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On June 26, 2025, the U.S. Supreme Court held that Medicaid beneficiaries have no recourse under 42 U.S.C. § 1983 (Section 1983) to enforce their right under the Medicaid Act to receive care from any qualified provider of their choice. The decision in Medina v. Planned Parenthood South Atlantic, No. 23-1275, 606 U.S. ___ (2025) resolves a circuit split and has broad implications for private enforcement of federal spending statutes, particularly in the Medicaid context.

Case Background

In July 2018, South Carolina’s governor issued an executive order prohibiting clinics that render abortion services from participating in the state’s Medicaid program, even if they provide other types of covered services in addition to abortions. Planned Parenthood, along with patient Julie Edwards, sued the state, claiming that the exclusion violates the “any-qualified-provider” provision in the Medicaid statute. That provision requires states to ensure that “any individual eligible for medical assistance . . . may obtain” it “from any [provider] qualified to perform the service . . . who undertakes to provide” it. 42 U.S.C. § 1396a(a)(23)(A). The plaintiffs brought a class action under Section 1983, which allows private parties to sue state actors who violate their “rights” under the federal “Constitution and laws.” The state argued that federal statutes, like Medicaid, do not automatically confer enforceable “rights” under Section 1983.Continue Reading Supreme Court Says Beneficiaries Have No Section 1983 Private Right of Action to Enforce Medicaid Provider Choice Provisions

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion regarding whether a proposed patient assistance program (“PAP”) would run afoul of Federal antifraud statutes.

Under the proposed PAP, a nonprofit organization would subsidize certain cost-sharing obligations for low-income Medicare enrollees who have diabetes and reside in a specified rural area. Although the PAP displayed the potential for the generation of prohibited remuneration and did not fall under a safe harbor for either the Federal Anti-kickback Statute (AKS) or the beneficiary inducement provisions of the Civil Monetary Penalties statute (CMP), OIG stated that it would not impose administrative sanctions on the requesting entity.

While this advisory opinion is only applicable to the specific program at issue and can only be relied upon by the requestor, there are some potential considerations that could be applied more broadly to other arrangements.Continue Reading HHS OIG won’t enforce antifraud statutes against patient assistance program

Note: This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity.

The Food and Drug Omnibus Reform Act of 2022 (FDORA) signed by President Biden on December 29, 2022, introduced significant changes to the way in which FDA will provide oversight for clinical trials as it pertains to “Clinical Trial Diversity and Modernization.” Under FDORA, among other things, FDA is required to issue guidance on decentralized clinical trials (which is a clinical trial in which some or all trial-related activities occur at a location separate from the investigator’s location) and to provide clarification on the use of digital health technologies (DHTs) in clinical trials.

Prior to the passage of FDORA, FDA set its sights on DHTs in the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, acknowledging the increased use of DHTs in drug development and the need for appropriate internal expertise and external guidance for their use and evaluation.Continue Reading New Opportunities, New Challenges: FDA Elaborates on use of Digital Health in Drug and Biological Product Development