HRSA Issues Long-Awaited 340B Mega-Guidance; HP&M Issues Summary

By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons –

On August 28, 2015, the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services published an omnibus guidance document to implement the 340B Drug Discount Program (the Proposed Guidance).

Since the inception of the 340B Program in 1992, HHS has implemented the program by issuing a series of guidances on various topics, typically after notice and comment.  The new Proposed Guidance accomplishes the dual purpose of consolidating and updating the previous guidances and implementing a number of program integrity mandates added to the 340B statute by the Patient Protection and Affordable Care Act in 2010.  As reported in this blog, the Proposed Guidance was initially intended to be issued as a regulation, but, before publication, HRSA transformed it into a guidance following a federal district court ruling, in a case involving a related 340B regulation, that HRSA has statutory authority to issue regulations only in specific, narrowly defined areas. 

The Proposed Guidance provides HRSA’s interpretation of the 340B statute, along with implementing policies, in a number of key areas: 

A.        340B Program eligibility and registration

B.        Drugs eligible for purchase under the 340B program

C.        Individuals eligible to receive 340B drugs

D.        Covered Entity responsibilities

E.         Contract pharmacy arrangements

F.         Manufacturer responsibilities

G.        Rebate option for AIDS Drug Assistance Programs

H.        HHS audits of Covered Entities and manufacturers, and manufacturer audits of Covered Entities

You will find here our memorandum summarizing the Proposed Guidance in each of these areas.