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71142 Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations DEPARTMENT OF THE TREASURY System (IPPS). This IFC provides for duration of the public health emergency separate payment for new COVID–19 for COVID–19, regulations at 42 CFR Internal Revenue Service treatments under the Outpatient part 433, subpart G, apply from Prospective Payment System (OPPS) for November 2, 2020, through the end of 26 CFR Part 54 the remainder of the PHE for COVID–19 the last month of the public health [TD 9931] when these treatments are provided at emergency for COVID–19 in accordance the same time as a Comprehensive with section 6008(b)(3) of the Families Office of the Secretary Ambulatory Payment Classification (C– First Coronavirus Response Act. APC) service. This rule also interprets Regulations at 42 CFR 510.300(a)(1)(i) 31 CFR Part 33 and implements the requirement to and (a)(1)(iii) are applicable October 1, maintain Medicaid beneficiary 2020. RIN 1545–BP97 enrollment in order to receive the Comment date: To be assured temporary increase in Federal funding DEPARTMENT OF LABOR consideration, comments must be in the Families First Coronavirus received at one of the addresses Response Act (FFCRA). This IFC Employee Benefits Security provided below, no later than 5 p.m. on modifies policies of the Comprehensive Administration January 4, 2021. Care for Joint Replacement (CJR) model ADDRESSES: In commenting, please refer and adds technical changes to 29 CFR Part 2590 to file code CMS–9912–IFC. accommodate these policy changes. Comments, including mass comment RIN 1210–AB98 Specifically, we are extending submissions, must be submitted in one Performance Year (PY) 5 by adding 6 DEPARTMENT OF HEALTH AND of the following three ways (please months, creating an episode-based choose only one of the ways listed): HUMAN SERVICES extreme and uncontrollable 1. Electronically. You may submit circumstances COVID–19 policy, electronic comments on this regulation Centers for Medicare & Medicaid providing two reconciliation periods for to http://www.regulations.gov. Follow Services PY 5, and adding DRGs 521 and 522 for the ‘‘Submit a comment’’ instructions. hip and knee procedures. This rule also 42 CFR Parts 410, 411, 414, 417, 433, amends regulations regarding coverage 2. By regular mail. You may mail and 510 of preventive health services to written comments to the following implement section 3203 of the CARES address ONLY: Centers for Medicare & Office of the Secretary Act, which shortens the timeframe Medicaid Services, Department of within which non-grandfathered group Health and Human Services, Attention: 45 CFR Parts 147, 155, and 182 health plans and health insurance CMS–9912–IFC, P.O. Box 8016, Baltimore, MD 21244–8016. [CMS–9912–IFC] issuers offering non-grandfathered group or individual health insurance Please allow sufficient time for mailed RIN 0938–AU35 coverage must begin to cover without comments to be received before the cost sharing qualifying coronavirus close of the comment period. Additional Policy and Regulatory preventive services, including 3. By express or overnight mail. You Revisions in Response to the COVID– recommended COVID–19 may send written comments to the 19 Public Health Emergency immunizations. This IFC also revises following address ONLY: Centers for Medicare & Medicaid Services, AGENCY: Centers for Medicare & regulations to set forth flexibilities in the public notice requirements and post Department of Health and Human Medicaid Services (CMS), Department Services, Attention: CMS–9912–IFC, of Health and Human Services (HHS); award public participation requirements for State Innovation Waivers under Mail Stop C4–26–05, 7500 Security Internal Revenue Service, Department of Boulevard, Baltimore, MD 21244–1850. the Treasury; Employee Benefits section 1332 of the Patient Protection For information on viewing public Security Administration, Department of and Affordable Care Act (PPACA) comments, see the beginning of the Labor. during the public health emergency for COVID–19. SUPPLEMENTARY INFORMATION section. ACTION: Interim final rule with request FOR FURTHER INFORMATION CONTACT: for comments. DATES: Effective date: These regulations are effective on November 2, 2020, Laura Kennedy, (410) 786–3377, for SUMMARY: This interim final rule with except for amendatory instructions 36 discussion related to COVID–19 vaccine request for comments (IFC) discusses and 37, which are effective on January and administration payment provided CMS’s implementation of section 3713 1, 2021. under Medicare Part B. of the Coronavirus Aid, Relief, and Applicability date: Except as Lina Rashid, (443) 902–2823, or Economic Security Act (CARES Act), otherwise specified in this paragraph, Michelle Koltov, (301) 