OIG Issues Guidance, Request for Information on DTC Programs

Last week, the OIG posted two important issuances on Direct to Consumer drug programs, including TrumpRx – a Special Advisory Bulletin and a Request for Information (RFI).

These issuances follow the announcement of Most Favored Nation Direct to Consumer pricing last May in White House Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (May 12, 2025).

Special Advisory Bulletin

On January 27, 2026, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Advisory Bulletin regarding the Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients with Federal Health Care Program (“FHCP) Coverage (Bulletin).[1] The Bulletin addressed the AKS implications of TrumpRX, the Administration’s new platform connecting cash-paying patients to direct-to-consumer (DTC) programs offered by pharmaceutical companies and other private companies. In the Bulletin, the OIG identified two ways in which DTC practices may present heightened risk of implicating the AKS. First, DTC programs may be used as a marketing tool to induce FHCP enrollees to order other prescription drugs that are payable by a FHCP and offered by the manufacturer. Second, manufacturers might use DTC programs to influence FHCP enrollees to choose the manufacturer’s drug, expecting that it may be covered by the FHCP in the future. The purpose of the Bulletin is to explain when a manufacturer’s offer of lower-cost prescription drugs to federal health care program (FHCP) enrollees is “low risk” under the AKS.

The Bulletin lists six factors that make DTC programs low risk –

1. Valid prescriptions from independent, third party prescribers;
2. No claims submitted to any insurer, including any FHCP (means it doesn’t count toward out-of-pocket or total expenditures);
3. No manufacturer use of a DTC product to market any of its other federally reimbursable products;
4. No conditioning of DTC pricing on any future purchases of that drug or any other items or services;
5. Availability for at least one full plan year to FHCP enrollees; and
6. No controlled substances offered by the DTC programs.

In addition to identifying these low risk factors, the Bulletin also suggests that manufacturers participating in DTC programs should develop a mechanism to report to FHCP enrollee plans, in order to reduce the risk of contraindicated or duplicative prescriptions.

The Bulletin is limited in scope, only addressing the potential AKS implications of transactions between a manufacturer and cash-paying patients. The Bulletin states that it does not address arrangements with physicians, pharmacies, pharmacy benefit managers, telemedicine vendors, marketers or any other individuals or entities. Nor does the Bulletin address the potential civil monetary penalties (CMPs) for beneficiary inducements because the CMP law does not apply to pharmaceutical manufacturers. Finally, the Bulletin does not address DTC sales to uninsured or commercially insured patients because the AKS generally “does not apply to such sales.”

Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP

Simultaneously, the OIG issued a Request for Information (RFI) Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, asking for input from the public as to whether modifications of the safe harbors and beneficiary inducement CMPs are needed for emerging DTC programs offered by pharmaceutical manufacturers, including Trump Rx.[2]

The RFI states that the OIG’s Special Advisory Bulletin only addresses arrangements between the manufacturers and consumers and does not address any other arrangements or remuneration that a manufacturer or others may have with other individuals or entities (e.g., pharmacies or telemedicine vendors) related to DTC programs. The RFI seeks information to further the OIG’s understanding of these arrangements and any perceived need for additional safe harbor or exception rulemakings. Specifically, the OIG asks for information regarding the following:

1. Potential DTC arrangements the industry is interested in pursuing, including structure and terms, how they promote access and affordability and prevent harm;
2. Additional or modified safe harbors or exceptions necessary to protect such arrangements and key provisions, including conditions and disclosures;
3. Why the existing safe harbors and exceptions are not adequate to protect the arrangement
4. Broader impacts and implications that may result from DTC programs, including the impacts and implications of any additional or modified safe harbors or exceptions;
5. Whether the Special Advisory Bulletin adequately addresses industry concerns;
6. Opportunities where the OIG could clarify its position through guidance instead of regulation; and
7. Operational difficulties and potential solutions to implementing the guardrails identified in the Special Advisory Bulleting to mitigate risk.

Although the RFI expressly mentions the personal services safe harbor to the AKS, we at EBG have long believed that it is the discount safe harbor that actually impedes what should be lawful discounting practices that are regularly engaged in by businesses outside the health care industry. Additionally, the issuance of the value based care safe harbor to the AKS, that effectively excludes the pharmaceutical supply chain from protection for virtually all value based care arrangements, has furthered this dynamic. While the Bulletin protects pharmaceutical manufacturers with respect to their DTC transactions, there are other segments of the health care community that have been prevented by federal regulation and policy from offering low cash-pay programs directly to consumers. In particular, attempts by pharmacies and other health care providers to offer low-priced cash programs directly to consumers have been met with federal enforcement actions and qui tam and third-party payor lawsuits. These lawsuits are predicated on federal policy and participating provider contractual provisions that require providers to pass through lower cash offerings to the health plan. Full protection of private DTC programs (outside of TrumpRx) will need to address the pricing (and potential CMP false claims) implications of these programs.

Other issues remain unaddressed in the Bulletin, including the potential implications for drug pricing requirements under such programs as Medicare Part B and the Medicaid Drug Rebate Program. The calculations of Average Sales Price, Average Manufacturer Price, and Best Price exclude “direct sales to patients” but neither the Bulletin nor CMS regulation or guidance describes in detail the kind of arrangements that would satisfy the terms of that exclusion. Other provisions that address different modalities of manufacturer assistance to consumers could also be applicable if they ensure that the full benefit from the manufacturer flows to the consumer. Further details will be required before the interplay of these provisions is clear.

Are these potential impacts (or others) keeping your organization from participating in private DTC programs? Do you have examples of discounting or value based practices in the pharmaceutical supply chain that ought to be protected because they would contribute to reducing health care costs or improving quality? Stakeholders should consider preparing comments to address these concerns. If you would like our assistance in developing your comments or have questions regarding these OIG issuances, please let us know by reaching out to one of the authors or your regular EBG attorney.

Comments are due by 5pm ET on March 30, 2026.

Endnotes

[1] Available at https://oig.hhs.gov/documents/special-advisory-bulletins/11450/OIG--FINAL--Special-Advisory-Bulletin.pdf.

[2] 91 Fed. Reg. 3,857 (Jan. 29, 2026), available at https://www.govinfo.gov/content/pkg/FR-2026-01-29/pdf/2026-01817.pdf