January 31, 2017—The Department of Health and Human and Human Services has withdrawn the final 340B program mega-guidance from White House review. The Office of Budget and Management announced the action on its Reginfo.gov website.
On Jan. 20, the Trump Administration asked all federal departments and agencies to freeze pending regulations and guidance documents – presumably including the 340B mega-guidance – for review by an administration appointee or designee. Incoming administrations commonly embargo the preceding presidency’s newest and planned rules. Several HHS rules were pending review at OMB at the time. The 340B mega-guidance was the last document of its sort that HHS withdrew from OMB.
Federal agencies must obtain OMB approval to publish regulations or sub-regulatory guidance documents like the mega-guidance in the Federal Register. The Health Resources and Services Administration sent its final mega-guidance to OMB for pre-publication review on Sept. 1.
It is not known what HRSA will do next.
The mega-guidance’s future was clouded even further yesterday when President Trump signed an executive order directing federal agencies to eliminate at least two regulations for each new one promulgated.
In a statement, the association of hospitals in the 340B program, 340B Health said, “This was expected given the president’s request for review of all pending regulations. Our members will continue to follow the rules and use their 340B savings to improve services and care for the underserved.”