WASHINGTON, D.C. — The U.S. Department of Health and Human Services on Tuesday released new guidance clarifying how pharmaceutical manufacturers may offer prescription drugs directly to patients at lower cost without violating the federal anti-kickback statute.

According to HHS, the guidance outlines conditions under which drug manufacturers may sell medications directly to consumers who choose to pay cash, including individuals enrolled in Medicare and Medicaid, as long as certain safeguards are met. The guidance was issued by the HHS Office of Inspector General to reduce legal uncertainty for manufacturers while maintaining protections against fraud and abuse.

Under the guidance, manufacturers may offer direct sales if the drugs are not billed to Medicare, Medicaid, or other federal health care programs, are not used to market other federally reimbursed products, and are not tied to future purchases or referrals. HHS emphasized that the guidance does not change the anti-kickback statute itself, which remains a criminal law enforced on a case-by-case basis.

The guidance also does not address financial relationships between drug manufacturers and other entities such as physicians, pharmacies, pharmacy benefit managers, or marketers. HHS said it plans to seek additional public input on those arrangements separately.

In addition, HHS announced a request for information to gather feedback on the potential creation of a formal regulatory safe harbor related to direct-to-consumer prescription drug sales. The request is intended to inform future rulemaking as the department considers broader changes to prescription drug pricing and distribution policies.

HHS officials said the guidance is intended to provide clarity for manufacturers while preserving safeguards for patients and federal health care programs.