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@Regulatory: April 2013

Preparing for 340B drug discount audits


The 340B Drug Discount Program (the “Program” or “340B”) has experienced significant growth and increased usage by both hospitals and contract pharmacies. Findings from the Government Accountability Office’s (GAO) first report on 340B, issued in September 2011 and mandated by the Patient Protection and Affordable Care Act (PPACA), concluded that too much reliance has been placed on program self-policing.1 These inquires have led HRSA to take a more active oversight role in determining program integrity. Now more than ever, it is imperative that organizations participating in the 340B Program have processes in place to ensure compliance with program requirements. Participant integrity, compliance and accountability is vital for continued success. In this issue of @Regulatory, understanding the compliance risks, Program requirements and necessary steps to maintain compliance is provided.

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For previous issues of the newsletter, visit the archive page.

1GAO Report to Congressional Committees - Drug Pricing - Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement, September 2011,

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