OIG Issues Special Advisory Bulletin on Direct-to-Consumer Drug Programs

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Advisory Bulletin on January 27 addressing how the federal Anti-Kickback Statute (AKS) applies to pharmaceutical manufacturers' direct-to-consumer (DTC) prescription drug programs.

Key Takeaways

• OIG identifies two primary ways DTC sales could be problematic under the AKS.
• DTC programs are generally at low risk of an AKS violation if they have certain characteristics that help minimize the risk of fraud and abuse.
• OIG released a companion Request for Information seeking public input on whether new safe harbors or additional guidance are needed for other aspects of DTC arrangements.

Background

The bulletin follows Executive Order 14297, "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," issued in May 2025, which focuses on lowering drug prices. One directive under the order is for HHS to develop initiatives that facilitate lower drug prices, including through DTC programs offered by pharmaceutical manufacturers.

The bulletin, the first in more than a decade, was issued in anticipation of the launch of TrumpRx, a platform to connect patients seeking lower-cost prescription drugs with DTC programs offered by manufacturers and other private companies.

The Bulletin: AKS Risks and Compliance Safeguards

The bulletin addresses whether the AKS applies when manufacturers sell prescription drugs directly to cash-paying patients, including those enrolled in federal healthcare programs. The AKS makes it a criminal offense to knowingly and willfully offer, pay or receive remuneration—cash or in-kind—to induce referrals for, or otherwise recommend or arrange for the furnishing, purchase or lease of items or services reimbursable by federal healthcare programs.

OIG identifies two key risks:

1. The manufacturer could offer the drug at a lower price than otherwise available as a marketing tool to induce the purchase of other drugs, products or services reimbursable under federal health care programs.
2. The manufacturer could use the program to influence enrollees to take the drug, with an expectation that a federal health care program might be billed for the drug in the future – sometimes referred to as a "seeding program.”"

OIG identifies the following characteristics for the offer and sale of prescription drugs in these DTC programs that, when present, help ensure a low risk under AKS:

• Patient has a valid prescription from an independent, third-party prescriber.
• No claims for DTC-purchased drugs are submitted to any insurer, including federal healthcare programs (e.g., the individual is not using their Medicare outpatient prescription drug benefit).
• Manufacturer does not use the DTC program for one product to market other federally reimbursable products.
• Manufacturer does not condition DTC pricing on future purchases of any drugs, other products or services.
• Manufacturer makes the drug available through its DTC program for at least one full plan year.
• Drugs do not include controlled substances.
• Bulletin also suggests that manufacturers operating a DTC program set up a system to communicate with a federal health care program enrollee’s plan (e.g., Medicare Advantage, Part D) to facilitate appropriate utilization review and medication management.

The RFI: Opportunities for Industry Input on Future Guidance

The RFI seeks public stakeholder input on whether existing laws or regulations should be modified to address manufacturer DTC programs, including those that will be available through TrumpRx. Specifically, OIG seeks comment on new or modified safe harbors to the AKS, new exceptions to the beneficiary inducements provision of the Civil Monetary Penalties Law, and other guidance that could promote prescription drug affordability while protecting against fraud and abuse.

As the bulletin focuses only on the DTC sales transaction between the manufacturer and the patients, the RFI asks about related arrangements manufacturers may have with physicians, pharmacies, telehealth companies, or other individuals or entities.  The RFI also asks whether the Special Advisory Bulletin adequately addresses industry concerns or if additional guidance is necessary.

Considerations Relevant to Telehealth Companies and Other Stakeholders

Although the RFI does not address arrangements with telehealth or other third-party entities, a review of the safeguards may be informative for telehealth companies and other stakeholders.

A recent letter from three senators raised concern with manufacturer DTC programs that will be available on TrumpRx, including regarding potential AKS violations and conflicts of interest.

Among the issues flagged, the letter asks the OIG whether "the TrumpRx website [will] vet manufacturers' DTC arrangements with telehealth companies to ensure consistency with the 2022 Special Fraud Alert?"

That 2022 alert, "OIG Alerts Practitioners to Exercise Caution When Entering Into Arrangements with Purported Telemedicine Companies," identified what OIG considered “suspect characteristics” that could suggest a heightened risk of fraud and abuse, including where the telehealth company is facilitating the ordering of prescription medications. 

Takeaways

Manufacturers should review current or planned DTC programs against the Special Advisory Bulletin’s safeguards. Though the bulletin’s focus is limited to the relationship between the manufacturer and the patient in these DTC programs, other entities that have a relationship with the DTC programs may also find the guidance informative when assessing potential compliance safeguards, in addition to review of other available OIG guidance.

Stakeholders wishing to provide input on potential safe harbor modifications or additional guidance, as requested in the RFI, should submit comments by March 30, 2026, at 5 p.m. via www.regulations.gov using file code OIG–2601–N.