How to Engage With Gov't's Direct-to-Consumer Drug Policy
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March 12, 2026 | Mary Kohler for Law360
The recent launch of TrumpRx accelerated an industry move toward direct-to-consumer sales and prompted the HHS OIG to analyze the Anti-Kickback Statute implications. The agency's Special Advisory Bulletin, however, reflects caution and was issued alongside a request for industry input. Attorney Mary Kohler says this request allows stakeholders a rare opportunity to help shape policy and suggests how companies can engage constructively.
Last month, TrumpRx launched alongside significant pharmaceutical benefit manager reforms.[1] Whether these events ultimately lower drug prices remains uncertain, but they reflect a broader tech-enabled shift toward manufacturers interacting directly with consumers.
This shift faces a familiar issue: the federal Anti-Kickback Statute. On Jan. 27, the U.S. Department of Health and Human Services Office of Inspector General issued a special advisory bulletin addressing direct-to-consumer drug sales by manufacturers.[2] HHS declared that the OIG had cleared the path for TrumpRx.[3]
But the bulletin itself is more cautious. It notes that direct-to-consumer programs are proliferating, and acknowledges the OIG is still learning how they operate. To address this, the agency issued a request for information seeking industry input through March 30.[4]
In a relatively rare move, the OIG is asking stakeholders to help shape policy. For leaders who would prefer prospective guidance to enforcement, now is the time to engage.
TrumpRx and Industry's Digital Evolution
TrumpRx aims to improve affordability. It does not dispense drugs. Instead, it provides a digital portal relying on manufacturer coupons and cash-pay pricing to bypass traditional insurance pathways.
Manufacturers have long used coupons to help patients manage rising copays. But the OIG has repeatedly warned these incentives can increase utilization by reducing price sensitivity. For this reason, coupon programs — and TrumpRx — exclude federal program beneficiaries.
The platform also directs patients to manufacturer websites, which are evolving beyond simple promotional pages into sophisticated digital storefronts that connect patients with a growing array of services. These can include physician-finder tools and telehealth consultations.[5]
Connecting patients with telehealth, however, requires arrangements with platforms and involves an area where the OIG has identified heightened kickback risk.[6] It also moves manufacturers one step closer to the prescribing decision, prompting thornier questions still.
The OIG's Cautious Guidance
The OIG acknowledges cash-pay sales that occur outside of federal programs should not implicate the statute. Still, it flags two scenarios where federal program payments could arise.
First, the reduced cash prices could induce patients to purchase other products. Second, they could seed later services that are reimbursed, such as laboratory testing, refills and follow-up appointments.
The bulletin outlines six factors that would point toward lower risk. These track the OIG's existing guidance and enforcement.
But the bulletin stops at the sale. It doesn't address other aspects of direct-to-consumer programs, including intermediary relationships, telehealth platform design or beneficiary inducement considerations. Rather than speculate, the OIG issued the request for information.
Industry's Opportunity to Engage
Whether or not this exercise yields formal guidance, industry leaders have an opportunity to help shape integrity principles for these programs. Here are several ways to advance the dialogue constructively.
Get specific about underlying arrangements
The OIG asks how direct-to-consumer programs can improve access and affordability without harming patients, distorting decisions or increasing federal program costs. Answering that question requires analyzing the complex networks that lie beneath.
Draw the pictures. Map the money, services and incentives. Then step back and assess the system. Where might incentives encourage problematic behavior, or increase prescribing that ultimately affects federal programs? Acknowledge the pitfalls and propose workable guardrails.
Some may feel uneasy sharing this information. But these are the details that cause business, legal and compliance leaders to churn. If workable guidance is possible, why not engage a willing OIG now?
Share ideas for maintaining prescriber independence
After senators reviewed programs offered by Pfizer Inc. and Eli Lilly & Co., they cautioned that manufacturer-sponsored telehealth platforms could increase prescriptions overall, and for the sponsor's products disproportionately.[7] They also questioned payments flowing to platform providers. After the bulletin's release, they asked how the inspector general intends to oversee TrumpRx.[8]
While the OIG itself faces pressure over these issues, companies engaging with telehealth platforms must surely be analyzing them. Finding common ground should not be difficult.
