HEALTHCARE POLICY FIGURES PROMINENTLY IN $1.7 TRILLION OMNIBUS GOVERNMENT FUNDING BILL

December 21, 2022

Congress is expected to vote this week on a massive omnibus government funding bill that would run through the end of the 2023 fiscal year. The legislative text was released on Tuesday. The $1.7 trillion, 4,155-page bill includes a number of significant healthcare provisions. Of particular interest to the life sciences industry are provisions included in the bill that would:

• Establish requirements for clinical trial diversity (DEPICT Act).
• Establish requirements for medical device cybersecurity. (PATCH Act).
• Reform the FDA accelerated approval drug pathway.
• Strengthen rare disease drug development.
• Delay for one-year Medicare cuts of up to 15 percent for hundreds of clinical laboratory tests that were scheduled to take effect January 1. 
• Strengthen the nation’s response to public health emergencies (PREVENT Pandemics Act).
• Allow predetermined change controls for medical devices.

Notably, the bill does not include the VALID Act for FDA regulation of laboratory developed tests, expanded reporting requirements for medical devices in shortage or the PASTEUR Act – the latter addresses antimicrobial resistance. Also sidelined was a much sought after tax change to restore the full deductibility of R&D expenses. Look for more discussion around these policy priorities next year in the new 118th Congress. The omnibus legislation also provides increased funding for the FDA and the CDC, and appropriated $1B for the Advanced Research Projects Agency or ARPA-H.

The $1.7 trillion package, totals $772.5 billion for non-defense discretionary programs, a $42.5 billion increase over current levels, and $858 billion for national defense, a $76 billion increase over current levels. Democrats will need 10 Republican Senators to pass the omnibus. A number of Republicans in the House and Senate are raising objections to the bill’s size, scope and cost. If passed, the omnibus will be the last item on the agenda of the 117th Congress. The House and Senate will convene on Tuesday, January 3, 2023 to begin the 118th Congress.

Jeffrey J. Kimbell & Associates, a Washington DC-based firm providing policy solutions to clients in the life sciences community, has provided a summary of provisions impactful for the industry.

View a summary of the omnibus bill’s key healthcare provisions from the Senate Finance Committee HERE and from the Senate HELP Committee HERE.

View a topline bill summary HERE.