The US Department of Health and Human Services (HHS) issued new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients, including those enrolled in Medicare and Medicaid, without triggering enforcement under the federal anti-kickback statute, provided specific safeguards are met.

The announcement marks a significant policy development as the Trump administration continues to advance efforts aimed at reducing drug prices and increasing transparency in the prescription drug market.¹

What was included in the guidance?

The guidance, released Jan. 27, 2026, takes the form of a bulletin from the HHS Office of Inspector General (OIG) and is intended to give manufacturers improved clarity on when direct-to-consumer (DTC) drug sales may be considered low risk under existing law, particularly in situations where patients choose to pay cash rather than seek reimbursement through federal health care programs.²

While the anti-kickback statute itself remains unchanged and continues to be enforced on a case-by-case basis, the bulletin outlines circumstances in which enforcement is unlikely.

“Americans pay too much for prescription drugs because middlemen profit from a system patients can’t see,” said HHS secretary Robert F. Kennedy, Jr. in the agency’s press announcement.¹ “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.”

Under the guidance, pharmaceutical companies will be granted the ability to sell prescription drugs directly to patients, including Medicare and Medicaid beneficiaries, as long as certain conditions are satisfied.² These conditions include ensuring that the drug is not billed to Medicare, Medicaid, or any other federal health care program, the arrangement is not used to market or steer patients toward other federally reimbursable products, and that pricing is not tied to future purchases, referrals, or other inducements.² The intent of these conditions is to allow manufacturers to offer lower cash-pay options while minimizing the risk of fraud, abuse, or inappropriate financial incentives.

“We are taking action to give patients more options while keeping strong guardrails in place,” said CMS Administrator Mehmet Oz, MD, in the press announcement.¹ “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.”

HHS issues information request

In parallel with the guidance, and ahead of the planned launch of TrumpRx, HHS OIG issued a request for information seeking public input on the potential creation of a formal regulatory safe harbor related to DTC drug sales.³ According to HHS, the process could eventually lead to more permanent regulatory changes, depending on stakeholder feedback and policy priorities.

Taken together, the actions of HHS are designed to provide drugmakers with clearer parameters for offering lower-priced, direct-purchase options while preserving oversight of federal health care spending.

Sources

1. HHS Clears Path for Lower-Cost Prescription Drugs Through Direct-to-Consumer Programs U.S Department of Health and Human Services January 27, 2026 https://www.hhs.gov/press-room/oig-clears-path-for-lower-cost-prescription-drugs.html
2. Special Advisory Bulletin:Application of the Federal Anti-Kickback Statute to Direct-to Consumer Prescription Drug Sales by Manufacturers to Patients With Federal Health Care Program Coverage U.S Department of Health and Human Services January 27, 2026 https://oig.hhs.gov/documents/special-advisory-bulletins/11450/OIG--FINAL--Special-Advisory-Bulletin.pdf
3. Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP U.S Department of Health and Human Services January 29, 2026 https://www.federalregister.gov/public-inspection/2026-01817/request-for-information-medicare-and-state-health-care-programs-fraud-and-abuse-federal