HHS Issues Guidance to Shield Pharma from Anti-Kickback Violations in TrumpRx Direct-to-Consumer Drug Sales
HHS OIG released a Special Advisory Bulletin on January 28, 2026, clarifying low-risk direct-to-consumer (DTC) prescription drug sales by manufacturers to federal health care program patients under the Federal Anti-Kickback Statute.146
The guidance supports TrumpRx, a Trump Administration platform connecting patients to DTC programs for lower-cost drugs available to cash-paying patients.1810
It aims to enable lower drug prices without violating anti-kickback laws or leading to improper federal program billing.689
Manufacturers can offer discounted drugs directly to patients if structured to avoid inducements for federal program-covered services.110
Sources:
1. https://benefitslink.com/newsletters/2026/20260128_welfare.html
4. https://firstwordpharma.com/story/7085424
6. https://www.bioworld.com/articles/728347-hhs-bulletin-lower-costs-direct-sales-no-kickbacks
8. https://www.hhs.gov/press-room/oig-clears-path-for-lower-cost-prescription-drugs.html
9. https://www.thepharmaletter.com/pharma-news/antikickback-law-sets-new-guardrails-for-directtoconsumer-sales
10. https://www.beckershospitalreview.com/pharmacy/hhs-outlines-path-for-lower-cost-drugs-via-direct-sales/