiv) Bonus points are also available for each measure submitted with end-to-end electronic reporting for a quality measure under certain criteria determined by the Secretary. Bonus points cannot exceed 5 percent of the total possible points.
(xv) A MIPS eligible clinician's quality performance score is the sum of all the points assigned for the measures required for the quality category criteria plus the bonus points in paragraph (b)(1)(xiii) and bonus points in paragraph (b)(1)(xiv) of this section. The sum is divided by the sum of total possible points.
(2)
(i) Each MIPS resource use measure has a measure benchmark that is based on the performance period.
(ii) Only measures meeting the required case minimum are scored under this category. Minimum case requirements for resource use measures are 20 cases.
(iii) A MIPS eligible clinician's resource use performance category score is the equally-weighted average of all scored measures.
(3)
(i) CMS assigns points for each reported CPIA within two weights: Medium-weighted; and high-weighted activities.
(ii) CPIA with high weighting receive 20 points.
(iii) CPIA with medium weighting receive 10 points.
(iv) MIPS eligible clinician or group in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, receives full credit for CPIA performance. For purposes of this paragraph (b)(3)(iv), “full credit” means that the MIPS eligible clinician or group has met the highest potential score. A practice is certified as a patient-centered medical home if it meets any of the following criteria:
(A) The practice has received accreditation from one of four accreditation organizations that are nationally recognized;
(
(
(
(
(B) The practice is a Medicaid Medical Home or Medical Home Model.
(C) The practice is a comparable specialty practice that has received the NCQA Patient-Centered Specialty Recognition.
(v) CMS compares the points associated with the reported activities against the CPIA highest potential score (60 points).
(vi) A MIPS eligible clinician or group's CPIA category score is the sum of points for all of their reported activities divided by the CPIA highest potential score of 60 points.
(vii) Non-patient-facing MIPS eligible clinicians and groups, small practices (consisting of 15 or fewer professionals), and practices located in rural areas and geographic HPSAs receive credit for CPIA by selecting one or two of any type of CPIA weighted activity.
(A) For purposes of this paragraph (b)(3)(vii), “credit” is considered 50 percent of the total of 60 points for one activity of any weight, and 100 percent of the total of 60 points for two activities of any weight.
(B) [Reserved]
(4)
(A) MIPS eligible clinicians earn a base score by reporting the numerator (of at least one)/denominator or yes/no statement as applicable (only a yes statement would qualify for credit under the base score) in the objectives and measures.
(B) MIPS eligible clinicians earn percentage points towards the performance score by reporting on the eight associated measures under the Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange objectives.
(C) MIPS eligible clinicians earn one additional bonus point for reporting any additional measures above the base score requirement for the Public Health and Clinical Data Registry objective.
(ii) [Reserved]
(c)
(1)
(i) Quality performance category weight is defined under § 414.1330(b).
(ii) Resource use performance category weight is defined under § 414.1350(b).
(iii) CPIA performance category weight is defined under § 414.1355(b).
(iv) Advancing care information performance category weight: 25 Percent for the 2019 MIPS payment year.
(2)
(ii) CMS calculates the CPS according to its finalized formulas.
(3) CMS reweights the performance category scores for MIPS eligible clinicians when they do not have sufficient applicable or available measures using the authority under section 1848(q)(5)(F) of the Act.
(4) The CPS forms the basis for payment adjustments under this section. The CPS must be based on a minimum of two scored performance categories. If a MIPS eligible clinician only has one scored performance category, the MIPS eligible clinician is assigned a CPS that is equal to the performance threshold and the MIPS eligible clinician receives a MIPS adjustment factor of 0 percent for the year.
(e)
(a)
(1) A MIPS eligible clinician may submit their election to request a targeted review to CMS within 60 days (or a longer period specified by CMS) after the close of the data submission period. All requests for targeted review must be submitted by July 31 after the close of the data submission period or by a later date that we specify.
(2) A response on whether or not a targeted review is warranted will be provided by CMS.
(3) There will not be a hearing or evidence submission process, although the MIPS eligible clinician may submit information to assist in the review.
(4) All decisions based on the targeted review will be final.
(5) There will be no further review or appeal.
(b)
(1) The methodology used to determine the amount of the MIPS adjustment factor and the amount of the additional MIPS adjustment factor and the determination of such amounts;
(2) The establishment of the performance standards and the performance period;
(3) The identification of measures and activities specified for a MIPS performance category and information made public or posted on a CMS public Web site; and
(4) The methodology developed that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.
(a)
(1) Comply with data sharing requests, providing all data as requested by us or our designated entity. All data must be shared with CMS or our designated entity within 10 business days or an alternate time frame that is agreed to by CMS and the MIPS eligible clinician or group. Data will be submitted via email, facsimile, or an electronic method via a secure Web site maintained by CMS.
(2) Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives, and activities. Primary source documentation also may include verification of records for Medicare and non-Medicare beneficiaries where applicable.
(b) [Reserved]
(a)
(b) [Reserved]
(a)
(i) A qualified registry;
(ii) A QCDR;
(iii) A health IT vendor that obtains data from a MIPS eligible clinician's CEHRT; or
(iv) A CMS-approved survey vendor.
(2) Qualified registries, QCDRs, and health IT vendors may submit data on measures, activities, or objectives for any of the following MIPS performance categories:
(i) Quality;
(ii) CPIA; or
(iii) Advancing care information, if the MIPS eligible clinician or group is using CEHRT.
(3) CMS-approved survey vendors may submit data for the CAHPS for MIPS survey under the MIPS quality performance category.
(4) Third party intermediaries must meet all the requirements designated by CMS as a condition of their qualification or approval to participate in MIPS as a third party intermediary, including the following requirements:
(i) For measures, activities, and objectives under the quality, advancing care information, and CPIA performance categories, if the data is derived from CEHRT, the QCDR, qualified registry, or health IT vendor must be able to indicate its data source.
(ii) All submitted data must be submitted in the form and manner specified by CMS.
(b)
(c)
(1) Be in existence as of January 1 of the performance period for which the entity seeks to become a QCDR.
(2) Have at least 25 participants by January 1 of the performance period.
(d)
(1) An entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR as long as the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR.
(2) Entities with a mere verbal, non-written agreement to work together to become a QCDR by September 1 of the year prior to the year for which the entity seeks to become a QCDR would not fulfill this requirement.
(e)
(1) A measure that is not contained in the annual list of MIPS quality measures for the applicable performance period.
(2) A measure that may be in the annual list of MIPS quality measures but has substantive differences, as determined by the Secretary, in the manner it is reported by the QCDR.
(3) CAHPS for MIPS survey.
(f)
(1) For non-MIPS quality measures, the quality measure specifications must include the following for each measure: Name/title of measures, NQF number (if NQF-endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. The narrative specifications provided must be similar to the narrative specifications we provide in our measures list. CMS will consider all non-MIPS quality measures submitted by the QCDR but the measures must address a gap in care and outcome or other high priority measures are preferred. Documentation or “check box” measures are discouraged. Measures that have very high performance rates already or address extremely rare gaps in care (thereby allowing for little or no quality distinction between eligible clinicians) are also unlikely to be approved for inclusion.
(2) For MIPS quality measures, the QCDR only needs to submit the MIPS measure numbers and/or specialty-specific measure sets (if applicable).
(3) The QCDR must publicly post the measure specifications (no later than 15 days following CMS approval of the measure specifications) for each non-MIPS quality measure it intends to submit for MIPS. The QCDR may use any public format it prefers. Immediately following posting of the measures specification, the QCDR must provide CMS with the link to where this information is posted.
(g)
(h)
(1) Be in existence as of January 1 the performance period for which the entity seeks to become a qualified registry.
(2) Have at least 25 participants by January 1 of the performance period.
(i)
(j)
(1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information will include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email.
(2) The entity must retain all data submitted to CMS for MIPS for a minimum of 10 years.
(k)
(2) CMS requires a corrective action plan from the third party intermediary to address any deficiencies or issues and prevent them from recurring. The corrective action plan must be received and accepted by CMS within 14 days of the CMS notification to the third party intermediary of the deficiency or probation. Failure to comply with this requirement will lead to disqualification from the MIPS program for the subsequent performance period.
(3) Probation means that, for the applicable performance period, the third party intermediary is not allowed to miss any meetings or deadlines and will need to submit a corrective action plan for remediation or correction of any deficiencies identified by CMS that resulted in the probation.
(4) If the third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, CMS will annotate on the CMS qualified posting that the entity furnished data of poor quality and will place the third party intermediary on probation for the subsequent MIPS performance period with the opportunity to go on probation for a year to correct deficiencies.
(5) If the third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary will continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS for one additional year. After two years on probation, the third party intermediary will be disqualified for the subsequent performance period.
(6) In placing the third party intermediary on probation; CMS would notify the third party intermediary of the identified issues, at the time of discovery of such issues.
(7) Data errors affecting in excess of 5 percent of the MIPS eligible clinicians or groups submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation in MIPS for the following performance period.
(8) If the third party intermediary does not submit an acceptable corrective
(a)
(b)
(c)
(d)
(1)
(2) MIPS eligible clinicians with a positive adjustment receive a payment against the applicable percentage and a scaling factor not to exceed 3.0.
(e)
(f)
(a)
(b)
(i)
(B) CMS updates the Advanced APM list on its Web site at intervals no less than annually.
(ii) Notwithstanding paragraph (b)(2) of this section, CMS includes notice of whether a new APM is an Advanced APM in the first public notice of the new APM.
(2)
(ii) CMS makes early Other Payer Advanced APM determinations prior to QP determinations under § 414.1440.
(iii) CMS makes final Other Payer Advanced APM determinations and notifies Advanced APM Entities and eligible clinicians of such determinations as soon as practicable.
(a)
(1)
(2)
(i) Require at least 50 percent of eligible clinicians in each participating APM Entity group, or each hospital if hospitals are the APM Entities, to use CEHRT to document and/or communicate clinical care to their patients or other health care providers.
(ii) For the Shared Savings Program, apply a penalty, reward, and/or similar financial component to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity.
(b)
(2) At least one of the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(i) Used in the MIPS quality performance category, as described in § 414.1330.
(ii) Endorsed by a consensus-based entity;
(iii) Developed under section 1848(s) of the Act;
(iv) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(v) Any other quality measures that CMS determines to have an evidence-based focus and be reliable and valid.
(3) In addition to the quality measure requirements under paragraph (b)(2) of this section, the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must include at least one outcome measure. This requirement does not apply if CMS determines that there are no available or applicable outcome measures included in the MIPS quality measures list for the Advanced APM's first QP Performance Period.
(c)
(1)
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iii) Require the APM Entity to owe payment(s) to CMS.
(2)
(i) Withholds payment for services to the APM Entity or the APM Entity's eligible clinicians.
(ii) Reduces payment rates to the APM Entity or the APM Entity's eligible clinicians.
(iii) Requires the APM Entity to owe payment(s) to CMS.
(iv) Causes the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
(3)
(A) A marginal risk rate of at least 30 percent; and
(B) Total potential risk of at least four percent of the expected expenditures.
(ii)
(A) In 2017, 2.5 percent of the APM Entity's total Medicare Parts A and B revenue;
(B) In 2018, 3 percent of the APM Entity's total Medicare Parts A and B revenue.
(C) In 2019, 4 percent of the APM Entity's total Medicare Parts A and B revenue.
(D) In 2020 and later, 5 percent of the APM Entity's total Medicare Parts A and B revenue.
(4)
(i) In the event that the marginal risk rate varies depending on the amount by which actual expenditures exceed expected expenditures, the lowest marginal risk rate across all possible levels of actual expenditures would be used for comparison to the marginal risk rate specified in paragraph (c)(3)(i)(A) of this section, with exceptions for large losses as described in paragraph (c)(4)(ii) of this section and small losses as described in paragraph (c)(4)(iii) of this section.
(ii) Allowance for large losses. The determination in paragraph (c)(4)(i) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by an amount sufficient to require the APM Entity to make financial risk payments to CMS greater than or equal to the total risk requirement under paragraph (c)(3)(i)(B) of this section.
(iii) Allowance for minimum loss rate. The determination in paragraph (c)(4)(i) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by less than 4 percent of expected expenditures.
(5)
(6)
(7)
(a)
(1) Use of CEHRT, as described in paragraph (b) of this section;
(2) Quality measures comparable to measures under the MIPS quality performance category apply, as described in paragraph (c) of this section; and
(3) Either:
(i) Requires APM Entities to bears more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures, as described in paragraph (d) of this section; or
(ii) Is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act, as described in paragraph (d)(3) of this section.
(b)
(1)
(2)
(c)
(2) At least one of the quality measures used in the arrangement with an APM Entity must have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(i) Used in the MIPS quality performance category, as described in § 414.1330;
(ii) Endorsed by a consensus-based entity;
(iii) Developed under section 1848(s) of the Act;
(iv) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(v) Any other quality measures that CMS determines to have an evidence-based focus and are reliable and valid.
(3) To meet the quality measure criterion, an Other Payer Advanced APM must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. If an Other Payer Advanced APM has no outcome measure, the Advanced APM Entity must attest that there is no applicable outcome measure on the MIPS list.
(d)
(1)
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iii) Require direct payment by the APM Entity to the payer.
(2)
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Require direct payment by the APM Entity to the payer;
(iii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians, or
(iv) Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
(3)
(A) A marginal risk rate of at least 30 percent; and
(B) Total potential risk of at least four percent of expected expenditures.
(ii)
(A) In 2019, 4 percent of the APM Entity's total Medicare Parts A and B revenue.
(B) In 2020 and later, 5 percent of the APM Entity's total Medicare Parts A and B revenue.
(4)
(i) In the event that the marginal risk rate varies depending on the amount by which actual expenditures exceed expected expenditures, the lowest marginal risk rate across all possible levels of actual expenditures would be used for comparison to the marginal risk rate specified in paragraph (d)(3)(i)(A) of this section, with exceptions for large losses as described in paragraph (d)(4)(ii) of this section and small losses as described in paragraph (d)(4)(iii) of this section.
(ii) Allowance for large losses. The determination in paragraph (d)(4)(i) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by an amount sufficient to require the APM Entity to make financial risk payments under the Other Payer Advanced APM greater than or equal to the total risk requirement under paragraph (d)(3)(i)(B) of this section.
(iii) Allowance for minimum loss rate. The determination in paragraph (d)(4)(i) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by less than 4 percent of expected expenditures.
(5)
(6)
(7)
(ii) For each Medical Home Model that is expanded under section 1115A(c) of the Act, CMS will publish the characteristics of such models against which Medicaid Medical Home Models will be compared under paragraph (a) of this section through notice and comment rulemaking.
(a)
(b)
(1)
(2)
(c)
(2) An eligible clinician cannot be both a QP and a Partial QP for a year. A determination that an eligible clinician is a QP means that the eligible clinician is not a Partial QP.
(3) An eligible clinician is a QP for a year if the eligible clinicians that constitute the group for the QP Determination under paragraph (b) of this section for an Advanced APM Entity collectively achieve a Threshold Score that meets or exceeds the corresponding QP threshold for that
(4) Notwithstanding paragraph (c)(3) of this section, an eligible clinician is a QP for a year if:
(i) The eligible clinician is grouped with eligible clinicians for the QP Determination pursuant to paragraph (b) of this section for more than one Advanced APM Entity;
(ii) None of the eligible clinician's Advanced APM Entity eligible clinician groups meets the QP threshold; and
(iii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the corresponding QP threshold.
(5) An eligible clinician is a Partial QP for a year if the eligible clinician group used for the QP Determination pursuant to paragraph (b) of this section collectively achieves a Threshold Score that meets or exceeds the corresponding Partial QP threshold for that year, as described in § 414.1430(a)(2), (4), (b)(2), and (4).
(6) Notwithstanding paragraph (c)(5) of this section, an eligible clinician is a Partial QP for a year if:
(i) The eligible clinician is grouped with eligible clinicians for the QP Determination pursuant to § 414.1425(b) for more than one Advanced APM Entity;
(ii) None of the eligible clinician's Advanced APM Entity eligible clinician groups meets the QP or Partial QP threshold; and
(iii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the corresponding Partial QP threshold.
(d)
(e)
(2) For payment years 2021 and later, CMS performs QP determinations for eligible clinicians under the Medicare Option, as described in § 414.1435 and, except for (i) and (ii), the All-Payer Combination Option, described in § 414.1440.
(i) If CMS determines the eligible clinician or group of eligible clinicians to be a QP under the Medicare Option, then CMS does not perform a QP determination for such eligible clinician(s) under the All-Payer Combination Option.
(ii) If the Threshold Score for an eligible clinician or eligible clinician group under the Medicare Option is less than the amount in § 414.1430(b)(2)(ii) and (b)(3)(iii), then CMS does not perform a QP determination for such eligible clinician(s) under the All-Payer Combination Option.
(a)
(i) 2019 and 2020: 25 percent.
(ii) 2021 and 2022: 50 percent.
(iii) 2023 and later: 75 percent.
(2)
(i) 2019 and 2020: 20 percent.
(ii) 2021 and 2022: 40 percent.
(ii) 2023 and later: 50 percent.
(3)
(i) 2019 and 2020: 20 percent.
(ii) 2021 and 2022: 35 percent.
(ii) 2023 and later: 50 percent.
(4)
(i) 2019 and 2020: 10 percent.
(ii) 2021 and 2022: 25 percent.
(iii) 2023 and later: 35 percent.
(b)
(A) 2021 and 2022: 50 percent.
(B) 2023 and later: 75 percent.
(ii) To meet the QP payment amount threshold under this option, the eligible clinician group or eligible clinician must also meet a 25 percent QP payment amount threshold under the Medicare Option.
(2)
(A) 2021 and 2022: 40 percent.
(B) 2023 and later: 50 percent.
(ii) To meet the QP payment amount threshold under this option, the eligible clinician group or eligible clinician must also meet a 20 percent Partial QP payment amount threshold under the Medicare Option.
(3)
(A) 2021 and 2022: 35 percent.
(B) 2023 and later: 50 percent.
(ii) To meet the QP patient count threshold under this option, the eligible clinician group or eligible clinician must also meet a 20 percent QP patient count threshold under the Medicare Option.
(4)
(A) 2021 and 2022: 25 percent.
(B) 2023 and later: 35 percent.
(ii) To meet the Partial QP patient count threshold under this option, the eligible clinician group or eligible clinician must also meet a 10 percent QP patient count threshold under the Medicare Option.
(a)
(1)
(2)
(3)
(b)
(1)
(2)
(3)
(4)
(c)
(2) When operationally feasible, this attributed beneficiary list will be the final beneficiary list used for reconciliation purposes in the Advanced APM.
(3) When it is not operationally feasible to use the final attributed beneficiary list, the attributed beneficiary list will be taken from the Advanced APM's most recently available attributed beneficiary list at the end of the QP Performance Period.
(d)
(e)
(a)
(i) The Secretary of Defense for the costs of Department of Defense health care programs.
(ii) The Secretary of Veterans Affairs for the cost of Department of Veterans Affairs health care programs.
(iii) Under Title XIX in a state in which no Medicaid Medical Home Model or APM is available.
(2) Title XIX payments will only be included in the numerator (paragraph (b)(2) of this section) and denominator (paragraph (b)(3) of this section) for an Advanced APM Entity if:
(i) A state has at least one Medicaid Medical Home Model (as defined in § 414.1305) or Medicaid APM (as defined in § 414.1305) in operation that is determined to be an Other Payer Advanced APM; and
(ii) The Advanced APM Entity is eligible to participate in at least one of such Other Payer Advanced APMs during the QP Performance Period, regardless of whether the Advanced APM Entity actually participates in such Other Payer Advanced APMs. This will apply to both the payment amount and patient count methods.
(b)
(2)
(3)
(c)
(2)
(3)
(d)
(2) CMS may count a single patient in the numerator and/or denominator for multiple different Advanced APM Entities or eligible clinicians.
(3) If the same Advanced APM Entity participates in two or more Other Payer Advanced APMs and at least one of those Other Payer Advanced APMs is an episode payment model, the numerator of the episode payment model Advanced APM Entity would be added to the non-episode payment model Advanced APM Entities' numerator(s), regardless of whether eligible clinicians are on the Participation List or Affiliated Practitioner List for an Advanced APM Entity.
(4) For purposes of this section, Advanced APM Entities are considered the same entity across Other Payer Advanced APMs if CMS determines that the Participation Lists are substantially similar or if one entity is a subset of the other.
(a)
(b)
(1) Payment arrangement information necessary to assess the Other Payer APM on all Other Payer Advanced APM criteria under § 414.1420;
(2) For each Other Payer APM, the amount of revenues for services furnished through the arrangement, the total revenues from the payer, the numbers of patients furnished any service through the arrangement, and the total numbers of patients furnished any service through the payer.
(3) An attestation from the payer that the submitted information is accurate.
(c)
(1) If an Other Payer Advanced APM has no outcome measure, the Advanced APM Entity must submit an attestation in a manner and by a date determined by CMS that there is no applicable outcome measure on the MIPS list of quality measures.
(2)
(A) The eligible clinician's Advanced APM Entity submits the information required under this section for CMS to assess the APM Entity group under the All-Payer Combination Option; and
(B) The eligible clinician submits adequate information under this section.
(ii) If neither the Advanced APM Entity nor the eligible clinician submit the information required under this section, then CMS does not make a QP assessment for such eligible clinician under the All-Payer Combination Option.
(a)
(2) CMS provides notice of the amount of the APM Incentive Payment to QPs as soon as practicable following the calculation and validation of the APM Incentive Payment amount, but in any event no later than 1 year after the incentive payment base period.
(b)
(2) The estimated aggregate payment amount for covered professional services includes all such payments to any and all of the TIN/NPI combinations associated with the NPI of the QP.
(3) The incentive payment base period, as defined in § 414.1305, is the entire calendar year immediately preceding the payment year.
(4) In calculating the estimated aggregate payment amount for a QP, CMS uses claims submitted with dates of service from January 1 through December 31 of the incentive payment base period, and processing dates of January 1 of the base period through March 31 of the subsequent payment year.
(5) Adjustments, such as use of a completion factor, are not made to the estimated aggregate payment amount.
(6) The payment adjustment amounts, negative or positive, as described in sections 1848(m), (o), (p), and (q) of the Act are not included in calculating the APM Incentive Payment amount.
(7) Incentive payments made to eligible clinicians under sections 1833(m), (x), and (y) of the Act are not included in calculating the APM Incentive Payment amount.
(8) Financial risk payments such as shared savings payments or net reconciliation payments are excluded from the amount of covered professional services in calculating the APM Incentive Payment amount.
(9) Supplemental service payments in the amount of covered professional services are included in calculating the APM Incentive Payment amount according to this paragraph (b). Supplemental service payments are included in the amount of covered professional services when calculating the APM Incentive Payment amount when the supplemental service payment meets the following four criteria:
(i) Is payment for services that constitute physicians services authorized under section 1832(a) and defined under section 1861(s) of the Act.
(ii) Is made for only Part B services under the criterion in paragraph (b)(9)(i) of this section.
(iii) Is directly attributable to services furnished to an individual beneficiary.
(iv) Is directly attributable to an eligible clinician, including an eligible clinician that is a group of individual eligible clinicians.
(v) For payment amounts that are affected by a cash flow mechanism, the payment amounts that would have occurred if the cash flow mechanism were not in place are used in calculating the APM Incentive Payment amount.
(c)
(2) In the event that an eligible clinician is no longer affiliated with the TIN associated with the QP's participation in the Advanced APM Entity that met the applicable QP threshold during the QP Performance Period, CMS makes the APM Incentive Payment to the TIN listed on the eligible clinician's CMS-588 EFT Application form.
(3) In the event that an eligible clinician becomes a QP through participation in multiple Advanced APMs, as described in § 414.1425(c)(4)(iii), CMS divides the APM Incentive Payment amount between the TINs associated with the QP's participation in each Advanced APM during the QP Performance Period. Such payments will be divided in proportion to the amount of payments associated with each TIN that the eligible clinician received for covered professional services during the QP Performance Period.
(d)
(e)
(2) APM Incentive Payments made under this section will not be included in calculations for the purposes of rebasing benchmarks in an APM.
(f)
There is no administrative or judicial review under sections 1869, 1878, or otherwise, of the Act of the following:
(a) The determination that an eligible clinician is a QP under § 414.1425 and the determination that an APM Entity is an Advanced APM Entity under § 414.1410.
(b) The determination of the amount of the APM Incentive Payment under § 414.1450, including any estimation as part of such determination.
(a)
(b)
(c)
(d)
(e)
(1) CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the Advanced APM Entity of eligible clinician at least 30 days before the formal disposition date; or
(2) There has been a termination, dispute, or allegation of fraud or similar fault against the Advanced APM Entity or eligible clinician, in which case the Advanced APM Entity or eligible clinician must retain records for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.
(f)
(a)
(b)
(1)
(ii) Flexibility: Provide the flexibility needed for practitioners to deliver high-quality health care.
(ii) Quality and Cost: Are anticipated to improve health care quality at no additional cost, maintain health care quality while decreasing cost, or both improve health care quality and decrease cost.
(iv) Payment methodology: Pay APM Entities with a payment methodology designed to achieve the goals of the PFPM Criteria. Addresses in detail through this methodology how Medicare, and other payers if applicable, pay APM Entities, how the payment methodology differs from current payment methodologies, and why the Physician-Focused Payment Model cannot be tested under current payment methodologies.
(v) Scope: Aim to either directly address an issue in payment policy that broadens and expands the APM portfolio or include APM Entities whose opportunities to participate in APMs have been limited.
(vi) Ability to be evaluated: Have evaluable goals for quality of care, cost, and any other goals of the Physician-focused Payment Model.
(2)
(ii) Patient Choice: Encourage greater attention to the health of the population served while also supporting the unique needs and preferences of individual patients.
(iii) Patient Safety: Aim to maintain or improve standards of patient safety.
(3)
(ii) [Reserved]
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(1) Subject to paragraph (3) of this definition, an EP, eligible hospital or CAH that, for an EHR reporting period for a payment year or payment adjustment year, demonstrates in accordance with § 495.40 meaningful use of certified EHR technology by meeting the applicable objectives and associated measures under §§ 495.20, 495.22, and 495.24, supporting information exchange and the prevention of health information blocking and cooperating with the authorized surveillance of health
(2)(i) Except as specified in paragraph (2)(ii) of this definition, a Medicaid EP or Medicaid eligible hospital, that meets the requirements of paragraph (1) of this definition and any additional criteria for meaningful use imposed by the State and approved by CMS under §§ 495.316 and 495.332.
(ii) An eligible hospital or CAH is deemed to be a meaningful EHR user for purposes of receiving an incentive payment under subpart D of this part, if the hospital participates in both the Medicare and Medicaid EHR incentive programs, and the hospital meets the requirements of paragraph (1) of this definition.
(3) To be considered a meaningful EHR user, at least 50 percent of an EP's patient encounters during an EHR reporting period for a payment year (or, in the case of a payment adjustment year, during an applicable EHR reporting period for such payment adjustment year) must occur at a practice/location or practices/locations equipped with certified EHR technology.
The revision and additions read as follows:
(a)
(2) * * *
(i) * * *
(E) For CY 2015 and 2016, satisfied the required objectives and associated measures under § 495.22(e) for meaningful use.
(F) For CY 2017, the EP may satisfy either the objectives and measures specified in § 495.22(e); or the objectives and measures specified in § 495.24(d).
(G) For CY 2018 and subsequent years, EPs, satisfied the required objectives and associated measures under § 495.24(d) for meaningful use.
(H)
(I)
(
(
(
(
(iii) Implemented in a manner that allowed for timely access by patients to their electronic health information; and
(
(
(b) * * *
(2) * * *
(i) * * *
(H)
(I)
(
(
(
(
(
(
(
The revisions read as follows:
(d)
(2) * * *
(iv) For 2018, 97 percent, except as provided in paragraph (d)(3) of this section.
(3)
(g) * * *
(2) Subject to paragraph (h)(2) of this section, provider-level attestation data for each eligible hospital that attests to demonstrating meaningful use for each payment year beginning with 2013.
(3) Subject to paragraph (h)(2) of this section, provider-level attestation data for each eligible EP that attests to demonstrating meaningful use for each payment year beginning with 2013 and ending after 2016.
The following Appendix will not appear in the Code of Federal Regulations.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of proposed rulemaking (NOPR) and announcement of public meeting.
The U.S. Department of Energy (DOE) proposes to revise its test procedures for commercial water heaters, unfired hot water storage tanks, and hot water supply boilers (henceforth, “commercial water heating (CWH) equipment”) established under the Energy Policy and Conservation Act of 1975 (EPCA), as amended. In this NOPR, DOE proposes several changes, including: Updating references of industry test standards to incorporate by reference the most recent versions of the industry standards; proposing modifications to the existing test methods for certain classes of CWH equipment; developing new test procedures for determining the efficiency of unfired hot water storage tanks, commercial heat pump water heaters, and flow-activated instantaneous water heaters; proposing clarifications on test set-up and settings for various classes of CWH equipment; revising the certification requirements for CWH equipment; and proposing associated implementing regulations including definitions. DOE announces a public meeting to receive comment on these proposed test procedure amendments, and it also welcomes written comments and data from the public on all aspects of this proposal.
The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585. To attend, please notify Ms. Brenda Edwards at (202) 586-2945. Further attendance instructions can be found in section V, “Public Participation.”
•
•
•
DOE will not accept telefacsimilies (faxes). For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this document (Public Participation).
A link to the docket Web page can be found at:
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
For more information on how to submit a comment, or review other public comments and the docket, contact Ms. Brenda Edwards, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-2945. Email:
DOE intends to incorporate by reference the following industry standards into part 431:
(1) Gas Appliance Manufacturers Association (GAMA) Standard IWH-TS-1, March 2003 edition, “Method to Determine Performance of Indirect-Fired Water Heaters,” sections 4, 5, 6.0, and 6.1;
(2) American National Standards Institute (ANSI) Standard Z21.10.3-2015/Canadian Standards Association (CSA) Standard 4.3-2015, “Gas-fired Water Heaters, Volume III, Storage Water Heaters with Input Ratings Above 75,000 Btu Per Hour, Circulating and Instantaneous,” annex E.1;
(3) ANSI/American Society of Heating Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard 118.1-2012, “Method of Testing for Rating Commercial Gas, Electric, and Oil Service Water-Heating Equipment”;
(4) ASTM International (ASTM) C177-13, “Standard Test Method for
(5) ASTM C518-10, “Standard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus;” and
(6) ASTM D2156-09, “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels.”
Copies of GAMA IWH-TS-1, March 2003 edition, can be obtained from the Air-conditioning, Heating, and Refrigeration Institute (AHRI), 2111 Wilson Blvd., Suite 500, Arlington, VA 22201, (703) 524-8800, or by going to
Copies of ANSI Z21.10.3-2015/CSA 4.3-2015 and ANSI/ASHRAE 118.1-2012 can be obtained from the American National Standards Institute, 25 W. 43rd Street, 4th Floor, New York, NY 10036, (212) 642-4800, or by going to
Copies of ASTM C177-13, ASTM C518-10, and ASTM D2156-09 can be obtained from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959, (610) 832-9585, or by going to
See IV.M. for a further discussion of these standards.
Title III, Part C
Under EPCA, energy conservation programs generally consist of four parts: (1) Testing; (2) labeling; (3) establishing Federal energy conservation standards; and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products and equipment must use as both the basis for certifying to DOE that their products and equipment comply with the applicable energy conservation standards adopted pursuant to EPCA, and for making representations about the efficiency of that equipment. (42 U.S.C. 6293(c); 42 U.S.C. 6295(s); 42 U.S.C. 6314; 42 U.S.C. 6316)
The initial test procedures for CWH equipment were added to EPCA by the Energy Policy Act of 1992 (EPACT 1992), Public Law 102-486, and correspond to those referenced in ASHRAE and Illuminating Engineering Society of North America (IESNA) Standard 90.1-1989 (
If DOE determines that a test procedure amendment is warranted, it must publish a proposed test procedure in the
The Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, amended EPCA to require that at least once every 7 years, DOE must review test procedures for each type of covered equipment, including CWH equipment, and either: (1) Amend the test procedures if the Secretary determines that the amended test procedures would more accurately or
42 U.S.C. 6314(a)(3) requires that if the test procedure is a procedure for determining estimated annual operating costs, such procedure must provide that such costs are calculated from measurements of energy use in a representative average-use cycle (as determined by the Secretary), and from representative average unit costs of the energy needed to operate such equipment during such cycle. The Secretary must provide information to manufacturers of covered equipment regarding representative average unit costs of energy.
