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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. The thirty-day public comment period ends on March 11, 2023. Is the Guidance Final or Open to Comment? Interestingly, the answer is – both. 9, 2023). [2] 11] See DOJ Press Release No. 17-921 (Aug.

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Healthcare Reforms Under the IRA: Expanding Access to Care

Sheppard Health Law

With respect to biological products, however, such drugs must be licensed in accordance with the Public Health Service Act (“PHSA”) for at least 11 years, and marketed in conformance with the PHSA. A safe harbor applicable to flat fee arrangements paid by pharmaceutical manufacturers directly to PBMs for PBM services.