On January 27, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Advisory Bulletin addressing how the federal Anti-Kickback Statute (AKS) applies to direct-to-consumer (DTC) prescription drug sales by pharmaceutical manufacturers to cash-paying patients who are enrolled in federal healthcare programs, including Medicare and Medicaid. This guidance comes amid the expansion of manufacturer-led DTC programs—including those operating as part of or alongside the TrumpRx platform—and provides guidance on when such arrangements may present a low risk under the AKS.
Overview of the Bulletin
Although the AKS is a criminal statute requiring a case-by-case, fact-specific assessment, OIG explains that a manufacturer's direct sale of prescription drugs to cash-paying federal healthcare program enrollees may present a low risk of AKS violation where specific conditions are satisfied. The guidance is intentionally narrow and applies only to the direct financial arrangement between the manufacturer and the patient. It does not address arrangements involving physicians, pharmacies, pharmacy benefit managers, telemedicine vendors, marketers, or other third parties, nor does it apply to sales to uninsured individuals or individuals insured solely through commercial health plans. Notably, OIG does not endorse or approve any particular DTC business model and expressly reiterates that the AKS remains an intent-based, criminal statute requiring a fact-specific analysis of each arrangement.
When DTC Sales Are Considered "Low Risk"
According to OIG, a manufacturer's DTC prescription drug sale to a federal healthcare program enrollee presents a low risk of AKS violation where the patient has a valid prescription from an independent third-party prescriber; no claims are submitted to any insurer, including Medicare or Medicaid, for the DTC-purchased drug (and, for Medicare Part D enrollees, the DTC price does not count toward true out-of-pocket or total Part D spending); the DTC program is not used as a marketing vehicle for other federally reimbursable products or services; the DTC price is not conditioned on current or future purchases of any drug, item, or service; the drug is offered through the DTC program for at least one full plan year; and the program does not include controlled substances. Taken together, these conditions reflect OIG's focus on ensuring that DTC programs operate as stand-alone cash-pay offerings and are not used to influence the use of drugs or services reimbursed by federal healthcare programs.
Practices Raising Concerns over Heightened AKS Risk
OIG also identifies two DTC practices that raise heightened concern under the AKS because they may reflect an intent to induce federally reimbursable business. First, OIG cautions against using discounted DTC pricing as a marketing tool to influence a federal healthcare program enrollee to purchase, order, or recommend other prescription drugs, items, or services manufactured or offered by the same company that may be reimbursed by a federal health care program, as such discounts may constitute remuneration rather than a stand-alone cash-pay transaction. Second, OIG raises concern with so-called seeding programs, in which manufacturers encourage patients to initiate therapy with a drug in anticipation that a federal healthcare program will later cover the drug, such as following changes in coverage status, formulary placement, or pricing. In both cases, OIG is concerned that a DTC arrangement could be used to influence future federally reimbursable purchasing or ordering decisions, rather than function as a one-time, arm's-length cash-pay transaction.
Additional Compliance Considerations
Because the AKS is intent-based, OIG emphasizes that program design, documentation, and internal communications are critical. The guidance also encourages manufacturers to consider mechanisms to communicate with patients' health plans to support appropriate drug utilization review and medication therapy management. While OIG expresses confidence that qualifying DTC programs are unlikely to increase federal healthcare program costs, it notes that the guidance may evolve as DTC models continue to proliferate.
Conclusion
The OIG's January 2026 guidance reflects a cautious but pragmatic approach to manufacturer-led DTC prescription drug programs. While the Bulletin signals regulatory tolerance for carefully structured cash-pay programs, AKS risk remains highly fact-specific and intent-driven. Companies should anticipate continued scrutiny as DTC programs expand, while recognizing that carefully structured arrangements can operate with "low risk" under AKS within the boundaries outlined by OIG.
Please let us know if you would like further analysis of how this guidance may affect DTC prescription drug programs, pricing structures, or compliance programs. Venable's Healthcare and Healthcare Policy teams are ready to provide support and counsel when you need it.