{"abstract":"This final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. This rule also explains how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. In addition, this rule implements certain privacy and security requirements, and imposes assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement required by the qualified entity program.","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/2016/07/07/2016-15708.html","cfr_references":[{"chapter":null,"citation_url":null,"part":401,"title":42}],"citation":"81 FR 44456","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These regulations are effective on September 6, 2016.","disposition_notes":null,"docket_ids":["CMS-5061-F"],"dockets":[],"document_number":"2016-15708","effective_on":"2016-09-06","end_page":44482,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/07/2016-15708.xml","html_url":"https://www.federalregister.gov/documents/2016/07/07/2016-15708/medicare-program-expanding-uses-of-medicare-data-by-qualified-entities","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15708?publication_date=2016-07-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-07/2016-15708/mods.xml","not_received_for_publication":null,"page_length":27,"page_views":{"count":6267,"last_updated":"2026-09-21 14:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-07/pdf/2016-15708.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15708.pdf?1467386133","publication_date":"2016-07-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/07/2016-15708.txt","regulation_id_number_info":{"0938-AS66":{"issue":"201510","html_url":"https://www.federalregister.gov/regulations/0938-AS66/expansion-of-the-cms-qualified-entity-program-cms-5061-p-","title":"Expansion of the CMS Qualified Entity Program (CMS-5061-P)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201510&RIN=0938-AS66&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0938-AS66"],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0938-AS66/expansion-of-the-cms-qualified-entity-program-cms-5061-p-","title":"Expansion of the CMS Qualified Entity Program (CMS-5061-P)"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CMS-2016-0008","supporting_documents_count":0,"docket_id":"CMS-2016-0008","regulation_id_number":"0938-AS66","title":"Expansion of the CMS Qualified Entity Program CMS-5061-P","checked_regulationsdotgov_at":"2016-07-27T06:00:14Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":44456,"subtype":null,"title":"Medicare Program: Expanding Uses of Medicare Data by Qualified Entities","toc_doc":"Expanding Uses of Medicare Data by Qualified Entities","toc_subject":"Medicare Program:","topics":["Claims","Freedom of information","Health facilities","Medicare","Privacy"],"type":"Rule","volume":81}