However, the patient handoff from manufacturer to telehealth raises harder questions. "Talk to your doctor" is different than "here is our product — let's connect you."[9] Still, this alone does not necessarily increase federal program spending.
Long before telehealth platforms existed, physicians complained of patients self-diagnosing and arriving in their physical offices demanding specific treatments. Whether consumers get their information from drug ads or influencers and AI tools can be hard to parse. Ultimately, doctors can say no.
But a system that penalizes them — or nudges their decisions toward yes — changes things.
Compliance leaders could help the OIG articulate foundational principles for interacting with telehealth professionals. That might help all parties avoid missteps.
Propose telehealth guardrails that protect patients and federal programs
The request for information arrives as the federal government continues to grapple with telehealth more broadly. COVID-era telehealth flexibilities have been extended repeatedly.[10] It's hard to imagine going back.
At the same time, the OIG's experience has identified concerns and prompted a special fraud alert.[11]
Last fall, the founders of ADHD telehealth platform Done were convicted of healthcare fraud and unlawful controlled substance distribution following a jury trial.[12] Prosecutors alleged they engaged in deceptive advertising, pressured prescribers and disregarded reports of patient harm. A competitor, Cerebral Inc., resolved similar allegations by settlement.[13]
These cases illustrate the learning curve many platforms face.
Manufacturers must vet — and oversee — their technology partners. Do staff know what they're looking for? If not, are they missing depth in an effort to meet business pressure to move fast? Or perhaps they stall decisions instinctively without being able to identify specific concerns.
Disconnects like these can cause churn — or worse, mistakes in execution. Guidance on telehealth governance seems ripe, and cross-functional proposals would be timely.
Illuminate thinking on which products might be appropriate, and which are not
Not every product will be suitable for direct-to-consumer sales or manufacturer-sponsored telehealth. Following the ADHD cases, the bulletin states programs offering controlled substances cannot be considered low-risk, but this is low-hanging fruit.
Subscription model telehealth platforms have thrived where patients face access barriers. Even after generics lowered the cost of erectile dysfunction treatments, patients still hesitated to discuss their conditions with doctors.
Manufacturers, however, must also consider how their products are used. For example, telehealth models seem inappropriate for infused oncology therapies, which involve medical benefits, boxed warnings and physician oversight. But would they be acceptable for an oral formulation?
Also, what if a telehealth platform coordinates labs, infusion clinics and oncologists to deliver generic chemotherapy by subscription? If the answer is no, would it change if the platform aims to serve patients who've lost insurance coverage but still want treatment and can no longer afford branded monoclonal therapies?
Some proposals may exceed the OIG's immediate concerns about federal program impacts, but the bulletin subtly recognizes product fit is an issue.
Rather than waiting for market forces to push these arrangements into unacceptable places, safety and clinical teams could help the OIG advance guidance beyond excluding controlled substances.
Flesh out inherent payor tensions
The OIG worries cash-pay access could bypass payor utilization management and later shift costs to federal programs. To mitigate this, the bulletin suggests manufacturers communicate with payors. This may be easier said than done.
Many access barriers reflect payor cost-containment strategies that override prescriber judgment. Diagnostic and genetic testing denials, for example, can prevent physicians from establishing medical necessity for high-cost therapies.
Market access leaders could lend valuable perspectives on mitigating federal program risk without relying on payor discussions that may reach impasse.
Outline appropriate data collection and use principles
Federal investigations involving manufacturer-sponsored genetic testing have scrutinized how companies collect and use prescribing data.[14] The U.S. Senate report similarly treats data collection as suspect. At the same time, it criticizes prescribing trends without considering how companies could detect problems without data.
Business and compliance teams alike can struggle to establish appropriate boundaries for acceptable data collection and use. Thoughtful proposals addressing these tensions, and identifying ways to overcome them, could help shape guidance that moves the risk needle for direct-to-consumer programs and beyond.
Conclusion
The genie is out of the bottle. Even absent TrumpRx, technology, payor dynamics and patient expectations were already reshaping manufacturer-patient interactions in this direction.
