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.

 

button

 

Authored by Alice Valder Curran, Christopher Schott, and Kathleen Peterson

Contacts
Alice Valder Curran
Partner
Washington, D.C.
Christopher Schott
Partner
Washington D.C.
Kathleen Peterson
Counsel
Washington D.C.

 

This website is operated by Hogan Lovells Solutions Limited, whose registered office is at 21 Holborn Viaduct, London, United Kingdom, EC1A 2DY. Hogan Lovells Solutions Limited is a wholly-owned subsidiary of Hogan Lovells International LLP but is not itself a law firm. For further details of Hogan Lovells Solutions Limited and the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses ("Hogan Lovells"), please see our Legal Notices page. © 2020 Hogan Lovells.

Attorney advertising. Prior results do not guarantee a similar outcome.