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ARTICLE · 23 APRIL 2013

340B Drug Pricing Program: Recent Developments

Foley & Lardner LLP
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The HRSA issued new policy guidance regarding the 340B Program statutory prohibition on certain covered entities obtaining covered outpatient drugs through a GPO.

United StatesFood, Drugs, Healthcare, Life Sciences
Foley & Lardner
Foley & Lardner
Anil Shankar
Anil Shankar
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The 340B Drug Pricing Program (340B Program) continues to undergo a period of intense scrutiny and debate over how compliance with program rules is enforced. As previously reported in the May 30, 2012 edition of Foley's Legal News Alert: Health Care, in 2012 the U.S. Health Resources and Services Administration (HRSA) initiated new enforcement efforts with respect to covered entities participating in the 340B Program in response to scrutiny from drug manufacturers, the Governmental Accountability Office (GAO), and members of the U.S. Congress. These enforcement efforts will be expanded upon in 2013, including increased use of 340B Program audits, increased focus on the Group Purchasing Organization (GPO) prohibition applicable to certain covered entities, and new recertification requirements. HRSA also has begun issuing guidance for covered entities addressing issues raised during the audits, and establishing timetables for covered entities to come into compliance.

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