Overview

The President signed H.R. 1, the One Big Beautiful Bill Act (the “Act”), into law on July 4, 2025. In Section 71113, the Act restricts the flow of Federal Medicaid funds to certain “Prohibited Entities” for the one-year period following its enactment.

Section 71113 puts forth a set of specific criteria. The prohibition applies to any entity—and its affiliates, subsidiaries, successors, and clinics—that: 

  • As of October 1, 2025:
    • Will be an “essential community provider,” as defined by 45 C.F.R. § 156.235, that is primarily engaged in family planning services, reproductive health, and related care;
    • Will be structured as a 501(c)(3) nonprofit organization; and
    • Will provide abortions (except cases involving rape or incest or if the woman’s life is endangered); and
  • Received more than $800,000 in Federal and State Medicaid payments in fiscal year 2023.

The structure of Section 71113 has created considerable uncertainty. The restriction went into effect on July 4, 2025, but requires both a forward-looking assessment of the services a provider will provide as of October 1, 2025, and a backward-looking assessment of how much a provider received in Medicaid payments in 2023. This ambiguity has led to two separate legal challenges in the weeks following the Act’s enactment. As of July 28, 2025, the U.S. Department of Health and Human Services (“HHS”), HHS Secretary Kennedy, the Centers for Medicare and Medicaid Services (“CMS”), and CMS Administrator Oz are enjoined from enforcing, retroactively enforcing, or otherwise applying the provisions of Section 71113 against all Planned Parenthood health care providers pursuant to a preliminary injunction issued by the U.S. District Court for the District of Massachusetts.[1] On July 29, 2025, twenty-one state attorneys general and the Governor of Pennsylvania also filed suit regarding the constitutionality of Section 71113 in the U.S. District Court for the District of Massachusetts.[2]

Continue Reading Legal Challenges to the One Big Beautiful Bill Act’s Restrictions on Federal Medicaid Funding

On June 12, 2025, the Fifth Circuit ruled in Guardian Flight I[i] and Guardian Flight II[ii] that the No Surprises Act (“NSA”) does not confer a private right of action on parties to confirm an  Independent Dispute Resolution (“IDR”) award in court. The Fifth Circuit is the first United States Court of Appeals to weigh in on the issue, which has divided some district courts. On July 11, 2025 the Fifth Circuit denied Appellant’s request for en banc review of the Court’s finding that the NSA lacks a private right of action.[iii] The panel’s ruling is now final and controlling precedent for the Fifth Circuit unless overturned by the Supreme Court.

Continue Reading Not So Surprising: The Fifth Circuit Finds No Private Right of Action in the No Surprises Act

On July 2, 2025, the U.S. Department of Justice (DOJ) Civil Division and the U.S. Department of Health and Human Services (HHS) jointly announced the formation of a False Claims Act (FCA) Working Group. This new initiative underscores a coordinated federal enforcement strategy focused on identifying and addressing fraud in federally funded health care programs, particularly Medicare Advantage and Medicaid managed care. The announcement comes days after Matthew R. Galeotti, Head of DOJ’s Criminal Division, announced the results of the “largest coordinated health care fraud takedown in the history of the Department of Justice”  and the creation of a “Health Care Fraud Data Fusion Center” comprised of data specialists that will “break down information silos, using coordinated data analysis to enable our investigative teams to quickly identify and dismantle emerging fraud schemes.” Taken together, these announcements demonstrate the DOJ’s effort—in both civil and criminal divisions—to strengthen its collaboration with HHS to investigate and prosecute health care fraud.

Continue Reading DOJ and HHS Launch FCA Working Group: Heightened Enforcement Risk for Health Care Entities

Two recent federal cases are providing insight into what to expect in state court litigation related to information blocking, defined in the 21st Century Cures Act (Cures Act) as a practice that interferes with the access, exchange, or use of electronic health information. 

