On May 8, 2019, the Centers for Medicare and Medicaid Services (CMS) released a final rule to require direct-to-consumer (DTC) television advertisements for prescription drug and biological products distributed in the United States and covered by Medicare or Medicaid to include the list price of the product if the price is $35 or more based on a one-month supply or the usual course of therapy. The final rule, which is scheduled to become effective on July 9, 2019, was finalized largely as proposed with only minor modifications and technical changes.
The final rule represents the first regulatory action that the Trump Administration has finalized following release of the Department of Health and Human Services (HHS) Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs in May 2018. In a press release accompanying the final rule, HHS noted that it is considering stakeholder comments on a number of recent proposed rules that aim to address “opaque systems” and “perverse incentives.” Accordingly, industry stakeholders should be actively preparing for significant regulatory actions in the near term that could affect the drug supply chain and market access.
Below is an overview of key provisions of the final rule.
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