HHS Releases New Guidance on Direct-to-Patient Prescription Drug Sales

Last week, the U.S. Department of Health and Human Services (HHS) issued new guidance on how pharmaceutical manufacturers can supply lower-cost prescription drugs directly to patients — including those enrolled in Medicare and Medicaid. In a press release, HHS stated that, as long as key safeguards are met, it will be considered low risk under the federal anti-kickback statute.

The guidance from 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, according to the press release. HHS indicated that 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 through the TrumpRx program.

The guidance 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, HHS stated. “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.”

HHS noted that the guidance does not alter 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.

“We are taking action to give patients more options while keeping strong guardrails in place,” CMS Administrator Dr. Mehmet Oz shared in a statement.