DOE's test procedure for CWH equipment is found at 10 CFR 431.106,
The American Energy Manufacturing Technical Corrections Act (AEMTCA), Public Law 112-210, was signed into law on December 18, 2012, and amended EPCA to require that DOE publish a final rule establishing a uniform efficiency descriptor and accompanying test methods for consumer water heaters and certain CWH equipment. (42 U.S.C. 6295(e)(5)) AEMTCA required DOE to replace the current efficiency metric for consumer water heaters (energy factor) and the current efficiency metrics for commercial water heaters (thermal efficiency and standby loss) with a uniform efficiency descriptor. (42 U.S.C. 6295(e)(5)(C)) Further, AEMTCA required that the uniform efficiency descriptor and accompanying test method apply, to the maximum extent possible, to all water heating technologies currently in use and to future water heating technologies. (42 U.S.C. 6295(e)(5)(H)) However, AEMTCA allowed DOE to exclude from the uniform efficiency descriptor, specific categories of covered water heaters that do not have residential uses, that can be clearly described, and that are effectively rated using the current thermal efficiency and standby loss descriptors. (42 U.S.C. 6295(e)(5)(F))
DOE published a final rule for test procedures for certain CWH equipment on July 11, 2014 (“July 2014 final rule”). 79 FR 40542. The final rule modified the current consumer water heater metric (energy factor) to create uniform energy factor (UEF), the descriptor to be used as the uniform efficiency descriptor for all consumer water heaters and certain CWH equipment that have residential uses.
In this rulemaking for CWH equipment test procedures, DOE only considers amended test procedures for the CWH equipment classes that do not have residential applications and that are not “residential-duty commercial water heaters” as adopted in the July 2014 final rule.
In support of its rulemaking effort, DOE typically seeks comments from the public and uses them to conduct in-depth technical analyses of publicly-available test standards and other relevant information. As noted above, this NOPR discusses the comments received by DOE in response to the February 2014 RFI and summarizes all proposed updates and amendments to the current test procedure. In its efforts to continually engage the public and interested parties in the rulemaking process, DOE seeks data and public input on all aspects of this rulemaking, in order to improve the testing methodologies, to accurately reflect commercial use, and to produce repeatable results. DOE also requests feedback from interested parties and stakeholders on the proposed amendments to the current test procedures for CWH equipment.
The February 2014 RFI raised several issues regarding the thermal efficiency and standby loss test methods for CWH equipment. Several other issues which were not part of the RFI were brought up through stakeholder feedback and comments on the RFI. In this NOPR, DOE discusses all issues identified by DOE and interested parties, and proposes to modify the current test procedures based on these issues, as necessary, in order to improve the consistency and accuracy of test results generated using the DOE test procedure while minimizing test burden.
As provided in 10 CFR 431.105, the current DOE test procedure incorporates by reference the ANSI Z21.10.3-2011 test method for use in 10 CFR 431.106, and that latter provision specifically directs one to follow Exhibits G.1 and
After a careful review of ANSI Z21.10.3-2015, DOE found one significant difference between the sections of the test standard that are currently referenced by DOE (
DOE's current test procedure for oil-fired CWH equipment at 10 CFR 431.106 also refers to ASTM Standard D2156-80 (“ASTM D2156-80”), “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels.” Specifically, this industry method is cited to determine that smoke in the flue does not exceed a No. 1 smoke spot number. A more recent version of this standard, ASTM Standard D2156-09 (“ASTM D2156-09”), “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels,” was approved in 2009 and reapproved in 2013. DOE carefully reviewed the two versions of this industry method and identified no significant differences that would affect the determination of smoke spot number as referred to in DOE's test procedure. Therefore, DOE proposes to incorporate by reference ASTM D1256-09 for the purpose of determining the smoke spot number.
However, DOE also proposes clarifications to the procedure for determining the smoke spot number. First, DOE proposes to clarify that the smoke spot number must be determined prior to taking measurements for the efficiency tests (
DOE's current definition for “R-value” at 10 CFR 431.102 references two industry test methods: (1) ASTM Standard Test Method C177-97 (“ASTM C177-97”), “Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded-Hot-Plate Apparatus”; and (2) ASTM Test Standard C518-91 (“ASTM C518-91”), “Standard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus.” More recent versions of ASTM C177 and ASTM C518 were published in October 2013 and June 2010, respectively: (1) ASTM Standard Test Method C177-13 (“ASTM C177-13”), “Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded-Hot-Plate Apparatus”; and (2) ASTM Test
Among the comments received by DOE on the published RFI, several commenters raised concerns with regards to the repeatability of the standby loss test method as set forth in the current DOE test method (which references Exhibit G.2 of ANSI Z21.10.3-2011). To address these concerns of test repeatability, DOE proposes several improvements to both the thermal efficiency and standby loss test methods, which are discussed in detail in section III.B of this rulemaking.
Unfired hot water storage tanks are covered equipment included in the scope of this rulemaking. These tanks store hot water and do not consume fuel or electricity for the purpose of heating water, so any energy efficiency improvements would target standby loss associated with heat loss from the stored water. Currently, unfired hot water storage tanks are required to have thermal insulation with a minimum thermal resistance (R-value) of 12.5 °F·ft
Another issue raised by DOE in the February 2014 RFI regarded the method of setting the tank thermostat prior to conducting the thermal efficiency test. 79 FR 10999, 11002-03 (Feb. 27, 2014). The current Federal test procedure at 10 CFR 431.106 references Exhibits G.1 and G.2 of ANSI Z21.10.3-2011, which requires water heaters to achieve a maximum mean tank temperature of 140 °F ± 5 °F after the thermostat reduces the gas supply to a minimum. However, some CWH equipment may experience difficulty in attaining a mean tank temperature of 140 °F ± 5 °F due to the design of the heat exchanger and positioning of the thermostat sensor. Such systems may in fact be able to supply water at a temperature of 140 °F ± 5 °F, but yet not meet the mean tank temperature requirement. As a result, DOE proposes to modify the test procedure for gas-fired and oil-fired storage water heaters and storage-type instantaneous water heaters to use the outlet water temperature as the set point for setting the thermostat, rather than the mean tank temperature. This change would still ensure the water heater provides water at the specified temperature, while accommodating models that are not designed to have high mean tank temperatures (
In the February 2014 RFI, DOE requested information on whether any clarifications are needed in the thermal efficiency test procedure to indicate water flow requirements or to account for changes in thermal energy stored within the water heater during the duration of the test. 79 FR 10999, 11003 (Feb. 27, 2014). Based on the comments received, DOE has tentatively concluded that the current test procedure prescribed in 10 CFR 431.106 does not require any amendment to account for changes in stored thermal energy or water flow requirements during the thermal efficiency test method. The existing test procedure requires the water heater to attain steady-state conditions with no variation of outlet water temperature in excess of 2 °F over a period of 3 minutes. Once steady-state conditions are achieved, the internal tank temperature maintains a constant value, indicating that the stored energy in the water heater remains constant as long as the firing rate remains constant. While DOE has tentatively concluded that an amendment to account for stored energy changes is not needed, DOE proposes to introduce a statement clarifying that during the thermal efficiency test, the burner must continuously fire at the full firing rate (
In this NOPR, DOE proposes several changes to the definitions included in the regulations for consumer water heaters at 10 CFR 430.2 and for CWH equipment at 10 CFR 431.102. For consumer water heaters, DOE proposes to remove exemptions from the definitions that exclude units that heat water to temperatures greater than 180 °F and units with a storage capacity greater than 120 gallons. DOE also proposes to remove the definitions for consumer “electric heat pump water heater” and “gas-fired heat pump water heater.” DOE proposes the following changes to the definitions for CWH equipment: (1) Replacing all mentions of the terms “input rating” or “rated input” with the term “fuel input rate” in the context of gas-fired or oil-fired CWH equipment, based on the proposed changes regarding fuel input rate that are further discussed in section III.K; (2) modifying DOE's definitions for “instantaneous water heater” and “storage water heater” by adding the input criteria that separate consumer water heaters and commercial water heaters and removing several phrases that do not serve to clarify coverage of units under the definitions; and (3) removing the definition of “packaged boiler.” DOE also proposes to modify the definition for “residential-duty commercial water heater” by removing from its scope the following classes, for which the input criteria indicating
Water heaters with storage tanks and submerged fire-tube heat exchangers that have input ratings above 4,000 Btu/h per gallon of water stored are currently classified as instantaneous water heaters and hot water supply boilers with a storage volume greater than or equal to 10 gallons. However, DOE believes that these units that are equipped with storage tanks are fundamentally different from other instantaneous water heaters, and, therefore, the Department proposes to define the term “storage-type instantaneous water heater.” DOE also proposes that such units would be tested according to the same method as used for commercial storage water heaters. Additional discussion of these issues are contained in section III.F.4.
Instantaneous water heaters and hot water supply boilers are covered equipment subject to the current Federal test procedure as set forth in 10 CFR 431.106. In response to the February 2014 RFI, AHRI raised an issue with regards to the applicability of the standby loss test procedure described in Exhibit G.2 of ANSI Z21.10.3-2011 for instantaneous water heaters and hot water supply boilers that have no means of initiating burner operation without an active flow of water through the equipment. Additionally, ANSI Z21.10.3-2015 was updated from previous versions of the industry testing standard to include a new test method for measuring the standby loss of tube-type instantaneous water heaters, which AHRI recommended DOE use for determining the standby loss of such instantaneous water heaters and hot water supply boilers. DOE identified numerous problematic issues with this procedure and tentatively decided not to incorporate it by reference in its test procedures for CWH equipment. (The AHRI comments and this test method are discussed it in greater detail, along with DOE's proposed standby loss test procedure for flow-activated instantaneous water heaters, in section III.G.) The current standby loss test procedure involves shutting off the flow of water through the water heater and calculating the amount of energy required to raise the internally stored water temperature to a thermostatically-set value when it drops to a point at which it needs to be reheated. For such a test, it is assumed that when the stored water reaches the minimum allowable water temperature (below the thermostat set point) a control signal activates that will initiate the next firing or heating cycle. This is true for most CWH equipment; however, flow-activated instantaneous water heaters require flow of water through the heater to initiate the next firing or heating cycle. In these designs, if there is no continuous water flow, the next firing or heating cycle is not triggered even if the temperature of hot water inside the heater falls below the thermostat set point. To address this issue, DOE proposes to adopt a separate standby loss test for flow-activated instantaneous water heaters. DOE currently only prescribes standby loss standards for gas-fired and oil-fired instantaneous water heater and hot water supply boilers with a storage capacity greater than or equal to 10 gallons. The proposed test method would apply to all units that meet the proposed definition for “flow-activated instantaneous water heater,” and is described in detail in section III.G.
The current thermal efficiency and standby loss test method requires the water heater to be set up as per Figure 2 in ANSI Z21.10.3-2011, which is identical to Figure 3 in ANSI Z21.10.3-2015. Although the figures provide an unscaled pictorial arrangement of the test set up, neither Figure 2 in ANSI Z21.10.3-2011 nor Figure 3 in ANSI Z21.10.3-2015 specifies the exact location of the outlet water temperature measurement. DOE understands that this unspecified location for outlet water temperature measurement could lead to inconsistent test results and an inaccurate representation of the actual outlet water temperature, especially if the outlet water temperature represents the internal stored water temperature for instantaneous water heaters and hot water supply boilers (as proposed in this NOPR and discussed in section III.G and III.I). Moreover, the temperature-sensing installations, as set forth in Annex E.1 of ANSI Z21.10.3-2015, do not provide clear instructions for installing temperature-sensing means for instantaneous water heaters and hot water supply boilers. Considering the issues related to temperature measurement for instantaneous water heaters and hot water supply boilers, DOE proposes to specify the temperature-sensing location for the outlet water temperature such that the tip or junction of the sensor is less than or equal to 5 inches away from the water heater jacket and requirements for placement of the temperature-sensing probe in the water line for both supply and outlet water measurement. In addition to this issue, DOE also proposes to add supply and outlet water valves at locations closer to the water heater. Specifically, DOE proposes to add a supply water valve within a distance of 5 inches from the water heater jacket and an outlet water valve within a distance of 10 inches from the water heater jacket. Currently, the test set up does not clearly indicate the location of the water supply valves. These valves would be turned off at the start of the standby loss test for instantaneous water heaters and hot water supply boilers (as proposed in this NOPR and discussed in section III.G and III.I). DOE also proposes to add provisions for outlet water temperature measurement and placement of water valves for instantaneous water heaters and hot water supply boilers that have multiple supply and outlet water connections and that are shipped with piping installed by the manufacturer. Finally, DOE proposes to clarify the conditions for using a re-circulating loop. The proposed provisions are similar to those specified in ANSI Z21.10.3-2011 (and ANSI Z21.10.3-2015), and further details on this issue are contained in section III.H.
In response to the RFI, manufacturers also raised the issue of the applicability of the current Federal standby loss test procedure to instantaneous water heaters and hot water supply boilers that are not tank-type water heaters and that have a storage capacity of ten gallons or more (all comments on this topic are discussed in section III.I of this NOPR). The Federal standby loss test procedure in 10 CFR 431.106 incorporates by reference Exhibit G.2 of ANSI Z21.10.3-2011, which requires the measurement of mean tank temperature to calculate standby loss. Instantaneous water heaters and hot water supply boilers generally are not equipped with an integral storage tank, but rather the stored water is contained within the heat exchanger. Therefore, measuring the mean tank temperature for such type of equipment would not be possible (as a storage tank does not exist). Moreover, due to the complex geometry and design of the heat exchangers of such equipment, obtaining an accurate value of the mean stored water temperature inside the heat exchanger would be difficult, or in some cases, may be impossible. To address this issue, DOE proposes to use the outlet water temperature as a conservative estimate for the mean tank temperature. This approach is similar to that used for the standby loss test for
In the February 2014 RFI, DOE also requested comments on development of a test procedure for commercial heat pump water heaters (CHPWHs). 79 FR 10999, 11003 (Feb. 27, 2014). Based on the comments received, DOE proposes to incorporate by reference ANSI/ASHRAE Standard 118.1-2012,
In its current regulations for CWH equipment in subpart G to 10 CFR part 431, DOE includes several terms referring to the input capacity, and does not include any method for determining or verifying the input capacity during testing. In this NOPR, DOE proposes to define “fuel input rate” for gas-fired and oil-fired CWH equipment and proposes a procedure for calculating the fuel input rate during the thermal efficiency test. DOE proposes that the gas consumption be measured every 10 minutes, and that the calculated fuel input rates for each 10-minute interval of the thermal efficiency test cannot vary by more than ± 2 percent between each reading. DOE also proposes means to verify the fuel input rate. Additional discussion of these proposed changes regarding fuel input rate is contained in section III.K.
In this NOPR, DOE proposes several changes to its certification requirements at 10 CFR part 429. First, DOE proposes to add requirements to 10 CFR 429.44 that manufacturers must certify whether gas-fired and oil-fired instantaneous water heaters and hot water supply boilers contain submerged heat exchangers, so that such models can be classified under DOE's proposed definition for “storage-type instantaneous water heaters.” Second, DOE proposes to require manufacturers to certify whether instantaneous water heaters and hot water supply boilers require flow through the water heater to initiate burner ignition. Further discussion of these proposed changes are included in section III.M. Additionally, DOE proposes default values for these parameters to be used in testing if the parameters are not reported in manufacturer literature shipped with the equipment or the supplemental test instructions. Further discussion of these proposed default values are included in section III.L.
In any rulemaking to amend a test procedure, DOE must determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1); 42 U.S.C. 6314(a)(4)(C)) DOE expects that the proposed changes to the test procedure will not significantly alter the efficiency ratings for a most classes of CWH equipment. There could, however, be changes to the measured energy efficiency for unfired hot water storage tanks. If DOE adopts the changes to the existing test procedures proposed in this NOPR for those products, then DOE will establish energy conservations standards for unfired hot water storage tanks in terms of a new standby loss metric in a separate rulemaking, and the test procedure changes related to unfired hot water storage tanks will not apply until compliance is required with the new standards. DOE also proposes a new test procedure for measuring standby loss of flow-activated instantaneous water heaters with a storage capacity greater than or equal to 10 gallons. However, DOE does not believe this proposed test procedure will affect the measured energy efficiency of flow-activated instantaneous water heaters.
In response to the February 2014 RFI, DOE received eight written comments from the following interested parties: Bradford White Corporation (Bradford White); A.O. Smith Corporation (A.O. Smith); HTP, Inc. (HTP); Rheem Manufacturing Company (Rheem); Edison Electric Institute (EEI); Air-Conditioning, Heating, and Refrigeration Institute (AHRI); American Public Power Association (APPA); and the American Council for an Energy-Efficient Economy (ACEEE) and National Resources Defense Council (NRDC), who filed a joint comment (henceforth referred to as “Joint Advocates”). These interested parties commented on a range of issues, including those identified by DOE in the February 2014 RFI, as well as several other pertinent issues. The issues, the comments received, DOE's responses to those comments, and the resulting proposed changes to the test procedures for CWH equipment, are discussed in the following subsections.
DOE's test procedure for measuring the energy efficiency for CWH equipment currently incorporates by reference the industry standard ANSI Z21.10.3-2011 at 10 CFR 431.105. Additionally, DOE lists ASTM Standard Test Methods D2156-80, C177-13, and C518-10 as sources of information and guidance in 10 CFR 431.104. DOE defines “ASTM Standard Test Method D2156-80” at 10 CFR 431.102, and points to this source in DOE's current test procedure at 10 CFR 431.106. DOE points to ASTM C177-13 and ASTM C518-10 in its definition for “R-value” at 10 CFR 431.102. The following subsections discuss proposed revisions to DOE's test procedure for CWH equipment vis-à-vis these industry standards.
As noted above, DOE's test procedure for measuring the energy efficiency for CWH equipment currently incorporates by reference the industry standard ANSI Z21.10.3-2011 at 10 CFR 431.105. Specifically, the DOE test procedures at 10 CFR 431.106 directs one to follow Exhibits G.1 and G.2 of ANSI Z21.10.3-2011 for measuring thermal efficiency and standby loss, respectively. An updated edition of the industry test method, ANSI Z21.10.3-2013/CSA 4.3-2013, was approved on March 25, 2013, and released in July 2013.
In the February 2014 RFI, DOE requested feedback on the appropriateness of replacing references to ANSI Z21.10.3-2011 with equivalent references to ANSI Z21.10.3-2013 (which, at that time, was the most current industry testing standard). 79 FR 10999, 11001-02 (Feb. 27, 2014). All parties that commented on this issue agreed with DOE that ANSI Z21.10.3-2013 was an appropriate replacement for ANSI Z21.10.3-2011. (Bradford White, No. 8 at p. 1;
However, since publication of the February 2014 RFI, ANSI updated its test method twice. First, an updated version was approved on July 2, 2014, and released in August 2014—ANSI Z21.10.3-2014/Canadian Standards Association (CSA) 4.3-2014,
In Annex E.2 of ANSI Z21.10.3-2015, the equation is exactly the same, except that the Δ
DOE has tentatively concluded that the standby loss equation provided in ANSI Z21.10.3-2011 (and ANSI Z21.10.3-2013) is appropriate. If the Δ
DOE did not find any other substantive differences between Exhibits G.1 and G.2 of ANSI Z21.10.3-2011 and Annexes E.1 and E.2 of ANSI Z21.10.3-2015. Therefore, DOE proposes to incorporate by reference Annex E.1 of ANSI Z21.10.3-2015 in its proposed test procedures for CWH equipment. DOE does not propose to incorporate by reference Annex E.2 of ANSI Z21.10.3-2015; however, DOE has included certain language from Annex E.2 in its standby loss test procedures proposed in this NOPR.
ANSI Z21.10.3-2015 also includes a new efficiency test procedure—Annex E.3, “Method of test for measuring standby loss for tube type instantaneous water heaters with 10 or greater gallons of storage.” This procedure provides a method to test standby loss of instantaneous water heaters and hot water supply boilers, including those that require flow of water to activate the burner or heating element (
DOE also proposes a procedure similar to that specified in section 5.27 of ANSI Z21.10.3-2015 for determining the storage volume of CWH equipment. DOE's proposed language only includes clarifying differences from the language in section 5.27 of ANSI Z21.10.3-2015, and DOE believes that the clarifying differences would not affect conduct of the test procedure between DOE's proposed procedure and the method included in section 5.27 of ANSI Z21.10.3-2015. DOE's proposed procedure for determining storage volume is discussed in further detail in section III.G.
DOE's current test procedure for oil-fired CWH equipment at 10 CFR 431.106 points to ASTM Standard Test Method D2156-80. Specifically, DOE requires that smoke in the flue does not exceed No. 1 smoke as measured by the procedure in ASTM D2156-80. However, there is a more recent version of ASTM D2156 that was approved on December 1, 2009, and reapproved on October 1, 2013. After careful review of D2156-80 and D2156-09, DOE has tentatively concluded that no substantive changes were made between these versions in the test method for determining the smoke spot number. Therefore, DOE proposes to incorporate by reference this newer version, ASTM D2156-09, in its test procedures for oil-fired CWH equipment, in appendices A, C, and E to subpart G of 10 CFR part 431.
DOE's current requirement for smoke spot number of flue gas for oil-fired CWH equipment requires that the smoke in the flue does not exceed No. 1 smoke, but does not specify when during the test to determine the smoke spot number. To improve consistency and repeatability of testing of CWH equipment, DOE is proposing to specify when to conduct the smoke spot test. DOE considered several options for this specification. The first option DOE considered would be to require determination of the smoke spot number after steady-state operation has been achieved, but prior to beginning measurement for the thermal efficiency test. The second option considered would be to require determination of the smoke spot number before and after conduct of the test. The third option considered would be to require determination of the smoke spot number before, after, and during the test. Specifically, in the third option, the
After considering these three options and the relative benefits and test burden they might provide, DOE has tentatively concluded that determining the smoke spot number prior to conduct of efficiency testing sufficiently assesses the combustion performance while minimizing test burden for manufacturers. DOE reasoned that it is unlikely for the smoke density to change to a significant extent during a steady-state test if the burner settings are maintained throughout the test. As discussed in section III.E, DOE is also proposing to add a clarifying statement to the test procedure stating that the settings on CWH equipment during the thermal efficiency test are not be changed once steady-state conditions have been established. Therefore, DOE has tentatively concluded that it is not necessary to require determination of the smoke spot number during or after efficiency testing, and rather proposes to require determination of the smoke spot number before beginning measurement for efficiency testing. Specifically, for the thermal efficiency test, DOE proposes to require determination of the smoke spot number after steady-state condition has been reached (as determined by no variation of outlet water temperature in excess of 2 °F over a 3-minute period). For the standby loss test, DOE proposes to require determination of the smoke spot number after the first cut-out before beginning measurements for the standby loss test. DOE also proposes to require that the CO
DOE also proposes to clarify that the smoke spot test and measurement of CO
Additionally, to further clarify the appropriate method for determining the smoke spot number, DOE proposes to adopt specifications to the test procedure for the set-up for measuring the smoke density. Specifically, DOE proposes to require that the smoke measuring device be connected to an open-ended tube, and that this tube must project into the flue
DOE's current definition for “R-value” at 10 CFR 431.102 references two industry test methods: ASTM Standard Test Method C177-97 and ASTM Test Standard Method C518-91.
A more recent version of ASTM C177 was approved in September 2013 and published in October 2013 (ASTM C177-13). After careful review, DOE has tentatively concluded that there are no substantive differences in the procedures for measuring R-value between the two versions of ASTM C177. Additionally, a more recent version of ASTM C518 was approved in May 2010 and published in June 2010 (ASTM C518-10). After careful review, DOE has tentatively concluded that there are no substantive differences in the procedures for measuring R-value between the two versions of ASTM C518. Therefore, DOE proposes to incorporate by reference ASTM Standard Test Methods C177-13 and C518-10 and to update its references to these versions in the definition for “R-value” at 10 CFR 431.102.
As discussed in section III.A of this rulemaking, the DOE test procedure for CWH equipment currently incorporates by reference ANSI Z21.10.3-2011 at 10 CFR 431.105, and DOE proposes to incorporate by reference Annex E.1 of the updated version of the standard, ANSI Z21.10.3-2015, for measuring thermal efficiency and standby loss, respectively.
The test method for thermal efficiency of CWH equipment in Annex E.1 of ANSI Z21.10.3-2015 (and also in Exhibit G.1 of ANSI Z21.10.3-2011) requires that the thermostat be set so that the gas supply is reduced to a minimum, once the mean tank temperature reaches 140 °F ± 5 °F. Then water is supplied continuously to the water heater at a temperature of 70 °F ± 2 °F. The outlet water temperature is adjusted by varying the flow rate until the temperature is constant at 70 °F ± 2 °F above the supply water temperature. After the outlet water reaches steady state, water flow (measured by weight) is recorded for a 30-minute test period, along with supply and outlet water temperatures, the ambient room temperature, and fuel and electricity consumption. These data collected during the 30-minute test period are used to calculate the thermal efficiency.
The standby loss test method in Annex E.2 of ANSI Z21.10.3-2015 (and also in Exhibit G.2 of ANSI Z21.10.3-2011) stipulates that a commercial water heater must be set up as described for the thermal efficiency test and that the unit must be put into operation with the burner gas supply opened. After the first burner cut-out,
In the February 2014 RFI, DOE requested information and data pertaining to the repeatability of thermal efficiency and standby loss test methods included in the ANSI Z21.10.3-2011 and ANSI Z21.10.3-2013 test methods. 79 FR 10999, 11001-02 (Feb. 27, 2014).
HTP commented that the thermal efficiency test is repeatable and is reasonably consistent between testing sites. (HTP, No. 5 at p. 2) No other interested parties provided information on the repeatability of the thermal efficiency test method in ANSI Z21.10.3.
Several parties provided comments regarding the repeatability of the standby loss test method. HTP commented that the standby loss test
Based on these comments from interested parties, DOE investigated various potential test procedure modifications to reduce the variability of results from the test procedures for thermal efficiency and standby loss. In addition, DOE conducted investigative testing that helped inform the proposals discussed in this NOPR. DOE proposes the following seven modifications to the current thermal efficiency and standby loss test procedures, after tentatively determining that these modifications would reduce variation in results: (1) Stipulating a maximum air draft requirement of 50 ft/min as measured prior to beginning the thermal efficiency or standby loss tests; (2) tightening the ambient room temperature tolerance from ±10.0 °F to ±5.0 °F and the allowed variance from mean ambient temperature from ±7.0 °F to ±2.0 °F; (3) requiring measurement of test air temperature—the temperature of entering combustion air—and requiring the test air temperature not vary by more than ±5 °F from the ambient room temperature at any measurement interval during the thermal efficiency and standby loss tests for gas-fired and oil-fired CWH equipment; (4) establishing a requirement for ambient relative humidity of 60 percent ±5 percent during the thermal efficiency and standby loss tests for gas-fired and oil-fired CWH equipment; (5) requiring a soak-in period prior to testing in which the water heater must sit without any draws taking place for at least 12 hours from the end of a recovery from a cold start; (6) specifying the locations of inlet and outlet temperature measurements for storage water heaters, storage-type instantaneous water heaters, and UFHWSTs; and (7) decreasing the time interval for data collection from fifteen minutes to 30 seconds in the thermal efficiency and standby loss tests. While manufacturers cited concerns regarding only the repeatability of the standby loss test in response to comments to the February 2014 RFI, DOE has tentatively concluded that the following proposed modifications would improve the repeatability of both tests. Unless otherwise specified in the following paragraphs, DOE proposes that these changes would apply to thermal efficiency and standby loss tests for all CWH equipment (as applicable).
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DOE also considered three other modifications to improve standby loss test repeatability, but ultimately decided against proposing these modifications for the reasons provided. The three additional considered but rejected modifications include:
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EPCA defines an “unfired hot water storage tank” (UFHWST) as a tank used to store water that is heated externally. (42 U.S.C. 6311(12)(C)) The current Federal standard for this equipment type requires a minimum thermal insulation (R-value) of 12.5. 10 CFR 431.110. DOE defines “R-value” as the thermal resistance of insulating material as determined based on ASTM Standard Test Method C177-97 or ASTM Standard Test Method C518-91 and expressed in °F·ft
DOE is aware that some manufacturers ship UFHWSTs without insulation, and that uninsulated UFHWSTs may or may not then be insulated on-site. In this rulemaking, DOE makes clear that UFHWSTs shipped without insulation are not compliant with the Federal R-value standard. All UFHWSTs must either be shipped insulated to the R-value standard or shipped together with insulation meeting the R-value standard. Manufacturers of UFHWSTs must certify that the insulation meets the R-value standard prescribed in 10 CFR 431.110, and this certification must be based on testing according to the methods prescribed in the R-value definition. A UFHWST manufacturer may demonstrate compliance with the insulation requirements either by
Because DOE includes ASTM test methods for measuring R-value in its definition of “R-value,” DOE does not currently specify a test procedure for measuring energy efficiency of UFHWSTs in 10 CFR 431.106. In the February 2014 RFI, DOE requested comment on whether the R-value is an adequate energy efficiency descriptor for UFHWSTs. DOE also requested comment on the potential for replacing R-value with standby loss, or another metric, as the energy efficiency descriptor for UFHWSTs, and how to establish a standby loss test or other test for this equipment if such a metric is appropriate. 79 FR 10999, 11002 (Feb. 27, 2014).
A.O. Smith, AHRI, and Rheem commented that there is no need for a test procedure to measure the R-value of the insulation on UFHWSTs. (A.O. Smith, No. 7 at pp. 1-2; AHRI, No. 2 at pp. 2-3; Rheem, No. 3 at pp. 1-2) AHRI also commented that the R-value requirement is in no way a measurement of the “efficiency” of an unfired storage tank, and that ASHRAE deliberately did not include a thermal efficiency or standby loss requirement for this equipment in ASHRAE Standard 90.1. (AHRI, No. 2 at pp. 2-3) Bradford White and HTP support the current requirement of a minimum insulation R-value, and Bradford White estimated that replacing the R-value metric with a metric requiring an efficiency test would require 3 days of testing per model. (Bradford White, No. 8 at p. 1; HTP, No. 5 at p. 2) AHRI, HTP, and Rheem also expressed support for the current two ASTM test methods (C177-97 and C518-91) for testing the R-value of insulation for UFHWSTs. (AHRI, No. 2 at pp. 2-3; HTP, No. 5 at p. 2; Rheem, No. 3 at pp. 1-2)
Joint Advocates noted that the two ASTM test methods are intended for flat samples, while UFHWSTs are generally pressure vessels with curved surfaces. (Joint Advocates, No. 4 at p. 2) Joint Advocates recommended replacing the present R-value requirement for UFHWSTs with a standby loss test similar to the test used for electric and fuel-fired commercial water heaters because the current R-value requirement does not ensure that all surfaces of the tank are adequately insulated, nor does it encourage other methods to reduce heat loss, such as anti-siphon connections and/or eliminating thermal bridges. Joint Advocates also recommended that for any units with legitimate needs for field insulation of UFWHSTs, DOE could either allow for a waiver or establish a separate class of uninsulated UFHWSTs. (Joint Advocates, No. 4 at p. 2)
A.O. Smith and AHRI also pointed out that there exists a group of UFHWSTs that are larger than standard volume models and are often built to order. (A.O. Smith, No. 7 at p. 2; AHRI, No. 2 at pp. 2-3) A.O. Smith and AHRI stated that these units are often shipped without insulation and subsequently field-insulated due to shipping and installation considerations that make it impractical to insulate at the site of manufacture. (A.O. Smith, No. 7 at p. 2; AHRI No. 2 at pp. 2-3)
After considering these comments, DOE has tentatively determined that a measurement of energy efficiency of UFHWSTs is necessary to more fully comply with the requirements of 42 U.S.C. 6314(a)(2)-(3), and proposes a standby loss metric and test method to replace the current R-value requirement. Although DOE recognizes that requiring use of a standby loss test will increase test burden for manufacturers, DOE has tentatively concluded that the benefits of such a metric would outweigh this additional burden. Primarily, DOE agrees with Joint Advocates that a standby loss metric would encourage and credit energy-saving technologies that are not measured by the R-value of the insulation and ensure that all surfaces are adequately insulated. As a result, DOE proposes to establish a standby loss test method for UFHWSTs that monitors the decrease in tank temperature from a set temperature. In addition, DOE proposes to amend the definition of “standby loss” at 10 CFR 431.102 to include unfired hot water storage tanks.
Regarding the points from AHRI, A.O. Smith, and Joint Advocates about UFHWSTs that are shipped without insulation and subsequently field-insulated, DOE reiterates that all UFHWSTs must have a minimum thermal insulation R-value of 12.5 when they are shipped from the manufacturer. Any units shipped without a minimum thermal insulation of R-12.5 and then insulated on-site would not be compliant with DOE's current regulations.
