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

Sheppard Health Law

With respect to the Part D Rebate Program, CMS is also soliciting comments on (i) the extent to which CMS should consider rebatable drugs that are not covered under the Medicaid Drug Rebate Program, and (ii) penalties for manufacturers who fail to pay rebates. The thirty-day public comment period ends on March 11, 2023. 9, 2023). [2]

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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.