{"abstract":"On April 6, 2004, we published an interim final rule in the Federal Register implementing the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) related to the calculation and submission of manufacturer's average sales price (ASP) data on certain Medicare Part B drugs and biologicals by manufacturers. This final rule responds to the public comments received on the interim final rule concerning the methodology for estimating price concessions associated with manufacturers' ASP reporting requirements. Other issues and comments relating to the interim final rule will be addressed at a future time.","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/2004/09/16/04-20823.html","cfr_references":[{"chapter":null,"citation_url":null,"part":414,"title":42}],"citation":"69 FR 55763","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These regulations are effective September 16, 2004.","disposition_notes":null,"docket_ids":["CMS-1380-F"],"dockets":[],"document_number":"04-20823","effective_on":"2004-09-16","end_page":55765,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/09/16/04-20823.xml","html_url":"https://www.federalregister.gov/documents/2004/09/16/04-20823/medicare-program-manufacturer-submission-of-manufacturers-average-sales-price-asp-data-for-medicare","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-20823?publication_date=2004-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-09-16/04-20823/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1733,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-09-16/pdf/04-20823.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/09/16/04-20823.txt","regulation_id_number_info":{"0938-AN05":null},"regulation_id_numbers":["0938-AN05"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T13:25:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55763,"subtype":null,"title":"Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals","toc_doc":"Medicare Part B drugs and biologicals; manufacturer's average sales price data; manufacturer submission","toc_subject":"Medicare:","topics":["Administrative practice and procedure","Health facilities","Health professions","Kidney diseases","Medicare","Reporting and recordkeeping requirements"],"type":"Rule","volume":69}