OIG issues Special Advisory Bulletin on mitigating anti-kickback risks in direct-to-consumer prescription drug programs

On January 27, 2026, in anticipation of the upcoming launch of TrumpRx, a direct-to-consumer (DTC) prescription drug platform that aims to connect cash-pay patients to established DTC programs to reduce the cost of prescription medications, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Advisory Bulletin titled, “Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients with Federal Health Care Program Coverage” (Bulletin).

The Bulletin recognizes that DTC programs exist both as a part of and outside of TrumpRx and addresses when and how these DTC programs would pose a risk under the federal Anti-Kickback Statute (AKS). In assessing DTC programs, OIG emphasizes the importance of promoting patients’ access to, and affordability of, medically necessary drugs. It additionally sets forth multiple safeguards that, if met, would present a low risk under the AKS when a pharmaceutical manufacturer offers lower-cost prescription drugs to federal health care program (FHCP) enrollees through a DTC program.

OIG views DTC programs as low risk as long as:

1. No prescription drug is billed to an FHCP,
2. The sale of the prescription drug is not conditioned on the current or future order or purchase of any other item or service that is or could be billed to a FHCP, and
3. The arrangement aligns with the other safeguards set forth below.

Notably, the Bulletin does not address any other arrangements or remuneration relating to the provision of drugs offered and provided through a DTC program beyond the DTC program price offered and provided by the pharmaceutical manufacturer to the cash-pay individual. Accordingly, the Bulletin does not address the relationships that pharmaceutical manufacturers may have with physicians, pharmacies, pharmacy benefit managers, telemedical vendors, or marketers.

In conjunction with the Bulletin, OIG also published a Request for Information (RFI) seeking feedback on the need for any regulatory modifications to safe harbors under the AKS or exceptions under the Beneficiary Inducement Civil Monetary Penalty (BI CMP) to support DTC drug sales, including how such arrangements are structured, what parties are involved, how financial relationships are organized, and how these programs promote access to and affordability of medications while mitigating potential harms.

DTC programs and AKS implications

DTC programs established by pharmaceutical manufacturers provide opportunities for cash-paying patients, including patients enrolled in FHCPs, to purchase prescription medications directly from manufacturers at lower prices than those available through traditional channels (i.e., through insurance plans). The Bulletin identifies two primary ways that pharmaceutical manufacturers’ DTC sales to FHCP enrollees, even when such enrollees pay cash, may be problematic under the AKS:

1. Inducement to purchase other products: Offering lower-cost prescription drugs as a marketing tool to induce the purchase of other products or services reimbursable by FHCPs
   
   
2. Seeding programs: Using DTC programs to influence FHCP enrollees to use the manufacturer’s drugs with the expectation that future purchases may be billed to FHCPs (e.g., if the drug becomes more affordable through the enrollee’s FHCP)

OIG describes six characteristics that would mitigate potential overutilization risks and render a manufacturer’s DTC program at low risk of violating the AKS:

1. Valid prescription: The patient has a valid prescription from an independent, third-party prescriber who is not otherwise improperly influenced by the manufacturer to prescribe certain products
   
   
2. No claims submission: Claims for prescription drugs offered through the DTC program are not billed to any insurer, including FHCPs. This means that FHCP enrollees utilizing the DTC program would not utilize their Medicare outpatient prescription drug benefit, and the cost of such prescription drugs would not count toward any out-of-pocket maximum under a Medicare Part D plan
   
   
3. No marketing of other products: The DTC program is not used for one product as a vehicle to market other federally reimbursable products or services offered by the manufacturer
   
   
4. No conditional pricing: The pharmaceutical manufacturer does not condition the price for any drugs offered through the DTC program on future purchases of that drug or any other manufacturer item or service. This mitigates the risk that DTC programs will be viewed as remuneration to induce patients to purchase or order other items or services from pharmaceutical manufacturers that are reimbursable under an FHCP
   
   
5. Availability for at least one year: The prescription drugs offered through the DTC program are made available to the FHCP enrollee for at least one full plan year
   
   
6. No controlled substances: The prescription drugs offered through the DTC program do not include any federally controlled substances