The question now is whether industry will help define the boundaries of this shift or default to learning them through enforcement. The time to engage is now.
© 2026 Kohler Health Law, PC. | Mary Kohler is founder and principal of Kohler Health Law PC.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of their employer, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Consolidated Appropriations Act, 2026 (CAA 2026); and Federal Trade Commission, FTC Secures Landmark Settlement with Express Scripts to Lower Drug Costs for American Patients (Feb. 4, 2026).
[2] U.S. Department of Health and Human Services, Office of Inspector General, Special Advisory Bulletin: Application of the Federal Anti-Kickback Statute to Direct-to-Consumer Prescription Drug Sales by Manufacturers to Patients with Federal Health Care Program Coverage (Jan. 27, 2026). https://oig.hhs.gov/documents/special-advisory-bulletins/11450/OIG--FINAL--Special-Advisory-Bulletin.pdf.
[3] HHS Press Release, HHS Clears Path for Lower-Cost Prescription Drugs Through Direct-to-Consumer Programs (Jan. 27, 2026).
[4] HHS, Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, 91 Fed. Reg. 3857 (Jan. 29, 2026). https://www.federalregister.gov/documents/2026/01/29/2026-01817/medicare-and-state-health-care-programs-fraud-and-abuse-request-for-information-regarding-the.
[5] In 2024, Eli Lilly launched Lilly Direct, a one-stop-shop that pairs product education and support with lower cash prices and home delivery. It also connects them with telehealth platforms. Pfizer soon followed, but others have been working with telehealth platforms more quietly.
[6] HHS OIG, Special Fraud Alert: OIG Alerts Practitioners to Exercise Caution When Entering into Arrangements with Purported Telemedicine Companies, (Jul. 20,2022). https://oig.hhs.gov/documents/root/1045/sfa-telefraud.pdf. [7] Senate Report, Big Pharma's New Sales Scheme: Expanding Patient Access or a Virtual Pill Mill? A Direct-to-Consumer Telehealth Platform Investigation, U.S. Senate (Durbin, Sanders, Warren & Welch) (Jul. 2025). https://www.durbin.senate.gov/imo/media/doc/DTC%20Investigation%202025.pdf.
[8] Letter from Sen. Richard J. Durbin, Sen. Peter Welch & Sen. Elizabeth Warren, to Inspector General T. March Bell, Office of Inspector General, U.S. Department of Health and Human Services (Jan. 29, 2026). https://www.durbin.senate.gov/imo/media/doc/durbin_hhs_oig_letter_on_trumprx.pdf.
[9] K. Palmer, The Virtual Rx Boom: From Erectile Dysfunction to Weight Loss, How Telehealth Got Hooked on Drug-First Thinking, STAT (Oct. 6, 2025).
[10] See, CAA 2026.
[11] HHS OIG, Special Fraud Alert: OIG Alerts Practitioners to Exercise Caution When Entering into Arrangements with Purported Telemedicine Companies, (Jul. 20,2022). https://oig.hhs.gov/documents/root/1045/sfa-telefraud.pdf.
[12] U.S. Department of Justice Press Release, Founder/CEO and Clinical President of Digital Health Company Convicted in $100M Adderall Distribution and Health Care Fraud Scheme (Nov. 19, 2025).
[13] DOJ Press Release, Telehealth Company Cerebral Agrees to Pay Over $3.6 Million in Connection with Business Practices that Encouraged the Unauthorized Distribution of Controlled Substances (Nov. 4, 2024). https://www.justice.gov/usao-edny/pr/telehealth-company-cerebral-agrees-pay-over-36-million-connection-business-practices.
[14] M. Kohler, DOJ's Biopharma Settlement Raises Anti-Kickback Questions, Law360 (Jan. 23, 2024); https://www.kohlerhealthlaw.com/post/doj-s-biopharma-settlement-raises-anti-kickback-questions; and M. Kohler, 2 Anti-Kickback Developments Hold Lessons for Biopharma, Law360 (Feb. 13, 2025). https://www.kohlerhealthlaw.com/post/2-anti-kickback-developments-hold-lessons-for-biopharma.
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