In advance of the anticipated rollout of the “TrumpRx” website, a platform promising lower-priced drugs sold directly to consumers, the Office of Inspector General of the Department of Health and Human Services (OIG) released a special advisory bulletin on Jan. 27, 2026, outlining the Federal Anti-Kickback Statute (AKS) implications for direct-to-consumer (DTC) drug sales. The OIG concludes that the risk of AKS violations is minimal if certain guidelines are followed, adding that its bulletin “clears the path” for DTC programs including the TrumpRx program.
However, a letter from Sens. Richard Durbin, Elizabeth Warren, and Peter Welch to the OIG suggests that not all stakeholders share this confidence in TrumpRx, citing to concerns arising from a recent investigation into other DTC platforms.
Pharmaceutical companies and other stakeholders can submit public comments until March 30, 2026.
TrumpRx: A Government Gateway to Discounted Drugs
The current administration made lowering drug prices a policy priority, and a key vehicle for this initiative is the recently delayed but reportedly forthcoming “TrumpRx.gov” website. The website will not sell drugs directly. Instead, it will serve as a portal through which the public can search for their prescription medications and determine whether their drug is available through a cost-saving program offered by a pharmaceutical manufacturer’s own DTC website. If the drug is part of such a program, consumers will be redirected to the manufacturer’s DTC page, where they can purchase the drug directly using a cash-based payment system rather than through their insurance. At least 15 major drug companies have signed agreements to participate in the program.
The Pharmaceutical Research and Manufacturers Association (PhRMA) announced it was developing a website to connect patients with DTC programs last fall, dubbed americasmedicines.com.
According to a May 20, 2025, press release by the Department of Health and Human Services, pricing for TrumpRx is to be set using a “most favored nations” approach, under which U.S. consumers would pay no more for a drug than consumers in a defined group of other developed countries. HHS announced that the benchmark for the TrumpRx program would be the “lowest price in an OECD (Organisation for Ecomonic Co-operation and Development) country with a GDP per capita of at least 60 percent of U.S. GDP per capita.”
A full list of drugs available through TrumpRx has not been announced, however press releases from the White House and pharmaceutical manufacturers included a number of widely used drugs for diabetes, high cholesterol, weight loss, asthma, heart disease, hepatitis C, migraine, rheumatoid arthritis and other conditions. While the administration states that TrumpRx prices will offer universal cost savings, some commentators argue that many of these drugs are currently available through existing public and private insurance programs, potentially at a lower out-of-pocket cost to patients than they would be through the TrumpRx program, which only allows cash sales and does not permit the use of insurance.
DTC Programs and the AKS: A Complicated History
The Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) is a criminal law that prohibits the knowing and willful offer, payment, solicitation or receipt of any remuneration, direct or indirect, to induce or reward referrals of items or services covered by federal healthcare programs, including drugs covered by Medicare or Medicaid. Violations may result in criminal penalties of up to 10 years’ imprisonment and fines of up to $100,000 per offense, as well as civil monetary penalties, treble damages under the False Claims Act and potential exclusion from participation in federal healthcare programs.
In its special bulletin, the OIG identifies two scenarios that would trigger AKS concerns in connection with a DTC program:
- The prescription drug is subsequently billed to a federal healthcare program.
- The purchase of the drug is conditioned on future purchases of additional drugs or services that would be billed to a federal healthcare program.
The OIG also outlines additional guardrails to protect against potential AKS violations:
- The prescription must be issued by a valid, independent, third-party provider.
- The DTC program must not be used to leverage one product to induce sales of another product or service that is federally reimbursable.
- The prescription drug should be made available through the program for at least one full plan year.
- The products offered must not include controlled substances.
The OIG states that if the two triggering scenarios are avoided and the guardrails are followed, a DTC program should present “low risk” for an AKS violation, although OIG stops short of stating that such programs qualify for an actual statutory or regulatory safe harbor that applies to AKS. In addition, OIG reminds manufacturers that they may want to avail themselves of the usual advisory opinion process and FAQ process in the event a DTC arrangement contains other design features not mentioned in the bulletin.