To determine the standby loss of an UFHWST, the storage capacity of the tank must first be determined. Section 5.27 of ANSI Z21.10.3-2015 includes a method for measuring the storage capacity, and it states that this method is applicable to water heaters including storage vessels. DOE examined this method and found no reason why it would be inapplicable to UFHWSTs. Therefore, DOE proposes to use the test method described in section 5.27 of ANSI Z21.10.3-2015 to measure the storage capacity of UFHWSTs. DOE includes a procedure for determining storage volume in its proposed test procedure for UFHWSTs that has only clarifying differences from the method presented in section 5.27 of ANSI Z21.10.3-2015. DOE's proposed procedure for determining storage volume is discussed in further detail in section III.G.
Next, DOE considered three possible test methods to determine the standby loss coefficient and hourly standby losses of an UFHWST. The first method considered—and the one that DOE proposes as the test method for UFHWSTs—is based on a method for assessing the energy efficiency of indirect water heaters, which was originally developed by the GAMA,
As noted in this preamble, DOE proposes several modifications to Testing Standard IWH-TS-1 to be included in DOE's proposed test
DOE also proposes to adopt the same ambient room temperature requirement for all CWH equipment that is discussed in section III.B. Specifically, DOE proposes that the ambient room temperature must be maintained at 75 °F ± 5 °F during the test (as measured at each 30-second interval), and the measured room temperature must not vary by more than ±2.0 °F from the average ambient room temperature during the test. While Testing Standard IWH-TS-1 specifies an ambient room temperature of 70 °F, DOE notes that many manufacturers of UFHWSTs also manufacture storage water heaters. Therefore, DOE expects that manufacturer burden would be reduced if storage water heaters and UFHWSTs can be tested in the same test room, and DOE's proposal is consistent with that objective. Additionally, DOE proposes a requirement for maximum air draft in section III.B that applies to the soak-in period and standby loss test for UFHWSTs. Similar to ambient room temperature, DOE expects that aligning this requirement with that for other classes of CWH equipment will reduce testing burden for CWH manufacturers. DOE also proposes a requirement for a soak-in period to be conducted prior to beginning the standby loss test for UFHWSTs. In this soak-in period, the tank must sit without any draws taking place for at least 12 hours after being filled with water such that a mean tank temperature of 145 °F ± 5 °F is achieved. After completion of the soak-in period, DOE would require that the UFHWST be filled again such that a mean tank temperature of 145 °F ± 5 °F is achieved, because the stored water temperature would decrease during the soak-in period. Additionally, DOE proposes requirements for piping insulation and water supply similar to those for other classes of CWH equipment included in Annex E.1 of ANSI Z21.10.3-2015.
DOE also proposes to collect temperature data at intervals of 30 seconds during this test, as opposed to the 15-minute intervals specified by the IWH-TS-1 test method. DOE has determined that a higher number of data points will improve the accuracy of the least-squares regression and that, given the data storage capacity of modern data acquisition equipment, the higher frequency of data collection will pose only a negligible additional burden upon laboratories, as compared to the current 15-minute data collection interval. DOE also proposes to convert the decay rate metric to the standby loss metric currently applied to commercial storage water heaters, which has units of Btu/h.
DOE also considered two other approaches to determine the standby loss for UFHWSTs and is presenting these alternatives as part of this NOPR for comment on their merits compared to the proposed method. The first alternative is similar to the method proposed, but uses a different condition to end the standby loss test. Specifically, under this approach, the test would end 24 hours after the beginning of the test, instead of after the mean tank temperature reaches a specified temperature. However, the use of such a test ending condition would result in different final water temperatures for units with different rates of heat loss. This variation in final water temperature would impart an undesirable benefit to UFHWSTs that lose heat more quickly, because the rate of heat transfer from water to the surrounding air decreases as the corresponding temperature difference decreases. Additionally, DOE believes that a change in test ending condition to a 24-hour time limit may result in unnecessary test burden for manufacturers, as it would likely extend the duration of the test. In light of the potential downsides to this alternative, DOE has tentatively concluded that the test method proposed in this document (based on the industry-accepted IWH-TS-1 test method) would sufficiently capture the rate of heat loss from the tank while potentially allowing for a shorter test time.
DOE also considered a second alternative test method that would maintain the set point of the hot water within the UFHWST, by connecting an UFHWST to an external heat source (
DOE's test method for measuring the energy efficiency of CWH equipment currently requires that the thermostat be set to achieve specific conditions for the mean tank temperature before the test may begin. In particular, section g of Exhibit G.1 of ANSI Z21.10.3-2011 (which is currently incorporated by reference into the DOE test procedure) requires that before starting testing, the thermostat setting must be adjusted such that, when starting with the water in the system at 70 °F ± 2 °F, the maximum mean tank temperature will be 140 °F ± 5 °F after the thermostat reduces the gas supply to a minimum. DOE understands that some units may have difficulty achieving the required mean tank temperature condition, and in the February 2014 RFI DOE requested feedback on potential test procedure amendments to address this issue. 79 FR 10999, 11003 (Feb. 27, 2014).
In response to the February 2014 RFI, the four manufacturers among the interested parties (A.O. Smith, Bradford White, HTP, and Rheem), as well as AHRI, expressed support for changing the set point conditions to require monitoring the outlet water temperature rather than the mean tank temperature. (Bradford White, No. 8 at p. 1; Rheem, No. 3 at p. 2; HTP, No. 5 at p. 2; A.O. Smith, No. 7 at p. 2; AHRI, No. 2 at p. 4) A.O. Smith, Rheem, and AHRI expressed support for maintaining the set point condition at 140 °F ± 5 °F for the outlet water temperature. (A.O. Smith, No. 7 at p. 2; Rheem, No. 3 at p. 2; AHRI, No. 2 at p. 4) A.O. Smith stated that certain designs of CWH equipment cannot reach a mean tank temperature of 140 °F ± 5 °F, including down-fired, condensing equipment with reduced firing rates, and solar or other renewable source equipment. (A.O. Smith, No. 7 at p. 2) DOE received no comments opposing a potential change from setting the thermostat based on the mean tank temperature to setting the thermostat based on the temperature of the delivered water.
After carefully considering these comments, DOE proposes to modify the thermal efficiency and standby loss test procedures for gas-fired and oil-fired storage water heaters and storage-type instantaneous water heaters to require that before starting testing, the thermostat setting be adjusted such that, when starting with the water in the system at 70 °F ± 2 °F, the maximum outlet water temperature will be 140 °F ± 5 °F after the thermostat reduces the gas supply to a minimum. DOE has tentatively concluded that changing from a mean tank temperature requirement to an outlet temperature requirement would better accommodate designs of gas-fired and oil-fired water heaters that are not designed to have high mean tank temperatures (
DOE does not propose changing the mean tank temperature requirement to an outlet water temperature requirement for electric storage water heaters because of complications with setting tank thermostats. Electric storage water heaters have multiple heating elements and a thermostat corresponding to each element, and each thermostat needs to be set prior to beginning the standby loss test. Therefore, DOE reasons that electric storage water heaters, which vary in configuration and number of heating elements, are not well-suited to an outlet water temperature requirement because it is unclear how the lower thermostats would be set to achieve a designated outlet water temperature. A consistent, reproducible process for setting the thermostats is essential to having a repeatable test. Therefore, DOE proposes to maintain a mean tank temperature requirement for the standby loss test for electric storage water heaters. However, DOE proposes to clarify its language specifying the method for setting thermostats in an electric storage water heater with multiple thermostats. Specifically, DOE proposes to clarify that the thermostats are to be set in immediate succession, starting from the topmost thermostat. DOE also proposes to clarify that when setting each thermostat, the mean tank temperature is calculated using only temperature readings measured at locations higher in the tank than the heating element corresponding to the thermostat being set, with the exception of the bottommost thermostat. Finally, DOE proposes to clarify that all thermostats below the thermostat being tested must be turned off so that no elements below the thermostat being tested are in operation.
The calculation of thermal efficiency included in the current DOE test procedure for gas-fired and oil-fired CWH equipment at 10 CFR 431.106 (which incorporates the method used in Exhibit G.1 of ANSI Z21.10.3-2011) does not consider change in internal stored energy of the stored water.
In response, DOE received several comments from interested parties and stakeholders. AHRI commented that no change is required to the test procedure to address this issue. According to AHRI, the intent of the test method is that the burner be operated at a continuous, full-input firing rate, and once steady state is achieved, there would not be any issue with regards to potential changes in stored heat within the water heater. (AHRI, No. 2 at p. 4) Rheem deferred to AHRI's comments of not requiring any change in the thermal efficiency test method. (Rheem, No. 3 at p. 2) Bradford White, HTP, and A.O.
DOE considered all comments received from interested parties in response to this issue. Based on the comments received, DOE has tentatively decided not to implement any changes in the current thermal efficiency test methods or calculations for CWH equipment to account for changes in thermal energy stored in the water heater during the course of the 30-minute test. However, DOE proposes to clarify the requirements for maintaining steady-state operation throughout the thermal efficiency test. Specifically, DOE proposes to clarify that no settings on the water heater may be changed during the course of the thermal efficiency test, once steady-state operation is achieved, as determined by no variation of outlet water temperature in excess of 2 °F over a 3-minute period. This includes setting the flow rate during testing such that the heater operates at full firing rate (
Additionally, DOE proposes to clarify a similar requirement for the standby loss test for CWH equipment other than those meeting DOE's proposed definition for “flow-activated instantaneous water heater.” DOE proposes to require that after the first cut-out before beginning the standby loss test, no settings may be changed on the water heating equipment until measurements for the standby loss test are finished.
EPCA's definition of water heater specifies input ratings at or below which water heaters are to be classified as consumer water heaters (
In the July 11, 2014 test procedure final rule, in an effort to consolidate all relevant definitions in 10 CFR 430.2, DOE removed the definitions for specific kinds of consumer water heaters from its test method at appendix E to subpart B of part 430 and added definitions to 10 CFR 430.2 (
DOE now proposes to correct the definitions for specific types of consumer water heaters included at 10 CFR 430.2 by removing from the definitions the specifications related to the water temperature and storage capacity. Thus, a model that would otherwise meet the definition of a consumer water heater does not “become” commercial as the result of the unit's capability of producing water
Furthermore, DOE notes that, if a manufacturer offers a product that meets the definition of a water heater at 10 CFR 430.2, but cannot be tested by the applicable test procedure, the manufacturer should notify DOE and request a waiver from the applicable test method using the procedures at 10 CFR 430.27. If a waiver were granted, DOE would update its test procedure in the next rulemaking for consumer water heaters. DOE does not anticipate, however, that such a waiver would be needed. The UEF test procedure was developed quite recently and was designed to span the consumer product/commercial equipment boundary; accordingly, DOE expects that all units (irrespective of designed water temperature and/or rated storage capacity) can be tested without difficulty.
In its definitions at 10 CFR 430.2, DOE currently defines the terms “electric heat pump water heater” and “gas-fired heat pump water heater.” In its energy conservation standards for consumer water heaters at 10 CFR 430.32(d), DOE does not use the terms “electric heat pump water heater” or “gas-fired heat pump water heater.” DOE's Uniform Test Method for Measuring the Energy Consumption of Water Heaters at appendix E to subpart B of part 430 also does not use these terms. Therefore, DOE proposes to remove these terms.
As discussed in the previous paragraphs, DOE proposes to revise the definitions for “Electric instantaneous water heater”, “Electric storage water heater”, “Gas-fired instantaneous water heater”, “Gas-fired storage water heater”, “Oil-fired instantaneous water heater”, “Oil-fired storage water heater”, in its regulations of consumer water heaters at 10 CFR 430.2 as set out in the regulatory text at the end of this document.
DOE currently includes several definitions that include the terms “rated input” or “input rating” in its regulations for CWH equipment at 10 CFR 431.102. These definitions include “hot water supply boiler,” “instantaneous water heater,” “residential-duty commercial water heater,” and “storage water heater.” In section III.K of this NOPR, DOE proposes a new definition for “fuel input rate,” a value to be determined for all gas-fired and oil-fired CWH equipment. Therefore, DOE proposes to replace the terms “rated input” and “input rating” with the term “fuel input rate” for gas-fired and oil-fired CWH equipment in the definitions for CWH equipment at 10 CFR 431.102.
DOE's current definitions for “storage water heater” and “instantaneous water heater” in its regulations for CWH equipment codified at 10 CFR 431.102 do not include any criteria that exclude units that meet DOE's current definitions for consumer water heaters, as codified at 10 CFR 430.2. Therefore, DOE proposes to clarify these definitions for commercial water heaters by adding the input capacity criteria that distinguish between consumer and commercial water heaters for each energy source, as specified in EPCA's definition for consumer water heater. (42 U.S.C. 6291(27)) These proposed changes are consistent with DOE's proposed changes to its definitions for consumer water heaters, as discussed in section III.F.1.
DOE currently includes the definition for “instantaneous water heater” in its regulations for CWH equipment at 10 CFR 431.102. An instantaneous water heater is a water heater that has an input rating not less than 4,000 Btu/hr per gallon of stored water, and that is industrial equipment, including products meeting this description that are designed to heat water to temperatures of 180 °F or higher.
DOE believes that the last clause of the definition for “instantaneous water heater,” which includes units capable of heating water to temperature at or above 180 °F, does not serve a purpose in the definition. Without this clause, it would be assumed that units with this capability would be included in the definition because there is no restriction indicating otherwise. Therefore to simplify the definition, DOE proposes to remove this clause from the definition for “instantaneous water heater.” Additionally, with DOE's proposed addition of input criteria that distinguish between consumer and commercial water heaters previously discussed in this section, DOE believes that the clause “that is industrial equipment” does not serve to further clarify the scope of units covered by this definition. Therefore, DOE proposes to remove this clause from its definitions for “instantaneous water heater” and “storage water heater,” and revises the definitions as set out in the regulatory text at the end of this document.
In its regulations for CWH equipment at 10 CFR 431.102, DOE currently includes a definition for “packaged boiler” that is identical to that included for “commercial packaged boiler” at 10 CFR 431.82. DOE includes this definition for “packaged boiler” at 10 CFR 431.102 because the regulations for CWH equipment also include a definition for “hot water supply boiler,” and this definition specifies that a hot water supply boiler is a kind of packaged boiler. To simplify its regulations and reduce repetition, DOE proposes to remove the definition for “packaged boiler” from its regulations for CWH equipment at 10 CFR 431.102. Consequently, in its definition for “hot water supply boiler,” DOE proposes to replace the term “packaged boiler” with the term “packaged boiler (as defined in § 431.82).”
In section III.G, DOE discusses the reasons for a separate test procedure for water heaters and hot water supply boilers that require flow of water for heating water, and proposes a definition for “flow-activated water heater,” along with a test procedure for flow-activated water heaters as set out in the regulatory text at the end of this document.
In section III.J, DOE proposes a definition for “commercial heat pump water heater,” as well as a test procedure for commercial heat pump water heaters as set out in the regulatory text at the end of this document.
As required by AEMTCA, DOE established a uniform efficiency descriptor and accompanying test method for consumer water heaters and certain commercial water heaters in the July 2014 final rule. 79 FR 40542 (July 11, 2014). Specifically, AEMTCA required that the uniform efficiency descriptor and test method apply to all covered water heaters, including both consumer or commercial water heaters, except for certain commercial water heaters that do not have a residential use, can be clearly described, and are effectively rated using the thermal efficiency and standby loss descriptors. (42 U.S.C. 6295(e)(5)(F)) In the July 2014 final rule, DOE established input and volume criteria to distinguish commercial water heaters that do not have residential applications, based on comments from stakeholders. 79 FR 40542, 40586 (July 11, 2014). However, for four classes of residential-duty commercial water heaters—electric storage water heaters, heat pump water heaters, gas-fired instantaneous water heaters, and oil-fired instantaneous water heaters—the input criteria established to separate residential-duty commercial water heaters and commercial water heaters are identical to those codified at 10 CFR 430.2 that separate consumer water heaters and commercial water heaters. The criteria for these classes are shown in Table III-1. Because these input criteria are identical, by definition, no models can be classified under these four residential-duty equipment classes. Therefore, to eliminate potential confusion, DOE proposes to remove these classes from the definition for “residential-duty commercial water heater” codified at 10 CFR 431.102.
DOE proposes to revise the definition for “residential-duty commercial water heater” as set out in the regulatory text at the end of this document.
The definitions for “instantaneous water heater” and “hot water supply boiler” set forth in 10 CFR 431.102 include CWH equipment with an input rating of at least 4,000 Btu/h per gallon of stored water. These definitions, therefore, include both instantaneous water heaters and hot water supply boilers without integral storage tanks, as well as instantaneous water heaters with integral storage tanks (but with at least 4,000 Btu/h of input per gallon of stored water). DOE believes these two groups of equipment—water heaters with and without integral storage tanks—are fundamentally different in their construction and application and have different energy losses that need to be accounted for during efficiency testing. DOE has tentatively concluded that instantaneous water heaters with an integral storage tank (“storage-type instantaneous water heaters”) should be tested in a manner similar to commercial storage water heaters. Therefore, DOE proposes to adopt a test method specifically applicable to “storage-type instantaneous water heaters” that is the same as the test method for commercial storage water heaters. DOE proposes to define “storage-type instantaneous water heater” as set out in the regulatory text at the end of this document.
It is DOE's understanding that storage-type instantaneous water heaters are very similar to storage water heaters, but with a higher ratio of input rating to tank volume. This higher input-volume ratio is achieved with a relatively larger heat exchanger paired with a relatively smaller storage tank. However, through a review of product literature, DOE noted no significant design differences between models in these two proposed equipment classes that warrant separate test procedures for thermal efficiency or standby loss. Therefore, DOE proposes that the proposed test procedures for storage water heaters apply also to storage-type instantaneous water heaters.
The current Federal standby loss test method for CWH equipment incorporates by reference ANSI Z21.10.3-2011, including Exhibit G.2 which assumes that the water heater would automatically initiate the next firing cycle when the internal water temperature (measured using the internal tank thermostat) falls below its allowable minimum value. An underlying assumption for the standby loss test is that the ignition of the burner or activation of the electric element is solely dependent on the feedback control signal from the internal tank thermostat. This assumption, although true for most CWH equipment, is not applicable to certain instantaneous water heaters and hot water supply boilers that require continuous water flow through the heat exchanger in order to activate the next firing cycle.
Measuring standby loss for such flow-activated instantaneous water heaters with a storage volume greater than or equal to 10 gallons was raised as an issue by AHRI. (AHRI, No. 2 at pp. 4-5) Specifically, AHRI commented that the current standby loss test is designed for tank-type water heaters and does not address water heaters that can fire only when hot water is being drawn. (AHRI, No. 2 at pp. 4-5) On August 25, 2014, AHRI provided a supplemental comment with a recommended standby loss test method for tube-type instantaneous water heaters having a capacity of 10 gallons or more (“2014 AHRI-recommended test method”), which includes a suggested test method for models that are flow-activated. AHRI also mentioned in its comments that their recommended test method is being considered as an addition to the ANSI Z21.10.3 standard, and was at that time under review by the ANSI Z21/83 committee. (AHRI, No. 10 at p. 1)
DOE considered the comments received from AHRI and reviewed its
DOE notes that the requirement to measure a “mean tank temperature” to calculate the standby loss would also be an issue for all instantaneous water heaters and hot water supply boilers that have a storage capacity of 10 gallons or more and that do not meet DOE's proposed definition of “storage-type instantaneous water heater”, because these units do not have an integral tank, and the heat exchanger geometry can make obtaining an accurate reading of the water stored within the heat exchanger difficult to obtain. DOE has addressed this issue both in its proposed test method for flow-activated instantaneous water heaters contained within this section, and in proposed changes to the current standby loss test procedure for other instantaneous water heaters and hot water supply boilers discussed in section III.I of this NOPR.
To develop a new Federal standby loss test procedure for flow-activated instantaneous water heaters, DOE first reviewed the 2014 AHRI-recommended test method. After its review, DOE identified potential issues and provided AHRI with questions seeking further clarifications on various aspects of their recommended test method related to conduct of the test, duration of test, flow and temperature measurements, and the equations used to calculate standby loss. On August 17, August 18, and December 14, 2015, DOE received separate responses from AHRI members Thermal Solutions Inc., Raypak Inc. and A. O. Smith, respectively.
The response from Raypak Inc. can be found at:
The responses from A.O. Smith can be found at:
In November 2015, ANSI published an updated version of the ANSI Z21.10.3 test standard. This updated version, ANSI Z21.10.3-2015, includes Annex E.3, which describes a test method for measuring the standby loss of tube-type instantaneous water heaters having a storage capacity of 10 gallons or more. DOE reviewed this section carefully and found it to be similar to the Annex E.3 included in the 2014 AHRI-recommended test method. The only difference DOE identified between the two versions of Annex E.3 was the referenced section for determining the volume of water contained in the water heater. Specifically, Annex E.3 in the 2014 AHRI-recommended test method references to section 5.27 of ANSI Z21.10.3 for determining the water contained in the water heater, while Annex E.3 of ANSI Z21.10.3-2015 references section 5.28 of ANSI Z21.10.3-2015, “Capacities of tube type water heaters.” After carefully comparing the 2014 AHRI-recommended test method with Annex E.3 of ANSI Z21.10.3-2015, DOE believes that ANSI Z21.10.3-2015 renumbered section 5.27 as 5.28, and that AHRI's reference to section 5.27 was referring to the section titled “Capacities of tube type water heaters.” Therefore, DOE has tentatively concluded that there are no substantive differences between the 2014 AHRI-recommended test method and the test method contained in Annex E.3 of ANSI Z21.10.3-2015.
As previously discussed, prior to the publication of ANSI Z21.10.3-2015, DOE posed several questions and sought clarifications from AHRI on various aspects of the 2014 AHRI-recommended test method. Thermal Solutions Inc., Raypak Inc., and A.O. Smith provided responses to DOE's questions. The major issues on which DOE sought clarification, along with the manufacturer responses, are described in the following paragraphs.
First, DOE sought clarification as to whether the 2014 AHRI-recommended test method applies to all tube-type (thermostatically-activated and flow-activated) water heaters with a storage capacity of 10 gallons or more, or only to flow-activated instantaneous water heaters. DOE notes that AHRI's comments indicate that the test procedure is exclusively for flow-activated instantaneous water heaters. However, the title of the 2014 AHRI-recommended test method indicates that the test applies to all “tube-type” instantaneous water heaters. (AHRI, No. 10 at p.4) Judging by the title and the language used in the test method, DOE initially interpreted the test method as divided into two distinct parts: (1) The first part pertaining to tube-type instantaneous water heaters that are thermostatically-activated and are not flow-activated;
Thermal Solutions and Raypak did not comment on DOE's interpretation of the second part of the 2014 AHRI-recommended test method. However, judging by the response from A.O. Smith regarding the second part and the responses from A.O. Smith, Thermal Solutions, and Raypak regarding the first part, DOE infers that the second part of the test procedure is meant for flow-activated instantaneous water heaters that do not have any form of energy consumption or water circulation during the conduct of the standby loss test. (Thermal Solutions, No. 11 at p 1; Raypak, No. 12 at p. 2; A.O. Smith No. 14 at p. 1)
DOE also sought clarifications on the equations used to calculate the standby loss in both parts of the 2014 AHRI-recommended test method. In the first equation of the 2014 AHRI-recommended test method, DOE noticed an inconsistency in units of measurement. (AHRI, No. 10 at p. 5) When calculated, the first term of this equation has the units Btu/h, while the second term has the units 1/h. Mathematically, a subtraction or addition operation cannot be applied over two numbers that have different units of measurement. In their responses, the manufacturers also acknowledged the issues with regards to the equations for calculating standby loss and stated that AHRI has worked on a corrected derivation for the equations of this test procedure. (Thermal Solutions, No. 11 at p 3; Raypak, No. 12 at p. 4; A.O. Smith No. 14 at p. 3) DOE notes that later versions of the AHRI-recommended test methods (discussed later in this section) rectify this error in the first equation of the 2014 AHRI-recommended test method. However, the later versions of the AHRI-recommended test methods convert standby loss units from percent-per-hour of the heat content of the stored water to Btu-per-hour based on a temperature difference of the average value of the outlet water temperature minus the average value of the ambient temperature measured during the course of the test. This method of calculation does not match with the standby loss definition that is currently set forth in 10 CFR 431.102, which is based on a temperature difference of 70 °F between the stored water and the ambient air. Therefore, DOE has tentatively decided not to consider this equation for the proposed standby loss test procedure for flow-activated instantaneous water heaters.
In the second equation of the 2014 AHRI-recommended test method, DOE sought to understand the rationale for choosing a temperature difference term that is equal to the difference between the outlet water temperature and supply water temperature to calculate the thermal energy lost during the test. (AHRI, No. 10 at p. 5) In the third equation of the 2014 AHRI-recommended test method, DOE sought to understand the rationale for assuming a constant temperature difference of 70 °F between the supply water and the outlet water temperature. Further, the third equation appeared to assume that the outlet water in the water heater will cool down to the supply water temperature over a span of exactly 24 hours during the conduct of the test. (AHRI, No. 10 at p. 6) On the issue of considering the temperature difference between the outlet water temperature and supply water temperature to calculate the loss in thermal energy during the test, the manufacturers stated that AHRI has conservatively assumed the temperature of stored water inside the water heater to be equal to the outlet water temperature. The manufacturers stated that the geometry of these water heaters does not allow for the measurement of the mean stored water temperature inside the water heater. As a consequence, the commenters suggested using the outlet water temperature in place of the mean stored water temperature to carry out the standby loss calculations. (Thermal Solutions, No. 11 at pp. 3, 5; Raypak, No. 12 at pp. 4, 6; A.O. Smith No. 14 at pp. 3-5). The manufacturers also stated that they are willing to accept a conservative estimate of the standby loss in order to reduce the complexity and burden of the test method. (Thermal Solutions, No. 11 at p. 3; Raypak, No. 12 at p. 4; A.O. Smith No. 14 at p. 3-5)
DOE also sought clarification on the duration of the standby loss test. In particular, DOE sought an answer to whether any consideration was given to the possibility that flow-activated water heater burners may not cycle on at any point during the test and instead cool down completely in less than 24 hours. The manufacturers' responses to this question indicated that the suggested test method includes a one-hour test, and it is assumed that all the heat is lost in the heat exchanger. (Thermal Solutions, No. 11 at p 4; Raypak, No. 12 at p. 4; A.O. Smith No. 14 at p. 5)
Another issue that DOE sought clarification on is the method used to measure the storage volume of the water heater. Section 5.27 of ANSI Z21.10.3-2015 (that is the same as section 5.26 of ANSI Z21.10.3-2011, 2013, and 2014), “Capacities of storage vessels,” describes a method of test to measure the storage volume of a water heater containing a storage vessel or with an input rating less than 4,000 Btu/h per gallon of water stored. The 2014 AHRI-recommended test method specifies using the methodology described in section 5.27 of ANSI Z21.10.3, that DOE believes corresponds to section 5.28 of ANSI Z21.10.3-2015, “Capacities of tube type water heaters.” DOE reviewed section 5.28 of ANSI Z21.10.3-2015 carefully, and noticed that this section does not specify a method for determining the volume of tube-type water heaters; instead, it only states that the volume shall be determined. DOE sought clarifications on the rationale for using the test method described in section 5.28, “Capacities of tube type water heaters” of ANSI Z21.10.3-2015 as opposed to section 5.27, “Capacities of storage vessels” of ANSI Z21.10.3-2015 (that is the same as section 5.26 of ANSI Z21.10.3-2011, 2013 and 2014). Section 5.26 of ANSI Z21.10.3-2011 is used for measuring the storage volume of all CWH equipment in Exhibit G.2 of ANSI Z21.10.3-2011, which is incorporated by reference in the current Federal standby loss test procedure.
In response to this issue, the manufacturers stated that determining the stored volume using section 5.26 of ANSI Z21.10.3 (which DOE interprets as referring to section 5.26 of ANSI Z21.10.3-2011, 2013, and 2014, “Capacities of storage vessels,” which corresponds to section 5.27 of ANSI Z21.10.3-2015) is only required for water heaters that are known to have a stored water capacity greater than or equal to ten gallons and that the test is not required for water heaters with less than ten gallons of storage capacity. The manufacturers' comments indicate that they believe the test method to measure the storage volume is left to the discretion of the certification body. The manufacturers further stated that the test method in section 5.26 may not be a reliable test method for water heaters with small water volumes, manifold coils, and complex geometries. Moreover, they stated that heat exchangers used in the water heaters are
Another issue that DOE noticed with the test procedure in Annex E.3 of ANSI Z21.10.3-2015 is that (similar to the 2014 AHRI-recommended test method) the first part of Annex E.3 of ANSI Z21.10.3-2015 appears to be for thermostatically-activated units. Annex E.3 of ANSI Z21.10.3-2015 does not appear to be applicable exclusively to flow-activated instantaneous water heaters as is indicated by the manufacturers in their responses and AHRI in the 2014 AHRI-recommended test method. (AHRI, No. 10 at p. 4; Thermal Solutions, No. 11 at pp. 1; Raypak, No. 12 at pp. 1-2; A.O. Smith, No. 14 at p. 1)
On December 2, 2015, AHRI submitted another supplemental comment to the February 2014 RFI that included a revised recommendation for a test method for measuring standby loss for tube-type commercial instantaneous water heaters and hot water supply boilers that contain more than 10 gallons of water (“2015 AHRI-recommended test method”). (AHRI (2015), No. 13, pp.1, 6-8)
On January 11, 2016, AHRI submitted a third supplemental comment to the February 2014 RFI that included a further revised recommendation for a test method for measuring standby loss for tube-type commercial instantaneous water heaters and hot water supply boilers that contain more than 10 gallons of water (“2016 AHRI-recommended test method”). (AHRI (2016), No. 13, pp.1, 6-8) After carefully reviewing this submission, DOE tentatively determined that the only difference between the 2015 AHRI-recommended test method and the 2016 AHRI-recommended test method are the temperature differences used in equations for calculating standby loss. Specifically, the temperature difference used in the first two equations in Annex E.3 of the 2016 AHRI-recommended test method is Δ
DOE has considered the initially submitted 2014 AHRI-recommended test method, the clarifications provided by manufacturers, Annex E.3 of the recently published ANSI Z21.10.3-2015, and the recently submitted 2015 and 2016 AHRI-recommended test methods in developing the proposed standby loss test procedure for flow-activated instantaneous water heaters. DOE agrees with certain aspects of the recommended test methods and the related clarifications; however, DOE tentatively concludes that there are several modifications that need to be made to the 2016 AHRI-recommended test method for it to be used as a Federal standby loss test procedure for flow-activated instantaneous water heaters. As noted previously, the only difference between the 2016 AHRI-recommended test method and Annex E.3 of ANSI Z21.10.3-2015 is with regards to the first equation in both test methods and, similarly, DOE is not proposing to adopt the test method in Annex E.3 as the Federal test method. Rather, the following paragraphs describe DOE's proposed test method, including differences from both the 2016 AHRI-recommendation and the ANSI Z21.10.3-2015 test method, and the reasons such changes are deemed necessary.
As previously defined in this section, a flow-activated instantaneous water heater will initiate firing or heating only
The first part of Annex E.3 of ANSI Z21.10.3-2015 and the 2016 AHRI-recommended test method appears to apply to water heaters that may circulate water or initiate some other energy-consuming function when hot water is not being drawn. If a water heater consumes energy for the purpose of heating water during the standby mode, then such a water heater would not fit the proposed definition of a “flow-activated instantaneous water heater.” Such water heaters would instead be covered by the proposed standby loss test method for instantaneous water heaters and hot water supply boilers that are not flow-activated, as discussed in section III.I of this NOPR. However, to account for other types of fuel consumption during standby mode (
The driving temperature difference that causes the constant heat loss to the ambient air from the water heater is the difference between the stored water and the ambient air temperature. This temperature difference must be factored into the standby loss calculations, as included in the 2016 AHRI-recommended test method, instead of the temperature difference between outlet and supply water that is used in Annex E.3 of ANSI Z21.10.3-2015 and the 2015 AHRI-recommended test method. In addition, the current standby loss test procedure that is set forth in Exhibit G.2 of ANSI Z21.10.3-2011 (incorporated by reference into the current DOE test procedure) calculates the standby loss as a percentage per hour of the total heat content of the water heater. In DOE's test procedure for gas-fired and oil-fired CWH equipment as set forth in 10 CFR 431.106, DOE uses this percent-per-hour standby loss value to calculate the standby loss in terms of Btu/h based on the storage volume and a 70 °F temperature difference between the stored water and the ambient air temperature. DOE notes that the 2016 AHRI-recommended test method converts from standby loss in terms of percent-per-hour to standby loss in terms of Btu-per-hour by multiplying by a term that includes Δ
DOE notes that use of a fixed 70 °F temperature difference allows for straightforward conversion of standby loss from one set of units to another, while use of the measured temperature difference requires the availability of data from efficiency testing. DOE sees value in such a straightforward conversion, so that those without access to efficiency test data can still convert between the two values. Additionally, the standby loss test method that is proposed for flow-activated instantaneous water heaters already takes into account the measured temperature difference between the outlet water temperature and the ambient air temperature, making the additional inclusion of this term in the conversion unnecessary. Finally, use of a constant 70 °F temperature difference would make the conversion in this proposed standby loss test procedure consistent with that in DOE's current test procedure at 10 CFR 431.106, and DOE also proposes this method of conversion to standby loss in terms of Btu/h for other classes of gas-fired and oil-fired CWH equipment in appendices A and C to subpart G of 10 CFR part 431. Therefore, DOE proposes to use the same approach of a constant 70 °F temperature difference to calculate the standby loss for gas-fired and oil-fired flow-activated instantaneous water heaters. For electric flow-activated instantaneous water heaters, DOE proposes to maintain a standby loss metric in terms of a percent-per-hour value.
