Over the last year, Eli Lilly and Pfizer have launched direct-to-consumer (DTC) digital telehealth platforms intended to enable consumers to connect with remote prescribers and access medications. Eli Lilly’s program, “LillyDirect,” targets obesity, migraines and diabetes treatment, where Pfizer’s program, “PfizerforAll,” targets common illnesses like migraine, COVID-19 or flu, and those seeking adult vaccinations. PfizerforAll also offers potential savings on Pfizer medicines. Within each program, patients are able to access resources related to the respective manufacturer’s product(s), and directly connect with a prescriber via telehealth to obtain a prescription for the same, where indicated.
On October 21, 2024, several senators issued letters to these manufacturers eliciting responses to several pages of questions to address their concerns that this type of “manufacturer-sponsored arrangement appears intended to steer patients toward particular medications and creates the potential for inappropriate prescribing that can increase spending for federal health care programs.” While the senators acknowledge that telehealth helps to address barriers to patient care, they express several concerns including that: (i) the benefits of telehealth may be undermined by a lack of patient-practitioner relationship and any appearance of provider conflicts of interest; (ii) the platforms appear to contain characteristics of potentially suspect arrangements set forth by the Office of Inspector General (OIG); and (iii) any financial relationship between Pfizer and the chosen telehealth prescribers may implicate the federal Anti-Kickback Statute (AKS).
In 2022, to help practitioners identify suspect arrangements, the OIG offered an illustrative list of characteristics of fraudulent telehealth models in a Special Fraud Alert. The OIG noted that the list was not exhaustive, and the presence or absence of any single factor on its own would not be dispositive in determining grounds for legal sanctions. Nevertheless, the senators’ questions seem to focus on factors identified by the OIG related to arrangements where:
- The purported patients for whom the practitioner orders or prescribes items or services were identified or recruited by a telemedicine company, telemarketing company, sales agent, recruiter, call center, health fair, and/or through internet, television, or social media advertising for free or low out-of-pocket cost items or services.
- The practitioner does not have sufficient contact with or information from the purported patient to meaningfully assess the medical necessity of the items or services ordered or prescribed.
- A telemedicine company compensates the practitioner based on the volume of items or services ordered or prescribed, which may be characterized to the practitioner as compensation based on the number of purported medical records that the practitioner reviewed.
- A telemedicine company only furnishes one product or a single class of products, potentially restricting a practitioner’s treatment options to a predetermined course of treatment.
- Practitioners are not expected to follow up with purported patients, nor are they provided with the information required to follow up with purported patients.
Based on these concerns, among others, the letters sent to each manufacturer seek clarification on the innerworkings of the PfizerforAll and LillyDirect programs as it relates to characteristics that may create substantial risk for fraud, waste and abuse. Specifically, the senators expressed that prescribers may have an incentive to order the manufacturer’s medication, whether or not it is medically necessary or clinically appropriate, if the prescriber’s payment is funded by the manufacturer. Each manufacturer letter also cites to instances of telehealth vendor executives’ expressed and implied statements that their businesses can increase the likelihood of a patient receiving a prescription for a manufacturer product. In one instance, the letter cites to a telehealth vendor co-founder claiming that they are “driving prescriptions” and “more than 90 percent of eligible patients receive a prescription for the brand of drug whose marketing they clicked on.” Such statements serve to highlight the enhanced risk of fraud and abuse in these telehealth arrangements.
How Frier Levitt Can Help
Whether you are a manufacturer, pharmacy, prescriber, marketer, or technology developer, it is imperative to be conscientious of the regulatory framework applicable to your DTC telehealth program and what dynamics in your model may trigger various federal and state laws. While DTC telehealth has grown exponentially in recent years, there are compliance concerns that manufacturers or any entity wishing to join the telehealth space must consider when participating in or launching a telemedicine business model. As demonstrated by the scrutiny initiated in the senators’ letters, it is imperative that stakeholders in these arrangements act in accordance with applicable state and federal laws, not the least of which include the AKS and its state parities.
Separately, manufacturers or entities that seek to create a DTC telehealth programs and market specific drug products must comply with applicable rules and regulations pertaining to advertising drugs. For example, advertisements cannot be false or misleading, “claims” must be made in accordance with FDA rules, and if a marketed product is a compound, the advertisement must be carefully crafted to avoid FDA scrutiny, but the marketing must also be evaluated from an intellectual property infringement perspective.
Contact Frier Levitt to discuss the implications of the financial relationships present in your telehealth model, the relevance and likelihood that your practices will create a bona fide prescriber-patient relationship sufficient to bill and/or issue a valid prescription, and the permissibility of your marketing materials.