OIG’s bulletin also leaves out some important details that should likely be assessed on a case-by-case basis. For example, the bulletin does not clearly define an “independent” third-party provider. OIG’s bulletin also does not offer a position on the potential for other ancillary services, support, education, marketing or other potential interactions with the manufacturer and the patient that may relate back in some way to the DTC drug sale.
Finally, OIG states that it “would be prudent” for the manufacturer “to establish mechanisms to communicate with the Federal health care program enrollee’s plan (e.g., Medicare Part D, Medicare Advantage, Medicaid) to facilitate appropriate drug utilization review and medication therapy management by insurers.” However, there is currently no clear mechanism by which plans could receive and act upon such data.
It is also currently unclear how, whether and to what extent a plan could undertake a utilization review or therapy management with respect to a drug that was purchased with cash by a patient outside of their plan. Finally, it is unclear how a manufacturer’s failure to do so would weigh in OIG’s calculus as to whether the DTC arrangement is “low risk,” since this is a “prudent” not mandatory design factor.
Congressional Concerns: Senators Challenge OIG Conclusions
Sens. Durbin, Warren, and Welch raised multiple concerns regarding the OIG’s conclusions and the TrumpRx program generally in their Jan. 29, 2026, letter to the OIG. Notably, this is not a new area of concern for these lawmakers. Last year, these same senators, along with Sen. Bernie Sanders, released a report summarizing their investigation into other DTC programs and related telehealth platforms offered by two major pharmaceutical companies and the potential for AKS violations.
That report contained several key findings, including:
- Telehealth companies contracting with pharmaceutical companies were issuing prescriptions at rates significantly higher than baseline for certain drugs from those pharmaceutical companies.
- Appointments were often cursory, and video consultations were not necessarily required.
- Patients could select the drugs they wanted before appointments, rather than allowing the prescriber to recommend a medication following the consultation.
Their investigation found that, in one example, 100% of patients enrolled in telehealth consultations sponsored by a drug manufacturer received a prescription for that manufacturer’s drugs. In their 2026 letter, the senators question whether prescriptions from these telehealth companies and others affiliated with pharmaceutical manufacturers via TrumpRx would qualify as “independent, third-party prescriptions” under the just-issued OIG guidelines. The senators also raise concerns about direct-to-consumer advertising, which the Trump administration itself criticized for increasing healthcare costs by driving patients toward specific medications. This dynamic may be amplified by the availability of certain medications on the TrumpRx website, accompanied by claims of significant savings by participating pharmaceutical manufacturers.
The senators further question how GLP-1 medications, for which an initial dose will be available for purchase through links on TrumpRx, will align with OIG and AKS requirements. Patients typically increase their dosage as they continue treatment and would likely purchase subsequent doses through their insurance. Similarly, other medications require ongoing monitoring and laboratory testing. It remains unclear how such testing would be viewed by the OIG if the drug were purchased through TrumpRx, but related services are billed to a federal healthcare program. The senators argue that both scenarios suggest potential AKS violations and may conflict with the OIG’s special bulletin.
What’s Next?
On the same day the special bulletin was released, the OIG issued a Federal Register notice seeking public comment on whether additional guidance, updates to current AKS safe harbor regulations, or exemptions to civil monetary penalty provisions prohibiting beneficiary inducements are warranted in connection with DTC programs offered by the pharmaceutical industry.
The OIG’s special bulletin did not include specific recommendations or proposals to alter existing safe harbor positions. However, pharmaceutical companies will likely offer comments and proposals to further clarify the appropriateness of DTC programs, the TrumpRx program, or other prevalent and emerging pharmaceutical sales and distribution practices.
Despite the OIG’s assurances that DTC programs and TrumpRx participation present low AKS risk, some uncertainty remains. Without visibility of the actual TrumpRx website and its operational details, the true AKS risks are not yet clear.
McGuireWoods’ Life Sciences Industry Team continues to monitor congressional and regulatory developments related to DTC programs, the TrumpRx program, and the OIG’s pronouncements and their call for comments and proposals impacting the AKS safe harbors. For questions about related topics, contact the authors or a member of the team.