As discussed in this preamble, the 2016 AHRI-recommended test method specifies setting a time duration of one hour for flow-activated water heaters that would not have any form of energy consumption to maintain the water temperature and that would eventually cool down to ambient temperature. DOE sees merit in setting a maximum time duration to mark the end of the test. However, DOE does not agree with having the time duration as the only criterion for ending the standby loss test. As noted previously, the standby loss test for flow-activated instantaneous water heaters resembles a constant cool down test where the main burner or heating element does not cycle on at any point in the course of the test. For these water heaters, it is very likely that the stored water in the unit cools down to the ambient temperature before 24 hours. In such a scenario, from the time the stored water temperature reaches the ambient temperature to the end of the 24 hours, the water heater will not experience any standby energy loss. However, the standby loss equation provided in the 2016 AHRI-recommended test method assumes that the entire heat loss takes place over a duration of 24 hours. As a result, using the 2016 AHRI-recommended test method, the standby loss value calculated for water heaters that cool down before the 24-hour time period would understate the actual hourly heat loss from the water heater. Based on the 2016 AHRI-recommended test method, two water heaters that have the same storage volume and electricity consumption but different cooling rates as they both cool down to the ambient temperature within 24 hours would have the same standby loss value. DOE has determined that this would lead to an inaccurate comparison of the standby loss between two water heaters that lose heat at different rates. A similar issue would arise if the time duration were set to one hour or any specific value that might be less than the time it takes some water heater to cool to ambient temperature, because such a time criterion would capture the heat loss to different final water temperatures for different water heaters (
To avoid these issues and to compare standby loss of different water heaters with a more consistent approach, DOE proposes to use a temperature criterion in addition to a fixed maximum time duration to mark the end of the test. DOE proposes that the standby loss test be stopped at the first instance that the measured outlet water temperature is 35 °F below the outlet water temperature measured at the start of the test. If the specified temperature drop in the outlet water temperature does not occur within a 24 hour time period then the test shall be stopped at the end of 24 hours from the start of the test.
Finally, DOE must specify a method for determining the storage volume of the water heater. The manufacturers' responses stated that for some water heaters, it will not be necessary to measure the volume if it is less than 10 gallons. Although DOE does not currently prescribe a standby loss standard for instantaneous water heaters and hot water supply boilers with a storage volume below 10 gallons, DOE requires certification of the rated storage volume for all gas-fired and oil-fired instantaneous water heaters and hot water supply boilers. These certification requirements are set forth at 10 CFR 429.44(c)(2)(iv) and (v).
Because flow-activated instantaneous water heaters have heat exchanger designs similar to thermostatically-activated instantaneous water heaters, the issue of measuring the storage volume applies to all instantaneous water heaters and hot water supply boilers. Exhibit G.2 of ANSI Z21.10.3-2011 (that is incorporated by reference into the current DOE test procedure) references section 5.26 of the same testing standard as a method to measure the storage volume of CWH equipment. In response to the February 2014 RFI, HTP raised an issue with regards to the measurement of storage volume for instantaneous water heaters and hot water supply boilers. HTP commented that due to various geometries and sizes, measurement of the storage volume by a third-party laboratory or manufacturer's facility would be difficult and may produce inconsistent results. (HTP, No. 5 at p. 2) As discussed earlier, this issue was also raised by manufacturers in response to DOE's questions on the 2014 AHRI-recommended standby loss test method for flow-activated instantaneous water heaters.
DOE acknowledges the issues highlighted by manufacturers regarding use of section 5.26 of ANSI Z21.10.3-2011 (which corresponds to section 5.27 of ANSI Z21.10.3-2015) to measure the storage volume of instantaneous water heaters and hot water supply boilers, including flow-activated and thermostatically-activated units. To find alternatives to this test method, DOE investigated other options for measuring the storage volume of such water heaters. Through its review, DOE did not identify an alternative test method suitable to measure the storage volume of instantaneous water heaters and hot water supply boilers that would not significantly increase the testing burden for manufacturers. Moreover, section 5.28, “Capacities of tube type water heaters,” of ANSI Z21.10.3-2015 does not specify a test method to measure the storage volume. Instead, section 5.28 of ANSI Z21.10.3-2015 only states that the “volume contained in the water heater shall be determined.” The wording of this section and the manufacturers' responses on this test method appear to suggest that the actual method of determination of the volume is left to the discretion of the testing agency.
The test method in section 5.27 of ANSI Z21.10.3-2015 requires the water heater to be weighed dry and empty, and then reweighed when filled with water. The difference in the two values of the weight equate to the weight of the stored water in the water heater. The weight of stored water can be converted into gallons by dividing by the density of water. Although section 5.27 of ANSI Z21.10.3-2015 specifically states that the test be used for storage vessels or water heaters having an input rating of less than 4,000 Btu/h per gallon of capacity, the test method appears to be applicable to any CWH equipment that can be weighed both dry and after being filled with water. The energy conservation standards for instantaneous water heaters are dependent on the rated storage volume. The rated storage volume is needed to determine the appropriate equipment class and, for units with storage volume greater than or equal to 10 gallons, it is required to calculate the standby loss standard. Therefore, DOE must specify a test method to measure the storage volume of water heaters, rather than leave the decision of the appropriate method (
Based on the AHRI-recommended test methods and the responses received from manufacturers, DOE proposes a new standby loss test procedure for flow-activated instantaneous water heaters. The proposed test procedure is based on the 2016 AHRI-recommended test method, specifically the second part of the test method that applies to flow-activated water heaters that will not initiate burner operation over the course of the test. However, in developing the proposed test method, DOE has departed from the 2016 AHRI-recommended test method in several areas, including the method of test, time duration, and equations to calculate standby loss. DOE also conducted
The proposed standby loss test for flow-activated instantaneous water heaters can be started immediately after the thermal efficiency test, using the same test set-up and test conditions. Otherwise, if the standby loss test is conducted separately, install the water heater as per the specifications in section 2 of appendix E to subpart G of part 431. As discussed in section III.H, DOE proposes required locations for temperature-sensing instrumentation for instantaneous water heaters and hot water supply boilers, including flow-activated instantaneous water heaters. For water heaters with multiple outlet water connections leaving the water heater jacket, apply the test set-up provisions proposed in section III.H (also included in appendix C to subpart G of part 431). The representative value of the outlet water temperature used for the standby loss calculations is obtained by taking the average of the water temperatures measured at each water connection leaving the water heater jacket. DOE proposes that the test entity set the data acquisition system to record the supply water temperature, outlet water temperature, ambient room temperature, and electrical consumption (as applicable) at intervals of every 30 seconds.
DOE proposes the test be conducted as follows:
Once the water heater is set up, supply water to the equipment being tested as per section (d) of Annex E.1 of ANSI Z21.10.3-2015. Adjust the water flow rate in such a way that the outlet water reaches a temperature of 70 °F ± 2 °F above the supply water temperature. After the outlet water temperature has remained constant with no variation of more than 2 °F over a 3-minute period and maintains a temperature of 70 °F ± 2 °F above the supply water temperature, turn off the supply and outlet water valves that are installed closest to the water heater (as per the provisions in appendix C to subpart G of part 431), and the water pump, simultaneously. Allow the water heater to cut-out. Immediately after the cut-out, begin recording measurements for the standby loss test.
At this time, start the clock and record the initial outlet water temperature, ambient room temperature, and fuel (and electricity) meter reading. Continue to monitor and record the outlet water temperature, the ambient room temperature, the time elapsed from the start of the test, and the electricity consumption at 30-second intervals using a data acquisition system.
Stop the test if the outlet water temperature decreases by 35 °F from the initial outlet water temperature within 24 hours from the start of the test. Record the final outlet water temperature, final ambient room temperature, fuel consumed, electricity consumed, and the time elapsed from the start of the test.
If the outlet water temperature does not decrease by 35 °F from the initial outlet water temperature within 24 hours from the start of the test, then stop the test after 24 hours from the start of the test. Record the final outlet water temperature, final ambient room temperature, fuel consumed, electricity consumed, and the time elapsed from the start of the test.
Use the equation below to calculate the standby loss in terms of percent of total heat content per hour.
For gas-fired and oil-fired flow-activated instantaneous water heaters, to calculate the standby loss in terms of Btu per hour, use the following equation:
Where, SL refers to the standby loss of the water heater, defined as the amount of energy required to maintain the stored water temperature expressed in Btu per hour.
The current thermal efficiency and standby loss test methods as described in ANSI Z21.10.3-2011 require commercial instantaneous water heaters and hot water supply boilers to be set up in accordance with Figure 2 of that test standard. Although the figure is not drawn to scale and no measurements are specified, DOE notes that the temperature-sensing instruments for measuring outlet water temperature appear to be placed at a considerable distance away from the water heater being tested. Measuring the temperature at a significant distance away from the water heater could lead to an inaccurate representation of the outlet water temperature due to heat loss in the piping. Even if the pipes are insulated,
To address these issues, DOE proposes to specify the location and a set of requirements for placement of the temperature sensors to ensure that they accurately represent the outlet water temperature for the CWH equipment. Specifically, DOE proposes that the tip or junction of the temperature sensor be placed: (1) In the water; (2) less than or equal to 5 inches away from the water heater jacket; (3) about the central axis of the water pipe; and (4) with a radiation protection shield. The type and number of temperature-sensing instruments is left to the discretion of the testing operator.
Certain instantaneous CWH models have multiple outlet water connections leaving the jacket that are combined externally using common piping. For such units, DOE proposes that the temperature sensor placement conditions as proposed in the paragraph above be applied to each outlet water connection leaving the water heater jacket. To clarify, DOE proposes that for each outlet water connection leaving the water heater jacket, the temperature sensor be placed: (1) in the water; (2) less than or equal to 5 inches away from the water heater jacket; (3) about the central axis of the water pipe; and (4) with a radiation protection shield. For obtaining a single outlet water temperature value that is representative of the entire water heater, DOE proposes to take the average of the all outlet water temperature measurements (for each outlet water connection leaving the water heater jacket) for each recording of the data-acquisition unit. In addition to these provisions, DOE also proposes that while verifying steady-state operation (prior to the thermal efficiency test) and during the thermal efficiency test, the water temperatures recorded for each outlet water connection leaving the water heater jacket must: (1) Be maintained at 70 °F ± 2 °F above the supply water temperature, and (2) not differ from each other by more than 2 °F.
Figure III.4, an adaptation of Figure 3 of ANSI Z21.10.3-2015, shows DOE's proposed location requirements for the temperature-sensing instruments for measuring the inlet and outlet water temperature of instantaneous water heaters (other than storage-type instantaneous water heaters) and hot water supply boilers.
The current test procedure for instantaneous water heaters and hot water supply boilers does not clearly indicate the location and installation of the supply and outlet water valves. To obtain accurate measurements during standby operation, the water supply must be cut off to prevent mixing of water in the piping lines with that in the water heater during the standby loss test. To address this issue, DOE proposes to require supply and outlet water valves to be installed within a specified distance of the water heater. Specifically, for instantaneous water heaters and hot water supply boilers shipped without external piping installed at the point of manufacture, DOE proposes to require the supply water valve to be installed within 5 inches of the jacket, and the outlet water valve to be installed within 10 inches of the jacket. For instantaneous water heaters and hot water supply boilers with external piping assembled at the manufacturer's premises prior to shipment, DOE proposes to require the supply and outlet water valves to be installed within 5 inches of the end of the piping shipped with the unit. DOE also proposes that the supply and outlet water valves be used to turn off the water flow at the start of the standby loss test for instantaneous water heaters and hot water supply boilers (including “flow-activated instantaneous water heaters”). Figure III.4 shows the location of the valves with respect to other instrumentation used in the test set-up for units shipped without external water piping installed.
The current Federal thermal efficiency test as set forth in 10 CFR 431.106, incorporates by reference Exhibit G.1 of ANSI Z21.10.3-2011, which requires the supply water temperature to be 70 °F ± 2 °F and the outlet water temperature to be 70 °F ± 2 °F above the supply water temperature with the burner or heating element operating at its full firing rate. Certain instantaneous water heaters and hot water supply boilers, including flow-activated instantaneous water heaters that are designed to operate at higher inlet water temperatures, may not be able to achieve such a temperature rise. The current test procedure addresses this issue by allowing for the use of a recirculating loop (see Figure 3 of ANSI Z21.10.3-2015). Section 5.1.7 of ANSI Z21.10.3-2015 (which contains Figure 3) also requires that the specified inlet water temperature shall not be less than 70 °F or more than 120 °F. In this NOPR, DOE proposes to retain the option of using a recirculating loop and the limits on the inlet water temperature for instantaneous water heaters and hot water supply boilers that are not able to meet the outlet water temperature requirement at the full firing rate. DOE proposes to explicitly state the conditions for using a recirculating loop (
Figure III.4 and the proposed specifications for the placement of temperature sensors, placement of water valves, and placement of a recirculating loop (when used) are included in appendix C to subpart G of part 431.
Currently, all instantaneous water heaters and hot water supply boilers having a storage capacity of ten gallons or more are required to be tested for standby loss as per the test method in Exhibit G.2 of ANSI Z21.10.3-2011, which is incorporated by reference into DOE's current test procedure. In the February 2014 RFI, DOE sought comments on the repeatability of thermal efficiency and standby loss test methods included in the ANSI Z21.10.3-2011 and ANSI Z21.10.3-2013 test methods. 79 FR 10999, 11001-02 (Feb. 27, 2014). DOE discussed the comments received in response to this issue generally in section III.B of this NOPR. In its response to this issue, HTP stated that currently, there is no standby loss test method that is suitable for hot water supply boilers containing ten gallons or more of stored water. (HTP, No. 5 at p. 2) While responding to a different issue related to the applicability of standby loss test procedure to flow-activated water heaters, AHRI commented that the current standby loss test procedure is designed for tank-type water heaters which are thermostatically-activated. (AHRI, No. 2 at p. 4)
DOE reviewed the comments made by HTP and AHRI with regards to the standby loss test procedure for instantaneous water heaters and hot water supply boilers. DOE notes that the equation used to calculate standby loss in DOE's test method for instantaneous water heaters and hot water supply boilers (as specified in Exhibit G.2 of ANSI Z21.10.3-2011) uses two temperature differential terms that both include the measurement of the mean tank temperature taken during the course of the test. To calculate the standby loss of CWH equipment, the current Federal test method requires parameters to be measured that allow for the calculation of: (1) The amount of energy consumed to maintain the stored water at the required temperature during standby mode; (2) the heat lost to the atmosphere from the stored water; and (3) the change in total heat content of the water heater between the start and the end of the test. Both the terms described in (2) and (3) are calculated using the stored water temperature, which are represented in DOE's current test method by the mean tank temperature measured during the standby loss test. Instantaneous water heaters and hot water supply boilers that do not meet DOE's proposed definition for “storage-type instantaneous water heater” (see section III.F of this document) are generally not equipped with an integral hot water storage tank, but rather, the stored water is contained within the heat exchanger. Unlike storage water heaters and storage-type instantaneous water heaters, these instantaneous water
DOE encountered the same issue for flow-activated water heaters and addressed this problem in the proposed test procedure described in section III.G. While thermostatically-activated instantaneous water heaters and hot water supply boilers differ from flow-activated instantaneous water heaters in their mechanism to initiate burner or heating element operation, these two kinds of equipment share similar heat exchanger geometries and designs. In section III.G of this rulemaking, DOE discusses the responses received from manufacturers on this issue for the standby loss test method for flow-activated instantaneous water heaters. In summary, manufacturers suggested that a measurement of the outlet water temperature could be used as an approximation of the mean stored water temperature within the heat exchanger for the purpose of calculating standby loss. Due to the similarity in heat exchanger design between flow-activated and thermostatically-activated instantaneous water heaters and hot water supply boilers, DOE has tentatively concluded that the same rationale would apply for thermostatically-activated instantaneous water heaters and hot water supply boilers (
DOE also considered several other options to calculate or measure the average stored water temperature (
DOE is also aware that in many applications, instantaneous water heaters or hot water supply boilers are used to supply hot water to an external tank where the water is stored at a fixed temperature. In these applications, a thermostat is often used to maintain the desired water temperature in the external tank as part of a recirculation loop. If the water temperature in the tank falls below the set point, then the thermostat directs the water heater to cycle on, and the recirculation pump circulates water throughout the loop, withdrawing water from the tank, and resupplying heated water back into the tank. While reviewing the standby loss test procedure for its applicability to thermostatically-activated instantaneous water heaters and hot water supply boilers, DOE considered the option of specifying an external UFHWST with specific characteristics (
Based on the discussion above, DOE proposes the following test procedure for determining the standby loss of instantaneous water heaters and hot water supply boilers (except for those that meet the proposed definition of a “storage-type instantaneous water heater” and “flow-activated instantaneous water heater”). This proposal includes some language from Annex E.2 of ANSI Z21.10.3-2015.
The proposed standby loss test method for instantaneous water heaters and hot water supply boilers (except those meeting the definition of “storage-type instantaneous water heater” and “flow-activated instantaneous water heater”) can be started immediately after the thermal efficiency test, using the same test set-up and test conditions. Otherwise, if the standby loss test is conducted separately, one would install the water heater as per Figure III.4 in section III.H of this rulemaking (Figure 4 in appendix C to subpart G of part 431) and section 2 of appendix C or D (as applicable) to subpart G of part 431 to set up the water heater for testing. As discussed in section III.H, DOE proposes required locations for temperature-sensing instrumentation and water valves for all instantaneous water heaters and hot water supply boilers, including flow-activated instantaneous water heaters, but excluding storage-type instantaneous water heaters. For water heaters with multiple supply or outlet water connections entering the water heater jacket, apply the outlet water temperature sensor and water valves placement provisions proposed in section III.H to each pipe connection entering or leaving the water heater. The representative value of the outlet water temperature used for the standby loss calculations is obtained by taking the average of the water temperatures measured at each water connection leaving the water heater jacket.
DOE proposes that the test be conducted as follows:
Once the water heater is set up, open the flow valves, start the water pump, open the gas supply valves (as
At this point, start the clock and record the initial outlet water and ambient room temperatures. Keep recording the outlet water temperature, the ambient room temperature, the time elapsed from the start of the test, the electricity consumption, and the fuel consumption at an interval of 30 seconds (as proposed in this rulemaking and discussed in section III.B) using a data acquisition system.
The duration of this test will be the earlier of: (1) The first cut-out that occurs after 24 hours or (2) 48 hours.
At the conclusion of the test, record the total fuel flow, electricity consumption, the final ambient room temperature, the time duration in hours rounded to the nearest one hundredth of an hour, and the final outlet water temperature.
Use the equation below to calculate the standby loss in terms of percent of total heat content per hour.
The standby loss expressed in Btu per hour must be calculated as follows: SL (Btu per hour) = S (% per hour) × 8.25 (Btu/gal-°F) × Measured Volume (gal) × 70 (degrees F).
In the February 2014 RFI, DOE raised an issue with regards to implementing a new test procedure for commercial heat pump water heaters (CHPWHs). 79 FR 10999, 11003 (Feb. 27, 2014). Currently, DOE does not have a test procedure for commercial heat pump water heaters (although a section is reserved at 10 CFR 431.107). Additionally, DOE does not currently have a definition for “commercial heat pump water heater,” as would help classify such units. Therefore, DOE proposes the following definition for commercial heat pump water heaters that includes air-source, water-source, and direct geo-exchange CHPWHs.
DOE is aware that ANSI/ASHRAE Standard 118.1-2012 (“ASHRAE 118.1-2012”),
DOE received several comments from interested parties in response to this issue. Bradford White supported the use
The Joint Advocates also commented that they strongly support DOE's efforts to adopt a consensus test procedure standard for CHPWHs. To assist DOE in the rulemaking, the Joint Advocates posed several questions that may influence DOE's direction for this rulemaking. The Joint Advocates asked whether there are any international standards that have lessons for U.S. practice. (Joint Advocates, No. 4 at pp. 2-3) DOE reviewed the Collaborative Labeling and Appliance Standards Program's (CLASP's) Global Standards and Labeling Database
The Joint Advocates asked how first-hour supply capability is treated as a capacity measure for CHPWHs. (Joint Advocates, No. 4 at pp. 2-3) DOE acknowledges that delivery capacity of CWH equipment, including CHPWHs, is an important metric for selection and sizing of equipment. However, DOE does not believe such a capacity measure is needed in its test procedure for energy efficiency, as information regarding capacity is already typically readily available in manufacturer literature.
The Joint Advocates asked about the potential impacts of ambient conditions on the test procedure. (Joint Advocates, No. 4 at pp. 2-3) In response, DOE conducted exploratory tests on different CHPWH units at the different rating conditions specified in ASHRAE 118.1-2012 and AHRI 1300. DOE considered the information and results gathered from these tests in the development of the proposed test procedure for CHPWHs. The exploratory tests are discussed in more detail later in this section.
The Joint Advocates raised the issue of the need to consider the capabilities of different refrigerants to achieve temperature rise that is required for commercial applications (
The Joint Advocates suggested that DOE should consider a different requirement such as maximum rated temperature instead of a constant test temperature. (Joint Advocates, No. 4 at pp. 2-3) DOE's proposed test procedure for CHPWHs includes a provision allowing units that are unable to meet the outlet water temperature at low entering water temperatures to be tested using a higher supply temperature. These provisions are discussed in greater detail later on in this section.
The Joint Advocates asked whether the cooled evaporator air could be used for cooling spaces and whether the energy value of this benefit could be included. (Joint Advocates, No. 4 at pp. 2-3) DOE appreciates that in some sites, cool air rejected from the evaporator coil may provide an ancillary benefit by providing additional space cooling. However, DOE does not propose to include a methodology to measure the cooling performance of a commercial heat pump water heater. DOE finds that such a methodology would be overly burdensome to manufacturers in relation to the uncertain benefit provided to commercial consumers.
In addition, the Joint Advocates expressed their goals for the CHPWH standard as: (1) Allowing fair comparison between products and (2) giving contractors enough information to help customers make informed decisions. According to the Joint Advocates, CHPWHs will require a single metric to be useful and have suggested a blend of the current metrics as a single rating parameter. (Joint Advocates, No. 4 at pp. 2-3) Although DOE proposes a test procedure for CHPWHs in this NOPR, the scope of this rulemaking does not include amending energy conservation standards for CHPWHs. In this NOPR, DOE only proposes a test procedure that manufacturers can use to rate their products, without a requirement to certify COP
The second supplemental comment from AHRI in response to the February 2014 RFI includes recommended rating conditions for testing several kinds of CHPWHs. (AHRI (2015), No. 13, pp. 1-2) AHRI recommended four categories of CHPWHs based on the heat source (
DOE
ASHRAE 118.1-2012 includes a similar classification with separate test procedures for air-source, direct geo-exchange, and water-source CHPWHs. The test procedure for water-source CHPWHs in ASHRAE 118.1-2012 applies to both indoor water-source CHPWHs and ground water-source CHPWHs. After considering the applications and characteristics of the different kinds of CHPWHs and the classification used in ASHRAE 118.1-2012, DOE proposes separate test procedures for air-source, direct geo-exchange, and water-source CHPWHs. The proposed test procedure for water-source CHPWHs would be used to rate both ground water-source and indoor water-source models with different rating conditions for each category.
To differentiate the four categories of CHPWHs from each other, DOE proposes to add definitions for “Air-source commercial heat pump water heater”, “Direct geo-exchange commercial heat pump water heater”, “Indoor water-source commercial heat pump water heater”, and “Ground water-source commercial heat pump water heater,” as set out in the regulatory text at the end of this document.
To develop new test procedures for all four categories of CHPWHs, DOE reviewed both ASHRAE 118.1-2012 and AHRI 1300. As noted earlier, AHRI 1300 only provides rating conditions and references ASHRAE 118.1-2012 for the actual test method. ASHRAE 118.1-2012 is an industry test method used to rate gas-fired, electric, and oil-fired CWH equipment. For the purpose of testing, ASHRAE 118.1-2012 classifies CHPWHs into two types: (1) “Type IV”—equipment that can be operated without requiring a connection to a storage tank; and (2) “Type V”—equipment that requires connection to a storage tank for operation. ASHRAE 118.1-2012 specifies separate test methods to rate the two types of equipment. The test procedure described in ASHRAE 118.1-2012 for Type V units requires the unit to be connected to a tank that is either supplied by the manufacturer along with the unit or is specified by the manufacturer. However, after reviewing product literature, DOE notes that generally, CHPWH manufacturers neither supply a storage tank with the equipment, nor specify a tank appropriate for that equipment. The ASHRAE 118.1-2012 test procedure does not include a test method for Type V units for which an appropriate tank is neither supplied nor specified by the manufacturer. Without connecting an appropriate tank, Type V equipment cannot be tested using the Type V equipment test procedure as specified in ASHRAE 118.1-2012.
DOE considered establishing a “standard” tank for rating the energy efficiency of Type V units that are not shipped with a tank and for which manufacturers do not specify the tank to be used. However, DOE tentatively determined that testing and rating a CHPWH by connecting it with a separately supplied tank could be an unfair representation of the actual rating of the unit itself since the efficiency of the system is highly dependent on the characteristics of the tank. Further, different CHPWHs may be designed for use with tanks having different characteristics. Theoretically, the combined efficiency rating of a CHPWH unit when operated along with the tank would be lower than the actual rating of that CHPWH unit alone, because the addition of a tank would allow for heat loss through the tank jacket and piping. Also, there may be inconsistencies in selecting tanks used for efficiency testing if manufacturers do not supply or specify an appropriate tank for the CHPWH units. This inconsistency could lead to energy savings smaller than expected for commercial consumers if CHPWHs are tested with storage tanks more efficient than those that those commercial consumers use.
Considering these issues associated with testing a CHPWH unit with an external tank connected to it, DOE explored the possibility of formulating a new test method to test all CHPWH units as Type IV equipment (
The test procedure for air-source CHPWHs as specified in ASHRAE 118.1-2012 requires the CHPWH to be set up according to Figure 5 of that test standard. The water flow rate through the unit is adjusted in such a way that the outlet water temperature is maintained at 120 °F ± 5 °F with no variation of more than 2 °F over a three-minute period. DOE conducted the tests under six different rating conditions, which consist of three different evaporator entering air temperatures and two supply water temperature conditions. In all, DOE conducted six tests on each CHPWH unit. These test conditions are shown in Table III-3:
The results obtained from these tests indicate that not all the units were capable of achieving an outlet water temperature of 120 °F ± 5 °F. The 30,000 Btu/h unit was the only unit capable of delivering the required outlet water temperature for all six rating conditions. For rating conditions 1, 2, and 3, the flow rate for the 30,000 Btu/h unit had to be sharply reduced to achieve the high temperature rise from a supply water temperature of 70 °F to outlet water temperature of 120 °F ± 5 °F. However, for the rating conditions 4, 5, and 6, the unit successfully delivered water at a temperature of 120 °F ± 5 °F at the manufacturer's specified flow rate.
The 100,000 Btu/h unit was not able to achieve an outlet water temperature of 120 °F ± 5 °F at rating conditions 1 and 2. Moreover, the unit was unable to operate at rating conditions 3 and 6 (evaporator entering air dry bulb temperature of 50 °F) due to low ambient temperature conditions. When the unit was tested at rating conditions 4 and 5, the unit was successful at achieving the 120 °F ± 5 °F outlet water temperature at the manufacturer-rated water flow rate.
The 275,000 Btu/h unit was capable of achieving the required 120 °F ± 5 °F outlet water temperature when tested at rating conditions 1 and 2 with the manufacturer's rated water flow rate. However, the unit did not achieve the required outlet water temperature for any of the other rating conditions. A possible reason for this is the low ambient temperature resulting in lower heat being utilized by the heat pump. For rating conditions 4, 5, and 6 where the supply water temperature is maintained at 110 °F, the outlet water temperature exceeded 120 °F ± 5 °F. The water flow rate for these conditions was at the manufacturer's rated flow rate, and the unit's design did not allow the flow rate to be increased above that value.
Based on these tests, two conclusions can be drawn. First, rating conditions 3 and 6, representing an evaporator entering air dry bulb temperature of 50 °F, were not achievable for two of the tested units, (
On the basis of these exploratory tests, DOE was able to determine applicability of the test procedure described for “Type IV” units in ASHRAE 118.1-2012 to air-source CHPWH units. Based on the results and the discussion above, DOE has tentatively concluded that the method of test described for “Type IV” units in ASHRAE 118.1-2012 can be used to test air-source CHPWHs but with certain modifications. These proposed modifications include establishing: (1) A single evaporator air entering rating condition with a dry bulb temperature of 80.6 °F ± 1 °F and a wet bulb temperature of 71.2 °F ± 1 °F; (2) a supply water temperature of 70 °F ± 1 °F (or 110 °F ± 1 °F, only if the required outlet water temperature condition is not achieved while testing at a supply water temperature of 70 °F ± 1 °F).
DOE did not conduct exploratory tests for other categories of CHPWHs (
ASHRAE 118.1-2012 provides several test procedure metrics for measuring energy efficiency (
As previously noted, DOE's proposed test procedure for rating CHPWHs would incorporate by reference certain relevant sections of ASHRAE 118.1-2012. The succeeding paragraphs highlight various sections that are relevant to testing units of all four categories of CHPWHs.
DOE proposes that the instrumentation required for the new test procedure would be as described in section 6 of ASHRAE 118.1. Further, DOE proposes that the test set-up, piping, and temperature-sensing locations be as described in sections 7.1, 7.2.1, 7.3.2, 7.3.3, 7.5, and 7.6 of that industry standard for testing Type IV equipment. DOE also proposes to incorporate subsections 7.7.1 to 7.7.6 with the exclusion of section 7.7.5 of ASHRAE 118.1-2012. Section 7.7.5 of ASHRAE 118.1-2012 contains special requirements for testing a heat pump water heater for measurement of space cooling. Section 7.7.7 of ASHRAE 118.1-2012 refers to Table 2 of the same test standard, which provides values for supply (or entering) water temperatures for testing CHPWHs. DOE has tentatively decided not to directly adopt section 7.7.7 of ASHRAE 118.1-2012 and instead proposes to adopt the following provisions to replace section 7.7.7 as follows:
DOE proposes to test direct geo-exchange, indoor water-source, and ground water-source CHPWHs with a nominal entering water temperature of 110 °F instead of the temperature specified in Table 2 referenced by section 7.7.7 of ASHRAE 118.1.
