On May 15, 2026, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 26-11 (the “Opinion”), a favorable opinion for a proposed arrangement that involved providing patients a free supplemental cancer screening report (the “Proposed Arrangement”). The Opinion provides guidance for healthcare companies navigating the
The U.S. Department of Health and Human Services Office of Inspector General (OIG) updated its FAQs on Fraud and Abuse Authorities to add a new answer on fair market value (FMV) in FAQ 17 and revise the answer on how the physician self-referral law (Stark Law) overlaps with the federal Anti-Kickback Statute (AKS) in FAQ
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
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.
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
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
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.
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
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
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