Age of Loper Bright –Forget Chevron Doctrine

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  • RE Sachs, EC Fuse Brown. NEJM 2024: 391: 777-779. Supreme Power — The Loss of Judicial Deference to Health Agencies
  • YouTube: NEJM Interview Erin Fuse Brown (12 minutes)

Excerpts from this commentary:

  • “On June 28, 2024, the U.S. Supreme Court issued its decision in the companion cases of Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce, overturning the 40-year-old Chevron doctrine. Under Chevron, courts would defer to reasonable agency interpretations of ambiguous statutes.”
  • “Loper Bright will touch every aspect of society, but the potential consequences of putting generalist judges at the center of power are especially troubling for scientific and technical agencies within the Department of Health and Human Services. These implications could include increased litigation and regulatory uncertainty for the health care industry as well as diminished expert authority over the regulation of health care products and services — with heightened risks to patient safety and public health.”
  • For Centers for Medicare and Medicaid Services (CMS): “Well-funded industry actors will now have an incentive to challenge every unfavorable payment rule, hoping to convince a court to adopt their preferred interpretation of a particular statute. The result is likely to be greater uncertainty, more litigation, and generalist judges making consequential and often technical determinations about Medicare payment policies…Well-funded industry actors will now have an incentive to challenge every unfavorable payment rule, hoping to convince a court to adopt their preferred interpretation of a particular statute. The result is likely to be greater uncertainty, more litigation, and generalist judges making consequential and often technical determinations about Medicare payment policies.”
  • For the FDA: “The FDA has had the authority to regulate devices, which are defined by statute to include various types of instruments or other articles, including those that are “intended for use in the diagnosis of disease or other conditions…decision by a court to adopt the industry’s interpretation would hamstring the FDA’s ability to regulate the accuracy of tests that are intended to, for example, detect cancers, enable noninvasive prenatal screening, or identify the presence of a new pandemic pathogen.”
  • “Whereas Chevron favored the government experts charged with administering public programs, Loper Bright favors well-funded industry insiders with the resources to litigate rules that threaten to curb waste, fraud, or abuse. For example, industry-driven litigation has hampered government implementation of the No Surprises Act, which has resulted in far less savings and weaker protections for patients from surprise out-of-network bills than anticipated.”
  • “The net effect of Loper Bright will be to move regulatory policy in an industry-friendly — and in many cases deregulatory — direction, to the detriment of patient welfare, public health, and safety…Disavowing any deference to agency expertise, the Supreme Court has claimed greater authority for generalist judges like themselves to decide whether to allow efforts aimed at “keeping air and water clean, food and drugs safe, and financial markets honest.” In this regard, Loper Bright continues the Court’s assault on administrative authority and scientific expertise.”

My take: By overturning the Chevron doctrine, in the event of legislative ambiguity, technical decisions will be in the hands of judges rather than in those with expertise in the federal agencies. This is going to lead to all sorts of ill-informed policy changes.

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