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CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

Sheppard Health Law

All rebate payments will be deposited into the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund. Is the Guidance Final or Open to Comment? Interestingly, the answer is – both. Part D inflation rebates are measured on an annual basis, with the first measuring period having begun on October 1, 2022.

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Healthcare Reforms Under the IRA: Expanding Access to Care

Sheppard Health Law

Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation. A safe harbor applicable to flat fee arrangements paid by pharmaceutical manufacturers directly to PBMs for PBM services.