Chevron ruling underscores companies' need for updated regulatory strategy

On June 28, 2024, the Supreme Court voted to overturn “Chevron deference,” a longstanding precedent that compelled federal courts to defer to administrative agencies’ interpretations of statutes that Congress directed the agency to implement and expand on. The ruling, Loper Bright Enterprises v. Raimondo, held that courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, and courts can’t defer to an agency's interpretation of law simply because the statute is ambiguous.

Our view is that Loper Bright Enterprises marks an important change in administrative law, but that it will likely take time and further litigation to understand the full, practical implications. Here are our initial observations.

  • Chevron is explicitly overruled. 
  • The decision is prospective, only. The Court makes clear that prior decisions relying on Chevron are still good law and “are still subject to statutory stare decisis despite our change in interpretive methodology.”
  • Courts can still rely on agency interpretations for guidance. An agency’s interpretation of a regulation constitutes “a body of experience and informed judgment to which courts and litigants may properly resort for guidance” and, when an issue is technical, the agency’s opinion may “have particular power to persuade.”
  • Congress can require courts to defer to agency interpretations. Congress can include in statutes a requirement that courts defer to agency interpretations, in the manner of Chevron.
  • Agency “policymaking” and “fact finding” actions remain subject to deferential standards under the Administrative Procedures Act. It’s not clear from the opinion exactly how courts will draw the lines between interpretation, policymaking and fact finding. Those distinctions will be important going forward and likely subject to further litigation.

Potential impact and takeaways

What should companies do?

For most organizations, there are no significant, immediate impacts from the decision, but the likelihood of increased litigation and courts scaling back agency authority presents an uncertain future of regulatory change and jurisdictional inconsistency. In response, companies should consider taking several proactive steps.

1. Assess the key regulations that impact your organization

Inventory the regulations that are important to your business. Ask your legal team to identify which ones have not been previously reviewed or approved under Chevron and might now be more subject to court challenge. Then decide which of those regulations are harmful (or helpful) to your organization’s interests and prioritize them for potential action.

Considerations for sectors and executives

As a highly regulated industry, healthcare oversight relied heavily on the legal principle of Chevron deference as it underpinned the current framework of agency rulemaking from CMS to FDA and Federal Trade Commission (FTC). It is embedded into regulatory topics as wide ranging as product development and approval to reimbursement, coverage and administration of Medicare and Medicaid. Beyond this, Chevron deference also played a key role in current oversight of fraud and abuse laws such as Stark, Anti-kickback and False Claims Act.

Within these broad regulatory frameworks, the healthcare sector has its share of contested policies. While past court decisions that relied on Chevron will not be called into question, this does not limit the ability for new cases to be brought forth on topics such as the annual Medicare payment rules, FDA exclusivity policies, IRA price negotiations, quality ratings and the 340B program, among others. Litigants may also seek to bring forth cases regarding nondiscrimination rules, coverage for preventative services or FDA’s recent rulemaking regarding lab developed tests.

Health industry leaders should be prepared for new litigation of these contested policies with particular attention on decisions that do not implicate agency expertise and are not scientifically focused. These will be policies that focus more on legal or factual questions of interpreting statute into rulemaking.

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