In advance of the anticipated rollout of the “TrumpRx” website, a platform promising lower-priced drugs sold directly to consumers, the Office of Inspector General of the Department of Health and Human Services released a special advisory bulletin on Jan. 27, 2026, outlining the Federal Anti-Kickback Statute implications for direct-to-consumer drug sales. The OIG concludes that
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OIG Solicits Proposals for AKS Safe Harbors and Special Fraud Alerts
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is accepting public proposals for new or modified safe harbor provisions under the Federal Anti-Kickback Statute, as well as recommendations for new Special Fraud Alerts. The deadline to submit ideas is 5 p.m. ET on February 9, 2026.
OIG Issues Remote Patient Monitoring Report: Billing Pitfalls and Compliance Risks
On August 25, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a report analyzing Medicare billing practices for remote patient monitoring (“RPM”) services during 2024. As RPM technologies have matured and become more accessible, their availability has driven widespread adoption and enhanced patient care by enabling continuous, data-informed
Marketing, Misconduct and Healthcare: Ninth Circuit Issues First EKRA Appellate Ruling
On July 11, 2025, in United States v. Schena, the U.S. Court of Appeals for the Ninth Circuit issued the first appellate decision interpreting the Eliminating Kickbacks in Recovery Act (“EKRA”). The decision marks a significant development in EKRA’s enforcement, as it represents the first time a federal appeals court has addressed EKRA’s reach and
Seventh Circuit Allows Percentage-Based Marketing Relationship
On April 14th, 2025, the U.S. Court of Appeals for the Seventh Circuit reversed the Anti-Kickback Statute (AKS) conviction of Mark Sorensen, the owner and operator of a Medicare-registered durable medical equipment distributor in United States v. Sorensen, 134 F.4th 493, 496 (7th Cir. 2025). The lower court had found that Sorensen’s practice of hiring
$18.5 Million DOJ Settlement On Free Housing For Substance Abuse Patients
On June 26, the Department of Justice announced an $18,500,000 settlement agreement with NUWAY Alliance (NUWAY), a substance use disorder treatment clinic, arising out of medical necessity and kickback allegations. The complaint, filed first in 2021 by a whistleblower and unsealed last month, alleges that NUWAY and its CEO, David Vennes, engaged in a scheme
Defense Contractor, Private Equity Firm to Pay $1.75M to Settle FCA Allegations Regarding Cybersecurity Violations
On July 31, 2025, the U.S. Department of Justice announced a $1.75 million False Claims Act (FCA) settlement with Aero Turbine, a California-based defense contractor, and private equity firm Gallant Capital Partners. The settlement arises out of allegations that Aero Turbine failed to comply with cybersecurity requirements under a U.S. Air Force contract and provided
DOJ Targets Remote Patient Monitoring Company in $1.29M FCA Settlement
Remote patient monitoring (“RPM”) continues to see increased growth and evolution. With that industry growth, the government has begun to examine whether certain RPM models may have fraud and abuse concerns when others will not. To that end, on June 26, 2025, the Department of Justice (“DOJ”) announced that Health Wealth Safe, Inc. (“Health Wealth
DOJ Targets Neurofeedback Billing in $15 Million Behavioral Health Fraud Case
On March 6, 2025, federal prosecutors charged a Minnesota couple with orchestrating a $15 million healthcare fraud scheme involving overbilling and submission of false claims for neurofeedback and other behavioral health services performed by a network of behavioral health clinics. This newly unsealed federal indictment underscores the Department of Justice’s increasing focus on fraud involving
First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard
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