DOE proposes that air-source CHPWH equipment be tested with a supply water temperature of 70 °F ± 1 °F. If the required outlet water temperature condition (specified in section 8.7.2 of ASHRAE 118.1-2012) is not met while testing the unit at 70 °F ± 1 °F, only then should the supply water temperature be provided at 110 °F ± 1 °F. DOE proposes to use the following steps for setting the supply water temperature that would be applicable to the air-source CHPWH unit being tested:
(1) Set the supply water temperature at 70 °F ± 1 °F and the water flow rate to the rated pump flow rate and start operating the unit. Measure the outlet water temperature at this flow rate to check if an outlet water temperature of 120 °F ± 5 °F is achieved as specified in section 8.7.2 of ASHRAE 118.1-2012. If the outlet water temperature is maintained at this condition (
(2) If the outlet water temperature condition is not met, then adjust the flow rate in order to meet the required outlet water temperature condition as per section 8.7.2 of ASHRAE 118.1-2012. Measure the outlet water temperature at the adjusted flow rate to check if an outlet water temperature of 120 °F ± 5 °F is achieved as specified in section 8.7.2 of ASHRAE 118.1-2012. If the outlet water temperature is maintained at this condition (
(3) If, after adjusting the flow rate within the range that is achievable by the pump, the equipment is unable to operate or deliver the required outlet water temperature, then reset the flow rate to the rated pump flow rate and change the supply water temperature to 110 °F ± 1 °F. Measure the outlet water temperature at the rated pump flow rate to determine whether the outlet water temperature requirement is met as per section 8.7.2 of ASHRAE 118.1-2012. If the outlet water temperature is maintained at this condition (
(4) If the outlet water temperature condition is not met, then adjust the flow rate in order to meet the required outlet water condition as per section 8.7.2 of ASHRAE 118.1-2012. Measure the outlet water temperature at the adjusted flow rate to check if an outlet water temperature of 110 °F ± 1 °F is achieved as specified in section 8.7.2 of ASHRAE 118.1-2012. If the outlet water temperature is maintained at this condition (
(5) If the outlet water temperature condition cannot be met, then a test procedure waiver is necessary to specify an alternative set of test conditions.
DOE proposes to retain Table 3 of ASHRAE 118.1-2012, which provides tolerances of different parameters (
To calculate the final COP
To further assess the new test method, DOE conducted a second round of experimental testing on the 100,000 Btu/h CHPWH unit. In this round, the test was carried out exactly as per the proposed test procedure specified in appendix F to subpart G of part 431 and proposed in this section of the NOPR. DOE tested the unit with evaporator entering air temperatures specified in appendix F to subpart G of part 431 (also specified in Table III-4). As proposed, the unit was first tested with a supply water temperature of 70 °F ± 1 °F. At these rating conditions, the unit was unable to achieve an outlet water temperature of 120 °F ± 5 °F, even after varying the supply water flow rate. The supply water temperature was then re-adjusted to 110 °F ± 1 °F. At this temperature, the unit was successful in delivering and maintaining an outlet water temperature of 120 °F ± 5 °F with no variation of more than 2 °F over a three-minute duration. Results show that the COP
In DOE's existing regulations, equipment classes and the standards that apply to them are determined partly on the basis of the input capacity of the CWH equipment. However, several terms are used in the existing DOE test procedures and energy conservation standards to describe the capacity of the CWH equipment, each of which is derived from the maximum rated fuel input rate to the CWH equipment. For example, the existing DOE test procedure for CWH equipment at 10 CFR 431.106 uses the term “hourly Btu input rate” to describe the measured input rate during the test and “manufacturer's specified input rate” as the value to which the measured input rate should be compared. The energy conservation standards for CWH equipment at 10 CFR 431.110 use the term “nameplate input rate,” which is intended to mean the same thing as “manufacturer's specified input rate.” While DOE's test procedure for oil-fired CWH equipment requires the hourly Btu input rate to be within ±2 percent of the manufacturer's specified input rate, no procedure is included for measuring the input rate.
To clarify standardize terminology throughout its regulations for CWH equipment and to determine the appropriate equipment class for CWH equipment, DOE proposes to define the term “fuel input rate” as set out in the regulatory text at the end of this document.
DOE proposes to use this term in the division of equipment classes and applicable testing provisions to determine the fuel input rate. Manufacturers would be required to measure the fuel input rate during certification testing and use the mean of the measured values, after applying the applicable rounding provisions (discussed later in this section), in certification reports pursuant to 10 CFR 429.44(c)(2). DOE also notes that, for CWH equipment certified using an AEDM, the AEDM would be used to determine the fuel input rate and the same rounding provisions would apply. DOE believes it is critical to clarify how the fuel input rate is to be determined because the applicable standards for certain classes of CWH equipment are based in part on the fuel input rate. These proposed additions would clarify for manufacturers what energy conservation standard applies to a given basic model.
DOE also proposes to include equations for determination of fuel input rate in its test procedures for gas-fired and oil-fired CWH equipment. DOE proposes to include Equations C2 and C3 from section C7.2.3 of AHRI 1500-2015 in its test procedures for calculation of fuel input rate for gas-fired and oil-fired CWH equipment, respectively. DOE also proposes that the fuel input rate be determined by measuring fuel consumption at 3 consecutive 10-minute intervals during the 30-minute thermal efficiency test. The overall fuel input rate for the thermal efficiency test will be calculated using the fuel consumption over the entire 30-minute test. DOE proposes that during the thermal efficiency test, the measured fuel input rate must not vary by more than ±2 percent between 10-minute interval readings.
Section 5.2.2 of AHRI 1500-2015 specifies rounding gross output (as defined in section 3.20 of AHRI 1500-2015) to the nearest 1,000 Btu/h. However, DOE regulations are based on input rate, not gross output. Therefore, DOE proposes adding a requirement to the DOE test procedure that values of
Additionally, DOE proposes that, for its enforcement testing, the overall fuel input rate for the thermal efficiency test would be measured pursuant to 10 CFR 431.106 and compared against the fuel input rate certified by the manufacturer. If the measured fuel input rate is within ±2 percent of the certified value, then DOE will use the certified value when determining which equipment class to regulate a model. If the measured fuel input rate is not within ±2 percent of the certified value, then DOE will attempt the following steps to bring the fuel input rate to within ±2 percent of the certified value. First, DOE will attempt to adjust the gas pressure in order to increase or decrease the fuel input rate within the gas pressure range allowed by the test procedure. If the fuel input rate is still not within ±2 percent of the certified value, DOE will then attempt to modify the gas inlet orifice (
DOE incorporates by reference Exhibits G.1 and G.2 of ANSI Z21.10.3-2011 (which correspond to Annexes E.1 and E.2 of ANSI Z21.10.3-2015) in its current test procedure for thermal efficiency and standby loss for CWH equipment. Some of the equipment settings for performing the test procedures as per Annex E.1 of ANSI Z21.10.3-2015 (
For all commercial water heating equipment, DOE proposes a default value for maximum water supply pressure of 150 pounds per square inch (psi). For gas-fired commercial water heating equipment powered with natural gas, DOE proposes a default range of allowable gas supply pressure of 4.5 inches of water column (in. w.c.) to 10.5 in. w.c. For gas-fired commercial water heating equipment powered with propane, DOE proposes a default range of 11 in. w.c. to 13 in. w.c.
DOE also includes several requirements specific to oil-fired equipment in its current test procedure for commercial water heating equipment as set forth in 10 CFR 431.106. These requirements include:
(1) Venting Requirements—Connect a vertical length of flue pipe to the flue gas outlet of sufficient height so as to meet the minimum draft specified by the manufacturer; and (2) Oil Supply—Adjust the burner rate so that: (a) The hourly Btu input rate lies within ±2 percent of the manufacturer's specified input rate, (b) the CO
These requirements depend on manufacturer specifications, including the minimum draft, input rate, CO
DOE proposes several changes to its certification requirements for commercial water heating equipment
The Office of Management and Budget (OMB) has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993). Accordingly, this regulatory action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB).
The Regulatory Flexibility Act (5 U.S.C. 601
This proposed rule would prescribe test procedure amendments that would be used to determine compliance with energy conservation standards for CWH equipment (except for CHPWHs). The proposed amendments would: (1) Update the referenced industry test standards by incorporating by reference ASTM D2156-09, ASTM C177-13, ASTM C518-10, and Annex E.1 of ANSI Z21.10.3-2015; (2) modify the thermal efficiency and standby loss tests for CWH equipment to improve repeatability; (3) include an updated test method for determining the efficiency of unfired hot water storage tanks; (4) change the method for setting the thermostat in the thermal efficiency test for gas-fired and oil-fired storage water heaters and storage-type instantaneous water heaters from measurement of mean tank temperature to measurement of outlet water temperature; (5) clarify test conditions required in the thermal efficiency test method with regard to stored energy loss and steady-state operation; (6) define “storage-type instantaneous water heater” and modify several definitions for consumer water heaters and commercial water heating equipment included at 10 CFR 430.2 and 10 CFR 431.102, respectively; (7) include a new test method for measurement of standby loss for flow-activated instantaneous water heaters; (8) specify temperature-sensing locations, water valve locations and clarifications for using a recirculating loop for thermal efficiency and standby loss testing of instantaneous water heaters and hot water supply boilers; (9) replace the measurement of mean tank temperature with outlet water temperature for thermostatically-activated instantaneous water heaters (other than storage-type instantaneous water heaters); (10) include a new test method for rating commercial heat pump water heaters; (11) establish a procedure for determining the fuel input rate of gas-fired and oil-fired CWH equipment and specify DOE's measures to verify fuel input rate; (12) add default values for certain testing parameters for commercial water heating equipment; and (13) modify DOE's certification requirements for commercial water heating equipment. DOE reviewed all of these proposed amendments to the existing test procedure under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. 68 FR 7990. Accordingly, DOE has prepared the following IRFA for the equipment that is the subject of this rulemaking.
For manufacturers of covered CWH equipment, the Small Business Administration (SBA) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. 65 FR 30836, 30848 (May 15, 2000), as amended at 77 FR 49991, 50000, 50011 (August 20, 2012) and codified at 13 CFR part 121. The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available at:
To estimate the number of companies that could be small business manufacturers of equipment covered by this rulemaking, DOE conducted market research and created a database of CWH equipment manufacturers that identified the manufacturers which qualify as small businesses among that list. DOE's research involved industry trade association membership directories (including AHRI
In the following sections, DOE discusses the potential burdens that could be faced by manufacturers of CWH equipment, particularly small businesses, as a result of each of the test procedure amendments proposed in this NOPR.
The proposal to update the currently-referenced industry test method edition from ANSI Z21.10.3-2011 (Exhibits G.1 and G.2) to ANSI Z21.10.3-2015 (Annex E.1) would not impact the requirements, conditions, or duration of DOE's test procedures. DOE only identified one substantive difference between the efficiency test methods in each version—the standby loss equation. Because DOE tentatively concluded that the equation in the currently referenced ANSI Z21.10.3-2011 is correct and proposes to retain that equation in its test procedures, this updated reference to the industry test method should not affect conduct of or ratings from DOE's test procedure.
DOE's current test procedure, specified at 10 CFR 431.106, also requires that flue gases from oil-fired CWH equipment not contain smoke that exceeds No. 1 smoke, as determined by ASTM Standard D2156-80. In this NOPR, DOE proposed to update this reference and incorporate by reference the most recent version of this test method, ASTM D2156-09. DOE did not identify any significant differences between the two versions of this test method; therefore, DOE has tentatively concluded that this updated reference should not affect results from its test procedure. Additionally, DOE proposes several clarifications to the procedure for determining smoke spot number. First, DOE proposes to clarify that the smoke spot number is to be determined once steady-state operation is achieved but before beginning measurements for the thermal efficiency test. Second, DOE proposes to require that the smoke measuring device be connected to an open-ended tube that projects into the flue
DOE proposes clarification of the test procedure for determining smoke spot number because the current procedure as specified in 10 CFR 431.106 does not specify the timing or location of measuring the smoke spot number. DOE considers conduct of the smoke spot test and measurement of CO
DOE's current definition for “R-value” at 10 CFR 431.102 references two industry test methods, ASTM C177-97 and ASTM C518-91. In this NOPR, DOE proposes to incorporate by reference the most recent versions of these test methods: ASTM C177-13 and ASTM C518-10. DOE did not identify any significant differences in the procedures for measuring R-value between the two versions of ASTM C177 or between the two versions of ASTM C518. Therefore, this updated reference should not affect results for calculation of R-value per DOE's definition at 10 CFR 431.102.
The proposed modifications to the thermal efficiency and standby loss test methods include: (1) Stipulating a maximum air draft requirement of 50 ft/min as measured prior to beginning the thermal efficiency or standby loss tests; (2) tightening the ambient room temperature tolerance from ±10.0 °F to ±5.0 °F and the allowed variance from mean ambient temperature from ±7.0 °F to ±2.0 °F; (3) requiring measurement of test air temperature—the temperature of entering combustion air—and requiring the test air temperature not vary by more than ±5 °F from the ambient room temperature at any measurement interval during the thermal efficiency and standby loss tests for gas-fired and oil-fired CWH equipment; (4) establishing a requirement for ambient relative humidity of 60 percent ±5 percent during the thermal efficiency and standby loss tests for gas-fired and oil-fired CWH equipment; (5) requiring a soak-in period prior to testing in which the water heater must sit without any draws taking place for at least 12 hours from the end of a recovery from a cold start; (6) specifying the locations of inlet and outlet temperature measurements for storage water heaters, storage-type instantaneous water heaters, and UFHWSTs; and (7) decreasing the time interval for data collection from fifteen minutes to 30 seconds in the thermal efficiency and standby loss tests.
For the first modification, depending on the conditions in the manufacturer's testing area, the manufacturer may need to protect the testing area from drafts greater than 50 ft/min. This draft protection could be accomplished by using wind barriers such as moveable walls, minimizing the opening and closing of doors near the test stand, or sealing windows. To measure draft velocity, manufacturers may have to purchase instrumentation that DOE estimates could cost up to $250. However, any manufacturer of residential water heaters should already have this instrumentation and be able to comply with this stipulation, because it is similar to the requirement established for testing residential water heaters in the July 2014 final rule. 79 FR 40542, 40569 (July 11, 2014).
For the second, third, and fourth modifications that propose changes to specified ambient conditions, manufacturers may not need to make any changes if the ambient temperature and relative humidity in their testing area already meet the proposed tolerances. DOE is aware that the proposed constraints may in some cases require laboratories to move testing from an uncontrolled environment (
For the third modification, manufacturers need to measure the test air temperature, which is measured within two feet of the combustion air inlet. While this requirement was adopted from an industry test method for commercial packaged boilers, AHRI 1500-2015, it is not currently required for testing of CWH equipment. Therefore, manufacturers would need to install temperature measuring devices in close proximity to the air intake. However, DOE believes that a requirement for this temperature measurement would not present any significant testing burden to manufacturers, because it would simply involve one more temperature measurement than is already being conducted, and the temperature readings could be recorded using the same data acquisition software that is used for measuring the ambient room temperature.
The fifth modification specifies a 12-hour pre-conditioning period prior to conducting the standby loss test for storage water heaters and storage-type instantaneous water heaters. While this would add to the time required to conduct the test, it would not require extra personnel and would not necessitate the development of additional test platforms. DOE understands that a preconditioning period is already implemented by manufacturers as a best practice to allow the water heater to achieve operational temperature, so the added burden from the 12-hour soak-in would be minimal. In addition, these tests can be conducted in the same facilities used for the current energy testing of these products, so there would be no additional facility costs required by this proposal.
The sixth modification specifies the location for measurement of inlet and outlet temperature for storage water heaters, storage-type instantaneous water heaters, and UFHWSTs. DOE expects these lengths to align with the piping set-ups currently used in most testing of CWH equipment. If slight modifications would be needed to the set-ups currently used, DOE believes that these modifications would be simple and merely involve adding or removing several inches of piping. Additionally, DOE proposes set-ups for tanks water heaters and storage tanks with connections on the top, side, or bottom—thereby minimizing the likelihood that a significant change to the set-up currently used by manufacturers would be needed. Therefore, DOE has tentatively concluded that this aspect of its proposal would not present a significant burden to manufacturers, including small businesses.
Finally, DOE proposes reducing the time interval for data collection during the thermal efficiency test from 1 minute to 30 seconds and during the standby loss test from 15 minutes to 30 seconds. Because manufacturers are already required to measure at one-minute intervals for the current thermal efficiency test, DOE reasons that manufacturers already use a computer-connected data acquisition system. Changing the time intervals for recording measurements on a data acquisition system is a quick process that requires the operator to simply change the parameters on the computer using the data acquisition system software. Therefore, the manufacturers would not incur any additional testing costs due to the proposed changes in the data recording time intervals.
DOE also proposes to adopt a new metric and test procedure for testing the efficiency of unfired hot water storage tanks. In order to comply with Federal regulations, unfired hot water storage tanks are currently required to meet a minimum thermal insulation R-value of 12.5 ·°F·ft
Manufacturers likely already have all necessary equipment and instrumentation for the proposed test method for unfired hot water storage tanks, because such equipment and instrumentation are already needed for testing of other CWH equipment classes. Through its review of the market, DOE found that all unfired hot water storage tank manufacturers also produce other covered CWH equipment, such as storage water heaters, instantaneous water heaters, or hot water supply boilers. Therefore, DOE has tentatively concluded that manufacturers would not incur any additional test facility costs. Small manufacturers with a small number of UFHWST offerings could choose to conduct testing with a third-party lab, which DOE estimates would cost no more than $3,000 per tested UFHWST.
DOE estimates that testing of each unfired hot water storage tank would take less than 2 days, including set-up and testing of storage volume and standby loss. However, the majority of this time would not require attendance by any employees. DOE estimates that setting up and removing the unfired hot water storage tanks from the test stand might require 2-3 hours of time from a laboratory technician. At a rate of $40 per hour for a laboratory technician, DOE estimates the cost for this amount of labor to be no more than $80-$120. Additionally, DOE estimates it would take approximately 1 hour of a lab technician's time to complete the test procedure per model tested, which would result in a cost of $40. Therefore, the total labor cost of testing an unfired hot water storage tank would be $120-$160 per model.
DOE proposes to change the measurement of temperature in the thermal efficiency test by measuring the outlet water temperature rather than the mean tank temperature for gas-fired and oil-fired storage water heaters and storage-type instantaneous water
DOE proposes to add clarifying statements to its thermal efficiency and standby loss test procedures. Specifically, DOE proposes to clarify that that during the thermal efficiency test, the burner must continuously fire at the full firing rate for the entire duration of the test and that the outlet water temperature must be maintained at 70 °F ± 2 °F above the supply water temperature. DOE also proposes to clarify that during the thermal efficiency and standby loss tests, no settings on the water heating equipment can be changed until measurements for the test have finished. As discussed in section III.E, several manufacturers indicated that there was not a problem with the current test procedure, as there is a general understanding that the burner must fire at its full input rate throughout the course of the test. Additionally, DOE expects that the majority of manufacturers already perform the thermal efficiency and standby loss tests in a manner as clarified in DOE's proposal. Therefore, DOE has tentatively concluded that its proposed clarifying statements would only serve to remove any potential confusion regarding its test procedures, and would not add any burden to manufacturers, including small businesses.
DOE proposes a new definition for “storage-type instantaneous water heater,” which are instantaneous water heaters with integral storage tanks and a submerged heat exchanger(s) or heating element(s). DOE believes this kind of water heater should be tested similar to storage water heaters. However, DOE does not currently prescribe separate test procedures for storage water heaters and instantaneous water heaters. Only in the test procedures proposed in this NOPR does DOE prescribe separate standby loss test methods for storage water heaters and instantaneous water heaters. Additionally, DOE's research suggests that manufacturers already categorize units falling under DOE's proposed definition for “storage-type instantaneous water heater” with storage water heaters. Therefore, DOE has tentatively concluded that applying the test procedure prescribed for storage water heaters to storage-type instantaneous water heaters would not present a burden for manufacturers, including small businesses.
Currently, all instantaneous water heaters and hot water supply boilers having a capacity of 10 gallons or more are required to undergo the same standby loss test that is prescribed in Exhibit G.2 of ANSI Z21.10.3-2011. However, in this NOPR, DOE is proposing a new and separate standby loss test procedure for flow-activated instantaneous water heaters.
In the proposed standby loss test procedure, the flow-activated instantaneous water heater being tested would not cycle on at any point in the course of the test. Therefore, the amount of fuel consumption is not needed for standby loss calculations. This modification will simplify the test and reduce the amount of data processing required for calculating standby loss metric. As a result, this modification would be beneficial to all manufacturers, including small businesses.
The second difference pertains to the duration of the test. In the current test procedure, the equipment is tested until the first cut-out that occurs after 24 hours or 48 hours, whichever comes first. In the proposed standby loss test procedure for flow-activated instantaneous water heaters, the test ends when the outlet water temperature drops by 35 °F or after 24 hours, whichever comes first. DOE has tentatively concluded that it is very likely that a 35 °F drop in outlet water temperature will occur before 24 hours. Therefore, this proposed modification would likely be beneficial to all manufacturers, including small businesses, as it would reduce the time required to conduct the standby loss test. In addition, DOE notes that the maximum test length of 24 hours in the proposed test method is the same as the current minimum test length in the existing test procedure, so the proposed test would always result in a test length either shorter or equal to that of the current test.
The third difference is with regards to the measurement recording intervals. In the current test procedure, the time interval between two successive readings is 1 minute for the thermal efficiency test and 15 minutes for a standby loss test. In the proposed standby loss test method for flow-activated instantaneous water heaters, DOE has proposed to shorten the time interval to 30 seconds. As with other types of CWH equipment, because manufacturers are already required to measure at one-minute intervals for the thermal efficiency test, DOE believes that manufacturers already use a computer-connected data acquisition system. Changing the time intervals for recording measurements on a data acquisition system is a quick process that requires the operator to simply change the parameters on the computer using the data acquisition system software. Therefore, DOE believes that manufacturers would not incur any additional testing costs due to the proposed changes in the data recording time intervals.
In summary, DOE has tentatively concluded that the proposed standby loss test procedure for flow-activated water heaters would not impose any significant additional burden on manufacturers, including small businesses.
For the thermal efficiency and standby loss tests of instantaneous water heaters and hot water supply boilers, DOE proposes to move the outlet water temperature-sensing location closer to the CWH equipment being tested, with several requirements for the placement of the temperature-sensing probe in the outlet water line. DOE also proposes to require the supply water valve be within a distance of 5 inches and an outlet water valve be within a distance of 10 inches from the water heater jacket. These modifications in the test set-up would require: (1) Moving the tee pipe fitting that is used to hold the outlet water temperature sensing instrument to a location immediately outside the CWH equipment; and (2) moving the supply water valve and outlet water valve that are already installed further away from the water heater to the a location closer to the CWH equipment. In case a new tee is required, DOE estimates that such a fitting would cost approximately $50. DOE reasons that the benefits of better representation of the outlet water temperature and close proximity of the water valves that need to be shut off to retain the hot water in the water heater during the standby loss test outweighs the small potential cost of an additional pipe fitting. In addition to these changes, DOE also proposes to clarify
DOE's current standby loss test procedure for CWH equipment at 10 CFR 431.106, which incorporates by reference Exhibit G.2 of ANSI Z21.10.3-2011, requires the measurement of the mean tank temperature to calculate standby loss. In this NOPR, DOE proposes to replace the measurement of mean tank temperature with the outlet water temperature for conducting the standby loss test for instantaneous water heaters and hot water supply boilers that do not meet DOE's proposed definition of “storage-type instantaneous water heater.” This proposed modification to the current test procedure would only change the terms that are used in calculating standby loss. The recording of the outlet water temperature is already required in the thermal efficiency test procedure for all CWH equipment. Therefore, the only change that the manufacturers would be required to make would be to record the outlet water temperature during the standby loss test. Accordingly, DOE has tentatively concluded that these proposed changes would not be unduly burdensome to manufacturers, including small businesses.
DOE currently does not prescribe a test procedure for commercial heat pump water heaters. In this NOPR, DOE proposes to adopt a new test procedure for measurement of the COP
DOE believes that manufacturers of CHPWHs already have the equipment, instrumentation, and facilities (including psychrometric chambers) for testing their units according to the proposed test method, because these would be needed for product development and measurement of COP
Given the small market size of air-source CHPWHs, DOE believes that most manufacturers without test facilities capable of testing air-source CHPWHs according to DOE's proposed test procedure would choose to conduct testing at a third-party lab. DOE estimates that the average air-source CHPWH manufacturer sells six models, and that the cost of testing an air-source CHPWH would not exceed $10,000. Therefore, the average testing burden for manufacturers of air-source CHPWHs without testing facilities should not exceed $60,000.
For indoor water-source and ground water-source CHPWHs, water solution conditioning and recirculation equipment similar to a chiller would be required for testing, in addition to equipment needed for testing air-source CHPWHs (
Based on the proposed test procedure, the test set-up for ground or indoor water-source CHPWHs would be similar to that for direct geo-exchange CHPWHs, with the only difference being that the test set-up for direct geo-exchange CHPWHs includes an additional solution heat exchanger. Similar to water-source CHPWHs, DOE expects that most manufacturers of direct geo-exchange CHPWHs already have such equipment in order to test and provide ratings for their current product offerings. DOE understands that the cost of this solution heat exchanger would be the only cost to be added to the total estimated cost for testing ground and indoor water-source CHPWHs in order to arrive at the estimated cost of testing a direct geo-exchange CHPWH. DOE estimates the cost of a liquid-to-liquid heat exchanger to be not more than $30,000. Therefore, the total estimated capital investment cost for testing a direct geo-exchange CHPWH would not exceed $55,000. Similar to water-source CHPWH manufacturers, DOE understands that many manufacturers of direct geo-exchange CHPWHs, including small businesses, may choose to test their units at third-party laboratories instead of investing in in-house testing facilities. DOE estimates the cost of such testing would not exceed $5,000 per unit.
In this NOPR, DOE proposes to add to its test procedure at 10 CFR 431.106 default values for certain test parameters for CWH equipment, to be used if manufacturers do not report these in either the product literature that is shipped with the unit (
DOE is not aware of any rules or regulations that duplicate, overlap, or conflict with the rule being proposed in this document.
DOE considered alternative test methods and modifications to the test procedures for CWH equipment, and tentatively determined that there are no better alternatives than the modifications and procedures proposed in this NOPR. DOE examined relevant industry test standards, and incorporated these standards in the proposed test procedures whenever appropriate to reduce test burden to manufacturers. Specifically, this NOPR updates its test procedures for CWH equipment to incorporate by reference the following updated standards: ASTM D2156-09, ASTM C177-13, ASTM C518-10, and Annex E.1 of ANSI Z21.10.3-2015. Additionally, DOE proposes three new test procedures in this NOPR: A standby loss test procedure for UFHWSTs, a standby loss test procedure for flow-activated instantaneous water heaters, and a test procedure for measurement of COP
Manufacturers of CWH equipment must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for CWH equipment, including any amendments adopted for those test procedures, on the date that compliance is required. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including CWH equipment. 76 FR 12422 (March 7, 2011); 80 FR 5099 (Jan. 30, 2015). The collection-of-information requirement for certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Notwithstanding any other provision of the 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 PRA, unless that collection of information displays a currently valid OMB Control Number.
In this proposed rule, DOE proposes test procedure amendments that it expects will be used to develop and implement future energy conservation standards for commercial water heating equipment. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has tentatively determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the equipment that is the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) Therefore, Executive Order 13132 requires no further action.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Regarding the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. (This policy is also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Pursuant to Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), DOE has determined that this proposed rule would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with the applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
DOE has tentatively concluded that the regulatory action in this document, which proposes amendments to the test procedure for measuring the energy efficiency of commercial water heating equipment, is not a significant energy action because it is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects for this proposed rule.
Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101
This proposed rule incorporates testing methods contained in the following commercial standards: (1) GAMA IWH-TS-1, “Method to Determine Performance of Indirect-Fired Water Heaters,” March 2003 edition, sections 4, 5, 6.0, and 6.1; (2) ANSI Z21.10.3-2015/CSA 4.3-2015, “Gas-fired Water Heaters, Volume III, Storage Water Heaters with Input Ratings Above 75,000 Btu Per Hour, Circulating and Instantaneous,” annex E.1; (3) ANSI/ASHRAE Standard 118.1-2012, “Method of Testing for Rating Commercial Gas, Electric, and Oil Service Water-Heating Equipment”; (4) ASTM D2156-09, “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels”; (5) ASTM C177-13, “Standard Test Method
In this NOPR, DOE proposes to incorporate by reference the following test standards:
(1) GAMA IWH-TS-1, “Method to Determine Performance of Indirect-Fired Water Heaters,” March 2003 edition, sections 4, 5, 6.0, and 6.1;
(2) ANSI Z21.10.3-2015/CSA 4.3-2015, “Gas-fired Water Heaters, Volume III, Storage Water Heaters with Input Ratings Above 75,000 Btu Per Hour, Circulating and Instantaneous,” annex E.1;
(3) ANSI/ASHRAE Standard 118.1-2012, “Method of Testing for Rating Commercial Gas, Electric, and Oil Service Water-Heating Equipment”;
(4) ASTM D2156-09, “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels”;
(5) ASTM C177-13, “Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded-Hot-Plate Apparatus”; and
(6) ASTM C518-10, “Standard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus.”
GAMA IWH-TS-1 (March 2003 edition) is an industry-accepted test procedure for measuring the performance of indirect water heaters. In this NOPR, DOE proposes to incorporate by reference sections of this test procedure that address test set-up, instrumentation, and test conditions. GAMA IWH-TS-1, March 2003 edition, is available on AHRI's
ANSI Z21.10.3-2015/CSA 4.3-2015 is an industry-accepted test procedure for measuring the performance of commercial water heaters. In this NOPR, DOE proposes to incorporate by reference sections of this test procedure that address test set-up, instrumentation, test conditions, and test conduct. ANSI Z21.10.3-2015/CSA 4.3-2015 is available on ANSI's Web site at
ANSI/ASHRAE Standard 118.1-2012 is an industry-accepted test procedure for measuring the performance of commercial water heaters. ANSI/ASHRAE 118.1-2012 is available on ANSI's Web site at
ASTM D2156-09 is an industry-accepted test procedure for determining the smoke spot number of flue gases. ASTM D2156-09 is available on ASTM's Web site at
ASTM C177-13 is an industry-accepted test procedure for determining the R-value of a sample using a guarded-hot-plate apparatus. ASTM C177-13 is available on ASTM's Web site at
ASTM C518-10 is an industry-accepted test procedure for determining the R-value of a sample using a heat flow meter apparatus. ASTM C518-10 is available on ASTM's Web site at
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Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
The Secretary of Energy has approved publication of this notice of proposed rulemaking.
Confidential business information, Energy conservation, Household appliances, Imports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Intergovernmental relations, Small businesses.
Administrative practice and procedure, Confidential business information, Incorporation by reference, Test procedures, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, DOE proposes to amend parts 429, 430, and 431 of chapter II, subchapter D of title 10, Code of Federal Regulations, as set forth below:
42 U.S.C. 6291-6317.
The additions and revisions read as follows:
(b)
(1)
(i) The general requirements of § 429.11 apply; and
(ii) A sample of sufficient size must be randomly selected and tested to ensure that:
(A) Any represented value of energy consumption or other measure of energy use of a basic model for which consumers would favor lower values must be greater than or equal to the higher of:
(
(
(B) Any represented value of energy efficiency or other measure of energy consumption of a basic model for which consumers would favor higher values must be less than or equal to the lower of:
(
(
And
(2)
(i) Any represented value of energy consumption or other measure of energy use of a basic model for which consumers would favor lower values must be greater than or equal to the output of the AEDM and less than or equal to the Federal standard for that basic model; and
(ii) Any represented value of energy efficiency or other measure of energy consumption of a basic model for which consumers would favor higher values must be less than or equal to the output of the AEDM and greater than or equal to the Federal standard for that basic model.
(3) The representative value of fuel input rate of a basic model reported in accordance with paragraph (c)(2) of this section must be either the mean of the fuel input rate(s) measured for each tested unit of the basic model and determined in accordance with the test procedure in § 431.106 of this chapter, or the value determined with an AEDM, and rounded to the nearest 1,000 Btu/h.
(c)
(1) The requirements of § 429.12 apply; and
(2) Pursuant to § 429.12(b)(13), a certification report must include the following public equipment-specific information:
(i) Commercial electric storage water heaters: The standby loss in percent per hour (%/h) and the measured storage volume in gallons (gal).
(ii) Commercial gas-fired and oil-fired storage water heaters: The thermal efficiency in percent (%), the standby loss in British thermal units per hour (Btu/h), the rated storage volume in gallons (gal), and the fuel input rate in British thermal units per hour (Btu/h) rounded to the nearest 1,000 Btu/h.
(iii) Commercial water heaters and hot water supply boilers with storage capacity greater than 140 gallons: The thermal efficiency in percent (%), whether the storage volume is greater than 140 gallons (Yes/No); whether the tank surface area is insulated with at least R-12.5 (Yes/No); whether a standing pilot light is used (Yes/No); for gas or oil-fired water heaters, whether the basic model has a fire damper or fan-assisted combustion (Yes/No); and, if applicable, pursuant to 10 CFR 431.110, the standby loss in British thermal units per hour (Btu/h) and measured storage volume in gallons (gal).
