{"abstract":"This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for Coronavirus Disease 2019 (COVID-19) vaccine and its administration. This IFC implements requirements in the CARES Act that providers of COVID-19 diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements. This rule also establishes an add-on payment for cases involving the use of new COVID- 19 treatments under the Medicare Inpatient Prospective Payment System (IPPS). This IFC provides for separate payment for new COVID-19 treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for COVID-19 when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. This rule also interprets and implements the requirement to maintain Medicaid beneficiary enrollment in order to receive the temporary increase in Federal funding in the Families First Coronavirus Response Act (FFCRA). This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes. Specifically, we are extending Performance Year (PY) 5 by adding 6 months, creating an episode-based extreme and uncontrollable circumstances COVID-19 policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This rule also amends regulations regarding coverage of preventive health services to implement section 3203 of the CARES Act, which shortens the timeframe within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover without cost sharing qualifying coronavirus preventive services, including recommended COVID-19 immunizations. This IFC also revises regulations to set forth flexibilities in the public notice requirements and post award public participation requirements for State Innovation Waivers under section 1332 of the Patient Protection and Affordable Care Act (PPACA) during the public health emergency for COVID-19.","action":"Interim final rule with request for comments.","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Internal Revenue Service","name":"Internal Revenue Service","id":254,"url":"https://www.federalregister.gov/agencies/internal-revenue-service","json_url":"https://www.federalregister.gov/api/v1/agencies/254","parent_id":497,"slug":"internal-revenue-service"},{"raw_name":"Office of the Secretary"},{"raw_name":"DEPARTMENT OF LABOR","name":"Labor Department","id":271,"url":"https://www.federalregister.gov/agencies/labor-department","json_url":"https://www.federalregister.gov/api/v1/agencies/271","parent_id":null,"slug":"labor-department"},{"raw_name":"Employee Benefits Security Administration","name":"Employee Benefits Security Administration","id":131,"url":"https://www.federalregister.gov/agencies/employee-benefits-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/131","parent_id":271,"slug":"employee-benefits-security-administration"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/11/06/2020-24332.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"54","title":26},{"chapter":null,"citation_url":null,"part":"2590","title":29},{"chapter":null,"citation_url":null,"part":"33","title":31},{"chapter":null,"citation_url":null,"part":"410","title":42},{"chapter":null,"citation_url":null,"part":"411","title":42},{"chapter":null,"citation_url":null,"part":"414","title":42},{"chapter":null,"citation_url":null,"part":"417","title":42},{"chapter":null,"citation_url":null,"part":"433","title":42},{"chapter":null,"citation_url":null,"part":"510","title":42},{"chapter":null,"citation_url":null,"part":"147","title":45},{"chapter":null,"citation_url":null,"part":"155","title":45},{"chapter":null,"citation_url":null,"part":"182","title":45}],"citation":"85 FR 71142","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: These regulations are effective on November 2, 2020, except for amendatory instructions 36 and 37, which are effective on January 1, 2021.","disposition_notes":null,"docket_ids":["TD 9931","CMS-9912-IFC"],"dockets":[],"document_number":"2020-24332","effective_on":"2020-11-02","end_page":71205,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/11/06/2020-24332.xml","html_url":"https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-24332?publication_date=2020-11-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-11-06/2020-24332/mods.xml","not_received_for_publication":null,"page_length":64,"page_views":{"count":64029,"last_updated":"2026-07-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-11-06/pdf/2020-24332.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-24332.pdf?1604351725","publication_date":"2020-11-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/11/06/2020-24332.txt","regulation_id_number_info":{"1545-BP97":null,"0938-AU35":{"issue":"202210","html_url":"https://www.federalregister.gov/regulations/0938-AU35/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency-tempo","title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Temporary Increase in Federal Medical Assistance Percentage (FMAP) (CMS-9912)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0938-AU35&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"},"1210-AB98":{"issue":"202010","html_url":"https://www.federalregister.gov/regulations/1210-AB98/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency-","title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency\n","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202010&RIN=1210-AB98&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0938-AU35","1210-AB98","1545-BP97"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Medicaid Program: Temporary Increase in Federal Medical Assistance Percentage in Response to the COVID-19 Public Health Emergency","document_id":"CMS-2020-0129-0221"},{"title":"CMS-9912-N","document_id":"CMS-2020-0129-0220"},{"title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency CMS-9912-IFC","document_id":"CMS-2020-0129-0002"},{"title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency CMS-9912-IFC Display","document_id":"CMS-2020-0129-0001"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0938-AU35/additional-policy-and-regulatory-revisions-in-response-to-the-covid-19-public-health-emergency-tempo","title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Temporary Increase in Federal Medical Assistance Percentage (FMAP) (CMS-9912)"},"comments_count":213,"agency_id":"CMS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CMS-2020-0129","supporting_documents_count":4,"docket_id":"CMS-2020-0129","document_id":"CMS-2020-0129-0002","regulation_id_number":"0938-AU35","title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency CMS-9912-IFC Display","checked_regulationsdotgov_at":"2021-01-13T04:30:12Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":71142,"subtype":null,"title":"Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency","toc_doc":"Additional Policy and Regulatory Revisions in Response to the COVID19 Public Health Emergency","toc_subject":null,"topics":["Administrative practice and procedure","Advertising","Biologics","Brokers","Child support","Citizenship and naturalization","Civil rights","Claims","Consumer protection","Diseases","Drugs","Employee benefit plans","Excise taxes","Grant programs-health","Health care","Health facilities","Health insurance","Health maintenance organizations (HMO)","Health professions","Health records","Hospitals","Indians","Individuals with disabilities","Intergovernmental relations","Laboratories","Loan programs-health","Medicaid","Medicare","Organization and functions (Government agencies)","Penalties","Pensions","Privacy","Public assistance programs","Reporting and recordkeeping requirements","Rural areas","Sex discrimination","Technical assistance","X-rays"],"type":"Rule","volume":85}