HHS-OIG Guidance on Manufacturer DTC Platforms and Congressional Pushback

Executive Summary

In late January 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published guidance addressing the application of the federal Anti-Kickback Statute (AKS) to manufacturer direct-to-consumer (DTC) prescription drug platforms, including a Special Advisory Bulletin (SAB),¹ a contemporaneous press release describing the guidance as “clearing the path” for lower-cost prescription drugs, and a Request for Information (RFI). The guidance was issued weeks before TrumpRX, a government-branded website intended to aggregate manufacturer DTC offerings, launched.

Taken together, these developments provide manufacturers with an actionable framework to launch or expand DTC platforms. The SAB clearly delineates design features that OIG views as materially reducing AKS risk, effectively offering a roadmap for compliant implementation. Importantly, OIG’s simultaneous issuance of an RFI signals that the agency may engage in future rulemaking, potentially issuing new safe harbors.

Senators Richard Durbin, Elizabeth Warren, and Peter Welch collectively sent OIG a detailed letter sharply criticizing the guidance and questioning whether the TrumpRx model — and manufacturer DTC platforms more broadly — can comply with the AKS as currently structured.² While congressional engagement underscores the high visibility of this policy shift, the guidance, particularly when paired with the TrumpRx initiative, reflects an enforcement posture that appears durable and will be difficult to unwind absent further regulatory or legislative action.

I. Background: Manufacturer DTC Platforms and Renewed Enforcement Focus

Manufacturer DTC prescription platforms through which patients purchase prescription drugs directly from manufacturers, often following a telehealth encounter, have expanded rapidly in recent years. These models are frequently positioned as cash-pay alternatives intended to reduce patient out-of-pocket costs, bypass traditional pharmacy benefit structures, or address access challenges.

At the same time, OIG and the Department of Justice have repeatedly expressed concern that certain DTC and telehealth arrangements may improperly steer patients, compromise prescriber independence, function as vehicles for indirect remuneration tied to federally reimbursable products, or facilitate downstream federal program claims following an initial cash-pay transaction.

OIG’s January 2026 guidance articulated how it analyzes these AKS risks, particularly in light of the Trump Administration’s policy push to promote DTC purchasing through TrumpRx. Prior OIG guidance generally addressed DTC- or telehealth-related concerns indirectly or through enforcement warnings. In contrast, the January 2026 materials prospectively outline specific structural features that OIG views as relevant to fraud and abuse risk. In doing so, OIG appears to be responding to the practical need for clarity as manufacturer-operated DTC models move from isolated pilots to more visible and scalable distribution channels.

II. Overview of the January 2026 OIG Materials

A. SAB on DTC Platforms

The centerpiece of OIG’s guidance is an SAB, issued January 27, 2026, addressing manufacturer DTC platforms and AKS risk. The SAB reiterates several foundational principles:

• The AKS is a criminal statute that broadly prohibits remuneration intended to induce or reward the purchase or ordering of items reimbursable by federal health care programs.
• There is no existing safe harbor that squarely protects manufacturer-operated DTC platforms.
• Compliance depends on a fact-specific, totality-of-the-circumstances analysis.

The SAB then identifies a set of characteristics that, according to OIG, may “minimize the risk of fraud and abuse” under the AKS.

B. Guardrails Identified by OIG

OIG highlighted the following safeguards as important to reducing AKS risk:

1. Independent Prescribing: Patients must have a valid prescription issued by an independent, third-party prescriber.

2. No Federal Health Care Program Claims: Drugs purchased through the DTC platform should not be billed to Medicare, Medicaid, or other federal health care programs.

3. No Cross-Marketing of Federally Reimbursable Products: The DTC platform should not be used as a vehicle to market or promote other products that are reimbursable by federal health care programs.

4. No Conditioning or Tying to Future Transactions: DTC pricing should not be conditioned on future purchases or other remuneration.

5. Program Stability: Making the drug available through the DTC program for at least one full plan year may mitigate concerns about short-term loss-leader pricing designed to induce later reimbursable utilization.

6. No controlled substances: Prescriptions for controlled substances may not be included in the DTC program.

Notably, OIG frames these factors as risk-reducing, not dispositive. The SAB repeatedly cautions that arrangements lacking these features, or presenting countervailing risk factors, may still violate the AKS.

C. Telehealth as a Heightened Risk Area

OIG’s prior enforcement and guidance regarding telehealth fraud and abuse is instructive.³ OIG’s Telehealth Special Fraud Alert warned against arrangements involving, among other traits: limited or cursory patient interactions; prescribers directed to issue prescriptions for preselected products; and financial relationships that compromise clinical judgment. DTC models relying on telehealth prescribers may receive scrutiny, especially where prescribers are selected, paid, or otherwise influenced by manufacturers or their vendors.

III. OIG Request for Information: Potential Pathway to Formalizing DTC Protections

In parallel with issuing the SAB, OIG published an RFI seeking public input on fraud and abuse considerations related to emerging pharmaceutical distribution and pricing models, including manufacturer DTC platforms.

The RFI suggests that OIG is actively evaluating whether to formalize its DTC framework through future rulemaking, such as creating a new AKS safe harbor or other regulatory protections. OIG may also need to provide additional clarity on the civil monetary penalty (CMP) beneficiary inducement statute, which the SAB does not directly address.