(iv) Commercial gas-fired and oil-fired instantaneous water heaters with storage capacity greater than or equal to 10 gallons and gas-fired and oil-fired hot water supply boilers with storage capacity greater than or equal to 10 gallons: The thermal efficiency in percent (%), the standby loss in British thermal units per hour (Btu/h); the rated storage volume in gallons (gal); the fuel input rate in British thermal units per hour (Btu/h) rounded to the nearest 1,000 Btu/h; whether a submerged heat exchanger is used (Yes/No); and whether flow through the water heater is required to initiate burner ignition (Yes/No).
(v) Commercial gas-fired and oil-fired instantaneous water heaters with storage capacity less than 10 gallons and gas-fired and oil-fired hot water supply boilers with storage capacity less than 10 gallons: The thermal efficiency in percent (%), the rated storage volume in gallons (gal), and the fuel input rate in British thermal units per hour (Btu/h) rounded to the nearest 1,000 Btu/h.
(vi) Commercial unfired hot water storage tanks: The thermal insulation (
(3) Pursuant to § 429.12(b)(13), a certification report must include the following additional, equipment-specific information:
(i) Whether the basic model is engineered-to-order; and
(ii) For any basic model rated with an AEDM, whether the manufacturer elects the witness test option for verification testing. (See § 429.70(c)(5)(iii) for options.) However, the manufacturer may not select more than 10 percent of AEDM-rated basic models to be eligible for witness testing.
(4) Pursuant to § 429.12(b)(13), a certification report may include supplemental testing instructions in PDF format. If necessary to run a valid test, the equipment-specific, supplemental information must include any additional testing and testing set-up instructions (
(d) [Reserved]
(e) Alternative methods for determining efficiency or energy use for commercial water heating equipment can be found in § 429.70.
(m)
(i) If the certified fuel input rate is found to be valid, then the certified fuel input rate will serve as the basis for determination of the appropriate equipment class and calculation of the standby loss standard (as applicable).
(ii) If the measured fuel input rate is not within two percent of the certified fuel input rate, attempt to achieve the certified fuel input rate (within two percent), DOE will first attempt to increase or decrease the gas pressure within the range specified in manufacturer's instructions in the installation and operation manual shipped with the commercial water heating equipment being tested or in supplemental instructions provided by the manufacturer. If the gas pressure range is not specified by the manufacturer in either of these sources, DOE will use the default range for gas pressure included in appendices A, C, and E to subpart G of part 431 of this chapter. If the measured fuel input rate is still not within two percent of the certified fuel input rate, DOE will attempt to modify the gas inlet orifice. If the measured fuel input rate still is not within two percent of the certified fuel input rate, the measured fuel input rate will serve as the basis for determination of the appropriate equipment class and calculation of the standby loss standard (as applicable).
(2) [Reserved]
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
The revisions read as follows:
42 U.S.C. 6291-6317.
The revisions and additions read as follows:
(1) Has a fuel input rate (for gas-fired or oil-fired equipment) or input rating (for electric equipment) from 300,000 Btu/h to 12,500,000 Btu/h and of at least 4,000 Btu/h per gallon of stored water;
(2) Is suitable for heating potable water; and
(3) Meets either or both of the following conditions:
(i) It has the temperature and pressure controls necessary for heating potable water for purposes other than space heating; or
(ii) The manufacturer's product literature, product markings, product marketing, or product installation and operation instructions indicate that the boiler's intended uses include heating potable water for purposes other than space heating.
(1) Gas-fired instantaneous water heaters with a fuel input rate both greater than 200,000 Btu/h and not less than 4,000 Btu/h per gallon of stored water;
(2) Oil-fired instantaneous water heaters with a fuel input rate both greater than 210,000 Btu/h and not less than 4,000 Btu/h per gallon of stored water; and
(3) Electric instantaneous water heaters with an input capacity both greater than 12 kW and not less than 4,000 Btu/h per gallon of stored water.
(1) For models requiring electricity, uses single-phase external power supply;
(2) Is not designed to provide outlet hot water at temperatures greater than 180 °F; and
(3) Does not meet any of the following criteria:
(1) For electric commercial water heating equipment (not including commercial heat pump water heaters), the average hourly energy required to maintain the stored water temperature expressed as a percent per hour (%/h) of the heat content of the stored water above room temperature and determined in accordance with appendix B, D, or E to subpart G of part 431 (as applicable), denoted by the term “S.”
(2) For gas-fired and oil-fired commercial water heating equipment, the average hourly energy required to maintain the stored water temperature expressed in British thermal units per hour (Btu/h) based on a 70 °F temperature differential between stored water and ambient room temperature and determined in accordance with appendix A, C, or E to subpart G of part 431 (as applicable), denoted by the term “SL”; or
(3) For unfired hot water storage tanks, the average hourly energy lost from the storage tank when in standby mode expressed in British thermal units per hour (Btu/h) and determined in accordance with appendix G to subpart G of part 431, denoted by the term “SL.”
(1) Gas-fired storage water heaters with a fuel input rate both greater than 75,000 Btu/h and less than 4,000 Btu/h per gallon of stored water;
(2) Oil-fired storage water heaters with a fuel input rate both greater than 105,000 Btu/h and less than 4,000 Btu/h per gallon of stored water; and
(3) Electric storage water heaters with an input capacity both greater than 12 kW and less than 4,000 Btu/h per gallon of stored water.
The revisions and additions read as follows:
(b)
(1) GAMA Testing Standard IWH-TS-1, “Method to Determine Performance of Indirect-fired Water Heaters,” March 2003 edition, sections 4, 5, 6.0, and 6.1, IBR approved for appendix G to this subpart.
(2) [Reserved]
(c)
(1) ANSI Z21.10.3-2015/CSA 4.3-2015 (“ANSI Z21.10.3-2015”), “Gas-fired Water Heaters, Volume III, Storage Water Heaters with Input Ratings Above 75,000 Btu Per Hour, Circulating and Instantaneous,” Annex E.1, approved by ANSI on October 5, 2015, IBR approved for appendices A, B, C, D, and E to this subpart.
(2) [Reserved]
(d)
(1) ANSI/ASHRAE Standard 118.1-2012, “Method of Testing for Rating Commercial Gas, Electric, and Oil Service Water-Heating Equipment,” approved by ASHRAE on October 26, 2012 and by ANSI on October 27, 2012, IBR approved for appendix F to this subpart.
(2) [Reserved]
(e)
(1) ASTM C177-13, “Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded-Hot-Plate Apparatus,” approved by ASTM on September 15, 2013, IBR approved for § 431.102.
(2) ASTM C518-10, “Standard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus,” approved by ASTM on May 1, 2010, IBR approved for § 431.102.
(3) ASTM D2156-09, “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels,” approved by ASTM on December 1, 2009 and reapproved by ASTM on October 1, 2013, IBR approved for appendices A, C, and E to this subpart.
(a)
(b)
(1)
(2)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
Prior to (
Determine the thermal efficiency and standby loss (as applicable) in accordance with the following sections of this appendix. Certain sections reference sections of Annex E.1 of ANSI Z21.10.3-2015 (incorporated by reference; see § 431.105). Where the instructions contained in the sections below conflict with instructions in Annex E.1 of ANSI Z21.10.3-2015, the instructions contained herein control.
2.1.
2.2.
2.3.
2.4.
2.5.
2.6.
2.7.
2.7.1. The quantity and rate of fuel consumed.
2.7.2. The quantity of electricity consumed by factory-supplied water heater components, and of the test loop recirculating pump, if used.
3.
3.1.
3.1.1. The pressure of the water supply must be maintained between 40 psi and the maximum pressure specified by the manufacturer of the unit being tested. If the maximum water pressure is not specified by the manufacturer in literature shipped with the unit or supplemental test report instructions included with a certification report, then a default maximum value of 150 psi is to be used. The accuracy of the pressure-measuring devices must be ± 1.0 pounds per square inch (psi).
3.1.2. Isolate the water heater using a shutoff valve in the supply line with an expansion tank installed in the supply line downstream of the shutoff valve. There must be no shutoff means between the expansion tank and the appliance inlet.
3.1.3. During conduct of the thermal efficiency test, the temperature of the supply water must be maintained at 70 °F ± 2 °F.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.8.1.
3.8.2.
3.8.2.1. The CO
3.8.2.2. The fuel pump pressure is within ± 10 percent of manufacturer's specifications;
3.8.2.3. If either the fuel pump pressure or range for CO
3.8.2.4. Smoke in the flue does not exceed No. 1 smoke as measured by the procedure in ASTM D2156-09 (incorporated by reference, see § 431.105). To determine the smoke spot number, connect the smoke measuring device to an open-ended tube. This tube must project into the flue
3.8.2.5. For the thermal efficiency test, measure the CO
3.9.
3.9.1.
3.9.2.
3.9.3.
4.
5.
6.
6.1.
6.1.1. The outlet water temperature must be maintained at 70 °F ± 2 °F above the supply water temperature.
6.1.2. The burner must fire continuously at full firing rate (
6.2.
6.3.
6.3.1. For gas-fired CWH equipment, calculate the fuel input rate using the following equation:
6.3.2. For oil-fired CWH equipment, calculate the fuel input rate using the following equation:
7.1. Begin fuel flow to the main burner(s) and put the appliance into operation.
7.2. After the first cut-out, allow the water heater to remain in standby mode. At this point, do not change any settings on the water heating equipment until measurements for the standby loss test are finished.
7.3. At the second cut-out, record the time and ambient room temperature, and begin measuring the fuel and electric consumption. Record the initial mean tank temperature.
7.4. The duration of the test must be until the first cut-out that occurs after 24 hours or 48 hours, whichever comes first.
7.5. Immediately after conclusion of the test, record the total fuel flow and electrical energy consumption, the final ambient room temperature, the duration of the standby loss test, and the final mean tank temperature. Calculate the average of the recorded values of the mean tank temperature and of the ambient air temperatures taken at each measurement interval, including the initial and final values.
7.6.
7.6.1. The standby loss expressed as a percentage (per hour) of the heat content of the stored water above room temperature must be calculated using the following equation for gas-fired equipment:
7.6.2. The standby loss expressed in Btu per hour must be calculated as follows: SL (Btu per hour) = S (% per hour) × 8.25 (Btu/gal-°F) × Measured Volume (gal) × 70 (°F).
Prior to (
Determine the standby loss in accordance with the following sections of this appendix. Certain sections reference sections of Annex E.1 of ANSI Z21.10.3-2015 (incorporated by reference; see § 431.105). Where the instructions contained in the sections below conflict with instructions in Annex E.1 of ANSI Z21.10.3-2015, the instructions contained herein control.
2.1.
2.2.
2.3.
2.4.
2.5.
2.6.
3.1.
3.1.1. The pressure of the water supply must be maintained between 40 psi and the maximum pressure specified by the manufacturer of the unit being tested. If the maximum water pressure is not specified by the manufacturer in literature shipped with the unit or supplemental test report instructions included with a certification report, then a default maximum value of 150 psi is to be used. The accuracy of the pressure-measuring devices must be ± 1.0 pounds per square inch (psi).
3.1.2. Isolate the water heater using a shutoff valve in the supply line with an expansion tank installed in the supply line downstream of the shutoff valve. There must be no shutoff means between the expansion tank and the appliance inlet.
3.2.
3.3.
3.4.
3.5.
3.5.1. For water heaters with a single thermostat, the thermostat setting must be obtained by starting with the water in the system at 70 °F ± 2 °F. The thermostat must be set so that the maximum mean tank temperature after cut-out is 140 °F ± 5 °F.
3.5.2. For water heaters with multiple adjustable thermostats, set the topmost thermostat first to yield a maximum mean water temperature after cut-out of 140 °F ± 5 °F. Immediately after setting the top thermostat, sequentially set the lower thermostat(s) from highest to lowest so that each yields a maximum mean water temperature after cut-out equal to 140 °F ± 5 °F. When setting each thermostat (with the exception of the bottommost thermostat), calculate the mean tank temperature using only the temperature readings measured at locations higher in the tank than the heating element corresponding to the thermostat being set. While setting each thermostat, all thermostats below the thermostat being tested must be turned off so that no elements below the thermostat being tested are in operation. When setting the bottommost thermostat, calculate the mean tank temperature using all tank thermocouples. After cut-out by all thermostats in the water heater, the maximum mean tank temperature must be 140 °F ± 5 °F.
3.6.
3.6.1.
3.6.2.
4.
5.
6.1. Initiate normal operation of the water heater.
6.2. After the first cut-out, allow the water heater to remain in standby mode. At this point, do not change any settings on the water heating equipment until measurements for the standby loss test are finished.
6.3. At the second cut-out, record the time and ambient room temperature, and begin measuring the electric consumption. Record the initial mean tank temperature.
6.4. The duration of the test must be until the first cut-out that occurs after 24 hours or 48 hours, whichever comes first.
6.5. Immediately after conclusion of the test, record the total electrical energy consumption, the final ambient room temperature, the duration of the standby loss test, and the final mean tank temperature. Calculate the average of the recorded values of the mean tank temperature and of the ambient air temperatures taken at each measurement interval, including the initial and final values.
6.6.
6.6.1. The standby loss expressed as a percentage (per hour) of the heat content of the stored water above room temperature must be calculated using the following equation:
Prior to (
Determine the thermal efficiency and standby loss (as applicable) in accordance with the following sections of this appendix. Certain sections reference sections of Annex E.1 of ANSI Z21.10.3-2015 (incorporated by reference; see § 431.105). Where the instructions contained in the sections below conflict with instructions in Annex E.1 of ANSI Z21.10.3-2015, the instructions contained herein control.
2.1.
2.2.
2.2.1. If the instantaneous water heater or hot water supply boiler does not have any external piping, install a supply water valve within 5 inches of the water heater jacket, and install an outlet water valve within 10 inches of the water heater jacket. If the instantaneous water heater or hot water supply boiler includes external piping assembled at the manufacturer's premises prior to shipment, install water valves in the supply and outlet piping (as applicable) within 5 inches of the end of the piping supplied with the unit.
2.2.2. If the water heater is not able to achieve an outlet water temperature of 70 °F ± 2 °F above the supply water temperature at a constant maximum fuel input rate, a recirculating loop with pump as shown in Figure 4 in section 2.2 of this appendix must be used.
2.2.2.1. If a recirculating loop with a pump is used then ensure that the inlet water temperature labeled as T
2.3.
2.4.
2.5.
2.6.
2.7.
2.7.1. The quantity and rate of fuel consumed.
2.7.2. The quantity of electricity consumed by factory-supplied water heater components, and of the test loop recirculating pump, if used.
3.1.
3.1.1. The pressure of the water supply must be maintained between 40 psi and the maximum pressure specified by the manufacturer of the unit being tested. If the maximum water pressure is not specified by the manufacturer in literature shipped with the unit or supplemental test report instructions included with a certification report, then a default maximum value of 150 psi is to be used. The accuracy of the pressure-measuring devices must be ±1.0 pounds per square inch (psi).
3.1.2. During conduct of the thermal efficiency test, the temperature of the supply water must be maintained at 70 °F ± 2 °F.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.8.1. The outlet water temperature measured from each connection leaving the water heater, must be maintained at 70 °F ± 2 °F above the supply water temperature, and must not differ from any other outlet water connection by more than 2 °F during the thermal efficiency test.
3.8.2. To calculate the outlet water temperature representative for the entire unit, calculate the average of the outlet water temperature measured at each connection leaving the water heater jacket. This average must be taken for each reading recorded by the data acquisition unit. The outlet water temperature obtained for each reading must be used for carrying out all calculations for the thermal efficiency and standby loss tests.
3.9.1.
3.9.2.
3.9.2.1. The CO
3.9.2.2. The fuel pump pressure is within ±10 percent of manufacturer's specifications;
3.9.2.3. If either the fuel pump pressure or range for CO
3.9.2.4. Smoke in the flue does not exceed No. 1 smoke as measured by the procedure in ASTM D2156-09 (incorporated by reference, see § 431.105). To determine the smoke spot number, the smoke measuring device shall be connected to an open-ended tube. This tube must project into the flue
3.9.2.5. For the thermal efficiency test, measure the CO
3.10.
3.10.1.
3.10.2.
4.
5.
5.1.
5.1.1. The outlet water temperature must be maintained at 70 °F ± 2 °F above the supply water temperature.
5.1.2. The burner must fire continuously at full firing rate (
5.2.
5.3.
5.3.1. For gas-fired CWH equipment, calculate the fuel input rate using the following equation:
5.3.2. For oil-fired CWH equipment, calculate the fuel input rate using the following equation:
6.1. Begin fuel flow to the main burner(s) and put the appliance into operation. Prior to beginning the standby loss test, the outlet water temperature must become constant, as indicated by no variation in excess of 2 °F over a 3-minute period, unless no settings on the water heater were changed and the water heater has not been turned off since the completion of the thermal efficiency test.
6.2. After ensuring the outlet water temperature is constant or if no settings on the water heater have been changed and the water heater has not been turned off since completion of the thermal efficiency test, turn off the supply water valve(s), the outlet water valve(s) (installed as per the provisions in section 2.2 of this appendix), and the water pump simultaneously and ensure that there is no flow of water through the water heater.
6.3. After the first cut-out, allow the water heater to remain in standby mode. At this point, do not change any settings on the water heating equipment until measurements for the standby loss test are finished.
6.4. At the second cut-out, record the time and ambient room temperature, and begin measuring the fuel and electric consumption. Record the initial outlet water temperature.
6.5. The duration of the test must be until the first cut-out that occurs after 24 hours or 48 hours, whichever comes first.
6.6. Immediately after conclusion of the test, record the total fuel flow and electrical energy consumption, the final ambient room temperature, the duration of the standby loss test, and the final outlet water temperature. Calculate the average of the recorded values of the outlet water temperature and of the ambient air temperatures taken at each measurement interval, including the initial and final values.
6.7.
6.7.1. The standby loss expressed as a percentage (per hour) of the heat content of the stored water above room temperature must be calculated using the following equation for gas-fired equipment:
And using the following equation for oil-fired equipment:
6.7.2. The standby loss expressed in Btu per hour must be calculated as follows: SL (Btu per hour) = S (% per hour) × 8.25 (Btu/gal-°F) × Measured Volume (gal) × 70 (°F).
Prior to (
Determine the standby loss (as applicable) in accordance with the following sections of this appendix. Certain sections reference sections of Annex E.1 of ANSI Z21.10.3-2015 (incorporated by reference; see § 431.105). Where the instructions contained in the sections below conflict with instructions in Annex E.1 of ANSI Z21.10.3-2015, the instructions contained herein control.
2.1.
2.2.
2.2.1. If the instantaneous water heater or hot water supply boiler does not have any external piping, install a supply water valve within 5 inches of the water heater jacket, and install an outlet water valve within 10 inches of the water heater jacket. If the instantaneous water heater or hot water supply boiler includes external piping assembled at the manufacturer's premises prior to shipment, install water valves in the supply and outlet piping (as applicable) within 5 inches of the end of the piping supplied with the unit.
2.2.2. If the water heater is not able to achieve an outlet water temperature of 70 °F ± 2 °F above the supply water temperature at a constant maximum fuel (or electricity) input rate, a recirculating loop with pump as shown in Figure 4 in section 2.2 of appendix C to this subpart must be used.
2.2.2.1. If a recirculating loop with a pump is used then ensure that the inlet water temperature labeled as T
2.3.
2.4.
2.5.
2.6.
3.1.
3.1.1. The pressure of the water supply must be maintained between 40 psi and the maximum pressure specified by the manufacturer of the unit being tested. If the maximum water pressure is not specified by the manufacturer in literature shipped with the unit or supplemental test report instructions included with a certification report, then a default maximum value of 150 psi is to be used. The accuracy of the pressure-measuring devices must be ± 1.0 pounds per square inch (psi).
3.2.
3.3.
3.4.
3.5.
3.6.
3.6.1. The outlet water temperature measured from each connection leaving the water heater prior to conducting the standby loss test must be maintained at 70 °F ± 2 °F above the supply water temperature, and must not differ from any other outlet water connection by more than 2 °F prior to starting the standby loss test.
3.6.2. To calculate the outlet water temperature representative for the entire unit, calculate the average of the outlet water temperature measured at each connection leaving the water heater jacket. This average must be taken for each reading recorded by the data acquisition unit. The outlet water temperature obtained for each reading must be used for carrying out all calculations for the standby loss test.
3.7.
4.
5.1. Initiate normal operation of the water heater. Prior to beginning the standby loss test, the outlet water temperature must become constant, as indicated by no variation in excess of 2 °F over a 3-minute period.
5.2. After ensuring the outlet water temperature is constant, turn off the supply water valve(s), the outlet water valve(s) (installed as per the provisions in section 2.2 of this appendix), and the water pump simultaneously and ensure that there is no flow of water through the water heater.
5.3. After the first cut-out, allow the water heater to remain in standby mode. At this point, do not change any settings on the water heating equipment until measurements for the standby loss test are finished.
5.4. At the second cut-out, record the time and ambient room temperature, and begin measuring the electric consumption. Record the initial outlet water temperature.
5.5. The duration of the test must be until the first cut-out that occurs after 24 hours or 48 hours, whichever comes first.
5.6. Immediately after conclusion of the test, record the total electrical energy consumption, the final ambient room temperature, the duration of the standby loss test, and the final outlet water temperature. Calculate the average of the recorded values of the outlet water temperature and of the ambient air temperatures taken at each measurement interval, including the initial and final values.
5.7.
5.7.1. The standby loss expressed as a percentage (per hour) of the heat content of the stored water above room temperature must be calculated using the following equation:
16. Add appendix E to subpart G of part 431 to read as follows:
Prior to (
Determine the thermal efficiency and standby loss (as applicable) in accordance with the following sections of this appendix. Certain sections reference sections of Annex E.1 of ANSI Z21.10.3-2015 (incorporated by reference; see § 431.105). Where the instructions contained in the sections below conflict with instructions in Annex E.1 of ANSI Z21.10.3-2015, the instructions contained herein control.
2.1.
2.2.
2.2.1. If the instantaneous water heater does not have any external piping, install a supply water valve within 5 inches of the water heater jacket, and install an outlet water valve within 10 inches of the water heater jacket. If the instantaneous water heater or hot water supply boiler includes external piping assembled at the manufacturer's premises prior to shipment, install water valves in the supply and outlet piping (as applicable) within 5 inches of the end of the piping supplied with the unit.
2.2.2. If the water heater is not able to achieve an outlet water temperature of 70 °F ± 2 °F above the supply water temperature at a constant maximum fuel input rate, a recirculating loop with pump as shown in Figure 4 in appendix C to this subpart must be used for conducting the tests.
2.2.2.1. If a recirculating loop with a pump is used then ensure that the inlet water temperature labeled as T
2.3.
2.4.
2.5.
2.6.
2.7.
2.7.1. The quantity and rate of fuel consumed (for gas-fired and oil-fired equipment).
2.7.2. The quantity of electricity consumed by factory-supplied water heater components, and of the test loop recirculating pump, if used.
3.1.
3.1.1. The pressure of the water supply must be maintained between 40 psi and the maximum pressure specified by the manufacturer of the unit being tested. If the maximum water pressure is not specified by the manufacturer in literature shipped with the unit or supplemental test report instructions included with a certification report, then a default maximum value of 150 psi is to be used. The accuracy of the pressure-measuring devices must be ± 1.0 pounds per square inch (psi).
3.1.2. During conduct of the thermal efficiency test, the temperature of the supply water must be maintained at 70 °F ± 2 °F.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.7.1. The outlet water temperature measured from each connection leaving the water heater must be maintained at 70 °F ± 2 °F above the supply water temperature and must not differ from any other outlet water connection by more than 2 °F during the thermal efficiency test.
3.7.2. To calculate the outlet water temperature representative for the entire unit, calculate the average of the outlet water temperature measured at each connection leaving the water heater jacket. This average must be taken for each reading recorded by the data acquisition unit. The outlet water temperature obtained for each reading must be used for carrying out all calculations for the thermal efficiency and standby loss tests.
3.8.1.
3.8.2.
3.8.2.1. The CO
3.8.2.2. The fuel pump pressure is within ±10 percent of manufacturer's specifications;
3.8.2.3. If either the fuel pump pressure or range for CO
3.8.2.4. Smoke in the flue does not exceed No. 1 smoke as measured by the procedure in ASTM D2156-09 (incorporated by reference, see § 431.105). To determine the smoke spot number, the smoke measuring device shall be connected to an open-ended tube. This tube must project into the flue
3.8.2.5. For the thermal efficiency test, measure the CO
3.9.
3.9.1.
3.9.2.
4.
5.
5.1.
5.1.1. The outlet water temperature must be maintained at 70 °F ± 2 °F above the supply water temperature.
5.1.2. The burner must fire continuously at full firing rate (
5.2.
5.3.
5.3.1. For gas-fired CWH equipment, calculate the fuel input rate using the following equation:
5.3.2. For oil-fired CWH equipment, calculate the fuel input rate using the following equation:
6.1. Initiate normal operation of the water heater. Prior to beginning the standby loss test, unless no settings on the water heater were changed and the water heater has not been turned off since the completion of the thermal efficiency test, achieve steady-state conditions for the outlet water temperature using the following provisions: set the supply water temperature to 70 °F ± 2 °F. Adjust the water flow rate to attain an outlet water temperature of 70 °F ± 2 °F above the supply water temperature. Once the outlet water temperature is achieved, maintain the flow rate such to ensure that the outlet water temperature does not vary in excess of 2 °F over a 3-minute period.
6.2. After ensuring the outlet water temperature is constant or if no settings on the water heater have been changed and the water heater has not been turned off since completion of the thermal efficiency test, turn off the supply water valve(s) and the outlet water valve(s) (installed as per the provisions in section 2.2 of this appendix), and the water pump simultaneously and ensure that there is no flow of water through the water heater. Allow the water heater to cut out. After the burner or heating element cuts out, start recording the measurements for the standby loss test.
6.3. At this time, record the time as t = 0 and record the initial outlet water temperature, ambient room temperature, and fuel and electricity meter readings. Continue to monitor and record the outlet water temperature, the time elapsed from the start of the test, and the electricity consumption at 30-second intervals using a data acquisition system.
6.4. Stop the test when one of the following occurs:
(1) The outlet water temperature decreases by 35 °F from the initial outlet temperature within 24 hours from the start of the test, or
(2) 24 hours has elapsed from the start of the test.
Record the final outlet water temperature, fuel consumed, electricity consumed, and the time elapsed from the start of the test.
6.5. Once the test is complete, use the applicable equation to calculate the standby loss in percent per hour:
For gas-fired equipment:
6.6. For gas-fired and oil-fired flow-activated instantaneous water heaters, calculate the standby loss in terms of Btu per hour as follows:
Where, SL refers to the standby loss of the water heater, defined as the amount of energy required to maintain the stored water temperature expressed in Btu per hour.
On and after (
1.
2.
3.
4.
4.1. Test set-up and installation instructions
4.1.1. For air-source CHPWHs, set up the unit for testing as per section 7.1 and Figure 5a in section 7.7.1 of ASHRAE 118.1-2012.
4.1.2. For direct geo-exchange CHPWHs, set up the unit for testing as per section 7.1 and Figure 5b in section 7.7.2 of ASHRAE 118.1-2012.
4.1.3. For indoor water-source and ground water-source CHPWHs, set up the unit for testing as per section 7.1 and Figure 5c in section 7.7.3 of ASHRAE 118.1-2012.
4.2. Use the water piping instructions described in section 7.2 of ASHRAE 118.1-2012 and the special instructions described in section 7.7.6 of ASHRAE 118.1-2012. Insulate all the pipes used for connections with material having a thermal resistance of not less than 4 h·°F·ft
4.3. Install the thermocouples, including the room thermocouples, as per the instructions in sections 7.3.2 and 7.3.3 of ASHRAE 118.1-2012.
4.4. Section 7.6 of ASHRAE 118.1-2012 must be used if the manufacturer neither submits nor specifies a water pump applicable for the unit for laboratory testing.
4.5. Install the temperature sensors at the locations specified in Figure 5a, 5b, or 5c as applicable as per section 4.1 of this appendix. The sensor shall be installed in such a manner that the sensing portion of the device is positioned within the water flow and as close as possible to the center line of the pipe. Follow the instructions provided in sections 7.7.7.1 and 7.7.7.2 of ASHRAE 118.1-2012 to install the temperature and flow-sensing instruments.
4.6. Use the following evaporator side rating conditions as applicable for each category of CHPWHs. These conditions are also mentioned in Table 4 of this appendix:
4.6.1. For air-source CHPWHs, maintain the evaporator air entering dry-bulb temperature at 80.6 °F ± 1 °F and wet-bulb temperature at 71.2 °F ± 1 °F throughout the conduct of the test.
4.6.2. For direct geo-exchange CHPWHs, maintain the evaporator refrigerant temperature at 32 °F ± 1 °F.
4.6.3. For indoor water-source CHPWHs, maintain the evaporator entering water temperature at 68 °F ± 1 °F.
4.6.4. For ground water-source CHPWHs, maintain the evaporator entering water temperature at 50 °F ± 1 °F.
4.7. The CHPWH being tested must be installed as per the instructions specified in sections 4.1 to 4.6 (as applicable) of this appendix. For all other installation requirements, use section 7.7.4 of ASHRAE 118.1-2012 to resolve any issues related to installation (other than what is specified in this test procedure) of the equipment for testing. Do not make any alterations to the equipment except as specified in this appendix for installation, testing, and the attachment of required test apparatus and instruments.
4.8. Use Table 3 of ASHRAE 118.1-2012 for measurement tolerances of various parameters.
4.9. If the CHPWH is equipped with a thermostat that is used to control the throttling valve of the equipment then use the provisions in section 7.7.7.3 of ASHRAE 118.1-2012 to set up the thermostat.
Test all CHPWHs as per the provisions described in ASHRAE 118.1-2012 for “Type IV” equipment. Tests for all CHPWH equipment must follow the steps described below.
5.1. Supply the CHPWH unit with electricity at the voltage specified by the manufacturer. Follow the provisions in section 8.2.1 of ASHRAE 118.1-2012 to maintain the electricity supply at the required level.
5.2. Set the condenser supply water temperature and outlet water temperature per the following provisions and as set forth in Table 5.1 of this section:
5.2.1. For air-source CHPWHs:
5.2.1.1. Set the supply water temperature to 70 °F ± 1 °F.
5.2.1.2. Initiate operation at the rated pump flow rate and measure the outlet water temperature. If the outlet water temperature is maintained at 120 °F ± 5 °F with no variation in excess of 2 °F over a three-minute period, as required by section 8.7.2 of ASHRAE 118.1-2012, skip to section 5.3 of this appendix.
5.2.1.3. If the outlet water temperature condition as specified in section 8.7.2 of ASHRAE 118.1-2012 is not achieved, adjust the water flow rate over the range of the pump's capacity. If, after varying the water flow rate, the outlet water temperature is maintained at 120 °F ± 5 °F with no variation in excess of 2 °F over a three-minute period, as required by section 8.7.2 of ASHRAE 118.1-2012, skip to section 5.3 of this appendix.
5.2.1.4. If, after adjusting the water flow rate within the range that is achievable by the pump, the outlet water temperature condition as specified in section 8.7.2 of ASHRAE 118.1-2012 is still not achieved, then change the supply water temperature to 110 °F ± 1 °F and repeat the instructions from sections 5.2.1.2 and 5.2.1.3 of this appendix.
5.2.1.5. If the outlet water temperature condition cannot be met, then a test procedure waiver is necessary to specify an alternative set of test conditions.
5.2.2. For direct geo-exchange, indoor water-source, and ground water-source CHPWHs use the following steps:
5.2.2.1. Set the condenser supply water temperature to 110 °F ± 1 °F.
5.2.2.2. Follow the steps specified in section 8.7.2 of ASHRAE 118.1-2012 to obtain an outlet water temperature of 120 °F ± 5 °F with no variation in excess of 2 °F over a three-minute period.
5.3. Conduct the test as per section 9.1.1, “Full Input Rating,” of ASHRAE 118.1-2012. The flow rate, “FR,” referred to in section 9.1.1 of ASHRAE 118.1-2012 is the flow rate of water through the CHPWH expressed in gallons per minute obtained after following the steps in section 5.2 of this appendix. Use the evaporator side rating conditions specified in section 4.6 of this appendix to conduct the test as per section 9.1.1 of ASHRAE 118.1-2012.
5.4. Calculate the COP
On and after (
Determine the standby loss in accordance with the following sections of this appendix. Certain sections reference sections of GAMA Testing Standard IWH-TS-1 (incorporated by reference; see § 431.105). Where the instructions contained in the sections below conflict with instructions in GAMA IWH-TS-1, the instructions contained herein control.
2.
2.1.
3.1.
