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. 

Covered entities, including group health plans, must update and distribute their Health Insurance Portability and Accountability Act of 1996 (HIPAA) Notice of Privacy Practices (NPP) by February 16, 2026, to comply with new rules for handling substance use disorder ) records.

On December 30, 2025, the U.S. Department of Health and Human Services Office of Inspector General (the OIG) issued an unfavorable advisory opinion (AO 25-12 or the Opinion) regarding a home care agency’s (the Company) proposal to market sign-on bonuses to prospective employees of the Company, who would provide in-home support services primarily to the family members of these prospective employees (the Proposed Arrangement). Pursuant to AO 25-12, the OIG concluded that the Proposed Arrangement would result in prohibited remuneration under the federal Anti-Kickback Statute (the AKS) and implicate the civil monetary penalty provision prohibiting inducements to beneficiaries (the Beneficiary Inducements CMP).