OIG Issues New Guidance On DTC Drug Sales And AKS Risk

On January 27, 2026, the Office of the Inspector General of the Department of Health and Human Services (OIG) issued a  Special Advisory Bulletin on the Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients with Federal Healthcare Program Coverage. The Bulletin explains when a pharmaceutical manufacturer's offer and sale of prescription drugs to federal health care program (FHCP) enrollees through a direct-to-consumer (DTC) program is low risk under the federal Anti-Kickback Statute (AKS). The Bulletin also suggests several characteristics manufacturers should include when structuring DTC programs to minimize AKS risks.

The Bulletin is narrow in scope, addressing only DTC sales between manufacturers and cash-paying patients enrolled in an FHCP (Enrollees). The Bulletin does not address sales to uninsured individuals or individuals insured solely by commercial health plans, nor does it provide guidance on the application of the AKS to any arrangements manufacturers may have with physicians, pharmacies, pharmacy benefit managers, telemedicine vendors, marketers, or other individuals or entities or arrangements those individuals or entities may have among themselves, or with Enrollees. OIG also issued a companion  request for information (RFI) seeking input on whether any additional guidance or rulemaking is necessary to protect DTC programs.

Key Context

The Bulletin comes on the heels of deals announced by the White House for drug manufacturers to provide DTC discounts based on international prices. Last spring, President Trump issued an  executive order directing federal agencies to set most-favored nation (MFN) price targets based on international prices and, if manufacturers do not bring down prices, take regulatory action to deliver lower prices. On July 31, 2025, the White House sent letters to 17 drug manufacturers giving them a 60-day deadline to lower prices. To date, the White House has announced deals with 16 of the manufacturers under which they will sell certain products at discounts tied to international prices directly to patients through a TrumpRx website. Medicaid will also access the reduced prices. Industry stakeholders expected the TrumpRx website to go live by the end of January 2026, but the launch has reportedly been delayed.

The executive order also directed the Department of Health & Human Services to facilitate DTC purchasing programs for drug manufacturers that sell their products to patients at MFN prices “to the extent consistent with law.” The Bulletin lays out a legal pathway for how manufacturers can provide discounted drug prices through a DTC program to FHCP patients—either through the TrumpRx website or elsewhere—without violating the AKS. However, stakeholders have questioned the value of such DTC programs to patients if the discounts do not accrue to deductibles or other spending requirements, as is the case in the Bulletin.

How the AKS Applies to DTC Programs

The Bulletin outlines two primary ways manufacturers' DTC sales to Enrollees could implicate and potentially violate the AKS:

• If a manufacturer offers Enrollees prescription drugs at a discount as a marketing tool to induce Enrollees to purchase the manufacturer's other prescription drugs, items, or services that may be wholly or partially reimbursed by a FHCP.
• If a manufacturer uses the DTC program to influence Enrollees to use a medication with an expectation that the Enrollee's FHCP might be billed for the drug in the future (a/k/a “seeding”).

OIG noted that manufacturers' DTC programs will be unlikely to violate the AKS if: (1) the drugs are not billed to FHCPs; (2) manufacturers do not condition the sale of the drug on the current or future order or purchase of any other federally reimbursable item or service; and (3) the DTC program satisfies the following criteria:

• The Enrollee has a valid prescription from an independent, third-party prescriber.
• No claims for the drugs are submitted to any insurer, including FHCPs. In addition, Medicare patients' spending on the drug must not count toward the Medicare Part D true-out-of-pocket cost or total Part D spending (i.e., the Part D annual spending limit).
• The manufacturer does not use the DTC program for one product as a vehicle to market its other federally reimbursable products or services, or condition the DTC program price on any future purchases of that drug or any other items or services.
• The drug is available to Enrollees through the DTC program for at least one full plan year.
• The drugs are not controlled substances. OIG noted that it will continue to evaluate if providing other types of drugs through DTC programs presents risk of inappropriate utilization.

OIG also recommended that manufacturers communicate with Enrollees' FHCP plans to facilitate appropriate drug utilization review and medication therapy management.

Although the Bulletin does not address remuneration between manufacturers and pharmacies, it includes a statement in a footnote acknowledging that some DTC programs are effectuated using buy-down coupons, under which a dispensing pharmacy passes the manufacturer's discount through to the Enrollee, and noting that such arrangements are low-risk under the AKS if they comply with the above criteria. This footnote is notable, as it provides written support for the notion that coupons offered to Enrollees for cash-pay drugs generally are low-risk under the AKS if they satisfy certain criteria.

Takeaways

The Bulletin indicates that—as long as the specified protections are in place—OIG believes the benefits of lower cost drugs outweigh any potential fraud and abuse risks under the AKS and that DTC programs are unlikely to inappropriately increase costs to FHCPs.

Manufacturers with existing or planned DTC programs should review their programs with this Bulletin in mind and consider whether any additional safeguards may be necessary. Other entities involved in the implementation of DTC programs, such as pharmacies, pharmacy benefit vendors, telemedicine vendors and others, also may wish to evaluate their DTC arrangements against the Bulletin's recommended safeguards.

OIG noted that they cannot yet predict all the fraud and abuse concerns that might be associated with DTC programs or how best to minimize those risks, and as such, OIG may periodically amend the Bulletin as the agency gains more experience with DTC programs. Manufacturers, pharmacy providers, and other individuals or entities involved in DTC programs should monitor for any additional guidance and be prepared to modify their operations accordingly.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.