HHS OIG Releases Guidance and Solicits Input on Direct-to-Consumer Prescription Drug Programs

On January 27, 2026, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released a Special Advisory Bulletin (the “Bulletin”) addressing the application of the federal Anti-Kickback Statute (“AKS”) to direct-to-consumer (“DTC”) prescription drug sales.  The OIG also issued a Request for Information (“RFI”) seeking public comments, due at the end of next month, on additional guidance or regulatory modifications that may be needed to accommodate DTC programs under the fraud and abuse laws. 

The Bulletin is narrow in scope, addressing only DTC transactions between manufacturers and Federal health care program enrollees who elect to purchase drugs without insurance.  The Bulletin does not address the AKS’s application to DTC arrangements involving other industry stakeholders, including pharmacies, pharmacy benefit managers, physicians, telemedicine companies, or marketers. The Bulletin also does not address DTC sales to uninsured or commercially insured patients because, according to the OIG, those transactions generally do not implicate the AKS.   

Although designed to provide assurance for manufacturers seeking to offer DTC products—whether through the TrumpRx website or otherwise (the Bulletin is not limited to TrumpRX)—the Bulletin gives rise to several important questions and leaves many issues unaddressed. 

Below, we cover the background and key elements of the Bulletin and RFI, as well as the open questions, takeaways, and potential next steps for industry stakeholders.

 Background

In May 2025, President Trump issued an executive order, which Reed Smith briefed, seeking to make available to American patients most-favored-nation (“MFN”) prescription drug pricing that reflects the costs of such products internationally.  The executive order directed federal agencies to communicate MFN price targets to prescription drug manufacturers and, absent voluntary actions by manufacturers to reduce prices, to take actions to deliver lower cost prescription drugs.  

After the White House sent letters to manufacturers in July 2025, the White House reached deals with over a dozen manufacturers to sell certain of their products at lower rates tied to international prices directly to patients through a to-be-launched TrumpRx website. Although the TrumpRx website was previously expected to go live at the end of January 2026, its launch has reportedly been delayed for technical reasons.

The executive order also included a directive for HHS to facilitate DTC sales programs for manufacturers that agree to sell their products at MFN prices, “consistent with law.”  As HHS stated in a January 27, 2026 press release, this Bulletin is designed to “clear[ the] path” for these DTC offerings by manufacturers through outlining the conditions that will result in a DTC program being deemed low risk under the AKS.

Overview of the Bulletin

In the Bulletin, the OIG acknowledges that DTC sales could present risk under the AKS in two ways.  First, a manufacturer might offer Federal health care program enrollees prescription drugs at reduced cost through a DTC program as a tool to encourage those patients’ purchase of other prescription drugs, items, or services, including those for which a Federal health care program will be financially responsible, from that same manufacturer.  Second, a manufacturer might use the DTC program as a seeding arrangement.  In other words, a DTC program might be used to influence patients to begin taking the manufacturer’s drug without insurance, but with the expectation that a Federal health care program may in the future be billed for the drug (e.g., because the product becomes more affordable through the patient’s Federal health care program coverage). 

For manufacturers to structure their DTC programs, the OIG describes six characteristics that, in its view, mitigate the risk of fraud and abuse presented by manufacturers’ offer or sale of prescription drugs directly to a Federal health care program enrollee:

• The patient has a valid prescription from an independent, third-party prescriber.
• No claims for the DTC products are submitted to any Federal health care program or other insurer.  That is, it is OIG’s expectation that the DTC program price paid by a Federal health care program enrollee will not count toward their deductible or other out-of-pocket responsibility.
• The manufacturer does not use the DTC program as a vehicle to market other products for which a Federal health care program may ultimately be billed.
• DTC program prices are not conditioned on any future purchases, whether of the DTC product or any other items or services offered by the manufacturer.
• The manufacturer makes the prescription drug available to Federal health care program enrollees in its DTC program for at least one full plan year.
• No controlled substances are offered through the DTC program.

The Bulletin also indicates that, to protect patient safety and reduce the risk of contraindicated or duplicative prescriptions, manufacturers offering DTC programs should develop mechanisms to communicate with Federal health care program plans in a manner that facilitates appropriate drug utilization review and medication therapy management by the applicable enrollee’s insurance.

As to the rest of the health care industry participants who may be involved—directly or indirectly—in DTC programs, including pharmacies, the Bulletin generally refrains from addressing their AKS risks.  The OIG does, however, acknowledge in a footnote that manufacturers may implement DTC programs using buy-down coupons to dispensing pharmacies.  The OIG notes that, when that arrangement results in enrollees’ purchase without insurance of reduced cost drugs in similar circumstances, it may also present low risk. 

The Request for Information

The companion RFI is designed to allow stakeholders the opportunity to provide OIG with public comments on potential regulatory roadblocks facing the DTC space, beyond those addressed by the Bulletin.  In particular, the RFI asks for commenters to consider at least some of the following topics: 

• DTC arrangements that may implicate the AKS or beneficiary inducements provision of the Civil Monetary Penalties Law, including how the arrangements promote access to and affordability of prescription drugs while minimizing the harms that the fraud and abuse laws seek to combat.
• Proposals for modifying existing safe harbors and exceptions, as well as proposals for new safe harbors and exceptions, to provide additional assurances for DTC programs.
• Identification of any reasons why existing safe harbors or exceptions do not adequately protect beneficial DTC-related arrangements.
• Potential broader impacts or implications that may result from an increase in DTC programs or from modified or additional safe harbors and exceptions.
• Whether the Bulletin adequately addresses stakeholders’ concerns in connection with DTC programs offered to Federal health care program enrollees, and any operational challenges associated with implementing the guardrails outlined in the Bulletin.
• Additional opportunities for OIG to clarify its guidance regarding DTC programs. 

