The End of the Road for HRSA’s 340B Mega Guidance?

A couple of weeks ago, we were in an uncertain landscape. On January 30, 2017, HRSA’s long-anticipated – and much debated — 340B “Mega Guidance” was withdrawn from the White House Office of Management and Budget (OMB). To move forward, the guidance would need to be resubmitted to OMB.

While OMB review was expected to take at least 60 days, with this withdrawal, there is no longer a timeline. It isn’t clear what HRSA’s next step will be. The recent executive order requiring the elimination of two regulations for every new one implemented will make it more difficult for agencies across the board to implement any new regulations. It is now quite possible that the guidance may be unrecognizable when it is resubmitted, or that it may not come at all.

Although the pharmaceutical manufacturers generally supported the Mega-Guidance, some hospitals raised concerns. Moreover, some elected representatives have indicated they believe the 340B Program has grown beyond its original intent, while the new administration has signaled support for mechanisms that would result in lower drug prices.

So once again, we are in the unenviable position of waiting and watching. At CiiTA LLC, we will be keeping our eyes and ears out for any additional information.