OIG has stated that, when pharmaceutical manufacturers offer prescription drugs DTC consistent with the above characteristics, absent unforeseen circumstances, the benefits of lower costs for prescription drugs outweigh the potential risks. OIG further recommends that pharmaceutical manufacturers operating such DTC programs establish mechanisms to communicate with FHCP enrollee plans to facilitate appropriate drug utilization review and medication therapy management by such insurers. Coordination with health plans, such as Medicare Part D plans, Medicaid, and Medicare Advantage plans, may promote patient safety by reducing the risk of contraindicated or duplicative prescriptions being issued.

OIG Request for Information regarding existing law and DTC programs

The Bulletin is limited only to manufacturers’ sale of prescription drugs through a DTC program to cash-paying patients. It does not address DTC programs involving reimbursable products, nor does it address other financial relationships between the manufacturer and third-party partners involved in the DTC program, such as physicians, pharmacies, telemedicine platforms, and others. These additional arrangements are intended to be covered under the RFI that OIG published on January 29, 2026. Given the emergence of DTC programs, including those available through TrumpRx, the RFI seeks industry input on (1) whether any additions or modifications are needed to the AKS safe harbors, (2) whether any additions or modifications are needed to the exceptions under the BI CMP, or (3) whether OIG should propose new safe harbors, exceptions, or guidance to address perceived regulatory obstacles in safely offering DTC programs that reduce costs to patients and health plans, while mitigating potential AKS and inducement risks.

Of particular interest to OIG is how these new DTC programs or arrangements promote access to and increase affordability of prescription drugs for patients, while preventing the following potential harms: (1) increased costs, (2) inappropriately steering patients toward a particular product, (3) unfair competition, (4) inappropriate utilization of the pharmaceutical product (resulting in potentially higher costs), (5) poor quality of care, and (6) distorted clinical decision making.

In pertinent part, the RFI specifically asks for stakeholder input regarding whether existing AKS safe harbors and BI CMP exceptions are insufficient to support the offering of DTC arrangements and how the AKS safe harbors and BI CMP exceptions could be modified or expanded to protect such DTC arrangements. Specifically, the RFI highlights the AKS safe harbor for personal services and management contracts as potentially relevant and seeks input as to why this safe harbor would not adequately cover contemplated DTC arrangements. It seeks additional input on the conditions that would be appropriate to include in a new or modified safe harbor or exception to protect enrollees, including required patient and health plan disclosures.

Additionally, OIG seeks industry views on whether guidance (rather than regulation) would suffice to provide clarity or protection in some instances. OIG further requests feedback on operational challenges in implementing the Bulletin’s risk mitigating guardrails and on potential solutions or additional guardrails that may be needed to appropriately address AKS risks.

Industry considerations

In response to the Bulletin and RFI, industry stakeholders are encouraged to consider the below steps.

• Pharmaceutical manufacturers should review existing DTC programs offered to FHCP enrollees and ensure that such programs align with the Bulletin.
  
  
• Pharmaceutical manufacturers and parties that collaborate closely with pharmaceutical manufacturers may consider whether participating in the comment period for the RFI would potentially advance their current and contemplated future DTC programs, particularly if they anticipate any negative impacts due to the Bulletin or have success stories to share regarding how DTC arrangements promote access to and affordability of prescription drugs while preventing harm to FHCP enrollees and programs.
  
  
• Given that OIG indicated continued evaluation of non-controlled substances to determine whether DTC programs may present risk with respect to such drugs, pharmaceutical manufacturers may consider taking the opportunity to demonstrate ways DTC programs do not present risk with respect to their particular products.
  
  
• Interested stakeholders should continue to monitor proposed rulemaking concerning the application of fraud and abuse laws to their DTC arrangements, as well as monitor possible amendments to the Bulletin as OIG collects more information on fraud and abuse risk in DTC programs.

For more information

For additional information regarding the Bulletin or the RFI and how such guidance may affect your business, or if you would like assistance in submitting comments to the RFI, please contact the authors or any member of DLA Piper’s Healthcare Regulatory team.