HHS Clears Path for Lower-Cost Prescription Drugs Through Direct-to-Consumer Programs

WASHINGTON-JANUARY 27, 2026-The U.S. Department of Health and Human Services (HHS) today announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients - including Medicare and Medicaid enrollees - in a manner that's low risk under the federal anti-kickback statute, so long as key safeguards are met.

"Americans pay too much for prescription drugs because middlemen profit from a system patients can't see," said HHS Secretary Robert F. Kennedy, Jr. "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 as a bulletin by the HHS Office of Inspector General (OIG), 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 the Trump 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.

"We are taking action to give patients more options while keeping strong guardrails in place," CMS Administrator Dr. Mehmet Oz said. "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."

The guidance issued today provides pharmaceutical manufacturers with assurance 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.

Importantly, the 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, pharmacy benefit managers, or marketers. HHS OIG has indicated it will seek additional public input on those arrangements separately.

Additionally, in advance of the launch of TrumpRx, HHS OIG issued a request for information (RFI) to gather public input on creating a formal regulatory safe harbor on matters related to direct-to-consumer drug sales.

These actions taken today will give drug companies clarity so they can safely offer lower direct-purchase prices of pharmaceuticals to all Americans, including Medicare and Medicaid beneficiaries.