On March 12, 2025, the Fourth Circuit upheld the Maryland District Court’s preliminary injunction for the plaintiff in Real Time Medical Systems Inc. v. PointClickCare Technologies, 131 F.4th 205 (2025).  In sum, the Fourth Circuit agreed with the District Court that PointClickCare’s “use of indecipherable CAPTCHAs and choice to block certain users is illegal under the information-blocking provision of the federal Cures Act, which supports [Real Time’s] unfair competition claims” under Maryland law.  The Fourth Circuit relied in part on Intus Care, Inc. v. RTZ Assocs., Inc., Case No. 24-cv-01132, 2024 U.S. Dist. LEXIS 100190 (June 5, 2024), where a District Court judge found that a violation of the Cures Act would constitute an “independently wrongful” act sufficient to support a claim for intentional interference with prospective economic advantage under California law, even though the Cures Act lacks a private right of action.

Continue Reading Recent Federal Cases on Information Blocking Violations Pave Way for State Court Claims and Shed Light on Manner Exception

The United States Court of Appeals for the Seventh Circuit recently reversed the conviction of Mark Sorensen, the owner of SyMed Inc., a Medicare-registered distributor of durable medical equipment (DME), for alleged violations of the federal Anti-Kickback Statute (“AKS”).  This case, described by the court as one that “tests some of the outer boundaries” of the AKS, highlights the distinction between illegal kickbacks and lawful advertising payments under the AKS.

Continue Reading Seventh Circuit Clarifies Limits on Advertising Payments under the AKS

On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.

Continue Reading HHS Suggests It Will Provide Less Notice and Opportunity for Comment on Grant and Contract Rules

The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged on the meaning of the phrase “resulting from” within the 2010 amendment to the AKS, which provided that a claim that includes items or services “resulting from” a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. The meaning of “resulting from” for purposes of establishing such FCA liability has been hotly debated by courts. The First Circuit now joins the Sixth and Eighth Circuits in adopting this stricter but-for standard, while the Third Circuit has opted for a much looser approach.

This case, United States of America v. Regeneron Pharmaceuticals, Inc., centered on whether Medicare claims for the drug Eylea, which were allegedly influenced by AKS violations through copayment coverages, constituted false or fraudulent claims under the FCA.  On the question of causation under the AKS, Regeneron claimed that the 2010 amendment imposed a “but-for” causation standard and urged the court to adopt the standards applied by the Eight and Sixth Circuits.  Regeneron argued that the government “b[ore] the burden of proving that an AKS violation . . . actually caused [a] physician to provide different medical treatment (and thus caused the false claims).” United States v. Regeneron Pharms., Inc., No. 20-11217, 2023 WL 6296393, at *10 (D. Mass. Sept. 27, 2023).  The government, on the other hand, urged the court to adopt the Third Circuit’s view that the AKS only requires proof of a causal link between a claim submitted to the government and medical care that was provided in violation of the AKS. Id.

The First Circuit’s adoption of the but-for causation standard is expected to have broad implications on the FCA landscape, potentially narrowing the field of actionable claims under the FCA, impacting both the government’s and whistleblowers’ ability to pursue damages for AKS violations that result in false claims to federal healthcare programs.

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On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality. The guidance discusses the use of AI models in the nonclinical, clinical, post-marketing, and manufacturing phases of the drug product life cycle. This is the first time FDA has proposed draft guidance on the use of AI for the development of drug and biological products and may provide insight on how AI models in medical product regulation should be assessed. The FDA is seeking public comment on the proposed guidance by April 7, 2025.     

Continue Reading FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making

Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”).  Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws.  Last week, the United States District Court for the Eastern District of New York dismissed Relators’ case because they failed to plead their allegations with particularity as required by Federal Rule of Civil Procedure 9(b).

Continue Reading Stringent Requirements for Pleading Fraud Under Rule 9(b).

The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals.  The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud under the False Claims Act (FCA) and the Stark Law.

Continue Reading General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss