340B Program Restatements and Refunds: A whitepaper by Hogan Lovells and Deloitte Risk and Financial Advisory

It is a time of change in the 340B Program. Manufacturers should closely monitor 340B Program developments and prepare to respond promptly and effectively to changes in legal requirements. This may make it necessary to devote additional resources to 340B Program compliance today.

The effective date of the Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, which was published in January 2017, has been delayed until July 1, 2019, and revisions to that regulation remain possible. In addition, congressional or executive action regarding the 340B Program is possible and could result in further changes to the program that could affect manufacturer compliance obligations.

The whitepaper discusses key elements that manufacturers may want to consider in preparation for future 340B Program requirements related to restatements and refunds, including the impact of Medicaid restatements on 340B ceiling price obligations, trueing-up estimated ceiling prices, and offsetting/applying a de minimis threshold. We hope this whitepaper will help manufacturers plan ahead for possible changes in these areas, particularly as it is never clear how much time manufacturers will have to establish compliance once a new requirement is announced or becomes effective.

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