3.1.1. The pressure of the water supply must be maintained between 40 psi and the maximum pressure specified by the manufacturer of the unit being tested. If the maximum water pressure is not specified by the manufacturer in literature shipped with the unit or supplemental test report instructions included with a certification report, then a default maximum value of 150 psi is to be used. The accuracy of the pressure-measuring devices must be ± 1.0 pounds per square inch (psi).
3.2.
3.3.
3.4.
3.4.1.
3.4.2.
4.
5.
6.1. After conduct of the soak-in period but prior to the start of the standby loss test, fill the storage tank with water that is heated sufficiently to achieve a mean tank temperature of at least 145 °F.
6.2. When the mean tank temperature falls to 142 °F, start recording mean tank temperature and ambient room temperature at regular 30-second intervals as the tank temperature decays.
6.3. When the mean tank temperature falls below 138 °F, stop the test and record the final mean tank temperature reading.
6.4. Calculate the standby loss in Btu per hour as follows:
6.4.1. Select the data points starting when the mean tank temperature first falls to 142 °F and ending when the mean tank temperature first falls below 138 °F. Calculate the uncorrected decay rate, DR
6.4.2. Calculate the mean tank water temperature decay rate, DR, in °F/h, as follows:
6.4.3. The standby loss, SL, in Btu per hour, for unfired hot water storage tanks is determined as:
Civil Rights Division, Department of Justice.
Supplemental advance notice of proposed rulemaking.
The Department of Justice (Department) is considering revising the regulation implementing title II of the Americans with Disabilities Act (ADA or Act) in order to establish specific technical requirements to make accessible the services, programs, or activities State and local governments offer to the public via the Web. In 2010, the Department issued an Advance Notice of Proposed Rulemaking (2010 ANPRM) titled
The Department invites written comments from members of the public. Written comments must be postmarked and electronic comments must be submitted on or before August 8, 2016.
You may submit comments, identified by RIN 1190-AA65 (or Docket ID No. 128), by any one of the following methods:
•
•
•
Rebecca Bond, Chief, Disability Rights Section, Civil Rights Division, U.S. Department of Justice, at (202) 307-0663 (voice or TTY). This is not a toll-free number. Information may also be obtained from the Department's toll-free ADA Information Line at (800) 514-0301 (voice) or (800) 514-0383 (TTY). You may obtain copies of this Supplemental Advance Notice of Proposed Rulemaking (SANPRM) in an alternative format by calling the ADA Information Line at (800) 514-0301 (voice) or (800) 514-0383 (TTY). This SANPRM is also available on the ADA Web site at
Please note that all comments received are considered part of the public record and will be made available for public inspection online at
On July 26, 1990, President George H.W. Bush signed into law the ADA, a comprehensive civil rights law prohibiting discrimination on the basis of disability. The ADA broadly protects the rights of individuals with disabilities as to employment, access to State and local government services, places of public accommodation, transportation, and other important areas of American life. The ADA also requires newly designed and constructed or altered State and local government facilities, public accommodations, and commercial facilities to be readily accessible to and usable by individuals with disabilities. 42 U.S.C. 12101
Title II applies to State and local government entities, and, in subtitle A, protects qualified individuals with disabilities from discrimination on the basis of disability in services, programs, and activities provided by State and local government entities. Title II extends the prohibition on discrimination established by section 504 of the Rehabilitation Act of 1973, as amended, 29 U.S.C. 794 (section 504), to all activities of State and local governments regardless of whether these entities receive Federal financial assistance. 42 U.S.C. 12131-65.
Title III prohibits discrimination on the basis of disability in the full and equal enjoyment of places of public accommodation (privately operated entities whose operations affect commerce and that fall into one of 12 categories listed in the ADA, such as restaurants, movie theaters, schools, day care facilities, recreational facilities, and doctors' offices) and requires newly constructed or altered places of public accommodation--as well as commercial facilities (privately owned, nonresidential facilities, such as factories, warehouses, or office buildings)--to comply with the ADA Standards for Accessible Design (ADA Standards). 42 U.S.C. 12181-89.
On July 26, 1991, the Department issued its final rules implementing title II and title III, codified at 28 CFR part 35 (title II) and part 36 (title III), which included the ADA Standards. At that time, the Web was in its infancy and was not used by State and local governments as a means of providing services or information to the public and thus was not mentioned in the Department's title II regulation.
In June 2003, in recognition of how the Internet was transforming interactions between the public and governmental entities, the Department published a document entitled
On September 30, 2004, the Department published an Advance Notice of Proposed Rulemaking (2004 ANPRM) to begin the process of updating the 1991 regulations to adopt revised ADA Standards based on the relevant parts of the ADA and Architectural Barriers Act Accessibility Guidelines (2004 ADA/ABA Guidelines). 69 FR 58768 (Sept. 30, 2004). On June 17, 2008, the Department issued a Notice of Proposed Rulemaking (2008 NPRM) to adopt the revised 2004 ADA/ABA Guidelines and revise the title II and title III regulations. 73 FR 34466 (June 17, 2008). The 2008 NPRM addressed the issues raised in the public's comments to the 2004 ANPRM and sought additional comment.
The Department did not propose to include Web accessibility provisions in the 2004 ANPRM or the 2008 NPRM, but the Department received numerous comments urging the Department to issue Web accessibility regulations under the ADA. Although the final title II rule, published on September 15, 2010, did not include specific requirements for Web accessibility, the guidance accompanying the final title II rule responded to these comments.
On July 26, 2010, the Department published an ANPRM titled
As mentioned previously, title II entities are increasingly using the Internet to disseminate information and offer services, programs, and activities to the public. Today, among other things, public entities use Web sites to promote employment opportunities and economic growth, improve the collection of payments and fees, encourage civic participation, and enhance educational opportunities. However, individuals with disabilities are often denied equal access to many of these services, programs, and activities because many public entities' Web sites are inaccessible. Thus, there is a digital divide between the ability of citizens with disabilities and those without disabilities to access the services, programs, and activities of their State and local governments.
Public entities have created a variety of online Web portals to streamline their services, programs, and activities. Citizens can now make a number of online service requests—from requesting streetlight repairs and bulk trash pickups to reporting broken parking meters—and can often check the status of a service request online. Public entities also have improved the way citizens can obtain access to most common public services and pay fees and fines. Many States' Web sites now offer citizens the opportunity to renew their vehicle registrations, submit complaints, purchase event permits, and pay traffic fines and property taxes, making some of these otherwise time-consuming tasks easy to complete with a few clicks of a mouse at any time of the day or night. Moreover, many Federal benefits, such as unemployment benefits and food stamps, are available through State Web sites.
Public entities also use their Web sites to make civic participation easier. Many public entities allow voters to begin the voter registration process and obtain candidate information on their Web sites. Individuals interested in running
Many public entities use online resources to promote employment opportunities and economic growth for their citizens. Individuals can use Web sites of public entities to file for unemployment benefits and find and apply for job openings. Pertinent job-related information and training opportunities are increasingly being provided on the Web sites of public entities. Through the Web sites of State and local governments, business owners can register their businesses, apply for occupational and professional licenses, bid on contracts to provide products and services to public entities, and obtain information about laws and regulations with which they must comply. The Web sites of many State and local governments also allow members of the public to research and verify business licenses online and report unsavory business practices.
Public entities are also using Web sites as a gateway to education. Public schools at all levels are offering programs and classroom instruction through Web sites. Some public colleges and universities now offer degree programs online. Many public colleges and universities rely on Web sites and other Internet-related technologies to allow prospective students to apply for admission, request on-campus living assignments, register for courses, access assignments and discussion groups, and to participate in a wide variety of administrative and logistical functions required for students and staff. Similarly, in elementary and secondary public school settings, communications via the Web are increasingly becoming the way teachers and administrators notify parents and students of grades, assignments, and administrative matters. These issues are also discussed in the 2010 ANPRM,
Millions of individuals in the United States have disabilities that affect their use of the Web. Many of these individuals use assistive technology to enable them to navigate Web sites or access information contained on those sites. For example, individuals who do not have use of their hands may use speech recognition software to navigate a Web site, while individuals who are blind may rely on a screen reader to convert the visual information on a Web site into speech. Many Web sites, however, fail to incorporate or activate features that enable users with disabilities to access all of the Web site's information or elements. For instance, individuals who are deaf are unable to access information in Web videos and other multimedia presentations that do not have captions. Individuals with low vision may be unable to read Web sites that do not allow text to be resized or do not provide sufficient contrast. Individuals with limited manual dexterity or vision disabilities who use assistive technology that enables them to interact with Web sites cannot access sites that do not support keyboard alternatives for mouse commands. These same individuals, along with individuals with intellectual and vision disabilities, often encounter difficulty using portions of Web sites that require timed responses from users but do not provide the option for users to indicate that they need more time to respond.
Individuals who are blind or have low vision often confront significant barriers to Web access. This is because many Web sites provide information visually without features that allow screen readers or other assistive technology to retrieve information on the Web site so it can be presented in an accessible manner. A common barrier to Web site accessibility is an image or photograph without corresponding text describing the image. A screen reader or similar assistive technology cannot “read” an image, leaving individuals who are blind with no way of independently knowing what information the image conveys. Similarly, complex Web sites often lack navigational headings or links that would facilitate navigation using a screen reader or may contain tables with header and row identifiers that display data but fail to provide associated cells for each header and row so that the table information can be interpreted by a screen reader.
Online forms, which are essential to accessing services on many government Web sites, are often inaccessible to individuals with disabilities who use screen readers. For example, field elements on forms, which are the empty boxes on forms that hold specific pieces of information, such as a last name or telephone number, may lack clear labels that can be read by assistive technology. Also, visual CAPTCHAs (Completely Automated Public Turing Test To Tell Computers and Humans Apart), which is distorted text that must be inputted by a Web site user to verify that a Web submission is being completed by a human rather than a computer, is not always accompanied by an audio CAPTCHA that is accessible. Inaccessible form fields and CAPTCHAs make it difficult for persons using screen readers to pay fees or fines, submit applications, and otherwise interact with a Web site. Some governmental entities use inaccessible third-party Web sites to accept online payments, while others request public input through inaccessible Web sites. These barriers greatly impede the ability of individuals with disabilities to access the services, programs, and activities offered by public entities on the Web. In many instances, removing certain Web site barriers is neither difficult nor especially costly. For example, the addition of invisible attributes known as alternative (alt) text or tags to an image, which can be done without any specialized equipment, will help keep an individual using a screen reader oriented and allow the individual to gain access to the information on the Web site. Similarly, headings, which also can be added easily, facilitate page navigation for those using screen readers. A discussion of barriers to Web access also appears in the 2010 ANPRM,
The Internet as it is known today did not exist when Congress enacted the ADA and, therefore, neither the ADA nor the regulations the Department promulgated under the ADA specifically address access to Web sites. Congress contemplated that the Department would apply the statute in a manner that evolved over time and delegated authority to the Attorney General to promulgate regulations to carry out the Act's broad mandate.
It has been the policy of the United States to encourage self-regulation with regard to the Internet wherever possible and to regulate only where self-regulation is insufficient and government involvement may be necessary.
Voluntary standards can be sufficient in certain contexts, particularly where economic incentives align with the standards' goals. Reliance on voluntary compliance with Web site accessibility guidelines, however, has not resulted in equal access for persons with disabilities.
Despite the availability of voluntary Web accessibility standards and the Department's clearly stated position that title II requires all services, programs, and activities of public entities, including those available on Web sites, to be accessible, individuals with disabilities continue to struggle to obtain access to the Web sites of public entities. As a result, the Department has addressed Web access in many agreements with State and local governments. Moreover, other Federal agencies have also taken enforcement action against public entities regarding the lack of access for persons with disabilities to their Web sites. In April 2013, for example, the Department of Labor cited the Florida Department of Economic Opportunity Office of Unemployment Compensation for violating Federal statutes, including title II of the ADA, for requiring unemployment compensation applicants to file claims online and complete an online skills assessment as part of the claims-filing process even though the State's Web site was inaccessible.
The Department believes that adopting Web accessibility standards would provide clarity to public entities regarding how to make accessible the services, programs, and activities they offer the public via their Web sites. Adopting specific Web accessibility standards to guide public entities in maintaining accessible Web sites would also provide individuals with disabilities with consistent and predictable access to the Web sites of public entities. As noted above, many services, programs, and activities that public entities offer on their Web sites have not been accessible to individuals with disabilities. Because Web sites can be accessed at any time, these services, programs, and activities are available to the public at their convenience. Accessible alternative means for obtaining access to services, programs, and activities offered on Web sites, such as a staffed telephone line, would need to afford individuals with disabilities equivalent access to such Web-based information and services (
After considering the comments that it received in response to its 2010 ANPRM, the Department has refined its proposal and is issuing this SANPRM to focus on the accessibility of Web information and services of State and local government entities and to seek further public comment.
The Department is seeking comments in response to this SANPRM, including the proposed framework, definitions, requirements, and timeframes for compliance under consideration, and to the specific questions posed in this SANPRM. The Department is particularly interested in receiving comments from all those who have a stake in ensuring that the Web sites of public entities are accessible to people with disabilities or who would otherwise be affected by a regulation requiring Web site access. The Department appreciates the complexity and potential impact of this initiative and therefore also seeks input from experts in the field of computer science, programming, networking, assistive technology, and other related fields whose feedback and expertise will be critical in developing a workable framework for Web site access, which respects the unique characteristics of the Internet and its transformative impact on everyday life. In your comments, please refer to each question by number. Please provide additional information not addressed by the proposed questions if you believe it would be helpful in understanding the implications of imposing ADA regulatory requirements on the Web sites of State and local government entities.
The Department is generally considering including within the scope of its proposed rule all Web content public entities make available to the public on their Web sites and Web pages, regardless of whether such Web content is viewed on desktop computers, notebook computers, smart phones, or other mobile devices. WCAG 2.0 defines Web content as “information and sensory experience to be communicated to the user by means of a user agent, including code or markup that defines the content's structure, presentation, and interactions.”
Information or sensory experience—including the encoding that defines the structure, presentation, and interactions—that is communicated to the user by a Web browser or other software. Examples of Web content include text, images, sounds, videos, controls, and animations.
The above definition of “Web content” attempts to describe the different types of information and experiences available on the Web. The definition of “Web content” also would include the encoding (
The above definition of Web content would not, however, include a Web browser or other software that retrieves and interprets the programming code and displays it as a Web site or Web page. Web browsers are a vehicle for viewing Web content and are usually separate from the information, experiences, and encoding on a Web site. Typically, a person needs a Web browser to access the information or experiences available on the Web. A Web browser is the primary software on a desktop or notebook computer, or on a smart phone or other mobile device, which enables a person to view Web sites and Web pages. Common Web browsers used on desktop computers and mobile devices include Chrome, Firefox, Internet Explorer, Opera, and Safari. Web browsers retrieve and display different types of information and experiences available from Web sites and Web pages. Web browsers display the information and experiences by retrieving and interpreting the encoding—such as HTML—that is used to create Web sites and Web pages.
The definition of “Web content” also would not include other software, such as plug-ins, that help to retrieve and display information and experiences that are available on Web sites and Web pages of public entities. For example, when a person clicks on a PDF document or link on a Web page, Adobe Reader—which is a plug-in software—will open the PDF document either within the Web browser or directly in Adobe Reader, depending on the Web browser's settings. Similarly, other popular plug-ins, such as Adobe Flash Player, Apple QuickTime Player, and Microsoft Windows Media Player allow users to play audio, video, and animations. The fact that plug-ins are required to open the PDF document, audio file, or video file is not always apparent to the person viewing the PDF document, listening to the audio, or watching the video.
In sum, the Department is considering proposing a rule that would cover Web content available on public entities' Web sites and Web pages but that generally would not extend to most software, including Web browsers. The Department proposes a series of questions in section VI.B, however, regarding whether it should consider covering services, programs, and activities offered by public entities through mobile software applications (
In its 2010 ANPRM, the Department asked for public comment about which accessibility standard it should apply to the Web sites of covered entities. The 2010 ANPRM discussed three potential accessibility standards to apply to Web sites of covered entities: (1) WCAG 2.0; (2) the Electronic and Information Technology Accessibility Standards, more commonly known as the section 508 standards; and (3) general performance-based standards. As explained below, the Department is considering proposing WCAG 2.0 Level AA as the accessibility standard that would apply to Web sites and Web content of title II entities.
Since 1994, the W3C® has been the principal international organization involved in developing protocols and guidelines for the Web. The W3C® develops a variety of technical standards and guidelines, including ones relating to privacy, internationalization of technology, and,
WCAG 2.0 has become the internationally recognized benchmark for Web accessibility. In October 2012, WCAG 2.0 was approved as an international standard by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Several nations, including Australia, Canada, France, Germany, Hong Kong, Japan, New Zealand, and South Korea, have either adopted WCAG 2.0 as their standard for Web accessibility or developed standards based on WCAG 2.0. Within the United States, some States, including Alaska, Georgia, Hawaii, and Minnesota, are also using WCAG 2.0 as their standard for Web accessibility. The Web accessibility standards in other States, such as California, Florida, Illinois, Maryland, New York, and Texas, are based on the section 508 standards (which are currently based on WCAG 1.0), and efforts are underway in at least one of these States to review and transition to WCAG 2.0.
WCAG 2.0 was designed to be “technology neutral” (
WCAG 2.0 contains four principles that provide the foundation for Web accessibility. Under these four principles, there are 12 guidelines setting forth basic goals to ensure accessibility of Web sites. For each guideline, testable success criteria (
In order for a Web page to conform to WCAG 2.0, the Web page must satisfy all success criteria under one of the three levels of conformance: A, AA, or AAA. The three levels of conformance indicate a measure of accessibility. Level A, which is the minimum level of conformance, contains criteria that provide basic Web accessibility. Level AA, which is the intermediate level of conformance, includes all of the Level A criteria as well as enhanced criteria that provide more comprehensive Web accessibility. Level AAA, which is the maximum level of conformance, includes all Level A and Level AA criteria as well as additional criteria that can provide a more enriched user experience. At this time, the W3C® does not recommend that Level AAA conformance be required as a general policy for entire Web sites because it is not possible to satisfy all Level AAA criteria for some content.
The 2010 ANPRM asked the public to provide input on which of the three conformance levels the Department should adopt if it decided to use WCAG 2.0 as the standard for Web accessibility. Most of the comments the Department received overwhelmingly supported adopting Level AA conformance. Commenters emphasized that Level AA conformance has been widely recognized and accepted as providing an adequate level of Web accessibility without being too burdensome or expensive. Some commenters urged the Department to adopt Level A conformance under WCAG 2.0, stating that requiring any higher level of conformance would result in hardship for smaller entities because of their lack of resources and technical expertise. The commenters supporting the adoption of Level A conformance asserted that some Level AA criteria, such as the provision to caption all live-audio content in synchronized media, are expensive and technically difficult to implement. The W3C®, the creator of WCAG 2.0, submitted comments stating that the adoption of Level AA conformance is appropriate and necessary to ensure a sufficient level of accessibility for individuals with different kinds of disabilities and is feasible to implement for Web sites ranging from the most simple to the most complex. No commenters suggested that the Department adopt Level AAA in its entirety.
Based on its review of public comments and independent research, the Department is considering proposing WCAG 2.0 Level AA as the technical standard for public entity Web sites because it includes criteria that provide more comprehensive Web accessibility to individuals with disabilities—including those with visual, auditory, physical, speech, cognitive, developmental, learning, and neurological disabilities. In addition, Level AA conformance is widely used, indicating that it is generally feasible for Web developers to implement. Level A conformance does not include criteria for providing Web accessibility that some commenters generally considered important, such as minimum levels of contrast, text resizable up to 200 percent without loss of content, headings and labels, or visible keyboard focus (
Note that while WCAG 2.0 provides that for “Level AA conformance, the Web page [must] satisf[y] all the Level A and Level AA Success Criteria,” individual Success Criteria in WCAG 2.0 are labeled only as Level A or Level AA.
Adoption of WCAG 2.0 Level AA would make the ADA requirements consistent with the standard that has been most widely accepted internationally. As noted earlier, several nations have selected Level AA conformance under WCAG 2.0 as their standard for Web accessibility. Additionally, in 2012, the European Commission issued a proposal for member countries to adopt Level AA conformance under WCAG 2.0 as the accessibility standard for public sector Web sites, available at
The Department also considered whether it should propose adoption of the current section 508 standards instead of WCAG 2.0. The 2010 ANPRM sought public comment on this question. Section 508 of the Rehabilitation Act requires the Federal government to ensure that the electronic and information technology that it develops, procures, maintains, or uses—including Web sites—is accessible to persons with disabilities.
The Department's 2010 ANPRM also sought public comment on whether the Department should adopt performance standards instead of specific technical standards for accessibility of Web sites. Performance standards establish general expectations or goals for Web accessibility and allow for compliance via a variety of unspecified methods and means. While some commenters supported the adoption of performance standards for Web accessibility, pointing out that they provide greater flexibility in ensuring accessibility as Web technologies change, a vast majority of commenters supported the adoption of WCAG 2.0 instead. The majority of commenters stressed that performance standards are likely too vague and subjective and would prove insufficient in providing consistent and testable requirements for Web accessibility. Several commenters who supported the adoption of WCAG 2.0 also noted that, similar to a performance standard, WCAG 2.0 has been designed to allow for flexibility and innovation in the evolving Web environment. The Department recognizes the importance of adopting a standard for Web accessibility that provides not only specific and testable requirements, but also sufficient flexibility to develop accessibility solutions for new Web technologies. The Department believes that WCAG 2.0 achieves this balance because it provides flexibility similar to a performance standard, but also provides more clarity, consistency, and objectivity. Using WCAG 2.0 would also enable public entities to know precisely what is expected of them under title II, which may be of particular benefit to jurisdictions with less technological experience. It would also harmonize with the requirements adopted by certain other nations, some State and local governments in the U.S., and with the standard proposed by the U.S. Access Board that would apply to Federal agency Web sites. Thus, the Department is considering proposing that public entities comply with WCAG 2.0 Level AA.
The 2010 ANPRM asked for public comment regarding the effective date of compliance with any Web accessibility requirements the Department would adopt. Comments regarding the compliance date were extremely varied—ranging from requiring compliance upon publication to allowing a five-year window for compliance—with no clear consensus favored. Many of the comments advocating for shorter timeframes came from individuals with disabilities or disability advocacy organizations. These commenters argued that Web accessibility has long been required by the ADA and that an extended deadline for compliance rewards entities that have not made efforts to make their Web sites accessible. A similar number of commenters responded asking for longer timeframes to comply. Commenters representing public entities were particularly concerned about shorter compliance deadlines, often citing budgets and staffing as major limitations. Many public entities stated that they lack qualified personnel to implement Web accessibility requirements. The commenters stated that in addition to needing time to implement the changes to their Web sites, they also need time to train staff or contract with professionals who are proficient in developing accessible Web sites.
Despite the absence of a regulation, many public entities have some familiarity with Web accessibility. For over a decade, the Department has provided technical assistance materials, and engaged in concerted enforcement efforts, that specifically have addressed Web accessibility.
Effective two years from the publication of this rule in final form, a public entity shall ensure that the Web sites and Web content it makes available to members of the public comply with Level A and Level AA Success Criteria and Conformance Requirements specified in 2008 WCAG 2.0, except for Success Criterion 1.2.4 on live-audio content in synchronized media,
Under such a proposal, public entities would have two years after the publication of a final rule to make their Web sites and Web content accessible in conformance with WCAG 2.0 Level AA, unless compliance with the requirements would result in a fundamental alteration in the nature of a service, program, or activity or in undue financial and administrative burdens. (The limitations on a public entity's obligation to comply with the proposed requirements are discussed in more detail in section V. “Compliance Limitations and Other Duties” below.)
Level AA Success Criterion 1.2.4 under WCAG 2.0 requires synchronized captions for all live-audio content in synchronized media. The intent of Success Criterion 1.2.4 is to “enable people who are deaf or hard of hearing to watch
Because of the added cost of, and the lack of mature technologies for, providing real-time captions for live performances or events presented on the Web, some countries that have adopted WCAG 2.0 Level AA as their standards for Web accessibility, such as Canada and New Zealand, have specifically exempted the requirement for captioning of live-audio content in synchronized media. Also, as mentioned previously, several commenters urged the Department to not adopt Level AA conformance under WCAG 2.0 because of their concern that providing synchronized captions for all live-audio content in synchronized media on the Web would be technically difficult to implement.
The Department recognizes commenters' concerns that providing real-time captions for live performances or events may be technically difficult to implement and may create additional costs and burdens for public entities. However, the Department also recognizes that technologies used to provide real-time captions for Web content are improving and that covered entities are increasingly providing live Webcasts (
Effective three years from the publication of this final rule, a public entity shall ensure that live-audio content in synchronized media it makes available to members of the public complies with Level AA Success Criteria and Conformance Requirements specified in 2008 WCAG 2.0, unless the public entity can demonstrate that compliance with this section would result in a fundamental alteration in the nature of a service, program, or activity or in undue financial and administrative burdens.
The Department recognizes that a public entity should be permitted to use designs, products, or technologies as alternatives to those prescribed for any Web accessibility requirements, provided that such alternatives result in substantially equivalent or greater accessibility and usability. The Department is considering including a provision in a proposed Web access rule that addresses this principle, which is known as equivalent facilitation. The 1991 and 2010 ADA Standards for Accessible Design both contain a similar equivalent facilitation provision. The purpose of allowing for equivalent facilitation is to encourage flexibility and innovation by covered entities while still ensuring substantially equivalent or greater accessibility and usability. The Department believes, however, the responsibility for demonstrating equivalent facilitation rests with the covered entity.
The Department is also interested in exploring and receiving public comment about whether to consider proposing alternate conformance levels, compliance date requirements, or other methods to minimize any significant economic impact on small public entities. The discussion in this section provides the Department's thinking regarding potential ways to minimize any significant economic impact on small entities. However, the Department is open to other alternatives for achieving this purpose and that satisfy the requirements and purposes of title II of the Americans with Disabilities Act.
For the purpose of this rulemaking, a “small public entity” is one that qualifies as a “small governmental jurisdiction” under the Regulatory Flexibility Act of 1980 (RFA), which defines the term to mean “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand * * *”). 5 U.S.C. 601(5). In order to make the distinction between the population sizes of public entities clear for the purposes of a rulemaking, the Department is considering proposing that the population of a public entity should be determined by reference to the total general population of the jurisdiction as calculated by the U.S. Census Bureau, not the population that is eligible for or that takes advantage of the public entity's specific services. For example, a county school district in a county with a population of 60,000 would not be considered a small public entity regardless of the number of students enrolled in or eligible for services. As another example, individual county schools also would not be considered small public entities if they are components of a county government that has a population of over 50,000 (
In the 2010 ANPRM, the Department solicited public comment on whether it should consider different compliance requirements or a different timetable for small entities in order to reduce the impact on them as required by the RFA and Executive Order 13272.
Many commenters, especially Web developers and those representing covered entities, stated that compliance in incremental timeframes would be helpful in allowing covered entities—especially smaller ones—to allocate resources (both financial and personnel) to bring their Web sites into compliance. These commenters noted that many small entities do not have a dedicated Web master or staff. Even when these small entities develop or maintain their own Web sites, commenters stated that they often do so with staff or volunteers who have only a cursory knowledge of Web design and merely use manufactured Web templates or software, which may not be accessible, to create Web pages. Additionally, even when small entities do use outside help, a few commenters expressed concern that there is likely to be a shortage of professionals who are proficient in Web accessibility to assist all covered entities in bringing their Web sites into compliance all at once. Some commenters also expressed concern that smaller entities would need to take down their Web sites because they would not be able to comply with the accessibility requirements. Accordingly, the Department is interested in receiving comment on whether “small public entities”—again those with a population of 50,000 or less—should have an additional year (
In addition to a longer timeline for compliance, the Department is considering whether to propose applying WCAG 2.0 Level A to certain very small public entities. As mentioned previously, in the 2010 ANPRM the Department asked for public comment regarding what compliance alternatives the Department should consider for
WCAG 2.0 Level A does not include the requirement to provide captioning of live-audio content in synchronized media. However, were the Department to require WCAG 2.0 Level AA conformance for very small public entities, the Department is considering whether the requirement to provide captioning of live-audio content in synchronized media should be deferred for very small public entities. Also, the Department is considering whether the requirement to provide captioning of live-audio content in synchronized media should be deferred for all small public entities at this time.
The Department is also interested in gathering information and comments on how it should frame the requirements for Web access for special district governments. For the purposes of the Department's rulemaking, a special district government is a public entity—other than a county, municipality, township, or independent school district—authorized by State law to provide one function or a limited number of designated functions with sufficient administrative and fiscal autonomy to qualify as a separate government and with a population that is not calculated by the United States Census Bureau in the most recent decennial Census or Small Area Income and Poverty Estimates.
A lower conformance standard and a longer timeframe for compliance for special district governments may be appropriate for two reasons. First, because the U.S. Census Bureau does not provide population estimates for special district governments, it would be difficult for these limited-purpose public entities to obtain population estimates that are objective and reliable to determine their duties under any proposed rule that differentiates among public entities based on population size. While some special district governments may estimate their total populations, these entities may use varying methodologies to calculate population estimations leading to possible confusion and inconsistency in the application of the proposed accessibility requirements. Second, special district
In the 2010 ANPRM, the Department requested public comment on whether it should adopt certain coverage limitations when it develops its proposed ADA Web regulations. The Department was particularly interested in hearing about the challenges covered entities might face in making existing Web content accessible, whether it should except from any rule Web content posted by third parties, and whether it should except content on Web sites linked from the Web sites of public entities. Commenters that supported providing exceptions suggested that materials on the public entities' Web sites prior to the effective date of a regulation should not be subject to a Web access rule, as long as the materials are not subsequently modified or updated after any regulation becomes effective. These commenters believed that it would be burdensome to require public agencies to retroactively make all documents on their Web site accessible, noting that many of the outdated documents were hundreds of pages long and were scanned images. Several commenters requested that the Department except from any Web access rule links on public entities' Web sites to other Web sites unless either the public entities operate or control the other Web site or access to the linked content is important or necessary to participate in the public entities' services. Many commenters supported exceptions for Web content posted by third parties on public entities' Web sites and at least one commenter suggested that where practicable, public entities should make and publicize the availability of alternative accessible means for accessing the third-party Web content. On the other hand, a small number of comments—mostly from advocacy groups and private citizens—suggested that the title II regulation should not include any exceptions because the undue administrative and financial burdens compliance limitations would protect public entities from overly burdensome requirements resulting from such a regulation. Finally, a number of commenters urged the Department to require public entities to develop and deploy Web platforms (
At this juncture, the Department is considering a number of categories of Web content for potential exceptions: (1) Archived Web content; (2) certain preexisting conventional electronic documents; (3) third-party Web content linked from a public entity's Web site; and (4) certain Web content posted by third parties on a public entity's Web site.
The Web sites of many public entities often include a significant amount of archived Web content, which may contain information that is outdated, superfluous, or replicated elsewhere. Generally, this historic information is of interest to only a small segment of the general population. Still, the information may be of interest to some members of the public, including some individuals with disabilities, who are conducting research or are otherwise interested in these historic documents. The Department is concerned, however, that public entities would need to expend considerable resources to retroactively make accessible the large quantity of historic information available on public entities' Web sites. Thus, the Department believes providing an exception from the Web access requirements for Web content that meets a definition it is considering proposing for “archived Web content” is appropriate. A proposed definition of “archived Web content” may look like the following:
Archived Web content means Web content that: (1) Is maintained exclusively for reference, research, or recordkeeping; (2) is not altered or updated after the date of archiving; and (3) is organized and stored in a dedicated area or areas clearly identified as being archived.
Under the proposal presently under consideration by the Department, in order for archived Web content to be excepted from the Web access requirements of any proposed rule, all three prongs of the definition would have to be satisfied.
An archived Web content exception would allow public entities to keep and maintain historic Web content, while utilizing their resources to make accessible the many current and up-to-date materials that all citizens need to access for existing public services or to participate in civic life. As discussed below, despite any exception the Department might propose regarding archived Web content, individual requests for access to these excepted documents would still need to be addressed on a case-by-case basis in order to ensure that individuals with disabilities are able to receive the benefits or services of the public entity's archived Web content through other effective means. Under title II of the ADA, it is the responsibility of the public entity to make these documents accessible to individuals with disabilities,
The Department is considering excepting from any Web access rule, conventional electronic documents (
Conventional electronic documents means electronic files available on a public entity's Web site that are in the following electronic file formats: portable document file (PDF) formats, word processor file formats, presentation file formats, spreadsheet file formats, and database file formats.
