United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2004_register executive 2010-09-23 article Rules and Regulations D09002ee1c8134a32 D09002ee1c8134b4a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Centers for Medicare & Medicaid Services originator org United States Government Agency or Subagency 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. 69 FR 55763 https://www.govinfo.gov/app/details/FR-2004-09-16/04-20823 04-20823 fr16se04-10 RIN 0938-AN05 4120-01-P CMS-1380-F https://www.govinfo.gov/app/details/FR-2004-09-16/04-20823 https://www.govinfo.gov/content/pkg/FR-2004-09-16/html/04-20823.htm https://www.govinfo.gov/content/pkg/FR-2004-09-16/pdf/04-20823.pdf Administrative Practice and Procedure Health Facilities Health Professions Kidney Diseases Medicare Reporting and Recordkeeping Requirements 3 p. 55763 55765 69 FR 55763 Title 42 Part 414 42 CFR Part 414 RIN 0938-AN05 Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Federal Register Vol. 69, Issue RULE 04-20823 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 2004-09-16 CMS-1380-F 4120-01-P 04-20823 Final rule.

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.

These regulations are effective September 16, 2004. Marjorie Baldo, (410) 786-0548. Administrative Practice and Procedure Health Facilities Health Professions Kidney Diseases Medicare Reporting and Recordkeeping Requirements Medicare: Medicare Part B drugs and biologicals; manufacturer's average sales price data; manufacturer submission, Vol. 69, no. 179 Office of the Federal Register, National Archives and Records Administration 2004-09-16 continuing daily deposited born digital 230 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-09-16 P0b002ee180978744 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16se04 https://www.govinfo.gov/app/details/FR-2004-09-16 https://www.govinfo.gov/content/pkg/FR-2004-09-16/pdf/FR-2004-09-16.pdf https://www.govinfo.gov/content/pkg/FR-2004-09-16/xml/FR-2004-09-16.xml fdlp 55719 55939 DGPO 2010-09-23 2024-06-06 FR-2004-09-16 machine generated eng FR FR-2004-09-16 69 179