Comments to the RFI are due by 5 p.m. Eastern on Monday, March 30, 2026.

Takeaways and Next Steps for Industry Stakeholders

Manufacturers may consider implementing DTC programs for a variety of reasons.  First, they may serve political ends, such as responding to demands such as those arising out of the Executive Order, or highlighting intermediary transparency themes in current drug pricing policy debates.  Second, DTC distribution may offer alternative access pathways that may mitigate gross-to-net pressures associated with government discounting and rebate programs, by avoiding claims submission.  Third, of course, they may support commercial objectives, such as preserving sales as part of life cycle management strategies or maintaining an access pathway for products that are unable to secure viable payor formulary coverage. 

The Bulletin states that, so long as the outlined conditions are met, the OIG believes the benefits of offering reduced cost drugs through a DTC program outweigh any potential fraud-and-abuse risks under the AKS and should not result in increased costs to the Federal health care programs or their enrollees.  But as we noted at the outset, the Bulletin gives rise to several important questions and leaves many issues unaddressed.  Some of these issues are underscored in a letter that Senators Richard Durbin, Peter Welch, and Elizabeth Warren sent to the OIG on January 29, 2026, urging further OIG review of the TrumpRx website and related DTC programs before the launch of this initiative. 

Though far from exhaustive, some of the open items and points for consideration include the following: 

• Many of the Bulletin’s principles are not novel and are consistent with the OIG’s analysis in Advisory Opinion No. 14-05, a 2014 advisory opinion involving a manufacturer’s offering of a brand name product for a fixed price to patients outside of any applicable prescription drug insurance benefit. Notably, however, Medicare Part D benefit design has undergone significant changes in the 12 years since the prior advisory opinion (including elimination of the “donut hole” and the shifting of risk to Part D plans during the catastrophic phase of the benefit), in ways that may inherently change some of the fraud and abuse risks assumed by the Bulletin.
• As a practical matter, patients may choose to use a DTC program during a period of Part D coverage—because the DTC price is cheaper than their cost-sharing—then later switch to their Medicare Part D plan or other Federal health care program benefit once the copay or coinsurance becomes more cost-effective.  For example, if a plan’s negotiated price for a drug is $1,000 and if a patient’s coinsurance is 50%, then the patient will pay $500 using insurance.  But, if a DTC program offers the drug for $400, the patient may choose to purchase the drug through the DTC program.  It is also possible that a patient’s use of a DTC product could provide grounds for overcoming prior authorization or step therapy restrictions under a Part D plan, thereby allowing for Part D coverage at a later stage in their treatment.  It remains unclear whether a manufacturer’s knowledge (or even expectation) that this might occur for some subset of patients would increase the level of risk associated with a particular DTC offering, or whether this can be solved for by simply not “conditioning” participation in the DTC program on subsequent purchases, including those that a Federal health care program could ultimately be responsible for reimbursing. While the OIG’s 2014 Advisory Opinion effectively required patients to continue to pay without insurance for the duration of the calendar year to limit the risks of cost-shifting, the SAB guidance is somewhat more ambiguous in that it only requires manufacturers to “make available” DTC prices for a year.
• For a DTC program to present low risk pursuant to the Bulletin, no claims for the underlying products may be submitted to Federal health care programs.  Some stakeholders have questioned the value of a DTC program to patients if the reduced cost is not credited toward their deductible or other spending requirements.  Moreover, the assumption that these purchases without insurance will not be counted toward a Medicare Part D enrollee’s true out-of-pocket or total spending could be perceived as conflicting with current Centers for Medicare and Medicaid Services (“CMS”) guidance that allows submission of an enrollee’s purchases of covered lower-priced drugs without insurance to be counted towards their Part D deductible, or even covered by the Part D plan, if the DTC price is lower than the negotiated price at which the drug can be obtained from a network pharmacy using the enrollee’s benefits.  Historically, in accordance with this CMS guidance, some Part D plans have set up mechanisms for their beneficiaries to submit these non-insurance claims so that they count towards the beneficiary’s deductible.
• To support patient access, DTC programs may involve arrangements between the manufacturer and a telemedicine company or similar network of practitioners with the capacity to evaluate patients and, if medically necessary, issue prescriptions for the DTC product.  The OIG issued a Special Fraud Alert (“SFA”) in July 2022 that outlines suspect characteristics for arrangements with telemedicine companies. It remains unclear how the requirement in the Bulletin that prescriptions come from “independent, third-party prescribers” may be interpreted in light of the earlier SFA.
• DTC programs present a range of thorny regulatory considerations unrelated to the AKS, including, but not limited to, Medicaid best price reporting, whether and how pharmacies participate in DTC programs, and basic distribution principles. These elements may well be outside the scope of what the OIG intends to address, and instead require guidance from CMS and other regulatory agencies. 

In addition to evaluating their DTC programs with reference to the Bulletin, industry stakeholders may wish to consider raising the above questions (among others) in response to the OIG’s RFI. 

If you have any questions about DTC programs, or if you would like support in preparing comments to the RFI, please reach out to the authors of this post or to your health care attorneys at Reed Smith.