A. Scope and Focus of the RFI

The RFI solicits stakeholder input regarding, among other things:

• Novel manufacturer distribution models designed to lower patient out-of-pocket costs
• Cash-pay arrangements that operate outside traditional third-party reimbursement structures
• The extent to which existing AKS safe harbors and CMP beneficiary inducement exceptions adequately address these models
• Whether additional regulatory clarity is needed to promote innovation while protecting federal health care programs
• The potential role of future subregulatory guidance (including additional advisory bulletins or policy statements) to provide more timely, durable clarity for emerging issues that may not require formal notice-and-comment rulemaking

Although not limited to DTC platforms, the timing and substance of the RFI strongly suggest that manufacturer DTC arrangements are a central focus, particularly those designed to operate without federal program reimbursement and with independent prescribing safeguards.

B. Near-Term Outlook

The RFI reinforces that OIG views manufacturer DTC platforms as a durable and evolving market structure warranting a prospective regulatory framework. In contrast to prior OIG guidance, which has historically focused on identifying suspect arrangements and enforcement risk, the RFI reflects an uncommon willingness by the agency to consider whether and how compliant DTC models can be affirmatively accommodated within the AKS framework. Comparable prospective subregulatory guidance has been rare outside of exceptional contexts — most notably, OIG’s COVID-era guidance issued to enable rapid deployment of care models and the agency’s 2005 patient assistance program guidance released in advance of Medicare Part D implementation.

While the RFI does not commit OIG to a particular regulatory outcome or timeline, its issuance alongside the DTC SAB supports the view that OIG is laying groundwork for longer-term regulatory clarity. Any future safe harbor or formal guidance would necessarily follow notice-and-comment rulemaking and could evolve based on stakeholder feedback.

In the interim, manufacturers that structure DTC platforms consistent with the SAB’s framework are well positioned — both to mitigate current enforcement-risk and to anticipate potential future rulemaking.

IV. TrumpRx and the Political Context of the Guidance

TrumpRx, a government website intended to route patients to manufacturer DTC offerings, launched on February 5, 2026. HHS’s press release describes OIG’s guidance as “clearing the path” for lower-cost prescription drugs.⁴ Thus, the guidance appears designed, in part, to articulate the conditions under which manufacturer participation in TrumpRx could proceed without immediate enforcement action.

However, OIG stopped short of endorsing TrumpRx or approving any specific platform, instead reiterating that compliance turns on individual facts and circumstances.

V. Congressional Pushback: The Durbin/Warren/Welch Letter

A. Overview of the Letter

On January 29, 2026, Senators Durbin, Warren, and Welch sent a detailed letter to the HHS Inspector General (Senate Letter) expressing concern that OIG’s guidance fails to adequately address whether TrumpRx-linked DTC platforms comply with federal law, including the AKS. The letter frames the guidance as insufficiently protective, arguing that it leaves unresolved core legal and policy concerns while enabling a high-profile government initiative.

B. Independence of Prescribers

A central theme of the Senate Letter is skepticism about whether prescriptions issued through manufacturer-affiliated telehealth vendors can be considered “independent” for purposes of the AKS analysis set forth in the SAB. In support of that skepticism, the Senators invoke previous concerns they raised with manufacturers about DTC telehealth arrangements. Specifically, they question whether manufacturer-supported platforms create incentives favoring certain prescriptions or limit the depth of clinical encounters.

The Senate Letter does not make independent factual findings regarding those arrangements, nor does it allege that the cited practices were unlawful. Instead, it asks how OIG intends to evaluate and ensure that prescriptions generated through TrumpRx-linked platforms satisfy the independence criterion articulated in the SAB and comply with the AKS.

C. Telehealth Fraud and Prior OIG Warnings

The letter explicitly mentions OIG’s 2022 Special Fraud Alert on telehealth arrangements, noting that many characteristics flagged in that alert appear present in contemporary DTC models. The Senate Letter asks whether and how OIG will vet manufacturer-telehealth relationships, evaluate compliance with prior fraud alerts, and prevent the reemergence of telehealth schemes previously associated with fraudulent Medicare billing.

In addition, the Senate Letter also raises concerns about downstream federal reimbursement — particularly for drugs that require titration or long-term maintenance therapy — as well as DTC advertising, potential steering toward preferred manufacturers or products on TrumpRx, and a lack of transparency regarding vendor relationships and potential conflicts of interest.

VI. Conclusion and Practical Takeaways

OIG’s January 2026 guidance is the most detailed articulation yet of how it will analyze manufacturer DTC prescription drug platforms under the AKS. This guidance provides manufacturers an actionable framework to structure DTC models in a manner that mitigates AKS risk. At the same time, stakeholders should recognize the scope and limits of the current guidance and the possibility of potential future rulemaking indicated by the concurrent issuance of an RFI. The SAB focuses primarily on federal fraud and abuse considerations under the AKS and does not address all potential legal risks associated with DTC platforms.

Please consult with your Arnold & Porter relationship partner or any member of our Life Sciences & Healthcare Regulatory practice for any questions about the potential limitations on the scope of this guidance.

We will continue to monitor developments closely and are available to assist clients in assessing and structuring DTC, telehealth, and cash-pay models in light of this evolving landscape.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.