How Health-Care Regulatory Issues May Unfold in a Biden Administration

Bloomberg Health Law & Business News

Philo D. Hall and Robert E. Wanerman, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Bloomberg Health Law & Business News, titled “How Health-Care Regulatory Issues May Unfold in a Biden Administration.”

Following is an excerpt:

Any presidential transition is exciting for federal regulatory attorneys as new agency policymakers potentially take regulatory law down new or different paths. Given the prominent role of health-care issues during the pandemic and presidential campaign, it is useful to understand the tools available immediately to a new Biden administration to shape regulatory policy.

These tools can complement the traditional notice-and–comment rulemaking that can take months or years to complete, and will give important policy signals to providers, manufacturers, suppliers, health plans, consumers, and other interested parties.

Repealing or Revising Executive Orders

Although executive orders have the force of law if issued under a valid claim of constitutional or statutory authority, unlike statutes or regulations they can be revoked or modified at any time. Most contemporary health-care EOs do not alter regulations themselves, but direct agencies in their application or enforcement of regulations.

President Trump issued several health-care EOs directing actions to be taken by the secretary of HHS: reforming Medicare through “market-based approaches” (October 2019); drug importation and ending drug rebates (July 2020); “most-favored-nation prices” for Medicare Part B drugs (September 2020); and the Medicare Hospital Compare website (September 2020). These EOs will likely be repealed or revised in January or February to allow the Biden administration more latitude to set its own policy.