Tuesday, August 13, 2024

A New Article on Healthcare Policy in a Post-Chevron World (Includes ACLA FDA LDT Lawsuit)

There was no shortage of reactions in the healthcare policy world, to the over-ruling of the "Chevron" principal in June.  (This blog here, Tennessee v Becerrra here, JAMA here, NEJM here, policy associations here, here.)

A new essay on August 8 at the center-right think tank, American Action Forum.  Find it here:

https://www.americanactionforum.org/insight/post-chevron-impacts-on-health-three-case-studies/

The article discusses post-Chevron jurisprudence as it may apply to three cases:

  • How FDA defines "same drug."  (See skirmishes over Lymryz and Xywav for narcolepsy).
  • What is a medical device?  Yes, a discussion of ACLA vs FDA over LDTs.
  • Medicare, Medicaid, and places where statute is "silent."  One discussion area here is CMS, AMA, and RVU's.
The article was an easy read and a worthwhile one.  Here's the closing paragraph.

The Supreme Court’s decision to overturn Chevron deference in Loper Bright v. Raimondo marks a major shift in regulatory oversight within the health care sector. By requiring courts to independently interpret ambiguous statutes, this ruling affects key areas such as drug and device definitions and reimbursement determinations. As a result, Congress now faces the imperative to provide clear legislative guidance and potentially even expand agency authority in technically complex domains to foster effective health care regulation. The outcomes of ongoing legal battles will further shape the future landscape of health care policy and regulation after Chevron.