CMS Seeking Comment: HHS Releases Initial Guidance for Medicare Prescription Drug Inflation Rebate Program

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Under President Biden’s prescription drug law, drug companies will pay rebates to the federal government for raising prescription drug prices faster than the rate of inflation. The Centers for Medicare & Medicaid Services (CMS) released the initial guidance detailing the requirements and procedures for the new program.

Read full details and fact sheets here.

As part of the initial guidance, CMS is seeking comment from the public on key topics, including:

  • the process to determine the number of drug units for rebatable drugs
  • reduction of rebate amounts for certain Part B and Part D rebatable drugs in shortage and in cases of severe supply chain disruptions
  • the process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates
  • assuring accuracy of the inflation rebate payments

Comments must be received by March 11, 2023. More information here.