492–4225, which established Medicare Part B these regulations are applicable from Centers for Medicare & Medicaid coverage and payment for Coronavirus November 2, 2020, until the end of the Services, Department of Health and Disease 2019 (COVID–19) vaccine and public health emergency for COVID–19 Human Services, Services, Kimberly its administration. This IFC implements as determined by the HHS Secretary. Koch, (202) 622–0854, Department of requirements in the CARES Act that The regulations at 42 CFR 410.57, the Treasury, for issues related to State providers of COVID–19 diagnostic tests 410.152, 410.160, 411.15, 414.701, Innovation Waivers Policy and make public their cash prices for those 414.707, 414.900, and 414.904 and at 42 Regulatory Revisions in Response to the tests and establishes an enforcement CFR part 510 (other than 42 CFR COVID–19 Public Health Emergency. scheme to enforce those requirements. 510.300(a)(1)(i) and (iii)) are applicable Dr. Terri Postma or Rhonda Sheppard, This rule also establishes an add-on November 2, 2020. Because the (410) 786–8465, or via email at payment for cases involving the use of requirement at section 6008(b)(3) of the [email protected], for new COVID–19 treatments under the Families First Coronavirus Response provisions related to Price Transparency Medicare Inpatient Prospective Payment Act (FFCRA) is not limited to the for COVID–19 Diagnostic Testing. VerDate Sep<11>2014 20:42 Nov 05, 2020 Jkt 253001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\06NOR2.SGM 06NOR2 Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations 71143 Cristina Nigro, (410) 786–7763, for community in responding to COVID–19 with developmental disabilities and issues related to the Medicare Inpatient (hereafter referred to as the PHE for board-and-care facilities.3 Prospective Payment System (IPPS) COVID–19). On March 11, 2020, the As the health care community New COVID–19 Treatments Add-on WHO publicly declared COVID–19 a implements and updates recommended Payment (NCTAP) for the remainder of pandemic. On March 13, 2020, prevention and control practices, the public health emergency. President Donald J. Trump (the regulatory agencies operating under David Mlawsky, (410) 786–1565, President) declared the COVID–19 appropriate waiver authority granted by Centers for Medicare & Medicaid pandemic a national emergency. the PHE for COVID–19 are also working Services, Department of Health and Effective October 23, 2020, the Secretary to revise and implement regulations that Human Services, Elizabeth Schumacher, renewed the January 31, 2020 support these health care community (202) 693–8335, Employee Benefits determination that was previously infection prevention and treatment Security Administration, Department of renewed on April 21, 2020 and July 23, practices. Based on the current and Labor, Dara Alderman, (202) 317–5500, 2020 that a PHE exists and has existed projected increases in the incidence rate Internal Revenue Service, Department of since January 27, 2020. of COVID–19 in the US, observed the Treasury, for issues related to Rapid The Administration is committed to fatalities in the older adult population, Coverage of Preventive Services for ensuring that Americans have access to and the impact on health care workers Coronavirus. a COVID–19 vaccine through Operation at increased risk due to treating special Stephanie Bell, (410) 786–0617, for Warp Speed, a partnership among populations, CMS 4 is reviewing and issues related to the temporary increase components of the HHS, including the revising regulations, as appropriate, to in Federal Medicaid funding. Centers for Disease Control and offer states, providers, suppliers, and Bobbie Knickman, (410) 786–4161; Prevention (CDC), the Food and Drug group health plans and health insurance Heather Holsey, (410) 786–0028; Sarah Administration (FDA), the National issuers additional flexibilities in Mioduski, (410) 786–2014 or email Institutes of Health (NIH), and the furnishing and providing services to [email protected] for the Biomedical Advanced Research and combat the PHE for COVID–19 and to Comprehensive Care for Joint address and minimize the unique Replacement Model. Development Authority (BARDA). Operation Warp Speed engages with impact of the PHE for COVID–19 on SUPPLEMENTARY INFORMATION: private firms and other Federal other regulatory provisions. Inspection of Public Comments: All agencies, including the Department of CMS addressed additional policies in comments received before the close of Defense (DoD), Department of three previous interim final rules with the comment period are available for Agriculture, the Department of Energy, comment period (IFCs). The ‘‘Medicare viewing by the public, including

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