{"abstract":"This proposed rule would codify the Medicare Drug Price Negotiation Program (\"Negotiation Program\") and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would also propose a modification to the fixed combination drug policy.","action":"Proposed 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/2026/06/16/2026-12059.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"423","title":42},{"chapter":null,"citation_url":null,"part":"429","title":42}],"citation":"91 FR 36236","comment_url":"http://www.regulations.gov/commenton/CMS-2026-2080-0001","comments_close_on":"2026-08-17","correction_of":null,"corrections":[],"dates":"To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 17, 2026.","disposition_notes":null,"docket_ids":["CMS-4215-P"],"dockets":[{"supporting_documents":[],"agency_name":"CMS","documents":[{"comment_count":21,"comment_start_date":"2026-06-16","updated_at":"2026-07-27T01:55:53.920-04:00","comment_url":"https://www.regulations.gov/commenton/CMS-2026-2080-0001","allow_late_comments":false,"id":"CMS-2026-2080-0001","comment_end_date":"2026-08-18","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"CMS-2026-2080","title":"Medicare Drug Price Negotiation Program (CMS-4215-P)"}],"document_number":"2026-12059","effective_on":null,"end_page":36368,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/16/2026-12059.xml","html_url":"https://www.federalregister.gov/documents/2026/06/16/2026-12059/medicare-drug-price-negotiation-program-and-medicare-prescription-drug-benefit-program","images":{"EP16JN26.007":{"large":"https://img.federalregister.gov/EP16JN26.007/EP16JN26.007_large.png","medium":"https://img.federalregister.gov/EP16JN26.007/EP16JN26.007_medium.png","original_size":"https://img.federalregister.gov/EP16JN26.007/EP16JN26.007_original_size.png"},"EP16JN26.006":{"large":"https://img.federalregister.gov/EP16JN26.006/EP16JN26.006_large.png","medium":"https://img.federalregister.gov/EP16JN26.006/EP16JN26.006_medium.png","original_size":"https://img.federalregister.gov/EP16JN26.006/EP16JN26.006_original_size.png"},"EP16JN26.005":{"large":"https://img.federalregister.gov/EP16JN26.005/EP16JN26.005_large.png","medium":"https://img.federalregister.gov/EP16JN26.005/EP16JN26.005_medium.png","original_size":"https://img.federalregister.gov/EP16JN26.005/EP16JN26.005_original_size.png"}},"images_metadata":{"EP16JN26.007":{"large":{"identifier":"EP16JN26.007","content_type":"image/png","size":15270,"width":823,"sha":"eb5aa6090b3c32e0a480c0ae6634dbf8","url":"https://img.federalregister.gov/EP16JN26.007/EP16JN26.007_large.png","height":384},"medium":{"identifier":"EP16JN26.007","content_type":"image/png","size":6618,"width":518,"sha":"8b5c37562bed19338009c7ddb5616f9e","url":"https://img.federalregister.gov/EP16JN26.007/EP16JN26.007_medium.png","height":242},"original_size":{"identifier":"EP16JN26.007","content_type":"image/png","size":15361,"width":1954,"sha":"d1227f94349cfe33bcafd48ade382ce9","url":"https://img.federalregister.gov/EP16JN26.007/EP16JN26.007_original_size.png","height":911}},"EP16JN26.006":{"large":{"identifier":"EP16JN26.006","content_type":"image/png","size":31797,"width":823,"sha":"f928848dc2465ed65bb843bdea840d61","url":"https://img.federalregister.gov/EP16JN26.006/EP16JN26.006_large.png","height":435},"medium":{"identifier":"EP16JN26.006","content_type":"image/png","size":8531,"width":509,"sha":"a3c8e1f6959d9a5f933c5466365496ef","url":"https://img.federalregister.gov/EP16JN26.006/EP16JN26.006_medium.png","height":269},"original_size":{"identifier":"EP16JN26.006","content_type":"image/png","size":51680,"width":1927,"sha":"ed281050d3e487c9c97c4efc8a37692d","url":"https://img.federalregister.gov/EP16JN26.006/EP16JN26.006_original_size.png","height":1018}},"EP16JN26.005":{"large":{"identifier":"EP16JN26.005","content_type":"image/png","size":44881,"width":823,"sha":"40614279d7b5b7e25a70b8a7455679d8","url":"https://img.federalregister.gov/EP16JN26.005/EP16JN26.005_large.png","height":364},"medium":{"identifier":"EP16JN26.005","content_type":"image/png","size":17369,"width":574,"sha":"ce078631c20eca99d304858e301600ff","url":"https://img.federalregister.gov/EP16JN26.005/EP16JN26.005_medium.png","height":254},"original_size":{"identifier":"EP16JN26.005","content_type":"image/png","size":98141,"width":2167,"sha":"4387ab9c67d00b8d59067d89cfad4573","url":"https://img.federalregister.gov/EP16JN26.005/EP16JN26.005_original_size.png","height":959}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-12059?publication_date=2026-06-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-16/2026-12059/mods.xml","not_received_for_publication":null,"page_length":133,"page_views":{"count":4883,"last_updated":"2026-07-27 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-16/pdf/2026-12059.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12059.pdf?1781295308","publication_date":"2026-06-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/16/2026-12059.txt","regulation_id_number_info":{"0938-AV90":null},"regulation_id_numbers":["0938-AV90"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":21,"agency_id":"CMS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CMS-2026-2080","supporting_documents_count":0,"docket_id":"CMS-2026-2080","document_id":"CMS-2026-2080-0001","regulation_id_number":"0938-AV90","title":"Medicare Drug Price Negotiation Program (CMS-4215-P)","checked_regulationsdotgov_at":"2026-07-27T11:55:03Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/CMS-2026-2080-0001","significant":null,"signing_date":null,"start_page":36236,"subtype":null,"title":"Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program","toc_doc":"Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program","toc_subject":"Medicare Program","topics":["Administrative practice and procedure","Biologics","Health facilities","Medicare","Penalties","Prescription drugs","Privacy","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":91}