Relevant to: Drug Manufacturers
In August 2022, President Biden signed the Inflation Reduction Act (IRA) of 2022 (P.L. 117-169) into law. The IRA authorizes Medicare to directly negotiate prices for certain high expenditure, single source drugs covered under Medicare Part B or Part D. As instructed by section 1192(a)(1) of the Social Security Act (the Act), the Centers for Medicare and Medicaid Services (CMS) will announce up to 10 drugs selected for negotiation by September 1, 2023. Manufacturers of selected drugs who choose to participate in the Medicare Drug Price Negotiation Program (Negotiation Program) have a statutory deadline to enter into a Medicare Drug Price Negotiation Program Agreement (Agreement) by October 1 and submit certain information by October 2 as described in the revised guidance published on June 30, 2023. These actions will take place in the CMS Health Plan Management System (CMS HPMS), so manufacturers may wish to ensure they have the proper user permissions in place in the CMS HPMS by September 1 in the event that one of the manufacturer’s drugs is selected for participation in the Negotiation Program, since adding new users or changing user permissions can take several days.