In February 2026, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued its highly anticipated Industry Compliance Program Guidance for Medicare Advantage (MA ICPG), the first such compliance guidance for the MA industry in over 25 years. The MA ICPG is the second industry segment-specific compliance guidance published in a series
CMS Reaches $100 Million in Stark Self-Disclosure Settlements
The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2025 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark Law). Generally, two notable items arise from our annual review of CMS’ settlement data. First, CMS has now reported aggregate settlements reaching $105,090,031.
Ninth Circuit Ruling in FCA Case Predicated on 340B Pricing Violations Has Significant Implications for Pharma Manufacturers
On March 17, 2026, the United States Court of Appeals for the Ninth Circuit issued a significant opinion in United States ex rel. Adventist Health System of West v. AbbVie Inc., [1] reversing the district court’s dismissal of a qui tam complaint brought under the False Claims Act (“FCA”) against four major drug manufacturers. The
HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch
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
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