Global Life Sciences Update

Direct-to-Consumer Prescription Drug Platforms: New Government Guidance and Comment Opportunity

February 24, 2026

On January 27, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Advisory Bulletin (SAB) addressing the application of the federal Anti-Kickback Statute (AKS) to direct-to-consumer (DTC) prescription drug sales by manufacturers to patients with federal healthcare program coverage, including through the newly launched TrumpRx. On the same day, OIG published a Request for Information (RFI) seeking stakeholder input on whether new or modified AKS safe harbors or beneficiary inducement exceptions under the Civil Monetary Penalty Statute (CMP) are warranted for emerging DTC models. Together, these developments offer manufacturers an opportunity to consider how DTC models may be used in their business and shape OIG’s guidance on the topic. Comments to the RFI are due by 5 p.m. Eastern on March 30, 2026.

Key Elements of OIG’s Special Advisory Bulletin

The SAB addresses sales DTC sales between the manufacturer and a cash-paying patient and closely mirrors a 2014 advisory opinion under which OIG approved a manufacturer's DTC product sales program that allowed eligible patients to pay a fixed cash price for one of the manufacturer's products from an online retail pharmacy vendor.¹ Like the advisory opinion, OIG concludes that DTC programs pose low risk under the AKS if the following safeguards are met:

The patient has a valid prescription from an independent, third-party prescriber.
When the patient purchases prescription drugs through a DTC program, no claims for the drugs are submitted to any insurer, including any Federal healthcare program (FHCP).
The DTC program price paid by a Medicare Part D enrollee does not count toward their Medicare out-of-pocket spending.
The manufacturer does not use the DTC program for one product to market other products that are reimbursable under a FHCP.
The manufacturer does not condition the DTC price on any future purchases.
The manufacturer makes the drug available to the FHCP enrollee through the DTC program for at least one full plan year.
The drugs offered through the DTC program are not controlled substances.

OIG also states that when manufacturers effectuate DTC programs though a buy-down coupon to a dispensing pharmacy and “the pharmacy coupon passes through to the Federal health program enrollee — effectuating enrollees’ cash purchase of lower cost drugs — it presents a low risk when the arrangement aligns with the characteristics described here.”

OIG also suggests that it would be “prudent for manufacturers operating DTC programs to establish mechanisms to communicate with the [FHCP] enrollee’s plan ... to facilitate appropriate drug utilization review and medication therapy management by insurers.” This suggestion is very similar to guidance that OIG provided in the 2005 Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees.² Under the SAB on DTC programs, OIG does not provide additional detail or explicit instructions for how manufacturers could share communicate with insurers. OIG clarifies that the SAB applies only to manufacturer relationships with cash-paying patients and not manufacturer arrangements with others, including “physicians, pharmacies, pharmacy benefit managers, telemedicine vendors, marketers, or other individuals or entities.” If manufacturers seek OIG’s assessment of these other types of arrangements under the AKS, OIG directs them to the process for seeking advisory opinions or obtaining a response to OIG’s frequently asked questions mechanism for subregulatory guidance. OIG also flags that existing safe harbors may be available for such arrangements (e.g., personal services safe harbor). As noted below, the RFI seeks information from stakeholders on these other arrangements and what guidance or modifications to the safe harbors may be necessary to promote the DTC model.

The RFI: Potential Safe Harbor Modifications and Guidance

On the same day, OIG also published a Request for Information (RFI) seeking stakeholder input on whether new or modified AKS safe harbors or beneficiary inducement exceptions under the Civil Monetary Penalty Statute (CMP) are warranted for emerging DTC models. In the RFI, OIG outlines seven specific areas for comment:

Potential arrangements that the industry is interested in pursuing in connection with DTC programs that may implicate the AKS but promote access to care and affordability of prescription drugs.
What, if any, additional or modified AKS safe harbors may be necessary to protect such arrangements.
Why any existing safe harbors do not adequately protect the arrangements necessary to effectuate beneficial DTC programs (e.g., telehealth or pharmacy arrangements).
Any potential broader impacts or implications that may result from the proliferation of DTC programs.
Whether the SAB adequately addresses the concerns of industry stakeholders related to DTC programs or whether additional guidance, safe harbors, exceptions, or a combination are necessary to promote beneficial DTC programs.
Whether there are opportunities for OIG to clarify its position through guidance as opposed to regulation (e.g., amended SAB or FAQs)
Any operational difficulties in implementing the guardrails in the SAB and potential solutions, as well as any additional guardrails that may be necessary to promote beneficial DTC programs

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DTC programs present significant opportunities to enhance patient freedom of choice, reduce barriers to prescription drugs — particularly for patients facing geographic, mobility, socioeconomic, or other challenges impacting access — and promote patient safety and quality of care. Manufacturers and other stakeholders can shape OIG’s guidance on this increasingly important topic.

Notably, certain members of Congress continue to scrutinize DTC models³. After the SAB and RFI were published, Senators Durbin, Welsh and Warren sent a letter to the OIG Inspector General expressing concern with how OIG intends to conduct oversight and apply the AKS to DTC models as reflected in the SAB. As with prior oversight letters, the most recent letter expresses concern about how manufacturers will ensure that patients using manufacturer-sponsored telehealth platforms are able to receive a valid prescription from an independent, third-party prescriber. The letter also expresses specific concerns about TrumpRx, including potential conflicts of interest between the government-sponsored website and an online dispensing company. The letter includes several requests for information from the Inspector General focused on the operation of TrumpRx.

In addition to monitoring the OIG response to the congressional inquiry and any followup, manufacturers should closely review the SAB with their current or planned DTC models in mind, including potential arrangements with third parties to facilitate a DTC offering (e.g., telehealth, pharmacy), to consider providing focused comments in response to the RFI on substantive and technical issues that can streamline the compliance and commercial process for standing up a DTC program.

¹OIG, Adv. Op. No. 14-05 (July 28, 2014).
²70 Fed. Reg. 70623, 70627 (Nov. 22, 2005).
³Dick Durbin Press Release and Durbin HHS OIG Letter on TrumpRx

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