The annual False Claims Act (FCA) recovery statistics issued by the U.S. Department of Justice (DOJ) for Fiscal Year 2025 represent the highest single-year recovery in FCA history, underscoring that the FCA remains one of the government’s most effective tools for combating frauds involving federal funds. Winston attorneys outline expectations for FCA enforcement in 2026 and beyond based on an analysis of FY 2025 FCA activity and the priorities and goals of the current administration.

On February 19, 2026, the United States District Court for the Middle District of Alabama dismissed a declined qui tam whistleblower suit brought against Comfort Care Hospice, LLC, and several related hospice and home health service providers based in Alabama and Tennessee, claiming improper billing practices in violation of the False Claims Act and the Tennessee Medicaid False Claims Act.

On January 27, 2026, the U.S. Department of Health and Human Services Office of Inspector General (the OIG) issued a Special Advisory Bulletin (the Bulletin) addressing the application of the federal anti-kickback statute (the AKS) to direct-to-consumer (DTC) prescription drug sales. 

The Bulletin, the OIG’s first Special Advisory Bulletin since September 2014, was issued in response to the proliferation of DTC programs. The Bulletin, which sets forth the framework under which a manufacturer’s DTC program presents a low risk of violating the AKS, is viewed by the growing DTC industry as favorable guidance. DTC programs offering modern weight-loss medications, such as GLP-1 drugs, are becoming increasingly popular, and the Bulletin provides a helpful framework to support the viability of these programs.