TO 340B OR NOT TO 340B?
What is the question?
By Cori H. Loomis, JD
Proposed HRSA 340B Mega-Guidance Answers Some Questions
And Raises Others
On August 27, 2015, HRSA released proposed 340B Omnibus Guidance (or “Mega-Guidance”).The Mega-Guidance “proposes guidance for covered entities enrolled in the 340B program and drug manufacturers. . . When finalized after consideration of public comments solicited by [the] notice, the guidance is intended to assist 340B covered entities and drug manufacturers in complying with the [340B] statute.”80 Fed. Reg. 52300.
HRSA is accepting comments on this proposed guidance through October 27, 2015.The proposed Mega-Guidance contains several changes and clarifications that will impact federally qualified health centers (“FQHCs”) if finalized.FQHCs should review the proposed changes to determine if comments should be submitted and to prepare for the changes if implemented.The Mega-Guidance is organized into sections, labeled A-H.Some of the sections are directed to manufacturer requirements or other entities not applicable to FQHCs, and therefore, are not discussed.The sections that are applicable are summarized in the table below.