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Developments in the 340B Program - Legal and Strategic Perspectives on Program Integrity, Manufacturer Audits, and the Determination of "Reasonable Cause" for an Audit

March 5, 2013
via Webinar

Arnold & Porter's FDA and Healthcare group and Akara Group invite you to attend a free webinar entitled "Developments in the 340B Program - Legal and Strategic Perspectives on Program Integrity, Manufacturer Audits, and the Determination of 'Reasonable Cause' for an Audit," which will be held live online on March 5 at 12:30 p.m. EST.

The 340B Drug Pricing Program (the "340B Program") requires drug manufacturers to offer significant discounts on outpatient drugs to eligible entities ("covered entities"). Covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements. Covered entities are subject to audit by manufacturers and the Health Resources and Services Administration (HRSA), which administers the 340B Program. Under HRSA's guidance, a manufacturer may initiate an audit only if it is first able to demonstrate "reasonable cause." Given the rapid growth of the 340B Program over the last decade, manufacturers are increasingly interested in auditing covered entities that potentially are not complying with the 340B Program's rules. This webinar will provide legal and strategic perspectives on ensuring integrity within the 340B Program and how manufacturers might demonstrate that there is "reasonable cause" for an audit. CLE credit is pending.

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