Because of the substantial number of conventional electronic documents on public entities' Web sites, and because of the difficulty of remediating complex types of information and data to make them accessible after-the-fact, the Department is considering a proposal to except certain preexisting conventional electronic documents from the Web access requirements. The Department is considering such an exception because it believes covered entities should focus their limited personnel and financial resources on developing new conventional electronic documents that are accessible and remediating existing electronic documents that are used by members of the public to apply for or gain access to the public entity's services, programs, or activities. The Department believes this approach may reduce the burdens on covered entities but still provide Web access to key documents. An exception for “preexisting conventional electronic documents” could then provide the following:
Conventional electronic documents created by or for a public entity that are available on a public entity's Web site before the date the public entity is required to comply with this rule are not required to comply with the Web access standards, unless such documents are to be used by members of the public to apply for, gain access to, or participate in a public entity's services, programs, or activities.
Under such a proposal, the Department would anticipate requiring any preexisting document to be used by members of the public to apply for or gain access to the public entity's services, programs, or activities, including documents that provide instructions or guidance, would also need to be made accessible. For example, a public entity would not only need to make an application for a business license accessible, but it would also need to make accessible other materials that may be needed to obtain the license, complete the application, understand the process, or otherwise take part in the program. Accordingly, documents necessary to understand the process of obtaining the business license, such as business license application instructions, manuals, sample knowledge tests, and guides, such as “Questions and Answers” documents, would also be required to be accessible under such an exception. However, the Department believes that under such a proposal, if the public entity's Web site has the same information contained in multiple conventional electronic documents, the Department would expect that the public entity should only be required to ensure that a single complete set of instructions or guidance be available in an accessible format on the Web.
The Department received a variety of comments regarding whether or not covered entities should be responsible for ensuring that third-party Web content and Web content public entities link to is accessible. For purposes of the proposals under consideration herein, “third party” refers to someone other than the public entity. Many commenters maintained that covered entities cannot be held accountable for third-party content on their Web sites because many entities do not control such content. A number of commenters also suggested that public entities be responsible for providing a platform that would allow users to post accessible content, but the public entities should not be responsible for guaranteeing the accessibility of the resulting user-generated content. Several commenters suggested that covered entities should not be responsible for third-party content and links unless they are necessary for individuals to access the services, programs, or activities of the public entities. A number of commenters expressed the view, however, that covered entities should be responsible for all third-party content. These commenters stated that the boundaries between Web content generated by a covered entity and a third party are often difficult to discern and cited the undue burden defense as a factor favoring coverage of third-party content. Additionally, these commenters took the position that excluding the Web content of these third parties was a “loophole” to providing full access and that covered entities must be responsible for the content on their Web site, regardless of its origin.
After considering these comments, the Department is considering proposing certain limited exceptions related to third-party content. It is important to note, however, that even if the Department were to except Web content
Many public entities' Web sites include links to other Web sites that contain information or resources in the community offered by third parties that are not affiliated with the public entity. Clicking on one of these links will take an individual away from the public entity's Web site and send the individual to the Web site of a third party. Typically, the public entity has no responsibility for the Web content or the operation of the third party's Web site. The Department is considering proposing an exception to a Web access rule so that a public entity would not be responsible for the accessibility of a third-party Web site or Web content linked from the public entity's Web site unless the public entity uses the third-party Web sites or Web content to allow members of the public to participate in or benefit from its services, programs, or activities. A proposed exception may look like the following:
Third-party Web content linked from the public entity's Web site is not required to comply with the Web access standards unless the public entity uses the third-party Web site or Web content to allow members of the public to participate in or benefit from the public entity's services, programs, or activities.
Such an exception generally would allow public entities to provide relevant links to third-party Web sites or Web content that may be helpful without making them liable for the third party's Web content. However, the Department's title II regulation prohibits discrimination in the provision of any aid, benefit, or service provided by public entities directly or through contractual, licensing, or other arrangements.
The Department is considering generally excepting Web content posted by third parties on public entities' Web sites from compliance with WCAG 2.0 Level AA. However, the Department is considering requiring Web content posted by a third party that is essential for engaging in civic participation to comply with WCAG 2.0 Level AA.
The basis for this exception is that a public entity generally does not have control over the volume or substance of content posted by a third party on the public entity's Web site. To the extent that any content is reviewed by the public entity before it is posted, such review often is cursory or limited to automated pre-screening to prevent fraud, abusive language, or spamming. Public entities may not even be aware of when third parties post content on the public entities' Web sites. Where the posting of third-party Web content occurs in such an automated fashion, without notice to the public entity, the public entity may lack the practical capacity under these circumstances to make such material accessible.
The Department believes, however, that there are times when access to content posted by third parties on a public entity's Web site may be so essential for engaging in civic participation that the public entity should be required to make the Web content accessible. An example of third-party content which the Department would consider essential to engaging in civic participation is when a State seeks formal public comment on a proposed regulation and those comments are posted on the State Web site. Often the period for public comment is time sensitive, transparency is crucial, and a State will review and consider all such comments in finalizing its regulation. As such, it is vitally important that individuals with disabilities have access to that Web content, whether for framing their own comments, raising important points, reviewing and responding to comments posted by others, or evaluating the basis for the State's ultimate decision.
The Department notes that Web content created by a third party that a public entity decides to post itself would still be subject to WCAG 2.0 Level AA. The Department believes that a public entity should be responsible for Web content that it posts on its own initiative, even if the content is originally created or authored by a third party. In addition, if the Department were to except Web content posted by third parties as above, such an exception would provide public entities with a greater ability to direct their resources toward ensuring that the Web content the public entities themselves make available to the public is accessible.
While access to third-party filings in judicial and quasi-judicial administrative proceedings would seemingly fit within the category of information essential to access in order to engage in civic participation, the Department is considering including these types of filings within the exception for third-party content posted on a public entity's Web site. Courts and administrative agencies can receive vast amounts of third-party filings (
However, if the Department were to include within the exception from any Web access requirements third-party filings in judicial proceedings or quasi-judicial administrative proceedings, the Department would make clear that individual requests for access to these excepted documents would need to be addressed on a case-by-case basis in order to ensure that individuals with disabilities are able to receive the benefits or services of the public entity's records program through other effective means. Under title II, it is the responsibility of the public entity that is making the electronic record available to the public to also make these documents accessible to individuals with disabilities. In some instances, third parties that create or submit individual documents may also have an independent obligation to make these documents accessible to individuals with disabilities. However, that independent obligation would not extinguish the duty of public entities under such a proposed exception to provide alternative access to third-party documents that are posted on their Web sites to individuals with disabilities that request access to them. As noted earlier, the current ADA regulation states that “[i]n order to be effective, auxiliary aids and services must be provided in accessible formats,
The Department seeks public comment on the exception it is considering and has posed several questions.
Public entities are increasingly using third-party platforms, including social media platforms, to host forums for public discourse or to provide information about their services, programs, and activities in lieu of or in addition to hosting such forums and information on their own Web sites. At this time, the Department is considering deferring, in any proposed rule for Web access for public entities, proposing a specific technical accessibility standard that would apply to public entities' use of third-party social media platforms until the Department issues a rulemaking for public accommodations addressing Web site accessibility under title III. For the purposes of this possible deferral, third-party social media platforms would refer to Web sites of third parties whose primary purpose is to enable users to create and share content in order to participate in social networking (
Although the Department is considering deferring application of a technical standard to third-party social media Web sites that public entities use to provide services, programs, or activities, public entities would continue to have obligations under title II of the ADA to provide persons with disabilities access to these online services, programs, or activities. Under title II, a public entity must ensure that “[n]o qualified individual with a disability shall, on the basis of disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of a public entity, or be subjected to discrimination by any public entity,” and must refrain from using methods of administration that would subject qualified individuals with disabilities to discrimination on the basis of disability.
Public educational institutions (
In addition to the information available to the general public on the Web sites of public educational institutions, however, the Web sites of many schools, colleges, and universities also make certain services, programs, and activities available to a discrete and targeted audience of individuals (
Under the ADA, public entities are prohibited from providing any aid, benefit, or service directly, or through contracting, that discriminates against individuals with disabilities.
The Department is also concerned about the rights of parents with disabilities, particularly in the public elementary and secondary school context. Because parents of students in these contexts have greater rights, roles, and responsibilities with regard to their children and their children's education than may be present in the postsecondary education setting, and because these parents interact with such schools much more and in much greater depth and detail, the Department currently is considering expressly including parents with disabilities in any proposed exception and subsequent limitation for password-protected Web content. (The Department notes that the term “parent” in any proposed regulation would be intended to include, at present, natural, adoptive, step-, or foster parents, legal guardians, or other individuals recognized under Federal or State law as having parental rights.) Parents use educational platforms to access progress reports and grades, track homework and long-term project assignments, interact regularly with their children's teachers and administrators, and follow IEP plans and progress. Thus, under the proposal currently under consideration by the Department, once a student is enrolled in a particular class or course and that student has a parent with a disability, the content available on the password-protected Web site would also be required to be made accessible in a timely manner.
Public educational institutions are required to make the appropriate modifications and provide the necessary auxiliary aids and services to students with disabilities. It is the public institution, not the student, that is responsible for ensuring that the required modifications are made and necessary auxiliary aids and services are provided once it is on notice of a student's need. Such institutions, therefore, must think prospectively regarding the access needs of its students with disabilities, including those who would be unable to access course content on an inaccessible Web site. This also means that institutions should not expect or require that a student with a disability, whom the institution knows is unable to access content on an inaccessible Web site, first attempt to access the information and be unable to do so before the institution's obligation to make the content accessible arises.
The Department believes that considering a proposal for public educational institutions along these lines would provide a balanced approach, ensuring access to students with disabilities enrolled in a public educational institution while recognizing that there are large amounts of class or course content that may never need to be accessed by individuals with disabilities because they have not enrolled in a particular class or course.
The exception under consideration by the Department is not intended to apply to password-protected content for classes or courses, that are made available to the general public without enrolling at a particular educational institution and that generally only require perfunctory, if any, registration or payment to participate in the classes or courses, including those offered exclusively online (
The Department is considering allowing the use of conforming alternate
The Department is concerned that WCAG 2.0 will be interpreted to permit the development of two separate Web sites—one for individuals with disabilities and another for individuals without disabilities—even when doing so is unnecessary. The Department is also concerned that the creation of separate Web sites for individuals with disabilities may result in unequal access to information and functionality. However, as the W3C® explains, certain limited circumstances may warrant the use of conforming alternate versions of Web pages. For example, a conforming alternate Web page may be necessary when a new emerging technology is used on a Web page, but the technology is not yet accessibility supported (
(1) when it is not possible to make Web content directly accessible due to technical or legal limitations; or
(2) when used to provide access to conventional electronic documents.
Under this approach, it would not be permissible for public entities to provide conforming alternate versions in cases where making the main Web site accessible would result in an undue financial and administrative burden. As discussed below, in section V. “Compliance Limitations and Other Duties,” public entities are required to make their main Web sites accessible up to the point that full compliance with the proposed technical standard is an undue financial and administrative burden. The Department would not, at that point, also require the public entity to expend significant additional resources to develop a separate accessible and up-to-date Web site that contains the same information and functionality as the inaccessible Web content.
The Department believes persons with disabilities must be provided access to the same Web content that is available to persons without disabilities unless providing direct access to that Web content to persons with disabilities is not possible due to technical or legal limitations. The Department's proposed approach under the ADA would be slightly different than WCAG 2.0 because under WCAG 2.0 public entities, despite the W3C® guidance, can always choose to provide a conforming alternate version of a Web page to conform to WCAG 2.0 rather than providing Web content on the Web page that is directly accessible, even when doing so is unnecessary. Thus, the Department's proposal under consideration would permit the use of conforming alternate versions of Web pages and Web content to comply with Web accessibility requirements only where it is not possible to make Web pages and Web content directly accessible due to technical limitations (
For many individuals with disabilities, having direct access to a main Web page that is accessible is likely to provide the best user experience; however, the Department is aware that for some individuals with disabilities a Web page specifically tailored to accommodate their specific disability may provide a better experience. Nonetheless, requiring all individuals with disabilities who could have a better experience using the main Web page to use a separate or segregated Web page created to accommodate certain disabilities is concerning and inconsistent with the ADA's integration principles. 28 CFR 35.130(b)(2). Still, the Department's proposal under consideration would not prohibit public entities from providing alternate versions of Web pages in addition to its accessible main Web page to provide users with certain types of disabilities a better experience.
With regard to conventional electronic documents (
The Department is concerned about the work it may take to make multiple versions of the same conventional electronic documents accessible, particularly when public entities are already providing persons with disabilities access to the information contained in those documents. Additionally, making more than one format accessible may not improve the access to or experience of the document's content for individuals with disabilities. In the context of conventional electronic documents, the Department does not believe the same risks of separate and unequal access are necessarily present that may occur when using conforming alternate versions for other types of Web content and Web pages, which can lead to the unnecessary development of separate Web sites or unequal services for individuals with disabilities. It seems to the Department that conventional
The Department is considering a proposal that would provide that in meeting any access requirements in a Web accessibility rule, a public entity would not be required to take any action that would result in a fundamental alteration or undue financial and administrative burden. The limitations under consideration would be consistent with the compliance limitations currently provided in the title II regulation in 28 CFR 35.130(b)(7) (reasonable modifications in policies, practices, or procedures), 35.150(a)(3) (program accessibility), and 35.164 (effective communication) and, thus, are familiar to public entities. The regulatory text under consideration may look like the following:
(a) Where a public entity can demonstrate that full compliance with Web accessibility requirements would result in a fundamental alteration in the nature of a service, program, or activity or in undue financial and administrative burdens, compliance with Web accessibility requirements is required to the extent that it does not result in a fundamental alteration or undue financial and administrative burdens. In those circumstances where personnel of the public entity believe that the proposed action would fundamentally alter the service, program, or activity or would result in undue financial and administrative burdens, a public entity has the burden of proving that compliance with Web accessibility requirements would result in such alteration or burdens. The decision that compliance would result in such alteration or burdens must be made by the head of a public entity or his or her designee after considering all resources available for use in the funding and operation of the service, program, or activity, and must be accompanied by a written statement of the reasons for reaching that conclusion. If an action would result in such an alteration or such burdens, a public entity shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that individuals with disabilities receive the benefits or services provided by the public entity to the maximum extent possible.
(b) A public entity that has complied with (a) above is not required to make any further modifications to its Web site to accommodate an individual with a disability who cannot access the information, service, program, or activity on the public entity's Web site. However, the public entity must utilize an alternative method of providing the individual with a disability equal access to that information, service, program, or activity unless the public entity can demonstrate that alternative methods of access would result in a fundamental alteration in the nature of a service, program, or activity or undue financial and administrative burdens.
Generally, the Department believes that it would not be a fundamental alteration of a public entity's online services, programs or activities to modify a Web site or Web content in order to make it accessible and ensure access for individuals with disabilities to such services, programs or activities. Moreover, like the limitations in the title II regulation referenced above, the Department does not believe that such a proposal would relieve a public entity of all obligations to individuals with disabilities. Although a public entity would not be required to take actions that would result in a fundamental alteration in the nature of a service, program, or activity or in undue financial and administrative burdens, it nevertheless would be required to comply with the Web accessibility requirements under consideration
The Department believes that there are many steps a public entity could take to comply with WCAG 2.0 Level AA that would not result in undue financial and administrative burdens and that most entities that would assert a claim that full compliance would result in undue financial and administrative burdens would be able to attain compliance with at least some of the requirements of WCAG 2.0 Level AA. For instance, a public entity may be able to edit its Web content so that all non-text content (
In determining whether an action constitutes undue financial and administrative burdens, all of a public entity's resources available for use in the funding and operation of the service, program, or activity would need to be considered. The burden of proving that compliance with Web accessibility requirements under consideration would fundamentally alter the nature of a service, program, or activity or would result in undue financial and administrative burdens rests with the public entity. As the title II regulation has provided since the Department's adoption in 1991, the decision that compliance would result in a fundamental alteration or impose undue burdens must be made by the head of the public entity or the head's designee and must be memorialized with a written statement of the reasons for reaching that conclusion.
As contemplated by the Department in paragraph (b) above, once a public entity has complied with WCAG 2.0 Level AA, it would not be required to make further modifications to its Web page or Web content to accommodate an individual who is still unable to access the Web page or Web content due to a disability. While the Department realizes that the Web accessibility requirements under consideration may not meet the needs of and provide access to every individual with a disability, it believes that setting a consistent and enforceable Web accessibility standard that meets the needs of a majority of individuals with disabilities would provide greater predictability for public entities, as well as greater assurance of accessibility for individuals with disabilities.
As noted above, full compliance with the Web accessibility requirements under consideration means a public entity would not be required to make any further modifications to its Web page or Web content if an individual with a disability is still unable to access information on the public entity's accessible Web page. However, public entities would still have an obligation to provide the individual with a disability an alternative method of access to that information, service, program, or activity unless the public entity could demonstrate that alternative methods of access would result in a fundamental alteration or in undue financial and administrative burdens. Thus, full compliance with the Web accessibility standards would not mean necessarily full compliance with all of a public entity's obligations under the ADA. In these circumstances, a public entity would still need to take other steps to ensure that an individual with a disability is able to gain access through other effective means, although no further changes to its Web site would be required. This could be accomplished in a variety of ways, including ensuring that the information or services could be accessed by telephone or in person.
The Department would emphasize in a proposed rule that the public entity must make the determination on a case-by-case basis of how best to accommodate those individuals who cannot access the information or services through the public entity's fully compliant Web site. The Department also intends to convey that a public entity should refer to the existing title II regulation at 28 CFR 35.160 (effective communication) to determine its obligations to provide individuals with communication disabilities with the appropriate auxiliary aids and services necessary to afford them an equal opportunity to participate in, and enjoy the benefits of, the public entity's service, program, or activity. For individuals with other disabilities who are unable to access all the information or services provided through a public entity's fully compliant Web site, a public entity should refer to 28 CFR 35.130(b)(7) (reasonable modifications) to determine what reasonable modifications in policies, practices, or procedures are necessary to avoid discrimination on the basis of disability. Under any proposal it advances, the Department will strongly recommend that the public entity provide notice to the public on how an individual who cannot use the Web site because of a disability can request other means of effective communication or reasonable modifications in order to access the information or to participate in the public entity's services, programs, or activities that are being provided on the public entity's Web site. For example, a public entity could provide an email address, link, Web page, or other means of contacting the public entity to address issues that individuals with disabilities may encounter when accessing Web content. The Department seeks additional information with regard to compliance limitations and other duties. Please refer to Question 100 in section VI.C.8 “Compliance Limitations.”
As noted in the 2010 ANPRM, the Department believes that while there is a need to adopt specific standards for public entities to use in order to ensure that their Web content is accessible to individuals with disabilities, the Department must move forward with care, weighing the interests of all stakeholders, so that as accessibility for individuals with disabilities is improved, innovation in the use of the Web by covered entities is not hampered.
The Department is concerned that the type of ADA compliance measures it currently uses, such as the one used to assess compliance with the ADA Standards, may not be practical in the Web context. The ADA requires the facilities of public entities to be designed and constructed in such a manner that the facilities are readily accessible to and usable by individuals with disabilities. 42 U.S.C. 12146. Public entities must ensure that newly designed and constructed State and local government facilities are in full compliance with the scoping and technical specifications in the ADA Standards unless it is structurally impracticable to do so. 28 CFR 35.151(a). When making an alteration to a facility that affects or could affect usability, public entities are required to make those alterations accessible to the maximum extent feasible. 28 CFR 35.151(b).
Because of the dynamic and interconnected nature of Web sites and
The Department is considering whether it should address the accessibility of mobile applications (mobile apps) and, if so, what standard it should consider adopting to address the accessibility of these mobile apps. As mentioned in section II.A “The Meaning of `Web Content'” above, although the Department's proposal under consideration would generally not cover software, the Department is soliciting public comment on whether it should address the accessibility of mobile apps because public entities seem to be turning to mobile apps to provide their services, programs, and activities.
A mobile app is a software application designed to run on smart phones, tablets, or other mobile devices. Today, public entities are increasingly using mobile apps to provide services more effectively and to reach citizens in new ways. For example, using a city's mobile app, residents are able to submit to the city nonemergency service requests, such as cleaning graffiti or repairing a streetlight outage, and track the status of these requests. Public entities' apps take advantage of common features of mobile devices, such as Global Positioning System (GPS) and camera functions, so citizens can provide public entities with a precise description and location of street-based issues, such as potholes or physical barriers created by illegal dumping or parking. Some public transit authorities have transit apps that use a mobile device's GPS function to provide bus riders with the location of nearby bus stops and real-time arrival and departure times. In addition, public entities are not only using mobile apps as a new way to provide civil services, but are also using them to promote tourism, culture, and community initiatives.
One option for a standard would be to apply WCAG 2.0 Level AA to mobile apps of public entities as is being proposed by the Access Board in its update to the section 508 standards.
Additionally, the Mobile A11Y Task Force, another task force of the WAI, developed a W3C® First Public Working Draft that addressed the issue of applying WCAG 2.0 and other W3C® guidelines to mobile apps.
A second possible option for an accessibility standard to apply to mobile apps would be to apply the UAAG, which is also published by the W3C®. The W3C® has published a draft UAAG 2.0, which addresses the accessibility of Web browser software, mobile apps, and other software.
A third possible option for an accessibility standard to apply to mobile apps would be to apply the ATAG,
A fourth possible option for an accessibility standard to apply to mobile apps would be the Human Factors and Ergonomics Society's ANSI/HFES 200.
The Department anticipates that any proposed or final rule that the Department issues regarding the accessibility of Web information and services of public entities would likely have an economically significant impact. A proposed regulatory action is deemed to be “economically significant” under section 3(f)(1) of Executive Order 12866 if it has an annual effect on the economy of $100 million or more or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. Under Executive Order 12866, regulatory actions that are deemed to be economically significant must include a regulatory analysis—a report that documents an agency's analysis of the benefits and costs of the regulatory action. A benefit-cost analysis must include both qualitative and quantitative measurements of the benefits and costs of the proposed rule as well as a discussion of each potentially effective and reasonably feasible alternative.
Because this is a SANPRM, the Department is not required to conduct a benefit-cost analysis required for other more formal types of agency regulatory actions (
In its 2010 ANPRM, the Department requested public comment on the benefits and costs of a proposed rule regarding the accessibility of Web information and services of public entities and public accommodations. The Department received very little specific information or data on the anticipated costs or benefits of such a rule in response to the 2010 ANPRM. The Department therefore seeks additional information that will enable it to more precisely quantify and monetize the economic impact of a rule requiring public entity Web sites to be accessible. The Department asks that any responses to these requests for public comment on the potential benefits and costs of this rule include as much detail as possible and be supported by specific data, information, or research where applicable.
Millions of individuals in the United States have disabilities that could affect their use of the Web. Individuals who have vision disabilities often confront significant barriers to Web access because, among other limitations, many Web sites provide information visually without features that enable screen readers or other assistive technology to retrieve the information on the Web site so it can be presented in an audio or tactile form. Individuals with hearing disabilities face accessibility challenges when, for example, audio content is not presented in a visual form such as captions or transcripts. Individuals with cognitive disabilities can experience difficulties in accessing Web content when information cannot be presented in a text or audio form, distractions cannot be reduced, or time limitations cannot be extended. Individuals with disabilities that affect manual dexterity might, for example, need Web sites to allow input from specialized hardware and software.
Lack of accessibility prevents individuals with disabilities from taking full advantage of Web-implemented governmental programs, services, and activities, which are becoming increasingly common and important. The Department believes that Web accessibility will provide significant benefits to individuals with disabilities, such as the ability to access additional information about government services, programs, or activities, and to access this information more quickly, easily, and independently. The Department has obtained limited information, however, that would enable it to quantify and monetize these and other benefits of Web accessibility for individuals with disabilities, particularly those with disabilities other than visual impairments. For example, it is unclear how much time an individual with a hearing disability would save by using an accessible Web site to access information about city council hearings instead of attempting to obtain this information on an inaccessible Web site or by using a video relay service. Similarly, it is unclear what monetary value should be associated with this time savings, whether time savings is the most appropriate way to measure the monetary value of Web accessibility, or if not, how a monetary value could be assigned to the many benefits Web accessibility provides to individuals with disabilities.
As described above, because the Department expects that any proposed or final rule it issues regarding the accessibility of Web information and
For the following question, please note that the Department is seeking this information for the sole purposes of estimating the rule's benefits. The information sought has no bearing on whether an individual with a vision or hearing disability or a manual dexterity limitation is covered under the ADA and in no way limits coverage of these individuals.
The Department is considering monetizing many of the benefits of the Web accessibility rule in terms of time savings—time saved by those current Web users with disabilities who must spend additional time performing tasks because the Web site is not accessible, as well as time saved by those individuals with disabilities who are currently accessing government services via another method but could do so more quickly via an accessible Web site. For example, if a Web site conforms with WCAG 2.0 by providing navigation information in a form that allows screen readers or other assistive technology to retrieve the information, it could take a person with a vision disability less time to locate information on the Web site than it would if the Web site were not accessible. It could also take less time for that individual to access the information on an accessible Web site than it would take them to call the public entity and ask an employee for the same information. The Department has been able to obtain some research on time savings for individuals with vision impairments due to Web accessibility, with one study (prepared in 2004 for the U.K. Disability Rights Commission) finding that users who were blind took approximately 34 percent less time to complete a task on an accessible Web site. U.K. Disability Rights Commission,
The Department seeks additional information regarding time savings for users with disabilities, other users, and public entities due to Web site
As discussed above, generally, the Department is considering proposing that public entities would have two years after the publication of a final rule to make their Web sites and Web content accessible in conformance with WCAG 2.0 Level AA. The Department is also considering whether to allow alternative conformance levels or compliance dates for small public entities or special districts.
The Department seeks information regarding the efforts public entities would need to undertake to comply with a Web accessibility rule, if such a rule were promulgated as framed in this SANPRM. The Department expects that public entities would be able to comply with a Web accessibility rule in several different ways. For example, they might choose to remediate their existing Web site by page or section, or they might instead choose to create a new Web site with accessibility incorporated during its creation. Public entities might choose to use existing staff to perform any needed testing and remediation or hire outside consultants who would do so. The Department seeks information regarding the various options public entities would consider for achieving compliance, and the financial impact of these choices, so that the Department can more precisely estimate the costs of a Web accessibility rule.
In each of your responses, please provide information about how a public entity would comply with WCAG 2.0 Level AA within two years after the publication of a final rule, and explain how your responses would vary if the Department required conformance with WCAG Level A instead of WCAG Level AA, or if the Department allowed additional time for compliance. Please include as much information as possible to support each of your responses, including specific data or research where possible.
The Department is attempting to estimate the costs a public entity would incur to make and maintain an accessible Web site in conformance with the technical standard under consideration by the Department. Several governmental entities in the
At present, the Department is considering three different approaches for estimating costs. The first is a per-page methodology that multiplies the average number of pages on a Web site by an established testing, remediation, or operation and maintenance cost per page (and possibly by type of page). The second approach under consideration is a level of effort methodology, which would estimate costs based on Web site size groupings or size `bins' (such as less than 100 pages, 100 to 500 pages, etc.). The third potential approach would combine the per-page and level of effort methodologies. The Department will also consider other feasible approaches to estimating costs that are proposed.
The Department seeks public comment on these potential methodologies, any alternative methodologies for estimating compliance costs that the Department should consider, and the appropriate input values that the Department should use for testing, remediation, and operation and maintenance if it chose one of these methodologies. Please include as much information as possible to support each of your responses, including specific data or research where possible.
The Department is also attempting to ascertain whether there are other types of compliance costs associated with the Web accessibility rule presently under consideration, such as the cost of “down time,” systems change, regulatory familiarization costs, or administrative costs. Regulatory familiarization and other administrative costs include the time a public entity spends evaluating and understanding the requirements of the rule and determining how to comply with those requirements, and time which might be needed for making or adjusting short- and long-term plans and strategies and assessing the public entity's resources. Please include as much information as possible to support each of your responses, including specific data or research where possible.
The benefits and costs of proposed regulations are commonly defined relative to a no-action baseline that reflects what the world would look like if the proposed rule is not adopted. In the case of a Web accessibility rule, the no-action baseline should reflect the extent to which public entities' Web sites would comply with accessibility requirements even in the absence of the proposed rule. In an attempt to establish this baseline, the Department considered studies regarding existing public entity Web site accessibility; the extent to which some public entities have adopted statutes or policies that require their Web sites to conform to accessibility requirements under section 508 of the Rehabilitation Act, WCAG 1.0, or WCAG 2.0; and the extent to which some public entities' Web sites have been made accessible due to settlement agreements with the Department of Justice, other agencies, or disability advocacy groups, and publicity surrounding these enforcement efforts. Based on this research, the Department is considering evaluating the benefits and costs of a Web accessibility rule relative to a no-action baseline that assumes that some percentage of Web sites are already accessible and that some percentage of pages on other Web sites are accessible, and therefore either would not incur testing or remediation costs at all, or would only incur these costs for a portion of the Web site.
In an attempt to evaluate the impact of a Web accessibility rule on public entities, the Department may consider publicly reported information about the annual revenues of public entities with different population sizes. Because this information is necessarily reported in the aggregate, it provides a limited view of the resources available to individual public entities for specific purposes, since many funds are targeted or restricted for certain uses. The Department is therefore seeking additional, specific information from public entities that explains, in detail, the impact of a proposed Web accessibility rule like the proposal currently under consideration by the Department, based on public entities' available resources. This information will enable the Department to strike an appropriate balance between access for individuals with disabilities and burdens on public entities when fashioning a proposed rule. Please include as much information as possible to support each of your responses, including specific data or research where possible.
The Department is considering proposing that, as with other ADA requirements, compliance with any technical Web accessibility standard the Department adopts would not be required to the extent that such compliance imposes undue financial and administrative burdens, or results in a fundamental alteration of the services, programs, or activities of the public entity. When compliance with the applicable standard would be an undue burden or fundamental alteration, a covered entity would still be required to provide effective communication or reasonable modifications to individuals with disabilities through other means upon request (
The Department seeks additional information about how these compliance limitations would apply, as well as proposals for less burdensome alternatives to consider. The data that commenters provide to help answer these questions should be well supported and explain whether public entities could comply to some extent with the Web accessibility requirements. It should also explain what provisions of the proposed requirements, if any, would result in undue burdens for certain public entities, and why. In each of your responses, please assume that the proposed rule would require compliance with WCAG 2.0 Level AA within two years after the publication of a final rule, and explain how your responses would vary if the Department required conformance with WCAG Level A instead of WCAG Level AA, or if the Department allowed additional time for compliance. Please include as much information as possible to support each of your responses, including specific data or research where possible.
In order to assess the potential costs of making conventional electronic documents accessible, the Department would like to know, on average, how many conventional electronic documents are currently on public entities' Web sites, and, on average, what percentage of these documents is being used to apply for, gain access to, or participate in a public entity's services, programs, or activities. In addition, the Department would like to know, on average, how many new conventional electronic documents are placed on public entities' Web sites annually, and whether additional compliance costs (beyond staff time) would be needed to make new documents accessible after the compliance date. Please include as much information as possible to support each of your responses, including specific data or research where possible.
WCAG 2.0 Level AA Success Criteria require captions for all recorded-audio and live-audio content in synchronized media, as well as audio description. Synchronized media refers to “audio or video synchronized with another format for presenting information and/or with time-based interactive components. . . .”
The Department is considering whether public educational institutions (
Consistent with the Regulatory Flexibility Act of 1980 and Executive Order 13272, the Department must consider the impacts of any proposed rule on small entities, including small governmental jurisdictions (“small public entities”).
The Department recognizes that small public entities may face resource constraints that could make compliance with some Web accessibility standards difficult. The Department therefore seeks additional, specific information regarding these constraints. The Department encourages small public entities to provide cost data on the potential economic impact of adopting the specific requirements for Web site accessibility under consideration by the Department. The Department also encourages small public entities to provide recommendations on less burdensome alternatives, with relevant cost information. The Department also seeks additional information that will enable it to quantify the benefits of any such rule for individuals with disabilities residing in small public entities. For example, individuals with manual dexterity limitations residing in small public entities may find Web accessibility more important than individuals with similar disabilities residing in larger public entities that may have more accessible public transportation and greater physical accessibility. However, it is also possible that Web accessibility is less important for individuals with manual dexterity limitations residing in small public entities because they do not need to travel very far to access government services in-person, or very little information is available on their town's Web site. In each of your responses, please assume that the proposed rule would require compliance with WCAG 2.0 Level AA within two years after the publication of a final rule, and explain how your responses would vary if the Department required conformance with WCAG Level A instead of WCAG Level AA, or if the Department allowed additional time for compliance. Please include as much information as possible to support each of your responses, including specific data or research where possible.
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 |