News & Analysis as of

Healthcare Enforcement Actions

Sheppard Mullin Richter & Hampton LLP

Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

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On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

Greenbaum, Rowe, Smith & Davis LLP

Navigating New Jersey’s Medical Spa Regulatory Landscape: Key Compliance and Risk Management Considerations

The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses,...more

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

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The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

Herbert Smith Freehills Kramer

No Rest for the Caretakers: Health Care Industry in Crosshairs for Expanded False Claims Act and Criminal Enforcement Activity

The health care industry – already bracing for the financial impact of Medicaid cuts – faces another hard truth: This administration isn’t slowing the pace of health care fraud enforcement. Rather, it’s doubling down on...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

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In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Rivkin Radler LLP

NY Medical Transport Owner Sentenced for Medicaid Fraud

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The owner of Sublime Medical Transportation in Schenectady County, New York was recently sentenced to three to nine years in state prison for orchestrating a large Medicaid fraud scheme. Muhammed Adnan Saeed netted over...more

Cozen O'Connor

The State AG Report – 07.17.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Have You Looked at Who is Coming to Dinner and How It Impacts Your Compliance?

Several States' Attorneys General reported resolving a case alleging that Gilead Sciences ran an illegal kickback scheme to promote the use of its HIV medications. The government alleged that Gilead utilized various methods,...more

Phelps Dunbar

Trump Administration Bolsters FCA Health Care Fraud Enforcement With New DOJ-HHS Working Group

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Emphasizing its commitment to enforcing the False Claims Act (FCA) and combating health care fraud, the Trump Administration recently instituted a DOJ-HHS False Claims Act Working Group dedicated to “combating health care...more

Davis Wright Tremaine LLP

Healthcare Industry in the Crosshairs at DOJ and HHS

Any suggestion that the Trump Administration might not be committed to healthcare fraud enforcement was definitively quashed by two recent developments. First, on July 2, 2025, the U.S. Department of Justice (DOJ) and the...more

Ballard Spahr LLP

Courts Split on Enforcement of No Surprises Rules

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The Fifth Circuit and the Federal District Court of Connecticut have issued conflicting decisions on whether service providers may sue to enforce arbitration awards under the No Surprises Rules in the Consolidated...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Troutman Pepper Locke

New York AG Intensifies Investigation and Enforcement Against Alleged Medicaid Fraud

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On June 30, 2025, New York Attorney General (AG) Letitia James announced new lawsuits, criminal charges, and settlements with 25 New York transportation companies related to alleged schemes to defraud Medicaid of millions....more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

King & Spalding

Trump Administration Revamps Working Group to Focus on False Claims Act

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On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a...more

Foley & Lardner LLP

Gender-Affirming Care: Key Takeaways from FTC’s July 2025 Workshop on Unfair Or Deceptive Trade Practices

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On July 9, 2025, the Federal Trade Commission (FTC) hosted a workshop focused on perceived “dangers” arising from unfair or deceptive trade practices in marketing a variety of health care services falling under the label of...more

Epstein Becker & Green

Latest Moves by Federal Agencies Regarding Gender-Affirming Care: Risks Mount for Providers

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Since day one, a policy priority of the Administration has been to discourage and prevent gender-affirming care for children and adolescents that involves surgery or medication....more

Alston & Bird

Getting the Band Back Together: DOJ and HHS Launch New False Claims Act Enforcement Working Group

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The Department of Health and Human Services and the Department of Justice have formed a False Claims Act (FCA) enforcement working group to target health care fraud. Our Health Care Litigation Group highlights what industry...more

Sheppard Mullin Richter & Hampton LLP

DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more

Shipman & Goodwin LLP

A Balancing Act: Privacy Issues And Responding to A Federal Subpoena Investigating Transgender Care

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On Wednesday, July 9, 2025, the United States Department of Justice (“DOJ”) issued more than 20 subpoenas to physicians and clinics (the “Providers”) who provide gender-affirming care to transgender youth. According to the...more

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