News & Analysis as of

Enforcement Actions Appeals Healthcare Fraud

King & Spalding

The Fourth Circuit Rejects a Non-Delegation Doctrine Challenge to the Anti-Kickback Statute

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On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more

King & Spalding

Ninth Circuit Decision Clarifies EKRA Enforcement

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On July 11, 2025, the Ninth Circuit issued a decision clarifying the scope of Eliminating Kickbacks in Recovery Act (EKRA). In affirming a Northern California-based medical testing laboratory’s convictions under EKRA, the...more

A&O Shearman

Pharma company challenges the US False Claims Act: what’s at stake for whistleblowers and government enforcement?

A&O Shearman on

A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the US False Claims Act (FCA) is unconstitutional. This case, now before the Court of Appeals for the...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...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

Polsinelli

EKRA Gets Teeth: Ninth Circuit Strengthens EKRA Enforcement in Schena Ruling

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Key Takeaways - First Appellate Interpretation of EKRA: The Ninth Circuit’s decision in United States v. Schena marks the first appellate court interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), affirming...more

Epstein Becker & Green

CMS Doubles Down on Medicare Advantage Recoupment: Announces Aggressive RADV Strategy to Reclaim Billions

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On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced an aggressive plan (Plan) to expand its efforts to address fraud, waste, and abuse in Medicare Advantage (MA)....more

Morgan Lewis

Seventh Circuit Overturns AKS Conviction in DME Marketing Case

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The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

Foley & Lardner LLP

Health Care Marketing: The Seventh Circuit Addresses “Referrals” Under The Anti-Kickback Statute

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Health care organizations working with marketers, independent sales representatives, advertising, and other consulting support to promote sales of products or services received welcomed news that their arrangements may be...more

McDermott Will & Schulte

CMS Poised for Medicare, Medicaid Integrity Enforcement Actions

The Trump administration and 119th Congress are preparing to reduce federal expenditures by targeting Medicare and Medicaid fraud, waste, and abuse. Medicare enrollment revocations, Medicaid enrollment terminations, and...more

Harris Beach Murtha PLLC

First Circuit Decision Raises Bar on Anti-Kickback Statute-Premised Liability Under the False Claims Act

The United States Court of Appeals for the First Circuit recently joined the Sixth Circuit (2023) and Eighth Circuit (2022) in holding that the term “resulting from” in the Federal Anti-Kickback Statute (“AKS”) (as amended in...more

Bradley Arant Boult Cummings LLP

First Circuit Joins Other Circuits in Adopting Stricter Causation Standard in FCA Cases Based on Anti-Kickback Statute

On February 18, 2025, the First Circuit joined the Sixth and Eighth Circuits in adopting a “but for” causation standard in cases involving per se liability under the federal Anti-Kickback Statute (AKS) and the False Claims...more

Robinson+Cole Health Law Diagnosis

First Circuit Makes Historic Decision: “But-For” Causation is the Majority Standard in AKS-Based FCA Claims

In a much-anticipated decision, the First Circuit unanimously ruled the government and relators must prove that a violation of the federal Anti-Kickback Statute (AKS) was the “but-for” cause of a false claim under the False...more

Goodwin

First Circuit Adopts Defense-Friendly “But-For” Causation Standard for AKS-Predicated FCA Claims

Goodwin on

In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more

Foley & Lardner LLP

Anti-Kickback Statute Premised False Claims Cases: The “But For” Causation Standard Finds Support from First Circuit

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It’s now 3–1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words “resulting from” — as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS)...more

Patterson Belknap Webb & Tyler LLP

The Fourth Circuit Broadly Interprets “Inducement” and “Remuneration” Under the Anti-Kickback Statute and Creates a Circuit Split

On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Foley & Lardner LLP

FCA Enforcement: Eighth Circuit Requires But-For Causation for Anti-Kickback FCA Violations

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The Eighth Circuit Court of Appeals’ recent ruling in United States ex rel. Cairns v. D.S. Med., LLC is a significant win for defendants facing False Claims Act (FCA) claims based on alleged violation of the Anti-Kickback...more

The Volkov Law Group

2021 False Claims Act Year in Review: Judicial and Congressional Developments (II of II)

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As for the Judiciary, the U.S. Supreme Court did not issue any relevant decisions nor grant certiorari in any notable FCA cases in FY21. To the contrary, they denied petitions to review appellate cases of potential...more

Bass, Berry & Sims PLC

Courts Grapple with Causation Requirement in FCA Cases Based on Violations of Anti-Kickback Statute

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Congress amended the Anti-Kickback Statute (AKS) in 2010 to confirm that a claim “resulting from” an AKS violation constitutes a false or fraudulent claim for purposes of the FCA. 42 U.S.C. 1320a-7b(g). However, Congress did...more

Morgan Lewis - Health Law Scan

Mere Differences of Judicial Opinion Emerge to Muddle Healthcare Providers False Claims Act Exposure for Mere Differences of...

In the Care Alternatives False Claims Act (FCA) appeal, a panel of the US Court of Appeals for the Third Circuit on March 4 reversed the summary judgment granted to hospice provider Care Alternatives at the district court,...more

Bass, Berry & Sims PLC

FCA Medical Necessity Cases May Stand on Firmer Footing After Recent Appellate Decisions

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In recent years, healthcare providers have increasingly faced civil and criminal enforcement actions premised on the allegation that services billed to government healthcare programs were not medically necessary. As a result,...more

Dorsey & Whitney LLP

Tuomey Settles, Post-Judgment, Alleged Violations of FCA and Stark Law

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The Department of Justice and Tuomey Healthcare have announced a $72.4 million settlement in a lawsuit that the DOJ touts as “another achievement for the [DOJ and DHS] Health Care Fraud Prevention and Enforcement Action Team...more

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