Articles and Blogs

The U.S. District Court for the Northern District of Texas (the “Court”) recently issued a memorandum opinion highlighting circumstances where compensated marketing conduct may fall outside the scope of Anti-Kickback Statute (“AKS”) liability. United States v. Gray, No. 3:24-CR-0250-S (N.D. Tex. Sept. 18, 2026). Specifically, the Court ordered a new trial after concluding that... READ MORE

On September 9, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published Advisory Opinion 26-18 (“AO 26-18”), a favorable advisory opinion considering a proposed paid referral service that would connect patients identified as having potential hearing loss with hearing providers (the “Arrangement”) operated by a company whose parent... READ MORE

In revisions released earlier this year to its General Questions Regarding Certain Fraud and Abuse Authorities, the Office of Inspector General (“OIG”) emphasized that compliance with the physician self-referral law (“Stark Law”) does not automatically resolve risk under the federal Anti-Kickback Statute (“AKS”). Furthermore, OIG clarified that fair market value (“FMV”) compensation, by itself,... READ MORE

On May 20, 2026, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable opinion, AO 26-11, regarding an arrangement in which a precision oncology company (“Requestor”) offers eligible patients undergoing a colorectal cancer screening test (“CRC Screening Test”) a free supplemental report (“Supplemental Report”) to identify risk of... READ MORE

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable opinion, AO 26-16, regarding a federally qualified health center’s (“FQHC’s”) provision of produce boxes and vouchers to patients diagnosed with certain health conditions (the “Arrangement”). Although the Arrangement would generate prohibited remuneration under the Beneficiary Inducements Civil Monetary... READ MORE

On May 1, 2026, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-09 (“AO 26-09”), which opines on a pediatric dental and orthodontic service provider’s (“Requestor’s”) proposal to offer free orthodontic treatment for one patient per year at each of Requestor’s three practice locations (the “Proposed Arrangement”).... READ MORE

On March 26, 2026, the Eighth Circuit, in Ghosh v. Abbott Lab’ys, Inc., 170 F.4th 1141 (8th Cir. 2026), affirmed the dismissal of whistleblower claims brought by a remote employee whose connections to Minnesota, where the employer was located, consisted of a 12-day visit to the state to participate in mandatory training. Case Background... READ MORE

On December 15, 2025, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 25‑11 (“Advisory Opinion”) and concluded it would not impose administrative sanctions under the federal Anti‑Kickback Statute (“AKS”) on a biopharmaceutical manufacturer for a series of discounts and rebates offered on multiple vaccines. Although portions of the arrangement failed to meet... READ MORE

On December 9, 2025, the Department of Health and Human Services’ (“HHS”) Office of the Inspector General (“OIG”) issued its annual solicitation for proposals and recommendations for developing new or modifying existing Anti-Kickback Statute (“AKS”) safe harbor provisions. In doing so, the OIG’s objective is to identify safe harbors that safeguard “beneficial and innocuous... READ MORE

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 25-08 (the “Advisory Opinion”), which addressed whether a proposed arrangement involving a medical device manufacturer’s payment of access fees to a third-party vendor’s billing portal (“Proposed Arrangement”) would violate the federal Anti-Kickback Statute (“AKS”). Based on the facts... READ MORE