HHS-OIG Issues Guidance and Seeks Input on Application of Fraud and Abuse Laws to Manufacturer Direct-to-Consumer Programs

On January 27, 2026, the Department of Health and Human Services Office of Inspector General (“HHS-OIG”) published a Special Advisory Bulletin, entitled Application of the Federal Anti-Kickback Statute to Direct-to Consumer Prescription Drug Sales by Manufacturers to Patients With Federal Health Care Program Coverage. HHS-OIG also issued a Request for Information seeking input on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute (“AKS”) or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the “Beneficiary Inducements CMP”) for emerging direct-to-consumer (“DTC”) sales programs established by pharmaceutical manufacturers, including those that will be available through TrumpRx. This client alert summarizes key information from HHS-OIG’s Special Advisory Bulletin and Request for Information.

Special Advisory Bulletin on Manufacturer DTC Programs for Federal Health Care Program Beneficiaries

The Special Advisory Bulletin addresses the application of the AKS to a pharmaceutical manufacturer’s offer and sale of prescription drugs through a DTC program to cash-paying patients, including Federal health care program beneficiaries. HHS-OIG identifies two primary ways that a manufacturer’s DTC sales to Federal health care program beneficiaries can implicate the AKS: (1) by offering a drug at a lower cost in order to induce the beneficiary to purchase the manufacturer’s other drugs, items, or services that are reimbursable by Federal health care programs, and (2) by influencing the beneficiary to use the manufacturer’s drug at the DTC price with an expectation that the beneficiary’s Federal health care program might be billed for the drug in the future (i.e., a seeding program). The Special Advisory Bulletin outlines several characteristics that would render a manufacturer’s sale of lower-cost drugs to Federal health care program beneficiaries “low risk” under the AKS:

• The individual has a valid prescription from an independent, third-party prescriber.
• No claims for drugs purchased through the manufacturer’s DTC program are submitted to any insurer, including any Federal health care program (i.e., neither the Medicare outpatient prescription drug benefit nor any other Federal health care program benefit is used to obtain the drugs). As such, the DTC program price that a Medicare Part D beneficiary pays does not count toward their Medicare Part D true-out-of-pocket or total Medicare Part D spending for any purpose.
• The manufacturer does not use the DTC program for one product as a vehicle to market other federally reimbursable products it manufactures or services it provides.
• The manufacturer does not condition the DTC price for any drugs offered through its DTC program on any current or future purchases (of that drug or any other items or services).
• The manufacturer makes the drug available to the Federal health care program beneficiary through its DTC program for at least one full plan year. Although the Special Advisory Bulletin does not clarify the exact timeframe contemplated by this element, in the context of patient assistance programs, HHS-OIG has recommended that manufacturers provide free drug for the whole Part D coverage year (or the portion of the coverage year remaining after the beneficiary first begins receiving the assistance).
• The drugs offered by the manufacturer through the DTC program do not include controlled substances. (The Special Advisory Bulletin notes that HHS-OIG will continue to evaluate whether offering other types of drugs through manufacturer DTC programs may present a risk of inappropriate utilization.)

The benefits of lower-cost drugs sold through manufacturer DTC programs that exhibit the above characteristics would, in HHS-OIG’s view, outweigh the risks under the AKS, “absent unforeseen circumstances.”

HHS-OIG also states that it would be “prudent” for manufacturers operating DTC programs to establish mechanisms to communicate with the Federal health care program beneficiary’s plan (e.g., Medicare Part D, Medicare Advantage, Medicaid) to facilitate appropriate drug utilization review and medication therapy management by insurers, due to concerns about patient safety and the risk of contraindicated or duplicative prescriptions. The Special Advisory Bulletin is expressly limited to DTC sales by a manufacturer to cash-pay patients and does not consider the application of the AKS to manufacturer arrangements with other DTC program stakeholders, such as physicians, pharmacies, pharmacy benefit managers, telemedicine vendors, marketers, and others.

Request for Information on Application of Fraud and Abuse Laws to Manufacturer DTC Programs

HHS-OIG also issued a separate Request for Information seeking public feedback with respect to rulemaking or guidance, if any, that may be needed regarding the application of certain fraud and abuse laws to manufacturer DTC programs. Specifically, the Request for Information seeks input on the following topics:

1. Potential arrangements that the pharmaceutical industry is interested in pursuing in connection with DTC programs that may implicate the AKS and Beneficiary Inducements CMP. HHS-OIG would like to understand the structure and terms of such DTC arrangements (e.g., categories or types of parties, financial relationships involving potential referral sources and seekers created by the arrangements, and types of items and services provided by the arrangements) and how the arrangements promote access to and affordability of prescription drugs and prevent potential harms (e.g., increased costs, inappropriate steering, unfair competition, inappropriate utilization, poor quality of care, and distorted decision making).
2. Additional or modified AKS safe harbors or exceptions to the definition of “remuneration” under the Beneficiary Inducements CMP that may be necessary to protect DTC arrangements, including conditions to protect against fraud and abuse and any required disclosures.
3. Why existing AKS safe harbors and exceptions to the definition of “remuneration” under the Beneficiary Inducements CMP do not adequately protect the arrangements necessary to effectuate beneficial DTC programs.
4. Broader implications of DTC programs or additional or modified AKS safe harbors or Beneficiary Inducements CMP exceptions, particularly for access to health care services and costs to Federal health care programs.
5. Whether the Special Advisory Bulletin adequately addresses concerns of DTC program stakeholders, or if additional guidance, safe harbors, and/or exceptions are necessary to promote beneficial DTC arrangements.
6. Whether there are opportunities for HHS-OIG to clarify its position on DTC programs through guidance.
7. The operational feasibility of the guardrails for manufacturer DTC programs outlined in the Special Advisory Bulletin and whether additional guardrails may be necessary to sufficiently address fraud and abuse risks under the AKS.

To ensure consideration, comments must be received no later than 5 p.m. on Monday, March 30, 2026.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Health Care practice.