{"abstract":"This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.","action":"Final rule.","agencies":[{"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/2021/01/14/2021-00707.html","cfr_references":[{"chapter":null,"citation_url":null,"part":405,"title":42}],"citation":"86 FR 2987","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective on March 15, 2021.","disposition_notes":null,"docket_ids":["CMS-3372-F"],"dockets":[],"document_number":"2021-00707","effective_on":"2021-03-15","end_page":3010,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/01/14/2021-00707.xml","html_url":"https://www.federalregister.gov/documents/2021/01/14/2021-00707/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-00707?publication_date=2021-01-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-01-14/2021-00707/mods.xml","not_received_for_publication":null,"page_length":24,"page_views":{"count":12251,"last_updated":"2026-04-11 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-00707.pdf?1610486130","publication_date":"2021-01-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/01/14/2021-00707.txt","regulation_id_number_info":{"0938-AT88":{"issue":"202104","html_url":"https://www.federalregister.gov/regulations/0938-AT88/medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and-necessary-cms-3372-","title":"Medicare Coverage of Innovative Technology (MCIT) and Definition of \"Reasonable and Necessary\" (CMS-3372)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0938-AT88&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0938-AT88"],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0938-AT88/medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and-necessary-cms-3372-","title":"Medicare Coverage of Innovative Technology (MCIT) and Definition of \"Reasonable and Necessary\" (CMS-3372)"},"comments_count":0,"agency_id":"CMS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CMS-2020-0098","supporting_documents_count":0,"docket_id":"CMS-2020-0098","document_id":"CMS-2020-0098-0346","regulation_id_number":"0938-AT88","title":"Medicare Coverage of Innovative Technology (MCIT) and Definition of \"Reasonable and Necessary (CMS-3372-P)","checked_regulationsdotgov_at":"2021-02-05T04:30:08Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":2987,"subtype":null,"title":"Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”","toc_doc":"Medicare Program; Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary","toc_subject":null,"topics":["Administrative practice and procedure","Diseases","Health facilities","Health professions","Medical devices","Medicare","Reporting and recordkeeping requirements","Rural areas","X-rays"],"type":"Rule","volume":86}