On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act (FCA). In United States v. Regeneron, the First Circuit held that for a violation of the
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CMS Nearly Doubles Prior Stark Self-Disclosure Dollar Record in 2024
The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2024 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark Law). In 2024, CMS settled an agency record 314 self-disclosures (an amount that the following chart shows towering over other years), with settlement…
Fourth Circuit Upholds OIG Advisory Opinion Process
On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the…
Department of Justice Suggests “Aggressive” Enforcement of False Claims Act
On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active…
D.C. Circuit Prohibits Pro Se Plaintiffs from Bringing FCA Cases
By Timothy Fry & Brett Barnett
In United States ex rel. Feliciano v. Ardoin, the D.C. Circuit joined every other circuit to consider the issue, holding that a pro se litigant cannot bring a False Claims Act (FCA) case. The court’s reasoning was straightforward: FCA claims belong to the government, not the relator. While individuals may represent themselves in legal matters,…
Cautionary Tale: Contractor Settles for $2.6M Over Alleged Falsely Obtained Small Business Contracts
On Jan. 7, 2025, the Department of Justice announced that R&K Enterprises agreed to pay over $2.6 million to resolve allegations under the False Claims Act, 31 U.S.C. §§ 3729-3733, among other causes. The settlement was predicated on allegations that the company represented it was a small business eligible for certain small business set-aside contracts…
OIG Recommends Increased RPM Oversight
On September 24, 2024, the Department of Health and Human Services Office of Inspector General (“OIG”) published a report (the “Report), reviewing and recommending increased oversight of remote patient monitoring (“RPM”) services and billing in the Medicare program. In the Report, OIG focused on three main issues: (1) Patients and providers are not using RPM…
Stark Law Regulations Under the Microscope in a Post-Chevron World
Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file supplemental briefs addressing the U.S. Supreme Court’s decision in Loper Bright Enterprises v. Raimondo. The judge’s order requires the parties to articulate…
Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare
On July 9, 2024, McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (“PE”) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space.…
Federal District Court Finds Private-Insurer Relator Can Proceed with False Claims Action
Last month, the U.S. District Court for the District of New Jersey held that a private company, Allstate Insurance Company, could proceed with its whistleblower action against a clinical laboratory, Phoenix Toxicology and Lab Services, LLC, which allegedly submitted false claims to the federal government for medically unnecessary urine drug tests (“UDT”). See generally United…