Four U.S. Senators have released the results of a nine-month investigation into direct-to-consumer (DTC) telehealth arrangements linked to pharmaceutical brand sites.
Their findings? According to the report, high prescription conversion rates, limited clinical encounters, payment structures, and patient data flowing back to manufacturers could be viewed as remuneration intended to induce prescribing of federally reimbursable drugs. All of these, they say, raise serious questions under the federal Anti-Kickback Statute (AKS) and related fraud and abuse laws.
If you have a DTC telehealth program that connects patients to paid telehealth partners, now is the time to review your design. This report is not the last word, but I think it’s a clear signpost that oversight is coming.
I’ve put together “Seven Guardrails for Lowering Risk Direct-to-Consumer Telehealth Models” based on what I’ve seen in the trenches. You can grab your copy here.
Where the Report Lands and What it Misses
The Senate report frames these models largely as mechanisms to steer patients toward a particular drug. Whether that is the intent or not, bad facts like the ones highlighted in the Senators’ report—like a 100% prescription rate with one vendor and limited patient/prescriber interaction—are not helpful.
In my view, the report doesn’t sufficiently acknowledge the fact that these models can and do expand access by giving patients options they may not otherwise have, particularly when traditional channels block them through medical gaslighting, denials, cost, or delays. They can also help empower people to take a more active role in their health. The report touches on these only lightly, which I see as a disservice to the bigger conversation
The reality is nuanced: the learned intermediary principle remains vital, but consumers also value the ease, choice, and accessibility these platforms can provide. I believe both can co-exist.
Key Findings from the Senate Report
The Senate’s investigation into DTC telehealth arrangements tied to pharmaceutical brand sites raised four main areas of concern:
- High prescription rates: In some programs, a significant majority of telehealth encounters resulted in a prescription for the sponsor’s drug, raising questions about whether prescribing decisions are appropriately individualized.
- Data flows to manufacturers: Telehealth arrangements often send detailed patient information back to pharma company sponsors, including information that could be sensitive even if provided in aggregate or de-identified form. This can create potential compliance and optics concerns.
- Depth and quality of patient interactions: In some cases, patients could request or receive a prescription with minimal (and arguably no) direct engagement with a healthcare professional, which may not always align with standard expectations for evaluating medical need.
Each of these factors, depending on how a program is structured, could create AKS or related fraud and abuse exposure.
My Observations from the Trenches
- Vendors can make or break compliance. Yes, as a threshold matter the programs need to be structured in a way that mitigates the fraud and abuse risk. However, even when they are, it is not uncommon in program audits to find the vendors (acting as the sponsor’s agent) aren’t following the sponsor’s expectations. Sponsors often assume vendors are executing as designed. Without robust SOPs, work instructions, and active oversight, however, that assumption can be costly. Active vendor oversight, while I appreciate time-consuming, is critical—particularly in high-risk programs.
- Bad facts matter. 100% prescription rates, questionable advertising claims, and zero patient interaction are red flags that regulators will seize on.
- It’s not always black and white. For example, the government dislikes “menu” models where patients choose a drug to discuss with an HCP. I don’t believe this inherently eliminates clinical judgment—but regulators hold the scepter here, so at a minimum it’s an area where sponsors should be thoughtful and proceed with caution.
- Marketing optics matter. Even if your intent is patient access, your materials shouldn’t create the impression you’re steering patients toward one specific drug.
- Data use is under the microscope. During a time when companies want more and more data to guide their strategy, resource use, and decision-making, it is critical to appreciate and understand that this is an area of growing government scrutiny with much unsettled. At a minimum, know exactly what is being collected, why, and how it’s used. Then document it.
- Patient history access is ideal, but not always practicable. Notably, telehealth isn’t the only model where a prescriber may not have a full health history (think retail clinics or urgent care). Still, DTC telehealth should build in as robust a process to capture critical clinical information wherever possible.
- Compensation to prescribers should not be volume-based. The OIG’s July 2022 Special Fraud Alert on telehealth made that clear.
- Build in follow-up. Consider regular check-ins before refills, especially for higher-risk therapies.
Want Lapis Legal’s “Seven Guardrails for Lowering Risk Direct-to-Consumer Telehealth Models?” Grab your copy here.
Final Thought & Next Step
Telehealth can be a powerful way to expand access and improve adherence, but if the commercial funnel influences clinical decisions, you’re on risky ground.
The Senate’s report is a warning shot. If you have a DTC telehealth model in place or in development, now is the time to pressure-test it before regulators do it for you.
If you’re exploring these issues in the context of your own model, Lapis Legal is here to help you think it through.
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