Health and Human Services Secretary Nomination

This week, the nomination of Representative Tom Price (R-GA) to lead the Department of Health and Human Services was confirmed by the Senate.  His confirmation may signal that the Administration will take a more active role in discussions around changes to the Affordable Care Act (ACA).  President Trump has previously stated that any replacement for the ACA would wait until Dr. Price was confirmed.

340B

The Federal Office for Management and Budget (OMB) has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program, creating further uncertainty about the 340B Program. The guidance was first proposed in the Fall of 2015 and was meant to update all areas of the program guidance.  In particular, the guidance was believed to have included significant changes to the definition of an “eligible patient.”  NCSD submitted comments responding to this draft guidance and rumors were that the Office of Pharmacy Affairs (OPA) was working on releasing final guidance late last year.  By withdrawing the guidance, OMB indicates that the guidance will not be adopted as it was previously proposed. Also impacting the 340B program is the Executive Order by President Trump on January 30th, “Reducing Regulation and Controlling Regulatory Costs,” that requires for every new regulation proposed, there must be two regulations repealed.  This will greatly impact OPA’s ability to issue new guidance for the regulation of the 340B program.

FY 2018 Administration Budget Proposal

White House Press Secretary Sean Spicer stated this week, the Administration will be releasing a “skinny budget” proposal for FY 2018 in the coming weeks.  The “skinny budget” is a term used to describe the budget request outline that new administrations often send to Congress their first year in office to get the budget process started; this document does not contain a lot of detail.  There had been previous statements this week that perhaps the Administration would forego submitting this shorter document.  A more in-depth FY 2018 proposal is not expected from the Administration until April or May.