340B Mega Guidance Withdrawn and Sent Back to HHS

In a move that should surprise no one, the Office of Information and Regulatory Affairs (OIRA) announced that the 340B Program Omnibus Guidelines, aka the 340B Mega Guidance, was withdrawn on January 30th. The proposed rule, which was released in draft form in August  2015, was widely expected to be finalized last December. As a unit of OMB, OIRA speaks directly for President Trump's executive branch.  

As we have written previously, and evidenced by the large number of comments submitted to HRSA, the draft contained a number of controversial provisions. Had the regulation been implemented as originally proposed, significant harm would have been inflicted on FQHCs and other Covered Entities, as well as the vulnerable patients they serve. For more detailed information on issues of concern specifically for FQHCs and Look-Alikes, read FQHC Associates' full analysis of the 340B Mega Guidance.

In the absence of updated regulations, in the near term the 340B program is expected to operate as it has for the last several years. The threatened repeal of the Affordable Care Act raises questions as to whether the expanded 340B provisions of the ACA will survive. These changes led to exponential growth of the program by extending 340B to additional types of safety net providers and allowing multiple contract pharmacies per covered entity.  

We are advising our clients to exercise extreme caution in any 340B-related decisions, particularly those that involve significant expenditure of resources, until the future direction of the program becomes better defined in the weeks and months to come.


Steve Weinman is a Vice President at FQHC Germane, a health care consulting firm specializing in the needs of established, new and potential Federally Qualified Health Centers (FQHCs).

Read more about Steve here.

To contact Steve, email him at sdweinman@fqhc.org.