The U.S. Department of Health and Human Services on Tuesday announced safeguards that will enable drugmakers to offer lower-cost prescription drugs directly to patients with less risk of violating the federal anti-kickback statute.
"Americans pay too much for prescription drugs because middlemen profit from a system patients can't see," HHS Secretary Robert F. Kennedy Jr. said. "This guidance makes clear that manufacturers can offer lower-cost drugs directly to patients without kickbacks or taxpayer billing. The Trump administration is putting patients first by increasing transparency, lowering costs and expanding access through TrumpRx."
The guidance, issued by the HHS Office of Inspector General, supports efforts to make medically necessary drugs more affordable while protecting patients and federal health care programs from fraud and abuse. It also aligns with administration's broader effort to lower drug prices, increase transparency across the prescription drug market and expand the availability of affordable direct-to-consumer pharmaceuticals as part of the TrumpRx program, according to an agency news release.
The guidance assures pharmaceutical manufacturers that they may sell prescription drugs directly to patients who choose to pay cash -- including patients enrolled in federal health care programs -- when the arrangement meets specific conditions. These include:
- Ensuring the drug is not billed to Medicare, Medicaid or other federal programs;
- Is not used to market other federally reimbursable products; and
- Is not tied to future purchases or referrals.
This guidance does not change the federal anti-kickback statute itself, which remains a criminal law enforced on a case-by-case basis. It also does not address financial relationships between manufacturers and other parties, such as physicians, pharmacies, PBMs or marketers HHS also issued a request for information seeking public input on creating a formal regulatory safe harbor on matters related to direct-to-consumer drug sales in advance of the TrumpRx launch.
"We are taking action to give patients more options while keeping strong guardrails in place," said Dr. Mehmet Oz, administrator of the Centers for the Centers for Medicare & Medicaid Services. "When patients can access affordable medicines without hidden incentives or gamesmanship, outcomes improve and prices come down. CMS supports efforts that protect program integrity while empowering patients to make informed choices."
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