Inauguration Day is approaching rapidly, and there will be changes from the Trump Administration that will have major impacts on the healthcare industry.  While some changes will take time to implement since they require a vote by the Senate, we may see a swift set of changes that will not require Congressional intervention. These can occur within agencies that have first time leadership under the new Administration and could also include areas where Trump will be able to take action under Executive orders.

Below are three different areas where the healthcare industry should expect changes that impact them early on in 2017 and 2018. However, keep in mind that other changes could happen as more developments get under way after January 20th.

Food & Drug Administration (FDA)

  • A new FDA Commissioner nomination is expected before January 20th, and who that nominee is will have a big impact on the direction of one of the key healthcare agencies in the US.
  • Jim O’Neill, a potential nominee and current Managing Director of Peter Thiel’s Mithril Capital, is in favor of reducing pre-market effectiveness testing for new drugs and instead limiting pre-market testing to safety only.
  • FDA has extended public comments for the use of the term “healthy” on food packaging which means any changes would come under Trump, who has continuously said he will do whatever he can to reduce business regulations.

Health & Human Services (HHS)

  • Trump has nominated physician and Senator Tom Price as Secretary of HHS, who has gone on record as being sympathetic to physician complaints about the burden related to quality reporting under Medicare, so reductions in those requirements should be expected.
  • Price is in favor of physician specialty groups having more control over the quality measures that they are evaluated against. His proposed ACA repeal bill proposed that federal payment programs could only incorporate quality measures that have been agreed upon by physician specialty groups.
  • Price has strongly opposed using comparative effectiveness research to set payment policy, claiming in 2010 that comparative effectiveness research legislation would strip doctors and patients of the right to make healthcare decisions, creating “a permanent government rationing board” that would prescribe care.
  • The Independent Payment Advisory Board that was commissioned under the ACA is likely to be dissolved, since typically Republicans in Congress have not liked to see outside groups developing policy.

Affordable Care Act (ACA)

  • Republican leaders have made the repeal of President Obama’s signature domestic achievement a top priority, and some of the first steps were taken this week as the Senate struck down Democratic efforts to protect certain parts of the ACA from future repeal as part of budget reconciliation voting.  
  • Trump can use his Executive Branch powers to settle or abandon existing lawsuits on terms less favorable to the ACA’s future, such as House v. Burwell which impacts whether cost sharing subsidy payments to ACA marketplace insurers can be made without an appropriation by Congress.
  • Executive action could be used to change the definition of Essential Health Benefits (EHBs) by directing the Health Resources and Services Administration to remove contraceptive funds from the list, ending the question of the religious exemption. EHBs were defined in regulation based on recommendations from the Institute of Medicine, which could easily be overruled without Congressional intervention.

The potential impact of pending changes will become clearer as the administration transitions and many new leaders can begin working in an official capacity after the inauguration, but one thing we know is that the President-Elect and his nominees for various agency positions will enact changes that impact the health of millions of Americans. Be sure to check out our blog as we continue to write about policy changes that affect healthcare and the digital health landscape.