OIG Provides Guidance on AKS Implications for Direct-to-Consumer Prescription Drug Sales
- January 30, 2026
The Department of Health and Human Services Office of Inspector General (OIG) issued January 27 a special bulletin to address concerns under the Anti-Kickback Statute (AKS) for pharmaceutical manufacturers that offer and sell discounted prescription drugs to federal health care program enrollees through direct-to-consumer (DTC) platforms.
Arrangements between manufacturers and cash paying customers run a low-risk of violating the AKS provided no federal health care programs are billed for the drugs, the sale isn’t conditioned on current or future orders that could be billable to federal health care programs, and other characteristics are present like a valid prescription from an independent prescriber and making the prescription drug available to the enrollee through the DTC program for at least one full plan year, according to the bulletin.
The bulletin comes as the Trump administration has announced a series of agreements with major pharmaceutical companies that include commitments to offer their drugs at discounted prices through the new TrumpRx platform, which is expected to be launching soon.
The characteristics of arrangements posing a low risk under the AKS address OIG’s major concerns that manufacturers’ DTC sales to federal health care program enrollees could be used to induce the purchase of other prescription drugs or services that may be reimbursable by federal health care programs or with the expectation that future sales to the enrollee may be billable to federal health care programs.
“To protect patient safety and reduce the risk of contraindicated or duplicative prescriptions, it also would be prudent for manufacturers operating DTC programs to establish mechanisms to communicate with the Federal health care program enrollee’s plan,” OIG noted.
The guidance is limited to DTC sales between manufacturers and cash-paying patients. The bulletin does not speak to any arrangements between manufacturers and physicians, pharmacies, pharmacy benefit managers, telemedicine vendors, marketers, or other individuals or entities.
OIG also emphasized that any determination as to whether an arrangement violates the AKS requires a case-by-case assessment.
In a Request for Information published January 29 in the Federal Register (91 Fed. Reg. 3857), OIG asked for public input on whether additional changes are needed to AKS safe harbor regulations or the exceptions to the Beneficiary Inducements CMP for emerging DTC sales programs. Comments are due March 30.