In October, four US Senators sent requests for more information to two of the largest pharmaceutical companies operating in the United States, Eli Lilly and Pfizer. The letters concerned both companies’ recent actions in establishing telehealth direct-to-consumer (DTC) platforms. As noted in a press release by Senator Dick Durbin (D-IL), these platforms operate by providing an opportunity for consumers to “talk to a doctor now” after they have read about the company’s medications and the potential benefits. The company’s telehealth platform provides a link for patients to speak with a doctor and fill prescriptions via an online pharmacy. Senator Durbin was joined on these letters by Senators Bernie Sanders (I-VT), Peter Welch (D-VT) and Elizabeth Warren (D-MA).
The Senators note that such a relationship between the pharmaceutical company and the telehealth provider is concerning because of the potential nature of their financial relationship. If there is an arrangement where the provider receives an incentive, or pressure, to prescribe Pfizer or Eli Lilly produced medications through their respective platforms and the patients are covered by Medicare or Medicaid, federal laws, such as the Anti-Kickback Statute, could be violated. The Anti-Kickback Statute (AKS) prohibits inducements or rewards to generate business when that service is being paid by a federal health care program. While exceptions to AKS, known as ‘safe harbors’, exist, they are very specific and arrangements must meet requirements in order to qualify.
The letter goes on to note that such platforms may make it easier to commit fraud. The release references the US Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) 2022 Special Fraud Alert: OIG Practitioners to Exercise Caution When Entering Into Arrangements With Purported Telemedicine Companies. In that document, the OIG noted that a common practice is for the telehealth company to potentially arrange with practitioners to order or prescribe medically unnecessary items or services for individuals who have been recruited by the company. In return, the practitioners are paid for ordering or prescribing these items though they may have limited, if any, interaction with the patients and without regard to medical necessity. See more information on the fraud alert in CCHP’s OIG newsletter (dated July 26, 2022). In their letter to Pfizer, the Senators flagged aspects of the pharmaceutical company’s platform that appeared to have features OIG raised concerns about:
“The nature of the PfizerForAll platform appears to reflect many aspects of the HHS OIG warning for potential fraud. Unsurprisingly, a patient coming straight from Pfizer’s website to a telehealth appointment with a prescriber chosen by Pfizer is overwhelmingly more likely to ask for Pfizer’s medication. Further, that prescriber may have an incentive to prescribe such medication, whether or not it is medically necessary or clinically appropriate. Payments by Pfizer hold the potential to induce specific actions of the prescribing pen.”
The issue of fraud and telehealth has been a long-standing concern for the federal government and the financial impacts on federal programs such as Medicare. Earlier this year, the US Department of Justice (DOJ) issued an indictment against the founder and CEO of Done Global, Inc. In that case, the company issued a high number of prescriptions for Adderall via telehealth. Among the allegations against Done made by the DOJ was that the company’s telehealth platform was structured to push medications, limited information that was available to prescribers, restricted time for initial encounters, and instructed providers to prescribe stimulants whether or not the patients were qualified for such a prescription. To read more about the case, you can access CCHP’s June 25, 2024 newsletter, which contains more details.
While the Done case was not specifically referenced in the letters, the similarities of the features in the platform raised concerns among the Senators. In the letters, written responses to a series of questions are requested from both companies by November 25, 2024. Similar questions were included in the Pfizer letter, though the Eli Lilly ones are noted below. Note: the companies Form Health, 9amHealth and Cove-affiliated are the telehealth provider companies contracting with Eli Lilly. Some of the questions in the letter include:
- Does Eli Lilly direct, encourage, or educate Form Health, 9amHealth, or Cove-affiliated health care providers to prescribe Eli Lilly’s medications?
- What is the average duration of the virtual health care visit between a Form Health, 9amHealth, or Cove-affiliated health care provider and a patient who is connected to them via Eli Lilly’s website?
- After initially filling out information, are such visits always conducted via a video platform, or are there other options available?
- Do Form Health, 9amHealth, or Cove-affiliated health care providers always review the medical history and records of a patient who is connected to them via Eli Lilly’s website? If so, please describe in detail how those records are accessed.
- How does Eli Lilly set the compensation paid to its telehealth partners? Please provide a copy of the terms of agreement between Eli Lilly and Form Health, between Eli Lilly and 9amHealth, and between Eli Lilly and Cove.
- Is Eli Lilly paying fair market value for the services of Form Health, 9amHealth, or Cove?
- Does Eli Lilly make a bonus payment to Form Health, 9amHealth, or Cove based on the number of prescriptions written, including refills?
- Does Eli Lilly contract with Form Health, 9amHealth, or Cove to furnish a certain number of prescriptions for certain medications?
- Would the Form Health, 9amHealth, or Cove-affiliated health care provider have actual or constructive knowledge that a patient was referred to them via Eli Lilly’s telehealth platform?
- What metrics does Eli Lilly use to evaluate the performance of its contracts with Form Health, 9amHealth, or Cove and affiliated health care providers?
Copies of the letters are available: Eli Lilly letter and Pfizer letter. Additionally, similar issues that often arise specific to DTC telehealth platforms, rather than traditional telehealth, are discussed in CCHP’s newsletter on Differences Between Teletherapy and Platform Therapy (dated June 4, 2024).
The request for information comes at an interesting time as there is not only the ongoing fraud case with Done mentioned earlier, but also concerns around extending the COVID-19 flexibilities on prescribing of controlled substances via telehealth beyond the current ending date of December 31, 2024. As was noted in a previous CCHP newsletter, the Drug Enforcement Administration (DEA) has sent in a proposal for approval to extend the waiver. At the time this newsletter is being written, no further details have been made public, so we do not know how long the extension request is nor if there are any other conditions attached.
To read the full press release from Senator Durbin, it can be accessed on his website. The entire letters to Eli Lilly and Pfizer are also available online. |
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CCHP knows that telehealth policy can be a complicated subject and from time to time questions about policies related to your specific situation may arise. You’re in luck…We’re here for you! Just submit your question via our easy to use contact us form, or send an email to info@cchpca.org
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