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The future of crypto ETPs
The regulatory landscape for crypto exchange-traded products (ETPs) is changing rapidly, placing new demands on legal leaders and compliance teams.
United States | Publication | August 2025
The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo, marked a significant shift in administrative law by overruling the longstanding Chevron deference doctrine. While the full impact of Loper Bright on agency rulemaking, particularly in the healthcare sector, remains to be seen, early trends are emerging in federal trial and appellate courts. This alert examines developments in healthcare cases since Loper Bright and key considerations for healthcare organizations and related entities.
In Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), the Supreme Court held that courts must exercise independent judgment when interpreting statutes administered by agencies. While courts may still consider agency expertise, they are not required to defer to agency interpretations simply because a statute is ambiguous. The Supreme Court emphasized that agency views may be persuasive, but only to the extent justified by their reasoning and consistency. This decision overruled forty years of the two-step framework established in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).
Under Chevron’s two-step framework for reviewing an agency’s interpretation of a statute, courts first determined whether Congress had directly addressed the specific question at issue. If Congress’s intent was clear in the statute, courts rejected any administrative interpretation that conflicted with that intent. If the statute was silent or ambiguous, courts deferred to the agency’s interpretation, provided it was based on a permissible construction of the statute. Critics argued that this approach led to inconsistent application of the law and allowed agencies to overstep their authority.
Before Chevron, courts applied the more limited Skidmore deference, under which agency rulings, interpretations and opinions, while not controlling, constituted a body of experience and informed judgment to which courts could look for guidance. The weight given to such judgment depended on several factors including thoroughness, validity and consistency. Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).
Justice Elena Kagan’s dissent in Loper Bright specifically addressed the anticipated increased role courts will play in federal healthcare policy: “Courts [will] have more say over regulation—over the provision of health care, the protection of the environment, the safety of consumer products, the efficacy of transportation systems and so on.” A recent ruling from the US District Court for the District of Maine illustrates how longstanding regulations may be disrupted, with implications for healthcare stakeholders.
In the case of Duffus v. MaineHealth, No. 2:24-cv-00268-SDN, 2025 WL 1928339 (D. Me. July 14, 2025), the court examined a longstanding CMS interpretation under the Emergency Medical Treatment and Labor Act (EMTALA). The plaintiff, a Jamaican citizen in the US on a work visa, suffered a hemorrhagic stroke and was admitted as an inpatient at Maine Medical Center. After a 12-day inpatient stay, the hospital discharged the plaintiff, who alleged that this violated EMTALA’s statutory requirement that a patient be stabilized before being transferred. The hospital sought to dismiss the case, relying on CMS’s regulation that EMTALA’s stabilization requirement is automatically satisfied when a patient is admitted in good faith as an inpatient. See 42 C.F.R. § 489.24(d)(2)(i). The court disagreed holding that the regulation exceeded CMS’s statutory authority. Relying on Loper Bright. the court found that:
EMTALA's text is clear. The stabilization requirement means that a hospital must provide treatment as required to stabilize a patient's medical condition before transfer. The transfer restriction means that a hospital may not transfer a patient until it actually stabilizes a patient's emergency medical condition. A hospital's decision to admit the patient has no effect on EMTALA's statutory requirements.
(emphasis added). Duffus, 2025 WL 1928339 at *18. This case illustrates the potential for disruption of longstanding precedent and polices that in turn will require significant and potentially costly changes in operations for hospitals.
Some courts are turning to Skidmore for guidance in evaluating agency interpretations they find persuasive. Notably, the Supreme Court cited Skidmore several times in Loper Bright, highlighting that courts and litigants may consider an agency’s interpretations and opinions based on specialized experience. The Supreme Court noted that in agency cases, courts will “go about [their] task with the agency’s ‘body of experience and informed judgment,’ among other information, at [their] disposal.” Id. at 402, quoting Skidmore. The agency’s expertise gives its interpretation the “power to persuade, if lacking power to control.” Id. quoting Skidmore.
District court cases decided before Loper Bright or during litigation when Loper Bright was decided are shifting course, especially where the agencies relied heavily on Chevron deference.
Despite some political calls to challenge regulations upheld under Chevron, courts appear reluctant to revisit settled matters absent other grounds.
Courts will continue to consider agency expertise, but only to the extent the agency’s reasoning is thorough, valid and consistent. As ongoing litigation demonstrates, courts are now demanding more than just an agency’s endorsed interpretation or a reading of the statute that is merely permissible. Healthcare organizations should ensure that any agency guidance they rely on is well-supported and carefully reasoned.
Generally, courts are not allowing parties to relitigate cases settled before Loper Bright because of reliance on Chevron deference, offering a measure of stability for healthcare stakeholders who depend on established interpretations of the law. However, as demonstrated in Duffus, consistent agency interpretation may not be enough to protect longstanding regulations from being reexamined.
Agencies perceived as aggressive in their policymaking may encounter greater challenges, with courts subjecting their actions to heightened scrutiny. While increased oversight could slow the pace of regulatory change, it may also result in greater consistency and predictability.
Our team of experienced lawyers and professionals at Norton Rose Fulbright will be closely monitoring trends in agency rulemaking after Loper Bright. If you have any questions, please do not hesitate to contact us.
Publication
The regulatory landscape for crypto exchange-traded products (ETPs) is changing rapidly, placing new demands on legal leaders and compliance teams.
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