The HHS Office of Inspector General Speaks: Direct-to-Consumer Discount Drug Programs under the Federal Anti-Kickback Statute

On January 27, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a special advisory bulletin applying the federal Anti-Kickback Statute to a pharmaceutical manufacturer’s offer and sale of prescription drugs to cash-paying individuals through direct-to-consumer (“DTC”) programs (“Bulletin”).¹ The Bulletin defines the OIG’s concerns with such DTC programs when federal health care program beneficiaries participate and provides guidance on structuring the programs to mitigate risk.

The Bulletin references efforts by the Trump Administration to reduce prescription drug prices and increase access to such drugs through TrumpRx, a government-sponsored web-based platform offering access to DTC programs implemented by certain manufacturers for certain drugs. TrumpRx is newly active, but DTC programs implemented by pharmaceutical manufacturers have proliferated in recent years, often operationalized in partnership with mail-order pharmacies, telehealth providers and other patient support vendors.

Although the Bulletin offers helpful and generally applicable guidance for DTC programs, open issues remain, as the OIG acknowledges. Pharmaceutical manufacturers and other parties involved in the design and operation of such programs must exercise ongoing care in implementing such programs.

What Does the Bulletin Say?

• Defining Concerns. The OIG identifies two key concerns with DTC programs under the federal Anti-Kickback Statute:
  • Drugs could be offered at a discount on a cash-pay basis to induce the purchase of other products or services covered and paid under federal health care programs; or
  • Drugs could be offered at a discount on a cash-pay basis to induce purchases of the same drug when and if covered and paid under federal health care programs in the future.
• Mitigating Concerns. The OIG states that a DTC program is low risk under the federal Anti-Kickback Statute if the program is structured appropriately:
  • The individual has a valid prescription from an independent, third-party prescriber.
  • The drug purchased is not billed to any insurer, including any federal health care program.The drug is purchased outside insurance, and the cost, for Medicare Part D purposes, does not count toward Medicare Part D true-out-of-pocket or total Medicare Part D spending.
  • Access to the drug under the DTC program, including access to any discounted price, is not conditioned on any current or future order or purchase of any product or service that is or could become billable to a federal health care program.
  • The DTC program for one drug is not used as a vehicle to market other federally reimbursable products or services.
  • The pharmaceutical manufacturer makes the drug available through its DTC program to an individual covered under a federal health care program for “at least one full plan year.”
  • The prescription drugs offered by the pharmaceutical manufacturer through the DTC program do not include controlled substances.

The OIG also separately suggests, for patient safety purposes, that pharmaceutical manufacturers operating DTC programs establish mechanisms to communicate with the relevant Medicare Part D or other federal health care program plan to facilitate appropriate drug utilization review and medication therapy.

What Does the Bulletin Do?

• The Bulletin establishes generally applicable standards for structuring DTC drug programs that operate on a cash-pay basis outside insurance, including federal health care programs.
  • Prior to the Bulletin, the OIG had issued two favorable advisory opinions addressing DTC programs offered by pharmaceutical manufacturers.²
  • The advisory opinions, like all advisory opinions, only protected the specific DTC programs that were the subject of the opinions and left open questions about what factors the OIG found “essential” versus “helpful” in reaching its favorable decision.
  • The Bulletin suggests that certain factors present in one or more of the opinions are not “essential” – e.g., limited federal health care program coverage for the drug purchased through the DTC program, data sharing with Medicare Part D or other federal health care program plans.
• The Bulletin makes clear that the standards apply to DTC programs implemented by pharmaceutical manufacturers whether or not the programs are accessible through TrumpRx.

What Does the Bulletin Not Do?

• The Bulletin is expressly limited to “the DTC sales transaction between the manufacturer and the cash-paying patient.” The Bulletin does not address other arrangements involved in the operation of a DTC program (such as arrangements with vendors administering the program) or related offerings (such as access to telehealth physicians or other practitioners).Such arrangements have been subject to scrutiny and enforcement action.³ The OIG indicates, however, that the agency is considering future guidance on other arrangements.
• The Bulletin does not elaborate on the requirement that a federal health care program beneficiary must have access to a drug under a DTC program for “at least one full plan year.”OIG guidance on free or discounted drug programs have typically indicated that a federal health care program beneficiary have access to drugs under the program through the end of the plan year.⁴
• The Bulletin does not foreclose the possibility that other types of drugs, in addition to controlled substances, may present “a risk of inappropriate utilization.”
• The Bulletin does not address whether and what disclosure should be provided to individuals purchasing drugs through DTC programs.Some disclosures could mitigate risk under the federal Anti-Kickback Statute consistent with the guidance (e.g., notice to individual purchasers that claims should not be submitted to federal health care programs) or under consumer protections laws.
• The Bulletin does not address DTC sales to the uninsured or the solely commercially insured because “as a general matter, the federal Anti-Kickback Statute does not apply to such sales,” suggesting that carving out federal health care program beneficiaries remains a viable option to reduce risk.
• The Bulletin is not a statutory exception or regulatory safe harbor and so cannot guarantee protection for DTC programs even if structured in according with its guidance.

Our team will continue to monitor developments in this area.

1. ^{See “Special Advisory Bulletin: Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients With Federal Health Care Program Coverage” (Jan. 27, 2026).}
2. ^{See HHS OIG Advisory Opinions 16-07 and 14-05.}
3. ^{See, e.g., Congressional Investigative Report, “Big Pharma’s New Sales Scheme: Expanding Patient Access or a Virtual Pill Mill? A Direct-To-Consumer Telehealth Platform Investigation” (July 17, 2025) and the Done Global prosecutions.}
4. ^{See, e.g., OIG Advisory Opinions 16-07 and 14-05 and OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees (70 Fed. Reg. 70623, 70727 (Nov. 22, 2005)).}