The Department of Health and Human Services issued a special advisory bulletin clarifying that pharmaceutical manufacturers may sell lower-cost prescription drugs directly to Medicare and Medicaid patients without violating the Anti-Kickback Statute, provided that specific safeguards are met.
The guidance, issued by HHS’ Office of Inspector General on Jan. 27, outlines criteria that “lower the risk” of such direct-to-consumer programs, including that drugs are not billed to federal programs, marketed alongside other reimbursable products or tied to future purchases. The statute remains a criminal law evaluated on a case-by-case basis, it said.
The bulletin coincides with the Trump administration’s upcoming launch of TrumpRx, a federal platform to connect patients with direct-pay drug options at “most-favored-nation” prices. As of mid-January, 16 of the 17 largest drugmakers have signed voluntary agreements offering select medications — including GLP-1 drugs and insulin — at discounted rates under the plan.
The policy is a key component of President Donald Trump’s 2026 healthcare proposal, which includes codifying drug price negotiations and expanding federal price transparency rules. According to the bulletin, direct-sale programs may lower patient costs without increasing federal spending when they meet established conditions.
The OIG also issued a request for public input to determine whether new rulemaking is needed to further define guardrails for manufacturer cash-pay drug programs.
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